Dialysis Water System Connecting Device with Selective Disinfection Capability and Controllable Valves

Abstract

A connecting device is disclosed for linking a dialysis water production device to a dialysis water distribution ring line The device comprises a feed-line section with two connecting portions for attachment to the feed lines of both the production device and the distribution ring line, and a return-line section with two connecting portions for attachment to the return lines of both systems. It includes first and second short-circuit lines between the feed-line and return-line sections. The device features multiple valves, including a first valve on the feed-line section, a second valve on the return-line section, a third valve upstream on the return-line section, and valves on each short-circuit line. The device is configured to allow separate disinfection of the production device and distribution ring line through selectively controllable valves, enabling different circulation paths.

Description

[0001] 240041W001

[0002] Dialysis Water System Connecting Device with Selective Disinfection Capability and Controllable Valves

[0003] Background

[0004] The present innovation pertains to the field of medical fluid distribution systems, specifically focusing on dialysis water systems utilized in healthcare facilities such as hospitals and dialysis clinics. In these environments, dialysis water is typically distributed through centralized production devices and ring lines to various treatment rooms. Prior art systems often employ separate distribution lines for dialysis water and dialysate concentrates to maintain fluid purity and prevent contamination. However, existing connecting devices between dialysis water production units and distribution lines face challenges in ensuring separate and efficient disinfection processes. These systems require the entire distribution line to be sanitized whenever the production device is disinfected, leading to increased time and resource consumption. Additionally, known devices may allow disinfectant chemicals to spill into the distribution line, posing potential risks to patients if not also disinfected subsequently. The innovation addresses these shortcomings by providing a connecting device with switching capabilities that enable independent disinfection of the dialysis water production device without affecting the distribution line.

[0005] It is common practice to install fixed ring mains in clinics and dialysis centers for the distribution of medical liquid media such as dialysis water, dialysis concentrate or dialysate. Dialysis concentrate is a precursor substance from which dialysate suitable for dialysis treatment can ultimately be prepared by diluting it with dialysis water. These lines run into treatment rooms where treatment machines can withdraw liquid media for consumption at withdrawal points.

[0006] The use of separate distribution ring lines for dialysis water (this would then be a dialysis water distribution ring line) on the one hand and for dialysate concentrates or dialysates on the other is known. This means that there are at least two separate distribution ring lines so that the different liquid media do not share one distribution ring line. These liquid media for dialysis treatments are often provided centrally in an operating room and fed into the corresponding distribution ring lines.

[0007] High demands are placed on the purity of medical fluids. This applies to any contamination with pathogens, including biofilm growth, but also pathogens and endotoxins. Therefore, distribution systems for medical liquid media must be designed in such a way that the medical liquid media in the distribution systems retain the required purity. To ensure the required purity of the medical fluids, distribution systems are therefore often designed as distribution ring lines, as this enables continuous circulation of the medical fluids. Pathogens can multiply over time in a stagnant liquid, which also poses a risk due to 240041W001 its exponential nature. In general, distribution systems should therefore be designed in such a way that areas in which the liquids stand or which are difficult to clean or disinfect are avoided. Therefore, for example, stub lines and line sections in which the liquid comes to a standstill are avoided. Even if a distribution system as a whole is designed as a distribution ring main, there may be pipe sections in any necessary connection areas or at branches and valves that are not completely in the area of continuous circulation.

[0008] Dialysis water is usually provided by a dialysis water production device. Its final water purification stage is usually a reverse osmosis system. Upstream of the reverse osmosis system, various other filter stages are typically used, e.g. media filters, activated carbon filters and / or softeners. There is often a compact, local ring line on the outlet side of a reverse osmosis system through which the pure water produced circulates, whereby the local ring line can be part of the reverse osmosis system. This circuit is located within the system and serves to ensure that the high purity of the water is not jeopardized by standstill on the one hand and to guarantee uninterrupted operation on the other. Fluctuations in flows due to withdrawal and, if necessary, high back pressure due to defective and undesirably closing valves can be compensated for without damage using such a circuit.

[0009] Medical devices and systems must be regularly disinfected and cleaned. This applies in particular to areas that are in direct contact with patients or in which media are transported that come into direct or indirect contact with patients. Disinfection removes pathogens such as pathogens and biofilm as well as their residues such as endotoxins using physical agents such as heat (e.g. hot water disinfection) or chemical agents (e.g. chemical disinfection). Disinfection is used to remove microorganisms and it may be required by regulations to prove a germicidal effect. Cleaning can include, for example, the removal of limescale deposits (e.g. with acids) or the removal of silica deposits (e.g. with bases).

[0010] In most cases, it is necessary to chemically disinfect the membranes of reverse osmosis systems because, for example, the thermal stress during hot disinfection would be harmful to the membranes. At the same time, hot disinfection is often the preferred method of disinfection for a distribution ring line. The advantages of hot disinfection are, for example, that no residues of chemical disinfectants have to be removed from long distribution ring lines, which can be time-consuming and water-intensive, and that it is easier to automate.

[0011] In an arrangement of a reverse osmosis system and a distribution ring line, which are connected to each other with a known connection device, separate disinfection of the reverse osmosis system is not possible, for example, but some of the chemical disinfectant always gets into the distribution ring line during chemical disinfection of the reverse 240041W001 osmosis system. Therefore, after chemical disinfection of the reverse osmosis system, it is necessary to carry out an extensive rinse or even disinfection of the connected distribution ring line afterwards to ensure that no disinfectant chemicals remain in the distribution ring line.

