A) TECHNICAL FIELD

[0001] The present invention generally relates to medical devices and particularly relates to an automated modular apparatus for dialyzer reprocessing. The present invention more particularly relates to a method and apparatus for automated pre-cleaning, reprocessing and pre-dialysis preparation of dialyzer.

B) BACKGROUND OF THE INVENTION

[0002] A chronic kidney disease and acute renal failure causes the kidneys to lose their ability to filter and remove waste and extra fluid from the body. Hemodialysis is a process that uses a man-made membrane (dialyzer) to remove wastes (urea, creatinine) from the blood, restore the proper balance of electrolytes in the blood and eliminate extra fluid from the body. The Hemodialysis is a form of dialysis where the blood in the body is continuously removed and passed through an artificial kidney for cleaning. This artificial kidney is called a dialyzer and is essentially a filter which has the capability of selectively removing the unwanted wastes. The Hemodialysis is an intermittent treatment and is repeated several times in a week.

[0003] Although a dialyzer is thought to be a single use disposable, reusing them for the same patient is in practice. Also various research studies have been performed to determine if there is any side effect related to the reuse of dialyzers. Fortunately, it has been found that there are significant benefits by reusing dialyzer. Primarily, the reused dialyzers are far superior bio-compatible to that of new dialyzers. At present, there is no fixed number of times that is considered safe for dialyzer reuse. As long as the Total cell volume (TCV) test shows that the dialyzer is working well, and the dialyzer looks clean, it should be safe to reuse dialyzer. A better method of cleaning between uses could reduce the expense of the individual treatment to the patient.

[0004] In order to re-use a dialyzer, it has to be thoroughly cleaned and preserved after each dialysis. During dialyzing process, the blood components such as proteins, glycoprotein, carbohydrates, cells, platelets remain on the surface of dialyzer such as pore surface and even present under the cap of the dialyzer. In addition to this, blood clots also accumulate on the dialyzer. Since the adhesive strength of these components is high, they cannot be easily removed by conventional liquid cleaning and as a result dialyzer will lose its permeability nature. Actually the effectiveness of the dialysis process depends on the available membrane surface area that permits blood-dialysate solute exchange termed as TCV. The TCV is one of the critical factors which decide whether to reuse the dialyzer or to discard. The TCV value of more than 80% is usually recommended for effective dialysis process.

[0005] Dialyzer blood compartment volume, sometimes called TCV or "fiber bundle volume," is an indirect measure of the total membrane surface area available for diffusive transport. TCV is an indirect yardstick of dialyzer function which decides whether to reuse the dialyzer or to discard. TCV value of more than 80% is usually recommended for effective dialysis process. Most of the conventional apparatuses provide better TCV when cleaned with their customized chemical, but eventually ends up in higher treatment cost. Almost all the existing procedures use a separate chamber to measure the TCV. The need for periodic calibration of this chamber makes measurement more complex. Further all of them had a jet pump to create a venturi effect to aspirate the fluids. This leads to increased water consumption and wastage of water.

[0006] In most of the dialysis centers/ hospitals, usually after every dialysis procedure the dialyzer is cleaned with Reverse Osmosis (RO) water manually and then this pre-cleaned dialyzer is mounted onto the dialyzer reprocessing apparatus for disinfection. The main drawback in manual pre-cleaning is lack of consistency and efficacy. Secondly most of the dialysis center has automated apparatus only for reprocessing and rest of the process such as pre-cleaning and post reprocessing procedure are done manually. As well as this monotonous work needs valuable time of skilled technician. Notably most of the automated reprocessing apparatuses have in-built mechanism for chemical preparation and emphasize on need of having a modular mixing apparatus to give freedom to use customized chemical as per hospital practices.

[0007] Hence, there is a need for an improved, low cost and efficient method and automated apparatus for reprocessing a dialyzer and related equipments. Also, there is a need for an apparatus and method for automatically cleaning, preparing dialysis and preserving dialysis related devices. Further, there is a need for a method and apparatus for accurately measuring the total cell volume of the membrane used in the dialyzer. Still further, there is a need for a method and apparatus for allowing users to select a desired cleansing chemical for sterilizing the dialysis equipments.

[0008] The above mentioned shortcomings, disadvantages and problems are addressed herein and which will be understood by reading and studying the following specification.

C) OBJECT OF THE INVENTION
[0009] The primary object of the present invention is to provide a fully automated apparatus for dialyzer reprocessing and method for automated pre-clean, reprocess and post reprocess of a dialyzer before performing the next dialysis to a patient.

[0010] Another object of the present invention is to provide a fully automated apparatus for dialyzer reprocessing with an individual module for each cleaning process.

[0011] Yet another object of the present invention is to provide a method for using the plurality of individual modules independently or as a combined single unit for dialyzer cleaning.

[0012] Yet another object of the present invention is to provide an apparatus and method for automatically preparing accurate formulation of chemicals for reprocessing the dialyzer.

[0013] Another object of the present invention is to provide a method for accurately measuring the Total cell volume (TCV).

[0014] Yet another object of the present invention is to provide an apparatus with one or more peristaltic pumps for aspirating the chemicals used in chemical disinfection of the dialyzer.

[0015] Yet another object of the present invention is to provide an apparatus for monitoring the entire dialyzer reprocessing process and to display the status, error messages and alerts to the user on necessary conditions.

[0016] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.

D) SUMMARY OF THE INVENTION

[0017] The various embodiments of the present invention provide a fully automated apparatus for dialyzer reprocessing. The apparatus for dialyzer disinfection comprising a pre-cleaner module or post dialysis preparation module for pre-cleaning used dialyzer with Reverse Osmosis (RO) water, a chemical mixer module for preparing chemicals for reprocessing dialyzer, a reprocessing system module for reprocessing dialyzer, while monitoring the reprocessing status and a post reprocessing module for post reprocessing disinfected dialyzers with Reverse Osmosis (RO) water for removing chemical residues.

