Apparatus for extracorporeal blood treatment and method of administering nutrients in an apparatus for extracorporeal blood treatment

Abstract

An apparatus for extracorporeal blood treatment for chronic therapy, comprising a nutrition bag (33) containing a nutrition liquid, a weighing device (36) configured to determine a weight (W) of the nutrition bag (33), and a nutrition line (34) for infusing the nutrition liquid into a blood return line (7) or into a patient's blood vessel system. An ultrafiltration device (30) is configured to remove fluid from the patient through a semipermeable membrane (5) of a filtration unit (2), sensors (31, 32) are configured for determining an ultrafiltration rate (UFR). A control unit (100) connected with the ultrafiltration device (30), the weighing device (33) and the sensors (31, 32) is programmed to receive a patient prescription and to control the ultrafiltration device (30) to achieve the patient prescription based on the weight (W) and the ultrafiltration rate (UFR).

Description

TECHNICAL FIELD

[0001] The present invention relates to an apparatus for extracorporeal blood treatment and a method of administering a nutrient in an apparatus for extracorporeal blood treatment.

[0002] Extracorporeal blood treatment involves taking blood from a patient, treating the blood outside the patient's body, and returning the treated blood to the patient. Extracorporeal blood treatment is often used to extract undesirable substances or molecules from a patient's blood and to add desirable substances or molecules to the blood. Extracorporeal blood treatment is used for patients who are unable to effectively clear substances from their blood, such as patients with temporary or permanent kidney failure. These and other patients can undergo extracorporeal blood treatment to add or remove substances from the blood, to maintain acid-base balance or to remove excess body fluids, or to perform, for example, extracorporeal gas exchange processes.

[0003] In particular, the present invention relates to a chronic (long-term) hemodialysis (HD) treatment system for the treatment of patients with chronic kidney failure. HD treatment is typically performed several times a week (e.g. 3 times a week) with an average duration of treatment of several hours (e.g. 3.5 hours to 4.5 hours) per treatment. During treatment, the patient has two accesses (arterial / venous) with blood flowing into / from the body, wherein the average blood flow is typically between 250 ml / min and 400 ml / min. BACKGROUND

[0004] The apparatus for chronic (long-term) hemodialysis (HD) treatment comprises a device for the online preparation of dialysis and / or replacement fluid. The device comprises one, two or more concentrate containers which are located on a respective injection line which is pre-provisioned to supply a preparation line which is connected to a water source and which is located upstream of a dialysis line with substances such as electrolytes, buffers and others or other substances. The concentrate containers can comprise liquid or solid concentrates (e.g. powders).

[0005] In patients receiving chronic hemodialysis, the National Kidney Foundation currently recommends a daily protein intake of 1.2 g / kg or more for patients receiving hemodialysis. When malnutrition occurs, a stepwise approach for treatment is used, starting with dietary counseling and dietary adjustment, followed by oral nutritional supplements, followed by enteral nutritional supplements (typically consisting of a mixture of amino acids, glucose and lipids) or parenteral nutritional supplements if necessary.

[0006] In hemodialysis, it is known to administer an intradialytic parenteral nutrition (IDPN) infusion into the patient, for example by intravenous, a few minutes after the start of dialysis and to continue it for the remainder of the dialysis process.

[0007] This is achieved by means of a dedicated device, such as a bag, dedicated lines and a manually operated pump. This requires additional nursing effort.

[0008] Furthermore, dialysis treatment parameters are manually calibrated based on the operator's experience, measurement results, or understanding of the additional fluid / weight being infused in this manner. Manual calibration of dialysis treatment parameters cannot accurately calculate the patient's mass balance.

[0009] This is also a cumbersome and invasive solution, which patients / users are usually not willing to accept.

[0010] The purpose of this invention is to provide a device for extracorporeal blood processing that can mitigate, minimize, or remedy the aforementioned disadvantages.

[0011] The purpose of this description is to provide an extracorporeal blood processing device and a method for administering nutrients in the device for extracorporeal blood processing, which takes into account the administered nutrients to properly manage the patient's quality balance during processing.

[0012] The purpose of this invention is to better control the administration of nutritional supplements during treatment.

[0013] Another objective of this description is to control the administration of nutrients using the same equipment used for extracorporeal blood processing.

[0014] Another purpose of this description is to reduce the workload of nurses.

[0015] Another objective of this description is to reduce the complexity of equipment used for extracorporeal blood processing while administering nutrients.

[0016] Another objective is to improve the comfort of patients receiving treatment.

