TW202327671A - Water-conserving hemodialysis systems and methods - Google Patents

Abstract

Dialysis fluid processing systems and methods to process used dialysis fluid and provide detoxified dialysis fluid to a hemodialysis machine. A dialysis fluid processing system includes a filtration module to filter used dialysis fluid and an oxidation module to generate detoxified dialysis fluid via photo-oxidation and/or electro-oxidation processes. A fluid input operably connects the system with the hemodialysis machine for transport of used dialysis fluid from the hemodialysis machine and a fluid output operably connects the system with the hemodialysis machine for transport of detoxified dialysis fluid to the hemodialysis machine for continued use in hemodialysis by the hemodialysis machine.

Description

Water saving hemodialysis system and method

Healthy kidneys keep blood urea levels low and relatively constant. Although hemodialysis is an effective treatment for prolonging the lives of patients with kidney failure, there are many known problems with hemodialysis machines and treatments. For example, blood processing systems, such as single-pass hemodialysis machines, need to be connected to a water source and use 400 liters or more of water per dialysis, which is a key obstacle for portable dialysis.

Such high levels of water usage, combined with single-use components, create an environmental disaster. Conventional hemodialysis removes excess metabolic waste products from the body by about 120 liters of dialysis fluid per run, which typically requires 3 to 4 hours of treatment. Dialysis may be required three times a week. Patients suffer from severe life disruption, including having to be immobilized for hours and having to arrange transportation to a dialysis center, which affects their quality of life.

Therefore, there is a need for a system that detoxifies the dialysis fluid, regenerates water from the dialysis fluid, and returns the detoxified dialysis fluid to the blood processing machine. Such a system will reduce the dependence on high volume water supply, enable patients to perform hemodialysis remotely or in the comfort of home, and reduce the environmental impact of hemodialysis treatment.

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

In various aspects, the present invention provides a dialysis fluid treatment system comprising a filtration module configured to filter unfiltered dialysis fluid and configured to pass through a photo-oxidation module and/or an electro-oxidation module One of the oxidation mods to detoxify toxic dialysis fluids. The filtration module and the oxidation module are each fluid with a fluid input of the system for receiving used dialysis fluid from a hemodialysis machine and a fluid of the system for sending regenerated dialysis fluid to the hemodialysis machine The output is in fluid communication. The used dialysis fluid is filtered by the filtration module and/or detoxified by the oxidation module to generate the regenerated dialysis fluid for continued use by the hemodialysis machine.

In certain advantageous embodiments, the fluid input can be positioned upstream of the filtration module, the filtration module can be positioned upstream of the oxidation module, and the oxidation module can be positioned upstream of the fluid output. By filtering the post-use dialysis fluid prior to detoxification, the oxidation module and the patient are protected.

The oxidation module may comprise the photo-oxidation module, or the photo-oxidation module and the electro-oxidation module, in which case the electro-oxidation module may be positioned upstream of the photo-oxidation module such that the dialysis fluid is Electrooxidation before photooxidation. The oxidation module oxidizes dialysis by-products (such as urea) present in the dialysis fluid and releases liquids (eg _H2O ) and gases (eg _O3 , _CO2 , _N2 ) as products. The water produced by the regeneration of the dialysis fluid after use is returned to the hemodialysis machine for continued use in dialysis, and in this way, large amounts of water are not required for regeneration of the dialysis fluid after use.

In order to assess the volume of fluid withdrawn during dialysis and the performance of the system, the photo-oxidation module may further include an ultrafiltration monitoring module configured to sense an amount of evaporated gas from the dialysis fluid that can be used changing the flow rate of the dialysis fluid through the photo-oxidation module, the pressure of the dialysis fluid through the photo-oxidation module and/or providing to the light source to maintain the dialysis fluid based on the amount of evaporated gas from the dialysis fluid A desired regeneration rate is based on a current. The ultrafiltration monitoring module can be further configured to sense a current draw of the photo-oxidation module, a voltage of the photo-oxidation module, and/or a thermal output of the photo-oxidation module.

In embodiments, an ultrafiltration monitoring module may be positioned downstream of the photo-oxidation module and/or the electro-oxidation module and may be configured to pass through a membrane in fluid contact with the output fluid stream, optionally Gas is evaporated from the detoxified dialysis fluid using a vacuum pump. This step can assist in the removal of gaseous products of detoxification (eg, _O3 , _CO2 , _N2 ) from the liquid phase.

In embodiments, the system may include a controller operably connected thereto, for example connected to the ultrafiltration monitoring module and/or the oxidation module. The controller may include a processor and processor-executable instructions that, when executed by the processor, cause the ultrafiltration monitoring module to measure an amount of gas removed from the detoxified dialysis fluid with a sensor , and determining, with the processor, an amount of fluid removed from a patient connected to the hemodialysis machine based on the amount of gas removed from the detoxified dialysis fluid. The processor-executable instructions, when executed by the processor, cause the oxidation module to perform a photo-oxidation process and/or an electro-oxidation process to oxidize post-use dialysis fluid. The processor-executable instructions may be stored or implemented in any suitable manner, such as on a non-transitory computer-readable medium.

To monitor system characteristics and a dialysis session, the system may further include a pH monitoring module to monitor a pH level of the dialysis fluid and adjust the pH level by adding electrolytes to the dialysis fluid. Since the pH level of the dialysis fluid can change during a dialysis session, the pH monitoring module can be configured to determine the pH of a blood run on the hemodialysis machine based on a measured pH level of the dialysis fluid. A completion parameter of a dialysis procedure and/or an operating condition of the dialysis fluid handling system, and/or can be configured to remove ammonia from the dialysis fluid. The determination of the pH monitoring module may be directed or performed by a processor during execution of processor-executable instructions.

The system can be configured to filter a byproduct excess fluid flow from the dialysis fluid and divert the byproduct excess fluid flow to an excess fluid output and can be configured to utilize a membrane such as a reverse or forward osmosis membrane The by-product excess fluid stream is filtered.

The system can include a cleaning module in fluid communication with the fluid inlet and the fluid outlet, the cleaning module configured to utilize a liquid disinfectant and/or an ozone by-product of the oxidation module to clean, disinfect and /or sterilize the oxidation module. The cleaning module can be fluidly connected between the fluid inlet and the fluid outlet.

In order to monitor the physical chemical properties of the dialysis fluid as it flows through the system, the system may include a flow monitoring module operably connected to the fluid input and a controller including a processor and a Processor-executable instructions communicating with the flow monitoring module. The flow monitoring module can thereby be configured to monitor an input temperature of the dialysis fluid near the fluid inlet, an output temperature of the dialysis fluid near the fluid outlet, a pressure of the dialysis fluid, and/or the dialysis fluid The velocity of one of the fluids.

To monitor the optical characteristic of the dialysis fluid as it flows through the system, the flow monitoring module can sense an input visual characteristic of the dialysis fluid in the fluid input and can sense an output of the dialysis fluid in the fluid output visual properties. The flow monitoring module may compare the input visual characteristic and the output visual characteristic with the processor to generate a comparison and determine with the processor a relative uremic toxin level of the dialysate fluid in the fluid output based on the comparison.

In order to improve the safety of the patient receiving dialysis, the flow monitoring module can be configured to when the input temperature, the output temperature, the pressure and/or the flow rate of the dialysis fluid in the fluid input deviate from a predetermined critical A safety action is performed when the limit value exceeds a preset deviation limit. The safety action may include transmitting a safety message to a remote receiver and/or reducing the flow rate of a pump in fluid communication with the dialysis fluid.

To maintain consistency or adjust performance characteristics of the system, the flow monitoring module can monitor and adjust the temperature, pressure and/or flow rate of the dialysis fluid received in the fluid input. The flow monitoring module can monitor a gas output of the photooxidation module, a current draw of the photooxidation module, a voltage of the photooxidation module, and/or a heat output of the photooxidation module Efficiency of the dialysis fluid handling system is monitored. The flow monitoring module can monitor and regulate an output temperature, a pressure and/or a flow rate of the dialysis fluid sent to the fluid output.

To improve communication with a patient or user, the system may include a communication module operatively connected to a controller such that the communication module is configured to receive a user input and transmit a user input based on the user input. A system service signal, a medical assistance signal and/or a dialysis fluid handling system operation signal. The communication module may be configured to receive a safety signal indicating that a temperature, a pressure, and/or a flow rate of the dialysis fluid in the fluid input has deviated from a predetermined threshold by more than a predetermined deviation limit, and based on The safety signal transmits a safety message to a user interface and/or a remote receiver of the dialysis fluid handling system.

Various components of the system, such as a fluid input conduit, a fluid output conduit, and other connectors and connections, can be decoupled for system cleaning, disinfection, and maintenance. In embodiments where a housing contains the oxidation module and the filtration module, the housing may include a service port accessible to the oxidation module.

