WO2022144910A1

WO2022144910A1 - Dialyzer reprocessing system

Info

Publication number: WO2022144910A1
Application number: PCT/IN2021/050182
Authority: WO
Inventors: Vikram VUPPALA; Venkatraman GANAPATHISUBRAMANIAN; Mahesh Kumar; Kamal Dilip SHAH
Original assignee: Nephrocare Health Services Pvt. Ltd.
Priority date: 2020-12-28
Filing date: 2021-02-25
Publication date: 2022-07-07

Abstract

A dialyzer reprocessing system (DRS) (100) and a method of remotely monitoring, calibrating, and servicing the DRS (100) are disclosed. The DRS includes a control board (102), a chemical tank (104), a manifold (106) connected to the chemical tank (104) and having one or more solenoid valves (108), a display unit, at least one each of a conductivity sensor (112), a pressure sensor (114), and a load cell (120) configured for supporting passage of the chemical to and from the chemical tank (104), and an input-output board (130). The method includes steps of accessing the control board (102) of the DRS (100) through a cloud-based data management system and directing the input-output board (130) through the control board (102) to activate any one or more of at least one conductivity sensor (112), pressure sensor (114), and load cell (120) of the DRS (100).

Description

DIALYZER REPROCESSING SYSTEM TECHNICAL FIELD [001] The present invention generally relates to dialyzer reprocessing systems and particularly relates to dialyzer reprocessing systems that can be monitored, calibrated, and serviced from a remote location and method of monitoring, calibrating, and servicing the dialyzer reprocessing systems from a remote location. BACKGROUND [002] A dialyzer is a product that is used as an artificial kidney to remove wastes (urea, creatinine etc.) from blood, restore balance of electrolytes in the blood and eliminate extra fluid from the body. The blood in the body is continuously removed and passed through the dialyzer that selectively removes the unwanted wastes through filtering. Haemodialysis using a dialyzer is an intermittent treatment that is repeated a few times a week for a patient having renal failure. [003] Reusing dialysers for the same patient is practised commonly. There are significant benefits in reusing a dialyzer. Primarily, the reused dialyzers are found to be superior in bio- compatibility in comparison with that of new dialyzers. A good and robust method of cleaning the used dialyzers between uses can reduce the cost of treatment to the patient. [004] During dialysis, blood components such as proteins, glycoprotein, carbohydrates, cells, platelets remain on the surface of dialyzer such as pore surface and are present even under the cap of the dialyzer. In addition to this, blood clots also accumulate in the dialyzer. Since the adhesive strength of these components is high, they cannot be easily removed by conventional liquid cleaning and, as a result, dialyzers lose their permeability. The effectiveness of dialysis depends on the available membrane surface area that permits blood-dialysate - solute exchange termed as Fibre Bundle Volume (FBV). FBV is one of the critical factors which decide whether to reuse the dialyzer or to discard. The FBV value of more than 80% is usually recommended for effective dialysis. In order to reuse a dialyzer, it has to be thoroughly cleaned and preserved after each dialysis. [005] Usually, after every dialysis procedure the dialyzer is cleaned with water purified by Reverse Osmosis (RO) and then mounted onto the dialyzer reprocessing system (DRS) for disinfection. The reprocessing procedure using a DRS involves cleaning, testing, filling the dialyzer with a sterilant, inspecting, labelling, storing, and rinsing before the dialyzer is reused for the next treatment. [006] DRSs that are used currently have limited accessibility and data storage features. Hence, if a DRS breakdown occurs, there is a need for a site visit by a biomedical engineer for servicing the device. The need for a personal visit of the biomedical engineer for servicing leads to increased device shut down time. Moreover, in existing DRSs the reprocessing bundle volume is provided as a printout after the cycle is completed and there is no provision of storing this data for later analysis. DRSs also usually have the ability to reprocess only one dialyser at a time thus greatly increasing the time required for reprocessing all the dialysers in a shift of multiple patients in a dialysis centre. Hence, there is a need for an improved DRS, addressing these challenges. OBJECTIVE OF THE INVENTION [007] The primary objective of the present invention is to provide an automated DRS configured for reprocessing multiple dialysers and that is amenable for online monitoring, maintenance, and servicing. [008] Another objective of the present invention is to provide an automated DRS apparatus having a manifold that facilitates easy servicing. [009] Yet another object of the present invention is to provide an automated DRS apparatus that has a chemical tank having better accessibility and avoids back flow of water and chemicals. [0010] These and other objectives and advantages of the present disclosure will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. SUMMARY OF THE INVENTION [0011] The various embodiments of the present disclosure provide a dialyzer reprocessing system (DRS) configured for being monitored, calibrated, and serviced from a remote location and a method for remotely monitoring, calibrating, and servicing the dialyzer reprocessing system. [0012] In one