Dialysis systems and methods

The modular dialysis system with a wheeled platform addresses the challenges of size, energy use, and technician dependency by integrating real-time water purification and automated setup, enhancing mobility and safety for home dialysis.

JP2025502204APending Publication Date: 2025-01-24OUTSET MEDICAL
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Patent Information

Application Number
JP2024541801
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-01-12
Filing Date
2023-01-12
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

Current dialysis systems are cumbersome, energy-intensive, and require significant technician involvement, making them unsuitable for home use and mobility, with water quality variability affecting filter life and dialysis efficacy.

Method used

A modular dialysis system with a wheeled platform that integrates water purification and dialysis delivery, allowing for real-time water purification using tap water, automated setup, and reduced technician intervention, featuring interchangeable filtration modules and a compact design for enhanced mobility.

Benefits of technology

The system provides flexible, efficient, and safe dialysis therapy with reduced energy consumption, enabling home use and improved mobility, while ensuring high-quality water purification and minimizing maintenance burdens.

✦ Generated by Eureka AI based on patent content.

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Abstract

A dialysis system and method are described that may include several features. The dialysis system described may provide dialysis therapy to a patient in the comfort of their own home. The dialysis system may be configured to prepare purified water in real time from a tap water source that is used to create the dialysate solution. The dialysis system described also includes features that facilitate a patient self-administering therapy.
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 298,916, filed January 12, 2022, the entire contents of which are incorporated by reference herein. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0002]

[0003] The present disclosure relates generally to dialysis systems and, more particularly, to systems and methods for producing dialysate in real time during dialysis treatment. [Background technology]

[0003]

[0004] Currently, there are hundreds of thousands of patients in the United States who suffer from end-stage renal disease. The majority of these patients require dialysis to live. Many patients receive dialysis treatments at dialysis centers, which can impose demanding, restrictive, and exhausting schedules on patients. Patients who undergo in-center dialysis typically must travel to the center at least three times a week, sitting in a chair for three to four hours each time while toxins and excess fluid are filtered from the blood. After treatment, patients must wait for the needle site to stop bleeding and for blood pressure to return to normal, which requires even more time to be taken away from other, more fulfilling activities in the patient's daily life. Furthermore, because a typical center treats three to five shifts of patients throughout the day, in-center patients must follow an inflexible schedule. As a result, many people who undergo dialysis three times a week report feeling fatigued for at least a few hours after the session.

[0004]

[0005] Many dialysis systems on the market require significant input and attention from technicians before, during, and after a dialysis therapy. Before therapy, technicians are often required to manually place the patient blood tubing set onto the dialysis system, connect the tubing set to the patient and the dialyzer, and manually prime the tubing set to remove air from the tubing set before therapy. During therapy, technicians are typically required to monitor venous pressure and fluid levels and administer boluses of saline and / or heparin to the patient. After therapy, technicians are often required to return the blood in the tubing set to the patient and drain the dialysis system. The inefficiencies of most dialysis systems and the need for significant technician involvement in the process make it even more difficult for patients to receive dialysis therapy away from large treatment centers.

[0005]

[0006] Given the demanding nature of in-center dialysis, many patients have turned to home dialysis as an alternative. Home dialysis offers patients scheduling flexibility by allowing them to choose treatment times to fit around other activities, such as commuting or caring for family members. Unfortunately, current dialysis systems are generally not suitable for use in a patient's home. One reason for this is that current systems are too large and bulky to fit into a typical home. Current dialysis systems are also energy inefficient in that they use large amounts of energy to heat large amounts of water for proper use. Although some home dialysis systems are available, they are generally difficult to set up and use. As a result, most dialysis treatments for chronic patients are performed in dialysis centers.

[0006]

[0007] Hemodialysis is also performed in acute hospital settings, either for hospitalized current dialysis patients or for patients with acute kidney injury. In these treatment settings, typically hospital rooms, water of sufficient purity to create dialysate is not readily available. Thus, hemodialysis machines in acute settings rely on large volumes of premixed dialysate, which are typically provided in large bags and are cumbersome for staff to handle. Alternatively, hemodialysis machines may be connected to portable RO (reverse osmosis) machines, or other similar water purification devices. This results in another separate piece of equipment that must be managed, transported, and sterilized.

[0007]

[0008] Dialysis machines are used in a variety of environments, including hospital rooms, dedicated clinics, and patients' homes. In some environments, such as home or clinic environments, minimal mobility requirements are required. In other environments, such as hospital rooms, mobility can be very important. The machine may need to be transported long distances, down corridors, or even over exterior surfaces that run from building to building. Additionally, in hospital rooms, space is at a premium and high maneuverability, e.g., the ability to rotate around its own axis, is desirable. However, a mobility solution optimized for one environment may not work well in other environments for size, footprint, or cost reasons. Thus, a modular approach is needed where a single dialysis machine can have a choice of mobility solutions, preferably with minimal installation overhead for modular mobility solutions.