[0017] Document US5776345 is also known. This document discloses a machine for acute treatment, having a blood circuit into which multiple infusion lines can infuse fluids. A dialysate container, a collection fluid container, a replacement fluid container, and an anticoagulant container are connected to a weighing scale to weigh the contents. The replacement fluid adds substances to the blood to adjust its pH, replenish nutrients, or add fluids.

[0018] Document US2012143116 discloses a renal failure treatment system comprising: a blood pump, a dialysate pump, a filtrate pump, one or more external infusion pumps, and a control unit configured to synchronize the operation of the infusion pumps with the blood pump and the filtrate pump. The external pumps are fluidly connected to the return blood line. Each external pump controller draws fluid from a supply unit capable of containing any suitable or required fluid, such as heparin, citrate, electrolyte solutions, intravenous infusions, antibiotics, vasoactive drugs, total parenteral nutrition solutions, or enteral nutrition solutions. The equation used to determine the calculated actual rate of the filtrate pump is based on filtrate pump rate = total input rate - total external output rate + specified net loss rate.

[0019] Document EP2644215 discloses an intensive care unit for extracorporeal blood processing, comprising a filtration unit, a blood circuit, pre-dilution and / or post-dilution fluid lines connected to the blood circuit, and a dialysis circuit. A pump acts on the fluid lines to regulate fluid flow. A control unit is configured to periodically calculate a new value for the patient fluid removal rate to be applied to the ultrafiltration actuator in order to maintain a predetermined patient fluid removal rate over a reference time interval, regardless of machine downtime. The device includes an infusion line connected to a blood collection line and an infusion container upstream of the blood pump, the infusion container containing medication, or a local anticoagulant, or a nutritional solution, etc. This infusion line is referred to as the pre-blood pump infusion line. Summary of the Invention

[0020] The device according to one or more of the appended claims achieves at least one of the above objectives, either alone or in any combination.

[0021] The following describes apparatus and methods according to various aspects of the invention, which are capable of achieving one or more of the above-described objectives.

[0022] In a first independent aspect, an apparatus for extracorporeal blood processing for chronic treatment is provided, comprising:

[0023] - Filter unit (2) has a main chamber (3) and a secondary chamber (4) separated by a semi-permeable membrane (5);

[0024] - Blood circuit, coupled to the filter unit (2) and including: blood collection line (6) connected to the inlet (3a) of the main chamber (3); and return line (7) connected to the outlet (3b) of the main chamber (3), the blood collection line (6) and the return line (7) being configured to connect to the patient’s cardiovascular system;

[0025] - Blood pump (10), configured to be coupled to the pump portion of the blood circuit;

[0026] - The dialysis circuit includes: a dialysis supply line (11) for fresh dialysis fluid, connected to the inlet (4a) of the sub-chamber (4); and a dialysis filter line (12) for waste dialysis fluid, connected to the outlet (4b) of the sub-chamber (4).

[0027] - A preparation apparatus (13) for preparing fresh dialysate, wherein the preparation apparatus (13) is connected to the dialysis supply line (11) and includes a regulating device (14) for regulating the composition of the fresh dialysate;

[0028] -At least one nutrient bag containing nutrient solution (33);

[0029] -Nutrition tubing (34) has a first end and a second end, the first end being in fluid communication with the nutrition bag (33), and the second end being used to infuse the nutrient solution into the return tubing (7) or directly into the patient's vascular system;

[0030] - At least one sensing element (36) is configured to provide a first signal related to the actual flow rate in the nutrient line;

[0031] - An ultrafiltration device (30) is configured to remove fluid from the patient through a semipermeable membrane (5);

[0032] - At least one sensor (31, 32) is configured to provide a second signal related to the ultrafiltration rate (UFR);

[0033] - A control unit (100), connected at least to the ultrafiltration device (30), the sensing element (36), and at least one sensor (31, 32), and programmed to:

[0034] ○ Receive prescriptions from patients who include at least one of the following:

[0035] ■ Total patient weight loss (WL) to be achieved at the end of blood treatment target ) and total processing time (T);

[0036] ■Desired net ultrafiltration rate (nUFR) target );

[0037] ○ Collect a first signal from the sensing element (36) and determine a first parameter (W) related to the actual flow rate in the nutrient line (34);

[0038] ○ Collect a second signal from at least one sensor (31, 32) and determine a second parameter (FR) related to the ultrafiltration rate (UFR);

[0039] ○ The ultrafiltration device (30) is controlled based on the first parameter (W) and the second parameter (FR) to realize the patient prescription.

