Preparing ports of a medical treatment device for a forthcoming treatment session

The medical treatment device automates port preparation using compressed air, vacuum, and pressure sources to ensure sterile connections and reduce fluid leakage, addressing hygiene and safety challenges in medical device setup.

WO2026082673A1PCT designated stage Publication Date: 2026-04-23FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
Filing Date
2025-10-14
Publication Date
2026-04-23

AI Technical Summary

Technical Problem

Existing medical devices face challenges in efficiently preparing ports for treatment sessions, particularly in ensuring hygiene and preventing fluid leakage and contamination during setup, which can compromise patient safety.

Method used

A medical treatment device with integrated ports and a control and/or regulating device that automates the preparation process, utilizing compressed air, vacuum, and pressure sources to clear, fill, and maintain ports under controlled conditions, ensuring sterile connections and reducing fluid escape.

Benefits of technology

The solution ensures a germ-free environment at fluid connections, reduces air carryover, and saves setup time by automating port preparation, enhancing patient safety and efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a medical treatment device (2000) comprising a compressed-air source (175), at least one substitution port (100) and a flushing port (101), each for establishing a fluidic connection between a fluid line (2002) of the treatment device (2000) and the exterior of the treatment device (2000). By specifically switching or activating the components already present in the medical treatment device (2000), such as the compressed-air source (175), valves (V22, V23, V24, V25, V26, V31, V32, V33, V42, V43) and / or pressure sources (131, 159, 169), i.e. pumps, it can advantageously be achieved that, at the end of the disinfection programme of the medical treatment device (2000) according to the invention, the flushing port (101) is emptied and the lines leading to the substitution port (100) are filled with liquid.
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Description