[0008]

[0009] A pre-configured dialysis machine is one that has on-board water purification hardware, such as a reverse osmosis system. These systems often have several water filters, such as sediment, carbon, and ultrafiltration devices, that purify the water that is later used to create the dialysate. The quality of the incoming water has a significant impact on the lifespan of many of these filters. Factors such as sediment content, chlorine / chloramine concentration, hardness, pH, alkalinity, and temperature can shorten the lifespan of the filter and / or affect the quality of the water after it is filtered. Due to the highly diverse nature of the incoming water, different options for treating the water are desirable. While it may be conceivable to produce a single water treatment system that can handle a wide range of input variables, doing so may be prohibitive in terms of size, weight, cost, or maintenance. Thus, there is a need for a modular approach to water purification, and preferably one in which maintenance, such as changing filters, is a minimal burden.

[0009]

[0010] Mobility of dialysis equipment has historically been provided by casters. Typically, these casters can be locked to brake the equipment and prevent movement when movement is not desired. If all four casters are allowed to rotate about their axes, the equipment has high maneuverability in tight spaces. However, when traveling long distances, the equipment may have a tendency to rotate about its axis and may be difficult to control. The need to allow the casters to turn along their arcs also necessitates the need to create large clearances, or wheel wells, which limits the ability to minimize the size of the equipment. Locking at least one of the casters from rotating may improve the control issue at the expense of maneuverability in tight spaces. Some casters have a "directional lock" feature that allows them to be switched from free-spinning to fixed.

[0010]

[0011] Water treatment carts are known in the art to provide portable water purification for dialysis machines. They tend to be very bulky and difficult to maneuver. Water treatment carts typically perform all water filtration functions because the dialysis machines they serve typically do not have their own on-board water filtration. For pre-configured dialysis machines that require a water connection, only supplemental water treatment is required, which may allow for a smaller form factor. Summary of the Invention [Means for solving the problem]

[0011]

[0012] A dialysis system is provided that includes a dialysis console configured to provide dialysis therapy to a patient; and a modular platform configured to interface with the dialysis console, the modular platform including fluid and / or power connections to the dialysis console, the modular platform further configured to receive one or more modular components configured to add filtration and / or fluid capabilities to the dialysis console.

[0012]

[0013] In some embodiments, the dialysis console is configured to rest on a modular platform.

[0014] In some examples, the modular platform further comprises a plurality of wheels.

[0013]

[0015] In one embodiment, the modular platform includes one or more slots configured to receive one or more modular components.

[0016] In some examples, the modular platform includes electrical connections configured to mate with corresponding electrical connections of one or more modular components.

[0014]

[0017] In some embodiments, the electrical connections are internal to the wheeled platform.

[0018] In one example, the electrical connections are external to the modular platform or dialysis console.

[0015]

[0019] In some examples, the one or more modular components are configured to be electrically and fluidly coupled within the one or more slots by inserting the one or more modular components into the slots and rotating the one or more modular components through a preset angle. In one embodiment, the preset angle includes up to 90 degrees. In other embodiments, the preset angle includes up to 45 degrees. In some examples, the preset angle includes between 1 and 360 degrees.

[0016]

[0020] In some embodiments, the one or more modular components include an outer handle.

[0021] In some examples, the one or more modular components include a first filtration component and a second filtration component.

[0017]

[0022] In one embodiment, the first filtration component comprises a filter and the second filtration component comprises a pump.

[0023] In another embodiment, the first filtration component comprises a first filter and the second filtration component comprises a second filter. In some examples, the filter, the first filter, or the second filter comprises a sediment filter, a carbon filter, a reverse osmosis filter, or an ultrafiltration device.

[0018]

[0024] In some examples, the one or more modular components include a manifold configured to direct incoming water into multiple streams.

[0025] In some embodiments, the modular platform comprises a fluid inlet line configured to be coupled to a source of tap water and a fluid outlet line configured to be coupled to the fluid inlet line of a dialysis console.

[0019]

[0026] In one embodiment, the dialysis console further comprises a fluid outlet line configured to be coupled to a drain.

[0027] In some examples, the dialysis console further comprises a fluid outlet line configured to be coupled to a drain inlet line of the modular platform.

[0020]

[0028] A method is provided that includes receiving a flow of fluid from a fluid source into a modular platform that is separate from but fluidly coupled to a dialysis system, filtering the fluid within the modular platform, and pumping the fluid from the modular platform to the dialysis system with a pump within the modular platform.