[0018] According to an embodiment of the present invention, the apparatus for dialyzer disinfection further comprises one or more peristaltic pumps for displacing the disinfectant solution accurately and independently to and from the blood compartment and the dialysate compartment. The one or more peristaltic pumps are driven by one or more motors.

[0019] According to an embodiment of the present invention, the pre-cleaner module automatically detects and indicates a presence and an absence of dialyzer by illuminating an LED light. The pre-cleaner module pre-cleans the blood compartment and the dialysate compartment with the Reverse Osmosis (RO) water as well as with chemicals such as H2O2 after every dialysis procedure for removing a blood residue inside the plurality of dialyzer compartments.

[0020] According to an embodiment of the present invention, the chemical mixer module prepares chemicals for reprocessing dialyzer. The chemicals are selected from a group consisting of peracetic acid, formaldehyde and glutaraldehyde.

[0021] According to an embodiment of the present invention, the reprocessing system module reprocesses the dialyzer and monitors the reprocessing status and gives error messages and alarms at necessary conditions.

[0022] According to an embodiment of the present invention, the reprocessing system module continuously monitors and measures a pressure with a pressure sensor and a weight from a load cell. The reprocessing system module cleans the dialyzer based on timings and sequences selected by a user. The reprocessing system module measures and calculates a Total Cell Volume (TCV) and detects any leakages between the blood compartment and the dialysate compartment and between a plurality of tubes and the dialyzer by a leak test process.

[0023] According to an embodiment of the present invention, the apparatus for dialyzer disinfection further comprises a dialyzer mounting assembly for mounting the dialyzer. The dialyzer mounting assembly comprises a mounting fixture for dialyzer cartridge and a load cell.
[0024] According to an embodiment of the present invention, the dialyzer is mounted directly on to the load cell.

[0025] According to an embodiment of the present invention, the apparatus for dialyzer disinfection further comprises at-least one controller for activating a plurality of solenoid valves for filling the blood compartment and the dialysate compartment with RO water as well as disinfection and storage chemicals..

[0026] According to an embodiment of the present invention, the apparatus for dialyzer disinfection further comprises one or more solenoid valves to drain out RO water as well as disinfection and storage chemicals from the blood compartment and the dialysate compartment.

[0027] According to an embodiment of the present invention, the reprocessing system module comprises Normal process, Heavy process, Custom-1 process and Custom-2 process. The Normal process of the reprocessing system module comprises sub-processes such as Leak test, Rinsing, Chemical cleaning,

Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment.

[0028] According to an embodiment of the present invention, the Heavy process of the reprocessing system module comprises sub-processes as in the normal process and comprises a programmability option by the user for repeating sub processes including Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment, selectively

[0029] According to an embodiment of the present invention, the Custom-1 and Custom 2 processes of the reprocessing system module comprise sub-processes including Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment, as in the normal process and comprises programmable option for the user to repeat or reduce any sub process selectively.

[0030] According to an embodiment of the present invention, the sequence of the sub-processes in the reprocessing system module such as Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment are customizable based on the user needs.

[0031] The various embodiments of the present invention provide a method for dialyzer disinfection. The method for dialyzer disinfection comprises the steps of: pre-cleaning a dialyzer with Reverse Osmosis (RO) water as well as with chemicals; reprocessing the dialyzer and wherein reprocessing the dialyzer comprises disinfecting dialyzer with chemicals such as Peracetic acid, formaldehyde or glutaraldehyde etc, and wherein a blood compartment and a dialysate compartment in the dialyzer are filled with chemicals for a specified time and cleaned with RO water to kill microorganisms; checking Total Cell Volume (TCV) for measuring a total membrane surface area available for diffusive transport filling chemical such as formalin to the blood compartment and the dialysate compartment to prevent a growth of microorganisms; and post reprocessing dialyzers with Reverse Osmosis (RO) water for removing chemical such as formalin and chemical residues.

[0032] According to an embodiment of the present invention, measuring the Total Cell Volume (TCV) comprises the steps of: filling the blood compartment and the dialysate compartment of the dialyzer with RO water; measuring a first filled weight, and wherein the first filled weight or a first filled volume is calculated by a summation of a dialyzer dry weight, a blood path liquid volume, a dialysate path liquid volume and the weights of tubing and connectors; draining out the RO water filled in the blood compartment; measuring a second filled weight, and wherein the second filled weight or a second filled volume is calculated by the summation of dialyzer dry weight, the dialysate path liquid volume and the weights of tubing and connectors; and calculating the Total Cell Volume by subtracting the second filled weight from the first filled weight.

[0033] 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.

E) BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:

[0035] FIG. 1 illustrates a block diagram of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0036] FIG. 2 illustrates a functional block diagram of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0037] FIG. 3a illustrates a side perspective view of a pre-cleaner module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0038] FIG. 3b illustrates a top perspective view of a pre-cleaner module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0039] FIG. 4a illustrates a side perspective view of a reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0040] FIG. 4b illustrates a cross sectional view of the reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0041] FIG. 5 illustrates a front view of a dialyzer mounting apparatus, according to an embodiment of the present invention.

[0042] FIG. 6a illustrates a front view of the dialyzer, according to an embodiment of the present invention.

[0043] FIG. 6b illustrates a top cross sectional view of the dialyzer, according to an embodiment of the present invention.
[0044] FIG. 7 illustrates a side cross sectional view of the chemical mixer, according to an embodiment of the present invention.

[0045] FIG. 8 illustrates a block diagram of the chemical mixer, according to an embodiment of the present invention.

[0046] FIG. 9 illustrates a work flow diagram of the chemical mixer module, according to an embodiment of the present invention.

[0047] FIG. 10 illustrates a post reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0048] FIG. 11 illustrates a block diagram of the pre-cleaning module and the post reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0049] FIG. 12 illustrates a flow diagram of the pre-cleaning module and the post-reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0050] FIG. 13 illustrates a flow diagram of the reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0051] FIG. 14 is a table illustrating different modes of process for fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention.