[0001] Fresenius Medical Care Germany GmbH Description Preparing ports of a medical device for an upcoming treatment session The present invention relates to a medical device according to claim 1 and a control and / or regulating device according to claim 15; it further relates to a digital storage medium according to claim 16, a computer program product according to claim 17 and a computer program according to claim 18 or according to the respective preambles or generic terms of these claims. The present invention further relates to the method disclosed herein. Medical devices regularly have one or more ports. Fluid lines not belonging to the device or associated with the exterior of the device are connected to these ports in order to drain fluids from or into the interior of the medical device.If the lines connected to these ports are disposable or single-use, they are also referred to as disposables. An object of the present invention is to provide a medical treatment device with at least two such ports, namely a substitution port and a flushing port, as well as a control and / or regulating device. Furthermore, a digital storage medium, a computer program product, and a computer program are to be provided. Fresenius Medical Care Deutschland GmbH. The object of the invention can be achieved by a medical treatment device with the features of claim 1 and by a control and / or regulating device with the features of claim 15. It can also be achieved by a digital storage medium with the features of claim 16, a computer program product with the features of claim 17, and a computer program with the features of claim 18.The present invention relates to a medical treatment device (hereinafter also referred to as "treatment device") comprising a compressed air source, at least one substitute port, and a rinsing port. The compressed air source serves to introduce air or sterile air through or along a fluid line of the treatment device located inside the device. The at least one substitute port serves to establish a fluid connection between at least the fluid line and a connector of a fluid line of a disposable device, in particular a blood tubing set or a blood cassette, located on the outside of the treatment device. The rinsing port, also known as a rinse port or drain port, serves to establish a further fluid connection between the fluid line of the treatment device and the outside of the treatment device.The compressed air source is arranged to introduce air or sterile air downstream into both ports along and / or via the fluid line of the treatment device. The substitute port is preferably located downstream of the compressed air source, and the rinsing port is preferably located downstream of the substitute port. The treatment device further comprises a vacuum source, or first vacuum source, preferably located downstream of both ports, for applying a vacuum in the fluid line of the treatment device or in sections thereof. The treatment device further comprises a first pressure source, which is located downstream of the rinsing port in the fluid line or in fluid communication with the fluid line of the treatment device, or is switched to act downstream (e.g., in suitable valve positions).Such fluid communication can be established using existing elements of the treatment device. The fact that this might require opening valves, for example, does not impair its suitability. The treatment device also features a second pressure source, which is located upstream of the rinsing port and / or the substitution port, or is configured to act upstream (e.g., with suitable valve positions), and serves to fill the substitution port with fluid from a fluid source. The fluid source can be implemented using a secondary air separator of the medical treatment device. Furthermore, the medical treatment device features a multitude of valves, each arranged to temporarily interrupt fluid flow along the Fresenius Medical Care Deutschland GmbH fluid line.A first valve is arranged between the pressure source and the substitute port, a second valve between the substitute port and the rinsing port, and optionally a third valve between the rinsing port and the first pressure source. The treatment device further comprises a control device programmed to execute a procedure for preparing the two ports for subsequent or pending treatment of a patient using the treatment device. This procedure comprises the following steps: a) Causing the compressed air source to create overpressure in the fluid line and / or inside the ports using air or another gas, displacing any fluid optionally present in the rinsing port. b) Causing the first pressure source to create a vacuum in both ports. This is done along the fluid line or sections thereof.c) Optionally, causing the first pressure source and / or the second pressure source to reduce the negative pressure in the rinsing port. d) Causing the second pressure source to fill the substitution port with liquid from a liquid source. The present invention further relates to a control and / or regulating device which is programmed to cause the Fresenius Medical Care Deutschland GmbH to execute the process steps of the process described herein in conjunction with a medical device, in particular a medical device according to the invention. The present invention further relates to a digital, in particular non-volatile, storage medium, in particular in the form of a machine-readable carrier, in particular in the form of a floppy disk, memory card, CD, DVD, EPROM, FRAM (ferroelectric RAM) or SSD (solid-state drive), in particular with electronically or optically readable control signals.It can interact with a programmable computer system in such a way that a medical treatment device, e.g., a conventional medical treatment device, a non-inventive medical treatment device, or a prior art medical treatment device, is programmed or reprogrammed to become a medical treatment device according to the invention, and / or that a control and / or regulating device, e.g., a conventional control and / or regulating device, a non-inventive control and / or regulating device, or a prior art control and / or regulating device, is programmed or reprogrammed to become a control and / or regulating device according to the invention.The present invention further relates to a computer program product comprising a volatile, transient, or machine-readable program code or a signal wave by means of which a medical treatment device, e.g., a conventional medical treatment device, a non-inventive medical treatment device, or a prior art medical treatment device, is programmed or reprogrammed to become a medical treatment device according to the invention, and / or a control and / or regulating device, e.g.,A conventional control and / or regulating device, a non-inventive control and / or regulating device, or a prior art control and / or regulating device is programmed or reprogrammed to become an inventive control and / or regulating device when the computer program product runs on a computer. According to the invention, a computer program product can be understood, for example, as a computer program stored on a medium, an embedded system as a comprehensive system with a computer program (e.g., an electronic device with a computer program), a network of computer-implemented computer programs (e.g., a client / server system, a cloud computing system, etc.), or a computer on which a computer program is loaded, runs, is stored, is executed, or is being developed.The term "machine-readable carrier," as used herein, in certain embodiments of the present invention, refers to a carrier containing data or information interpretable by software and / or hardware. The carrier can be a data storage medium, such as a floppy disk, CD, DVD, USB stick, flash card, SD card, and the like, as well as any other storage medium or memory device mentioned herein. Fresenius Medical Care Deutschland GmbH. A computer program according to the invention comprises program code by means of which a medical treatment device, e.g.,A conventional medical treatment device, a non-inventive medical treatment device, or a prior art medical treatment device is programmed or reprogrammed to become a medical treatment device according to the invention, and / or a control and / or regulating device, e.g., a conventional control and / or regulating device, a non-inventive control and / or regulating device, or a prior art control and / or regulating device, is programmed or reprogrammed to become a control and / or regulating device according to the invention when the computer program runs on a computer. The method disclosed herein comprises carrying out the steps disclosed herein, e.g., steps a) to d), using a treatment device, in particular as disclosed herein.The medical device treatment device discussed herein is the subject of the present invention and is therefore in accordance with the invention. The control and / or regulating device discussed herein is the subject of the present invention and is therefore in accordance with the invention. The digital storage medium discussed herein is the subject of the present invention and is therefore in accordance with the invention. The computer program product discussed herein is the subject of the present invention and is therefore in accordance with the invention. The computer program discussed herein is the subject of the present invention and is therefore in accordance with the invention. The Fresenius Medical Care Deutschland GmbH method discussed herein is the subject of the present invention and is therefore in accordance with the invention. Embodiments of the invention may, e.g., based on any one of the independent claims, have and / or consist of one or more of the features mentioned above and / or below.The features mentioned herein may, in any combination, be the subject of embodiments according to the invention, based on any of the independent claims or any part thereof, provided that a person skilled in the art does not recognize a specific combination as technically impossible. In all the above and subsequent explanations, the use of the expressions "may be" or "may have," etc., is to be understood synonymously with "is preferably" or "preferably