[0021]

[0029] The novel features of the invention are set forth with particularity in the claims which follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings. [Brief description of the drawings]

[0022] [Figure 1]

[0030] FIG. 1 illustrates one embodiment of a dialysis system. [Diagram 2]

[0031] FIG. 1 illustrates one embodiment of a water purification system for a dialysis system. [Diagram 3]

[0032] FIG. 1 illustrates one embodiment of a dialysis delivery system of a dialysis system. [Figure 4A]

[0033] FIG. 4A illustrates one embodiment of a dialysis system having a wheeled platform configured to house or receive modular dialysis system components. [Figure 4B] FIG. 4B illustrates one embodiment of a dialysis system having a wheeled platform configured to house or accept modular dialysis system components. [Figure 4C] FIG. 4C illustrates one embodiment of a dialysis system having a wheeled platform configured to house or accept modular dialysis system components. [Figure 4D] FIG. 4D illustrates one embodiment of a dialysis system having a wheeled platform configured to house or accept modular dialysis system components. [Figure 4E] FIG. 4E illustrates one embodiment of a dialysis system having a wheeled platform configured to house or accept modular dialysis system components. [Figure 5A]

[0034] FIG. 1 illustrates another embodiment of a wheeled platform and modular dialysis system components. [Figure 5B]

[0035] FIG. 1 illustrates one embodiment of a dialysis system configured to accept modular dialysis system components. [Figure 6A]

[0036] FIG. 6A illustrates another embodiment of a modular dialysis system. [Figure 6B] FIG. 6B illustrates another embodiment of a modular dialysis system. [Figure 7]

[0037] FIG. 1 illustrates one example of a fluid circuit enabled within a modular dialysis system. [Figure 8]

[0038] FIG. 1 is a power diagram for a dialysis system having one or more modular components or platforms. [Figure 9A]

[0039] FIG. 1 illustrates fluid connections to a dialysis system. [Figure 9B]

[0039] A diagram illustrating fluid connections to a dialysis system. [Figure 9C]

[0039] A diagram illustrating fluid connections to a dialysis system. [Figure 10A]

[0040] FIG. 10A illustrates a conventional filtration cartridge. [Figure 10B] FIG. 10B is a diagram illustrating a conventional filtration cartridge. [Figure 11A]

[0041] FIG. 11A is a diagram illustrating a novel filtration cartridge. [Figure 11B] FIG. 11B is a diagram illustrating the novel filtration cartridge. [Figure 11C] FIG. 11C is a diagram illustrating the novel filtration cartridge. [Figure 12]

[0042] FIG. 1 illustrates one particular embodiment of the novel filtration cartridge. [Figure 13]

[0043] FIG. 1 is a system diagram of a dialysis system having five modular filtration components. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023]

[0044] The present disclosure describes systems, devices, and methods related to dialysis therapy, including dialysis systems that are simple to use and include automated features that eliminate or reduce the need for technician involvement during dialysis therapy. In some embodiments, the dialysis system may be a home dialysis system. Embodiments of the dialysis system may be automated and include various features that improve the performance, efficiency, and safety of dialysis therapy.

[0024]

[0045] In some embodiments, a dialysis system capable of providing acute and chronic dialysis therapy to a user is described. The system may include a water purification system configured to prepare water for use in the dialysis therapy in real time using an available water source, and a dialysis delivery system configured to prepare dialysate for the dialysis therapy. The dialysis system may include a disposable cartridge and a tubing set for connection to a user during dialysis therapy to collect and deliver blood from the user.

[0025]

[0046] FIG. 1 illustrates one embodiment of a dialysis system 100 configured to provide dialysis therapy to a user in either a clinical environment or a non-clinical environment, such as the user's home. The dialysis system 100 may include a water purification system 102 and a dialysis delivery system 104 disposed within a housing 106. The water purification system 102 may be configured to purify a water source in real time for dialysis therapy. For example, the water purification system may be connected to a residential water source (e.g., city water) and prepare purified water in real time. The pasteurized water may then be used for dialysis therapy (e.g., with a dialysis delivery system) without the need to heat and cool large bulk quantities of water typically associated with water purification methodologies.

[0026]

[0047] The dialysis system 100 may also include a cartridge 120 that may be removably coupled to the housing 106 of the system. The cartridge may include a patient tubing set that is attached to an organizer. The cartridge and tubing set, which may be sterile, disposable, single-use components, are configured to connect to the dialysis system prior to therapy. This connection properly aligns corresponding components between the cartridge, tubing set, and dialysis system prior to dialysis therapy. For example, the tubing set is automatically associated with one or more pumps (e.g., peristaltic pumps), clamps, and sensors when the cartridge is coupled to the dialysis system to draw and pump the user's blood through the tubing set. The tubing set may also be associated with a saline source of the dialysis system for automatic priming and air removal prior to therapy. In some embodiments, the cartridge and tubing set may be connected to a dialyzer 126 of the dialysis system. In other embodiments, the cartridge and tubing set may include an implantable dialyzer that is pre-attached to the tubing set. A user or patient may interact with the dialysis system via a user interface 113 that includes a display.