[0040] In a second independent aspect, a method for administering a nutrient product in an extracorporeal blood processing device is provided, wherein the method includes:

[0041] - During extracorporeal blood processing for chronic (long-term) treatment of patients, nutrient solution is delivered from at least one nutrient bag to the return blood line of the device used for extracorporeal blood processing or directly to the patient's vascular system.

[0042] - Collect a first signal from a sensing element, particularly a weighing device, and determine a first parameter (W) related to the actual flow rate in the nutrient pipeline, particularly the weight of at least one nutrient bag, based on the first signal;

[0043] - Collect a second signal from at least one sensor and determine a second parameter (FR) related to the ultrafiltration rate (UFR) (i.e., the difference between waste dialysate leaving the secondary chamber of the filtration unit of the device for extracorporeal blood processing and prepared fresh dialysate being directed to the main chamber of the filtration unit and / or infused into the blood circuit of the device) based on the second signal;

[0044] - The ultrafiltration device is controlled based on a first parameter (W) and a second parameter (FR) to fulfill a patient prescription; wherein the patient prescription includes at least one of the following:

[0045] Total patient weight loss (WL) to be achieved at the end of blood treatment target ) and total processing time (T);

[0046] Desired net ultrafiltration rate (nUFR) target ).

[0047] In another aspect of the foregoing, at least one sensing element (36) is a weighing device, particularly a weighing scale, configured to provide the weight of at least one nutrient bag (33), wherein the control unit (100) is configured to receive a weight signal from the weighing device and determine a first parameter (W) based on the weight change of the nutrient bag over time, the first parameter optionally being the actual flow rate in the nutrient pipeline.

[0048] Desired net ultrafiltration rate (nUFR) target The value can be instantaneous during blood processing or determined according to the function nUFR during blood processing. target (t) varies over time.

[0049] Sensing elements, particularly scales, are used to collect the weight of nutrient bags over time.

[0050] In another aspect of any of the foregoing, the patient's prescription includes at least one of the following:

[0051] i. Total patient weight loss (WL) to be achieved at the end of blood treatmenttarget ) and total processing time (T);

[0052] ii. Ultrafiltration rate (UFR) and total treatment time (T);

[0053] iii. Total patient weight loss (WL) to be achieved at the end of blood treatment target and ultrafiltration rate (UFR);

[0054] iv. Expected net ultrafiltration rate (nUFR) target The nutrient flow rate (or the total weight of nutrients to be infused during treatment) together with the total treatment time (T) or together with the total patient weight loss (WL) target ).

[0055] It is important to note that, since the treatment is chronic, one of the prescribing goals is to achieve total patient weight loss (WL) at the end of the treatment, i.e., at the end of the total treatment time (T). target To set up the machine, the operator inputs enough data to calculate, determine, or obtain these values. On one hand, typical prescriptions include total patient weight loss (WL). target The total treatment time (T) and total processing time (T) can be provided by the physician or included in the patient's prescription card. However, as an alternative, the total treatment time (T) can be provided together with the ultrafiltration rate (UFR). These two values ​​allow for the calculation of total patient weight loss (WL). target In fact, these three values ​​are linked together through the following relationship:

[0056]

[0057] In other words, obtaining two of the three quantities allows us to determine the third quantity (e.g., UFR and WL). target (Total processing time can be determined).

[0058] Whenever a further infusion (nutritional infusion) is added and not detected by the sensors (31, 32), the net ultrafiltration rate must increase by the same amount as the nutritional infusion rate to achieve total patient weight loss (WL) at the end of treatment. target Sensors (31, 32) are configured to provide a second signal related to the ultrafiltration rate (UFR). Therefore, in order to achieve total patient weight loss (WL)... target The prescription may include the desired net ultrafiltration rate (nUFR). target The nutritional flow rate or the total weight of nutrients to be infused during treatment. These two values, along with the total treatment time (T) or total patient weight loss (WL), are used to determine the nutritional intake. target The equipment can then control the dialysis process again to achieve the desired and specified total weight loss within the desired and specified total treatment time.

[0059] In the third aspect according to aspect one or two, the nutrient solution feeding rate (Q) nutr Nutrients are delivered via nutrient lines; optionally, an infusion pump is coupled to the nutrient lines to deliver the nutrient solution at a feed rate (Q) through the nutrient lines. nutr ).

[0060] Infusion pumps, especially peristaltic pumps.

[0061] In the fourth aspect according to any one of aspects one through three, the control unit is connected to the infusion pump and is programmed to control the infusion pump and optionally change the nutrient solution feed rate (Q). nutr ).

[0062] In the fifth aspect according to any one of aspects one through four, the nutrient solution is delivered by issuing a command to an infusion pump coupled to the nutrient pipeline.