has," etc., and is intended to explain embodiments according to the invention. Whenever numerical terms are mentioned herein, a person skilled in the art understands them as indicating a lower numerical limit. Therefore, unless this leads to a contradiction apparent to a person skilled in the art, a person skilled in the art will always interpret the use of "a" or "a" as meaning "at least a" or "at least one."This understanding is encompassed by the present invention, as is the interpretation that a numerical word such as "one" can alternatively be meant as "exactly one," wherever this is technically feasible to a person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein. Fresenius Medical Care Deutschland GmbH. Whenever spatial references such as "above," "below," "left," or "right" are mentioned herein, a person skilled in the art understands this to mean the arrangement in the figures attached herein and / or in the state of use. "Below" is closer to the Earth's center or the lower edge of the figure than "above." Advantageous further developments of the present invention are the subject of dependent claims and embodiments.Whenever an embodiment is mentioned herein, it refers to an exemplary embodiment according to the invention, based on one of the independent claims, and is not to be understood as limiting. If it is disclosed herein that the subject matter according to the invention has one or more features in a particular embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other embodiments, which are also according to the invention, e.g., in the sense of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, formulated, for example, as a negation, is therefore also disclosed. Embodiments as disclosed herein further develop the invention as defined by the independent claims.Where process steps are mentioned herein, the device according to the invention is configured in some embodiments by Fresenius Medical Care Deutschland GmbH to execute one, several, or all of these process steps, particularly if they are automatically executable steps, in any combination, or to control corresponding devices, which preferably bear a name derived from the designation of the respective process step (e.g., "Determine" as a process step and "Device for Determining" for the device, etc.) and which may also be part of the device(s) according to the invention or be connected to it by signal communication. The process steps can take place in any embodiment of the device according to the invention, or within the process described herein, in the sequence described herein.Thus, a step designated as process step a) can always take place before a process step designated b), and so on. Any or all of the process steps can directly follow the step preceding it by its designation and / or precede the step following it by its designation (e.g., b) before c) and / or after a)), or intermediate steps not mentioned herein (e.g., b), x), c)) can lie between the steps mentioned herein. When the terms "programmed" or "configured" are used herein, these terms may be interchangeable in some embodiments. The control and / or regulating device can be in signal or communication connection with any of the components mentioned herein, e.g., valve, pump, etc. Fresenius Medical Care Deutschland GmbH. When a signal or communication connection between two components is mentioned herein, this may refer to a connection already in use.This can also be understood to mean that preparation for such a signal connection (wired, wireless, or implemented in any other way) exists, for example, by coupling both components, such as through pairing, etc. Pairing is a process that takes place in connection with computer networks to establish an initial connection between computer units for the purpose of communication. The best-known example of this is establishing a Bluetooth connection, by means of which various devices (e.g., smartphone, headphones) are connected to each other. Pairing is sometimes also referred to as bonding. If procedural steps are mentioned herein, in some embodiments it is provided that these take place before or after treatment of the patient, for example, while the patient is not, e.g.,The device is connected to the patient via an extracorporeal blood circulation or the like, or whether treatment has not yet started or has already ended. The control and / or regulating device can initiate the execution of all or substantially all process steps. The method according to the invention can be substantially or completely executed by the control and / or regulating device. It can be partially executed by the control and / or regulating device; in particular, those steps that do not require or involve human intervention and / or provision can be executed by the control and / or regulating device. In some embodiments, the control and / or regulating device is located in or on the treatment device, for example, together with other components or devices of the treatment device in a common housing of the treatment device.In some embodiments, the first and second pressure sources can be identical. In some embodiments, the vacuum source can be one of the pressure sources, for example, one of the pumps, e.g., running in reverse. In some embodiments, the first valve is open in step a) of the method. In some embodiments, pressurized air can be present in the fluid line in step a) or as a result of step a). In some embodiments, the medical device can have a fluid source, a connection for one, or be connected to one. In some embodiments, the first valve is closed in step b) or as a result of step b). Fresenius Medical Care Deutschland GmbH. In some embodiments, a vacuum is present in both ports and downstream of the first valve in step b) or as a result of step b).In some embodiments, in step b), the line collapses completely or partially downstream of the first valve due to the negative pressure, optionally at least between the ports or between the purge port and the first valve, and / or its volume is thereby reduced. In some embodiments, the first valve remains closed in step c), particularly to maintain or preserve the pressure or negative pressure prevailing between the first and second valves. In some embodiments, the closed state of the first valve can be tested, for example, before the start of step a), perhaps by means of a dedicated test routine. In some embodiments, the third valve is or remains closed in step c). In some embodiments, the liquid is drawn from a balancing chamber of the device in step d). In some embodiments, the first and second valves are closed in step d).In some embodiments, in step d), fluid, which is preferably introduced into the substitute port along a further line, flows through the substitute port into the fluid line via fluid paths provided for this purpose inside the substitute port. Thus, a fluid connection exists between the second pressure source and the fluid line, although they do not necessarily have to be directly connected. The control device can be programmed to open such a fluid path in step d) by acting on components such as valves, etc. In some embodiments, the method performed by the treatment device for preparing the ports further comprises step e) causing the second pressure source to pressurize or place under pressure sections downstream of the substitute port, and, for example, downstream of the irrigation port, particularly by means of fluid.For this purpose, fluid can be conveyed upstream from a fluid source towards the rinsing port. A desired pressure within the components involved can be set or maintained by means of a balancing device, which may be included in the medical device. The third valve may be closed in step e). In some embodiments, a desired pressure can be set or maintained in step e) by means of the balancing device. In some embodiments, the port preparation method performed by the device further includes the step: f) Building up overpressure in the rinsing port.In some embodiments, step f) only occurs once a desired pressure has been achieved in step e), which can be determined by means of a pressure gauge, optionally also included in the medical device. In some embodiments, the third valve is or is opened in step f). In some embodiments, the process steps described herein run automatically or (semi-)automatically as a routine, i.e., as program points or sections that only need to be started by a user. They can run in the sequence described herein. Intermediate steps not mentioned herein are provided in some embodiments and not in others. When "automated" or "automatic" steps are mentioned herein, this preferably includes the use of a correspondingly programmed control device, or, for example, aA largely unmanned system can execute these steps automatically, i.e., without human intervention, without human input, and / or without a specific contribution to the execution of the process by a human. The initiation and thus ultimately the execution of these steps occurs through self-control and / or self-regulation of the control device or system, or is initiated by it, i.e., without operator influence that would or could affect the process or its outcome. An automatically initiated step can therefore be one that is triggered or initiated by the control device of Fresenius Medical Care Deutschland GmbH, particularly because it is recognized (e.g., based on sensor signals, upon reaching a program section, upon reaching a predetermined time, because a previous step has been completed, etc.).) that the said step is now pending and its execution is therefore initiated or triggered by the control device. In some embodiments, the treatment device is configured as a blood treatment device, in particular as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, most especially as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CRRT). In some embodiments, the method does not serve to make a statement about a verified function of a functional device, such as a blood cassette or an extracorporeal blood circuit, and / or does not serve to verify its function and / or does not include a corresponding step.Some or all embodiments of the invention may have one, several, or all of the advantages mentioned above and / or below. The