In another aspect, the present invention provides a hemodialysis system comprising a hemodialysis machine fed by a water supply and configured to produce a dialysis fluid and a dialysis fluid as disclosed and/or claimed herein processing system. The dialysis fluid handling system receives used dialysis fluid from the hemodialysis machine and provides regenerated dialysis fluid to the hemodialysis machine. In at least some embodiments, the oxidation module can be contained within a housing that is detachable from the hemodialysis machine.

In another aspect, the present invention provides a method of treating dialysis fluid, the method comprising: receiving used dialysis fluid from a hemodialysis machine; filtering the used dialysis fluid; flowing between a cathode and illuminating the anode with a light source converting urea in the used dialysis fluid to _CO2 , _N2 and _H2O ; and providing _H2O to the hemodialysis machine. The method may include flowing oxygen through the cathode to the post-use dialysis fluid to facilitate conversion of urea in the oxidation module. The method may comprise filtering post-use dialysis fluid with a osmotic membrane, monitoring and/or adjusting the pH of the dialysis fluid, and/or determining a completion parameter of a hemodialysis procedure and/or a dialysis fluid handling system based on the pH - safe operating conditions. The method may further comprise determining a gas output from a photo-oxidation module, a current draw of a light source, a voltage applied to an anode/cathode array, and/or a heat output of the light source. To maintain dialysis, in an embodiment of the method, the method may further comprise adjusting the flow of the dialysis fluid and/or the illumination of the dialysis fluid based on the gas output, the current draw, the voltage and/or the heat output.

Other aspects of the present invention will become apparent after reading the specification, drawings, and claims.

Cross References to Related Applications

This application claims the benefit of US Patent Application Serial No. 63/283059, filed November 24, 2021; the entire contents of which are incorporated by reference.

The present invention relates to the removal of toxins from dialysis fluids. The present technology can be used in blood treatment, such as dialysis, including kidney dialysis, hemodialysis, hemofiltration, hemodiafiltration, removal of impurities, and the like. In particular, the present invention provides dialysis fluid treatment systems that remove urea, non-urea uremic toxins, electrolytes, oxidation byproducts, free radical byproducts, chlorine, and/or other toxins from dialysis fluid. The regenerated detoxified dialysis fluid may be provided to one or more dialysis machines, such as machines performing renal dialysis, hemodialysis, hemofiltration, hemodiafiltration, and similar procedures. This enables the dialysis machine to operate independently of a traditional water supply (e.g., connected to a municipal water supply), thereby freeing the patient for dialysis treatment from the comfort of their own home or another remote location, and reducing the environmental impact of dialysis treatment . Dialysis fluid regeneration system, hemodialysis machine and hemodialysis system

In summary, the present invention provides an improved dialysis fluid handling system, and a hemodialysis machine combined with this dialysis fluid handling system, for an efficient and environmentally friendly dialysis procedure that can be performed at home, remotely, or in transit, compared to previous efforts , water consumption is significantly reduced. The filtration module of the system filters unfiltered dialysis fluid and the oxidation module detoxifies toxic dialysis fluid using a photo-oxidation module and/or an electro-oxidation module to produce detoxified or regenerated dialysis fluid for reuse by the hemodialysis machine. In particular, water is produced as a product of urea degradation and is returned to the dialysis fluid for use by the hemodialysis machine during continuous dialysis without the need for additional water supply from a source external to the system.

Referring to FIG. 1 , there is shown a side view of a hemodialysis machine fluidly connected to a dialysis fluid treatment system according to an example embodiment of the present invention. A hemodialysis system 100 includes a hemodialysis machine 102 fluidly connected to a dialysis fluid treatment system 104 of the present invention. In operation, a patient 106 is connected to hemodialysis system 100 such that the patient's blood flows through tubing 108 into hemodialysis machine 102 . Conduit 108 passes through a blood pump 110 (eg, a peristaltic pump). The pumping action of blood pump 110 pushes the patient's blood through hemodialysis machine 102 and back into the patient.

Dialysis fluid, a fluid that includes one of water, electrolytes, and saline, is one that assists in the removal of unwanted waste products, such as urea, from a patient's blood. During treatment by hemodialysis machine 102, dialysis fluid (in the form of highly purified water) and the patient's blood flow into hemodialysis machine 102 separately via conduit 112 and conduit 108, respectively. The two fluids do not physically mix. Instead, the flow of fresh dialysis fluid is separated from the blood flow by a membrane. Impurities from the patient's blood are filtered through the membrane into the dialysis fluid. For example, it is usually necessary to remove 12 g to 24 g of urea per day from the blood of a normal adult, but on a low protein diet, removal of 15 g of urea per day from the patient's blood is sufficient. Other impurities are also filtered out of the bloodstream into the dialysis fluid. Next, the dialysis fluid containing filtered waste, in particular uremic toxins, and excess electrolytes exits the hemodialysis machine 102 .

In previous existing hemodialysis machines, the dialysis fluid containing filtered toxins and other by-products was disposed of and not reused, which resulted in substantial waste and continued reliance on an external supply of new dialysis fluid for continued operation. Since hemodialysis works by diffusion into the dialysis fluid with a low target solute concentration, a large amount of dialysis fluid is inherently required. Conventional hemodialysis achieves the removal of excess metabolic waste products from the body by running approximately 120 liters of dialysis fluid per run, which typically requires 3 to 4 hours of treatment.

In contrast, the dialysis fluid treatment system 104 of the present invention produces detoxified dialysis fluid by removing uremic toxins and other unwanted elements from post-use dialysis fluid. This detoxified regenerated dialysis fluid is then returned to the hemodialysis machine 102 . In particular, dialysis fluid treatment system 104 receives used dialysis fluid (eg, via conduit 114 ), processes the used dialysis fluid and then provides detoxified regenerated dialysis fluid to hemodialysis machine 102 (eg, via conduit 112 ).

Referring to FIG. 2 , there is shown a schematic diagram of a dialysis fluid treatment system according to an example of the present invention. A dialysis fluid handling system 200 is configured to provide detoxified dialysis fluid to a separate hemodialysis machine, such as described above with respect to FIG. 1 . In an embodiment, the dialysis fluid handling system 200 and the hemodialysis machine are part of a hemodialysis system. The hemodialysis machine and dialysis fluid treatment system 200 may be primed with water from a water source, such as a batch of 10 liters to 100 liters of water.

In the illustrated embodiment, the dialysis fluid handling system 200 is a modular unit that continuously receives post-use dialysis fluid from a hemodialysis machine via a fluid input, such as fluid input conduit 202, followed by at least one pump 204 ( Used dialysis fluid is processed through a dialysis fluid processing circuit into detoxified regenerated dialysis fluid (comprising water and other by-products such as CO ₂ and N ₂ ) through a dialysis fluid processing circuit under operation such as a peristaltic pump, and is output via a fluid output (such as a fluid output conduit 206) Continuously returning regenerated dialysis fluid to the hemodialysis machine, thereby enabling the hemodialysis machine to operate without connection to a traditional water source. To facilitate cleaning of the dialysis fluid handling system 200, one or more portions of the fluid input conduit 202 and/or the fluid output conduit 206 may be detachable from the dialysis fluid handling system 200 and may be consumable or disposable or may be sterilizable. For reuse (eg, consumable and/or sterilizable sections of fluid conduits).

The dialysis fluid handling circuit and associated dialysis fluid handling modules may be contained within a housing 208 that enables rapid and reversible fluid connection of the dialysis fluid handling system 200 to a hemodialysis machine, such as at couplers 210 , 212 . In this way, fluid input conduit 202 can be disconnected at coupler 210 from a dialysis fluid output of the hemodialysis machine, and fluid output conduit 206 can be disconnected at coupler 212 from a return fluid input of the hemodialysis machine. In an embodiment, the housing 208 has one or more service hatches 214 to enable access to the modules contained therein for cleaning and maintenance.

An oxidation module 228 is fluidly coupled to receive post-use dialysis fluid from the hemodialysis machine via fluid input conduit 202 . The oxidation module 228 utilizes at least one of a photo-oxidation module or an electro-oxidation module to generate an output fluid stream of detoxified dialysis fluid comprising water from the post-use dialysis fluid. That is, the oxidation module 228 utilizes at least one electrochemical process to oxidize the urea in the used dialysis fluid into one or more components, namely _H2O , _CO2 and _N2 . Oxidation module 228 provides detoxified dialysis fluid (comprising water) as an output fluid stream. The output fluid flow is then provided to the hemodialysis machine via fluid output conduit 206 . A representative oxidation module and its submodules are described in detail below with respect to FIGS. 3 , 4A, 4B, 5A, 5B, and 5C.

A filtration module 230 is fluidly coupled between the fluid input conduit 202 and the oxidation module 228 and filters select toxins from the dialysis fluid prior to treatment by the oxidation module 228 . Advantageously, this protects the oxidation module 228 and the patient. In an embodiment, the filtration module 230 utilizes one or more toxin selective membranes 232 to filter the dialysis fluid, such as a urea permselective membrane (forward or reverse osmosis membrane), nanofiltration membrane or ion exchange membrane, to separate the dialysis fluid into a dialysis fluid stream containing urea, which is sent to the oxidation module 228, and a by-product excess fluid stream containing uremic toxins, sodium, and other by-products. Filtration module 230 filters the byproduct excess fluid flow from the dialysis fluid and diverts the byproduct excess fluid flow to an excess fluid output conduit 234 and/or an optional additional filtration stage.

In at least some instances, treatment of the dialysis fluid, such as with oxidation module 228 and filtration module 230, can remove desired electrolytes from the dialysis fluid. An optional pH monitoring module 236 may be fluidly coupled to fluid input conduit 202 and/or fluid output conduit 206 and may monitor a pH level of the dialysis fluid, and optionally adjust the pH level, such as by Adding electrolytes to the dialysis fluid upstream or downstream of group 228, and/or by removing ammonia from the dialysis fluid (eg, with an ammonia removal sorbent). In an embodiment, pH monitoring module 236 is positioned upstream of oxidation module 228 (eg, between oxidation module 228 and filtration module 230 ).

In an embodiment, the pH monitoring module 236 determines a completion parameter of a hemodialysis procedure running on the hemodialysis machine based on the pH level of the dialysis fluid. Because the pH of the dialysis fluid will change during a hemodialysis treatment procedure as the hemodialysis machine removes less and less urea from the patient's blood, when the pH monitoring module 236 senses that the pH of the dialysis fluid exceeds or falls below the The pH monitoring module 236 determines a completion parameter (eg, percent complete, time remaining, toxins removed, excess fluid removed) at a threshold associated with a completion level of the hemodialysis treatment.

In an embodiment, the pH monitoring module 236 determines an operating condition of the dialysis fluid treatment system based on the sensed pH level of the dialysis fluid. For example, if residual disinfectants or other chemicals contaminate the hemodialysis machine and/or the fluid conduits of the dialysis fluid handling system 200, and the pH monitoring module 236 senses that the pH of the dialysis fluid exceeds or falls below the dialysis fluid handling system 200 and/or If the pH monitoring module 236 determines that the operating condition is not safe if it is a threshold value for safe operation of the patient. In this case, pH monitoring module 236 sends (e.g., via communication module 226) a system service signal (e.g., to a clinician or manufacturer) indicating that dialysis fluid treatment system 200 requires service, and/or indicates dialysis fluid treatment A dialysis fluid handling system operating signal (to a clinician and/or a patient) that the system 200 is not ready for dialysis fluid regeneration. The pH monitoring module 236 may also send a medical assistance signal (eg, to a clinician) indicating that a patient requires medical assistance when the pH of the dialysis fluid deviates from a predetermined threshold by more than a predetermined deviation limit.

A flow monitoring module 238 may be operatively connected to at least fluid input conduit 202 and a controller 216 and may include a sensor array 240 and circuitry to monitor and optionally adjust operating parameters of dialysis fluid handling system 200 . In an embodiment, the flow monitoring module 238 is configured to monitor at least one of an input temperature, a pressure, or a flow rate of the dialysis fluid in the fluid input conduit 202 . To perform these functions, in an embodiment, sensor array 240 includes at least one of a temperature sensor, a pressure sensor, or a flow rate sensor. In an embodiment, the flow monitoring module additionally or alternatively monitors one of the output fluid flows in the fluid output conduit 206 with a second temperature sensor, a second pressure sensor, and a second flow rate sensor, respectively. At least one of temperature, a pressure, or a flow rate is output.

In an embodiment, sensor array 240 includes an input visual characteristic (e.g., a color, a transparency, and/or opacity) and a second optical sensor positioned to sense an output visual characteristic of the output fluid flow from the oxidation module 228 (eg, in the fluid output conduit 206). In such embodiments, the flow monitoring module 238 may make a comparison between the input visual characteristic and the output visual characteristic and based on the comparison determine a relative urea level of the output fluid flow (for example) to determine the oxidation module 228 Efficiency in removing urea.

In an embodiment, when at least one of the temperature, pressure or flow rate of the dialysis fluid in the fluid input conduit (as sensed by the sensors of the sensor array 240) deviates from a threshold value, such as a predetermined threshold value ) exceeds a predetermined deviation limit (eg, 5%, 10%, 15%, 20%, etc.), the flow monitoring module 238 performs a safety action. The safety action may include at least one of: transmitting a safety message via the communication module 226 to a receiver (e.g., a clinician or a mobile device of the patient), reducing the flow rate of the pump 204, or shutting off or pausing the dialysis fluid Processing system 200 and/or hemodialysis machine or hemodialysis system. In an embodiment, the safety message includes an alert that a sensed parameter has deviated from a threshold value and/or an alert that the dialysis fluid handling system 200 and/or hemodialysis machine has been shut down, suspended, or adjusted based on a sensed parameter deviated from a threshold value .

In an embodiment, the flow monitoring module 238 uses at least one of a temperature control device 242 (eg, a heater, a thermoelectric cooler, a tortuous flow path heat exchanger, and the like), a pump 204, or a valve. or to adjust at least one parameter (temperature, pressure, flow rate) of the dialysis fluid received in fluid input conduit 202 and/or the output fluid flow in fluid output conduit 206 . For example, the flow monitoring module 238 can adjust the flow rate of the dialysis fluid so that it does not exceed about 300 mL/min during a 3 to 4 hour treatment cycle, and/or can adjust the flow rate so that it does not exceed about 300 mL/min during a 6 to 8 hour treatment cycle. Do not exceed approximately 100 mL/min in a treatment cycle or a priming procedure. In an embodiment, the flow monitoring module 238 uses the temperature control device 242 to vary the temperature of the dialysis fluid in the output fluid flow to approximately equal the temperature of the dialysis fluid in the input fluid flow, such as 37°C or 38°C, Or prevent the temperature of one of the dialysis fluids in the output fluid stream from exceeding a maximum temperature, eg about 45°C.

In an embodiment, the flow monitoring module 238 monitors an efficiency level of the dialysis fluid handling system by monitoring at least one of the following parameters of the oxidation module 228: a gas output of the oxidation module 228 (e.g., from photo-oxidation A CO ₂ gas output for electrochemical oxidation of urea in the module), a current draw, a voltage or a heat output. In an embodiment, the flow monitoring module 238 monitors the gas output with at least one of an ultrasonic sensor or an optical sensor positioned to count bubbles generated by the oxidation module 228, using an electrical current Sensors monitor the current draw of a light source in the oxidation module 228, monitor the voltage across a cathode/anode pair in the oxidation module 228 with a voltage sensor, and/or monitor the heat output of the light source with a temperature sensor .

Optionally, flow monitoring module 238 adjusts the efficiency of oxidation module 228 . For example, in an embodiment, the flow monitoring module 238 includes a control loop that, based on the determined gas output, adjusts the current draw of the light source and/or provides a voltage across a cathode/anode pair, which in turn regulates the dialysis fluid One of the oxidation rates of urea.

A cleaning module 244 may be in fluid communication with fluid input conduit 202 and fluid output conduit 206, for example, as shown, and may be configured to utilize a liquid sterilant from oxidation module 228 and/or an ozone by-product ( O ₃ ) to clean, disinfect and/or sterilize the oxidation module 228 . For example, in an embodiment, cleaning module 244 provides a liquid sterilant, such as a citrate, to fluid input conduit 202 and circulates the liquid sterilant through oxidation module 228 under pressure from pump 204 . In one embodiment, as shown, the cleaning module 244 is disposed in a fluid conduit 246 between the fluid input conduit 202 and the fluid output conduit 206, thereby forming a fluid circuit such that when the dialysis fluid treatment system 200 is in contact with blood When the dialysis machine is disconnected, the liquid disinfectant can be recirculated through the oxidation module 228 and other modules.

A controller 216 may be disposed on housing 208 and may be operatively connected to one or more or each of the modules described herein with respect to dialysis fluid treatment system 200 . Controller 216 may include a processor 218 (e.g., a microprocessor) and data storage 220 (e.g., a non-transitory computer-readable storage medium, e.g., a random access memory), these instructions, when executed by the processor 218, configure the processor to cause the dialysis fluid treatment system 200 to perform the functions described below with respect to the different modules. Controller 216 , along with the modules and hardware described herein, can be connected to a power source 222 , such as a D/C battery housed in housing 208 .

An optional user interface 224 can be operatively connected to the controller 216 and disposed in or on the housing 208 and can enable a user (e.g., a clinician and/or a patient) to monitor and/or control Dialysis fluid handling system 200 . An optional communication module 226 can be operatively connected to the controller 216 and can be configured to communicate to one or more recipients and/or recipient devices (e.g., a patient, a clinician, and/or a manufacturer, A remote computer system, a remote mobile device, a remote server, etc.) transmit signals and receive signals therefrom, consistent with the structures and functions described below. In embodiments, communication module 226 is configured to receive a user input (e.g., via user interface 224 and/or a remote device such as a smartphone) and to cause the dialysis fluid handling system to 200 performs any of the functions described below.

In an embodiment, the communication module 226 transmits a system service signal (eg, to a manufacturer) indicative of a diagnostic parameter of the dialysis fluid treatment system 200 based on receipt of one or more signals from any of the sensors described below , a medical assistance signal indicating that a patient needs medical assistance (for example to a clinician) or a dialysis fluid handling system operating signal (to a clinician and/or a patient) indicating an operational status of the dialysis fluid handling system 200 at least one.

The aforementioned modules are representative, not limiting. In an embodiment, any feature described above with respect to a particular module may be associated with a different module. Certain embodiments may include additional features not described in detail above. For example, the dialysis fluid treatment system may include one or more sorbent-based cartridges and/or urease conversion cartridges to further aid in the removal of uremic toxins from the dialysis fluid. As another example, embodiments may include a weighing system (eg, a scale) positioned below the dialysis fluid handling system 200 to weigh the dialysis fluid in the system.

Example structures and techniques for filtering dialysis fluids include those described in US Provisional Application Ser. No. 63/171503, filed April 6, 2021, the entire contents of which are incorporated by reference.

Referring to FIG. 6 , there is shown a schematic diagram of an example organizational layout of a dialysis system comprising a toxin removal circuit for use with a patient 800 for hemodialysis according to the present invention. At least some embodiments of a fluid dialysis circuit include a dialysant circuit 804 separated from a patient blood circuit 802 by a dialysis membrane 810 . The fluid dialysis circuit can include a toxin removal circuit 806 configured to selectively transfer toxins from the dialyser circuit 804 to a toxin removal circuit 806 separated by a toxin selective membrane 812 . The fluid dialysis circuit includes a toxin removal element 818, which may include an oxidation module and/or a filtration module as disclosed herein.

The dialysis agent in circuit 804 can be any commercial or conventional dialysis agent currently in use. The fluid in loop 806 may include, for example, a saline solution, an aqueous solution mixed with a non-NaCl electrolyte, an aqueous solution at an acidic or basic pH. The toxin removal circuit 806 can protect the toxin removal element 818 by using a toxin selective membrane 812 in contact with the dialysis agent. For example, the urea removal elements described herein may benefit from a urea selective membrane 812 that separates the dialyzer circuit 804 and the toxin removal circuit 806 . In an embodiment, the toxin to be removed is a uremic toxin. In an embodiment, the toxin to be removed is urea.

As used herein, a "circuit" or "loop" means conveying fluid through one or more conduits of one or more devices. The blood flow in the blood circuit 802 can be unidirectional, which means that fresh or fresh blood is continuously supplied into the blood circuit 802 . Dialysis agent and fluid flow in circuits 804 and 806 are designed to be multi-passed, which means that the fluid is regenerated and available for a longer period of time. The flow in the circuits 804, 806 can be in a continuous or semi-continuous manner such that the fluid is repeatedly circulated through the conduits and various devices in the circuits. Flow may be generated by a pump, such as a peristaltic pump. Chemicals and/or fluids are allowed to transfer between the dialyzer circuit 804 and the blood circuit 802 and between the dialyzer circuit 804 and the toxin removal circuit 806 through the membranes 810 and 812, respectively. External fluid and/or nutrients may also be introduced into circuits 804, 806 and circuit 802, and fluid within circuits 804, 806 and circuit 802 may also be removed continuously or semi-continuously. In an embodiment, a circuit may have a constant flow rate through one of the circuits. In an embodiment, the flow rate of a primary circuit may increase or decrease over time.

Using urea as an example, the toxin removal circuit 806 is separated by a urea selective membrane 812 configured to selectively pass urea from the dialyzer circuit 804 to the toxin removal circuit 806 . In this case, the dialysant circuit 804 in FIG. 6 includes a cartridge 814 containing a similar amount of activated carbon sorbent (bottom layer) to adsorb non-urea toxins and potentially add other selective sorbents as needed or developed (top level). Activated carbon is a typical filter material, but any other compatible filter or method could be used.

In the liquid dialysis circuit shown in Figure 6, urea from the dialysant circuit 804 is removed across the urea selective membrane 812 along with other unavoidable compounds. Urea is then removed from the urea circuit 812 by any of the urea removal elements as disclosed herein. For example, urea removal element 818 may comprise a photo-oxidative urea removal element (dump). When using a dump as the urea removal element 818, it is also advantageous to include an additional activated carbon filter 816 in the toxin removal circuit 806 to remove oxychlorine species which may be a by-product during urea oxidation. Urea is used as a representative toxin, but it is understood that by selecting an appropriate toxin selective membrane 812, other uremic toxins can be removed from the dialyser circuit 804 to the toxin removal circuit 806. Furthermore, more than one toxin removal circuit, each with a different toxin selective membrane, can be included to remove more than one toxin. Alternatively, more than one different toxin selective membrane may be used at the interface between the dialysant circuit 804 and the toxin removal circuit 806 . The toxin removal element 818 can be enzyme-based (urease), bacteria-based (bioreactor), sorbent-based, and oxidation-based. 4A, 4B, 5A, 5B, and 5C show example embodiments of photo-oxidized urea removal elements.

In the present invention, the use of the toxin removal circuit 806 and toxin selective membrane 812 described with respect to FIG. And one of the hemodialysis filtration systems is conceived. In addition, the kidney dialysis system of the present invention can be configured to have a form factor selected from the group of portable, wearable, mobile and stationary systems, and the kidney dialysis system can be configured for home use Or use in dialysis centers. Dialysis Fluid Therapy and Performance Monitoring Module

The dialysis fluid handling circuit includes several modules described herein.

Referring to FIG. 3 , there is shown a schematic diagram of an oxidation module of an example of a dialysis fluid treatment system according to the present invention. An oxidation module 300 is compatible with any of the dialysis fluid treatment systems described herein, and is used to remove urea, non-urea uremic toxins, oxidation by-products, free radical by-products from post-use dialysis fluid received by a hemodialysis machine products, chlorine and/or other toxins.

Oxidation module 300 receives used dialysis fluid from fluid input conduit 302, uses a photo-oxidation module 304 and/or an electro-oxidation module 306 to oxidize urea into components (including CO ₂ , N ₂ and H ₂ O) from dialysis The fluid removes urea and provides detoxified dialysis fluid to fluid output conduit 308 . In the illustrated embodiment, the oxidation module 300 includes both a photooxidation module 304 and an electro-oxidation module 306, wherein the electro-oxidation module 306 is positioned upstream of the photo-oxidation module 304 so as to The oxidation module 304 removes selected toxins prior to processing. In another embodiment, the oxidation module 300 only includes a photooxidation module 304 (instead of an electro-oxidation module). In yet another embodiment, the oxidation module 300 only includes an electro-oxidation module 306 (rather than a photo-oxidation module).

The photo-oxidation module 304 removes urea from the dialysis fluid using a photo-oxidation process. Photo-oxidation module 304 includes a photo-oxidation fluid cell having at least two electrodes (an anode and a cathode) separated by a dielectric spacer (eg, a rubber, silicon or plastic spacer). In operation, dialysis fluid containing urea is held in a photo-oxidizing fluid cell between two electrodes and is illuminated with light that promotes the photo-oxidation of urea to _CO2 , _H2O and _N2 . In an embodiment, oxygen (eg, in the form of ambient air) is pumped through the cathode and flows through the dialysis fluid to the anode. Example photo-oxidation modules are described below with respect to Figures 4A, 4B, 5A, 5B, and 5C.

Optional electro-oxidation module 306 utilizes an electro-oxidation process to remove urea from the dialysis fluid. Electro-oxidation module 306 includes an electro-oxidation fluid cell having two electrodes (an anode and a cathode) spaced therein. In operation, dialysis fluid containing urea is maintained in the electro-oxidative fluid cell between two electrodes. Application of a voltage across the two electrodes results in the formation of free radicals near the anode surface which degrade urea in the dialysis fluid.

Gaseous by-products (e.g., _CO2 , _N2 , _O3 , and _H2O vapors) are produced by the photooxidation process within photooxidation module 304, either from chemical reactions occurring therein or due to the transfer of thermal energy to the dialysis Evaporation of fluids. Additionally, in an embodiment, oxygen is pumped into the photo-oxidizing fluid cell, generating gas bubbles. Accordingly, an optional ultrafiltration monitoring module 310 is configured to remove gas from the dialysis fluid circuit through at least one membrane 312 in fluid contact with the output fluid stream. In an embodiment, the ultrafiltration monitoring module 310 utilizes a vacuum pump 314 to create a pressure differential across the membrane 312, thereby facilitating the removal of gas from the dialysis fluid. In an embodiment, the ultrafiltration monitoring module 310 is fluidly coupled to a cleaning module of the dialysis fluid treatment system and provides a removal gas (eg, _O3 ) to the cleaning module for use as a disinfectant.

Advantageously, evaporation of the dialysis fluid can remove excess fluid, eg 0.5 L/hr, from a patient. In an embodiment, the ultrafiltration monitoring module 310 measures an amount of gas removed from the output fluid stream and determines a fluid removed from a patient connected to a hemodialysis machine based on the amount of gas removed from the output fluid stream quantity. The ultrafiltration monitoring module 310 employs at least one sensor 316 (such as an ultrasonic sensor, an optical sensor, or an oxygen sensor positioned to count air bubbles generated by the photooxidation module 304) Sensing the amount of evaporated gas.

In addition to removing excess fluid from a patient, evaporated gas is also indicative of the efficiency of the oxidation module 300, ie, the rate of chemical conversion of dialysis fluid to _CO2 and _N2 per unit time. In an embodiment, based on the sensed amount of evaporated gas, the ultrafiltration monitoring module 310 adjusts the flow rate or pressure of the dialysis fluid passing through the oxidation module 300 (such as by controlling a pump and/or A valve), a current supplied to a light source of the photo-oxidation module 304 and/or a voltage applied to an electrode in the oxidation module 300 and/or the photo-oxidation module 304. These changes in turn alter the rate of the oxidation process in photo-oxidation module 304 and electro-oxidation module 306 .

Representative photooxidation modules include those described in U.S. Patent Application No. 16/536277, filed August 8, 2019, and U.S. Provisional Patent Application No. 63/165098, filed March 23, 2021, which The entire contents of et al. are incorporated herein by reference.

Referring to FIG. 4A , there is shown an exploded view of an example oxidation module according to the present invention, such as the type used as photooxidation module 304 in FIG. 3 . An example urea treatment unit 20 in the form of an oxidation module is a photoelectric urea treatment unit that removes urea by an electrochemical reaction. System 20 includes two electrodes 24, 26 separated by a dielectric spacer 27 (eg, rubber, silicon or plastic spacer). In operation, a dialysis agent containing urea is held between the two electrodes 24, 26 and is illuminated by light which promotes the photooxidation of urea to _CO2 , _H2O and _N2 .

The required light source can be provided by an ultraviolet (UV) lamp 22. Electrochemical reactions also require oxygen. Providing the required oxygen is described below with reference to Figure 4B.

Referring to Figure 4B, there is shown a side view of an example oxidation module in operation according to the present invention. An example urea treatment unit 20 in the form of an oxidation module enables air to flow into conduit 28 and further to the dialysis agent containing urea inside the photovoltaic urea treatment unit 20 . Arrow 29 indicates the flow of incoming air generating air bubbles 31 in the dialysate. While effective, in this example the quantum efficiency of incident photons from the UV lamp 22 to the electrochemical reaction can be relatively low, sometimes less than 1%. Therefore, the urea treatment unit may still be too large to achieve the target of about 15 g to 20 g urea removal in a portable device. Improved oxygen supply is described below with reference to FIG. 5A.

Referring to FIG. 5A , there is shown an exploded view of an oxidation module according to an example of the present invention. A urea treatment unit 720 is an oxidation module according to an embodiment of the present invention. In an embodiment, dialysant 715 flows through a spacer 732 from an inlet 734 to an outlet 736 . Dialysis agent 715 carries urea that electrochemically decomposes into _CO2 and _N2 . Spacers 732 may be sandwiched between an anode 722 and a cathode 742, each connected to a voltage source 792 (eg, a DC voltage source). In an embodiment, the voltage source 792 provides a voltage difference in a range from about 0.6V to about 0.8V. In the embodiment of spacer 732, the entire dialysant fluid is directed through the _Ti02 layer.

In embodiments, the cathode may be a gas and/or air permeable cathode 742 that blocks liquids such as water but passes gases such as air and/or oxygen. In operation, gas stream 760 comprising oxygen may flow through cathode 742 to a dialysant comprising urea. In an embodiment, cathode 742 is made of conductive fabric. For example, the conductive fabric can be a platinum-coated (Pt-coated) fabric or carbon cloth. In an embodiment, the cathode 742 may be a conductive paper-based cathode. The gas permeable (breathable air) cathode 742 may be mechanically held in place by one or more spacers (such as spacers 732) having support elements for the cathode 742, for example, the spacers may have mesh support elements or other Breathable structural elements.

In an embodiment, the anode 722 is equipped with nanostructures (eg, TiO ₂ nanowires). In operation, anode 722 is illuminated by a light source that emits light (eg, UV light) for the electrochemical reaction shown in Equation 1 . One or more light sources may be used to emit light (eg, light emitting diodes (LEDs), lasers, discharge lamps, etc.). The light sources may be arranged in a two-dimensional (2D) array. In an embodiment, the LED emits light at a wavelength of 365 nm. In an embodiment, the LED emits light at an ultraviolet (UV) or visible wavelength. In an embodiment, the LED produces light at an intensity of less than 4 mW/cm2 at the anode surface (eg, at the surface of the substrate 721). In other embodiments, other higher light intensities may be used, such as light with an intensity greater than 4 mW/cm2 at the anode surface. In an embodiment, the quantum efficiency of incident photons (incident photoelectric efficiency) is about 51%. In an embodiment, nanostructured anode 722 may operate based on incident natural light with or without dedicated light array 750 . At the anode, photoexcited _TiO2 nanostructures provide holes for oxidation of solution species on the surface, while electrons are collected on the underlying conducting oxide (such as fluorine-doped thin oxide or FTO) and are then Transported to the cathode electrode to split water into OH-. Photoexcitation can be provided by a light source 750 or by natural light. In embodiments, a controller 794 may control the operation of the pump to regulate blood input and flow of dialysant during use.

In an embodiment, the urea processing unit 720 may be used to prepare a dialysis fluid. For example, water to be treated may be passed between anode 722 and cathode 742 to oxidize impurities in the water to be treated, thereby producing dialysis fluid. An example embodiment of a urea processing unit 720 is described below with reference to FIGS. 5B and 5C .

Referring to FIG. 5B, there is shown a perspective view of an example oxidation module in an exploded configuration in accordance with the present invention. The illustrated photo-oxidation module 400 may form part of any oxidation module of the present invention. The photo-oxidation module 400 includes a photo-oxidation fluid cell 402 through which dialysis fluid flows between an anode 404 and a cathode 406 . In the illustrated embodiment, dialysis fluid 408 flows through a divider 410 from an inlet 412 to an outlet 414 . Dialysis fluid 408 carries urea that is electrochemically decomposed into _CO2 and _N2 . In an embodiment, spacer 410 is disposed between anode 404 and cathode 406, each individually connected to a voltage source 416 (eg, a DC voltage source). In an embodiment, the voltage source 416 provides a voltage difference in a range from about 0.6V to about 0.8V. In the embodiment of spacer 410 , the entire flow of dialysis fluid 408 is directed through anode 404 .

Anode 404 is configured to generate photoelectrons or holes when exposed to light. In an embodiment, the anode 404 has a substrate 418 carrying nanostructures 420 formed of a nanomaterial, such as TiO ₂ nanowires. Anode 404 may be held in a substrate holder 422 . In operation, the anode 404 is illuminated by at least one light source 424 that emits light (eg, UV light) for the electrochemical reaction shown in Equation 1 . At the anode 404, photoexcited nanostructures 420 provide holes for oxidation of solution species on the surface, while electrons are collected on the underlying conductive oxide (such as fluorine-doped thin oxide or FTO) and then transported to the cathode electrode To decompose water into OH ^- .

The light required for the photochemical decomposition of urea may be provided by a light array 426 comprising one or more light sources 424 such as light emitting diodes (LEDs), lasers, discharge lamps, and the like. Light sources 424 may be arranged in a two-dimensional (2D) array, such as on a panel. In an embodiment, the light source 424 emits light at a wavelength of 365 nm. In an embodiment, the light source 424 emits light at an ultraviolet (UV) or visible wavelength. In an embodiment, the light source 424 produces light at an intensity of less than 4 mW/cm2 at the surface of the anode 404 (eg, at the surface of the substrate 418). In embodiments, higher light intensities may be used, such as light having an intensity of 4 mW/cm2 or higher at the surface of the anode 404 . In an embodiment, one quantum efficiency of incident photons (incident photoelectric efficiency) is about 51%. In an embodiment, anode 404 may operate based on incident natural light with or without dedicated light array 426 .

Cathode 406 is liquid (eg, water) resistant and, in an embodiment, gas permeable, allowing gas (eg, air or oxygen) to pass through. In an embodiment, cathode 406 is made of conductive fabric. For example, the conductive fabric can be a platinum coated (Pt coated) fabric or carbon cloth, or titanium felt. In an embodiment, the cathode 406 may be a conductive paper-based cathode. Cathode 406 may be mechanically held in place by spacers 428, 430 with support elements for cathode 406, such as mesh support elements 432, mesh support elements 434 (or other gas-permeable structural elements). In an embodiment, ambient air is pumped through the cathode 406 towards the anode 404 . In other embodiments, cathode 406 is not formed from a gas permeable material such as a stainless steel plate. In these embodiments, air or oxygen is introduced into the system through an air introduction member. In example embodiments, the air introduction means include fluid conduits formed through the cathode 406 or fluid conduits formed through an end plate.

The electrochemical reactions occurring in the photooxidation module 400 can be described as follows: (Equation 1)

For at least some embodiments of the present invention, significant and unexpected performance improvements were observed when compared to the performance of the prior art. For example, to match a daily urea production to a 6e ^- oxidation program with a daily target of 15 grams (0.25 moles), use a current of 1.7 A over a 24 hour period. For a target 1 mA/cm ² photocurrent density on a TiO ₂ nanostructured anode, the total device area becomes about 1700 cm ² or 1.82 ft ² . With this total device area, it becomes feasible to deploy a relatively small, portable and/or wearable device that oxidizes approximately 15 g of urea per day. At least some embodiments of such a device will utilize about a dozen 8000 mAh batteries for 8 hours of operation without recharging and use proportionally fewer batteries for shorter operations, ultimately providing a significant advantage over prior existing efforts Technical advantages.

Furthermore, the high conversion efficiency of urea decomposition at low concentrations demonstrates the high selectivity of _TiO2 for oxidation of urea versus the production of generally undesirable oxochlorine species. In addition, the photocurrent density is more than an order of magnitude higher than that achieved by the prior art without nanostructures or optical arrays.

The photo-oxidation module 400 in FIG. 4 is representative and not limiting. Other embodiments may utilize different photo-oxidation modules, such as described below with reference to FIG. 5C.

Referring to FIG. 5C , there is shown a perspective view of an oxidation module according to another example of the present invention. The illustrated oxidation module 500 may form part of any oxidation module of the present invention. Similar to photooxidation module 400 of FIG. 5B , photooxidation module 500 includes at least one cathode, anode, and light source that act on the dialysate fluid in a photooxidation fluid unit, as described below.

In use, dialysis input fluid flow 518 enters fluid distribution member 512a, which distributes dialysis fluid between the three photo-oxidizing panels 502a, 502b, 502c. As the dialysis fluid flows through the fluid channel 506 of each photo-oxidation panel, the light panels 504a, 504b illuminate the anode of each photo-oxidation panel, thereby initiating the oxidation of urea in the dialysis fluid to _CO2 , _N2 and _H2O . Oxidative dialysis output fluid flow 520 exits photo-oxidative panels 502a, 502b, 502c via fluid distribution member 512b. The gaseous components of the oxidative dialysis fluid, including _CO2 and _N2 , are separated from the _H2O as gas bubbles, which exit the fluid conduit through a membrane (eg, in an ultrafiltration monitoring module as described above).

Specifically, the photo-oxidation module 500 can be formed as a stack of photo-oxidation panels 502a, 502b, 502c and a plurality of photo-oxidation panels 504a, 504b. Each light panel 504a, 504b is positioned adjacent to at least one photo-oxidized panel, for example between two adjacent photo-oxidized panels.

Although the illustrated embodiment includes three photooxidized panels, other embodiments may include a different number of panels, such as one, two, four, five or more panels. Similarly, although the illustrated embodiment includes two light panels, other embodiments may include a different number of panels, such as one, three, four, five, or more panels, to increase urea transfer. remove capacity or reduce size. In an embodiment, the photo-oxidation module 500 includes the same number of photo-oxidation panels as the number of photo-oxidation panels, or one less photo-oxidation panel than the number of photo-oxidation panels. In an embodiment, the light array is integrally formed with the photo-oxidation panel, and thus the photo-oxidation module 500 does not have any separate light panels.

Each photo-oxidation panel 502a, 502b, 502c comprises a photo-oxidation fluid cell having a plurality of parallel fluid channels 506 branching from a fluid inlet 508 and converging at a fluid outlet 510 . Photooxidation panels 502a, 502b and 502c are fluidly connected to each other on the input and output sides by fluid distribution members 512a and 512b, respectively. In an example embodiment, fluid distribution members 512a and 512b include manifolds and/or flexible conduits.

Each photo-oxidation panel includes an anode/cathode array 514 disposed in the fluid channel 506 . In one embodiment, a first side of the anode/cathode array 514 is a _TiO2 /FTO anode ( _TiO2 hydrothermally grown on conductive fluorine-doped thin oxide glass). In one embodiment, a second side of the anode/cathode array 514 is a Pt/C gas permeable cathode catalyst (Pt coated carbon paper side). According to certain embodiments, anode/cathode arrays 514 each have an effective surface area of between about 0.25 to 2.0 square feet to remove 12 to 15 g of urea (a representative level of human urea production) in 24 hours. Although a _Ti02 /FTO anode and a Pt/C cathode are used in the depicted embodiment, other embodiments may utilize different anode and/or cathode compositions.

Light panels 504a, 504b each include a light array 516 (eg, LEDs) facing the anode of at least one adjacent photo-oxidation panel and providing light activation to initiate oxidation of urea in the dialysis fluid flowing through fluid channel 506 . Although LEDs are used in the illustrated light panels 504a, 504b for their equivalent efficiency and output, other embodiments include other forms of illumination such as lasers, discharge lamps, and the like. Dialysis fluid regeneration method

Referring to Figure 7, there is shown a schematic diagram of an example method of treating dialysis fluid according to the present invention. An example method 600 of treating dialysis fluid may be implemented with any of the dialysis fluid treatment systems described herein, but is not limited to such dialysis fluid treatment systems.

In step 602, a dialysis fluid is received from a hemodialysis machine, such as by any of the dialysis fluid handling systems described herein.

In optional step 604, the pH of one of the dialysis fluids is determined and optionally adjusted. In an embodiment, the determined pH is used in a feedback loop to regulate the flow of dialysis fluid between an anode and a cathode. For example, a completion parameter of hemodialysis treatment is determined based on the determined pH, and the flow of dialysis fluid is optionally slowed or stopped based on the determined pH.

In step 606, the dialysis fluid is separated into a urea-containing dialysis fluid stream and a urea-containing dialysis fluid stream by filtering the dialysis fluid, such as with a urea-selective membrane (forward or reverse osmosis membrane), nanofiltration membrane, or ion exchange membrane. One by-product excess fluid flow of disease toxins, sodium and other by-products.

In step 608, dialysis fluid is flowed between an anode and a cathode while a light source illuminates the anode to oxidize urea in the dialysis fluid and generate _H2O . Optionally, when the anode is illuminated with a light source, oxygen flows through the dialysis fluid through the cathode and towards the anode.

In optional step 612, one or more gases (eg, _CO2 , _N2 ) are removed from the dialysis fluid. In an embodiment, an amount of gas removed is determined and optionally used to measure an efficiency 610 of the urea oxidation process and optionally adjust one of current draw, voltage, flow rate or pressure of the dialysis fluid conversion process.

In step 614, H ₂ O produced by oxidation of urea in the dialysis fluid is provided to a hemodialysis machine.

In optional step 616, a dialysis treatment is performed using the _H2O provided in step 614 as the dialysis fluid. Circuitry, processor and computer implementation

Embodiments disclosed herein, including those that include or utilize a controller, a processor, and/or processor-executable instructions, may utilize circuitry to implement the techniques and methods. The circuitry may operably connect two or more components, generate information, determine operating conditions, control an appliance, device or method, and/or the like. Any type of circuitry can be used. In an embodiment, the circuitry includes dedicated hardware with electronic circuitry configured to perform operations or calculations on a dedicated basis without the use of any microprocessors, central processing units or software or firmware or processors Executable instructions. However, in embodiments, the circuitry includes, inter alia, one or more computing devices, such as one or more processors (eg, microprocessors), one or more central processing units (CPUs), one or more digital signal processing (DSP), one or more Application Specific Integrated Circuits (ASICs), one or more Field Programmable Gate Arrays (FPGAs), or the like, or any variation or combination thereof, and may include discrete digital and/or Or analog circuit elements or electronic devices, or combinations thereof.

In an embodiment, the circuitry includes one or more ASICs having a plurality of predefined logic components. In an embodiment, the circuitry includes one or more FPGAs having a plurality of programmable logic elements. In an embodiment, the circuitry includes hardware circuitry implementations (eg, analog circuitry implementations, digital circuitry implementations, and the like, and combinations thereof). In an embodiment, circuitry includes circuits and computer program products having software or firmware processor-executable instructions stored on one or more computer-readable memories (e.g., non-transitory computer-readable storage media) Combinations that work together to cause an apparatus or system to perform one or more of the methods or techniques described herein.

In an embodiment, the circuitry includes circuitry that requires software, firmware, and the like for operation, such as, for example, a microprocessor or a portion of a microprocessor. In an embodiment, the circuitry includes an implementation including one or more processors, or portions thereof, and accompanying software, firmware, hardware, and the like. In an embodiment, the circuitry includes a baseband IC or an application processor IC or a similar IC in a server, a cellular network device, other network device, or other computing device. In an embodiment, the circuitry includes one or more remote positioning components. In an embodiment, the remote location component (e.g., server, server cluster, server farm, virtual private network, etc.) is operatively connected to a non-remote location component (e.g., desktops, workstations, mobile devices, controllers, etc.). In an embodiment, the remote positioning component is operatively connected via one or more receivers, transmitters, transceivers, or the like.

Embodiments include, for example, one or more data stores for storing instructions and/or data. Non-limiting examples of one or more data stores include volatile memory (e.g., random access memory (RAM), dynamic random access memory (DRAM), or the like), nonvolatile memory ( For example, read only memory (ROM), electrically erasable programmable read only memory (EEPROM), compact disc read only memory (CD-ROM) or the like), nonvolatile memory or the like. Further non-limiting examples of one or more data stores include erasable programmable read only memory (EPROM), flash memory, or the like. One or more data storage devices may be connected to, for example, one or more computing devices by one or more command, data or power buses.

In an embodiment, the circuitry includes one or more computer-readable media drives, interface sockets, universal serial bus (USB) ports, memory card slots, or the like, and one or more input/output components, such as, for example, a graphical user interface, a display, a keyboard, a keypad, a trackball, a joystick, a touch screen, a mouse, a switch, a dial or the like, and any other peripherals. In an embodiment, the circuitry includes one or more user input/output components operably connected to at least one computing device for control (electrical, electromechanical, software-implemented, firmware-implemented, or other control, or a combination thereof) One or more aspects of an embodiment.

In an embodiment, the circuitry includes a computer-readable media drive or memory socket configured to accept a signal-bearing medium (eg, a computer-readable memory medium, a computer-readable recording medium, or the like). In embodiments, a program for causing a system to perform any of the disclosed methods may be stored, for example, on a computer readable recording medium (CRMM), a signal bearing medium, or the like. Non-limiting examples of signal bearing media include a recordable type of media such as any form of flash memory, magnetic tape, floppy disk, a hard drive, a compact disk (CD), a digital video disk (DVD), Blu-ray Disc , a digital tape, a computer memory or the like, and transmission type media such as a digital and/or analog communication medium (e.g., an optical cable, a waveguide, a wired communication link, a wireless communication link (eg, transmitter, receiver, transceiver, transmit logic, receive logic, etc.) Further non-limiting examples of signal bearing media include, but are not limited to, DVD-ROM, DVD-RAM, DVD+RW, DVD- RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, Video Compact Disc, Super Video Disc, Flash Memory, Tape, Magnetic CD-ROM, mini-disc, non-volatile memory card, EEPROM, CD-ROM, optical storage, RAM, ROM, system memory, web server or the like. Terms and Conditions

The above detailed description set forth in conjunction with the accompanying drawings (where the same reference numerals refer to the same elements) is intended as a description of various embodiments of the present invention, and is not intended to represent the only embodiment. Each embodiment described in this disclosure is provided as an example or illustration only and should not be construed as preferred or preferred over other embodiments. The illustrative examples provided herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Similarly, any steps described herein may be interchanged with other steps or combinations of steps in any suitable combination and/or order to achieve the same or substantially similar results. In general, the embodiments disclosed herein are non-limiting, and the inventors contemplate that other embodiments within the scope of the invention may include structures from more than one of the specific embodiments shown in the drawings and described in the specification and functions.

In the foregoing description, specific details are set forth in order to provide a thorough understanding of example embodiments of the invention. However, it will be apparent to those skilled in the art that the embodiments disclosed herein may be practiced without all of the specific details. In some instances, well known procedural steps have not been described in detail in order not to unnecessarily obscure aspects of the invention. Further, it should be understood that embodiments of the invention may employ any combination of the features described herein and/or alternatives thereto.

Although the term "hemodialysis" is used throughout this disclosure for consistency and ease of understanding, the dialysis fluid treatment systems disclosed herein, either expressly or implicitly, are not limited to use with a hemodialysis machine.

As used herein, the terms "fluid" and "fluidly" when used to refer to the connection of specific structures, such as channels, conduits, connections, and the like, mean that these elements are directly or indirectly fluid or fluid with each other. The nature of communication such that a fluid, such as a liquid, can flow from one such element to another such element via one or more connections therebetween.

This application may contain references to directions such as "vertical," "horizontal," "front," "back," "left," "right," "top," and "bottom," among others. These references and other similar references in this application are intended to aid in the description and understanding of particular embodiments, such as when the embodiments are used in orientation, and are not intended to limit the invention to such orientations or positions.

This application may also refer to quantities and numbers. Unless specifically indicated, such quantities and numbers should not be considered limiting, but examples of possible quantities or numbers associated with the present application. Also in this regard, this application may use the term "plurality" to refer to a quantity or number. In this regard, the term "plurality" means any number greater than one, such as 2, 3, 4, 5 and so on. The terms "about," "approximately," "approximately," and the like include stated values as well as unstated values that are near or approximately to the stated value within a practicable range that one skilled in the art will recognize. The term "based on" means "based at least in part on."

For the purposes of the present invention, the phrase "at least one of A, B, and C" means (A), (B), (C), (A and B), (A and C), (B and C) or (A, B, and C), when more than three elements are listed, includes all further possible permutations. Likewise, as used herein, the term "A, B and/or C" means (A), (B), (C), (A and B), (A and C), (B and C) or (A, B and C), when more than three elements are listed, all further possible permutations are included. Unless otherwise indicated, the term "or" is an inclusive "or" and the phrase "A or B" means (A), (B) or (A and B). The term "and" requires two elements unless otherwise indicated; for example, the phrase "A and B" means (A and B).

In the claims and for the purposes of the present invention, the terms "comprising", "comprises", "comprise" and the like are open ended and do not exclude any additional feature, element, material or step.

The principles, representative embodiments and modes of operation of the present invention have been described in the foregoing description. However, the intended aspects of the invention should not be construed as limited to the particular embodiments disclosed. Further, the embodiments described herein are to be considered as illustrative and not restrictive. It is to be understood that changes and changes can be made by others, and equivalents employed, without departing from the spirit of the invention. Accordingly, all such alterations, modifications, and equivalents are expressly intended to fall within the spirit and scope of the claimed invention.

While illustrative embodiments have been shown and described, it should be understood that various changes may be made therein without departing from the spirit and scope of the invention.

20: Urea treatment unit 22: Ultraviolet (UV) lamp 24: electrode 26: electrode 28: pipeline 29: Arrow 31: Bubbles 100:Hemodialysis system 102: Hemodialysis machine 104: Dialysis fluid handling system 106: Patient 108: pipeline 110: blood pump 112: pipeline 114: pipeline 200: Dialysis fluid handling system 202: Fluid input conduit 204: pump 206: Fluid output conduit 208: shell 210: Coupler 212: Coupler 214: Service Hatch 216: Controller 218: Processor 220: data storage 222: power supply 224: user interface 226:Communication module 228: Oxidation module 230: Filter module 232: Toxin Selective Membrane 234: Excess Fluid Outlet Conduit 236: pH monitoring module 238:Flow monitoring module 240: sensor array 242: Temperature control device 244: Cleaning module 246: Fluid Conduit 300: oxidation module 302: Fluid input conduit 304:Photooxidation module 306: Electro-oxidation module 308: Fluid output conduit 310:Ultrafiltration monitoring module 312: Membrane 314: vacuum pump 316: sensor 400: photooxidation module 402: photooxidation fluid unit 404: anode 406: Cathode 408: Dialysis fluid 410: spacer 412: entrance 414: export 416: Voltage source 418: Substrate 420: Nanostructure 422: substrate support 424: light source 426: light array 428: spacer 430: spacer 432: mesh support element 434: mesh support element 500: photooxidation module 502a: Photooxidation panel 502b: Photooxidation panel 502c: photooxidation panel 504a: Light panel 504b: Light panel 506: Fluid channel 508: Fluid inlet 510: fluid outlet 512a: Fluid distribution member 512b: Fluid distribution member 514: anode/cathode array 516: light array 518: Dialysis input fluid flow 520: oxidative dialysis output fluid flow 600: method 602: Step 604: Step 606: Step 608: Step 610: Step 612: Step 614:Step 616: Step 715: Dialysis agent 720: Urea treatment unit 722: anode 732:Spacer 734:Entrance 736: Export 742: Cathode 750: dedicated light array 760: Airflow 792:Voltage source 794:Controller 800: Patient 802:Patient blood circuit 804: Dialysate circuit 806: Toxin Removal Circuit 810: Dialysis membrane 812: Toxin Selective Membrane 814: barrel 816: Activated carbon filter 818:Toxin removal component

The foregoing aspects of the present invention, and the many attendant advantages thereof, will be more readily understood, and likewise better understood, when reference is made to the following detailed description, taken in conjunction with the accompanying drawings, in which:

Figure 1 is a side view of a hemodialysis machine fluidly connected to a dialysis fluid handling system according to an example embodiment of the present invention.

Figure 2 is a schematic diagram of a dialysis fluid treatment system according to an example of the present invention.

Fig. 3 is a schematic diagram of an oxidation module of an example of a dialysis fluid treatment system according to the present invention.

FIG. 4A is an exploded view of an oxidation module according to an example of the present invention.

Figure 4B is a side view of an example oxidation module in operation according to the present invention.

FIG. 5A is an exploded view of an oxidation module according to an example of the present invention.

5B is a perspective view of an example oxidation module in an exploded configuration in accordance with the present invention.

Fig. 5C is a perspective view of an oxidation module according to another example of the present invention.

6 is a schematic diagram of an example organizational layout of a dialysis system including a toxin removal circuit according to the present invention.

7 is a schematic diagram of an example method of treating dialysis fluid according to the present invention.

200: Dialysis fluid handling system

202: Fluid input conduit

204: pump

206: Fluid output conduit

208: shell

210: Coupler

212: Coupler

214: Service Hatch

216: Controller

218: Processor

220: data storage

222: power supply

224: user interface

226:Communication module

228: Oxidation module

230: Filter module

232: Toxin Selective Membrane

234: Excess Fluid Outlet Conduit

236: pH monitoring module

238:Flow monitoring module

240: sensor array

242: Temperature control device

244: Cleaning module

246: Fluid Conduit

Claims (20)

A dialysis fluid handling system comprising: a filtration module configured to filter unfiltered dialysis fluid; and an oxidation module configured to detoxify toxic dialysis fluid via a photo-oxidation module and/or an electro-oxidation module; Wherein the filtration module and the oxidation module are a fluid input to the system for receiving used dialysis fluid from a hemodialysis machine and for feeding A fluid output of the system sending detoxified regenerated dialysis fluid to the hemodialysis machine is in fluid communication. The dialysis fluid treatment system of claim 1, wherein the oxidation module includes both the photo-oxidation module and the electro-oxidation module, and the electro-oxidation module is disposed upstream of the photo-oxidation module, wherein the fluid The input is upstream of the filtration module, the filtration module is upstream of the oxidation module, and the oxidation module is upstream of the fluid output. The dialysis fluid treatment system of claim 1, wherein the oxidation module includes the photo-oxidation module, and wherein the photo-oxidation module includes an anode, a light source configured to illuminate the anode, and an oxygen-permeable cathode . The dialysis fluid treatment system of claim 3, wherein the anode comprises nanomaterials, nanostructures or titanium dioxide nanowires configured to generate photoelectrons or holes when exposed to light. The dialysis fluid treatment system of claim 3, wherein the light source comprises a light array or a plurality of LEDs formed on a light panel, and wherein the anode and the cathode are connected to a voltage source and placed in configured One of the photooxidized fluid units to receive the dialysis fluid. The dialysis fluid treatment system according to claim 3, wherein the anode and the cathode are formed as a photo-oxidation panel or a plurality of photo-oxidation panels. The dialysis fluid treatment system of claim 1, wherein the photo-oxidation module further comprises an ultrafiltration monitoring module configured to sense an amount of evaporated gas from the dialysis fluid with a sensor. The dialysis fluid treatment system of claim 7, wherein the ultrafiltration monitoring module is configured to vary based on the amount of evaporated gas from the dialysis fluid: the flow rate of the dialysis fluid through the photo-oxidation module, the pressure of the dialysis fluid through the photo-oxidation module, and/or the current supplied to the light source; and/or Gas is evaporated from the detoxified dialysis fluid through a membrane in fluid contact with the output fluid stream, optionally using a vacuum pump. The dialysis fluid treatment system of claim 7, wherein the ultrafiltration monitoring module is configured to sense a current draw of the photooxidation module, a voltage of the photooxidation module, and/or the photooxidation module One heat output. The dialysis fluid treatment system of claim 7, further comprising a sensor operatively connected to the oxidation module and a controller, wherein the controller includes a processor and processor-executable instructions, the instructions causing the ultrafiltration monitoring module when executed by the processor to: using the sensor to measure an amount of gas removed from the detoxified dialysis fluid, and Based on the amount of gas removed from the detoxified dialysis fluid, a fluid amount removed from a patient connected to the hemodialysis machine is determined with the processor. The dialysis fluid treatment system of claim 1, further comprising a pH monitoring module disposed upstream of the oxidation module, wherein the pH monitoring module is configured to: monitoring a pH level of the dialysis fluid, and adjusting the pH level by adding electrolytes to the dialysis fluid; determining a completion parameter of a hemodialysis procedure run on the hemodialysis machine and/or an operating condition of the dialysis fluid treatment system based on the pH level of the dialysis fluid; and/or Ammonia is removed from the dialysis fluid. The dialysis fluid treatment system of claim 1, further comprising a flow monitoring module operatively connected to the fluid input and a controller including a processor and processor-executable instructions, wherein the flow monitoring module is passed Configure to: sensing an input visual characteristic of the dialysis fluid in the fluid input, sensing an output visual characteristic of the dialysis fluid in the fluid output, and comparing the input visual characteristic and the output visual characteristic with the processor to generate a comparing, and based on the comparison, using the processor to determine a relative uremic toxin level of the dialysis fluid in the fluid output; and/or monitoring an input temperature of the dialysis fluid near the fluid inlet, an output temperature of the dialysis fluid near the fluid outlet, a pressure of the dialysis fluid and/or a flow rate of the dialysis fluid; and When the input temperature, the output temperature, the pressure and/or the flow rate deviate from a threshold value and exceed a deviation limit, perform a safety action, wherein the safety action includes: transmit a secure message to a remote receiver, regulating the temperature of the dialysis fluid received in the fluid input, and/or The flow rate of one of the pumps in fluid communication with the dialysis fluid is decreased. The dialysis fluid treatment system of claim 1, further comprising a flow monitoring module configured to monitor a gas output of the photooxidation module, a current draw of the photooxidation module, and and/or a thermal output of the photo-oxidation module to monitor an efficiency level of the dialysis fluid treatment system; and adjust a flow rate of the dialysis fluid and/or an illumination of the dialysis fluid based on the efficiency level. The dialysis fluid treatment system of claim 1, further comprising a communication module operatively connected to a controller, the communication module configured to receive a user input, and based on the user input to transmit a system service signal, a medical assistance signal, and/or a dialysis fluid handling system operation signal; wherein the communication module is further configured to receive a temperature, a pressure, and/or a flow rate indicative of the dialysis fluid in the fluid input A safety signal has deviated from a threshold value by more than a deviation limit, and based on the safety signal, a safety message is transmitted to a user interface of the dialysis fluid treatment system and/or to a remote receiver. A hemodialysis system comprising: a hemodialysis machine supplied with water from a water source and configured to produce a dialysis fluid; and The dialysis fluid treatment system of claim 1, wherein the dialysis fluid treatment system is configured to receive used dialysis fluid from the hemodialysis machine and provide detoxified dialysis fluid to the hemodialysis machine. A method of treating dialysis fluid, the method comprising: receiving used dialysis fluid from a hemodialysis machine; filtering the used dialysis fluid; converting urea in the used dialysis fluid to _CO2 , _N2 and H by ₂ O: flowing the used dialysis fluid between an anode and a cathode; and illuminating the anode with a light source; and providing H ₂ O to the hemodialysis machine. The method of claim 16, wherein converting urea further comprises flowing oxygen through the cathode to the post-use dialysis fluid; and/or Wherein filtering the post-use dialysis fluid comprises filtering the post-use dialysis fluid with a permeable membrane prior to converting the urea of the dialysis fluid. The method of claim 17, further comprising adjusting a pH of the dialysis fluid before regenerating the dialysis fluid; and/or A completion parameter of a hemodialysis procedure and/or a safe operating condition of a dialysis fluid treatment system are determined based on the pH. As the method of claim 16, further comprising determining from the urea converted from the dialysis fluid: a gas output from a photo-oxidation module, A current drawn by one of the light sources, A voltage applied to an anode/cathode array, and/or A heat output of the light source. The method of claim 19, further comprising adjusting the flow of the dialysis fluid and/or the illumination of the dialysis fluid based on the gas output, the current draw, the voltage and/or the heat output.