aspect, a dialyzer reprocessing system is disclosed. The DRS includes a control board for controlling the operation of the DRS, a chemical tank for storing a chemical for circulating through a dialyzer unit that is under reprocessing, a manifold connected to the chemical tank and having one or more solenoid valves, a display unit configured for receiving inputs and for displaying at least one output, at least one each of a conductivity sensor, a pressure sensor, a load cell configured for supporting the passage of the chemical to and from the chemical tank, and an input-output board connected to and configured for activating any one or more of the at least one conductivity sensor, pressure sensor, and load cell, on receiving a control signal from the control board. The DRS is configured for being monitored, calibrated, and serviced from a remote location, by accessing the control board through a cloud-based data management system. [0013] In another aspect of the present disclosure, a method of remotely monitoring, calibrating, and servicing a DRS is disclosed. The method includes the steps of accessing a control board of the DRS through a cloud-based data management system and directing an input-output board of the DRS through the control board to activate any one or more of the at least one conductivity sensor, pressure sensor, and load cell of the dialyzer reprocessing system. [0014] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating the preferred embodiments and numerous specific details thereof, are given by way of an illustration and not of a limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications. BRIEF DESCRIPTION OF THE DRAWING [0015] To further clarify the advantages and features of the disclosure, a more particular description of the disclosure will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawing. It is appreciated that this drawing depicts only typical embodiments of the disclosure and is therefore not to be considered limiting of its scope. The disclosure will be described and explained with additional specificity and detail with the accompanying drawing in which: [0016] Fig. 1 illustrates a design of a DRS, according to one of the embodiments of this disclosure. [0017] It may be noted that to the extent possible, like reference numerals have been used to represent like elements in the drawing. Further, those of ordinary skilled in the art will appreciate that elements in the drawing are illustrated for simplicity and may not have been necessarily drawn to scale. For example, the dimensions of some of the elements in the drawing may be exaggerated relative to other elements to help to improve understanding of aspects of the disclosure. Furthermore, the one or more elements may have been represented in the drawing by conventional symbols, and the drawing may show only those specific details that are pertinent to understanding the embodiments of the disclosure so as not to obscure the drawings with details that will be readily apparent to those of ordinary skilled in the art having the benefits of the description herein. DETAILED DESCRIPTION OF THE INVENTION [0018] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the disclosure as illustrated therein being contemplated as would normally occur to one skilled in the art to which the disclosure relates. [0019] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the disclosure and are not intended to be restrictive thereof. Throughout the patent specification, a convention employed is that in the appended drawings, like numerals denote like components. [0020] Reference throughout this specification to “an embodiment”, “another embodiment” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. [0021] It will be understood by those working in the art that, in general, terms used herein, and especially in the appended claims. The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other sub-systems. It will be further appreciated that functions or structures of a plurality of components or steps may be combined into a single component or step, or the functions or structures of one-step or component may be split among plural steps or components. The present invention contemplates all of these combinations. Unless stated otherwise, dimensions and geometries of the various structures depicted herein are not intended to be restrictive of the invention, and other dimensions or geometries are possible. In addition, while a feature of the present invention may have been described in the context of only one of the illustrated embodiments, such feature may be combined with one or more other features of other embodiments, for any given application. It will also be appreciated from the above that the fabrication of the unique structures herein and the operation thereof also constitute methods in accordance with the present invention. The present invention also encompasses intermediate and end products resulting from the practice of the methods herein. The use of “comprising” or “including” also contemplates embodiments that “consist essentially of” or “consist of” the recited feature. [0022] It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to inventions containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). [0023] One or more of the embodiments of the present disclosure includes a DRS that is configured for being monitored, calibrated, and serviced from a remote location and a method for remotely monitoring, calibrating, and servicing the DRS. The remote