present invention provides a treatment device comprising fluidic interfaces in the form of multiple ports, which can advantageously meet the highest hygiene standards required for medical technology or medical treatment procedures. An advantage of the present invention may be that, by clearing the flushing port of fluid during setup for subsequent treatment, no fluid can escape from the flushing port when opening the flushing port or inserting the flushing plug.A further advantage of the present invention is that, at the end of the disinfection program of the medical treatment device according to the invention, the flushing port is emptied and the lines leading to the substitution port are filled with fluid. This allows a healthcare worker to simultaneously connect the flushing port and the mounting of a blood cassette before a patient's treatment, which can save time when setting up the medical treatment device. This means that the fluid communication methods described herein can be implemented using elements already present in the medical treatment device. The fact that, for example, valves would have to be opened or closed for this purpose does not detract from the suitability of the existing elements. This can represent a further advantage of the present invention.By generating a negative pressure leading to the collapse or partial collapse of lines or line sections as described herein, even lines arranged as dead ends or made so by appropriate valve circuits (Fresenius Medical Care Deutschland GmbH) or line sections can subsequently be largely filled with fluid. According to the invention, it is thus possible to largely fill the substitute port of the treatment device with fluid and to prepare the adjacent rinsing port, emptied of fluid and under slight overpressure, for the next treatment session. The present invention advantageously ensures a virtually germ-free environment at the connections between the disposable and the treatment device. This can help prevent germs from entering the patient's bloodstream and thus increase patient safety.This is a consequence of the optional provision of the flushing port under positive pressure for its next connection. A further advantage of the present invention can be that the substitute port is left filled with liquid, so that, upon its next connection with a disposable, the carryover of air from the substitute port into the disposable is advantageously reduced or prevented by the present invention. The present invention is described below with reference to the accompanying drawing. In the figures, identical reference numerals denote the same or similar elements. The following applies: Fig. 1 shows a schematically simplified process diagram of an embodiment of the hydraulic side, or parts thereof, of a medical treatment device according to the invention of Fresenius Medical Care Deutschland GmbH; Fig.Figure 2 schematically simplifies the components involved in step a) of the procedure, such as pipes, valves, pumps, etc., of the medical treatment device of F. ig. 1; Fig. 3 shows, in a simplified schematic representation, the components of the medical treatment device of F that are involved as examples in step b) of the procedure. ig. 1; Fig. 4 shows, in a simplified schematic representation, the components of the medical treatment device of F that are involved as examples in step c) of the procedure. ig. 1; Fig. 5 shows, in a simplified schematic representation, the components of the medical treatment device of F that are involved as examples in step d) of the procedure. ig. 1; Fig. 6 shows, in a simplified schematic representation, the components of the medical treatment device of F that are involved as examples in step e) of the procedure. ig. 1; undFig. 7 shows, in a simplified schematic representation, the components of the medical treatment device of F that are involved as examples in step f) of the procedure. ig. 1.Fresenius Medical Care Deutschland GmbH. Fig. 1 shows a simplified schematic diagram of an embodiment of the hydraulic side of a medical treatment device 2000 according to the invention, here a blood treatment device, which could be connected to an extracorporeal blood circuit for the treatment of a patient by means of a blood filter or dialyzer. The blood filter, extracorporeal blood circuit and patient are not shown in Fig. 1, but a connection or connector 303a for connecting a dialyze fluid inlet line 104 to the inlet side and a connection or connector 303b for connecting a dialysate outlet line 102 to the outlet side of the blood filter are.A compressed air source 175, for example a compressor, for introducing air or sterile air along a fluid line 2002 associated with and / or running within the interior of a treatment device 2000 is clearly visible and is in fluid communication with at least one substitute port 100, optionally via a filter F42, and a first valve V42. Alternative compressed air sources may be provided for the purpose described herein. During the treatment of a patient, the substitute port 100 serves to establish a fluid connection between at least the fluid line 2002 and a connector of a fluid line associated with the exterior of the treatment device 2000 of a disposable, in particular a Fresenius Medical Care Deutschland GmbH blood tubing set or a blood cassette (not shown in Fig. 1).Furthermore, a rinse port 101, also known as a rinse port or drain port, is provided for establishing an additional fluid connection between the fluid line 2002 of the treatment device 2000 and the exterior of the treatment device 2000. The compressed air source 175, arranged for introducing air or sterile air downstream into both ports 100 and 101 along and / or by means of the fluid line 2002, is shown here by way of example arranged upstream of the substitute port 100, and the rinse port 101 is shown by way of example arranged downstream of the substitute port 100. Compressed air from the compressed air source 175 can thus flow along the fluid line 2002 into both the substitute port 100 and the rinse port 101, provided a suitable valve control is in place.According to the invention, it is irrelevant whether the line 2002 runs through the respective port 100, 101, or whether the respective port 100, 101 is located on the fluid line 2002, for example, connected to it by a branch line or the like, as is exemplified in Fig. 1. There, the fluid line 2002 passes through the flushing port 101, while the substitute port 100 is located on it and connected to it by a short connecting line. Downstream of the two ports 100, 101, in the fluid line 2002 or in fluid communication with the fluid line 2002, a first pressure source 169 is arranged, for example, designed as a flow pump (e.g., Fresenius Medical Care Deutschland GmbH). The term "pressure source" used herein also includes the possibility that it may be a vacuum source. Using the first pressure source 169, for example, a negative pressure can be created in the fluid line 2002 or in sections thereof.A second pressure source 159, also designed here as a flow pump, is arranged upstream of the flushing port 101 and / or the substitute port 100. It can be used to fill the substitute port 100 with liquid, e.g., from a liquid source 155. The second pressure source 159 can be suitable for degassing parts of the fluid line 2002. Additionally or alternatively, fluid can be supplied from a liquid source 190. This can be a secondary air separator of the medical treatment device 2000. A plurality of valves V22, V23, V24, V25, V26, V31, V32, V33, V42, V43 are arranged to prevent fluid flow, among other things, along the fluid line 2002. Herein a valve V42, hereinafter also referred to as the first valve, is arranged between the pressure source 175 and the substitute port 100 and a valve V32, hereinafter also referred to as the second valve, is arranged between the substitute port 100 and the flushing port 101.Optionally, a valve V33, also referred to herein as the third valve, is arranged between the rinsing port 101 and the first pressure source 169. A control and / or regulating device 150 can be connected to any of the components of the medical treatment device 2000 mentioned herein via a wired or wireless signal connection for controlling or regulating the Fresenius Medical Care Deutschland GmbH medical treatment device 2000. In particular, it can be configured to execute a method for preparing ports 100, 101 for subsequent or pending treatment of a patient using the medical treatment device 2000. The control and / or regulating device 150 can be encompassed by the medical treatment device 2000. (Left in Fig.)Figure 1 shows an optional mixing device 161, which provides a predetermined mixture for the respective solution from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168) for use by the treatment device 2000. The solution preferably contains water (online, e.g., as reverse osmosis water or from bags) from the liquid or water source 155, which can be supplied to the system, for example, by means of a second pressure source 159, heated, e.g., by means of an optional heat exchanger 157. An optional pump 171, which can be referred to as a concentrate pump or sodium pump, is fluidically connected to and / or pumps from the optional mixing device 161 and preferably a source of sodium, such as container A. An optional pump 173, which is assigned to container B, for example for bicarbonate, can be identified. Further details are shown in Fig.Figure 1 shows an optional drain or discharge line 153, which preferably terminates in a drain (not shown in Figure 1) into which liquids, e.g., rinsing fluid or effluent generated during the treatment of a patient by Fresenius Medical Care Deutschland GmbH, can be disposed of. Several pressure sensors S03 and S07 can be provided in the arrangement shown. Pressure sensor S03, which is located upstream of the blood filter in the dialysis fluid inlet line 104 during patient treatment, and pressure sensor S07, which is located downstream of the blood filter in the dialysate outlet line 102 during patient treatment, can be used to measure the filtrate pressure or membrane pressure of the blood filter. Further optional pressure measuring points can also be provided.The optional online mixing device for the dialysis fluid allows for variation of its sodium content within certain limits, controlled by the control and / or regulating device 150. For this purpose, the measured values ​​transmitted by the optional conductivity sensors 163a, 163 can be taken into account. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or the substitute be necessary or desired, this can be achieved by adjusting the flow rate of the optional sodium pump 171. Furthermore, the treatment device 2000 includes means for conveying fresh dialysis fluid and dialysate. For example, a valve V24 can be provided between the first flow pump 159 and the connector 303a for the blood filter, which would open or close the inlet to the blood filter during patient treatment. The second flow pump 169 is, for example,Downstream of connector 303b for the blood filter, Fresenius Medical Care Deutschland GmbH, is provided, which would pump dialysate to the drain or outflow line 153 during patient treatment. A further valve V25 can be provided between connector 303b for the blood filter and the second flow pump 169, which would open or close the outflow of the blood filter during patient treatment. Furthermore, the treatment device 2000 optionally includes a device 162 for monitoring the flows in and out of the dialyzer 303 on the machine side. The monitoring device 162 is preferably arranged in a line section between the second pressure source 159 and the first pressure source 169.The treatment device 2000 further comprises means for the precise removal of a fluid volume specified by the user and / or by the control and / or regulating device 150 from the balanced circuit, such as the ultrafiltration pump 131. Sensors such as the optional conductivity sensors 163a, 163b may be provided and serve to determine the conductivity, which in some embodiments is temperature-compensated, as well as the fluid flow upstream and downstream of the dialyzer 303. Temperature sensors 165a, 165b may be provided individually or in groups. Temperature values ​​supplied by them can be used to determine a temperature-compensated conductivity. Fresenius Medical Care Deutschland GmbH. Additional flow pumps, supplementing or as an alternative to, for example, those with reference numerals 159, 169, 131, may be provided.Based on the measured values ​​of the aforementioned optional sensors, the control and / or regulating device 150 determines the electrolyte and / or fluid balance in some embodiments. Optional filters F04 and F05 can be connected in series. Filter F04 serves here as an example to generate sufficiently pure dialysis fluid, even using non-sterile water, by means of the mixing device 161. This fluid could then flow through the blood filter 303 during patient treatment, e.g., using the countercurrent principle. Filter F05 serves here as an example to generate sterile or sufficiently filtered substitute from the sufficiently pure dialysis fluid leaving the first filter F04 by filtering out, for example, pyrogenic substances. This substitute could then be safely supplied to the patient's extracorporeal blood flow and thus ultimately to the patient's body.A fluid source 190 downstream of the flushing port 101 can serve as a reservoir or equalization tank. It can be arranged such that it can be permeated by fluid and / or can store fluid. It can have an indirect and / or a direct connection to a drain for fluids. It can be arranged in fluid communication with the fluid line 2002. The treatment device 2000 is shown in Fig. 1 optionally as a device for hemo(dia)filtration. However, hemodialysis devices also fall within the scope of the present invention, although not specifically illustrated in the figure. The present invention is not limited to the embodiment described above; this serves only for illustration. The arrowheads shown in the figures generally indicate the usual or momentary flow direction of a fluid.Figure 2 schematically and simplified shows the components involved in step a) of the process, such as lines, valves, pumps, etc., of the treatment device 2000 of Fig. 1 in one embodiment. In step a), the compressed air source 175, in particular by means of the control and / or regulating device 150, is caused to build up overpressure in the fluid line 2002 and / or inside the ports 100, 101 by means of air or another gas, which optionally displaces any liquid present in the flushing port 101 from the flushing port 101 towards the drain or discharge line 153. The displaced liquid can be at least partially stored in the liquid source 190 or discarded. Fresenius Medical Care Deutschland GmbH. This ensures that the flushing port 101 is, preferably completely, cleared of fluid. In step a), the optional valve V23 is preferably closed, while the valves V42, V32, V33 along the fluid line 2002 are open.Optionally, pressure can already be built up before the first valve V42 opens. This advantageously ensures that no fluid from the piping system enters the section of the line between the first valve V42 and the compressed air source 175, as this area usually cannot be sterilized. Lines filled with air are shown as dashed lines in Fig. 2 and in the following figures. In some embodiments, the closed state of the first valve V42 can be tested, for example, before the start of step a), perhaps using a dedicated test routine. Fig. 3 schematically shows, in simplified form, the components of the medical device 2000 of Fig. 1 involved in step b) of the process, or the flow path in one embodiment. In step b), a vacuum is created, for example, by means of the first pressure source 169, in both ports 100, 101 and along the fluid line 2002, or sections thereof.For this purpose, valve V26 (if present) and the first valve V42 must be closed or become closed. In some embodiments, the fluid line 2002 collapses in step b) due to the generated negative pressure downstream of the first valve V42, optionally at least between ports 100, 101 or between the flushing port 101 and the first valve V42, at least partially and / or its volume is thereby reduced. When the negative pressure is built up by means of the first pressure source 169, as indicated in Fig. 3, the second valve V32 and the third valve V33 are open. Figure 4 schematically simplifies the components of the medical treatment device 2000 of Fig. 1 involved in the optional step c) of the procedure, or the flow path in one embodiment. In the preceding steps, a negative pressure was built up in the rinsing port 101, which is then to be released.In step c), the first pressure source 169 (shown in Fig. 3) and / or the second pressure source 159 are optionally caused, for example by means of the control device 150, to reduce the negative pressure in the flushing port 101. Venting of the flushing port 101 via the drain or discharge line 153 should be avoided to prevent contaminated fluid from being drawn into the system. In some embodiments, the third valve V33 is or remains closed in step c). In some embodiments, the first valve V42 remains closed in step c) to maintain the pressure prevailing between the first valve V42 and the second valve V32. In step c) of Fig. 4, the connection between the structures designated with reference numerals 157 and 190 is shown, bypassing the ultrafiltration pump 131, which is also optionally positioned at the location shown in Fig. 1 (if present).It is evident that the ultrafiltration pump 131 can be present at the position shown in Fig. 1, but this is not mandatory. Furthermore, it is possible that it can be bypassed, for example, by means of a bypass, valve arrangement, or the like, if required, optionally for the purpose of step c). In step c), liquid is gradually introduced between the structures designated by reference numerals 190 and V33. This is indicated partly by a dashed line and partly by a solid line. Fig. 5 schematically shows, in simplified form, the components of the medical device 2000 of Fig. 1 involved in step d) of the process, or the flow path in one embodiment. In step d), the second pressure source 159 is caused, for example, by means of the control device 150, to fill the substitute port 100 with liquid from the liquid source 190 or another source.In some embodiments, the liquid can be withdrawn from the balancing chamber 162 of the medical treatment device 2000 in step d). In some embodiments, the first valve V42 and the second valve V32 are closed in step d). This results in an air-filled volume 180 remaining upstream of the closed valves V32 and V42, while the rest of the line is filled with liquid. In some embodiments, liquid is introduced into the substitute port 100 in step d), preferably along a further line, the liquid preferably finding its way into the fluid line 2002 through fluid paths provided in the substitute port 100. Thus, a fluid connection exists between the second pressure source 159 and the fluid line 2002, although they do not have to be directly connected to each other. Fig.Figure 6 schematically simplifies the components of the medical device 2000 of Fig. 1 involved in step e) of the procedure, or the flow path in one embodiment. In step e), the second pressure source 159 or another pressure source, for example by means of the control and / or regulating device 150, is caused to pressurize sections downstream of the substitute port 100, and e.g. downstream of the rinsing port 101. For this purpose, fluid can be conveyed from a fluid source 190 upstream towards the rinsing port 101. Here, a desired pressure within the components involved can be set or maintained by means of the balancing device 162. The third valve V33 can be closed in step e). Figure 7 schematically simplifies the components of the medical treatment device 2000 of Fig. 1 that are involved in step f) of the procedure.the flow path in one embodiment. Fresenius Medical Care Deutschland GmbH. In step f), an overpressure is built up in the rinsing port 101. In some embodiments, the third valve V33 is or is opened for this purpose in step f). In some embodiments, the valve V26 could additionally be or be closed, e.g., to prevent the pressure from rising too high. In some embodiments, step f) only takes place once the desired pressure has been reached in step e). This can be determined, for example, using the pressure gauge S07.

