Artificial diuretic devices

Abstract

The artificial diuretic device is wearable by a patient (H) and comprises a reusable machine (2) and a disposable unit (3), which is completely filled with a treatment liquid (Lt) before use.

Description

Technical Field

[0001] Cross - reference to related applications This patent application claims priority from Italian Patent Application No. 102021000000521 filed on January 13, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to an artificial diuretic device.

Background Art

[0003] In various clinical situations, along with urine (physiological diuresis), removing excess fluid accumulated in the body due to various medical conditions (heart failure, kidney failure, edematous diseases) is incomplete or insufficient. In these states, fluid overload causes serious clinical complications and increases hospitalization and mortality. In many of these cases, diuretic - based pharmacological solutions are used (forced diuresis) to increase urine excretion by the kidneys. Nevertheless, in a significant proportion of patients, the pharmacological approach fails to achieve the desired results, and the medical condition of fluid overload persists in the patient, resulting in negative clinical and social outcomes.

[0004] The use of techniques for removing excess fluid by using extracorporeal ultrafiltration is known, but the devices are cumbersome to handle and are suitable for use only in very specialized settings due to the complexity of use and the potential risk to the patient if used incorrectly. The said risk is related to the large amount of blood present in the extracorporeal circuit and the flow required to process blood using a conventional filter for an adult. If used inappropriately, it can result in the loss of blood that cannot be returned to the patient, potentially causing a significant drop in the body's blood pressure.

[0005] Therefore, known types of ultrafiltration devices are not commonly used to support other therapies or in departments for various medical conditions, due to both their difficulty of use and the need for specialized staff. Consequently, in these situations, pharmacological treatment is more frequently used to support other therapies, but it is not as effective as using ultrafiltration devices.

[0006] Ultrafiltration can demonstrate an established and well-known process for producing plasma water, rather than cells or colloids, from blood containing electrolytes and crystallizable substances, through separation obtained by passing through a thin film. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] European Patent Application EP3566729A1 [Patent Document 2] European Patent Application EP2946179A1 [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] The object of the present invention is therefore to provide an artificial diuretic device that overcomes the drawbacks described above.

[0009] The objective of the present invention is to provide a simple, portable, and safe device that enables ultrafiltration techniques to be performed in any environment, such as a hospital or home, and facilitates patients to perform some form of treatment themselves. [Means for solving the problem]

[0010] According to the present invention, an artificial diuretic device is provided in accordance with the appended claims.

[0011] To better understand the present invention, embodiments are described merely as examples. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of a preferred embodiment of an artificial diuretic device according to the present invention, with some parts removed for clarity. [Figure 2] This diagram shows the details of the device in Figure 1. [Figure 3] This is a schematic diagram of the details of the device in Figure 1 in its operating configuration. [Figure 4] This is a detailed view of Figure 3. [Figure 5] This is a cross-sectional view taken along line VV in Figure 4. [Figure 6] This is a cross-sectional view taken along line VI-VI in Figure 4. [Figure 7] This is a cross-sectional view taken along line VII-VII in Figure 4. [Figure 8] Figure 1 is a schematic diagram of the device's details. [Modes for carrying out the invention]

[0013] In Figure 1, number 1 shows the entire artificial diuretic device according to the present invention. Advantageously, the artificial diuretic device 1 is portable, i.e., it can be worn and used by patient H while moving (walking, sitting, and so on). In other words, the artificial diuretic device 1 has reduced dimensions and weight and can therefore be easily lifted and moved by any person.

[0014] Device 1 is configured to operate with a volume of extracorporeal blood of less than 40 ml, preferably less than 30 ml.

[0015] Device 1, being portable, having reduced dimensions, and operating with a volume of extracorporeal blood of less than 40 ml, inherently reduces the risk to the patient in the event of blood loss.

[0016] The artificial diuretic device 1 comprises a reusable machine 2 and a disposable unit 3.

[0017] As schematically shown in Figure 2, the machine 2 comprises a box-shaped body 21 having an inner cavity 22. Advantageously, thus, the most costly and difficult-to-handle component parts of the device 1 are enclosed (and inaccessible) within the cavity 22 of the machine 2 and, thus, they can be used several times.

[0018] As shown in more detail in Figure 3, the disposable unit 3 can be used only once and, in use, comprises components that come into contact with the organic liquid Lh of the patient H. At the end of each treatment, the disposable unit 3 is disposed of in accordance with the law.

[0019] As schematically shown in Figure 3, in use, the disposable unit - a vascular access device N1 (schematically shown, of a known type) for extracting the organic liquid Lh1 sent to the disposable unit 3, and - a vascular access device N2 (schematically shown, of a known type) for reinjecting the treated organic liquid Lh2 into the patient H is connected to the patient H.

[0020] For example, the vascular access devices N1 and N2 are needles and / or catheters, or the like. Each vascular access device N1, N2 is connected to the disposable unit 3 in use, as will be described in more detail below.

[0021] Advantageously, as will be described in more detail below, the disposable unit 3 is completely filled with a treatment liquid Lt before use. The treatment liquid Lt can be physiological saline, but, if necessary, is mixed with other substances such as, for example, heparin.

[0022] In the example shown in Figure 1, device 1 further comprises a cover 20 which, when coupled, substantially has the form of a cup-shaped body with a concave surface facing the body 21 of machine 2 coupled to it. When in use, the cover 20 covers and shields the disposable unit 3, at least partially.

[0023] According to the example shown, the disposable unit 3 comprises an operating box 4, multiple flexible tubes T for the flow of organic liquid Lh, a filtration unit 5, and a collection bag 6.

[0024] Advantageously, device 1 includes multiple measuring devices S to verify the correct execution of the process, as will be described in more detail below.

[0025] Device 1 further comprises a control unit 7, which is housed inside the inner cavity 22, and each measuring device S exchanges signals with the control unit 7 when in use.

[0026] Advantageously, the body 21 of machine 2 and the box 4 are configured to be coupled to each other in place by, for example, a shape and / or interference coupling (of a known type, not shown), which will be described in more detail below.

[0027] Advantageously, box 4 is made from a single piece. Advantageously, box 4 is made by molding from a polymer material. Thus, box 4 is lightweight and easy to install.

[0028] Furthermore, Box 4 has been optimized to reduce its overall dimensions, making it easier to carry.

[0029] Advantageously, box 4 is configured to minimize the amount of blood present in the extracorporeal circuit of the disposable unit 3.

[0030] Preferably, box 4 is configured to limit the amount of blood present in the extracorporeal circuit to less than 40 ml, preferably less than about 30 ml.

[0031] As shown in Figures 3 and 4, Box 4 is - Inlet I1 for the organic liquid Lh1 coming from patient H, which should be processed, - An outlet U1 for sending the organic liquid Lh1 to be processed to the filtration unit 5, - An inlet channel C1 connects the inlet I1 to the outlet U1, - Inlet I2 for the treated organic liquid Lh2 coming from filtration unit 5, - An outlet U2 for delivering the processed organic liquid Lh2 to patient H, - Exit channel C2 connects the inlet I2 to the outlet U2. It has.

[0032] Advantageously, box 4 has an interaction region A1 configured to interconnect with machine 2 when in use. The interaction region A1 is positioned along the inlet channel C1. According to the example shown, the interaction region A1 has a substantially cylindrical shape. Without loss of generality, the interaction region A1 may have a different shape and dimensions than that shown.

[0033] Device 1 includes a measuring device S1 (circularly shown in Figure 5) configured to detect the pressure of the organic liquid Lh1 to be processed in the interaction region A1.

[0034] Preferably, box 4 comprises a thin film 30, which defines the lateral extent of each portion of the interaction region A1. Machine 2 then comprises a pressure transducer 31, which, in use, detects pressure fluctuations of the organic liquid Lh1 to be processed inside the interaction region A1 according to the deformation of the thin film 30. The pressure transducer 31 is housed inside a cavity 22 of machine 2 and exchanges signals with the control unit 7 (in a known but not shown manner).

[0035] Advantageously, box 4 has an interaction region A2 configured to interconnect with machine 2 when in use. The interaction region A2 is positioned along the exit channel C2. According to the example shown, the interaction region A2 has a substantially cylindrical shape. Without loss of generality, the interaction region A2 may have a different shape and dimensions than those shown.

[0036] Device 1 comprises a measuring device S2 (Schematically shown in Figure 6), which is configured to detect the pressure of the treated organic liquid Lh2 flowing out of the filtration unit 5 and into the area of ​​interaction region A2. Preferably, box 4 comprises a thin film 32 that defines the lateral extent of each portion of interaction region A2. Machine 2 then comprises a pressure transducer 33, which, in use, detects pressure fluctuations of the treated organic liquid Lh2 inside interaction region A2 in accordance with the deformation of the thin film 32. The pressure transducer 33 is housed inside a cavity 22 of machine 2 and exchanges signals with control unit 7 (in known but not shown manner).

[0037] To the advantage, Box 4 is, - Inlet I3 for the ultrafiltrate LU, - Outlet U3 for sending the ultrafiltrate LU to collection bag 6, - An ultrafiltration channel C3 connects the inlet I3 to the outlet U3. It also possesses.

[0038] Advantageously, as will be described in more detail below, box 4 further has an inlet I4 for guiding the auxiliary liquid LA into the ultrafiltration channel C3. The auxiliary liquid LA can correspond to the processing liquid Lt, or another type.

[0039] Advantageously, box 4 has an interaction region A3 configured to interconnect with machine 2 when in use. In particular, machine 2 then includes a measuring device S3 for detecting the flow of ultrafiltrate LU in the interaction region A3.

[0040] The measuring device S3 is equipped with a flow meter 34.

[0041] Advantageously, the measuring device S3 includes a flow adjustment element 35 that cooperates with the flow meter 34. In the example shown in Figure 7, the adjustment element 35 is a cartridge with a shape contour that faces the inside of the ultrafiltration channel C3 and comes into contact with the ultrafiltrate LU when in use.

[0042] The shape of the contour is predetermined according to the desired flow rate value of the ultrafiltrate LU in the interaction region A3, particularly in the region of the flow meter 34.

[0043] Advantageously, the cartridge 35 is fixed to the box 4 in the interaction region A3 to define the range of each section Q of the ultrafiltration channel C3.

[0044] Advantageously, the flow meter 34 is fixed to the box 4 to determine the range of each section Q of the ultrafiltration channel C3.

[0045] The flow meter 34 and cartridge 35 define, at least partially, the lateral extent of the same passage section Q as the ultrafiltration channel C3.

[0046] Advantageously, the cartridge 35 is selected from a group of different cartridges 35 with respect to the shape and dimensions of the shape contour intended to come into contact with the ultrafiltrate LU during use.

[0047] The shape and dimensions of the cartridge 35's contour are advantageous because they allow for different flow rates of the ultrafiltrate LU flowing through the passage section Q.

[0048] According to an unshown variant, the adjustment element 35 is made from the box 4 and a single part. In other words, the adjustment element 35 is substantially obtained using the corresponding appropriate shaped portion of the box 4.

[0049] For example, the flow meter 34 is manufactured in accordance with the principles described in European Patent Application EP3566729A1 or European Patent Application EP2946179A1, the teachings of which are deemed to be included herein.

[0050] Advantageously, though not limited to, the flow meter 34 comprises an electrical / electronic measuring circuit 41, the electrical / electronic measuring circuit 41 comprising at least one thermal resistance electrical component 42. For convenience, the thermal resistance electrical component 42 may include, for example, preferably a thermal sensor which is a thermal anemometer, and the thermal resistance (sensitive) electrical component is used as both a diffusion sensor and a temperature sensor. It should be understood that the thermal resistance electrical component 42 is used for fluid temperature compensation and therefore makes the flow independent of the fluid temperature.

[0051] Preferably, the thermal resistance electrical component 42 may include a positive temperature coefficient (PTC) resistor or any similar thermistor electrical / electronic component.

[0052] The thermal resistance electrical component 42 may be associated with / coupled to / configured with the ultrafiltration channel C3 (circumstantially shown by a dashed line in Figure 8), and therefore it may directly or indirectly transfer and / or receive heat to and from the liquid passing through the ultrafiltration channel C3.

[0053] In this method, the thermal resistance electrical component 42 is conveniently surrounded by (in contact with) the ultrafiltrate LU, and its resistance changes according to the temperature and flow rate of the ultrafiltrate LU.

[0054] According to unshown variants, the ultrafiltration channel C3 may be provided at least partially via the flow meter 34.

[0055] The measurement circuit 41 may further include a voltage measuring device 45, which is electrically coupled to a thermal resistance component 42, for example, at its end (termination). The voltage measuring device 45 is configured to measure voltages VL and VH at the end of the thermal resistance component 42.

[0056] The flow meter 34 may further include a computing device 46 configured to perform calculation operations to determine the liquid flow rate.

[0057] The computing device 46 is, - The voltages VL and VH of the thermal resistance component 42, measured according to a pre-defined method, are received from the voltage measuring device 45. - Calculate the resistance values ​​R of each component R of the thermal resistance equation, which represent the electrical resistance of the 42 components. It can be programmed / configured in this way.

[0058] Advantageously, the flow meter 34 is a miniaturized, integrated electromechanical microsystem, commonly known as a micro-electromechanical system (MEMS). In other words, advantageously, the flow meter 34 is miniaturized.

[0059] Advantageously, the flow meter 34 is disposable, meaning it can only be used once.

[0060] The flow meter 34 is configured to exchange signals related to the detected resistance value R with the control unit 7.

[0061] Advantageously, box 4 has an interaction region A4 configured to interconnect with machine 2 when in use. In particular, machine 2 then includes a measuring device S4 that measures traces of blood in the interaction region A4 to detect any blood loss in the ultrafiltrate LU.

[0062] For example, the measuring device S4 includes an optical sensor 36, such as a sensor of the type commonly known as a BLD. The measuring device S4 further includes a reflective element 37 facing the optical sensor 36, so that when the ultrafiltrate LU passes through the interaction region A4 during use, the ultrafiltrate LU flows between the sensor 36 and the reflective element 37. For example, the reflective element 37 is a mirror that defines the lateral range of the ultrafiltration channel C3.

[0063] Advantageously, the reflective element 37 is configured to increase contrast in order to optimize the detection of any traces of blood.

[0064] Without loss of generality, and as an example, as shown in Figure 7, interaction regions A3 and A4 are distinct regions.

[0065] According to the unshown deformation morphology, interaction regions A3 and A4 coincide and overlap, meaning that detection of blood flow and presence occurs in a single region.

[0066] According to an unshown variant, the flowmeter 34 and the optical sensor 36 are inserted inside the cartridge 35, which is configured to be applied to the box 4 in the interaction region A3 / A4, by shape and / or interference coupling. The differential pressure flowmeter 34 and the optical sensor 36 face the inside of the ultrafiltration channel C3.

[0067] Advantageously, device 1 includes a measuring device S5 for detecting bubbles in the processed organic liquid Lh2 before the organic liquid Lh2 is delivered to patient H. For example, the measuring device S5 is applied to the area of ​​the outlet U2.

[0068] Advantageously, device 1 further comprises a measuring device S6 for each vascular access device N1, N2 to detect the correct insertion of the latter during processing.

[0069] Advantageously, each measuring device S, S1, S2, S3, S4, S5, and S6 exchanges signals with the control unit 7 when in use.

[0070] According to the example shown, filtration unit 5 is a filter. According to variations not shown, the filtration unit may include multiple filters mounted in parallel or in series. Filtration unit 5 is of a known type and is shown schematically.

[0071] To give a non-exclusive example, filtration unit 5 is a blood filter with hollow capillary fibers having a cutoff lower than 55 kDa to avoid albumin loss in the ultrafiltrate LU. The hollow capillary membrane of filtration unit 5 can be made from polysulfone (Medica SpA's Medisulfone®) or, alternatively, from polyethersulfone / polyvinylpyrrolidone (commonly known as PUREMA® H membrane made by 3M®).

[0072] Advantageously, the filtration unit 5 ensures a flow rate of ultrafiltrate LU equal to at least 5% of the flow rate of pump 12. For example, the flow rate of ultrafiltrate LU is between 1 ml / min and 4 ml / min.

[0073] According to an unshown variant, the filtration unit 5 is not a hemofilter but a plasma filter of hollow capillary fibers with a membrane in PES / PVP (Versatile-PES®) made by Medica SpA, the plasma filter performing plasma filtration, i.e., separation of blood cell components (remaining in the lumen of the fibers) from the plasma. The filter has a cutoff of approximately 1000 kDa, which advantageously allows for slow, continuous plasma filtration.

[0074] In known methods, filtration unit 5 is - Inlet I5 for incoming organic liquid Lh1, - Outlet U4 for the ultrafiltrate LU, - Outlet U5 to the processed organic liquid Lh2 and It has.

[0075] The filtration unit 5 further includes an inlet I6 for an auxiliary fluid LA which can be injected by a pre-installed manual pumping mechanism in case of any backflow.

[0076] As shown in Figure 3, the outlet U4 is in fluid communication with the inlet I3 of box 4.

[0077] As shown in Figures 1 and 2, the artificial diuretic device 1 further comprises a pump 12, which is specifically a peristaltic pump, for circulating an organic liquid Lh through a disposable unit 3. Advantageously, the pump 12 comprises a head 8 protruding from the outside of the body 21 of the machine 2, and an operating unit 9 inserted inside the cavity 22 of the machine 2, which, when in use, rotates the head 8 around a pivot axis Y. The head 8 of the peristaltic pump is configured to interact with the disposable unit 3 for circulating the organic liquid Lh, as will be described in more detail below. The peristaltic pump 12 is of a known type and will be described schematically.

[0078] Pump 12 is configured to provide a pumping rate of 20-40 ml / min. In other words, the flow rate of pump 12 is certainly lower than that of pumps commonly used in fixed machines of the type known for hemofiltration, which are typically 200 ml / min in size.

[0079] Disposable unit 3 is - An inlet tube T1 is fluidically connected to an inlet I1 and configured to connect to a vascular access device N1 for drawing organic liquid Lh1 from patient H when in use, - The outlet U1 of box 4 is fluidly connected to the inlet I5 of the filtration unit 5 via pipe T2, - The outlet U5 of the filtration unit 5 is fluidly connected to the inlet I2 of the box 4 by a pipe T3, - A tube T4 is fluidly connected to the outlet U2 of box 4 and configured to connect to a vascular access device N2 for reinjecting the processed organic liquid Lh2 into patient H when in use. - Tube T5 connects the outlet U3 of box 4 to the collection bag 6. To further prepare.

[0080] The tubes T1, T2, T3, T4, and T5 shown above are of known types and are shown schematically. In particular, they are made from flexible PVC and are disposable.

[0081] Advantageously, device 1 includes one or more electrical contacts (of a known type, though not shown) between box 4 and machine 2 to transmit signals from one or more sensitive elements S, S1, S2, S3, S4 to control unit 7.

[0082] Advantageously, device 1 is powered by battery 14. This method also has the advantage that device 1 does not need to be connected to a fixed power supply network, and patient H can move around during treatment.

[0083] Device 1 is of a known type and further comprises several clamps Z schematically shown, each configured to close off a region through which each pipe T passes in order to stop the fluid passage. In particular, Device 1 is - Clamp Z1 applied to pipe T1, - Clamp Z2 applied to pipe T4, and - Clamp Z3 applicable to pipe T5 It is equipped with.

[0084] Advantageously, device 1 further comprises a needleless valve 15 applied to close the inlet I4 of box 4. The valve 15 is of a known type and is shown schematicly. Advantageously, an operator can inject liquid into the ultrafiltration channel C3 through the valve 15 using a syringe.

[0085] Advantageously, before use, the disposable unit 3 is completely filled with saline solution. Doing so ensures that no air is present inside the disposable unit 3 when connected to the vascular access devices N1 and N2, and allows the device 1 to be used immediately without performing the series of operations commonly known as priming operations, which must be carried out on the fixed hemofiltration board.

[0086] In other words, before first use, the following are completely filled with saline solution: tube T1, inlet channel C1, tube T2, filtration unit 5, tube T3, outlet channel C2, tube T4, ultrafiltration channel C3, and tube T5.

[0087] Advantageously, the type of device 1 described above is portable and therefore can be used by patient H at any location, while also allowing the patient to move.

[0088] Advantageously, the type of device described above does not require the intervention of specialized medical staff in hemofiltration therapy for application to the patient.

[0089] Therefore, the type of device 1 described above can also be used in any type of department and by medical staff who are not specialists in hemofiltration.

[0090] According to the example provided, machine 2 further comprises a display 25 configured to interact with a control unit 7 and exchange data with a user. For example, the display could be a graphic interface applied to the outside of the box-shaped body 21 of machine 2. Alternatively, the display could be a graphic interface for a remote device, such as the screen of a computer, tablet, smartphone, or similar device.

[0091] When in use, machine 2 and disposable unit 3 are prepared in advance.

[0092] Advantageously, the disposable unit 3 is sealed and pre-filled with saline solution inside a sterilized package to ensure its use, without the need to perform the circuit preparation and filling steps as with conventional devices.

[0093] After being removed from its packaging, the disposable unit 3 is applied to the box-shaped body 21 of the machine 2. In particular, the box 4 is coupled to the body 21 by a shape and / or interference coupling provided to ensure that the disposable unit 3 takes a predetermined position during use.

[0094] Therefore, pipe T is positioned in a predetermined manner.

[0095] In particular, tube T2 is partially wrapped around the head 8 of pump 12. If cartridge 35 is not yet present, it is inserted into its housing. If collection bag 6 is not yet present, it is connected to tube T5.

[0096] Simultaneously with or following the preparation of disposable unit 3 for machine 2, vascular access devices N1 and N2 are applied to patient H according to a known but not shown hemofiltration therapy.

[0097] A vascular access device N1 for withdrawing organic liquid Lh1 from patient H is then connected to the inlet tube T1, and similarly, a vascular access device N2 for reinjecting the processed organic liquid Lh2 is connected to the outlet tube T2.

[0098] For example, when a start signal for device 1 is given via display 25, pump 12 operates, causing the organic liquid Lh1 coming from pipe T1 to flow and push the organic liquid Lh1 into filtration unit 5.

[0099] The organic fluid Lh1 taken from patient H enters channel C1 of disposable unit 3 and passes through interaction region A1. In interaction region A1, pressure measuring device S1 detects the inlet pressure P1 of the incoming organic fluid Lh1. Advantageously, the inlet pressure value P1 works to determine whether there is an obstruction or whether the vascular access device N1 remains detached.

[0100] After the organic liquid Lh1 flows out of the inlet channel C1, it passes through the pipe T2 and is pushed into the filtration unit 5 by the pump 12.

[0101] Filtration unit 5 separates the ultrafiltrate LU from the treated organic liquid Lh2 by known means.

[0102] At the outlet of the filtration unit 5, the treated organic liquid Lh2 is pushed into the outlet channel C2 and passes through the interaction region A2.

[0103] In interaction region A2, the pressure measuring device S2 detects the outlet pressure P2 of the processed organic liquid Lh2.

[0104] Advantageously, the outlet pressure value P2 helps determine whether there is any obstruction or whether the vascular access device N2 remains detached.

[0105] As will be explained in more detail below, if bubbles are detected in the processed organic liquid Lh2, the measuring device S5 exchanges signals with the control unit 7 to stop the operation of device 1.

[0106] As the ultrafiltrate LU flows out of the filtration unit 5 through outlet U4, it is pushed into the ultrafiltration channel C3.

[0107] In the ultrafiltration channel C3, the ultrafiltrate LU passes through interaction regions A3 and A4. In interaction regions A3 and A4, the flow rate is detected by the flow detection device S3 and / or the presence of any trace of blood is detected by the blood measurement device S4. At the outlet of the ultrafiltration channel C3, the ultrafiltrate LU enters the collection bag 6.

[0108] During processing, if the control unit 7 detects an abnormal function based on a signal detected by one or more of the measuring devices S, namely S1, S2, S3, S4, and S5, the control unit adjusts the operating unit 9 of the pump 12, in particular, to reduce its speed or stop it. This method is advantageous because the processing is stopped in a relatively short time.

[0109] The control unit 7 is advantageous because it has software for adjusting the operating unit 9 according to the type of processing to be performed.

[0110] The display 25 is configured to emit audible or visual alarms to attract the attention of the health management operator.

[0111] To perform a cleaning operation on the filtration unit 5, clamp Z3 is tightened to close the passage section of tube T5. The operator can then inject the treatment fluid Lt into the ultrafiltration channel C3 through the needleless valve 15 to backwash the filtration unit 5. Additionally, or alternatively, the operator, equipped with a pre-installed manual pumping means, can introduce auxiliary fluid LA through the inlet I6 for any backflushing.

[0112] Advantageously, the type of device 1 described above has reduced dimensions and is easy to apply.

[0113] Advantageously, considering the reduced flow rate of the organic liquid Lh through device 1, device 1 can be used to perform processing for a longer period of time than would be possible with conventional equipment.

[0114] Considering the reduced amount of organic liquid Lh circulating through device 1, stopping device 1 would not harm the patient.

[0115] Advantageously, the type of device 1 described above is, - Continuous (Device 1 can perform processing that lasts for several hours, such as 24 hours, part of a day, or 2-3 hours), - Do it slowly and gradually. - Adjustable and safe, - Can be managed at the patient's bedside or at home. To achieve an artificial diuretic effect.

[0116] Advantageously, the type of device described above is easy to apply and therefore enables the implementation of the ultrafiltration process even in situations where these types of treatments have not been applicable or have only been achieved through drug-based treatments.

[0117] As a simple example, device 1 can be used to perform the following operations: 1. Acute cardiac decompensation: Slow, gradual removal of fluid at a variable rate, similar to physiological diuresis. 2. Critical conditions in intensive care: Fluid balance management in cases of hypovolemia or excessive need for infusion, independent of dialysis treatment. 3. Recent kidney transplants: Fluid balance management in cases of slow transplant function, 4. Patients in ECMO: Management of fluid balance after or during extracorporeal oxygen administration, 5. Nephrotic syndrome and generalized edema due to decompensation: Management of fluid overload, 6. Decompensated cirrhosis: Generalized edema and ascites, 7. Chronic cardiac decompensation: Management of fluid overload in the early stages of decompensation (rescue treatment), or management to prevent rehospitalization using regular treatment (selective treatment), 8. Patients with early renal failure who require fluid rebalancing, 9. Hypoalbuminemia and systemic edema: Reduction of fluid overload 10. Pediatric patients requiring optimized fluid balance: The miniaturized nature of the device allows for use in young patients, down to neonatal levels. 11. In patients undergoing hemodialysis three times a week, treatment of fluid overload during the interval between dialysis sessions, 12. Routine treatment of fluid overload in peritoneal dialysis patients with insufficient transperitoneal fluid removal. 13. Treatment in a protected environment: e.g., care homes and limited care centers, 14. Home treatment: Home management of chronic edema [Explanation of symbols]

[0118] 1. Artificial diuretic device, device 2. Reusable machinery, machines 3 Disposable units 4. Operation box, box 5 Filtration Unit 6 Collection Bags 7 Control Unit 8 heads 9. Operating Unit 12 pumps 14 Batteries 15 Needleless valve, valve 20 Covers 21 Box-shaped main body, main body 22 Inner cavity, cavity 25 displays 30 Thin Films 31 Pressure transducer 32 Thin film 33 Pressure transducer 34 Flow meter 35 Flow adjustment elements, cartridges, adjustment elements 36 Light sensors, sensors 37 Reflection elements 41 Electrical / electronic measuring circuits, measuring circuits 42. Thermal resistance electrical components, thermal resistance components 45 Voltage Measurement Devices 46 Computing Devices R resistance value A1~A4 interaction region C1 Inlet Channel, Channel C2 Exit Channel C3 ultrafiltration channel H patient I1~I6 Entrance LA support fluid Lh1 Organic liquid to be processed Lh2-treated organic liquid Lt Treatment Solution LU ultrafiltrate N1 Vascular Access Device N2 Vascular Access Device P1 Inlet pressure, inlet pressure value P2 Outlet pressure, outlet pressure value Q Aisle section, section S, S1~S6 measuring device T Flexible tube, tube T1 inlet pipe, pipe T2 outlet pipe, tube T3, T4, T5 tube U1~U4 exit VH Voltage VL Voltage Y axis of rotation Z, Z1~Z3 clamps

Claims

1. An artificial diuretic device that can be worn by a patient (H) and comprises a reusable machine (2) and a disposable unit (3), wherein the disposable unit (3) is completely filled with a processing fluid (Lt) before use.

2. The artificial diuretic device according to claim 1, wherein the disposable unit (3) comprises an operating box (4), the artificial diuretic device then comprises a plurality of measuring devices (S, S1, S2, S3, S4, S5), and the machine (2) and the box (4) are configured to be coupled to each other in a predetermined configuration.

3. The aforementioned operating box (4) is A first inlet (I1) for the organic liquid (Lh1) to be processed, which was extracted from the patient (H), A first outlet (U1) for sending the organic liquid (Lh1) to be processed to a filtration unit (5), An inlet channel (C1) connects the first inlet (I1) to the first outlet (U1), A second inlet (I2) for the treated organic liquid (Lh2) coming from the filtration unit (5), A second outlet (U2) for delivering the treated organic liquid (Lh2) to the patient (H), An exit channel (C2) connects the second inlet (I2) to the second outlet (U2) and An artificial diuretic device according to claim 1 or 2, comprising:

4. The device according to claim 3, wherein the box (4) has a first interaction region (A1) along the inlet channel (C1), and the device (1) comprises a first measuring device (S1), the first measuring device (S1) detects the pressure of the organic liquid (Lh1) to be processed in the first interaction region (A1) when in use.

5. The device according to claim 3 or 4, wherein the box (4) has a second interaction region (A2), the device (1) comprises a second measuring device (S2), and the second measuring device (S2) detects the pressure of the treated organic liquid (Lh2) in the second interaction region (A2) when in use.

6. The box (4) has a second interaction region (A2), the device (1) is equipped with a second measuring device (S2), the second measuring device (S2) detects the pressure of the processed organic liquid (Lh2) in the second interaction region (A2) when in use. The device according to claim 4, wherein the machine (2) comprises a body (21) having an inner cavity (22), and one or more measuring devices (S1, S2) are housed inside the inner cavity (22) and, when in use, interact with each part of the disposable unit (3) in the first and second interaction regions (A1, A2), respectively.

7. The device according to any one of claims 3 to 6, comprising a fifth measuring device (S5) configured to detect the presence of bubbles inside the treated organic liquid (Lh2), wherein the fifth measuring device (S5) is located in the region of the second outlet (U2).

8. The device according to any one of claims 3 to 7, wherein the box (4) is a single, indivisible body, and the channels (C1, C2, C3) are acquired inside the body of the box (4).

9. The aforementioned box (4) is, A third inlet (I3) for the ultrafiltrate (LU), A third outlet (U3) for sending the ultrafiltrate (LU) to a collection bag, An ultrafiltration channel (C3) is connected to the third inlet (I3) and the third outlet (U3). An artificial diuretic device according to any one of claims 2 to 8, comprising:

10. The artificial diuretic device according to claim 9, wherein the box (4) has a fourth inlet (I4) for injecting liquid into the ultrafiltration channel (C3).

11. The device according to claim 9 or 10, wherein the box (4) has a third interaction region (A3) along the ultrafiltration channel (C3) for interacting with the machine (2), and the device (1) comprises a third measuring device (S3) for detecting the flow of the ultrafiltrate (LU) in the third interaction region (A3).

12. The device according to any one of claims 9 to 11, wherein the box (4) has a fourth interaction region (A4) along the ultrafiltration channel (C3), and the device (1) comprises a fourth measuring device (S4) for detecting traces of blood in the ultrafiltrate (LU).

13. The box (4) has a fourth interaction region (A4) along the ultrafiltration channel (C3), and the device (1) comprises a fourth measuring device (S4) for detecting traces of blood in the ultrafiltration solution (LU), The device according to claim 11, wherein the third interaction region (A3) and the fourth interaction region (A4) coincide.

14. The box (4) has a fourth interaction region (A4) along the ultrafiltration channel (C3), and the device (1) comprises a fourth measuring device (S4) for detecting traces of blood in the ultrafiltration solution (LU), The device according to claim 11, wherein the third measuring device (S3) and the fourth measuring device (S4) are incorporated into a disposable unit (3) that can be used only once.

15. The box (4) has a fourth interaction region (A4) along the ultrafiltration channel (C3), and the device (1) comprises a fourth measuring device (S4) for detecting traces of blood in the ultrafiltration solution (LU), The device according to claim 11, wherein the machine (2) comprises a reflective element (37) which interacts with the fourth measuring device (S4) to define the lateral range of each portion of the fourth interaction region (A4) and the range of the passage section (Q) to the ultrafiltrate (LU) to enhance the contrast of any possible traces of blood in the ultrafiltrate (LU).

16. The device according to any one of claims 4 to 15, comprising a control unit (7), one or more measuring devices (S1, S2, S3, S4, S5) exchanging signals with the control unit (7), and the control unit (7) being configured to stop the operation of the device (1) and / or emit an audible and / or optical alarm signal when a value not conforming to a predetermined parameter is detected.

17. The device according to claim 16, wherein the machine (2) comprises a peristaltic pump (12), and the control unit (7) adjusts the operation of the pump (12) in response to the signal detected by one or more measuring devices (S1, S2, S3, S4, S5).

18. The device according to claim 16 or 17, comprising an interface (25), particularly a display, for exchanging setting data and / or operating parameters and / or alarm signals with an external device, wherein the interface (25) can be integrated with the machine (2) and / or with an external device such as a computer, tablet, smartphone, or the like.

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