monitoring, calibrating, and servicing of the DRS is enabled by one or more features and components of the DRS. Further, the disclosed variation and modifications in the construction and components of the DRS enable easy and robust operation and cleaning of the DRS. [0024] The DRS of the present disclosure is used for pre-cleaning one or more dialyzers, for preparing chemicals, for reprocessing dialyzers, for monitoring the reprocessing status, and for post reprocessing disinfected dialyzers for removing chemical residues. A method for disinfecting a dialyzer using the disclosed DRS includes the steps of pre-cleaning one or more dialyzers, disinfecting dialyzers with chemicals, checking Fibre Bundle Volume (FBV) for measuring available membrane surface area for diffusive transport, filling chemicals such as (Peracetic acid) to the blood compartment and the dialysate compartment to prevent a growth of microorganisms, and post reprocessing dialyzers for removing chemical such as Peracetic acid (PAA) and chemical residues. When more than one dialyzers are reprocessed using the DRS, the dialyzers may be reprocessed alternately or simultaneously. [0025] FIG. 1 illustrates a block diagram of a DRS 100, according to an embodiment of the present disclosure. The DRS 100 is configured for reprocessing one or more dialyzers before re-using. The DRS 100 shown in Figure 1 has two slots for two dialyzers D1 and D2 and is configured for processing the two dialyzers D1 and D2 at the same time. The DRS 100 is configured such that the individual steps of cleaning and processing of the two dialyzers D1 and D2 may be done alternately or simultaneously. In some embodiments of the DRS 100 described using Figure 1, the two dialyzers D1 and D2 are reprocessed simultaneously. [0026] The DRS 100 includes a control board 102 for controlling the operation of the DRS, a chemical tank (alternatively, a mixing tank) 104 for mixing and storing a chemical for circulating through one or more dialyzer units that are under reprocessing, at least one manifold 106 connected to the chemical tank 104 and having one or more solenoid valves 108, a display unit 110 configured for receiving inputs and for displaying at least one output, at least one conductivity sensor 112, at least one pressure sensor 114, at least one load cell 120 configured for supporting passage of the chemical to and from the chemical tank 104. Further, the DRS 100 includes an input-output board 130. The input-output board 130 is connected to any one or more of the at least one conductivity sensor 112, pressure sensor 114 and load cell 120. Further, the input-output board 130 is configured for activating one or more of the at least one conductivity sensor 112, pressure sensor 114, and load cell 120 on receiving a control signal from the control board 102. The DRS 100 is configured for being monitored, calibrated, and serviced from one or more remote locations by accessing the control board 102 through a cloud- based data management system. The controller 102, the display 110 and the input-output board 130 may be interconnected for their operations. The control board 102 is configured for controlling one or more other parts of the DRS 100 by passing signals to the parts either directly or through the input-out board 130. For example, the control board 102 is configured for receiving a signal from a remote location through the cloud-based data management system and open a solenoid valve 108 of the DRS 100 for servicing the manifold 106. In some embodiments, the control board 102 may receive the signal from the cloud-based data management system through the input-output board 130. It may be noted that, while the DRS 100 includes the configuration for remote monitoring, calibration, and servicing, the DRS 100 is also amenable for all kinds of local operations including monitoring, calibration, and servicing. Thus, the control board 102 is also configured for receiving a control signal from a local source, for example from the display unit 110 and is able to initiate action based on the signal, in the DRS, through the input-output board 130. [0027] The control board processes and controls self-testing, machine cleaning, pre-cleaning and post processing of dialyzers. In some embodiments, the control board used in the DRS 100 is a Raspberry Pi 4 board. The Raspberry Pi 4 board has several advantages such as a better CPU for processing and performing with high speed. It includes 1.5GHz quad-core 64-bit Arm Cortex- A72 CPU hardware. It has USB 3.0 and type C support for input power supply and has additional ports for adding devices. The Raspberry Pi 4 board also has a large memory which is essential to support the functions required for this machine. A person skilled in the art may, however, use any other hardware, software, or firmware to achieve the same features and all such variations are deemed to be implementations of the present disclosure. [0028] The input-output board 130 is used as a user interface. In some embodiments, an Arduino board is used as the input-output board 130. The Arduino board is inexpensive and can run on Microsoft Windows, Macintosh OSX, and Linux operating systems. It has Atmel’s ATMEGA8 & ATMEGA168 microcontrollers for hardware extensions. A person skilled in the art may, however, use any other hardware, software, or firmware to achieve the same features and all such variations are deemed to be implementations of the present disclosure. The input- output board 130 may also include a buzzer or an alarm device and