[0002] Fresenius Medical Care Germany GmbH Reference List 100 Substitution Port 101 Rinse Port 102 Dialysate Drain Line 104 Dialysis Fluid Inlet Line 131 Ultrafiltration Pump 150 Control and / or Regulating Device 153 Drain Line 155 Fluid Source; Water Source 157 Heat Exchanger 159 Second Pressure Source; Flow Pump 161 Mixing Device 162 Balancing Device 163a Conductivity Sensor 163b Conductivity Sensor 165a Temperature Sensor 165b Temperature Sensor 166 Concentrate Supply 168 Concentrate Supply 169 First Pressure Source; Flow Pump 171 Pump, Sodium Pump 173 Pump, Bicarbonate Pump 175 Compressed Air Source; Compressor 180 Air-Filled Volume 190 Fluid Source 303a Blood Filter Connector, Inlet Side 303b Blood Filter Connector, Outlet Side 2000 Medical Treatment Device 2002 Fluid Line Fresenius Medical Care Germany GmbH F04 FilterF05 Filter F06 Filter F42 Filter A Container B Container P Pressure measuring points S03 Pressure sensor (optional) S07 Pressure sensor (optional) V Ventile V22 Valve V23 Valve V24 Valve V25 Valve V26 Valve V31 Valve V32 (second) Valve V33 (third) Valve V42 (first) Valve V43 Valve