[0052] Although the specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.

F) DETAILED DESCRIPTION OF THE INVENTION

[0053] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.

[0054] FIG. 1 illustrates a block diagram of fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention. The fully automated dialyzer reprocessing apparatus 100 provides a method to automatically clean a dialyzer before re-using for patients. The fully automated dialyzer reprocessing apparatus or dialyzer cleaning system (DCS) 100 comprises plurality of individual modules for disinfecting dialyzer comprising a pre-cleaning module 101, a chemical mixing module 102, a reprocessing module 103, and a post reprocessing module 105. Each of the individual modules operates automatically and is designed to function either independently or as an integrated unit when combined. External processes which do not fall under scope of 100 are Storage process 104 and Dialysis process 106. The pre-cleaning module 101 is adopted for cleaning a used dialyzer with AAMI standard water (RO water) or chemical in both blood compartment and dialysate compartment. The pre-cleaning module 101 is activated just after a dialysis procedure is performed on a patient, for cleaning the dialyzer by removing residues of blood particles remained inside the blood fiber membrane. The pre-cleaning module 101 prevents any clotting of blood particles and thus in turn prevents any blockage of the blood membrane thereby increasing the life cycle of dialyzer.

[0055] According to one embodiment of the present invention, wherein the reprocessing module 103 performs the next phase of cleaning the dialyzer after pre-cleaning module 101.The reprocessing module 103 is connected to the chemical mixing module 102. The main purpose of chemical mixing module 102 is to mix one or more solutions both based on volume or ratio and provide to the reprocessing module 103 as per requirement. The chemical mixing module 102 provides a chemical solution to the reprocessing module 103 for disinfecting the pre-cleaned dialyzer. The reprocessing module 103 performs plurality of functions comprising but not limited to dialyzer disinfection, bundle volume check or total cell volume check and preserving. The dialyzer once disinfected, both the blood compartment and the dialysate compartments of the dialyzer are filled with chemical such as formaldehyde to prevent the growth of microorganisms. The chemical such as formaldehyde helps in preserving the dialyzer for long duration. The preserved dialyzer is then stored for next use in a preferred storage 104 area.
[0056] According to one embodiment of the present invention, wherein the dialyzer is cleaned with RO water for removing any chemical residuals and chemical such as formaldehyde in the post reprocessing module 105.When a patient visits a clinic or a hospital for dialysis procedure, the post reprocessed module 105 is adopted before starting a dialysis 106 procedure for removing any chemical residuals and chemical such as formaldehyde.

[0057] FIG. 2 illustrates a work flow diagram of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention. The fully automated dialyzer reprocessing apparatus performs plurality of cleaning processes in a sequence comprising pre-cleaning of the dialyzer (201), reprocessing the dialyzer, storing the reprocessed dialyzer (205) and post reprocessing the dialyzer (206).The pre-cleaning 201 process cleans a used dialyzer with RO water and/ or chemical (recommended to use AAMI standard compliant water) in both blood and dialysate compartments. The reprocessing process includes sub processes for cleaning, disinfection (202), performance assessment through bundle volume check (203), membrane and circuit integrity check through pressure tests and preserving the reprocessed dialyzer by filling a storage media chemical such as formaldehyde (204). The dialyzer disinfection process comprises receiving a chemical solution with a desired formulation from a chemical mixing module for disinfecting the pre-cleaned dialyzer. The user selects an option for formulating the chemical solution. A suitable chemical formulation is prepared based the user selected option. The bundle volume check (203) process measures the accurate membrane surface area available for further dialysis by using a load cell apparatus. Once the bundle volume check is performed on the dialyzer, the dialyzer is filled with a preserving solution such as formaldehyde (204). With the help of the chemical such as formaldehyde, the dialyzer is then stored for long duration without deteriorating the quality in the storage (205). Once the dialyzer is again required to be used for the same patient, a post reprocessing 206 is performed to remove any residual chemical. The dialysis 207 is performed on the patient and the cycle of the cleaning repeats.

[0058] FIG. 3a illustrates a side perspective view of a pre-cleaner module of the fully automated dialyzer reprocessing apparatus and FIG. 3b illustrates a top perspective view of a pre-cleaner module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention. After dialysis procedure, there will be residues of blood particles remained inside the blood fiber membrane. If not cleaned immediately, blood particles get clotted and block the membrane which in turn reduces the life cycle of Dialyzer. The main purpose of the pre-cleaning module 101 is to clean the used dialyzer with RO water (water compliant to AAMI standard) and disinfecting chemicals in both blood and dialysate compartments. This can be done either manually or using machine.

[0059] According to one embodiment of the present invention, the pre-cleaning module 101 provides cleaning simultaneously or individually for dual stations (dialyzer). Once dialyzer is mounted onto the mounting mechanism, the user starts the actual cleaning process. The Pre-cleaning apparatus automatically detects and indicates the presence or absence of the dialyzer by illuminating one or more LED lights adopted on the front face of the Pre-cleaning apparatus.

[0060] According to one embodiment of the present invention, the pre-cleaning module 101 comprises two modes of operation comprising a normal mode and heavy mode. The normal mode operation of the pre-cleaning module 101 further comprises plurality of sequences including: sequence-1: activating at-least two solenoid valves by a controller for filling blood compartment from top to bottom with RO water or chemical such as H2O2 or Peracetic acid, then waits for the user specified time and then activating at-least one solenoid valve by the controller to drain the RO water, sequence-2: activating at-least two solenoid valves by the controller for filling blood compartment from bottom to top with RO water, then waits for the user specified time and then activating at-least one solenoid valve by the controller to drain the RO water and sequence-3: activating at-least two solenoid valves by the controller for cleaning the dialysate compartment from top to bottom. Similarly, the normal mode operation of the pre-cleaning module is carried out with a chemical such as H2O2 or Peracetic acid.

[0061] According to one embodiment of the present invention, the heavy mode operation of the pre-cleaning module 101 further comprises plurality of sequences including those mentioned in the normal process and user programmable repetition of sub processes as needed.

[0062] According to one embodiment of the present invention, the pre-cleaner module eliminates the manual intervention by cleaning the used dialyzer automatically thus avoids exposure of blood particles/components present in the dialyzer to the technician. Further the cleaning efficiency in manual approach depends on the technician skill. Whereas in automated system, the efficiency as well as consistency is processed and tested.

[0063] FIG. 4a illustrates a side perspective view of a reprocessing module of the fully automated dialyzer reprocessing apparatus and FIG. 4b illustrates a cross sectional view of the reprocessing module of the fully automated dialyzer reprocessing apparatus, according to an embodiment of the present invention. The reprocessing module 103performs the next phase of cleaning the dialyzer after pre-cleaning module. The reprocessing process comprises three sub processes comprising dialyzer disinfection, bundle volume check and dialyzer preservation such as formalin filling. The reprocessing module 103 is connected to the chemical mixing module. The dialyzer disinfection process in the reprocessing module comprises an automatically formulated chemical solution received from a chemical mixing module for disinfecting the pre-cleaned dialyzer. The dialyzer reprocessing in the reprocessing module 103 is a process in which pre cleaned dialyzer are disinfected with chemicals such as Peracetic acid etc. During disinfection process, both the blood and dialysate compartments are filled with chemicals for a specified time and then cleaned with RO water thereby killing the microorganisms. The bundle volume or total cell volume (TCV) check is an indirect measure of the total membrane surface area available for diffusive transport. It is measured by displacement of air or water during the reprocessing procedure. For measuring the bundle volume, the dialyzer undergoes three phases comprising a filling phase, a waiting phase and a removal phase. As surface area is lost because of clotting, solute clearances decreases, putting the patient at risk for under dialysis. This risk would go undetected in a clinic that does not measure clearances or TCV with each reuse. The chemical such as formalin filling process in the reprocessing module 103 is adopted to prevent the growth of microorganisms during the storage period. Once dialyzer is disinfected, both the blood compartment and the dialysate compartment are filled with chemical such as formalin to prevent the growth of microorganisms and then the dialyzer is stored for the next use. The system further comprises one or more peristaltic pumps for displacing the disinfectant solution accurately and independently to and from the blood compartment and the dialysate compartment.

[0064] FIG. 5 illustrates a dialyzer mounting apparatus, according to an embodiment of the present invention. The dialyzer mounting assembly 500 comprises a holder (not shown in the figure) for holding a dialyzer cartridge 501 and a load cell 502. The dialyzer cartridge 501 comprises an inlet port 503 and an outlet port 504 for blood compartment. An inlet and outlet port for the dialysate compartment is also provided but shown in the FIG. 5.In first step: the RO water is filled in the blood compartment through the inlet port 503 and at the end the RO water is removed from the blood compartment through the outlet port 504.

[0065] According to one embodiment of the present invention, the measurement of bundle volume comprises three phases comprising a filling phase, a waiting phase and a removal phase. During filling phase, the RO water is run through inlet port 503 for filling the blood compartment and run through the inlet port of dialysate compartment 604. After preset time period and also ensuring that sufficient weight is accumulated, the system switches to the waiting phase. The duration of waiting phase is pre-set by the user. At the end of the waiting phase, the filled weight (WF) is measured and stored in a processor. Then, a removal phase starts and the RO water is removed through the outlet port 504. Once the duration of removal phase ends, the removed weight (WR) is measured and stored.

[0066] According to one embodiment of the present invention, the bundle volume is calculated by the equation:-
Bundle volume = (WF- WR)/Density
The density corresponds to the density of RO water. The present invention also allows a chemical other than RO water to be used for measuring the bundle volume comprising such as but not limited to H2O2, Peracetic acid, etc. The densities of RO water (which is 1.0g/cm3)), H2O2 (which is 1.45g/ cm3) and Peracetic acid (which is 1.04g/cm3) are considered for the volume calculation.

[0067] FIG. 6a illustrates a front view of the dialyzer and FIG. 6b illustrates a top cross sectional view of the dialyzer. The dialyzer cartridge 501 comprises an inlet port 503 and outlet port 504 for the blood compartment, and an inlet port 603 and an outlet port 604 for the dialysate compartment. The blood from the patient is piped into the dialyzer cartridge 501 through the inlet port 503 and at the same time a dialysate solution is passed from the inlet port 603. The flow of blood and the dialysate solution is opposite in direction. Due to the concentration gradient between the flows, the impurities in the blood diffuse in the dialysate solution through a semi-permeable membrane. The semi-permeable membrane allows flow of particles in a solution only in one direction.

[0068] FIG. 7 illustrates a side perspective view of a chemical mixer, according to an embodiment of the present invention. The chemical mixer module 102 is adopted for diluting the concentrated chemicals in required propositions (either volume or ratio based). The solution/chemical mixer module 102 comprises at-least two sub modules such as first sub module and second sub module, and wherein each sub modules i.e. first and second dilutes two different chemicals simultaneously or the same chemical based on the need. Further, the first sub module and the second sub module of the chemical mixer module 102 comprises user programmable options, wherein the user is allowed to program for using single sub module i.e. first or second or allowed to program for using both i.e. first and second sub modules simultaneously. Before mixing, the user connects a supply of first fluid (Fluid 1) such as RO water to a first inlet and the supply of second fluid (Fluid 2) such as H2O2 to a second inlet. The two fluids selected are automatically mixed together as per the settings. The user further sets the volume/ratio of both the fluids to be mixed. Example: volume based: 1000 ml of RO water with 50 ml of H2O2. Ratio based 20:1. Similarly, the user is allowed to use second chamber to dilute another chemical by connecting the Fluid 1 inlet to RO water and Fluid 2 inlet to second concentrated chemical and similarly set the volume/ratio for second mixer also. The user further is provided with an option to select for mode of mixing the fluids.

[0069] According to one embodiment of the present invention, the volume of the diluted chemical is calculated by considering the relative change in the density of fluid 2.

[0070] According to one embodiment of the present invention, the user further selects the mode of mixing. For example:

Fluidl (50%) + Fluid2 (100%) + Fluidl (50 %)
Fluidl (50%) + Fluid2 (50%) + Fluidl (25 %) + Fluid2 (50%) + Fluidl (25 %)
Once the user set the inputs, the chemical mixing is done as follows (Mode: (a)):l. VI opens -> allows RO water to beaker and beaker weight is constantly measured using load cell. Once weight reaches 50 % (or based on user defined value) of RO volume, VI closed.

2. Then V2 opened to allow the chemical and pump PI is ON to increase flow rate and then chemical is mixed with RO water in the beaker.V2 is opened till load cell measures= (50% of RO volume + Set volume of chemical).Then V2 closed.

3. Again VI is opened to mix the remaining RO water with chemical and it is opened till load cell measures = (100% of RO volume + Set volume of chemical). Then VI closed.

4. Once chamber is filled with the required proportions of RO water and chemical, then actual mixing process started. This involves Valve VI, V2 closed and V3 opened, thereby connects the drain outlet of the chamber to chamber inlet through V3.This process is repeated for few seconds and once completed, the mixture is ready to use.

5. Now the chemical mixture is ready to use and user can drain the mixture by selecting drain option in the user interface. Further, the chemical mixer module 102 comprises an option to interface with the dialyzer reprocessing module and /or pre-cleaner module. So both the modules (dialyzer reprocessing module and pre-cleaner module) trigger the solution/chemical mixer module 102 to drain the mixture whenever modules (dialyzer reprocessing module and pre-cleaner module) requires.

[0071] According to one embodiment of the present invention, though most of chemicals are powerful against bacteria and viruses but can cause severe side effects to the technicians who are exposed to it. Reactions can be either immediate or delayed, with a latent period ranging from a few weeks to several years. With the automated chemical mixer module 102 of the present invention, the technician need not handle the chemicals as well as mix the chemicals directly. Thereby eliminates the manual intervention in the solution preparation.

[0072] According to one embodiment of the present invention, the chemical mixer module 102 prepares two solutions of chemicals mixed with RO water for reprocessing and storage of a dialyzer. In specific the chemical mixer module 102 prepares chemicals for disinfecting a pre-cleaned dialyzer. The chemical mixer module 102 comprises two mixing sub-modules, each comprising of a PCB 701, an adapter 702, a radius door 703, a tank assembly 704, a foot 705, an outlet 706, a load cell 707, a first inlet 708, a second inlet 709 and a power socket 710 as shown in FIG. 7. The PCB 701 comprises a circuit for accurately formulating the chemical solution and also controlling the other parts of the chemical mixer module 102. The radius door 703 provides the feasibility of closing the chamber of the chemical mixer module 102 comprising the cylindrical tank assembly. The tank assembly 704 is detachable which allows to be replaced in case of breakage. The chemical mixer module 102 rests on plurality of foots 705 for a stable operation. An outlet port 706 is provided for letting out the used chemical solution. The load cell 707 provides an accurate measurement of weight of the solution. The first inlet 707 and the second inlet 708 provide entry of the chemicals to be used for preparing a chemical solution. The power socket provides input area to be plugged with a required power supply.

[0073] FIG. 8 illustrates a block diagram of a chemical mixer sub-module, according to an embodiment of the present invention. A power supply 801 with a Switched Mode Power Supply (SMPS) and a regulator is provided to control both the chemical mixer sub- modules. The regulated power supply is fed to a main PCB 803 of the chemical mixer sub-module for enabling the microcontroller interfaced in the PCB to turn ON and perform the task of preparing chemical solution accurately. The power is also supplied to a load cell driver circuit 802 which is connected to a load cell. A load cell driver circuit 802 measures the volume of the chemical and forms a solution as per the cleaning requirement. The main PCB 803 is also interfaced with a valve driver circuit 804. The valve driver circuit 804 control plurality of valves comprising VI, V2, V3, etc. The valve driver circuit 804 controls the flow of chemical through the plurality of valves for formulating the required chemical required for disinfecting the dialyzer. A pump valve 805 is further provided to pump the chemical for proper mixing and to enable the flow of chemical. Further, the main PCB 803 is linked with a user interface panel 806 for allowing the user to modify or fix or configure the settings. The user interface panel 806 comprises a LCD display, a LED indicator, a keypad and an alarm for status indication.

[0074] FIG. 9 illustrates a work flow diagram of the chemical mixer module, according to an embodiment of the present invention. The chemical mixer module is adopted for diluting the concentrated chemicals in required propositions (either volume or ratio based). The solution mixer module comprises at-least two sub modules such as first sub module and second sub module and wherein each sub modules i.e. first and second dilutes two different chemicals simultaneously or the same chemical based on the need. Further, the first sub module and the second sub module of the chemical mixer module comprises user programmable options, wherein the user is allowed to program for using single sub module i.e. first or second or allowed to program for using both i.e. first and second sub modules simultaneously. Before mixing, the user connects a supply of first fluid (Fluid 1) such as RO water to a first inlet and the supply of second fluid (Fluid 2) such as H2O2 to a second inlet. The two fluids selected are automatically mixed together as per the settings. The user further sets the volume/ratio of both the fluids to be mixed. Example: volume based: 1000 ml of RO water with 50 ml of H2O2. Ratio based 20:1. Similarly, the user is allowed to use second chamber to dilute another chemical by connecting the Fluid 1 inlet to RO water and Fluid 2 inlet to second concentrated chemical and similarly set the volume/ratio for second mixer also. The user further is provided with an option to select for mode of mixing the fluids.

[0075] FIG. 10 illustrates a post reprocessing module of the dialyzer cleaning apparatus, according to an embodiment of the present invention. When a patient visits a clinic or a hospital for dialysis procedure, the post reprocessed module 105is adopted before starting a dialysis procedure for removing any chemical residuals and chemical such as formalin. The reprocessed dialyzer, which is disinfected and filled with chemical such as formalin are cleaned with RO water to remove the chemical residuals. Thereby allows the dialyzer to be reused on patient.

[0076] FIG. 11 illustrates a block diagram of the pre-cleaning module and the post reprocessing module of the dialyzer cleaning apparatus, according to an embodiment of the present invention. The pre-cleaning system provides cleaning simultaneously or individually for dual stations (dialyzer). Once dialyzer is mounted onto the mounting mechanism, the user starts the actual cleaning process. The pre-cleaning module comprises a power supply module 1201, a dialyzer mounting sensor 1202, a central processing unit 1203, a user interface 1205 and a valve selection module 1204. The power supply module comprises an input connected to the main supply of 23 Ov, a transformer for optimizing voltage and a regulator for regulating/controlling power supply of 5v to the pre-cleaning module components. The central processing unit 1203 for processing and controlling all the pre-cleaning module components. The pre-cleaning module operates on the regulated power supply. The pre-cleaning module automatically detects the presence and absence of the dialyzer through the dialyzer mounting sensor 1202 and indicates the presence and absence of dialyzer by means of LED on the user interface 1205. The valve selection module 1204 further comprises valve switching circuits for switching plurality of valves. The user interface 1205 comprises a buzzer/alarming device and a LED lights for indicating status or on certain conditions. The user interface 1205 further comprises a mode selection switch for selecting different modes of operation for the user and a start/strop keys for controlling the pre-cleaning module operation.

FIG. 12 illustrates a flow diagram of the pre-cleaning module and the post-reprocessing module of the dialyzer cleaning apparatus, according to an embodiment of the present invention. The pre-cleaning module cleans the used dialyzer immediately after every dialysis procedure, in order to avoid blood clots in the blood compartment of the dialyzer. The pre-cleaning module comprises two modes of cleaning operations such as normal mode and heavy mode. The dialyzer of the present invention comprises dual stations and dual stations are cleaned simultaneously or individually in the pre-cleaning module. The pre-cleaning module provides options for pre cleaning either with RO water alone and/or with

Chemicals. Once dialyzer is mounted onto the mounting mechanism, the user is allowed to start the actual cleaning process. The Pre cleaning module automatically detects and indicates the presence and absence of dialyzer by means of LED. The pre-cleaning module comprises two modes of cleaning operations such as normal mode and heavy mode of cleaning with RO water as well as chemical. The user is allowed to program the dual station in such a way that one station cleans dialyzer with RO water and another station cleans the second dialyzer with chemical such as H202 simultaneously or both stations cleans with water or H202. Consider a scenario of normal mode cleaning of the dialyzer and wherein the valve sequence for cleaning at least one station with chemical is provided. The normal mode operation of the pre-cleaning module 101 further comprises plurality of sequences including: sequence-1: activating solenoid valves V2, V21 and V3 and deactivating solenoid valve VI0 by a controller for filling blood compartment from top to bottom with Chemical such as H2O2, then waits for the user specified time and then activating solenoid valve VI0 by the controller to drain the chemical, sequence-2: activating solenoid valves V2, V21 and V9 by the controller for filling blood compartment from bottom to top with chemical, then waits for the user specified time and then activating solenoid valve V4 by the controller to drain the chemical; sequence-3: activating solenoid valves V2, V21 and V5 by the controller for cleaning the dialysate compartment from top to bottom and activating solenoid valve V8 by the controller to drain the chemical and sequence-4: activating solenoid valves V2, V21 and V7 by the controller for cleaning the dialysate compartment from bottom to top and activating solenoid valve V6 by the controller to drain the chemical.

[0077] According to one embodiment of the present invention, the heavy mode operation of the pre-cleaning module 101 further comprises plurality of sequences including: sequence-1: activating solenoid valves V2, V21 and V3 and deactivating solenoid valve VI0 by the controller for filling blood compartment from top to bottom with chemical, activating solenoid valve V10 by the controller to drain the chemical, then immediately activating solenoid valves V2, V21 and V9 by the controller for filling blood compartment from bottom to top with chemical and activating solenoid valve V4 by the controller to drain the chemical;

sequence-2: activating solenoid valves V2, V21 and V9 by the controller for filling blood compartment from bottom to top with chemical, activating solenoid valve V4 by the controller to drain the chemical, then immediately activating solenoid valves V2, V21 and V3 by the controller for filling blood compartment from top to bottom with chemical and activating solenoid valve VI0 by the controller to drain the chemical; sequence-3: similarly, activating required solenoid valves by the controller for cleaning the dialysate compartment from top to bottom as well as bottom to top. Similarly, the dialyzer is cleaned with the RO water in both the modes (normal and heavy) as explained above. But, for RO water cleaning, instead of solenoid valve V2, solenoid valves VI and VI9 are opened to fill the RO water and the sequences i.e. (sequence-1 to sequence 4) are repeated with the same set of solenoid valves.
[0078] According to one embodiment of the present invention, for mixing or diluting a specific concentration of chemical for cleaning dialyzer in pre-cleaning module, the chemical mixer module is being adopted.

[0079] According to one embodiment of the present invention, the post reprocessing module comprises the same steps for disinfecting dialyzer as described above for the pre-cleaning module.

[0080] FIG. 13 illustrates a flow diagram of the reprocessing module of the dialyzer cleaning apparatus, according to an embodiment of the present invention. The reprocessing module 103 comprises a dialyzer including blood compartment top or BP in and blood compartment down or BP out and dialysate compartment top or DP in and dialysate compartment down or DP out, a pressure sensor (P.S), plurality of non-return valves (Nl, N2, N3, N4, N5, N6, N7, N8, N9 and N10), plurality of solenoid valves (VI, V2, V3, V4, V5, V6, V7, V8, N9, V10, VI1, V12 and V13), plurality of T-connectors (Tl, T2, T3, T4, T5, T6, T7, T8, T9 and T10), plurality of manifolds (manifold-1, manifold-2 and manifold-3) and one or more pumps(pump-l and pump-2) as shown in FIG. 13. The reprocessing module 103 performs the next phase of cleaning the dialyzer after pre-cleaning module. The reprocessing process comprises three sub processes comprising dialyzer disinfection, bundle volume check and chemical such as formalin filling. The reprocessing module 103 is connected to the chemical mixing module. The dialyzer disinfection process in the reprocessing module comprises an automatically formulated chemical solution received from a chemical mixing module for disinfecting the pre-cleaned dialyzer. The dialyzer reprocessing in the reprocessing module 103 is a process in which pre cleaned dialyzer are disinfected with chemicals such as Peracetic acid, formaldehyde or glutaraldehyde etc. During disinfection process, both the blood and dialysate compartments are filled with chemicals such as H2O2 for a specified time through solenoid valve V3 and then cleaned with RO water through solenoid valves VI and V2 thereby killing the microorganisms. The bundle volume or total cell volume (TCV) check is an indirect measure of the total membrane surface area available for diffusive transport. It is measured by displacement of air through solenoid valve V5 or water during the reprocessing procedure. For measuring the bundle volume, the dialyzer undergoes three phases comprising a filling phase, a waiting phase and a removal phase. The chemical such as formalin filling process in the reprocessing module 103 is adopted to prevent the growth of microorganisms. Once dialyzer is disinfected, both the blood compartment and the dialysate compartment are filled with chemical such as formalin through solenoid valve V4 to prevent the growth of microorganisms and then the dialyzer is stored for the next use.

[0081] According to one embodiment of the present invention, the process-valve details for controlling the plurality of solenoid valves in the dialyzer reprocessing module is illustrated in the below table:-

V15, Pump

1.2 LEAK WAIT V5
RINSING 2.1 DP RINSE dialysate path rinse DP bottom -- >DP top V1,V9,V12

2.2 DP
RINSE dialysate path rinse DP top --> DP
Bottom V1, V8, V13

2.3 DP RINSE dialysate path rinse DP bottom - >DP top V1, V9, V12

2.4 DP
RINSE dialysate path rinse DP top --> DP
Bottom V1, V8, V13

2.5 BP RINSE blood path rinse BP bottom --> BP top V1,V7,V10

2.6 BP RINSE blood path rinse BP top --> BP
Bottom V1,V6,V11

2.7 BP RINSE blood path rinse BP bottom -> BP top V1,V7,V10

2.8 BP
RINSE blood path rinse BP top --> BP
Bottom V1, V6, V11

2.9 BP CLEAR blood path clear BP bottom --> BP top V7,V10,V15, Pump

2.10 BP CLEAR blood path clear BP bottom --> BP top V7,V10,V15, Pump

2.11 DP
CLEAR dialysate path clear DP top --> DP
Bottom V8, V13, V15, Pump
Chemical Cleaning
3.1 DP FILL Dialysate path fill BLD top ~>BLD bottom V3, V9, V12, Pump

3.2 BP FILL Blood path fill DIA top --> DIA bottom V3, V7, V10, Pump

3.3 H20 BP RINSE every 10 sec V3, V6, V11,

24

REACT Pump

BP RINSE every 10 sec V3, V7, V10, Pump

3.4 DP
RINSE blood path rinse BP top --> BP
Bottom V1, V8, V13

3.5 DP CLEAR dialysate path rinse DIA top --> DIA
Bottom V1, V8, V13, VI5, Pump

3.6 BP CLEAR blood path air clean BP top --> BP bottom V6,V11,V15, pump

3.7 drain release V5, V11, V13
BUNDLE VOLUM

E 4.1 RO RINSE rRO rinse in blood path BP bottom --> BPtop V1, V5, V7, V10

4.2 VOL. FILL RO fill in blood path BP bottom --> BPtop V1, V5, V7

4.3 VOL CHECK priming volume check V5

4.4 BP CLEAR blood port clear BP top --> BP
Bottom V5, V6, V15, Pump

4.5


V6, V11, V15, Pump

4.6 BV CHECK V8, V13, V15, Pump
CHEMIC

AL SUCH AS FORMA

LIN FILLING 5.1 DIALY. PATH fill FORM in dialysate path DIA bottom -> DIA top V4, V9, V12, Pump

5.2 BLOOD PATH fill FORM in blood path BP bottom --> BPtop V4, V7, V10, Pump

5.3 Completion V10,V12(2 sec)
25

[0082] FIG. 14 is a table illustrating different modes of process for dialyzer reprocessing module, according to an embodiment of the present invention. The reprocessing module of dialyzer cleaning apparatus comprises four modes of operation such as Normal, Heavy, Customl and Custom2 as shown in FIG. 14. The user is allowed to select any of these process based on their requirement. Under each process, the number of sub process as well as sequence of sub process is allowed to be changed by the user.

[0083] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modifications.

[0084] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the embodiments herein with modifications.

CLAIMS

What is claimed is:
1. A fully automated apparatus for dialyzer reprocessing, the apparatus comprising:

a pre-cleaner module for pre-cleaning used dialyzer with Reverse Osmosis (RO) water and chemicals, and wherein the chemicals are selected from a group consisting of H202 and Peracetic acid;
a chemical mixer module for preparing chemicals for reprocessing dialyzer;

a reprocessing system module for reprocessing dialyzer, while monitoring the reprocessing status; and

a post reprocessing module for post reprocessing disinfected dialyzers with Reverse Osmosis (RO) water for removing chemical residues.

2. The apparatus according to claim 1, wherein the pre-cleaner module, the chemical mixer module, the reprocessing system module and the post reprocessing module works individually.

3. The apparatus according to claim 1, further comprises a plurality of pathways to clean the plurality of dialyzer compartments, an inlet port for the blood compartment, an outlet port for the blood compartment, an inlet port for the dialysate compartment, and an outlet port for the dialysate compartment, and wherein the plurality of dialyzer compartments comprises a blood compartment and a dialysate compartment.

4. The apparatus according to claim 1, further comprises a one or more peristaltic pumps for displacing the chemical accurately and independently to and from the blood compartment and the dialysate compartment, and wherein the one or more peristaltic pumps are driven by one or more motors.

5. The apparatus according to claim 1, wherein the pre-cleaner module automatically detects and indicates a presence and an absence of dialyzer by illuminating an LED light, and wherein the pre-cleaner module pre-cleans the blood compartment and the dialysate compartment with the Reverse Osmosis (RO) water and chemicals, and wherein the chemicals are selected from a group consisting of H202 and Peracetic acid after every dialysis procedure for removing a blood residue inside the plurality of dialyzer compartments.

6. The apparatus according to claim 1, wherein the chemical mixer module prepares chemicals for reprocessing dialyzer, and wherein the chemicals are selected from a group consisting of peracetic acid, formaldehyde and glutaraldehyde.
7. The apparatus according to claim 1, wherein the reprocessing system module reprocesses the dialyzer and monitors and displays the reprocessing status and gives error messages and alarms at necessary conditions.

8. The apparatus according to claim 1, wherein the reprocessing system module continuously monitors and measures a pressure with a pressure sensor and detects any leakages between a plurality of tubes and the dialyzer by a leak test process and measures a total cell volume using a load cell, and wherein the reprocessing system module cleans the dialyzer based on timings and sequences selected by an user, and wherein the reprocessing system module calculates a Total Cell Volume (TCV).

9. The apparatus according to claim 1, further comprises a dialyzer mounting assembly for mounting the at-least once used dialyzer for reprocessing, and wherein the dialyzer mounting assembly comprises a provision for holding a dialyzer cartridge, and a load cell.

10. The apparatus according to claim 1, wherein the dialyzer is mounted directly on to the load cell.

11. The apparatus according to claim 1, further comprises at-least one controller for activating a plurality of solenoid valves for filling the blood compartment and the dialysate compartment with RO water and chemicals.

12. The apparatus according to claim 1, further comprises a one or more solenoid valves to drain out RO water and chemicals from the blood compartment and the dialysate compartment.

13. The apparatus according to claim 1, wherein the reprocessing system module is adopted to execute Normal process, Heavy process, Custom-1 process and Custom-2 process.

14. The apparatus according to claim 1, wherein the Normal process of the reprocessing system module comprises sub-processes such as Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment.

15. The apparatus according to claim 1, wherein the heavy process of the reprocessing system module comprises a plurality of sub-processes, and wherein the plurality of sub-process comprises a programmability option by the user for repeating the plurality of sub processes and wherein the plurality of sub-process comprises Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment.

16. The apparatus according to claim 1, wherein the first custom process of the reprocessing system module comprises the plurality of sub-processes, and wherein the plurality of sub-process comprises Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment, and wherein the user has an option to disable any one of the sub-processes, and wherein the user has an option to repeat any one of the sub-processes.

17. The apparatus according to claim 1, wherein the second custom process of the reprocessing system module comprises the plurality of sub-processes, and wherein the plurality of sub-process comprises Leak test, Rinsing, Chemical cleaning, Checking Bundle volume, Disinfecting, Air flushing in the blood compartment and Air flushing in the dialysate compartment, and wherein the user has an option to disable any one of the sub-processes, and wherein the user has an option to repeat any one of the sub-processes.

18. The apparatus according to claim 1, wherein the sequence of the sub-processes in the reprocessing system module is customizable based on the user needs.

19. A method for dialyzer disinfection, the method comprising the steps of:

Pre-cleaning a dialyzer with Reverse Osmosis (RO) water and chemicals;

reprocessing the dialyzer and wherein reprocessing the dialyzer comprises disinfecting dialyzer with chemicals such as Peracetic acid, etc, which are mixed in a chemical mixer module and wherein a blood compartment and a dialysate compartment in the dialyzer are filled with chemicals for a specified time and cleaned with RO water to disinfect the used dialyzer;

Checking Total Cell Volume (TCV) as an indirect measure of the total membrane surface area available for diffusive transport for a reprocessing procedure;

Filling chemicals, and wherein the blood compartment and the dialysate compartment are filled with chemicals to prevent the growth of microorganisms, and wherein the chemical is formalin; and

Post reprocessing of dialyzers with Reverse Osmosis (RO) water for removing chemical and chemical residues if any just before the next use of the dialyzer, and wherein the chemical is formalin.

20. The method of claim 19, wherein the step of checking the Total Cell Volume (TCV) comprises the steps of:

Filling the blood compartment and the dialysate compartment of the dialyzer with RO water or chemical;

measuring a first filled weight, and wherein the first filled weight or a first filled volume is calculated by a summation of a dialyzer dry weight, a blood path liquid volume, a dialysate path liquid volume and a weights of tubing and connectors;

Draining out the RO water or chemical filled in the blood compartment;
measuring a second filled weight, and wherein the second filled weight or a second filled volume is calculated by the summation of dialyzer dry weight, the dialysate path liquid volume and the weights of tubing and connectors; and

Calculating the Total Cell Volume by subtracting the second filled weight from the first filled weight;

Wherein the peristaltic pumps displaces the RO water accurately and independently to and from the blood compartment and the dialysate compartment.