LEDs for visually indicating the status of the reprocessing or to indicate certain fault, alarm, status, or operating conditions. The input-output board 130 may further include a mode selection switch for selecting different modes of operation for the user and a start/stop keys for controlling the pre-cleaning module operation. The input-output board 130 is amenable for receiving, executing, and delivering signals through control board 102 from a remote location. This provides remote accessibility to the DRS 100 and is advantageous over the dialyzer reprocessing systems that use physical interface for inputs mainly through keypads or touch screen, thereby necessitating the presence of the user in physical proximity to the DRS. [0029] The DRS 100 may further include a power supply. The power supply may be through an input connected to the mains supply through a regulator. [0030] In some embodiments, the DRS 100 includes a switch-mode power supply (SMPS) for 24 Volt and 5 Volt channels for providing power supply to the control board 102. In some embodiments, DRS 100 includes a Mean well: PID- 250B AC-DC dual output series SMPS to step down the power input. [0031] In some embodiments, the DRS 100 includes a memory card for storing data. The data of each reprocessing instance may be stored in it. In some embodiments, the data from the memory card is stored in a cloud-based storage. This data can be used further for analysis based on requirement. [0032] The DRS 100 has remote Accessibility through an online system and can be controlled through a touch screen on the device and also through electronic gadgets connected to the cloud. For example, the DRS 100 can be controlled using a tablet, a mobile device, or a personal computer or a laptop, over various networks such as LAN, Wi-Fi, or Bluetooth. The cloud- based data storage in an online system used herein enables easy retrieval of the stored data anytime from anywhere. The online accessibility and cloud-based storage further helps in remote monitoring, maintaining, and troubleshooting of the DRS 100. A user of the DRS 100, who uses the DRS 100 for reprocessing the dialyzers, may be present in the physical proximity to the DRS 100 or may be controlling the functioning of the DRS 100 from a remote location. In some embodiments, a user in the form of a semi-trained person may be present in the physical proximity to the DRS 100 and a well-trained Biomedical Engineer may be able to monitor and troubleshoot the DRS 100 from a remote location. The remote-functionality to troubleshoot any possible challenges in the device from anywhere leads to a very high efficiency in time and resources. This remote trouble shooting is a particularly advantageous property of the DRS 100, which is in contrast to the currently used dialyzer reprocessing machines that have limited connectivity through a connected personal computer and require a physical site visit from a specially trained Biomedical Engineer leading to longer machine breakdown time, higher expenses, and inefficient resource utilization. [0033] Suitable software may be used for the online monitoring, controlling, and troubleshooting of the DRS 100. In some embodiments, one or more software such as Python, Java, and HTML Programming are used to enable easy operation and cloud storage for reprocessing data. Usage of only Python programming in many of the known dialyzer reprocessing machines makes them rigid in operation and creates more difficulty in processing the data for cloud storage. The wide variability of usage of software makes the DRS 100 particularly suitable for the remote trouble shooting and cloud-based data management. [0034] The DRS 100 is also configured as a printer friendly apparatus and can be connected easily to an external printer to generate and download real-time reports in various required formats such as XLS, PDF and CSV formats. This is in contrast to many of the known dialyzer reprocessing machines having rigid formats for reports that are generated only in the physical hard copy format to the user, if the user is present in the physical proximity to the device. [0035] In some embodiments, the chemical tank 104 is a top loading tank. This is in contrast to the chemical tanks normally used in the currently available dialyzer reprocessing systems which may be located elsewhere, rendering loading them difficult and prone to accidents such as spillage, for example. Bottom input chemical tanks impact the accessibility and create adverse backflow of water leading to an error in concentration of the chemical solution inside the tank. The top loading chemical tank of the DRS 100 in accordance with some embodiments of this disclosure provides better accessibility and also avoids the back flow of water and the chemicals to the tank. The top loading chemical tank ensures desirable level of concentration of the solution that can be used for processing and during storage of the dialyzers D1 and D2. [0036] The manifold 106 connects the chemical tank 104 and the dialyzers D1 and D2 and enables the chemical input and drain from the dialyzers D1 and D2. In some embodiments, the manifold 106 includes an acrylic material. In an exemplary embodiment, more than 90% of the manifolds are formed using acrylic material. Use of acrylic material aids in clear view, low maintenance, easy cleaning, and durability of the manifolds 106. Further, in some embodiments, the manifold 106 used herein has a larger cross-sectional area compared to currently used manifolds that