[0012] It is therefore a task of the present innovation to provide a connection device for connecting a dialysis water production device to a dialysis water distribution ring line which enables the dialysis water production device and the dialysis water distribution ring line to be disinfected or sanitized separately from one another. Another task is a connecting device design without dead spaces in the line systems.

[0013] The task is solved by a connecting device as presented in the following.

[0014] A connecting device (RBP) for connecting a dialysis water production device (RO) to a dialysis water distribution ring line (LP), comprising: o a feed-line section (FW) connectible to the feed line of a dialysis water production device and a dialysis water distribution ring line; o a return-line section (RT) connectible to the return line of a dialysis water production device and a dialysis water distribution ring line; o first and second short-circuit lines (LK1, LK2) bridging the feed-line section (FW) and the return-line section (RT); o a first valve (V22) on the feed-line section downstream of the short-circuit lines (LK1, LK2); o a second valve (V40) on the return-line section (RT) downstream of the short-circuit lines (LK1, LK2); o a third valve (VR40) on the return-line section (RT) upstream of the short- circuit lines (LK1, LK2); o a fourth valve (VR42) on the first short-circuit line (LK1); o a fifth valve (VR25) on the second short-circuit line (LK2).

[0015] This design minimizes dead spaces, prevents chemical spillover, and allows for flexible scheduling of disinfection cycles, thereby optimizing resource use and maintaining high hygiene standards.

[0016] The connecting device facilitates connecting a dialysis water production device to a dialysis water distribution ring line. In addition, the connecting device facilitates realization of circulation schemes for dialysis water.

[0017] Valves of the connecting device create the possibility of realizing different circulation schemes in different operation modes. 240041W001

[0018] The short-circuit lines create the possibility of realizing circulation schemes spanning only part of the overall line system. That is, short circuit lines in conjunction with valves allow circulation in one portion of the overall line system well separated from the rest of the line system.

[0019] The presence of a first short-circuit line and a second short-circuit line and the valves allow a dead-space free design because different disinfection circulation schemes can overlap.

[0020] Advantages of the invention:

[0021] • Independent chemical disinfection of the dialysis water production device, e.g., an RO, without disinfecting the connected dialysis water distribution ring is an advantage.

[0022] • Independent hot disinfection of the distribution ring line without hot disinfection of the water production device.

[0023] • Sampling of the machine for proof of absence of disinfectants with sampling port.

[0024] • Overlapping areas of disinfection of chemical and thermal disinfection to exclude areas that are not disinfected.

[0025] • Device and method save resources and time, as the entire distribution ring does not have to be disinfected and rinsed after each chemical disinfection of the RO.

[0026] • The development of the device according to the invention enables independent chemical disinfection with safe rinsing of the reverse osmosis. Independently (but not simultaneously) of this, hot disinfection of the ring line can be carried out in a different time regime.

[0027] • This reduces the amount of personnel required to supervise chemical disinfection. This also reduces the consumption of resources (disinfectant, rinsing volumes)

[0028] • Overlapping areas of disinfection of chemical and thermal disinfection to exclude areas that are not disinfected.

[0029] The invention makes it possible to carry out chemical disinfection of a dialysis water production device safely and limited to the dialysis water device, i.e. separately from downstream users of the dialysis water, such as may be present in the form of dialysis water distribution rings. Another advantage is that the dialysis water production device can be rinsed safely, verifiably and reliably after chemical disinfection. The reliable and hygienic separation of a dialysis water production device and a dialysis water distribution ring line arranged downstream. 240041W001

[0030] A benefit of the connecting device according to the invention is its capability to facilitate independent chemical disinfection of the dialysis water production device without disinfecting the dialysis water distribution ring line.

[0031] The connecting device according to the invention exhibits switching capabilities and liquid lines in an arrangement suitable for realizing several different circulation schemes for dialysis water, disinfection liquid, or cleaning liquid to circulate within a part of the connecting device with a safe and hygienic separation of the rest of the connecting device. Another further benefit is the connecting device's ability to shut off not-to-disinfect or rinse sections and allow for hygienic and safe rinsing of the parts of the connecting device that were disinfected. As a further benefit, the connecting device with its capability to provide a safe and hygienic separation of a disinfectant circulation loop in part of the connecting device from the portion of the connecting device that is not part of the currently switched circulation loop allows for separate and hygienic disinfection of either a connected connecting a dialysis water production device in a first mode or disinfection of a dialysis water distribution ring line in a second mode or, in a production mode, to circulate from a dialysis water production device to a dialysis water distribution ring line and back. This benefit is achieved by the connecting device's arrangement of lines and valves.

[0032] A benefit of the connecting device according to the invention is its capability to facilitate safe chemical disinfection of a portion of the connecting device and one connected device separate from heat disinfection of a different portion of the connecting device and one other connected device. A further benefit is that this allows much more flexibility in scheduling necessary disinfections or cleanings. Typically, the frequency of disinfections required is different for different instances in a dialysis water production and distribution cascade. For example, the frequency of disinfection for a dialysis water production device may be daily whereas the disinfection frequency for disinfection of a dialysis water distribution ring line may be once per week. A downside of connecting devices in the prior art is that connected instances of the dialysis water production and distribution cascade, such as dialysis water production device and dialysis water distribution ring line, need to be disinfected at the frequency of that device in the connected group that requires the highest disinfection frequency. This is due to the downside of known connecting devices that they cannot provide well separation and hygienic conditions for two or more overlapping disinfection circulation paths. Known connecting device often do not separate different branches and loops well enough so that circulated disinfectant can cross contaminate into portions of the liquid line systems that are not disinfected. A disadvantage of known connecting devices is they are sometimes exhibiting dead spaces which facilitate stagnation of liquids. Stagnation of liquids poses generally a high risk for medical applications and cannot be accepted. A disadvantage of known connecting devices is that disinfect 240041W001 both dialysis water production device and dialysis water distribution ring line at a high frequency is very time consuming and comes at costs for energy and water spent.

