JP2018525141A - Authentication system used in adsorbent-based dialysis systems for therapeutic optimization - Google Patents

Abstract

A dialysis authentication and management system comprising at least one dialysis component having at least one authentication component secured thereon. The dialysis component can be any one of a dialyzer, an adsorbent cartridge, a refiller, or any other dialysis component. The authentication component can be selected from the group of radio frequency identification markers, barcodes, 1-Wire security components and wireless authentication components. The authentication system can ensure that all components used are in proper use and / or certified. The system can also manage the replenishment of replenishable components and optionally manage the dialysis treatment.
[Selection] Figure 1a

Description

This application is a continuation-in-part (CIP) of US patent application No. 14 / 261,751 filed on April 25, 2014, which is a US provisional application filed on February 26, 2014. No. 61 / 945,095 claims priority, each of which is hereby fully incorporated by reference.

(Technical field)
The present invention relates to an authentication and tracking system that can be used for therapeutic optimization of an adsorbent-based dialysis system. The present invention can authenticate dialysis components to eliminate counterfeits and manage product characteristics such as the number of refills for reusable adsorbent modules and the unique filling for containers, among others. The present invention can be used to manage the correct combination of a particular patient and dialysis component, thereby improving the efficiency of the dialysis system and reducing the risk of transmitting an infection. The dialysis system can be optimized based on data including patient information transferred from the authentication system. The present invention can provide remote access to patient information, which improves the overall patient management and flexibility of dialysis treatment.

  The therapeutic outcome of hemodialysis treatment depends on many factors such as individual patient health, treatment options, dialysis system specific settings, use of consumables for dialysis, events occurring during treatment and Affected by related environmental factors. The individual components of the dialysis system, including the adsorbent cartridge, must provide a sufficient structural and functional foundation for proper coordination and optimized therapy.

  In an adsorbent dialysis system, spent dialysate is recirculated by the adsorbent cartridge rather than discarded. The adsorbent cartridge includes a layer of adsorbent material that selectively removes or degrades specific toxins in the dialysate. One of the disadvantages of adsorbent dialysis systems is the high cost due to the expensive materials used in the adsorbent cartridge. Discarding the cartridge after each use creates waste and further increases costs. Regeneration of some or all of the components of the adsorbent cartridge for reuse reduces long-term costs.

  Generally, only products that are manufactured, designed, or certified are to be used in dialysis systems. Inappropriate use of dialysis components can degrade system performance, which jeopardizes patient safety. Inappropriate use, use non-certified products, use replenishable components that are not fully replenished or have exceeded their useful life, dialysis components that do not meet specific patient needs Can be included. In addition, since many dialysis components are in contact with the patient through blood or other fluid communication, the mutual use of dialysis components between patients is strictly prohibited to avoid contamination.

  Accordingly, there is a need for a method and system for identifying specific components of a dialysis system, such as a modular adsorbent cartridge having removable components or parts. There is a need to track dialysis components to ensure that certified components are used within their useful life by the correct patient. There is a need for a system that can track the individual reusable modules of a modular adsorbent cartridge to ensure that the correct adsorbent material is used by the correct patient within their useful life. There is a further need for methods and systems in which patient information can be identified, updated and easily accessed. Patient information, such as previous session data, can be used to set up a treatment optimized dialysis system for a particular patient.

  A first aspect of the present invention is directed to a dialysis authentication system, which comprises at least one authentication component for managing an adsorbent-based dialysis system that includes data corresponding to at least one dialysis component of the dialysis system; At least one identifier for reading data of one authentication component and a processor for receiving data from the at least one identifier, the data being processed by the processor to make a decision regarding at least one dialysis component Including.

  In any embodiment of the first aspect of the present invention, the authentication component can be secured to any one or more selected from the group of dialyzers, adsorbent cartridges, and refillers.

  In any embodiment of the first aspect of the invention, dialysis authentication may be selected from the group comprising radio frequency identification (RFID) markers, barcodes, 1-Wire security components and wireless authentication components.

  In any embodiment of the first aspect of the present invention, the authentication component can include an embedded memory.

  In any embodiment of the first aspect of the present invention, the authentication component can include an RFID chip and a memory chip adhered within a smart card.

  In any embodiment of the first aspect of the present invention, the authentication component may be readable and writable that allows the authentication component's data to be updated.

  In any embodiment of the first aspect of the invention, the processor may determine a non-certified component or a fake component based on data received from the authentication component.

  In any embodiment of the first aspect of the invention, the authentication system may further include a patient authentication component that stores patient information including at least one of patient prescription, treatment history, and cartridge size information.

  In any embodiment of the first aspect of the present invention, the patient authentication component can be one of an implantable device, a card-like device and a wristband device.

  In any embodiment of the first aspect of the present invention, the identifier can communicate with the authentication component and the patient authentication component, and the data from the authentication component and the patient authentication component is related to the patient dialysis system with respect to the dialysis component. Can be communicated to the processor to determine an optimized setting.

  In any embodiment of the first aspect of the present invention, the processor determines whether the dialysis component is compatible with the patient based on data received from the first, second, third or fourth authentication component. One or more of whether the component settings are appropriate and whether any changes to the settings should be made for optimized performance can be determined.

  In any embodiment of the first aspect of the invention, the discriminator can be secured on the second dialysis component to read the authentication component, and the processor has the dialysis component having the authentication component on the second It can be determined whether it is compatible with the dialysis component.

  In any embodiment of the first aspect of the invention, the discriminator can be a multi-mode type reader capable of communicating with at least two different types of authentication components.

  In any embodiment of the first aspect of the invention, the discriminator can distinguish two or more authentication components from each other when the at least one authentication component includes two or more authentication components.

  Any of the features disclosed as being part of the first aspect of the present invention may be included in the first aspect of the present invention alone or in combination.

  The second aspect of the present invention reads the first data from the first authentication component corresponding to the first dialysis component by the identifier and corresponds to the second dialysis component or patient by the identifier. Reading the second data from the second authentication component; receiving the first data and the second data from the identifier by the processor; and based on the first data and the second data by the processor. Making a determination with respect to the first dialysis component from the perspective of the second dialysis component or patient and controlling the setting of the first dialysis component for optimized performance from the perspective of the second dialysis component or patient. And a method of managing a dialysis system for performing dialysis via a wireless signal .

  In any embodiment of the second aspect of the invention, the method further comprises storing data relating to dialysis in at least one of the first authentication component and the second authentication component during or after dialysis. be able to.

  Any of the features disclosed as being part of the second aspect of the present invention may be included in the second aspect of the present invention alone or in combination.

  A third aspect of the present invention includes the step of reading data from an authentication component secured to a refillable component for use in an adsorbent-based dialysis by an identifier; Communicating, determining whether to start replenishment of a refillable component by a refiller based on data received by the processor, and using to refill the refillable component based on a determination made by the processor Controlling and selectively replenishing the replenisher.

  In any embodiment of the third aspect of the invention, the determining step is whether the refillable component has been stored too long according to a predetermined standard, or is the refillable component not fully refilled? And determining one or more of whether a refillable component has reached a refill limit.

  In any embodiment of the third aspect of the present invention, the authentication component can be an RFID component.

  Any of the features disclosed as being part of the third aspect of the present invention may be included in the third aspect of the present invention alone or in combination.

  According to a fourth aspect of the present invention, the authentication component data fixed to the multi-use cartridge is read by the identifier fixed to the hemodialysis system, and the authentication component data is communicated to the processor by the identifier. And a method comprising: determining by the processor whether the cartridge is properly used according to data communicated to the processor; and controlling hemodialysis therapy according to the determination made by the processor.

  In any embodiment of the fourth aspect of the present invention, the determining step includes determining whether the cartridge has been stored for a long time according to a predetermined standard, whether the cartridge is not fully refilled, or the cartridge is refilled. Determining one or more of the following: and whether the cartridge is compatible with the patient.

  In any embodiment of the fourth aspect of the present invention, the authentication component can be an RFID component.

  Any of the features disclosed as being part of the fourth aspect of the present invention may be included in the fourth aspect of the present invention alone or in combination.

FIG. 1a shows an example of an authentication system having at least one authentication component, a discriminator and a processor, wherein signals are transferred within the system. FIG. 1b shows an example of an authentication system having at least one authentication component, a discriminator and a processor, where signals are transferred within the system. FIG. 1c shows an example of an authentication system having at least one authentication component, a discriminator and a processor, where signals are transferred within the system. FIG. 2a shows a dialysis component and patient having an authentication component secured thereon, including an adsorbent cartridge (a), a dialyzer (b), a refiller (c) and a container (d). FIG. 2b shows a dialysis component and patient having an authentication component secured thereon, including an adsorbent cartridge (a), a dialyzer (b), a refiller (c) and a container (d). FIG. 2c shows a dialysis component and patient having an authentication component secured thereon, including an adsorbent cartridge (a), a dialyzer (b), a refiller (c) and a container (d). FIG. 2d shows a dialysis component and patient having an authentication component secured thereon, including an adsorbent cartridge (a), a dialyzer (b), a refiller (c) and a container (d). FIG. 3 shows examples of different types of authentication components including barcodes, 1-Wire security components, direct electronic connections and RFID tags. FIG. 4 shows an RFID authentication system having RFID authentication components and readers between which data communication occurred. FIG. 5 shows a writer of an authentication system having an RFID authentication component. FIG. 6 shows an RFID tag with a microchip for storage memory. FIG. 7 shows remote data transfer of the RFID authentication system. FIG. 8 shows a patient information storage device that includes an RFID authentication component. FIG. 9 shows a wristband RFID component attached to a patient in which the information contained therein is readable by a reader of the dialysis component. FIG. 10 shows a diagram of another authentication component used for optimized configuration of patient information storage and dialysis machines. FIG. 11 shows a dialysis cabinet having one or more readers for reading authentication components on the cartridge, container and dialyzer. FIG. 12 shows a diagram for updating RFID component information during or after dialysis. FIG. 13 shows a diagram of an authentication system that manages the replenishment process after dialysis. FIG. 14 shows an example of an authentication system having an authentication component on a reusable module and an identifier on a refiller. FIG. 15 shows a diagram of an authentication system that manages the safe refilling of refillable cartridges. FIG. 16a shows a diagram of an authentication system that manages the safe use of refillable cartridges in dialysis. FIG. 16b shows a diagram of an authentication system that manages the safe use of refillable cartridges in dialysis. FIG. 17a shows an example of an authentication system that manages container filling and safe use in dialysis. FIG. 17b shows an example of an authentication system that manages container filling and safe use in dialysis. FIG. 18 shows a diagram of an authentication system that manages the filling and safe use of containers in dialysis. FIG. 19 shows an adsorbent-based dialysis system having a blood circuit and a dialysis circuit.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the relevant arts.