are known in the art. In some embodiments, the manifold 106 has a cross sectional area greater than 75 cm², for example. In one embodiment, the cross- sectional area of the manifold is greater than 80 cm², for example. In an exemplary embodiment, an acrylic manifold 106 with 160 x 300 x 26 mm volume is used. The larger surface area also provides adequate space to install the solenoid valves which leads to easy serviceability and durability. [0037] DRS 100 includes at least one solenoid valve 108. In some embodiments, the DRS 100 includes a plurality of solenoid valves 108 for allowing the filling of blood compartment and the dialysate compartment with water as well as disinfectant and also for storage of chemicals. The DRS 100 includes one or more solenoid valves to drain the washed water and disinfectant and storage chemicals from the blood compartment and the dialysate compartment of the dialyzers D1, D2, or both D1 and D2. For example, a pre-cleaning step may be carried out using water alone or water, for example, along with chemicals. The pre-cleaning may include a plurality of sequences such as activating filling solenoid valves and deactivating draining solenoid valves by using the control board 102 for filling blood compartment, dialysate compartment, or both the dialyzers D1 or D2 with chemicals, waiting for a user specified time and then activating draining solenoid valve using the control board 102 to drain the chemical. [0038] In some embodiments, the pressure sensor 114 used in the DRS 100 is a solid state (SS) sensor of 5 Volt. This sensor is more efficient in comparison with some of the currently used sensors that have inefficient high voltage devices leading to a greater number of circuit boards, making it susceptible to frequent breakdowns. The SS sensor of 5 Volt of the DRS 100 reduces the number of electronic boards that are required in the system. The reduction in number of electronic boards helps in producing a compact DRS 100 and avoids frequent breakdowns as well. [0039] In some embodiments, the conductivity cell 112 is a four-wire sensor. The Four-wire sensor used herein provides improved and efficient performance and delivers more accurate value in comparison with the two or three-wire sensors normally used in the DRS machines known in the art. [0040] In one aspect, a method of remotely monitoring, calibrating, or servicing the DRS 100 is provided. The method of remotely monitoring, calibrating, or servicing includes accessing the control board 102 of the DRS 100 through a cloud-based data management system accessible via a wired or wireless internet connection and directing the input-output board 130 of the DRS 100 through the control board 102 to activate any one or more of at least one conductivity sensor 112, pressure sensor 114, and load cell 120 of the dialyzer reprocessing system. In some embodiments, the solenoid valve 108 in the DRS 100 is activated through the control board 102 using a remote instruction given through a cloud-based data management system. A step of activating the solenoid valve 108 may include opening, closing, or both opening and closing the solenoid valves present in the manifold 106 of the DRS 100. Thus, in some embodiments, opening or closing the solenoid valve 108 of the manifold 106 of the DRS 100 is by sending a signal to the control board 102 from a remote location. The cloud-based data management system is part of a portal developed in Hypertext Preprocessor (PHP – originally called Personal Home Page and hence abbreviated to PHP). A service engineer can view the status of the machine remotely using this cloud-based portal and understand the process that is going on in the machine and analyse the status of the various components such as valves and so on. This cloud be based data management system helps in troubleshooting the challenges with the machine, if any, and taking steps to set the machines right – either remotely or by paying a visit to the location if it is necessary. [0041] The portal has at least a processor communicatively coupled to a memory. The memory contains computer programmes, routines, subroutines, and instructions configured for one or more of: Receiving data from the DRS at a location from the portal, analyse the data to either confirm that the DRS is functioning normally or not, make decisions about the fault if any, classify the fault, generate probable solutions to the problem, send instructions to the DRS to execute the steps of reprocessing, and so on. To put it briefly, it has all the capabilities to carry out the various steps of reprocessing, monitoring the processes, receive data from the DRS, detecting conditions, and communicate instructions to the DRS and the like necessary for reconditioning, trouble shooting and rectifying. [0042] In some embodiments, the method further includes storing of data of the DRS 100 in a cloud-based storage. The data stored may include data of each reprocessing instance and also data on the clinical outcomes of patients who have undergone dialysis using a dialyzer that is reprocessed using the DRS 100. This data can be further used for any kind of analysis of the dialyzer (D1 or D2) used, the DRS 100, or the clinical information of the patient. [0043] In some embodiments, when a single dialyzer is reprocessed using the DRS 100, the time taken is approximately ten minutes. In some embodiments, in which two dialyzers D1 and D2 are reprocessed simultaneously using the DRS 100, the total time taken for reprocessing both the dialyzers