[0063] In the second of the fifth aspect of any one of aspects one through five, the extracorporeal blood processing device includes a body, an infusion pump attached to the body, and in particular placed on the front panel of the body.

[0064] In the third of the fifth aspect of any one of aspects one through five, the nutrient pipeline includes: a pump section; a feed section connected to the inlet of the pump section; and a delivery section connected to the outlet of the pump section.

[0065] In particular, the cross-sectional area of ​​the channel for the nutrient solution in the pump section is larger than the cross-sectional area of ​​the delivery pipe section and / or the feed pipe section. More specifically, the cross-sectional area of ​​the delivery pipe section is equal to the cross-sectional area of ​​the feed pipe section. Optionally, the nutrient pipeline is a disposable pipeline.

[0066] In the fourth of the fifth aspects according to any of the foregoing aspects, the feed section and / or delivery section includes a respective detachable connector, in particular a Luer connector.

[0067] More specifically, the detachable connector of the delivery line can be connected to a corresponding reverse connector on the return line, such as on the degassing chamber.

[0068] In the fifth aspect of any one of the two aforementioned aspects, the nutrient pipeline further includes at least one rigid portion comprising: two pump connectors for receiving opposite ends of a pump section; a delivery section connector for receiving one end of a delivery section; and a feed section connector for receiving one end of a feed section.

[0069] In the fifth aspect of any of the foregoing aspects, the extracorporeal blood processing device includes a body, the body including a coupling device, the rigid body being configured to couple with the device coupling device to position the nutrient tubing on the body in a specific arrangement relative to the infusion pump, in particular the coupling device being placed on the front panel of the body.

[0070] In the sixth aspect according to any one of aspects three, four, or five, the method includes or the control unit being programmed to: command the infusion pump to operate during blood processing according to a feed rate target (Q). nutr target ) to deliver nutrient solution; optional delivery rate target (Q) nutr target ) can be an instantaneous value during blood processing, or it can be a value calculated based on the function (Q) during blood processing. nutr target (t) varies with time.

[0071] In the seventh aspect according to any one of aspects one through six, the first parameter (W) is the instantaneous weight of the nutrient bag (W(t)) or the actual feed rate in the nutrient pipeline.

[0072] In the second of the seventh aspect according to any one of aspects one through seven, the method includes or the control unit is programmed to:

[0073] The feed rate (Q) is determined based on the first parameter (W). nutr To control the infusion pump,

[0074] Comparison of feed rate targets (Q) during blood processing nutr target ) and feed rate (Q nutr ), and reduce the feed rate target (Q) nutr target ) and feed rate (Q nutr The difference between them.

[0075] In the eighth aspect according to any one of aspects one through seven, the second parameter (FR) is the ultrafiltration rate (UFR).

[0076] In the ninth aspect according to aspects seven and eight, the net ultrafiltration rate (nUFR) is the nutrient solution feed rate (Q) calculated based on the weight (W(t)) of the nutrient bag (33). nutr In particular, the weight change over time, and the difference between the ultrafiltration rate (UFR) and the feed rate (Q) nutr It is calculated using ).

[0077] In the second of the ninth aspect of aspects seven and eight, the net ultrafiltration rate (nUFR) is calculated by subtracting the feed rate (Q) from the ultrafiltration rate (UFR). nutr) to calculate.

[0078] As described above, in extracorporeal blood processing devices for chronic treatment (for feeding filtration units and / or infusing into extracorporeal blood circuits) that typically utilize freshly prepared dialysate online, sensors (31, 32) for providing a second signal related to the ultrafiltration rate (UFR) allow the control unit to calculate the ultrafiltration rate (UFR). In state-of-the-art chronic machines, the UFR takes into account all dialysate and replacement fluid flow rates because the sensors sense all fluids fed and removed from the blood. In the current embodiment according to this aspect and claims, the situation is different. In practice, the sensors (31, 32) providing a second signal related to the ultrafiltration rate (UFR) are not intended to consider, nor provide, a second signal taking into account the amount of nutrient solution infused.

[0079] In the third of the ninth aspect according to any of the preceding aspects, the sensors (31, 32) for providing a second signal related to the ultrafiltration rate (UFR) take into account the net volume / flow rate of the fresh dialysate prepared by the preparation device (13), without taking into account the fresh dialysate that is fed to the filtration unit, removed from the filtration device and infused into the blood circulation.

[0080] In the fourth of the ninth aspect according to any of the preceding aspects, the sensors (31, 32) used to provide a second signal related to the ultrafiltration rate (UFR) do not take into account the amount / flow rate of the nutrient solution.