  As used herein, the articles “a” and “an” refer to one or more (ie, at least one) of the grammatical objects of the article. For example, “an element” means one element or a plurality of elements.

  The term “fixed” means permanently or temporarily attached.

  An “antenna” is a component that can transmit or receive electromagnetic waves.

  The term “authentication component” or “identification component” can be used interchangeably and refers to a component that allows for the identification of the particular component to which the authentication component is attached.

  A “bar code” is a computer-readable pattern of parallel lines and various amounts of space that identifies the component to which the bar code is attached.

  The term “adhered” refers to a component that is either embedded in or secured to another component.

  A “card-like” device is a thin, substantially planar device.

  The term “cartridge” refers to any container designed to contain a powder, liquid or gas made for quick connection to a device or mechanism. A container can have one or more compartments. Instead of a compartment, a container is from a system of two or more modules that are connected together to form a cartridge, where two or more modules once formed can be connected to a device or mechanism. It can also be made.

  “Cartridge size information” refers to information regarding the amount of one or more adsorbent materials in the adsorbent cartridge.

  The term “container” refers to a container that is removably removable from a dialysis system, where the container is configured to hold one or more other containers. In any embodiment, the container can include one or more connectors for fluid connection from the container to the dialysis system.

  The term “cation infusion container” or “infusion container” refers to a source from which cations can be obtained. Examples of cations include, but are not limited to calcium, magnesium and potassium. The source can be a dry composition that is hydrated by a solution or system containing cations. The cation infusion container is not limited to cations and can optionally contain other substances that are injected into the dialysate or replacement fluid, non-limiting examples being glucose, dextrose, acetic acid and citric acid Can be included.

  A “certified product”, “certified component” or “certified part” is a component of a dialysis system in which components, parts, modules, sections of the dialysis system are determined to be certified. In some cases, the certificate can indicate that the component can be used securely and effectively in the system. A component that is not a certified component can be said to be “non-certified” or “false”.

  The term “communicate” refers to the transmission or reception of a signal from one component to another.

  The term “comprising” includes, but is not limited to anything following the word “comprising”. Thus, use of this term indicates that the listed elements are required or required, but other elements are optional and may or may not be present.

  The term “consisting of” includes and is limited to anything following the phrase “consisting of”. Thus, this phrase indicates that limited elements are required or required, and that no other element can be present.

  The term “console” refers to a device or part of a device that has a control function. In some examples, the console can control the device based on data received or stored on the console.

  The term “comprising data” refers to a component from which specific information can be obtained, including patient information, system information and component information.

  A “controller”, “control unit”, “processor” or “microprocessor” is a device that monitors and affects the operating state of a given system. Operating states are commonly referred to as system output variables, which can be affected by adjusting specific input variables.

  The term “control” refers to managing parameters within the system.

  The term “detachable” or “separated” refers to any component of the present invention that can be separated from the system, module, cartridge, or any component of the present invention. “Removable” can also refer to a component that can be removed from a larger system. In certain examples, components can be separated with minimal time or effort, but in other examples, additional effort may be required. Separate components can optionally be reattached to a system, module, cartridge or other component. The removable module can often be part of a reusable module.

  A “detector” is a device for receiving digital information transmitted from an antenna on an authentication component.

  The term “determining” refers to a process that causes or sets a particular control or setting for the process or method.

  A “dialysate” is a fluid that passes through the dialyzer and does not pass through the membrane toward the bloodstream.

  “Dialysis” or “hemodialysis” is a type of filtration or selective diffusion process through a membrane. Dialysis removes solutes of a specific range of molecular weight from a fluid dialyzed into dialysate via diffusion through a membrane. During dialysis, the fluid to be dialyzed passes over the filter membrane, while the dialysate passes over the opposite side of the membrane. The dissolved solute is transported across the filter membrane by diffusion between the fluids. Dialysate is used to remove solutes from the fluid being dialyzed. Dialysate can also provide enhancement to other fluids.

  A “dialysis authentication system” is a system used for dialysis that includes at least one authentication component secured to at least one dialysis component.

  A “dialysis component” is designed to be used for dialysis or as part of a dialysis system used for hemofiltration, hemodiafiltration, ultrafiltration and / or peritoneal dialysis. Every component that has been.

  A “dialysis system” is a system for performing dialysis that includes some or all dialysis components required for dialysis.

  The term “dialyzer” refers to a cartridge or container having two flow paths separated by a semipermeable membrane. One channel is for blood and one channel is for dialysate. The membrane can be in the form of hollow fibers, flat sheets or spirals or other conventional shapes known to those skilled in the art. The membrane can be selected from the following polysulfones, polyethersulfones, poly (methyl methacrylate), modified cellulose materials, or other materials known to those skilled in the art.

  An “embedded memory” is a circuit or circuits within a component that can store data.

  The term “identification information” refers to information about a component or class of components. The identification information can refer to information identifying the particular component in question, information identifying the type of component, or information identifying the manufacturer of the component.

  An “implantable” component or tag refers to a component or tag that can be implanted in a patient's torso.

  An “infusion solution” is a solution of one or more salts for adjusting the composition of the dialysate.

  “Replenishment limit” refers to the number of times a replenishable component can be used and replenished without problems.

  “Management” refers to the process of tracking or controlling the usage of the system or the process of control parameters used by the system.

  The term “adapting” refers to the state in which a particular user or setting is appropriate for the use of a particular component.

  A “memory” is a device that can store digital information on a temporary or permanent basis.

  A “memory chip” is a component that can store information and can be embedded in another component.

  A “memory device” is a device for recording digital information that can be accessed by a microprocessor, such as RAM, dynamic RAM, microprocessor cache or flash memory.

  “Module” refers to a careful component of the system. Each module can be snapped together to form a system of two or more modules. Once fitted, the module can be in a fluid connection and can withstand inadvertent disconnection. If the module is designed to include all necessary components for the intended purpose, such as an adsorbent used for dialysis, a single module can be a cartridge that fits into a device or mechanism. . In such a case, the module can consist of one or more compartments within the module. Alternatively, two or more modules can form a cartridge that fits into a device or mechanism, in which case each module individually carries a separate component, but only as a whole when connected together Including all necessary components for the intended purpose (eg adsorbents used in dialysis). Modules are referred to as “first modules”, “second modules”, “third modules”, etc., and refer to any number of modules. Designations such as “first”, “second”, “third” do not refer to the respective arrangement of modules in the direction of fluid or gas flow, but one module and one unless otherwise stated It will be understood that it is only the role of distinguishing between.

  The term “multi-use” refers to a component that can be used multiple times, possibly by replenishment of the component during use, as defined herein.

  The terms “non-reusable” or “disposable” refer to a component that cannot be reused in the current state of the component. In certain instances, the term non-reusable can include the concept of disposable but is not necessarily limited to being disposable.

  A “1-Wire security component” is a component that includes two parts that can be connected by a wire, where the first part sends an identification signal to the second part, and then the second part Sends a unique identification signal back to the first part, but both transmissions occur on the same wire. Although the term wire is used, any type of contact between one or more surfaces sufficient to provide electrical signal transmission between the two surfaces is also encompassed by the present invention. For example, two plates of electrical contacts can be considered connected by wires.

  The terms “optimized settings”, “optimized performance”, “optimized treatment results” refer to controlling the proper use of one or more components of the device and some examples Now, it can include adjusting the settings of one or more components to achieve the best results of the functionality of the device. In some examples, the optimized settings are directed to a particular subject, such as a patient, to protect the patient's best interest. For example, dialysis system settings use certified products, maintain safe use of refillable components, ensure that dialysis components are compatible with dialysis systems, and optimized settings for dialysis systems for specific patients However, the present invention is not limited to this.

  The terms “path”, “transport path”, “fluid flow path” and “flow path” refer to a route through which a fluid or gas such as dialysate or blood travels or a route through which an inert gas travels.

  “Patient information storage device” or “patient authentication component” refers to an authentication component that stores information about a patient, including but not limited to patient identification, medical prescription, information from previous sessions, cartridges Includes special events that occurred during size and prior medical treatment, especially dialysis treatment. The patient information storage device may be any type of authentication component.

  “Patient information” refers to any data relating to a particular patient, including patient name, medical prescription, information from previous sessions, cartridge size and special events that occurred during previous medical treatments, especially dialysis treatments.

  The “predetermined standard” is a parameter for a device, and if the device is outside the predetermined standard, it is determined that the device is not safe for use.

  “Prescription” or “patient prescription” refers to one or more system settings during a patient's dialysis session.

  A “processor” is a device that monitors and affects the operational state of a given system. Operating conditions are commonly referred to as system output variables, which can be affected by adjusting specific input variables.

  “Product History” refers to any or a combination of features related to the product for use, type of use, usage time, source, manufacturer, component, user and any other time-dependent data of the product, including but not limited to Point to.

  The term “pump” refers to any device that causes fluid or gas movement by applying suction or pressure.

  “Radio Frequency Identification”, “RFID”, “RFID Tag”, “RFID Marker” or “RFID Chip” can either passively or actively transmit, receive or both transmit or receive radio frequency signals with the receiver. Refers to any type of device, component or electrical circuit that can be performed between.

  “Radio signal” refers to electromagnetic radiation having a frequency between about 3 kHz and about 300 GHz.

  The term “read data” refers to the process of receiving information from an authentication component.

  The term “readable” refers to a memory component that contains information that can be obtained by another component.

  A “reader” or “identifier” is a component that can receive information from an RFID tag, a 1-Wire security component or a wireless authentication component, or by scanning a barcode. A “multi-mode” reader is a type of reader that can read at least two different types of authentication components, such as RFID tags and barcodes.

  The term “receive data” refers to the process of obtaining information from a source.

  A “replenishable component” is a component that can be used and then returned to a reuse state.

  A “replenisher” is a component that can replenish spent adsorbent material to its original state or close to it. The refiller may be part of the dialysis system or may be separate from the rest of the system. If the refiller is separate from the rest of the dialysis system, the term includes a separate facility where spent sorbent material is sent back to its original state or close to it. it can.