D1 and D2 is about thirteen minutes. The method of reprocessing using the DRS 100 follows a highly rigorous procedure including procedure of rinse, clean, test, and fill. The DRS 100 allows for a defined increased contact time of disinfectant with dialyzer membranes, ensuring a high level of effectiveness of the cleaning process. [0044] The reprocessing process using the DRS 100 includes cleaning, disinfection, performance assessment through bundle volume check, membrane and circuit integrity check through pressure tests and preserving the reprocessed dialyzer by filling a storage media chemical such as PAA. The dialyzer disinfection process includes receiving a chemical solution with a desired formulation from a chemical tank for disinfecting the pre-cleaned dialyzer. A suitable chemical formulation may be prepared based on a user selected option. The bundle volume check process measures the accurate membrane surface area available for further dialysis. After the bundle volume check is performed, the dialyzer is filled with a preserving solution such as PAA and stored for a long duration without deterioration in quality. Once the dialyzer needs to be used after this period, a post reprocessing is performed to remove any residual chemicals. [0045] In some embodiments, the DRS 100 uses a four-step process to clean the dialyzers. In some embodiments, process for simultaneous reprocessing of two dialyzers using DRS 100 may take about thirteen minutes in total. Steps given below illustrate a short summary of the reprocessing process in an example embodiment. While specific processing sequence, chemicals and timings used in the example embodiment are mentioned in the steps below and throughout the description of working of the DRS 100, it must be understood that further variations and modifications in the chemicals, timings, and the sequences would occur to the personnel working in the field of dialyzer reprocessing systems. [0046] Rinsing: Process starts with the rinsing process to clean dialyzers with water. Dialyzers undergo in total three water wash cycles and two reverse ultrafiltration cycles during this step. First and second water wash cycles are followed by reverse ultrafiltration cycle and process ends with a water wash cycle. A typical rinsing process may take about 125 seconds. [0047] Cleaning: In a cleaning step, dialyzers are cleaned with a dialysate solution. The DRS 100 selects chemicals or prepares chemical mixtures for reprocessing dialyzers. In some embodiments, the chemical used in DRS 100 is peracetic acid. In a first step of cleaning, the chemical tank 104 is drained and a 3% v/v disinfectant is prepared in the chemical tank. The prepared solution is passed through the dialyzers. The DRS 100 may include one or more peristaltic pumps for displacing the disinfectant solution accurately and independently to and from the blood compartment and the dialysate compartment of the dialyzers. The one or more peristaltic pumps may be driven by one or more motors of the DRS. After the first chemical cleaning cycle, a reverse ultrafiltration process and water wash cycle is completed. After that, a chemical is passed through dialyzer again. The process ends with another reverse ultrafiltration cycle and two water wash cycles. In total, the cleaning process takes about 244 seconds. [0048] Testing: The DRS monitors the reprocessing status and is configured to generate error messages and alarms at prompted conditions. In a testing step, dialyzers are tested for any leakage and blockages. Fiber Bundle Volume (FBV) of the dialyzers are measured in this stage. FBV is measured to detect any blockage in the blood compartment and in any of the tubes in the dialyzers using a leak test process. After draining the tank, FBV of one or both the dialyzers are checked one after the other. This step ends with checking the blood leak in the dialyzers. In total, the testing process takes about 170 seconds. [0049] Filling of Chemical: A chemical filling cycle is a final step before storing the dialyzers. In a chemical filling cycle, dialyzers are filled with chemicals for storage after cleaning. Process starts with thoroughly cleaning the dialyzers. Both the blood compartment and the dialysate compartments of the dialyzer are filled with a dialysate solution such as PAA to prevent the growth of microorganisms. The chemical such as PAA helps in preserving the dialyzers for long duration. The preserved dialyzers are then stored for next use in a preferred storage area. A dialysate solution (3.5% v/v) is prepared in the chemical tank and the dialysate solution filled in the dialyzers from the chemical tank. The process of chemical filling takes about 242 seconds. [0050] The DRS 100 has an improved design and components in comparison to the currently known designs of the DRS machines in the art. Specifically, the DRS 100 is designed for easy cleaning of the manifolds and dialyzer blood and dialysate compartments through the usage of manifolds having large cross-sectional area and the top loaded chemical tank that prevents the backflow of chemicals. [0051] Embodiments of the disclosure have been described in detail for purposes of clarity and understanding. However, it will be appreciated that certain changes and modifications may be practiced within the scope of the present disclosure. Thus, although the disclosure is described with reference to specific embodiments and Figure thereof, the embodiments and Figure are merely illustrative, and not limiting of the disclosure.