[0027]

[0048] 2-3 illustrate the water purification system 102 and the dialysis delivery system 104, respectively, of one embodiment of the dialysis system 100. The two systems are illustrated and described separately for ease of explanation, but it should be understood that both systems may be included in a single housing 106 of the dialysis system. FIG. 2 illustrates one embodiment of the water purification system 102 included within the housing 106, which may include a front door 105 (shown in an open position). The front door 105 may provide access to features associated with the water purification system, such as one or more filters, including a sediment filter 108, a carbon filter 110, and a reverse osmosis (RO) filter 112. The filters may be configured to help purify water from a water source (such as tap water) in fluid communication with the water purification system 102. The water purification system may further include heating and cooling elements, including a heat exchanger configured to pasteurize and control the temperature of fluids within the system, which will be described in more detail below. The system may optionally include a chlorine sample port 195 to provide a sample of the fluid for measuring the chlorine content.

[0028]

[0049] In FIG. 3, the dialysis delivery system 104 contained within the housing 106 may include a top lid 109 and a front door 111, both shown in an open position. The top lid 109 may be open to allow access to various features of the dialysis system, such as a user interface 113 (e.g., a computing device including an electronic controller and a display such as a touch screen) and a dialysate container 117. The front door 111 may be opened and closed to allow access to a front panel 210, which may include various features configured to interact with the cartridge 120 and its associated tubing set, including alignment and mounting features configured to couple the cartridge 120 to the dialysis system 100. The dialyzer 126 may be mounted within the front door 111 or on the front panel, and may include lines or ports that connect the dialyzer to prepared dialysate, dialysate concentrate, liquid concentrate, etc., as well as the cartridge's tubing set. In one implementation, described in more detail below, the dialysis machine and / or dialyzer may include lines or ports configured to connect to a disposable reservoir containing multiple powder and / or liquid compartments for dialysate preparation and delivery.

[0029]

[0050] In one embodiment, referring to Figures 4A-4E, a wheeled platform 401 is provided upon which a pre-configured dialysis system 400 (such as dialysis system 100 of Figure 1) may be mounted. Figure 4A shows the wheeled platform 401 separate from the dialysis system 400, while Figures 4B-4C show the dialysis system mounted on the wheeled platform.

[0030]

[0051] As shown, the wheeled platform 401 may include multiple wheels 403 configured to provide the dialysis system with additional maneuverability and / or mobility when the wheeled platform is engaged with the system. It should be understood that while the dialysis system itself may have two or more wheels 404 for portability, these wheels typically come with drawbacks as described above that do limit the maneuverability of the system. The entire dialysis system, including the embedded wheels 404, is configured to fit within, connect to, or mate with the wheeled platform. In some embodiments, the dialysis system has its own wheels that do not need to be removed to attach it to the wheeled platform. In some embodiments, the wheels of the wheeled platform are larger and more sturdy than the wheels of the dialysis machine. For example, the diameter of the dialysis machine may be 4 inches or less, and the wheel diameter of the wheeled platform may be 5 inches or more. The increased size allows the wheeled platform to more easily overcome obstacles such as thresholds or uneven ground. The wheeled platform may also have a wider wheelbase than the dialysis machine to provide improved stability.

[0031]

[0052] The dialysis machine can be securely and rigidly fastened to the platform, either by its wheels or by some other mounting feature designed for the purpose of fastening the dialysis machine. In some embodiments, the wheeled platform 401 can be connected to the dialysis machine using threaded connections, quick release connections, magnets, or the like. The wheeled platform 401 in some embodiments is attached to the wheels 404 of the dialysis system. It has a shroud 405 that can be configured to fit and / or connect with it. In some embodiments, the shroud 405 can effectively visually hide the wheels 404 of the dialysis machine to promote a seamless look. Additionally, any service activities that need to be performed on the dialysis machine that involve removing panels from the dialysis machine can be performed while the machine is attached to the wheeled platform 401. Thus, the wheeled platform can be made to be specially tailored to the dialysis system so as not to prevent those panels from being removed. Alternatively, the wheeled platform itself can have removable panels that allow for the removal of all panels of the dialysis system.

[0032]

[0053] As described in more detail below, and with reference to FIGS. 4D-4E, the wheeled platform 401 may be further configured to house or accept modular dialysis system components that expand or enhance the functionality of the dialysis system when attached to the wheeled platform. In FIGS. 4D-4E, the wheeled platform includes an augmentation module 407 configured to expand and enhance the functionality of the dialysis system. In some embodiments, the augmentation module is removable / insertable from the wheeled platform 401. When the augmentation module is removed from the wheeled platform, the individual components within the augmentation module may be accessed, serviced, or replaced. When the augmentation module is inserted into the wheeled platform 401, the additional functionality provided by the augmentation module may be automatically detected and activated by the dialysis system.

[0033]

[0054] In some embodiments, the augmentation module 407 may include water treatment equipment (e.g., water filters, ultrafiltration devices, carbon filters, etc.), pumping equipment (e.g., additional pumps), dialysis / dialysate equipment (e.g., dialyzers, additional dialyzers, drip chambers, air removal systems, priming fluids, etc.), waste management equipment (e.g., waste containers for spent dialysate or blood waste), filtration equipment, etc., or some combination thereof, and may include both fluid and electrical connections to both the dialysis machine and the wall (power and water). The electrical connections between the wheeled platform and the dialysis system may further include one or both of data transfer and / or power transfer. Additionally, the augmentation module 407 may include a user interface 409, which may optionally include a display. In some embodiments, the display may provide information to the user regarding the functionality of the augmentation modular components.