[0033] An advantage of the connecting device according to the invention is that it allows for running disinfection cycles and frequencies in different positions of the system optimized for reduced effort of staff and reduced resource spend such as energy, water, disinfectant.

[0034] An advantage of creating an overlap between the different disinfectant circulation loops is increased hygiene. Because of the overlap, it is safeguarded there is no non disinfected area remaining. To the contrary, the interface portions where different disinfection circulation loops overlap is disinfected in more than one disinfection mode.

[0035] An advantage of the connecting device according to the invention is that it can prevent backflow of hot water into the dialysis water production device during thermal disinfection of the dialysis water distribution ring line in case a dialysis water production device and a dialysis water distribution ring line are connected to the connecting device.

[0036] A benefit of the connecting device according to the invention in an embodiment in which the third valve (VR40), arranged on the return line section (RT) in such a way that the return line section (RT) can be shut off in the return flow direction (DR-R) upstream of the first and of second connecting lines, is a non-return valve opening upon adjacent pressure at the inflow side, e.g. a spring-loaded non-return valve, is that it can provide that a predefined minimum pressure is always present in a dialysis water distribution ring line connected to the connecting device.

[0037] Description

[0038] In the realm of medical facilities, centralized dialysis water production devices and distribution ring lines are frequently employed to ensure a consistent supply of dialysis water to various treatment rooms. These systems are integral to hospitals and dialysis clinics, where the purity of medical fluids is paramount. However, maintaining such purity presents challenges, particularly due to the risk of contamination and biofilm growth within the distribution systems. Traditional methods of connecting dialysis water production devices to distribution ring lines often fall short, as they do not allow for the independent disinfection of system components. This limitation necessitates the disinfection of the entire distribution ring line whenever the production device is sanitized, leading to potential chemical spillover and the need for additional rinsing. The innovation at hand addresses these issues by introducing a connecting device that facilitates the separate disinfection of the dialysis water production device and the distribution ring line. This is achieved through a configuration of selectively controllable valves that enable distinct circulation paths, thereby conserving time and resources while enhancing the overall hygiene of the 240041W001 system.

[0039] The innovation can be summarized as a connecting device designed to link a dialysis water production device with a dialysis water distribution ring line. This device comprises several integral components, including a feed-line section and a return-line section, both equipped with connecting portions that interface with the respective lines of the dialysis water production and distribution systems. Additionally, the device features short-circuit lines that bridge the feed and return sections, along with multiple valves strategically positioned to manage the flow of liquids. The functionality of this device is centered around its ability to provide distinct disinfection paths for both the dialysis water production device and the distribution ring line. This is accomplished by utilizing selectively controllable valves that can create various circulation paths, allowing for the independent disinfection of each component. A notable aspect of this innovation is its ability to address the challenges of chemical spillover and dead-space commonly encountered in traditional systems. By enabling separate disinfection processes, the device not only prevents the unwanted transfer of disinfectants but also ensures that no stagnant areas are left untreated, thereby maintaining the integrity and hygiene of the entire system.

[0040] The innovation presents several advantages by enabling the independent chemical disinfection of the dialysis water production device without impacting the distribution ring line. This capability allows for resource and time savings by eliminating the need to disinfect the entire distribution ring line each time the production device undergoes disinfection. The design incorporates overlapping disinfection areas, ensuring comprehensive coverage and preventing any non-disinfected zones from remaining within the system. This feature is particularly beneficial in maintaining high hygiene standards, as it allows for multiple disinfection modes to overlap, thereby ensuring thorough sanitation. Furthermore, the innovation provides flexibility in scheduling disinfection cycles, as it can accommodate different disinfection frequencies for various components of the system. This adaptability is crucial in optimizing maintenance routines, allowing for more efficient use of resources such as disinfectants, water, and energy. When compared to traditional approaches, this innovation significantly reduces resource consumption and enhances hygiene by preventing chemical spillover and ensuring that all areas are effectively disinfected. The ability to independently manage disinfection processes not only streamlines operations but also minimizes the risk of contamination, making this innovation a substantial improvement over existing methods. 240041W001

[0041] The third valve brings the benefit of preventing that disinfectant is pushed into a dialysis water distribution ring line that may be connected to a connecting device according to the invention.

[0042] It is crucial for the connecting device according to the invention that it is configured to realize at least two different disinfection or cleaning circulation loops which both run through part of the connecting device and at the same time exhibiting a portion where the two disinfection or cleaning circulation loops overlap.

[0043] In further embodiments, the connecting device is configured as a connecting mechanism with a specific arrangement of feed-line and return-line sections, short-circuit lines, and valves. This configuration is designed to facilitate the creation of distinct circulation paths that enable separate disinfection modes. The use of controllable solenoid valves and nonreturn valves is integral to achieving these circulation paths, as they allow for precise control over the flow of liquids within the system. In some embodiments, additional valves may be incorporated into the feed or return line sections to enhance the device's functionality and prevent potential design modifications. The inclusion of flow restrictions and symmetrical arrangements of non-return valves can further optimize the device's performance by ensuring efficient liquid movement and preventing backflow. The method of operation for different disinfection modes involves strategically opening and closing specific valves to create unique flow paths, thereby ensuring that the device's features remain effective and cannot be easily circumvented. This approach not only enhances the device's versatility but also reinforces its ability to maintain high hygiene standards across various operational scenarios.