Claims

We Claim: 1. A dialyzer reprocessing system (100), comprising: a control board (102) for controlling the operation of the dialyzer reprocessing system; a chemical tank (104) for storing a chemical for circulating through a dialyzer unit under reprocessing; a manifold (106) connected to the chemical tank (104) and comprising one or more solenoid valves (108); a display unit configured for receiving inputs and for displaying at least one output; at least one each of a conductivity sensor (112), a pressure sensor (114), and a load cell (120) configured for supporting passage of the chemical to and from the chemical tank (104); and an input-output board (130) connected to and configured for activating any one or more of the at least one conductivity sensor (112), pressure sensor (114), and load cell (120) on receiving a control signal from the control board (102), wherein the dialyzer reprocessing system (100) is configured for being monitored, calibrated, and serviced from remote location by accessing the control board (102) through a cloud-based data management system.

2. The dialyzer reprocessing system (100) as claimed in claim 1, wherein the control board (102) is a Raspberry Pi 4 board.

3. The dialyzer reprocessing system (100) as claimed in claim 1, wherein the input-output board (130) is an Arduino board.

4. The dialyzer reprocessing system (100) as claimed in claim 1, wherein the chemical tank (104) is a top input tank.

5. The dialyzer reprocessing system (100) as claimed in claim 1, comprising a switch mode power supply for 24 Volt and 5 Volt channels for providing power supply to the control board (102).

6. The dialyzer reprocessing system (100) as claimed in claim 1, comprising a memory card for storing data.

7. The dialyzer reprocessing system (100) as claimed in claim 1, wherein the manifold (106) comprises an acrylic material and has a cross sectional area greater than 75 square centimeters.

8. The dialyzer reprocessing system (100) as claimed in claim 1, wherein the conductivity sensor (112) is a four-wire sensor.

9. The dialyzer reprocessing system (100) as claimed in claim 1, comprising multiple slots to accommodate multiple dialyzers and configured to simultaneously reprocess the multiple dialyzers.

10. A method of remotely monitoring, calibrating, and servicing a dialyzer reprocessing system (100), the method comprising: accessing a control board (102) of the dialyzer reprocessing system (100) through a cloud-based data management system; and directing an input-output board (130) of the dialyzer reprocessing system (100) through the control board (102) to activate any one or more of at least one conductivity sensor (112), pressure sensor (114), and load cell (120) of the dialyzer reprocessing system (100).

11. The method as claimed in claim 10, comprising opening or closing a solenoid valve (108) of a manifold (106) of the dialyzer reprocessing system (100) by sending a signal to the control board (102) from a remote location.

12. The method as claimed in claim 10, comprising storing of data of the dialyzer reprocessing system (100), data of each reprocessing instance and data on clinical outcomes of patients who have undergone dialysis using a dialyser, the storage being in a cloud-based storage, for analysis of the data.