[0034]

[0055] As shown in FIG. 4E, in one particular embodiment, the enhancement module 407 may include, among other features, a water pretreatment module that may include filters (e.g., sediment and chlorine variants), increased filtration and / or treatment capacity over filters found in conventional dialysis systems, an optional boost pump, and the ability to integrate a pH equilibration system.

[0035]

[0056] In other embodiments, the wheeled platform does not include a removable augmentation module as described above, but instead is configured to directly receive certain modular components for enhancing the functionality of the dialysis system. With reference to FIG. 5A, the wheeled platform 501 may be configured to receive a removable modular component 509. Furthermore, additional space 511 in the wheeled platform 501 may be dedicated to other modular dialysis components (not shown) that are not removable. For example, the wheeled platform may include permanent components such as batteries, pumps, sensors, or filter cartridges. For example, a fixed booster pump may be integrated into the wheeled platform along with valves and sensors for monitoring the performance of the water treatment functionality. As another example, a pressure sensor may be integrated into the wheeled platform and configured to monitor the pressure drop across a filter in the base. Additionally, a removable filter may be integrated into the base, and a visual indicator on the outside of the wheeled platform or on the console of the dialysis system may provide the user with an indication of the remaining filter life. Alternatively, the wheeled platform may comprise or include one or more microprocessors that can communicate with the dialysis machine to which it is connected, either wirelessly or via a wired connection between the wheeled platform and the dialysis system. Firmware on the dialysis machine may be configured to interpret signals transmitted by the microprocessor in the wheeled platform and display status or otherwise issue alerts on the GUI of the dialysis machine. The microprocessor may also wirelessly communicate remotely with a remote server or other device to provide status of the performance of the water filtration.

[0036]

[0057] In some embodiments, the modular components are optional. In some cases where the water treatment functionality embedded in the dialysis device is sufficient, the device can still benefit from the improved mobility afforded by a separate wheeled platform. In these cases, the volume within the wheeled platform can be empty and used for storage instead. For example, the storage area within the wheeled platform can be accessed, for example, by a drawer or hinged door.

[0037]

[0058] In another embodiment, referring to FIG. 5B, the dialysis machine itself can be configured to accept modular dialysis system components 509 that can be accessed through a drawer or door 513 on the dialysis machine.

[0038]

[0059] 6A-6B, and as discussed above, in some embodiments, the modular dialysis component 609 can include an electrical connection 615 to the wheeled platform (or directly to the dialysis machine). In one embodiment, as shown in FIG. 6A, the electrical connection 615 can be on the front portion of the modular component and can be configured to plug into or be electrically connected to a corresponding electrical connection 617 on the wheeled platform (or the dialysis machine). In other embodiments, the electrical connection can be provided automatically when the modular component is inserted into the wheeled platform or dialysis machine. For example, an electrical contact or connection on the back side of the modular component can be configured to electrically mate with a corresponding electrical contact or connection on the inside of the wheeled platform or dialysis machine.

[0039]

[0060] 6B, the modular components may also include one or more fluid connections 616. The fluid connections 616 may provide fluid communication between the modular components, such as a filter or fluid reservoir 618 and a source of fluid (e.g., tap water) and / or the dialysis machine, as described in more detail below. In this example, when the modular components are inserted into the wheeled platform or dialysis machine, fluid connections may be automatically provided between the modular components, the wheeled platform, the dialysis machine, and / or the source of fluid.

[0040]

[0061] The modules may be simple flow-through filters or they may have electronic components (pumps, valves, sensors). For example, one module may be a chemical reservoir with a low-flow water pump that injects fluid into the water and processes it. By plugging the connector, it may also help to identify what type of module is inserted.

[0041]

[0062] FIG. 7 is a schematic diagram illustrating one embodiment of a fluid circuit 700 in a dialysis system including modular components as described herein and above. In one example, a dialysis machine can be mounted on a wheeled platform and configured to take in incoming water and produce dialysate. The water can be routed through the fluidic modular components in the wheeled platform. Under operating conditions, the incoming water passes through the fluidic modular components, which can include one or more filters, pumps, valves, and / or sensors. For example, a boost pump can be provided in one or more of the modular components to increase the pressure of the incoming water, which can help create sufficient flow to the filtration media of the fluidic modular components and / or on or in the dialysis machine itself.

[0042]

[0063] 7 is a basic flow diagram of a fluid modular component with two filters. It should be understood that other embodiments may include any number of filters, including one filter or more than two filters. Incoming water may pass through a backflow preventer 702. A booster pump 704 may be included in one or more of the modular components and configured to boost pressure on the two filters 706. The two filters may be arranged in series or parallel, as desired. Preferably, the filters may be switched between parallel and series configurations, for example, by a manual valve.