[0044] The connecting device is to be used in all modes of operation of a dialysis water supply system. These modes of operation include water production mode and at least two different disinfection modes.

[0045] Liquid line naming such as feed line or return line generally refers to the supply operation of a dialysis water production device feeding dialysis water to a dialysis water distribution ring line. That is, water is fed from the production device to the distribution device via the feed lines and returned from the distribution device to the production device via the return lines.

[0046] Upstream and downstream, if not denoted differently, refers to the relative arrangement of locations with respect to the flow direction in normal production operation. As an example, when speaking about the feed line section, upstream and downstream refer to the relative arrangement with respect to the feed flow direction. Likewise, when speaking 240041W001 about the return line section, upstream and downstream refer to the relative arrangement with respect to the return flow direction.

[0047] For a valve, shut-off can mean that it closes depending on the direction of flow. To implement the invention, a valve can therefore be a non-return valve in order to achieve the required shut-off capability. However, shut-off can also mean that the valve blocks independently of the direction of flow. The more general term shut-off valve can also refer to controllable valves. Lower acquisition costs can be an advantage of non-return valves. Another advantage of non-return valves can be that the shut-off function does not require any further control, meaning that costs for a control unit, control lines or a control system can be lower. One advantage of controllable valves is that they can be freely switched between open and closed - regardless of the direction of flow of a medium.

[0048] The exact arrangement of short-circuit lines and the flow directions realized therein for different disinfection modes is not fixed in the context of the invention. It is essential that the loops for the circulation of disinfection liquid or cleaning liquid, which should be realizable with the valve arrangement, overlap at least minimally. If two parallel short-circuit lines are arranged between them, it is necessary to switch the short-circuit line that is further away from the inlet of the disinfectant or cleaning agent for use in a given circulation for disinfection or cleaning. The necessary switchability can be achieved by means of switchable valves or non-return valves or a mixture thereof.

[0049] Closing and opening of valves can be facilitated by switching switchable valves or by feeding a liquid flow in case of a non-return valve.

[0050] Summary

[0051] In some embodiments, the connecting device may include a sixth valve on the feed-line section upstream of the short-circuit lines. Additionally, a drain line may be connected to the return-line section, equipped with a ninth valve. At least one of the valves could be a controllable solenoid valve, while the third valve might be a non-return valve that opens upon adjacent pressure at the inflow side. A flow restriction could be arranged on the feed-line section upstream of the short-circuit lines. The fourth and fifth valves may be non-return valves with opposite orientations. Furthermore, the device may incorporate a third short-circuit line with a seventh valve. The length of each short-circuit line from its branching point to its respective valve may be one and a half times the diameter of the short-circuit line or less. This configuration provides flexibility in managing the circulation paths for disinfection and operational purposes.

[0052] In some embodiments, the system with a connecting device may include a reverse osmosis device as the dialysis water production device. The connecting device may also feature a 240041W001 sampling port for fluid testing to ensure the absence of disinfectants. It is configured to allow independent chemical disinfection of the dialysis water production device or hot disinfection of the distribution ring line. The short-circuit lines may create overlapping disinfection areas between chemical and thermal processes. A sixth valve may be included upstream of the short-circuit lines to prevent backflow during thermal disinfection. The device may facilitate chemical disinfection by directing a mixed disinfectant liquid through specific pathways, and thermal disinfection by circulating heated water through the distribution ring line.

[0053] Brief Descriptions of Figures

[0054] Fig. 1 : The diagram shows a schematic of a connecting device for connecting a dialysis water production device with a dialysis water distribution ring line with labeled components.

[0055] Fig. 2: The image shows a schematic diagram of a connecting device for dialysis systems of figure 1 with additionally depicting a circulation path for disinfection of part of the connecting device and, if connected, a dialysis water production device. Hence the circulation path spans the portions connectible to such production device. The circulation may be utilized for chemical disinfection of a dialysis water production device, particularly if it is a reverse osmosis device.

[0056] Fig. 3: The diagram illustrates a connecting device for a dialysis water system with a second circulation path highlighted spanning a part of the connecting device connectible to a dialysis water distribution ring line.

[0057] Fig4: The image shows a schematic diagram of a dialysis line connecting device with optional additional valves and lines as well as further components.

[0058] Fig5 : The image shows a schematic diagram of a connecting device for dialysis systems according to figure 4 with additionally highlighting a circulation flow path extending from the first connecting portion to a drain branch.

[0059] In the figures, identical or similar elements may be referenced with the same reference signs.