  “Replenishment” refers to a method of treating spent sorbent material or any other dialysis component to return the material to a state for use in sorbent dialysis. Once “replenished”, the material can then be said to be “replenished”.

  “Reusable” refers, in one example, to an adsorbent material that can be used multiple times, possibly by replenishment or treatment of the adsorbent material during use. A reusable or refillable component also refers to an adsorbent cartridge that includes an adsorbent material that can be replenished by replenishing the adsorbent material contained within the adsorbent cartridge.

  A component “setting” refers to one or more parameters of the component used in a dialysis session.

  A “smart card” is a component that includes at least one tracking or authentication component.

  An “adsorbent-based dialysis system” is a dialysis system in which at least a portion of the dialysate passes through an adsorbent cartridge containing an adsorbent material to remove at least one solute from the dialysate.

  “Adsorbent cartridge” refers to a cartridge that can contain one or more adsorbent materials. The cartridge can be connected to a dialysis channel. The adsorbent material of the adsorbent cartridge is used to remove specific solutes from solutions such as urea. The adsorbent cartridge can be a single compartment design in which all the adsorbent material necessary to perform dialysis is contained within a single compartment. Alternatively, the adsorbent cartridge can be a modular design in which the adsorbent material is distributed throughout at least two different modules, which can be connected to form a unitary structure. Once at least two modules are connected together, the connected modules can be referred to as an adsorbent cartridge, which can be fitted into a device or mechanism. It will be appreciated that a single module can be referred to as an adsorbent cartridge when the single module contains all the adsorbent material necessary to perform dialysis.

  An “adsorbent material” is a material that can remove a specific solute from a solution such as urea.

  A “used dialysate” is a dialysate that comes into contact with blood by a dialysis membrane and includes one or more impurities or waste types or waste materials such as urea.

  The term “stored too long” means that a refillable or reusable component has not been used or refilled for a length of time that would make it unsafe to use the component further Refers to that.

  “Storing data” refers to the process of providing data to a memory component from which the data can be read later.

  “Treatment history” refers to relevant information about a patient's previous medical treatment, in particular dialysis treatment, which includes the prescription of the previous treatment, the status of the dialysis component of the previous treatment and the setting of the dialysis system, the previous treatment Including, but not limited to, events occurring during and medical outcomes of dialysis treatment.

  “Unique identifier” is information stored in an authentication component that can distinguish one component from another component of the same type.

  The term “water source” refers to a source from which drinking water or non-drinking water can be obtained.

  The “wireless authentication component” is an authentication component that transmits identification information to the receiver without being directly connected to the receiver.

  “Wristband” refers to a device that contains a functional structure such as a banded structure and an authentication component, and the wristband device is connected to the patient's wrist, arm, ankle or any other part of the torso by the banded structure. can do.

  A “writer” is a component that can send digital information to a reader.

  The term “writable” refers to a memory component that can add additional information to memory.

Dialysis Authentication System A dialysis authentication system can be provided for therapeutic optimization of hemodialysis. The dialysis authentication system is secured to the dialysis component and includes at least one authentication component containing data used in the dialysis process, at least one identifier for performing data communication with the authentication component, and the authentication component data via the identifier. May include a processor. The processor can further process the data and can make a determination regarding the dialysis component based on the received data.

  1a-1c show different embodiments of a dialysis authentication system. FIG. 1 a shows an authentication system that includes an authentication component 110 that is secured to the dialysis component 130 and communicates through an identifier 120 and data transfer therebetween. The identifier 120 can signal the authentication component 110, can read the authentication component 110, and can forward data received from the authentication component 110 to the processor 140.

  FIG. 1 b shows an authentication system having an identifier 120 that is secured to the dialysis component 130 and communicates with the authentication component 110 of the dialysis component 130. Data communication can occur between the identifier 120 and the authentication component 110 when the two dialysis components are assembled together or brought close together. Data received by the identifier 120 can be further transferred to the processor 140.

  FIG. 1 c shows that the identifier 120 can communicate with the authentication components 110 and 110 ′ of the different dialysis components 130 and 130. Data received from authentication components 110 and 110 can then be transferred to processor 140 via identifier 120. The processor 140 can then determine for the plurality of dialysis components 130 and 130 ', for example, that the dialysis components 130 and 130' are compatible with each other. In a non-limiting example, the dialysis component 130 can be a refiller and the dialysis component 130 'can be a cartridge with a reusable module.

  In any embodiment of the first, second, third, or fourth aspects of the present invention, the authentication component 110 can be attached to at least one of a dialyzer, an adsorbent cartridge, and a refiller. The authentication component 110 can also be attached to the patient and other dialysis components including, but not limited to, containers, reservoirs, blood tubes, infusions and other consumables used for dialysis.

  The identifier 120 can be attached to the dialysis component or can be a separate device. The identifier 120 may be a multi-mode type reader that can communicate with at least two different types of authentication components. The identifier 120 can distinguish at least two of the authentication components from each other when at least two authentication components are simultaneously available to the identifier. The identifier 120 can also include additional information from other sources, such as pre-stored information including what was previously received from different authentication components. Information received or stored in the identifier 120 can be further transferred to the processor 140. The identifier 120 can also receive information from the processor 140.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the processor 140 makes a determination based on the received data from the identifier 120 for one or more dialysis components 130. Can do. The processor 140 may be part of the identifier 120, part of the dialysis component 140, or other component of any dialysis system such as a console or dialysis cabinet. The processor 140 may be a device that can be wired or connected to the dialysis system by wireless communication. The determination made by the processor 140 can then be displayed on a screen (not shown) to notify the user in a timely manner. The screen may be part of the processor 140, part of the dialysis component 130, part of the identifier 120 or a separate device. The user can also be notified of the determination result of the processor 140 by an audio signal, an optical signal or any other suitable information distribution means.

  The processor 140 can associate unique information specific to the dialysis component with unique information specific to the user, and can associate a unique identifier unique to the manufacturing with information unique to the dialysis component, such as When information is received from the authentication component 110 by the processor 140 via the identifier 120. The processor 140 can then determine, for example, whether the dialysis component is suitable for a particular user and whether the dialysis component is manufactured and designed or certified.

  The processor 140 can also determine other characteristics of the dialysis component, such as whether the dialysis component is OK and used properly. For example, when the refillable component is fully refilled, the adsorbent cartridge is compatible with the dialysis system, and the patient information is available from the patient authentication component, the processor 140 may configure the dialysis system to It is possible to judge whether it is appropriate. The processor 140 can further control dialysis system settings such as blood flow, ultrafiltration rate and ultrafiltration profile. The processor 140 can stop using the dialysis component if inappropriate use is found.

  In a non-limiting example, activation of the authentication system can begin with communication between one or more identifiers 120 and one or more authentication components 110 in response to a particular event. Certain events may occur when a user brings an identifier near the authentication component. For example, when two dialysis components carrying an authentication component and an identifier are each being installed in the dialysis system. Communication between the identifier and the authentication component may occur when an operation such as a refill process is initiated. Activation of an authentication system, such as an RFID system for signals communicated or received from an RFID component, can be one of the first steps in the replenishment process. The communication process between the identifier 120 and the authentication component 110 can be manually initiated by the user at any stage of the communication process. In a non-limiting example, once communication has begun, the identifier 120 can continuously communicate with the authentication component 110. The communication may be interrupted by a user command or controlled and stopped by an automated process. For example, if it is determined that the reusable module is not suitable for a refiller, the identifier 120 can stop communicating with the reusable module's authentication component 110.

Authentication component on a dialysis component In any embodiment of the first, second, third or fourth aspects of the present invention, the authentication component is one or more dialysis components such as a refiller, cartridge, container and dialyzer. Can be fixed on top. The authentication component can be secured on the dialysis component by the manufacturer or user. The fastening technique requires the use of a specific adhesive or other adhesive, considering whether the user wants it to be removable and whether removing the authentication component will cause the dialysis component to break It can be.

  In general, a manufacturer may wish to distinguish the installation of authentication components by unqualified users from those by qualified users. Manufacturers can provide specific securing materials and authentication components only for qualified users. In addition, the dialysis component may be able to detect whether a manufacturing-approved fixing material or an authentication component is used, based on which the dialysis system can invalidate any fake product.

  2a-2d show non-limiting examples of different dialysis components having an authentication component. FIG. 2 a shows an adsorbent cartridge 210 for adsorbent-based dialysis, where authentication components 211, 212, 213, and 214 include a first reusable module 215, a second reusable module of the adsorbent cartridge 210. Mounted on the usable module 216, disposable module 217 and consumable material 218, respectively. FIG. 2 b shows the dialyzer 220 and the authentication component 221 is attached to one end of the dialyzer 220. FIG. 2 c shows the refiller 230, and the authentication component 231 is attached to the frame of the refiller 230. FIG. 2 d shows a container 240 having at least one container 242 for infusion and a container for disinfecting chemicals, and the authentication component 241 is attached to the frame of the container 240. The container 240 can have a plurality of containers for infusion, each container having an authentication component mounted thereon for information about a particular container, eg, a different type or concentration of infusion (not shown). Can have.

  Each of the adsorbent cartridge 210, dialyzer 220, refiller 230, and container 240 can have multiple authentication components, and the authentication components can be attached to different locations of the underlying device. Those skilled in the art are not limited to attaching the authentication component to the dialysis component described above, but to the patient and other dialysis components including, but not limited to, circuit tubes, reservoirs, valves, mixers and heaters. Understand that you can.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the authentication component may be of any type suitable for identification and authentication purposes known to those skilled in the art. FIG. 3 shows various forms of the authentication component 310 that can be read by the corresponding reader 320. For example, the authentication system can include any one or more of a bar code 331, a 1-Wire security system 340, direct electronic communication 350 and an RFID tag 361. The dialysis component can have one or more authentication components 310 and is not limited to a particular type of authentication component. The dialysis component can have a combination of several different types of authentication components.

  The authentication system can include a barcode 331 that can be read by a barcode reader 332. The barcode reader 332 can be permanently secured to the dialysis component, or the barcode reader 332 can be an external device. The barcode reader 332 can transmit information from the barcode 331 to the processor by wired communication or wirelessly. For example, the authentication component 211 of the first reusable module 215 of FIG. 2 can be a bar code 331 and the information contained in the bar code 331 indicates that the reusable module 215 is a certified part, It can be used to determine patient fit and / or track usage of the reusable module 215.