[0043]

[0064] The pressure drop across the filter 706 can be measured by pressure gauges PG1 and PG2. In some embodiments, the pressure gauges can be integrated into the modular components. In other embodiments, the pressure gauges can be permanently located in the dialysis system or the wheeled platform. The pressure measurements can be used by the microprocessor or controller of the system to determine the pressure drop across the filters. If the pressure drop is excessive, the proportional valve V1 can be opened, bypassing the filter in the fluid module and sending the incoming water directly to the dialysis machine, which has its own filter; V1 can be a proportional valve, the degree to which it is opened (and therefore the amount of water sent directly to the dialysis machine relative to the amount of water sent to the filter) can vary depending on the pressure drop across the filter. In one example, the pump 704 can be set to a pressure control mode, in which case a target pressure at PG2 is desired. If there is no water required from the fluid module by the dialysis machine, for example when the dialysis machine is powered off, PG2 reaches a nominal pressure and the pump stops. Valve V2 is another bypass valve configured to be normally open so that it is open when it is not powered. In this manner, when the fluid module is not powered, the incoming water can flow directly to the dialysis machine and is not blocked by the unpowered pump. A check valve can be included that allows the system to hold pressure in no-flow conditions. Optionally, backflow prevention measures such as a series of check valves or reduced pressure zone assemblies can be provided upstream of all functions. A tank 708 can be used to control dP / dT and also handle pressure spikes in the system.

[0044]

[0065] Both the dialysis machine and the fluid module of the wheeled platform to which it is attached may include electrical connections. In one embodiment, referring to FIG. 8, a single power cord to the wall may be configured to power both the dialysis machine and the fluid module / wheeled platform. Even if not connected to the wheeled platform and the fluid module, the dialysis machine has its own power connection and power source. Preferably, a power cord from a wall outlet connects to the power source IN of the fluid module and provides power to it (via switch SW). From there, the fluid module or power cord may also include a power output (OUT) with a direct connection to the power of the dialysis system, from which a second power cord connects from the fluid module to the power connector of the dialysis machine. The power source of the fluid module provides power to a printed circuit assembly (PCA), which then distributes the power to the various components. The PCA may be present in the wheeled platform described above. The PCA may also have a USB connection that may be utilized for expandability, for example, a wireless communication module, or a memory device that can store recorded pressure or other data.

[0045]

[0066] The dialysis system and wheeled platform may further include various fluid connections to external fluid sources (such as a tap water source). With reference to FIG. 9A, the dialysis machine may include a fluid supply line 902 for providing fluid / tap water to the system, and a drain line 904 for discarding spent fluid / dialysate. These connections are made directly to the dialysis machine. FIG. 9B shows an embodiment when the dialysis machine is connected or mated to the wheeled platform described above. In this example, the wheeled platform includes a fluid supply inlet line 906 that has a corresponding fluid supply outlet line 908 that connects directly to the fluid supply line 902 of the dialysis machine. Similarly, the drain line 904 of the dialysis machine is fluidly coupled to the drain line of the wheeled platform, which in turn is fluidly connected to a corresponding drain outlet line of the wheeled platform for discarding spent fluid / dialysate.

[0046]

[0067] 9C, the dialysis system's drain outlet line 904 does not pass through the wheeled platform, but instead goes directly to drain. In this configuration, water enters the wheeled platform from a water source through a fluid supply inlet line 906, is fluidly coupled to the dialysis system's supply line 902, and goes directly to drain through the dialysis system's drain line 904.

[0047]

[0068] The present disclosure also provides a novel filtration cartridge that may be used in any of the present systems and embodiments described above, such as in a wheeled platform or as a modular filtration component. Figures 10A-10B show one example of a conventional filtration cartridge 100, including a filter housing 1001 and a filter media 1003. In this example, the filtration cartridge may include an inlet 1002 for incoming water, and the incoming water passes radially through one or more filtration media within the cartridge, indicated by arrows 1004. The filtered water then passes through the center and exits through an outlet 1006 within the cartridge. As shown in Figure 10B, the multiple filtration media may be separated diametrically to accommodate different filter media types.

[0048]

[0069] 11A-11C illustrate one embodiment of a modular filter component that may be used in conjunction with the wheeled platform and / or dialysis system described herein. As noted above, the modular component may provide additional functionality to the dialysis system / wheeled platform, including filtration capabilities. Additionally, the modular component may include electrical connections. The novel water filtration system described in this disclosure revolves around a common housing design. The water filters use a common large size housing 1101, but add a handle 1103 at the end of the filter (as shown in FIGS. 11A-11B). Having a handle at the rear of the filter cartridge eliminates the need to have space between the filters to service them (due to the physical space required for the hands). Thus, the handle on the filter allows for the positioning of multiple filters in close proximity to each other. This reduces the space required within the system and minimizes the fluid connection line length between each filter. FIG. 11B shows the space enabled by adding a handle to the cartridge, while FIG. 11C shows the space required without the handle. This allows more cartridges to be packed into a smaller space (such as in a wheeled platform) than would be possible without the handle.