[0060] FIG. 1 is a schematic diagram of a connecting device RBP for interfacing a dialysis water production device RO with a dialysis water distribution ring line LP. The connecting device RPB comprises a feed-line section FW and a return-line section RT, which are essential for the transport of dialysis water between the production device and the distribution ring 240041W001 line. The feed-line section FW is connectible to the feed line of a dialysis water production device via a first connecting portion RO-F and to a dialysis water distribution ring line via a second connecting portion LP-F. Similarly, the return-line section RT is connectible to the return line of a dialysis water production device through a third connecting portion RO-R and to a return line of a dialysis water distribution ring line via a fourth connecting portion LP-R. The device includes first and second short-circuit lines LK1 and LK2, which bridge the feed-line section FW and the return-line section RT, minimizing dead space and enhancing the efficiency of the system. The first valve V22, which may be a controllable valve, particularly a solenoid valve, is positioned on the feed-line section FW downstream of the short-circuit lines, while the second valve V40 is located on the return-line section RT downstream of the short-circuit lines. The third valve VR40, which may be a non-return valve, is situated on the return-line section RT upstream of the short-circuit lines. The fourth valve VR42, potentially a non-return valve, is placed on the first short- circuit line LK1, and the fifth valve VR2, potentially a non-return valve, 5 is on the second short-circuit line LK2. These valves are configured to provide switching capabilities for at least two disinfection modes and a part or all of them may be controllable by a control unit of the dialysis water production device, allowing for dynamic operation based on specific conditions. The shown embodiment has a flow resistance FR located in the feedline section FW upstream of the short-circuit lines LK1, LK2. In some embodiments, the device may include a sixth valve VR20 on the feed-line section FW upstream of the short- circuit lines LK1, LK2 instead of the flow restriction, potentially a non-return valve, and a drain line connected to the return-line section RT, which may be equipped with a ninth valve V46, potentially a controllable valve such as a solenoid valve, to facilitate rinsing after disinfection. The arrangement of these components ensures efficient operation and maintenance of the dialysis water system, providing advantages such as reduced contamination risk and improved system longevity.

[0061] FIG. 2 illustrates a schematic diagram of a connecting device for dialysis systems, specifically designed to facilitate the connection between a dialysis water production device and a dialysis water distribution ring line. This connecting device, denoted as RBP, includes several key components that enable the creation of a circulation path for disinfection purposes. The first circulation path, labeled as cil, traverses part of the connecting device, incorporating its first RO-F and third connecting portions (RO-R). The first connecting portion, RO-F, is connectible to the feed line of a dialysis water production device, while the third connecting portion, RO-R, connects to the return line of the same device. Additionally, the second connecting portion, LP-F, and the fourth connecting portion, LP-R, are designed to connect to the feed and return lines of a dialysis water distribution ring line, respectively. The first circulation path cil does not encompass the second and fourth connecting portions. The device includes a series of valves strategically placed to control 240041W001 the flow of dialysis water, cleaning agent or disinfectant, depending on the operation mode. The first valve, V22, is positioned on the feed line section and the second valve, V40, on the return line section. The third valve, VR40, located on the return line section upstream of the short-circuit lines, may be configured as a non-return valve. The fourth valve, VR42, on the first short-circuit line, may be a solenoid valve, while the fifth valve, VR.25, is placed on the second short-circuit line. These valves are integral to the device's operation, allowing for at least two disinfection modes, which may be switched between via control of at least some of the valves by a control unit within the dialysis water production device. The configuration of the short-circuit lines is optimized to minimize dead space, enhancing the efficiency of the disinfection process. The device may also include additional components, such as a drain line with a ninth valve, to facilitate the removal of disinfectant post-process. This system is particularly beneficial for chemical disinfection, especially when the dialysis water production device operates as a reverse osmosis unit, ensuring thorough cleaning and maintenance of the dialysis setup. The first flow path cil encompasses the first connecting portion RO-F, part of the feed-line section FW, the second short-circuit line LK2, the fifth valve VR25, part of the return-line section RT, the second valve V40 and the third connecting portion RO-R. Thus, chemical disinfectant for example can be circulated at a part of the device and a connected dialysis water production device well separated from the portions connectible to a dialysis water distribution ring line.

[0062] FIG. 3 is a diagram illustrating a connecting device RPB for a dialysis water system, emphasizing a second circulation ci2 path extending through a part of the connecting device, which is connectible to a dialysis water distribution ring line. The connecting device RPB is designed to facilitate the connection between a dialysis water production device and a dialysis water distribution ring line, ensuring efficient water flow and disinfection processes. The device comprises a feed-line section and a return-line section, each connectible to the respective lines of both the dialysis water production device and the distribution ring line. The feed-line section includes a first valve (V22), positioned downstream of the short-circuit lines, which regulates the flow of liquid in this line. The return-line section features a second valve (V40) downstream and a third valve (VR40) upstream of the short-circuit lines, with the third valve optionally being a non-return valve to prevent backflow. Additionally, the device incorporates first (LK1) and second (LK2) short-circuit lines bridging the feed-line and return-line sections, each equipped with a fourth valve (VR42) and a fifth valve (VR25), respectively. These short-circuit lines are strategically arranged to minimize dead space, enhancing the system's efficiency. The fourth valve may be a non-return valve. The first and / or second valves may be solenoid valves, providing precise control over the flow. The system's configuration allows for multiple disinfection modes, controlled by a control unit within the dialysis water production 240041W001 device, which can manipulate valves to achieve desired cleaning and disinfection outcomes. In some embodiments, the device may include a sixth valve on the feed-line section upstream of the short-circuit lines, and a drain line connected to the return-line section, featuring a ninth valve for additional control. The integration of these components ensures optimal performance, allowing for effective disinfection and cleaning of the dialysis water distribution ring line, with the potential to use chemical or thermal agents as disinfectants. The system's design facilitates the seamless transition between operational and maintenance modes, ensuring the reliability and safety of the dialysis water supply. The second circulation path does not encompass portions RO-F, RO-R connectible to a dialysis water distribution ring line but it encompasses the first short-circuit line further away from the second and fourth connecting portion LP-F, LP-R connectible to a dialysis water distribution ring line.

[0063] FIG. 4 is a schematic diagram of a dialysis line connecting device, referred to as connecting device RBP, which facilitates the connection between a dialysis water production device and a dialysis water distribution ring line. The connecting device includes several key components and sections, each serving specific functions to ensure efficient operation. The first connecting portion RO-F is designed to connect to the feed line of a dialysis water production device, while the third connecting portion RO-R connects to the return line of the same device. The second connecting portion LP-F and the fourth connecting portion LP-R are connectible to the feed and return lines of a dialysis water distribution ring line, respectively. The feed-line section FW and return-line section RT are integral parts of the system, allowing for the flow of dialysis water between the production device and the distribution line. Short-circuit lines LK1 and LK2 bridge these sections, providing pathways for water flow and minimizing dead space. The system is equipped with multiple valves, including the first valve V22 on the feed-line section, the second valve V40 on the return-line section, and the third valve VR40, which may be a non-return valve, on the return-line section. Additional valves such as the fourth valve VR42 on the first short- circuit line and the fifth valve VR25 on the second short-circuit line are crucial for controlling flow paths. The optional sixth valve VR20 is located on the feed-line section upstream of the short-circuit lines, while the optional seventh valve VR24 and eighth valve VR41 are positioned on an optional third short-circuit line and the return line section, respectively. The optional ninth valve V46 is connected to an optional drain line, facilitating drainage when necessary. An optional pump P5 and an optional heater Hl are included to assist with water movement and temperature regulation. The optional optional conductivity measurement sensor CD-P and sampling port SP provide monitoring and sampling capabilities, ensuring the quality and safety of the dialysis water. The valves are configured to allow for at least two disinfection modes, for which at least a part of the valves is selected to be controllable by a control unit of the dialysis water production device, 240041W001 enhancing the system's operational flexibility. This configuration supports both chemical and thermal disinfection methods, as well as cleaning processes for the distribution ring line, demonstrating the device's versatility and effectiveness.

[0064] FIG. 5 illustrates a schematic diagram of a connecting device for dialysis systems, highlighting a circulation flow path extending from the first connecting portion to a drain branch. The connecting device, labeled as RBP, otherwise exhibits the same features as that of figure for and is designed to interface with both the feed line and return line of a dialysis water production device and a dialysis water distribution ring line. The first connecting portion (RO-F) is connectible to the feed line of a dialysis water production device, while the third connecting portion (RO-R) connects to the return line. Similarly, the second connecting portion (LP-F) and fourth connecting portion (LP-R) are connectible to the feed and return lines of a dialysis water distribution ring line, respectively. The feedline section (FW) and return-line section (RT) facilitate the flow of dialysis water between these connections. The device includes first and second short-circuit lines (LK1, LK2) which bridge the feed-line and return-line sections, minimizing dead space and allowing for efficient flow management. This configuration enables efficient disinfection and cleaning processes, enhancing the overall functionality and safety of the dialysis system.

[0065] Embodiments

[0066] According to a preferred embodiment, the connecting device for connecting a dialysis water production device to a dialysis water distribution ring line comprises:

[0067] A feed-line section (FW) comprising a first connecting portion (RO-F) connectible to the feed line of a dialysis water production device (RO) and the feed-line section (FW) comprising a second connecting portion (LP-F) connectible to a feed line of a dialysis water distribution ring line,

[0068] A return-line section (RT) comprising a third connecting portion (RO-R) connectible to the return line of a dialysis water production device (RO) and the return-line section (RT) comprising a fourth connecting portion (LP-R) connectible to a return line of a dialysis water distribution ring line,

[0069] A first short-circuit line (LK1) between the feed line section (FW) and the return line section (RT),

[0070] A second short-circuit line (LK2) between the feed line section (FW) and the return line section (RT), 240041W001

[0071] A first valve (V22), arranged on the feed line section (FW) in such a way that the feed line section (FW) can be shut off downstream of the first short-circuit line (LK1) and of the second short-circuit line (LK2) in feed flow direction (DR-F),

[0072] A second valve (V40), arranged on the return line section (RT) so that the return line section (RT) can be shut off in the return flow direction (DR-R) downstream of the second short-circuit line (LK2) and of the first short-circuit line (LK1),

[0073] A third valve (VR40), arranged on the return line section (RT) in such a way that the return line section (RT) can be shut off in the return flow direction (DR-R) upstream of the first and of second connecting lines,

[0074] A fourth valve (VR42) arranged on the first short-circuit line (LK1), which can shut off the first short-circuit line (LK1),

[0075] A fifth valve (VR25) arranged on the second short-circuit line (LK2), which can shut off the second short-circuit line (LK2).

[0076] According to embodiments of the connecting device, the feed-line section (FW) may comprise a first connecting portion (RO-F) connectible to the feed line of a dialysis water production device (RO) and a second connecting portion (LP-F) connectible to a feed line of a dialysis water distribution ring line.

[0077] According to embodiments of the connecting device, the return-line section (RT) may comprise a third connecting portion (RO-R) connectible to the return line of a dialysis water production device (RO) and a fourth connecting portion (LP-R) connectible to a return line of a dialysis water distribution ring line.

[0078] In a preferred embodiment, the connecting device comprises two parallel short-circuit lines which connect the connecting device's feed line section and return line section. This configuration of lines allows for establishing two or more circulation loop paths which flow through only part of the connecting device. Circulating a liquid through only a part of the connecting device makes sense for cleaning or disinfection operation of only one area that is connectible with another device for cleaning or disinfecting exactly one connected device along with the connecting device. Examples for such cleaning or disinfection operation include disinfecting part of the connecting device and a dialysis water production device that may be connected to the connecting device utilizing its first connecting portion and third connecting portion. In this case, the circulation loop inside the connecting device encompasses one short-circuit line and parts of the feed-line section and of the return-line section but it does not encompass the second and fourth connecting portions of the connecting device where a dialysis water distribution ring line can be connected. Another example is the other way round: The circulation loop through the connecting device encompasses the second and fourth connecting portions and one short-circuit line 240041W001 and parts of the feed-line section and of the return-line section but that circulation loop path does not encompass the first and third connecting portion. At the second and fourth connecting portion, a dialysis water distribution ring line can be connected to the connecting device. The partial circulation scenarios shall, in short, always include either the connecting portions for connecting a dialysis water distribution ring line or the connecting portions for connecting a dialysis water distribution ring line but not both. Setting up those circulation paths encompassing only part of the connecting device in a way that always the short-circuit line is utilized that is further away from the connecting portions that are encompassed in the circulation safeguards overlapping of the different circulation paths encompassing only part of the connecting device. Overlapping of the different circulation paths brings the benefit that all parts of the connecting device encompassed by subsequential use of two different circulation paths encompassing part of the connecting device and one time the first and third connecting portions and the other time the second and fourth connecting portions. The area between the two short-circuit lines is in fact even encompassed twice as it is the part of the connecting device where the two circulation paths are overlapping. According to this preferred embodiment, the device comprises one valve located at each of the two short-circuit lines and it comprises, in each of the feed-line section and return-line sections, two valves or flow restrictions each, wherein one of the valves or flow restrictions is located upstream of the short-circuit lines in both feed-line and return line sections while the other valves or flow restrictions are located downstream of both short-circuit lines in both the feed-line and return-line sections. That means the connecting device altogether comprises six elements of either valve or other flow restriction which are located on and around the short-circuit lines. In one of such exemplary embodiments, all six of the elements are valves. In another embodiment, the connecting device comprises five valves and a flow restriction. In yet another embodiment, the connecting device comprises 4 valves and two flow restrictions. Flow restrictions other than valves can be located at the feed-line section or at the return-line section. At least two valves of those six elements must be controllably independent from the flow direction, e.g., controllable valves not check valves, and located at the feed-line section or return line section. The flow restriction other than a valve can only be utilized at the feed-line section or return-line section. In a further preferred embodiment, the connecting device comprises two controllable valves, one at the feed-line section and one at the return-line section, and two non-return valves at the short-circuit lines as well as one of a non-return valve or a flow restriction other than a valve at both the feed-line section and one at the return-line section. In one embodiment, there are two controllable valves and four non-return valves making up the six elements. In one other embodiment, the connecting device comprises three non-return valves, two controllable valves and one flow restriction which could be water pressure provided by a 240041W001 connected device such as a dialysis water production device. Non-return valve and check valve may be used as synonyms.

[0079] In one embodiment of the connecting device, the first short-circuit line is arranged on the supply line section such that it is connected to the supply line section upstream of the second short-circuit line in the supply flow direction, and at the same time the first short- circuit line is arranged on the return line section such that it is connected to the return line section downstream of the second short-circuit line in the return flow direction.

[0080] In embodiments of the invention, there is a drain line connected to the return line section of the connecting device and there may be ninth valve located in the drain line. This ninth valve is a drain valve. The advantage of the drain valve and drain line is that such configuration allows quickly flushing disinfectant from the connecting device - quicker than it would be possible to drain via a connected dialysis water production device or a dialysis water distribution ring line.

[0081] In one method according to the invention, the valves of the connecting device are switched to allow liquid flowing from the feed port of the dialysis water production device through the short circuit line more distant from the dialysis water production device and back to the dialysis water production device and then disinfectant or a cleaning liquid is circulated along that path.

[0082] According to one method embodiment of the invention, the valves of the connecting device are switched to cream a loop flow path from the loop return port through the return line section of the connecting device, through the short circuit line more distant from the dialysis water distribution ring line and to the dialysis water distribution ring line via the feed line section and then circulating cleaning liquid or disinfectant is circulated along that path.

[0083] In one embodiment of a kit of the invention, a control unit of a dialysis water production device is configured to switch valves of the connecting device in three different configurations for three different operation modes, namely a first disinfection or cleaning loop through a portion of the connecting device and the dialysis water production device, a second disinfection or cleaning loop through a different portion of the connecting device and possibly through a connected dialysis water disinfection ring line, and a third mode which is a supply mode for normal operation in which the connecting device guides dialysis water from the dialysis water production device to the dialysis water distribution ring line for dialysis water supply.

[0084] In embodiments, the connecting device can additionally have a seventh valve VR.24 in a third short-circuit line, which can be designed as a spring-loaded non-return valve, for example. This valve ensures that, for example, in the event of an unexpected blockage 240041W001 occurring downstream of a dialysis water production device, water supplied by a dialysis water production device can return to the dialysis water production device via the short- circuit line so that the inlet pressure at a dialysis water distribution ring line connected downstream of the dialysis water production device remains within the permissible range. In other words, the seventh valve in the third short-circuit line prevents a connected dialysis water production device from feeding water at too high a pressure into the connection device.

[0085] Embodiments of the invention can comprise two controllable valves while the further valves are non-return valves. Due to the lower cost and no control requirements of nonreturn valves, cost reduction is a benefit.