Claims

Fresenius Medical Care Deutschland GmbH Claims 1. Medical treatment device (2000), comprising: - a compressed air source (175) for introducing air or sterile air along a fluid line (2002) of the treatment device (2000) associated with the interior; - at least one substitute port (100) for establishing a fluid connection between at least the fluid line (2002) and a connector of a fluid line of a disposable, in particular blood tubing set or blood cassette, associated with the exterior of the treatment device (2000); - a flushing port (101) for establishing a further fluid connection between the fluid line (2002) of the treatment device (2000) and the exterior of the treatment device (2000);wherein the compressed air source (175) for introducing air or sterile air downstream into both ports (100, 101) is arranged along and / or by means of the fluid line (2002), wherein the substitute port (100) is arranged downstream of the compressed air source (175) and the rinsing port (101) is arranged downstream of the substitute port (100); further comprising; Fresenius Medical Care Deutschland GmbH - a (first) vacuum source (169) located preferably downstream of the two ports (100, 101) for applying vacuum in the fluid line (2002) or sections thereof; - a first pressure source (169) located downstream of the flushing port (101) in or in fluid communication with the fluid line (2002); - a second pressure source (159) located upstream of the flushing port (101) for filling the substitute port (100) with fluid from a fluid source (190); and- a plurality of valves (V22, V23, V24, V25, V26, V31, V32, V33, V42, V43), each arranged to temporarily stop a fluid flow along the fluid line (2002), wherein- a first valve (V42) is arranged between the pressure source and the substitute port (100), - a second valve (V32) is arranged between the substitute port (100) and the purge port (101), and- optionally a third valve (V33) is arranged between the purge port (101) and the first pressure source (169);- a control and / or regulating device (150), programmed to execute a procedure for preparing the ports (100, 101) for subsequent or pending treatment of a patient using the medical device; Fresenius Medical Care Deutschland GmbH Treatment device (2000), wherein the method comprises the steps of: - a) causing the compressed air source (175) to build up an overpressure in the fluid line (2002) and / or inside the ports (100, 101) by means of air or another gas, displacing any liquid optionally present in the flushing port (101) from the flushing port (101); - b) causing the first pressure source (169) to create a negative pressure in both ports (100, 101); - c) optionally causing the first pressure source (169) and / or the second pressure source (159) to relieve the negative pressure in the flushing port (101); and - d) causing the second pressure source (159) to fill the substitute port (100) with liquid from a liquid source (190).

2. Medical device (2000) according to claim 1, wherein in step a) the first valve (V42) is open.3.Medical device (2000) according to claim 1 or 2, wherein in step b) or as a result of step b) the first valve (V42) is closed. Fresenius Medical Care Deutschland GmbH 4. Medical treatment device (2000) according to one of the preceding claims, wherein in step b) or as a result of step b) negative pressure is present in both ports (100, 101) and downstream of the first valve (V42).

5. Medical treatment device (2000) according to the preceding claim, wherein in step b) the negative pressure causes the line (2002) downstream of the first valve (V42), optionally at least between the ports or between the irrigation port (101) and the first valve (V42), to collapse or partially collapse and / or reduce its volume.

6. Medical treatment device (2000) according to one of the preceding claims, wherein in step c) the first valve (V42) remains closed.

7. Medical device (2000) according to one of the preceding claims, wherein in step c) the third valve (V33) is or remains closed.8.Medical treatment device (2000) according to one of the preceding claims, wherein in step d) the liquid is taken from a device for balancing (162) of the device (2000).

9. Medical treatment device (2000) according to one of the preceding claims, wherein in step d) the first valve (V42) and the second valve (V32) are closed. Fresenius Medical Care Deutschland GmbH 10. Medical treatment device (2000) according to one of the preceding claims, wherein in step d) fluid is introduced into the substitute port (100), preferably along a further line, wherein the fluid preferably finds its way through fluid paths provided in the substitute port (100) into the fluid line (2002).

11. Medical treatment device (2000) according to one of the preceding claims, wherein the method for preparing the ports (100, 101) further comprises the step: e) causing the second pressure source (159) to pressurize the service water side or downstream connection of the substitute port (100), e.g. by means of fluid from a fluid source (190, 155).

12. Medical device (2000) according to one of the preceding claims, wherein the method for preparing the ports (100, 101) further comprises the step: f) Building up overpressure in the flushing port (101).13.Medical device treatment device (2000) according to the preceding claim, wherein step f) only takes place when a desired pressure has been achieved in step e), which is determined by means of a pressure gauge (S07). Fresenius Medical Care Deutschland GmbH 14. Medical treatment device (2000) according to one of the two preceding claims, wherein in step f) the third valve (V33) is or becomes open.

15. Control and / or regulating device (150), which is programmed to initiate the execution of the method steps of the method described in one of claims 1 to 14 in conjunction with a medical treatment device (2000), in particular according to one of claims 1 to 14.

16. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to interact with a programmable computer system in such a way that a medical treatment device, e.g.a conventional medical treatment device, a non-inventive medical treatment device or a prior art medical treatment device, is programmed or reprogrammed to become a medical treatment device (2000) according to any one of claims 1 to 14 and / or a control and / or regulating device, e.g. a conventional control and / or regulating device, a non-inventive control and / or regulating device or a prior art control and / or regulating device, is programmed or reprogrammed to become a control and / or regulating device (150) according to claim 15. Fresenius Medical Care Deutschland GmbH 17. Computer program product, as a signal wave or with program code stored on a machine-readable carrier, configured to interact with a programmable computer system in such a way that a medical treatment device, e.g., a conventional medical treatment device, a non-inventive medical treatment device, or a prior art medical treatment device, is programmed or reprogrammed to become a medical treatment device (2000) according to any one of claims 1 to 14, and / or that a control and / or regulating device, e.g., a conventional control and / or regulating device, a non-inventive control and / or regulating device, or a prior art control and / or regulating device, is programmed or reprogrammed to become a control and / or regulating device (150) according to claim 15. 18.Computer program with program code for initiating the programming or reprogramming of a medical treatment device, e.g., a conventional medical treatment device, a non-inventive medical treatment device, or a prior art medical treatment device, to a medical treatment device (2000) according to one of claims 1 to 14 and / or for initiating the programming or reprogramming of a control and / or regulating device, e.g., a conventional control and / or regulating device, a non-inventive control and / or regulating device, or. Fresenius Medical Care Deutschland GmbH a control and / or regulating device of the prior art, to a control and / or regulating device (150) according to claim 15.

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