[0049]

[0070] The front of the modular filter component in Figure 11A can include a filter head 1105 configured to allow up to a three-stream inlet / outlet for fluid flow by creating concentric and semi-concentric openings. Using a multi-layer filter head (shown in Figure 11A) with gradually decreasing diameters all the way to the tip of the filter head, each layer can be used to create new flow paths with corresponding sealing features (e.g., radial O-rings) between each layer.

[0050]

[0071] A manifold connection system may be utilized to connect the front of the filter cartridge to the overall fluid system. The passageway into the manifold system may include ramps at the connection points. Some of these ramps, coupled with a handle at the other end of the filter, allow for smooth 90 degree locking and unlocking of the cartridge filter (inside the manifold).

[0051]

[0072] The housing size of the modular filter components can accommodate various filter media / core types to add flexibility within the water filtration system. With the life and size of various filter media cores, a balance of the equation is required to find a common volume that encompasses all water specification requirements. In some embodiments, a single large filter housing can be used to separate and house two different types of media cores by utilizing the large space and housing structure.

[0052]

[0073] In one example, multiple media cores can be arranged in a common concentric separation as shown in FIG. 11C. This type of structure wraps around each other using the actual filter media core. The multiple media cores can be maintained by the filter media / core. Note that these tightly wrapped media cores can only be applied to regular filter media types (e.g., carbon, sediment, RO).

[0053]

[0074] In another embodiment, the second type of multimedia core can be provided in a housing with two sections of media / core separating the cores with the filter housing. This configuration is shown in FIG. 12. The second type of multimedia core can be contained in a single housing by constructing the structure of the filter housing in a way that creates a flow path from the inlet to bypass the filter core to create a flow path. Note that the arrows do not indicate the physical ports of flow input / output. Furthermore, this embodiment and all filters described in this disclosure can have inlets and outlets (for flow) centralized around the filter head as shown in FIG. 11A.

[0054]

[0075] The multi-media core in the filter housing can accommodate various modules required for the water filtration system. For purposes of the example presented in FIG. 12, the "spare" portion of the filter can represent any type of module, component, system, or electronics that can be inserted into the allocated space in the filter housing section. Either one of these two multi-media core options can be used to create an optimized multi-media filter system that is optimized for manufacturing and tailored to a specific need.

[0055]

[0076] These large filter housings can accommodate various types of filter cores (both single and multi-media cores) and internal components. By using a filter housing to control the water flow path, other types of modules can be incorporated into the housing core that mimics the tubes in the flow path. Additional modules can be placed in certain areas of the filter housing to accommodate the needs of various water filtration systems. These modules can include (but are not limited to) fluid pumps to control the flow rate without a water filtration system, injection systems to control water pH, and even electronics. With reference to FIG. 12, it should be understood that these modules, such as pumps, electronics, or injection systems, can be located in "spare" slots in the modular components, while filtration components, such as sediment filters, are located elsewhere in the housing. Other types of filtration media can be used in the "sediment" position as well.

[0056]

[0077] To accommodate any given electronics in the filtration system, one of two different types of connections can be used. The first option is a blind connection with an appropriate construction lead-in that can be accommodated due to the forced orientation of the handle that allows for an initial 90 degree rotation. The default orientation of the filter cartridge together with the 90 degree rotation / locking mechanism allows enough control to create a blind connection. The second option is to have an end connector on the handle area of ​​the filter cartridge. A female or male connection point can be placed onto the cartridge (rear) cap area to connect the electronic connections. One example of an end connector is shown in the embodiment of Figures 6A-6B.

[0057]

[0078] FIG. 13 illustrates one example of a multi-cartridge filtration water system incorporating the concepts described above. This system can provide a variety of configurations and flexibility within the water filtration system. By placing multiple filters in line, combinations of single media cores and multiple media cores can be arranged to provide an optimized water filtration system. The ability of the wheeled platform and / or dialysis system described above to accept multiple modular components allows numerous configurations and possibilities to be enabled by the present disclosure.

[0058]