[0081] In the fifth of the ninth aspects according to any of the foregoing aspects, the sensors (31, 32) for providing a second signal related to the ultrafiltration rate (UFR) detect one or more of the following:

[0082] ● The difference between the amount or flow rate of fresh dialysate prepared by the preparation device (13) and entering the filtration unit (2) and the amount or flow rate of waste dialysate leaving the filtration unit (2);

[0083] ● The difference between the volume or flow rate of fresh dialysate prepared by the preparation device (13) and infused into the blood circuit and the volume or flow rate of waste dialysate leaving the filtration unit (2); and

[0084] ● The difference between the amount or flow rate of fresh dialysate prepared by the preparation device (13) and infused into the filter unit (2) and the blood circuit and the amount or flow rate of waste dialysate leaving the filter unit (2).

[0085] In the tenth aspect according to any of the preceding nine aspects, the method includes or the control unit is programmed to: control the ultrafiltration device such that the net ultrafiltration rate (nUFR) is equal to the desired net ultrafiltration rate (nUFR). target )match.

[0086] In the eleventh aspect according to the aforementioned aspects seven and eight, the instantaneous patient weight loss (WL(t)) is calculated by integrating the instantaneous ultrafiltration rate (UFR) and subtracting the weight (W(t)) of the instantaneous nutrient bag (33) from the integrated rate (UFR).

[0087] In the twelfth aspect according to any of the foregoing aspects, the method includes or the control unit is programmed to:

[0088] The ultrafiltration device (30) is controlled such that the patient weight loss (WL) at the end of blood treatment is equal to the total patient weight loss (WL) to be achieved at the end of blood treatment (set, required, or anticipated). target )match.

[0089] In the thirteenth aspect according to any one of aspects one to twelve above, the method includes or the control unit is programmed to:

[0090] Receive the following as prescription input:

[0091] Desired blood flow rate (Q) b target );

[0092] Target nutrient delivery rate (Q) nutr target ) or the nutrient solution (W) to be applied at the end of treatment time (T). nutr target The total amount of );

[0093] Total patient weight loss (WL) target and total treatment time (T) or desired net ultrafiltration rate (nUFR) target );

[0094] The command blood pump operates according to the desired blood flow rate (Q). b target ) Pump blood or reach the total amount of nutrient solution (W) applied at the end of the total treatment time (T). nutr target );

[0095] Command the infusion pump according to the nutrient delivery rate target (Q) nutr target ) Delivery of nutrient solution;

[0096] Command the ultrafiltration device to achieve total patient weight loss (WL) target ) or desired net ultrafiltration rate (nUFR) target ).

[0097] In the second thirteenth aspect according to any of the foregoing aspects, the method includes or the control unit is programmed to receive the total amount (W) of nutrient solution to be applied at the end of the total treatment time (T). nutr target ) as prescription input to determine the nutrient delivery rate target (Q) nutr target Nutrient solution (W) shall be delivered no later than the end of the total treatment time (T). nutr target The total amount of nutrient feed is then determined, and the infusion pump is then commanded to operate according to the nutrient feed rate target (Q). nutr target ) Delivery of nutrient solution.

[0098] In the fourteenth aspect according to any one of aspects one through thirteen, the control unit is programmed to calculate and / or store data related to the nutrient solution applied during extracorporeal blood treatment.

[0099] In the fifteenth aspect according to the aforementioned aspect fourteen, the data may optionally include at least one of the following: the weight of at least one nutrient bag (33), the feed rate of nutrient solution through the nutrient pipeline (34) (Q nutr ), the amount of nutrient solution applied instantly, the total amount of nutrient solution to be applied, and the composition of the nutrient solution.

[0100] In the sixteenth aspect according to any one of aspects fourteen or fifteen, the method includes or the control unit is programmed to: display data related to the nutrient solution on a display screen.

[0101] In the seventeenth aspect according to any one of aspects one through sixteen, the device includes a display screen connected to the control unit.

[0102] In the eighteenth aspect according to any one of aspects one through seventeen, at least one weighing device is a weighing scale.

[0103] In the nineteenth aspect according to any one of aspects one through eighteen, at least one nutrient bag is configured to be suspended on at least one weighing device and / or the weighing device is configured to suspend the nutrient bag.

[0104] In the second of the nineteenth aspect according to any one of aspects one to five, the extracorporeal blood processing device includes a body, and at least one weighing device is attached to the body, particularly placed on the outer periphery of the body.

[0105] In the twentieth aspect according to any one of aspects one through nineteen, the collection of weight includes: measuring instantaneous weight; optionally, the acquisition frequency is between 0.01 Hz and 100 Hz.

[0106] In the second of the twenty-first aspects according to any of the foregoing aspects, the device includes an infusion line (11') branching from the dialysis supply line (11) to infuse fresh dialysate into the blood circuit, and sensors (31, 32) configured to provide a second signal related to the ultrafiltration rate (UFR), the sensors (31, 32) operating at least upstream of the branch of the infusion line (11') to take into account the fresh dialysate fed to the filtration unit (2) via the dialysis supply line (11) and / or the fresh dialysate fed to the blood circuit via the infusion line (11').

[0107] In the second of the twenty-first aspects according to any of the foregoing aspects, the infusion line (11') is a branch infusion line that receives fresh dialysate prepared by the preparation device (13).

[0108] In the twenty-first aspect according to any one of aspects one to twenty, at least one sensor includes at least one flow meter placed on at least one of the dialysis supply line and the dialysis filtration line; wherein the second signal is a signal from at least one flow meter.

[0109] In the second of the twenty-first aspect according to any one of aspects one to twenty-one, at least one sensor includes at least one differential flow meter placed on the dialysis supply line and the dialysis filtration line to detect the flow difference between the dialysis supply line and the dialysis filtration line; wherein the second parameter is a signal from at least one differential flow meter.

[0110] In the third of the twenty-first aspects according to any of the foregoing aspects, the device includes an infusion line (11') branching from the dialysis supply line (11) to infuse fresh dialysate into the blood circuit, and sensors (31, 32) configured to provide a second signal related to the ultrafiltration rate (UFR), the sensors (31, 32) operating at least upstream of the branch of the infusion line (11') to take into account the fresh dialysate fed to the filtration unit (2) via the dialysis supply line (11) and / or the fresh dialysate fed to the blood circuit via the infusion line (11').

[0111] In the fourth of the twenty-first aspect according to any one of aspects one to twenty-one, at least one sensor includes a flow meter placed on a dialysis supply line and another flow meter placed on a dialysis filtration line, and in particular, the control unit is configured to receive signals from the two flow meters to determine the flow difference between the dialysis fluid supplied to the supply line and the dialysis fluid removed using the dialysis filtration line.

[0112] In the fifth of the twenty-first aspects according to any of the foregoing aspects, the apparatus includes an infusion line (11') branching from the dialysis supply line (11) to infuse fresh dialysate into the blood circuit, wherein a flow meter on the dialysis supply line operates at least upstream of the infusion line (11') branch to account for fresh dialysate fed to the filter unit (2) via the dialysis supply line (11) and / or fresh dialysate fed to the blood circuit via the infusion line (11').

[0113] According to aspect twenty-two of any one of aspects one through twenty, the apparatus for extracorporeal blood processing further includes:

[0114] - A balancing chamber, operatively coupled to the dialysis circuit, for precisely balancing fresh dialysate prepared by the preparation apparatus with waste dialysate leaving the filtration unit; and

[0115] - An ultrafiltration line and pump for removing waste dialysate upstream of the equilibration chamber in the dialysis filtration line; at least one sensor detects the amount of waste dialysate removed by the ultrafiltration pump, wherein a second parameter is, for example, the flow rate in the ultrafiltration line or the volume of liquid removed through the ultrafiltration line.

[0116] In the twenty-third aspect according to any one of aspects one to twenty-two, the ultrafiltration apparatus includes at least one dialysis pump coupled to a dialysis supply line and / or a dialysis discharge line; optionally, at least one dialysis pump includes a first dialysis pump coupled to the dialysis supply line and a second dialysis pump coupled to the dialysis discharge line.

[0117] In the twenty-fourth aspect according to aspect twenty-two above, at least one dialysis pump is a volumetric pump.

[0118] In the twenty-fifth aspect according to the foregoing aspect twenty-four, at least one dialysis pump is through which dialysis / filtration fluid passes.

[0119] In the second of the twenty-fifth aspects according to any of the foregoing aspects, the first balancing chamber operates on the dialysis supply line and the second balancing chamber operates on the dialysis filtration line.

[0120] In aspect twenty-six, which is based on any one of aspects one through twenty-five, the infusion pump and / or blood pump is a peristaltic pump.

[0121] In aspect twenty-seven according to aspect twenty-six above, the infusion pump and / or blood pump is coupled to a segment of the respective nutrition tubing or blood circuit.

[0122] In aspect twenty-eight, according to any one of aspects one through twenty-seven above, the blood circuit and filtration unit are disposable and detachably coupled to the main body of the device and the blood pump.

[0123] In aspect twenty-nine, which is based on any one of aspects one through twenty-eight, the feeding tubing is disposable and detachably coupled to the body of the device and the blood pump.

[0124] In the thirtieth aspect according to any one of aspects one to twenty-nine above, the dialysis circuit is non-disposable; optionally, the dialysis circuit is configured to be sterilized after each or a predetermined number of blood treatments.

[0125] In the thirty-first aspect according to any one of aspects one through thirty, the device includes a body; wherein the infusion pump and the blood pump are supported by the body; optionally, the rotor of the infusion pump and the rotor of the blood pump are placed on the surface of the body.

[0126] In aspect thirty-one, the pump portion of the blood circuit is detachably coupled to the rotor of the blood pump; the pump portion of the nutrition line is detachably coupled to the rotor of the infusion pump.

[0127] In aspect thirty-one or thirty-two, aspect thirty-three, the dialysis circuit is integrated into the body; optionally, the dialysis circuit is mounted on the body; optionally, at least one dialysis pump is mounted on the body.

[0128] In the thirty-fourth aspect according to any one of the foregoing aspects thirty-one to thirty-three, the control unit is included in or supported by the body.

[0129] In the second of the thirty-fourth aspects according to any of the foregoing aspects, the equipment includes a body; wherein the body includes an inlet for feeding purified water into the preparation pipeline.

[0130] In the thirty-fifth aspect according to any one of the foregoing aspects one to thirty-four, the device includes a nutrient solution contained in at least one nutrient bag, wherein the nutrient solution is a parenteral nutrition solution.

[0131] In the thirty-sixth aspect according to any one of aspects one to thirty-five above, the nutrient solution comprises a mixture containing proteins, carbohydrates and fats; optionally, it comprises amino acids, glucose or glucose and lipids.

[0132] In the thirty-seventh aspect according to the aforementioned aspect thirty-six, the nutrient solution consists of an amino acid solution with a concentration of 10% to 20%, a glucose or dextrose solution with a concentration of 40% to 70%, and a lipid solution with a concentration of 15% to 30%.

[0133] In aspect thirty-eight, according to any one of aspects one through thirty-seven above, the nutrient solution delivery rate (Q) during blood processing nutr The flow rate is between 50 ml / h and 500 ml / h, optionally between 100 ml / h and 200 ml / h, and optionally 150 ml / h.

[0134] In the thirty-ninth aspect of the preceding aspect according to any one of aspects one to thirty-eight, the total amount of nutrient solution applied at the end of blood treatment is between 100 ml and 1000 ml, optionally between 300 ml and 500 ml.

[0135] In aspect 40, which is based on any one of aspects 1 to 39 above, the nutrient solution provides 150 kcal / h to 200 kcal / h.

[0136] In aspect forty-one, according to any one of aspects one to forty above, a plurality of nutrient bags are provided, each nutrient bag containing the components of a nutrient solution; optionally, the first bag contains an amino acid solution, the second bag contains a glucose or dextrose solution, and the third bag contains a lipid solution.

[0137] In aspect 42 of aspect 41 above, all of the multiple nutrition bags are connected to a public nutrition pipeline, a return vascular pipeline, or directly to the patient's vascular system.

[0138] In aspect 42, according to any one of aspects 1 to 41 above, the total processing time for extracorporeal blood treatment is between 0.5 hours and 10 hours, optionally between 3 hours and 5 hours.

[0139] In aspect 43 according to any one of aspects 1 to 42 above, the preparation apparatus includes a preparation pipeline and at least one concentrate container (optionally multiple containers); wherein the container is located on a corresponding injection pipeline and is pre-prepared to supply material to the preparation pipeline; wherein the preparation pipeline is connected to a liquid source, optionally to a water source, and optionally to a reverse osmosis water plant.

[0140] In the forty-fourth aspect of the forty-third aspect mentioned above, the regulating device includes at least one injection pump placed in the injection line.

[0141] In the forty-fifth aspect according to aspect forty-three or forty-four above, the regulating device includes at least one sensor placed on the injection line and / or preparation line.

[0142] In the forty-sixth aspect of the forty-fifth aspect, at least one sensor is configured to detect the flow rate, concentration, or conductivity of the substance and / or fresh dialysate through the injection line and / or preparation line.

[0143] In aspect 47, which is based on any one of aspects 1 to 46 above, at least one infusion line is connected to a blood circuit and an infusion source.

[0144] In aspect 48, according to any one of aspect 47 above, at least one infusion line is connected to the dialysis supply line and the infusion fluid is fresh dialysis fluid.

[0145] In aspect 49, according to any one of aspects 47 or 48 above, at least one infusion line is connected to a return line.