  The authentication system can include a 1-Wire security component 340 having an identification portion 341 and a reader portion 342, which can be connected by a wire 343. The identifier 341 can be fixed on one dialysis component, while the leader 342 can be fixed on another dialysis component. For example, the identification unit 341 and the reader unit 342 of FIG. 3 can be fixed to the first reusable module 215 and the adsorbent cartridge 210 of FIG. 2a, respectively. When two dialysis components having an identification portion 341 and a reader portion 342 are brought together, a connection can be made to the entire wire 343. The wire 343 can be attached to either or both of the identification portion 341 and the reader portion 342, or to one or both of the two dialysis components. A “wired connection” can be an electrical contact between any kind of one or more surfaces and does not require the physical wire to be considered a 1-Wire security component. The identification unit 341 can transmit an electrical signal to the reader unit 342 over the entire wire 343. This signal may include identification of the corresponding dialysis component and other information. The reader unit 342 can then relay this information to the processor so that it can determine if a dialysis component, such as a reusable module, is certified or exceeds its useful life and is reusable Module usage can be tracked and it can be determined whether the reusable module fits the correct patient.

  The authentication system can include a direct electronic connection 350, including an authentication component 351, a reader 352 connected by an electronic connection 353. The identification component 351 can be secured to the dialysis component and the reader 352 can be located on the dialysis machine. When the dialysis component connects to the flow path, reader 352 can read identification component 351 through electronic connection 353 and information can be transmitted from identification component 351 to reader 352.

  One skilled in the art can consider the two identifiers 341 and the reader 342 of the 1-Wire security component 340 to be relatively close to each other and physically considered as one component, but in the direct electronic connection 350, the dialysis component As long as is connected to the flow path, the authentication component 351 can be read by the reader 352. In that regard, it is understood that the direct electronic connection 350 is distinct from the 1-Wire security component 340.

  The authentication system can include a radio frequency identification (RFID) tag or RFID component 361 that can be read by the RFID reader 362, and for the purpose of automatically identifying and tracking the tag attached to the object. Transfer data by wireless use of wireless signals. The RFID tag 361 can include electronically stored information.

RFID Authentication System FIG. 4 shows the RFID authentication system and associated data transfer in detail. The RFID authentication system can include an RFID tag 410 that is attached to or integrated into the dialysis component 430. The RFID tag 410 can include a transponder 411 and an RF antenna 412. The RFID authentication system can also include an RFID reader 420, which can be located within the dialysis system. For example, the RFID reader 420 can be integrated into a second dialysis component that is different from the dialysis component 430 having the RFID tag 410. Alternatively, RFID reader 420 may be a separate component that can be held by a user and read RFID tag 410. The RFID reader 420 can include an RF source 421 and a detector 422. The RFID tag 410 can be activated when the RF signal 424 is transmitted by the RF power source 421 via the RF antenna 423. In response, the RFID tag 410 can transmit a portion of the initial RF signal 424 back to the detector 422 via the antenna 423 as a signal 413. The transponder 411 can carry identification and other data regarding the dialysis component 430. Information stored in transponder 413 can determine which portion of RF signal 424 is reflected back as signal 413. A single antenna 423 can be used by the source 421 and the detector 422. Source 421 and detector 422 can each have a separate antenna.

  The detector 422 can detect the RF signal reflected back by the RFID tag 410 and send the information to the processor 440 via either wireless communication with the wireless authentication component or by wired communication. Can do. This information can be used to determine whether the dialysis component 430 is certified or is used in accordance with predetermined standards and any other features or operations for the dialysis component 430. The processor 440 may also determine whether the dialysis component 430 is compatible with the correct patient or a particular dialysis prescription. The processor 440 can optionally include a memory device such as a processor used in a computer. The processor 440 can keep track of information received from the detector 422.

  The processor 440 can optionally include a user interface 450, such as when the processor is used in a computer. User interface 450 can be used by the user to interact with processor 440. Identification and other information stored in the RFID component transponder 411 can be displayed on the user interface 450 and made available to the user. A user can enter commands through the user interface 450 to override the automatic determination made by the processor 440. For example, when the processor 440 automatically disables the system due to a non-certified part, the user is determined that the non-certified part is newly certified or available for other reasons. You can wish to restart the system when

  The RFID component 410 can be secured to the dialysis component 430 using an adhesive. Ideally, the adhesive selected is an adhesive that does not degrade significantly over time of use or over time. This prevents the RFID component 410 from falling out during use, transportation or processing. Alternatively, the RFID component 440 can be embedded within the dialysis component 430, for example, within the reusable module housing of the sorbent cartridge, thereby preventing unauthorized modification of the RFID component 440. Other methods known in the art can also be used to secure the RFID tag 440.

  RFID component 440 may be active or passive. In passive devices, the input RF signal 424 provides sufficient power for the RFID component 440 to operate, thereby eliminating the need for additional power sources. The RFID component 440 can have its own power supply (not shown), operate as an active component, allow it to return a stronger feedback signal, and be used for the next dialysis session Can do.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the RFID system can include an authentication component that is readable and writable. FIG. 5 shows an RFID system that includes an RFID component 510 that is readable and writable. The RFID system of FIG. 5 further includes a writer 520 that can write to the RFID component 510. The writer 520 may be a device that can be secured to the dialysis component and separated from any dialysis component.

  The RFID component 510 includes a transponder 511 and an antenna 512. The RFID writer 520 includes a source 521 and an antenna 522. When the writer 520 receives an input that instructs the writer 520 to write to the RFID component 510, the source 521 generates an RFID signal 523 that is transmitted by the antenna 522. The signal 523 is received by the antenna 512 on the RFID component 510 and transmitted to the transponder 511. The transponder 511 then changes the specific information stored in the transponder circuit (not shown). The change information can then be included in the RFID component 510 and made readable.

  RFID technology can be used to protect patient safety and improve treatment efficiency by adapting dialysis components to the patient. For example, the RFID component 510 confirms that the refill process has begun within an acceptable time limit from a recent treatment session, and confirms that a new cartridge is not being refilled, and is a reusable module. The number of replenishments can be tracked. In a non-limiting example, a user can disable or discard a reusable module before the module is overused based on the RFID component 510 write information, and thus Treatment degradation can be avoided. RFID technology for dialysis treatment is not limited to the applications described above.

RFID component 510, manufactured by Texas Instruments TIRIS ^{Tag-It tm} such (R) smart label may be an RFID tag or commercially available RFID tags of any known type. Tag-It ^tm® smart labels provide an ultra-thin shape that can be laminated to paper or plastic labels, allowing easy attachment of smart labels to dialysis components or other objects without taking up extra space it can. Other labels known in the prior art can also be used by the authentication system for managing dialysis treatment.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the microchip can be included in an RFID component for storing and transmitting a larger amount of information. FIG. 6 shows an RFID component 610 having a transponder 611, an antenna 612 and a microchip 614 on an integrated circuit 613. Microchip 614 can include information about the history of the product, including manufacturer, date of manufacture, number of uses, and other relevant information. Information on the microchip 614 can be transmitted to the RFID reader. Using a microchip 614, such as the Maxim chip of the RFID component 610, the memory can be fully integrated into the RFID component 610, thus eliminating the need for an external processor to write to the RFID component 610.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the relevant data can be stored remotely using an RFID component that can respond to an RFID reader query. Can be accessed. Data contained in the RFID component can be collected and transferred to the processor by the RFID reader. FIG. 7 illustrates that the user 740 can send a request to the mobile host 720 to track a particular RFID tag 710 that is secured to the dialysis component 730. In response, the mobile host 720 can track the RFID tag 710. When the mobile host 720 detects the RFID tag 710 in the network, the host 720 can obtain the location of the RFID tag 710. The information of the RFID tag 710 can be stored in the host 720 together with the time stamp and becomes available to the user 740.

  The RFID system can track dialysis components where mobile phone networks are available. The distribution of dialysis components such as reusable modules can be easily tracked using RFID systems. In a non-limiting example, a clinician can remotely monitor dialysis treatment via an RFID system so that professional assistance can be provided outside the clinic dialysis center, such as at a patient's home or dialysis mobile station. Available in the settings.

  A dialysis center or clinic refers to a permanent location providing dialysis to a patient. A dialysis center or dialysis clinic can use a doctor, nurse or dialysis technician to simultaneously provide dialysis to multiple patients. Dialysis clinics can be of any size and range from clinics designed for one or two patients to clinics designed for dozens of patients or more.

  Home dialysis refers to dialysis performed by the user at the user's residence or other building outside the clinical setting. Home dialysis can occur under hospice nursing or other medical management of a doctor, nurse or clinician, but these are not necessary. However, at-home includes many other types of homes or settings outside the clinic that includes homes and settings for backward development areas. RFID authentication systems or other types of authentication systems can be used in regions, countries or locations where the support infrastructure is at a poor level, including data networks.

  A dialysis transfer setting refers to a moveable dialysis setting. The mobile setting can include a mobile dialysis unit that is sent to one or more locations to provide dialysis to the patient. The dialysis unit can be a large unit that can provide dialysis to multiple patients at a central location, or a smaller unit that can provide dialysis to only one or a few patients at a particular location. . A mobile dialysis unit can arrive at a location and install a “pop-up” dialysis clinic, ie a dialysis clinic that is only at a particular location for a short time. Mobile dialysis units can often only have a little permanent foundation or support, such as lacking an established data network as well as clinic dialysis centers.

  Those skilled in the art will appreciate that the dialysis component can be tracked using any other wireless technology. Non-limiting examples of possible radio technologies include Bluetooth, Wi-Fi, LTE, WiMax or any other radio technology known to those skilled in the art including dedicated radio technologies.

Patient Information Storage Device In any embodiment of the first, second, third or fourth aspects of the present invention, an RFID authentication component can be used as a patient information storage device. The patient information store may include one or more of the following information, including the patient's name, patient prescription, recent patient blood analysis, weight, when the previous session was performed, Other parameters containing information related to patient dialysis treatment such as alarms from previous sessions, cartridge size information, recent blood analysis, etc. required for performance optimization . For example, patient information can include session parameters, such as the date of the most recent session, the duration of the most recent session, and other conditions related to the most recent session.

  FIG. 8 shows an example of a patient information storage device 810 that can be any type of RFID component and other types of authentication components such as a USB memory stick 817. However, RFID technology is often used as a patient information storage device due to advantages known in the art. The RFID patient information storage device 810 can be manufactured as an RFID badge or card-like device, an RFID card 811, an implantable chip 812 having an optional sensor 813 or a RIFD tag 815 and a wristband device 814 having a wristband 816. . An RFID patient information storage device 810, for example, a credit card sized device such as an RFID card 811 that can include embedded memory and with RFID type communication, implements a treatment optimization idea in a more efficient manner. Enable. The RFID characteristics of the RFID card 811 can be used to easily perform wireless data transfer between memory devices before and after each dialysis. However, other devices such as USB memory stick 817 can also be used for treatment optimization.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the RFID component of the patient information storage device may consist of an RFID chip and a memory chip combined in a “smart card” package. it can. Integrated circuits embedded in smart cards can store and process data, and data can be transferred to and from the terminal via RFID signals. The smart card design is not limited to the RFID tag of the patient information storage device 810. One skilled in the art will appreciate that smart card RFID can be utilized with any dialysis component including consumables.

  For example, in a patient's fistula, the implantable RFID tag 812 can be implanted in the patient. A fistula is an abnormal association with two epithelialized surfaces, such as blood vessels, that often require vascular surgery to be performed. Patient information can be updated to incorporate real-time measurements of patient parameters with an integrated sensor 813 that can measure parameters of interest in the torso environment. The implantable RFID tag 812 can provide the clinician with the most updated information of the patient.

  In a non-limiting example, the dialysis system can read the patient information store 810 and obtain information stored therein for treatment optimization. The dialysis system can read the patient's name from the patient information store 810 and then use the patient's name to confirm that it matches the patient's name against the refillable cartridge. Can be compared. The patient name can be used to determine if other dialysis components, such as a dialyzer, match the patient name. The dialysis system can also read the patient description from the patient information store 810 and transfer the patient prescription to the dialysis machine for proper setup.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the patient information storage device 810 can store previous session data, including for multiple sessions. Previous session data stored in patient memory 810 can be used by the dialyzer and / or clinician to optimize the preparation of the machine / dialysis session and improve the optimal treatment for the shortest period of time. Session parameters can include, for example, alarms regarding patient blood pressure, blood flow, and ammonia breakthrough detected during a previous session. Session parameter information may also include the duration of the recent session or other previous session and the date of the recent session or other previous session.

  In any embodiment of the first, second, third or fourth aspects of the present invention, patient information regarding previous session alarms can be utilized by the clinician to adjust the dialysis machine and automatically It can also be used directly by a dialysis machine for adjustment. In either method, patient information, including previous session information, can be utilized to adapt the treatment to the optimized results. Non-limiting examples of adjustments include adapting blood flow to reduce hypotension episodes or blood flow alarms. An ammonia breakthrough alarm or ammonia breakthrough pattern can also be detected, which can be a signal to the clinician to utilize a larger capacity cartridge.

  The patient information store 810 can provide any relevant information that helps to optimize the treatment of dialysis treatment. For example, the patient information storage device 810 can store event alarms during past treatments, such as alarms regarding patient blood pressure or blood flow that are above a safe range. Non-limiting examples can include a hypotension event alarm and a hypertension event alarm. Clinicians can consider adapting blood flow to reduce the appearance of hypertension symptoms or blood flow alarms. Information from past sessions, such as hypotension event alarms, can also be obtained from the RFID patient store and used to adjust treatment parameters such as blood flow, UF rate, and UF profile. The alarm signal can also account for blood ammonia clearance during dialysis treatment. If ammonium breakthrough is detected or a breakthrough pattern is detected in a particular patient, the clinician can consider adjusting the dialysis system settings or using a larger size cartridge.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the patient storage device 810 can be updated to store newly measured data for a particular patient. The data can come from a sensor integrated in patient storage 810, such as sensor 813 of implantable RFID tag 812, or from a remote resource. For example, the scale can be set to write to the RFID card 811 wirelessly. Other devices capable of generating measurements can also be written to the RFID card 811 or any other authentication component. The recording of patient information through automatic data transfer performed by RFID technology allows real-time recording, greatly reducing human errors that occur with handwriting. Those skilled in the art will appreciate that other types of authentication components, such as USB memory stick 817, can also be used to record patient updated information.

  The patient information store 810 can improve overall patient management. Traditionally, when a patient arrives for dialysis, they are weighed and the weight information is used manually to set the UF amount and rate. In any embodiment of the first, second, third or fourth aspect of the present invention, a patient information storage device 810 (eg, RFID card 811) is used to record updated patient information including weight information. Can be used. For example, the scale can be set to write to the patient's RFID card 811 wirelessly. The updated information of the patient's weight can then be utilized by the dialyzer to automatically set the UF amount and rate. The use of RFID technology in patient management greatly reduces the burden of maintaining manual records, thereby reducing the likelihood of errors.

  In a non-limiting example, the patient information storage device 810 can be read by an identifier or reader 820. The reader 820 can be attached to or integrated with the dialysis component 830. Reader 820 may be a device that is separate from any dialysis component. The reader 820 can store the relevant information of the corresponding dialysis component 830. The reader 820 may be a smart card type device. Once patient information is received, the reader 820 or processor 840 can determine whether the dialysis component 830 and its settings are appropriate for the patient. For example, the reader 820 includes information about the consumable material, and the authentication process of the reader 820 or processor 840 determines whether the consumable material is compatible with the correct patient.

  Patient information storage 810, particularly with RFID technology, can provide more convenience to clinicians and patients. For example, session execution information can be accessed when the clinic center data network is unavailable. Based on the patient information in the patient information storage device 810, a portable device can be used and further adjusted outside the clinic center. The patient information store 810 also improves overall patient management by the clinician because patient information is available and can be used regardless of where the treatment occurs.

  RFID patient storage and other types of authentication components can be used to transfer data between memory devices wirelessly and easily, before and after each dialysis, and sometimes during dialysis Can thus significantly increase the flexibility of using a dialysis system. Treatment optimization can be enabled using RFID technology even in remote areas where the center network is not available or even when the center network is not functioning well.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the patient information storage device 810 can provide session execution information to a physician to help manage the patient. An RFID authentication system may not depend on a center having a network, for example, when using an RFID card having an embedded memory. Dialysis devices throughout the dialysis center can be more portable and flexible for use.

  FIG. 9 illustrates a non-limiting example that utilizes a wristband RFID 910 that is a patent information storage device in dialysis treatment of a patient 900. The wristband RFID 910 can be brought close enough to the RFID reader 920 by the patient 900. Reader 920 may be the same reader used for the dialysis component, or it may be a different reader that is separate from the dialysis component. For example, the reader 920 can be attached to the dialysis cabinet 930. The patient 900 can carry any type of patient information storage device, including but not limited to that of FIG. Information from a patient information store, such as an RFID wristband 910, can be transmitted to the processor 940 so that the user of the processor 940, such as a clinician, can use the correct component for a particular patient 900. Can be guaranteed.

  The patient information store can contain other information in addition to simple identification of the patient. For example, the wristband RFID 910 may include information about the patient's prescription, the date of the patient's recent treatment, or any other information related to the individual. Alternatively, the patient wristband RFID 910 may include only identification information. Patient wristband RFID 910 information, such as patient dialysis session date and updated patient prescription information, can be read and stored in a processor 940 having a memory component.

  FIG. 10 shows the steps of the authentication system that process the information at the beginning of the dialysis treatment. The authentication system can read patient information at step 1010. Patient information can include patient identification, dialysis prescription, and treatment history. After identifying the patient, the authentication system can identify a disposable or non-reusable module by reading an authentication component attached thereto at step 1020. The authentication system can verify in step 1021 that the non-reusable module matches the patient's name, and in step 1022 that the non-reusable module is properly used in the certified component. Can be determined. Proper use may be related to whether a non-reusable module is unused and within its expiration date. The authentication system may also identify the reusable module at step 1030 by loading the authentication component mounted thereon. The authentication system can verify in step 1031 that the reusable module is consistent with the patient identification, which can be in any form such as a patient name or serial number representing a particular patient. Can be. In step 1032, the authentication system confirms that the reusable module is a certified component, that the reusable module has been properly replenished, and that the reusable module is for safe refilling. It can be determined that the number of times is within an allowable range. The authentication system is not limited to making the above determination.

  In any embodiment of the first, second, third, or fourth aspects of the present invention, the authentication system can identify the dialyzer at step 1040, and the dialyzer matches the patient information at step 1041. In step 1042, it can be determined that the dialyzer is being used properly. In addition, the system can identify other dialysis components such as containers, circuits / blood tubes, infusions, and other components or consumables at step 1050, and these dialysis components fit the correct patient at step 1051. In step 1052, it is determined that they are certified products and are used appropriately, for example, that the containers contain infusions that are correctly filled to fit a particular patient.

  In a non-limiting example, the steps associated with the different dialysis components do not necessarily have to follow a specific order as indicated by the step numbers in FIG. One dialysis component can have information that can be identified before other dialysis components and processed thereafter before starting dialysis. Multiple dialysis components can also be identified and determined simultaneously when information can be read and processed simultaneously, for example by different readers and processors.

  In any embodiment of the first, second, third or fourth aspects of the present invention, information regarding disposable modules, reusable modules, dialyzer and other dialysis components can be obtained at step 1060. It can be used for customized settings. For example, a reusable module can be invalidated by the authentication system for inappropriate use, for example when the reusable module exceeds a replenishment limit. Optimizing the dialysis system settings may also include adjusting the fluid flow rate to meet expected values corresponding to the patient's prescription. The patient's prescription can be transferred as part of the patient information from the patient information store to the processor controlling the dialysis system. When the dialysis system settings are determined that the dialysis component is consistent with the patient information, it is a certified product and is used appropriately or according to any appropriate criteria determined by the user It can also be left unchanged.

  In a non-limiting example, the one or more dialysis components are adapted to a particular patient, including but not limited to adsorbent cartridges, dialyzers, and other consumables such as infusion solutions and blood tubing sets. You may need that. In a non-limiting example, one or more dialysis components may not need to be adapted to a particular patient for treatment optimization. For example, the adsorbent module reprocessing program or replenishment program may be general to different patients. Information used by the refiller or reprocessing device can include when the module has been used recently, how many times it has been used, pre-lifetime usage, cartridges and other relevant information, which includes the patient's name or description. Not necessarily included. The information used by the refiller or reprocessing device is patient information when, for example, the adsorbent module needs to be refilled / reprocessed to restore a functional capacity that is compatible with a particular patient. Can also be included.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the dialysis system reads the adsorbent cartridge and is effective and replenished to match the patient name and cartridge size. A reader can be included on the console to determine if a cartridge has been removed. The dialysis system can also extract past session information from an RFID component, such as a patient information store or attached to the dialysis component. Past session information can be a hypertension event alarm or a hypotension event alarm, which can be used to adjust treatment parameters including, but not limited to, blood flow, UF rate and UF profile.

  FIG. 11 shows an authentication system for a dialysis cabinet 1120 and a number of other dialysis components including an adsorbent cartridge 1110, a dialyzer 1130 and a container 1140. The dialysis cabinet 1120 can have a first reader 1121, a second reader 1122, and a third reader 1123, which include, but are not limited to, sorbent cartridges, refillers, dialyzer and containers. Authentication components, such as RFID tags, connected to can be read. These readers may each be able to read RFID tags attached to a particular type of dialysis component and may be able to read RFID tags attached to different dialysis components. First, second and third readers 1121-1123 may be provided at different locations in dialysis cabinet 1120 to correspond to one or more target dialysis components. The dialysis component 1120 can have one or more readers. The dialysis cabinet 1120 may only need one reader that can read all of the RFID tags attached to different dialysis components. The leader may be separated from the dialysis cabinet 1120.

  FIG. 11 shows an adsorbent cartridge 1110 that includes a multi-use module 1111 and 1112 having replenishable material and a disposable or consumable module 1113 having consumable material 1114. Authentication components such as RFID tags 1115, 1116 and 1117 can be attached to the multi-use modules 1111 and 1112 and the disposable module 1113, respectively. RFID tags 1115, 1116 and 1117 can be read by one or more readers located in dialysis cabinet 1120, such as first reader 1121 and second reader 1122. The first reader 1121 can read and distinguish the RFID tags 1115 and 1116 simultaneously. Alternatively, an additional reader (not shown) can be included in the dialysis cabinet 1120 to read in particular one of the multi-use modules.

  The authentication system of FIG. 11 can process cartridge size and multi-use module 1111 and 1112 performance information. For example, the RFID tag may be the efficiency of the modules 1111 to 1113 contained therein to remove specific solutes from the adsorbent cartridge 1110 or spent dialysate, or the specific adsorbent material in the modules 1111 to 1113. Information can be included regarding the combined capacity or variation in chemical performance of the consumable material. The authentication system can determine the total time that has elapsed since the reusable module 1111 or 1112 was used. This information can be conveniently used as an expiry date or time limit to avoid possible contamination from an increase in microorganisms or fungi in the replenishment / reprocessing unit or step.

  In any embodiment of the first, second, third or fourth aspect of the present invention, both the reusable module and the non-reusable module are both connected together and inserted into the dialysis cabinet. Sometimes it can be read. For example, the non-reusable module 1113 of the adsorbent cartridge 1110 can be read by the reader 1122 of the dialysis cabinet 1120. The readers 1121 and 1122 can read the necessary information in a coordinated manner or can read them separately. In addition, at least one of readers 1121 and 1122 or any additional readers can read RFID tags that are placed on consumable material 1114.

  FIG. 11 also shows a dialyzer 1130 having an RFID tag 1131. When the dialyzer 1130 is placed in the dialysis cabinet 1120, the reader 1122 can read the dialyzer RFID tag 1131. The dialyzer RFID tag 1131 can also be read by any suitable reader, such as a reader 1121 or reader 1122 located in the dialysis cabinet 1120 or a reader (not shown) separate from the dialysis cabinet 1120. it can. In any embodiment of the first, second, third, or fourth aspects of the present invention, the authentication system is such that the dialyzer 1130 is compatible with patient identification and the dialyzer 1130 is certified. The dialyzer 1130 is replenished and ready for use, the dialyzer 1130 is within the safe use limit, and the time interval for using the dialyzer 1130 is not too long. Can be confirmed.

  FIG. 11 shows a container 1140 having an infusion container 1142, a disinfection container 1143, and an RFID tag 1141. When the container 1140 is placed near or in the dialysis cabinet 1120, the RFID tag 1141 is at least one reader of the dialysis cabinet 1120, such as the reader 1123, or a reader (separated from the dialysis cabinet 1120). (Not shown). The dialysis system includes the following: the container 1140 conforms to patient identification, the container 1140 is certified, the container 1140 is filled according to the patient's prescription, and is ready for use. One or more can be verified that is within the safe use limit and that the storage during use of the container 1140 is not too long. The authentication system can also determine whether the container 1140 is properly hung in the dialysis cabinet 1120.

  The authentication system is not limited to making a determination on the functions of FIGS. RFID tags attached to the dialysis component can be read simultaneously by one or more readers of the authentication system and can be read separately in any order. In a non-limiting example, decisions on one dialysis component can affect the processing information of other dialysis components. For example, if it is determined that the dialyzer 1130 is a non-certified product, the authentication system may continue until the user takes further action, such as confirming use of the non-certified product or replacing with a certified dialyzer. Inability to continue the dialysis component. The authentication system of FIG. 11 can also read each RFID tag individually and make a determination at once for all of the dialysis components to which the RFID tag has been attached.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the writable RFID tag or system database can be updated during or after dialysis. FIG. 12 shows that dialysis begins at step 1201 and the dialysis component is subsequently used at step 1202. Events that occur during a dialysis session can be monitored as part of the treatment history for a particular patient at step 1203 and include events that occur during a dialysis session, such as an alarm for changes in blood pressure.

  Information regarding the recent use of the dialysis component can be stored in the corresponding RFID tag of the dialysis component in step 1204 of FIG. For example, in FIG. 11, the RFID tag 1117 on the non-reusable module 1113 can be updated to indicate that a non-reusable module 1113 has been used. The RFID tag 1115 on the reusable module 1112 can be updated to indicate that the reusable module 1112 has been used again and the reusable module 1112 is not currently being replenished. . The RFID tag 1131 on the dialyzer 1130 can also be updated to indicate that the dialyzer 1130 is used and the dialyzer 1130 is currently available. Other dialysis components such as circuit tubes and consumable materials can also be updated by storing newly generated information regarding their respective use of corresponding RFID tags or other authentication components.

  The authentication system may also update patient information at step 1205 of FIG. 12 during or after the dialysis session. For example, patient information including the most recent treatment history can be stored in a patient information storage device, such as the wristband RFID 910 of FIG. In a non-limiting example, the updated information of the dialysis component can also be stored in a reader or processor that is used for the current or next dialysis session.

  FIG. 13 outlines the usage for managing the replenishment of refillable dialysis components. FIG. 13 shows that after dialysis is completed in step 1301, the refillable component can be removed from the dialysis machine for refilling. In step 1302, the RFID tag attached to the refillable component can be read by a reader attached to the refiller. The refiller can then confirm that the refillable component can be refilled without problems at step 1303 prior to refilling. Once refilled, the refiller can optionally update the RFID tag information for the refillable component at step 1304 by incorporating the most recent refill information.

  In a non-limiting example, the reusable adsorbent cartridge 1400 of FIG. 14 can be removed from the dialyzer to the refiller 1410. The reusable adsorbent cartridge 1400 also includes a consumable module 1403 that does not require replenishment. The consumable module 1403 may include an authentication component that may not be readable by the reader of the refiller 1410, or the refiller 1410 may determine that the consumable module 1400 is not refillable (not shown). Before the refilling process begins, the reader 1411 of the refiller 1410 reads the RFID tag 1402 on the reusable module 1401 and the reusable module 1402 is in use and reusable. It can be verified that the module 1402 is within the number of times allowed for safe refilling. The reusable module 1401 can be refilled, and the refiller 1410 can provide the date the reusable module 1401 was refilled and any other information regarding the updated status of the reusable module 1401. , The RFID tag 1402 can be written. Alternatively, as RFID tag 1402 can only contain identification information, replenisher 1410 can transmit the date that the component was replenished and any other information for a central database (not shown). The reusable module 1401 can then be returned for the next dialysis session. At least one multi-use module for any of the adsorbent cartridges described in the present invention has been described, so that a non-limiting example is a multi-use module 1401, two, three It is understood that various sizes, shapes, configurations and functions of one, four or more multi-use modules are being considered. In addition, at least one disposable module is contemplated, a non-limiting example of which is a consumable module 1403, thereby allowing two, three, four, or various sizes, shapes, configurations and functions. More disposable modules can be used in any adsorbent cartridge of the present invention.

Multi-use cartridge protection system In any embodiment of the first, second, third or fourth aspects of the dialysis system, the authentication system may provide for the safe use of the multi-use cartridge or one or more during hemodialysis treatment. It can be a protection system that manages cartridges with reusable modules. The multi-use cartridge protection system is designed to check the amount of replenishment solution used to replenish a single patient, multi-use cartridge and monitor that the permittivity of the incoming replenishment solution is within acceptable limits Can monitor the waste water temperature / time for a single patient, multi-use cartridge disinfection cycle, and monitor the water dielectric constant during the rinse to ensure that the replenishment solution has been completely removed. Make sure that a complete replenishment cycle has been performed before writing to the RFID. The system is also designed to protect patient safety by reacting to possible misuse conditions.

  Management of the use of multi-use cartridges can include, but is not limited to, safe replenishment of multi-use cartridges in FIG. 15 and safe application of multi-use cartridges in the hemodialysis system (HDS) of FIG. .

  FIG. 15 shows that the multi-use cartridge 1501 or reusable module includes an authentication component 1502 that stores information on the multi-use cartridge 1501. The authentication component 1501 can be read by a reader 1504 that is fixed to the replenisher 1503, where information can be transferred from the reader 1504 to the processor 1505. The processor 1505 receives information at step 1510. The processor 1505 then determines at step 1520 regarding the multi-use cartridge 1501 based on the received information. For example, if the cartridge 1501 is found to be a new cartridge or a used cartridge that has been stored for a relatively long time, the processor 1505 determines that the refill process will not start, and then a refiller 1503 at step 1530. Control so that does not start replenishment. Those skilled in the art will appreciate that further requirements for safe use and replenishment of multi-use cartridges can be considered by the protection system.

  FIG. 16 a shows that the multi-use cartridge 1601 can include an authentication component 1602 that stores information for the multi-use cartridge 1601. An authentication component such as an RFID tag 1602 can be read by a reader 1604 that is secured to the HDS 1603 in any suitable location, eg, a dialysis cabinet. Information contained in the RFID tag 1602 can be transferred from the reader 1604 to the processor 1605. The processor 1605 can receive information about the RFID tag 1602 at step 1610 and can make a determination at step 1620. For example, the processor 1605 can determine whether the size of the cartridge 1601 is compatible with HDS and the patient. If it is determined that the cartridge 1601 is improperly sized, the processor 1605 generates an alert to the HDS at step 1607. The processor 1605 may request that the user approve whether a non-conforming cartridge 1601 can be used. If the user does not approve the use of the non-conforming cartridge 1601, the processor 1605 may refuse to use the cartridge 1601. The user can replace the non-conforming cartridge 1601 with the correct one and can restart the authentication process or the user can choose to begin treatment (not shown). If the user approves the use of a non-conforming cartridge 1601, the processor 1605 can determine other requirements for proper use of the cartridge. Alternatively, step 1640 can be omitted at the discretion of the user.

  In a non-limiting example, the processor 1605 determines in step 1640 that the cartridge 1601 has been stored for a relatively long time between dialysis sessions, has been fully replenished, has reached a replenishment limit, or has the correct patient. It is also possible to determine whether it conforms to or is not certified. If the answer is affirmative to any of these queries, the processor 1605 can issue a command at step 1650 to disable the use of the cartridge 1601 and control the treatment not to begin. Those skilled in the art will appreciate that further requirements for safe use and replenishment of multi-use cartridges can be considered by the protection system.

  In a non-limiting example, the processor 1605 can be located in the console of the dialysis system. The console may implement a dialysate temperature, dialysate composition, extracorporeal circuit, and an ultrafiltration controller and mechanism to monitor and / or control blood and dialysate flow.

  FIG. 16b shows a non-limiting example of a multi-use cartridge protection system. The same reference numbers in FIGS. 16a and 16b mean the same object. In FIG. 16b, after processor 1605 receives cartridge 1601 information from reader 1604 at step 1610, processor 1605 at step 1660, cartridge 1601 has the following requirements, cartridge 1601 has been stored too long between sessions, Determine if they are either not fully replenished, have reached an acceptable replenishment limit, are not fit for the right patient, are not certified products, or are non-conforming. If the answer is affirmative to any of these questions, the processor 1605 may disable the use of the cartridge 1601 at step 1670 and control it not to start treatment. In addition, the processor 1605 can display a specific reason for improper use of the cartridge 1601 on a user interface (not shown). For example, if it is found that the cartridge 1601 has an incompatible size, the processor 1605 sends a message to the user requesting that the user replace the cartridge or approve the use of the incompatible cartridge 1601. can do.

  In a non-limiting example, the protection system for the multi-use cartridge 1601 can include additional steps involving one or more additional multi-use modules and disposable modules included in the multi-use cartridge 1601. The protection system can also relate to consumable materials contained in the multi-use cartridge 1601.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the information used by the reprocessing device or replenisher is not limited, but with respect to the reprocessing program, the reprocessing program Can be items including when it was recently used, how many times it was used, pre-lifetime use, cartridge size. The reprocessing program may or may not require adaptation to a particular patient for treatment optimization. Patient information may not be needed for a reprocessing program that proceeds for treatment optimization when the reprocessing or supplementary program does not need to be adapted to a particular patient.

Table 1 includes a non-limiting example of misuse of the replenishment system based on the information that can be included in the authentication component and the decisions made by the system accordingly. Table 1 also includes examples where the type of misuse can be detected by a particular component. Although those skilled in the art provide examples of components that can detect specific misuse, Table 1 can be configured to detect any misuse of any component of the system, and in any embodiment Understand that an authentication component can be read by a stand-alone identifier that can detect misuse. In addition, Table 1 provides protection decisions made by the system in response to detecting misuse. Those skilled in the art will appreciate that any embodiment can make any protection decisions, including alarms or notifications to the user, and that specific provided examples can be modified.

Infusion Container Protection System In any embodiment of the first, second, third or fourth aspects of the present invention, the infusion container protection system is suitable for dialysis systems where the container is ready for a particular patient. It is possible to determine whether it is installed on the computer. Implementation of an infusion container protection system can include preparing the container for a particular patient's prescription, and comparing the patient information of the container with the patient information of the console, so that the container Reduce the risk of being installed and used by patients.

  FIG. 17a shows an infusion container protection system including a filling station 1720 having a reader 1721 for reading a patient information storage device, eg, a list type RFID 1710. The filling station 1720 can also obtain patient information from different data sources, such as a computer database pre-stored with patient information or another authentication component (not shown) attached to the dialysis component. After obtaining the patient information, the filling station 1720 can write the patient information on the RFID tag 1731 of the container 1730. Container 1730 can be filled at a filling station 1720.

  RFID tag 1731 can include additional information, such as previous usage of container 1730. The filling station 1720 may perform a filling operation based on additional information about the container 1730, for example, whether the container 1730 is a certified product or whether conventional use of the container 1730 is inconsistent with the current filling (not shown). You can also decide whether to continue.

  In any embodiment of the first, second, third or fourth aspects of the present invention, the container 1730 may include a plurality of containers each filled with a different infusion solution based on a particular patient's prescription. it can. RFID tag 1731 can include, but is not limited to, patient prescription and updated filling status of container 1730.

  The infusion container protection system can further include a console 1740 having a reader 1741 as shown in FIG. 17a. The reader 1741 can store patient information previously read from the patient information storage device 1710. The reader 1741 can also read the RFID tag 1731 of the container 1730 when the container 1730 is brought near or installed in the console 1740. The reader 1741 can obtain patient information and other information stored in the RFID tag 1731. A separate processor (not shown) of reader 1741 or console 1740 can then compare the information obtained from container 1730 with patient information read directly from patient storage device 1710.

  In a non-limiting example, as shown in FIG. 17b, the container 1730 can be placed at different locations other than where processing should occur, and the filling station 1720 reads patient information from different data sources 1711. It can be different from the data source of the list type RIFD 1710 that is read by the console 1740 where the treatment occurs. In other embodiments, any suitable location of the container 1730, filling station 1720, or console 1740 relative to each other for dialysis treatment, replenishment or convenience is also contemplated. Console 1740 can determine whether container 1730 has been applied to the correct patient and installed in the correct console based on information from different data sources, eg, patient information store 1711 and / or 1710. The console 1740 may also determine, for example, whether the container 1730 is a certified product and is within the lifetime of use that does not necessarily require patient-specific information. It will be appreciated that further combinations of patient storage devices can be adapted to the filling station and console. For example, at least one patient information store 1711 and / or at least one patient information store 1710 can be secured to any combination of dialysis components for identification. For example, two or more patient storage devices 1711 can be secured to two or more modules for separate tracking and identification by either console 1740 or filling station 1720, or both. Similarly, as shown in FIG. 17a, a wristband type patient information storage device 1710 can be used by the console 1740 or the filling station 1720, or both.

  FIG. 18 shows the operation of the infusion container protection system of FIG. 17a or 17b. In step 1801 of FIG. 18, the filling station can read patient information including the prescription by a reader attached to the filling station. The filling station reader can write patient information onto the RFID tag of the container at step 1802. The container can be filled in accordance with a particular patient's prescription by the filling station at step 1803, where the filling state of the container can be updated on the container's RFID. At step 1804, the filled container can be installed on the console at step 1804. The console can then read the RFID tag on the container by a reader on the console at step 1805 and compare the patient information obtained from the container with the patient information previously stored on the console at step 1806. Based on the comparison results obtained in step 1806, the console can determine in step 1807 whether the container is provided for the correct patient and is installed in the correct console.

  In a non-limiting example, if the console determines that the container is for the correct patient and is installed in the correct console, the console issues a dialysis command or other dialysis component (not shown). ) Can be continued. If the console determines that the container is not for the correct patient or for the correct console, the console can alert the user and not start dialysis (not shown).

Adsorbent Dialysis System FIG. 19 shows an adsorbent dialysis system that includes a blood circuit or flow path 11 and a dialysate regeneration circuit or flow path 12 separated by a membrane 13 of the dialyzer 10. Blood enters the dialyzer 10 through the blood line inlet 14 and exits through the blood line outlet 15. The dialysate flow loop 12 is a control-compatible flow loop. The flow of blood through the dialyzer 10 via the flow path 11 can replace unwanted compounds throughout the membrane 133 with dialysate flowing through the dialyzer 10 via the flow path 12.

  The dialysate that has passed through the dialyzer 10 exits as a used dialysate 16. The spent dialysate can pass through the ultrafiltration system 21, which can include an ultrafiltration pump 20 and an ultrafiltration reservoir 19. The ultrafiltration pump 20 can remove fluid from the dialysate flow path 22, which draws fluid across the membrane 13 from the blood. The fluid removed by the ultrafiltrate pump 20 is collected in the ultrafiltrate storage unit 19.

  Regeneration of the dialysate in the dialysate regeneration channel 12 occurs in the reusable adsorbent cartridge 17. The adsorbent cartridge 17 includes an adsorbent material that can remove specific toxins from the dialysate or decompose the toxins into non-toxic compounds. After leaving the adsorbent cartridge 17, the clean dialysate may be deficient in certain ions, such as potassium, calcium or magnesium, which need to be added before reentering the dialyzer 10. . This can be achieved by the infusion system 22. The infusion system 22 can include an infusion pump 24 and an infusion storage 23. The infusion reservoir 23 can include a concentrated solution that includes certain ions that need to be added to the dialysate before joining the dialyzer 10. After passing through the infusion system 22, the dialysate can be completely regenerated and returned back through the dialyzer 20.

  The adsorbent cartridge 17 may be reusable. In order to verify that the cartridge 17 is a certified component that fits correctly in the correct machine and is still within the useful life of the cartridge, the identification component 18 can be attached to or embedded within the cartridge 17. Can do.

  When dialysis is complete, the reusable adsorbent cartridge 17 can be removed from the dialysis circuit 12. This can be done to replace the cartridge 17 or to replenish the adsorbent material in the cartridge 17. After the adsorbent cartridge 17 is returned to the circuit 12 of FIG. 19, a reader (not shown) can read the identification component 18 to confirm that the correct cartridge is being used. The identification component or authentication component may additionally or alternatively be secured to any of the described dialysis system components.

  The first, second, third and fourth aspects of the present invention provide an authentication system for managing a dialysis system for the purpose of achieving therapeutic optimization. The certification system manages the proper use of certified products and ensuring the safety of the patient and the system efficiency in addition to protecting manufacturing economic concerns from fake products.

  The certification system also improves the proper use of certified products by monitoring replenishment operations, consumable usage, and other settings of the dialysis system for optimized settings of the dialysis system. The authentication system also provides a patient information storage device for storing, accessing and updating patient information, possibly by remote and automated processes. The authentication system can associate patient information with one or more specific dialysis components and can determine whether optimized settings are available for the dialysis system.

  The techniques described in this disclosure may also be incorporated in or encoded on a computer system readable medium, such as a computer system readable storage medium, including instructions. The instructions embedded in or encoded on the computer system readable medium, including a computer system readable storage medium, are one or more programmable processors using one or more of the techniques described herein. Or, it can be implemented in other processors, such as when instructions embedded or encoded in a computer system readable medium are executed by one or more processors. Computer system readable storage media include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable Includes read only memory (EEPROM), flash memory, hard disk, compact disk ROM (CD-ROM), floppy disk, cassette, magnetic media, optical media or other computer system readable media it can. In any embodiment of the first through seventh aspects of the present invention, the product can include one or more computer system readable storage media.

  Those skilled in the art will appreciate that various combinations and / or modifications and variations can be made in the described systems and methods according to the particular needs of operation. Furthermore, features illustrated or described as being part of an aspect of the present invention can be used in aspects of the present invention alone or in combination.

(Item 1)
At least one authentication component for managing an adsorbent-based dialysis system including data corresponding to at least one dialysis component of the dialysis system;
At least one identifier for reading the data of the at least one authentication component;
A processor for receiving the data from the at least one discriminator, wherein the data is processed by the processor to make a determination regarding the at least one dialysis component;
Dialysis authentication system including
(Item 2)
Item 2. The dialysis authentication system of item 1, wherein the authentication component is secured to any one or more selected from the group of a dialyzer, an adsorbent cartridge, and a refiller.
(Item 3)
2. The dialysis authentication system of item 1, wherein the authentication component is selected from the group comprising a radio frequency identification (RFID) marker, a barcode, a 1-Wire security component and a wireless authentication component.
(Item 4)
The dialysis authentication system of item 1, wherein the authentication component includes an embedded memory.
(Item 5)
The dialysis authentication system of item 1, wherein the authentication component includes a radio frequency identification (RFID) chip and a memory chip bonded to a smart card.
(Item 6)
Item 2. The dialysis authentication system of item 1, wherein the authentication component is readable and writable, allowing the data of the dialysis component to be updated.
(Item 7)
2. The dialysis authentication system of item 1, wherein the processor determines a non-certified component or a fake component based on the data received from the authentication component.
(Item 8)
The dialysis authentication system of item 1, further comprising a patient authentication component that stores patient information including at least one of patient prescription, treatment history, and cartridge size information.
(Item 9)
9. The dialysis authentication system of item 8, wherein the patient authentication component is one of an implantable device, a card-like device and a wristband device.
(Item 10)
The identifier communicates with the authentication component and the patient authentication component, and data from the authentication component and the patient authentication component determines an optimized setting of the dialysis system for the patient with respect to the dialysis component 9. The dialysis authentication system of item 8, communicated to the processor to do so.
(Item 11)
Based on the data received from the first and second authentication components, the processor determines whether the dialysis component is suitable for the patient, the dialysis component settings are appropriate, and optimized performance. Item 11. The dialysis authentication system according to item 10, wherein one or more of whether to change any of the settings is determined.
(Item 12)
The identifier is secured on a second dialysis component to read the authentication component, and the processor determines whether the dialysis component having the authentication component is compatible with the second dialysis component. 2. The dialysis authentication system according to 1.
(Item 13)
Item 2. The dialysis authentication system of item 1, wherein the identifier is a multi-mode type reader capable of communicating with at least two different types of the authentication component.
(Item 14)
Item 2. The dialysis authentication system of item 1, wherein the identifier distinguishes the two or more authentication components from each other when the at least one authentication component includes two or more authentication components.
(Item 15)
Reading the first data from the first authentication component corresponding to the first dialysis component by the identifier;
Reading second data from the second dialysis component or a second authentication component corresponding to the patient by the identifier;
Receiving the first data and the second data from the classifier by a processor;
Making a determination with respect to the first dialysis component from the perspective of the second dialysis component or the patient based on the first data and the second data by a processor;
Controlling settings of the first dialysis component for performance optimized from the second dialysis component or the patient;
A method of managing a dialysis system for performing dialysis via a wireless signal.
(Item 16)
16. The method of item 15, further comprising storing data relating to the dialysis in at least one of the first authentication component and the second authentication component during or after the dialysis.
(Item 17)
Reading data from an authentication component secured to a refillable component for use in adsorbent-based dialysis by an identifier;
Communicating the data from the authentication component to a processor;
Determining whether to start replenishment of the refillable component by the refiller based on the data received by the processor;
Controlling and selectively replenishing a refiller used to refill the refillable component based on the determination made by the processor;
Including a method.
(Item 18)
The determining step includes whether the refillable component has been stored for a long time using a predetermined standard, whether the refillable component is not fully refilled, and the refillable component is at a refill limit. 18. The method of item 17, further comprising the step of determining one or more of:
(Item 19)
Reading authentication component data fixed to the multi-use cartridge by an identifier fixed to the hemodialysis system;
Communicating the data of the authentication component to a processor by the identifier;
Determining by the processor whether the cartridge is properly used according to the data communicated to the processor;
Controlling hemodialysis therapy according to the determination made by the processor;
Including a method.
(Item 20)
The determining step includes determining whether the cartridge has been stored for a long time according to a predetermined standard, whether the cartridge is not fully refilled, whether the cartridge has reached a refill limit, and 20. The method of item 19, comprising determining one or more of whether the cartridge is compatible with the patient.

Claims (20)

An adsorbent cartridge comprising one or more adsorbent materials, and a replenisher for replenishing the adsorbent cartridge with one or more adsorbent materials;
At least one authentication component for managing an adsorbent-based dialysis system including data corresponding to at least one of the adsorbent cartridge or refiller;
At least one identifier for reading the data of the at least one authentication component;
A processor for receiving the data from the at least one discriminator, wherein the data is processed by the processor to make a determination regarding at least one of the adsorbent cartridge or refiller;
Including
The data from the authentication component and patient authentication component is communicated to the processor;
The processor executes instructions to determine an optimized setting of the dialysis system for the patient with respect to the adsorbent cartridge or dispenser;
The optimized settings of the dialysis system include whether any one of the adsorbent cartridges is fully refilled, whether the adsorbent cartridge is compatible with the dialysis system, or whether the dialysis system setting is the patient Whether the adsorbent cartridge is suitable for patient prescription, blood flow, adsorbent cartridge size, ultrafiltration rate, ultrafiltration profile and combinations thereof,
Dialysis authentication system.   The dialysis authentication system of claim 1, wherein the authentication component is secured to any one or more selected from the group of a dialyzer, an adsorbent cartridge, and a refiller.   The dialysis authentication system of claim 1, wherein the authentication component is selected from the group comprising a radio frequency identification (RFID) marker, a barcode, a 1-Wire security component, and a wireless authentication component.   The dialysis authentication system of claim 1, wherein the authentication component includes an embedded memory.   The dialysis authentication system of claim 1, wherein the authentication component includes a radio frequency identification (RFID) chip and a memory chip bonded to a smart card.   The dialysis authentication system of claim 1, wherein the authentication component is readable and writable to allow the data of the adsorbent cartridge or refiller to be updated.   The dialysis authentication system of claim 1, wherein the processor determines a non-certified component or a false component based on the data received from the authentication component.   The dialysis authentication system of claim 1, wherein the patient authentication component is one of an implantable device, a card-like device, and a wristband device.   The processor, based on data received from the authentication component and the patient authentication component, whether the adsorbent cartridge or refiller is suitable for the patient, the adsorbent cartridge or refiller settings are appropriate, and The dialysis authentication system of claim 1, wherein one or more of whether to change any of the settings for optimized performance is determined.   The identifier is secured on a second dialysis component to read the authentication component, and the processor determines whether the dialysis component having the authentication component is compatible with the second dialysis component. Item 2. The dialysis authentication system according to item 1.   The dialysis authentication system of claim 1, wherein the identifier is a multi-mode type reader capable of communicating with at least two different types of the authentication component.   The dialysis authentication system of claim 1, wherein the identifier distinguishes the two or more authentication components from each other when the at least one authentication component includes two or more authentication components. Reading the first data from the first authentication component corresponding to the first dialysis component by the identifier;
Reading second data from the second dialysis component or a second authentication component corresponding to the patient by the identifier;
Receiving the first data and the second data from the classifier by a processor;
Making a determination with respect to the first dialysis component from the perspective of the second dialysis component or the patient based on the first data and the second data by a processor;
Managing a dialysis system for performing dialysis via a wireless signal comprising controlling settings of the first dialysis component for the second dialysis component or the patient-optimized performance A method using the system according to claim 1.   16. The method of claim 15, further comprising storing data regarding the dialysis in at least one of the first authentication component and the second authentication component during or after the dialysis. Reading data from an authentication component secured to a refillable component for use in adsorbent-based dialysis by an identifier;
Communicating the data from the authentication component to a processor;
Determining whether to start replenishment of the refillable component by the refiller based on the data received by the processor;
Controlling and selectively replenishing a refiller used to refill the refillable component based on the determination made by the processor;
A method using the system of claim 1, comprising:   The determining step includes whether the refillable component has been stored for a long time using a predetermined standard, whether the refillable component is not fully refilled, and the refillable component is at a refill limit. The method of claim 17, further comprising determining one or more of: Reading authentication component data fixed to the multi-use cartridge by an identifier fixed to the hemodialysis system;
Communicating the data of the authentication component to a processor by the identifier;
Determining by the processor whether the cartridge is properly used according to the data communicated to the processor;
Controlling hemodialysis therapy according to the determination made by the processor;
A method using the system of claim 1 comprising:   The determining step includes determining whether the cartridge has been stored for a long time according to a predetermined standard, whether the cartridge is not fully refilled, whether the cartridge has reached a refill limit, and 20. The method of claim 19, comprising determining one or more of whether the cartridge is compatible with the patient.   The system of claim 1, wherein the patient authentication component stores whether ammonia breakthrough occurred in at least one previous session.   The system of claim 21, wherein if an ammonia breakthrough occurs in the at least one previous session, the processor determines that the optimized setting includes a larger adsorbent cartridge size.