[0086] Embodiments of the connecting device can feature a symmetrical arrangement of nonreturn valves in that the valves in the short circuit lines are both check valves with opposite orientations. This facilitates cost efficient design of the connecting device to enable switching capabilities for partially overlapping disinfectant circulation line loops of parts of the system. Embodiments of the connecting device furthering the aspect of symmetrically arranged non-return valves feature one non-return valve in each the feed line section and the return line section of the connecting device, further driving cost effective facilitation of overlapping disinfectant loop paths.

[0087] Embodiments with an optional third and an even more optional fourth short circuit line are possible. There may be a seventh valve be arranged in the third short-circuit line. There may be a tenth valve be located on a fourth short-circuit line.

[0088] Embodiments of the invention method may include the extra step of rinsing the part of the connecting device that was not disinfected currently after a disinfection run. Rinsing is quick and lean on resources yet allows removing water from the lines not part of that disinfection operation.

[0089] Controllable valves may be solenoid valves in embodiments of the invention.

[0090] In one embodiment, there is an eighth valve located in the return line section adjacent to the return portion connectible to a dialysis water production device.

[0091] In an embodiment of the invention, there is a flow restriction (FR) located in the feed line section upstream of the first and second short-circuit lines. This flow restriction may be present in the form of water pressure generated by a dialysis water production device connected to the connecting device, e.g., in a situation in which disinfectant or cleaning liquid flows in a circulation path within the connecting the device, the disinfectant or cleaning agent being fed from the fourth connecting portion (LP-R) connectible to a return line of a dialysis water distribution ring line through a short-circuit line and to the second connecting portion (LP-F) connectible to a feed line of a dialysis water distribution 240041W001 ring line. At the same time the dialysis water production device may supply dialysis water. At the location of the flow restriction, a equilibrium of pressures of circulating disinfectant and dialysis water may be realized, thus there is no flow through the flow restriction. Alternatively, the flow restriction may be a non-return valve or a controllable valve.

[0092] According to an embodiment of a method according to the invention, the following steps are performed to switch a circulation path for carrying out a disinfection or cleaning of a connecting device and a connected dialysis water distribution ring line: opening the third valve (VR40) feeding disinfectant or cleaning liquid via the return path section (RT) via the fourth connecting portion (LP-R) closing the fifth valve (VR25) opening the fourth valve (VR42) closing the second valve (V40) closing optionally either a sixths valve (VR20) or creating a flow restriction (FR) by providing water pressure equal to the pressure in the forward line section (FW) wherein closing and opening of valves is facilitated by switching switchable valves or by feeding a liquid flow in case of a non-return valve

Claims

240041W001Claims2. A connecting device (RBP) for connecting a dialysis water production device (RO) to a dialysis water distribution ring line (LP), comprising: o a feed-line section (FW) connectible to the feed line of a dialysis water production device and a dialysis water distribution ring line; o a return-line section (RT) connectible to the return line of a dialysis water production device and a dialysis water distribution ring line; o first and second short-circuit lines (LK1, LK2) bridging the feed-line section (FW) and the return-line section (RT); o a first valve (V22) on the feed-line section downstream of the short-circuit lines (LK1, LK2); o a second valve (V40) on the return-line section (RT) downstream of the short-circuit lines (LK1, LK2); o a third valve (VR40) on the return-line section (RT) upstream of the short- circuit lines (LK1, LK2); o a fourth valve (VR42) on the first short-circuit line (LK1); o a fifth valve (VR25) on the second short-circuit line (LK2).

3. The device (RBP) of claim 1, further comprising a sixth valve (VR20) on the feedline section (FW) upstream of the short-circuit lines (LK1, LK2).

4. The device of claim 1, wherein the third (VR40) and or fourth (VR42) and / or fifth valve (VR25) are non-return valves.

5. The device of claim 1, wherein the first (V22) and / or second (V40) valve are controllable valves, in particular solenoid valves.

6. The device of claim 1, further comprising a drain line connected to the return-line section (RT).

7. The device of claim 5, further comprising a ninth valve (V46) on the drain line, in particular controllable valves, preferably solenoid valves.

8. The device of claim 1, wherein the short-circuit lines (LK1, LK2) are designed with their length from feed-line section (FW) or return-line section (RT) to the valve (VR42, VR25) each not exceeding one and a half times the diameter, thus deadspace free.

9. The device (RBO) of claim 1, wherein the valves are selected from controllable and non-return valves in a composition providing switching capabilities to form at least two disinfection circulation paths encompassing only two of four end points of feed-line section and return-line sections.

10. The device of claim 1, wherein at least two of the valves are controllable by a control unit of the dialysis water production device.240041W00111. A system comprising a device according to claim 1 and a dialysis water production device (RO), wherein the dialysis water production device includes a control unit (CU) configured to control at least two of the valves of the device.

12. A method for disinfecting a dialysis water production device with a system comprising a connecting device and a dialysis water production device, comprising: o closing the first valve; o opening the second valve; o closing the third valve; o opening the fifth valve; o supplying disinfectant via the feed-line section.

13. The method of claim 11, further comprising the step of rinsing the return-line section after disinfection.

14. The method of claim 11, wherein the disinfectant is a liquid chemical agent.

15. A method for cleaning a dialysis water distribution ring line with a system comprising a connecting device and a dialysis water distribution ring line, comprising: o opening the third valve; o feeding cleaning liquid via the return-line section; o closing the fifth valve; o opening the fourth valve; o closing the second valve.

16. The method of claim 14, wherein the disinfectant is a hot water.

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