[0079] For example, referring to FIG. 13, this embodiment includes a water filtration system having a total of five modular components or cartridges. These components can be inserted into a wheeled platform that is then coupled to the dialysis system. Alternatively, as illustrated in FIG. 5B, the modular components can be inserted directly into corresponding slots directly on the dialysis system. In FIG. 13, the first modular component 1301 can include first and second reserve slots. The exact purpose of these slots is not defined in this example, but it should be understood that these reserve slots can serve any desired purpose, including filtration. Note that the manifold can directly provide dual input streams of water to each of the reserve slots. Additionally, the reserve slots can be arranged in series, such that the output of the first reserve slot goes into the second reserve slot, which in turn provides the output to the second modular component 1302. The second modular component 1302 may include first and second sediment filter media with various pore sizes, such as 5.0 μm and 1.0 μm. These may be arranged in series as shown. The output from this modular component may be provided to a third modular component 1303, which may include a carbon filter. This output may then be provided to a fourth modular component 1304, which may include, for example, a redundant carbon filter and a UV light arranged in series. Finally, the fifth modular component 1305 may include a reverse osmosis filter and a feed pump that draws the fluid from the filter and returns it into the reverse osmosis filter. The output from all these modular components may optionally be passed through an ultrafilter and then a chlorine sensor. In some embodiments, the ultrafilter / sensor may be disposed within the modular components, and in other embodiments, they may be disposed within the wheeled platform or dialysis system. The result of this filtration system is ultra-pure clean water suitable for use by the dialysis system for dialysis therapy.

[0059]

[0080] Although the specification contains many details, these should not be construed as limitations on the scope of the invention as claimed or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, features may be described above as acting in a particular combination and may initially be claimed as such, but one or more features from the claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination. Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring such operations to be performed in the particular order or sequence shown, or that all illustrated operations be performed, to achieve desired results. Only some examples and implementations are disclosed. Variations, modifications, and enhancements to the described examples and implementations, as well as other implementations, may be made based on what is disclosed.

[0060]

[0081] For additional details regarding the present invention, materials and manufacturing techniques may be adopted as within the level of ordinary skill in the art. The same may be true for method-based aspects of the present invention with respect to additional acts generally or logically adopted. It is also contemplated that any optional features of the described inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. Similarly, reference to a singular item includes the possibility of the same item being present in plural. More specifically, as used in this specification and the appended claims, the singular forms "a," "and," "said," and "the" include plural references unless the context clearly indicates otherwise. It is further noted that claims may be written to exclude any optional element. As such, this description is intended to serve as a predicate for the use of such exclusive terminology as "solely," "only," and the like in connection with the description of claim elements, or the use of "negative" limitations. Unless otherwise defined herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not limited by this specification, but rather only by the plain meaning of the claim terms employed.

Claims

1. 1. A dialysis system comprising: a dialysis console configured to provide dialysis therapy to a patient; a modular platform configured to interface with the dialysis console, the modular platform including fluid and / or power connections to the dialysis console, the modular platform further configured to receive one or more modular components configured to add filtration and / or fluid capabilities to the dialysis console; A dialysis system comprising:

2. The dialysis system of claim 1 , wherein the dialysis console is configured to rest on the modular platform.

3. The dialysis system of claim 1 , wherein the modular platform further comprises a plurality of wheels.

4. The dialysis system of claim 1 , wherein the modular platform includes one or more slots configured to receive the one or more modular components.

5. 10. The dialysis system of claim 1, wherein the modular platform includes electrical connections configured to mate with corresponding electrical connections of the one or more modular components.

6. The dialysis system of claim 1 , wherein the electrical connection is internal to the wheeled platform.

7. The dialysis system of claim 1 , wherein the electrical connections are external to the modular platform or dialysis console.

8. 5. The dialysis system of claim 4, wherein the one or more modular components are configured to be electrically and fluidly coupled within the one or more slots by inserting the one or more modular components into the slots and rotating the one or more modular components a preset angle.

9. 9. The dialysis system of claim 8, wherein the preset angles include up to 90 degrees.

10. 9. The dialysis system of claim 8, wherein the preset angles include up to 45 degrees.

11. The dialysis system of claim 8, wherein the preset angle comprises 1 to 360 degrees.

12. The dialysis system of claim 1 , wherein the one or more modular components include an outer handle.

13. The dialysis system of claim 1 , wherein the one or more modular components include a first filtration component and a second filtration component.

14. 14. The dialysis system of claim 13, wherein the first filtration component comprises a filter and the second filtration component comprises a pump.

15. 14. The dialysis system of claim 13, wherein the first filtration component comprises a first filter and the second filtration component comprises a second filter.

16. 16. The dialysis system of claim 14 or 15, wherein the filter, the first filter, or the second filter comprises a sediment filter, a carbon filter, a reverse osmosis filter, or an ultrafiltration device.

17. 14. The dialysis system of claim 13, wherein the one or more modular components include a manifold configured to direct incoming water into multiple streams.

18. 10. The dialysis system of claim 1, wherein the modular platform comprises a fluid inlet line configured to be coupled to a source of tap water and a fluid outlet line configured to be coupled to a fluid inlet line of the dialysis console.

19. 20. The dialysis system of claim 18, wherein the dialysis console further comprises a fluid outlet line configured to be coupled to a drain.

20. 20. The dialysis system of claim 18, wherein the dialysis console further comprises a fluid outlet line configured to be coupled to a drain inlet line of the modular platform.

21. receiving a flow of fluid from a fluid source into a modular platform that is separate from but fluidly coupled to the dialysis system; filtering the fluid within the modular platform; pumping the fluid from the modular platform to the dialysis system with a pump within the modular platform; A method comprising: