DEVICE FOR EVALUATING WATER VOLUME IN THE REPROCESSING OF DIALYZERS AND BLOOD LINES

Description

1 / 10 DEVICE FOR EVALUATING WATER VOLUME IN THE REPROCESSING OF DIALYZERS AND BLOOD LINES FIELD OF APPLICATION

[001] The present invention applies to the field of hemodialysis and dialyzer reprocessing. The device of the present invention, when coupled to a dialyzer and blood lines during the manual cleaning phase thereof, is capable of measuring the volume of water in real time by means of a flow meter comprising a propeller and a coupled magnet that work together with a Hall effect sensor. FUNDAMENTALS OF THE INVENTION

[002] The idea of ​​evaluating the water consumption used in the reprocessing of hemodialysis filters, called dialyzers, arose from the need to answer the question of what the impact of reprocessing dialyzers and blood lines would be on the total water consumption in the hemodialysis clinic.

[003] The reprocessing of these filters, despite being automated in one of its stages, goes through a manual phase in which free-flowing water is used, the volume of which is not measured by any known equipment.

[004] Existing reprocessors on the market, in addition to not directly measuring the volume of water, do not reprocess the blood lines that make up the system (dialyzer + blood lines).

[005] The present invention has as its primary objective to measure the volume of water in the manual stage of reprocessing. In this way, it solves the information gap regarding this water consumption which, until now, has been estimated empirically, a Petition 870250016429, dated 27 / 02 / 2025, page 7 / 26 2 / 10 because the equipment already in use on the market (automatic reprocessor) is deficient in two aspects: first - it does not record this information because it only covers the automated stage of the process; second - it does not reprocess blood lines, which are handled only manually.

[005] In the literature, many studies address the reuse of dialyzer filters. These studies have had diverse objectives, such as: implementation of KPIs (Key Performance Indicators) in the evaluation of water and electricity consumption and waste production (BENDINE et al., 2020); clinical and microbiological impact of reuse (RIBEIRO et al., 2019); critical approach to the study on the clinical and microbiological impact (UPADHYAY; ASHISH, 2019); impact of reuse on dialysis adequacy (HAMID et al., 2019); impact of reuse on biochemical and hematological markers, pyrogenic reactions and bacteremias (SILVA et al., 2020) and, finally, impact of reuse on the quality of life of patients (ABDULLAH et al., 2019).

[006] In none of the studies cited, however, was water consumption specifically demonstrated in the reprocessing of the extracorporeal hemodialysis circuit.

[006] Therefore, given this gap in knowledge about the volume of water in the reprocessing of this equipment, a flow meter was developed, according to the present invention, which is capable of measuring the volume of water in the reprocessing of dialyzers. STATE OF THE ART

[007] The article Flow Analyzer for Blood Pump, available at https: / / www.researchgate.net / publication / 344144774 Flow Ana Petition 870250016429, dated 27 / 02 / 2025, page 8 / 26 3 / 10 lyzer_for_Blood_Pump presents a device that collects real-time data emitted by the blood pump of the hemodialysis machine. The hemodialysis blood pump has a roller through which the arterial line passes, bringing the patient's blood to the dialyzer. When the rollers of this pump touch the arterial line, a negative pressure is generated that aspirates the patient's blood.

[008] Furthermore, the present invention is not related to the control or measurement or data collection of blood flow, but rather to the volume of water used in the manual cleaning phase of the dialyzer. The present invention relates to water consumption, while the one described in the article relates to patient safety by collecting blood-related data.

[009] The Quality-1 dialyzer reprocessing machine refers to a reprocessor that performs four steps: 1) automatic cleaning of the dialyzer, 2) measurement of the internal volume of the dialyzer (using water), 3) verification of the integrity of the dialyzer fibers and 4) filling the internal volume of the dialyzer with a sterilizing agent (water solution with peracetic acid).

[0010] The present invention relates to the dialyzer cleaning step that precedes step no. 1 of the machine described above. Before the dialyzer is taken to the Quality1 machine, it is placed on a workbench and subjected to a jet of water, manually, which passes through its fibers to remove excess blood clots.

[0011] After that, it remains on the bench connected to a pressurized water system (25 to 30 psi) for a few minutes, at which point reverse ultrafiltration occurs, or Petition 870250016429, dated 27 / 02 / 2025, page 9 / 26 4 / 10 That is, the water passes from the outside to the inside of the fibers, complementing their cleaning. It is precisely at these two moments that the present invention applies, that is, the measurement of the volume of water in the jet given in the dialyzer and the volume of water consumed during the period in which it remains coupled under pressure. This is the so-called manual phase of reprocessing. Only when it is removed from this water pressure does it go to the Quality-1 machine.

[0012] Therefore, in reprocessing, the dialyzer goes through a manual phase on the bench (when the present invention is employed) and an automated phase, in which the Quality-1 machine is already employed, the volume of water used in which is not the focus of the present invention. Thus, this equipment performs the technical procedure only on the dialyzer, and without the intention of measuring water consumption.

[0013] Furthermore, the present invention also measures the volume of water used in cleaning the blood lines, which only undergo manual cleaning and are not taken to the Quality-1 machine, which only reprocesses the dialyzer, although they make up the extracorporeal circuit, together with the dialyzer.

[0014] The device in US patent 11400192 features two interconnected pieces of equipment using water as an input for the preparation of peritoneal dialysis solution, another type of dialysis in which water is used to prepare the solution that will be used during the dialysis process. After preparation, the water remains in the system and is an integral part of the treatment, not being discarded.

[0015] The present invention relates to the water that is used for cleaning dialyzers after use and, Petition 870250016429, dated 27 / 02 / 2025, page 10 / 26 5 / 10 different from that used in the dialysis solution, this water is discarded after the washing process, being drained and lost - hence the importance of knowing its volume.

[0016] Both the Quality-1 machine and the US11400192 device use automated and predefined water flow mechanisms, the former in hemodialysis and the latter in peritoneal dialysis. However, the Quality-1 machine uses water stored in a gallon, in solution form, i.e., diluted with peracetic acid, previously measured, therefore with its volume well known and, moreover, only includes the dialyzer, as it does not reprocess the blood lines, thus not accounting for this water consumption.

[0017] The present invention has the primary objective of measuring the volume of water in the manual cleaning of the dialyzer and blood lines, by measuring the free flow of pure water, the volume of which is not previously known. It has the advantage of measuring the flow rate that does not depend on a machine, but rather on human action and, therefore, is susceptible to waste.

[0018] Thus, it can be concluded that the present invention differs from the prior art documents presented here, since none of them refers to a device that measures the volume of water in real time, specifically in the reprocessing of the extracorporeal hemodialysis circuit. SUMMARY OF THE INVENTION

[0019] The present invention applies to the field of hemodialysis and dialyzer reprocessing. The device of the invention, when coupled to the dialyzer and blood lines during the manual cleaning phase thereof, is capable of measuring the volume of water in real time, recording Petition 870250016429, dated 27 / 02 / 2025, page 11 / 26 6 / 10 Information for your further analysis. BRIEF DESCRIPTION OF THE FIGURES

[0020] The invention can be better understood through the brief description in the following figures: Figure 1 shows the assembled device, including the electronic device compartment, the battery power supply system, the water flow sensor, and the hoses with adapters; Figure 2 shows the electronic device compartment, the battery power supply system, the water flow sensor, and the hoses with adapters; Figure 3 shows a front view of the electronic device compartment, with the display incorporated into the system, the battery power supply system, the water flow sensor, and the hoses with adapters; Figure 4 shows the open compartment of the electronic device in a front view, where it is possible to observe the display, the micro SD card recorder and partially the microcontroller; Figure 5 shows the system mounted in an MDF package coupled to the water flow sensor; Figure 6 shows the probe with a water flow sensor coupled between the tap and the extracorporeal circuit (dialyzer and blood line); Figure 7 shows the system with the water flow sensor coupled between the tap and the extracorporeal circuit (dialyzer and blood line). DETAILED DESCRIPTION OF THE INVENTION

[0021] The invention may be better understood through the following detailed description, in accordance with Petition 870250016429, dated 27 / 02 / 2025, page 12 / 26 7 / 10 the attached figures.

[0022] The device for evaluating the volume of water in the reprocessing of dialyzers (10) and blood lines comprises a constructed probe used for measuring water flow. The device uses a microcontroller (7), a micro SD card read / write board (4) and a 16x2 LCD display (1) with I2C interface, contained in a compartment (8), in order to process the data collected by the water flow sensor (3), as shown in Figures 2 and 3.

[0023] To estimate the flow rate, the YF-S201 model water flow sensor (3) was used, adopted due to its low cost and ease of acquisition, and it is possible to implement it using other models with similar characteristics.

[0024] The measuring device of the present invention, as shown in Figure 1, has the capacity to measure a flow rate of 130 L / min. In addition, the water flow sensor (3) inside has a propeller and an attached magnet that works together with a Hall effect sensor, thus ensuring accurate measurement.

[0025] The meter detects the rotations of the propeller with the magnet by sending a pulse width modulation signal in which, through the pulses, it is possible to calculate the flow rate of water passing through it.

[0026] The data can be presented on a 16x2 LCD display (1) with an I2C interface on the outside of the compartment (8), capable of displaying characters in 16 columns and 2 rows, with white characters on a blue background. Such data is also recorded on a micro memory card. Petition 870250016429, dated 27 / 02 / 2025, page 13 / 26 8 / 10 SD, since an SD memory card connected to the microcontroller's SPI interface (7) allows the creation, reading and writing of files.

[0027] The components and each stage of operation of the device are described in greater detail below. Device components:

[0028] 1) Hoses (5) - Can be made of PVC or silicone, 25 to 50 cm long and half an inch in diameter, serve as a means of transporting water. One end of a hose (5) is connected to a water tap (9), while the other end of the hose (5) is coupled to the water flow sensor (3). Another hose (5) has one end coupled to the water flow sensor (3) and the other end connected to the dialyzer (10) or the blood line.

[0029] 2) Water flow sensor (3) - located between the tap (9) and the dialyzer (10), without needing a specific position, the water flow sensor (3) is responsible for measuring the volume of water that passes through it.

[0030] 3) Microcontroller board (7) - An electronic development platform that receives data from the water flow sensor (3) and is able to calculate the values ​​and send them to a micro SD card and to the 16x2 LCD display (1) with I2C interface.

[0031] 4) 16x2 LCD display (1) with I2C interface responsible for presenting process data in an interface with white letters on a blue background, having 16 columns and 2 rows. The LCD display (1) is located on top of compartment (8). Petition 870250016429, dated 27 / 02 / 2025, page 14 / 26 9 / 10

[0032] 5) Micro SD card read / write board (4) - Used to store water flow data recorded by the water flow sensor (3) on a micro SD card, connecting to the microcontroller (7) to facilitate data storage and transfer. To maintain power to the electronic circuit, a set of 10,000mA x 5Vdc batteries (11) is used. How the device works:

[0033] 1) Start of Process: The user opens the tap (9), allowing water to flow into a hose (5) through a tap adapter (2);

[0034] 2) Flow Measurement: As water flows through the hose (5), it passes through the water flow sensor (3), which detects the speed and volume of the water. The water flow sensor (3) is connected to another hose (5) comprising a connector (6), the connector (6) being connected to the dialyzer (10), as shown in Figure 7. The water flow sensor (3) starts and stops the measurement automatically upon detection or interruption of the water flow, respectively.

[0035] 3) Data Logging: The data collected by the water flow sensor (3) is transmitted in real time to the microcontroller board (7);

[0036] 4) Data Storage: The microcontroller (7) processes the received data and stores it on a micro SD card. Storage allows for later analysis and ensures traceability of the volume of water used;

[0037] 5) Process Completion: After the water flow has stopped, the hose (5) attached to the dialyzer is removed and reconnected to another one, for another cleaning process.

[0038] The present invention was disclosed in this report. Petition 870250016429, dated 27 / 02 / 2025, page 15 / 26 10 / 10 descriptive in terms of its preferred embodiment. However, other modifications and variations are possible from the present description, and are still within the scope of the invention disclosed herein. REFERENCE SIGNS (1) LCD display (2) Faucet adapter (3) Water flow sensor (4) Read / write board (5) Hose (6) Connector (7) Microcontroller (8) Compartment (9) Faucet (10) Dialyzer (11) Battery pack Petition 870250016429, dated 27 / 02 / 2025, page 16 / 26

Claims

1 / 2 CLAIMS 1. Device for evaluating water volume in the reprocessing of dialyzers and blood lines CHARACTERIZED by comprising an LCD display (1), a tap adapter (2), a water flow sensor (3), a read / write board (4), two hoses (5), a connector (6), a microcontroller (7) and a battery pack (11), the water flow sensor (3) being connected to a dialyzer (10) via a hose (5) coupled to a connector (6), wherein the water flow sensor (3) is connected to a tap (9) via another hose (5) coupled to a tap adapter (2), the water flow sensor (3) detecting water velocity and volume data, the microcontroller (7) processing and storing the data received from the water flow sensor (3) via a read / write board (4), the read / write board (4), the microcontroller (7) and the battery pack (11) being installed inside a compartment (8),and wherein the data received by the water flow sensor (3) are transmitted to an LCD display (1) on the outside of the compartment (8).

2. Device according to claim 1, CHARACTERIZED in that the water flow sensor (3) comprises a YF-S201 model sensor.

3. Device, according to claim 1, CHARACTERIZED in that it comprises measuring a flow rate of Petition 870250016429, dated 27 / 02 / 2025, page 17 / 26 2 / 2 1 to 30 L / min.

4. Device according to claim 1, CHARACTERIZED in that the hose (5) comprises 25 to 50 cm.

5. Device according to claim 1, CHARACTERIZED in that the water flow sensor (3) comprises a propeller and a magnet coupled with a Hall effect sensor.

6. Device according to claim 1, CHARACTERIZED in that the read / write board (4) comprises data transmission to a micro SD card.

7. Device according to claim 1, CHARACTERIZED in that the LCD display (1) comprises an I2C interface. Petition 870250016429, dated 27 / 02 / 2025, pp. 18 / 26

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