[0146] Further features of the invention will become more apparent from the following detailed description of some embodiments of the invention, which are illustrated by way of non-limiting examples in the accompanying drawings. Attached Figure Description

[0147] The description will now refer to the accompanying drawings, which are provided by way of non-limiting example, in which:

[0148] Figure 1a A front view of the extracorporeal blood processing device according to the present invention is shown;

[0149] Figure 1b A disposable nutrient tubing is shown;

[0150] Figure 2 schematically shown Figure 1a Extracorporeal blood processing equipment;

[0151] Figure 3 It shows Figure 2 The enlarged portion of the extracorporeal blood processing equipment;

[0152] Figure 4 It shows that according to Figure 2 and Figure 3 A variant of the equipment;

[0153] Figure 5 This is a flowchart of a method for applying nutritional supplements according to the present invention. Detailed Implementation

[0154] Devices for extracorporeal blood processing used in chronic (long-term) treatment, such as... Figures 1a to 1b and Figure 2 As shown, the device 1 includes a filtration unit 2, which has a main chamber 3 and a secondary chamber 4 separated by a semi-permeable membrane 5. Depending on the processing requirements, the semi-permeable membrane 5 of the filtration unit 2 can be selected to have different characteristics and performance.

[0155] The blood circuit is coupled to the main chamber 3 of the filtration unit 2. The blood circuit includes a blood collection line 6 and a return line 7. The blood collection line 6 is connected to the inlet 3a of the main chamber 3, and the return line 7 is connected to the outlet 3b of the main chamber 3. The blood collection line 6 and the return line 7 are configured to connect to the cardiovascular system of the patient "P".

[0156] In use, the blood collection line 6 and the return line 7 are connected to a needle or catheter or other access device (which is then placed in fluid communication with the patient's "P" vascular system), allowing blood to be drawn through the blood collection line 6, flow through the main chamber 3, and then return to the patient's vascular system through the return line 7. An air separator, such as a degassing chamber 8, may be present in the return line 7. Furthermore, a monitoring valve 9 may be present on the return line 7 downstream of the degassing chamber 8.

[0157] The blood flowing through the blood circuit is controlled by a blood pump 10 (e.g., a peristaltic blood pump, acting on the blood collection line 6 or the return line 7). Figure 2 The embodiment shows a blood pump 10 coupled to the pump section of the blood collection line 6. A control unit 100 is connected and controls the blood pump 10 to regulate the blood flow rate.

[0158] The dialysis circuit is connected to the sub-chamber 4 of the filtration unit 2 and includes a dialysis supply line 11 connected to the inlet 4a of the sub-chamber 4 and a dialysis filtration line 12 connected to the outlet 4b of the sub-chamber 4 and a drain pipe (not shown).

[0159] The dialysis supply line 11 is connected to a preparation apparatus 13 for preparing fresh dialysis fluid. The preparation apparatus 13 includes an adjustment device 14 for adjusting the composition of the fresh dialysis fluid. The dialysis filtration line discharges waste dialysis fluid into a drain pipe.

[0160] exist Figure 2 In the example, preparation apparatus 13 includes three concentrate containers 15, 16, and 17 located on pre-set corresponding injection lines 18, 19, and 20 to supply substances such as electrolytes, buffers, or other substances to the preparation line 21 of fresh dialysate. Concentrate containers 15, 16, and 17 may include liquid or solid (e.g., powder) concentrates.

[0161] The regulating device 14 includes injection pumps 22, 23, and 24 positioned on injection lines 18, 19, and 20 to move fluid along the respective injection lines 18, 19, and 20 toward the preparation line 21, which collects liquid (e.g., water) from a source 25. The preparation line 21 is located upstream of the dialysis supply line 11, with one end connected to the source 25 (e.g., a deionized / purified water source or a reverse osmosis water system) and the other end connected to the dialysis supply line 11. The source 25 may include a water source or an ultrapure liquid source as shown in the figure.

[0162] Concentration or conductivity sensors 26, 27, and 28 are located on the preparation line 21 and provide the control unit 100 with signals relating to the conductivity or concentration of a predetermined substance (e.g., sodium) in the fluid passing through the preparation line. This allows the control unit 100 to control the injection pumps 22, 23, and 24 to adjust the conductivity Cd or concentration (e.g., sodium [Na]) of the liquid passing through the dialysis supply line 11. If the liquid does not meet the required parameters, a liquid inspection mechanism 29 can be used to selectively allow or prevent the liquid from entering the filtration unit 2 through the dialysis line 21.

[0163] The infusion line 11' is separated from the dialysis supply line 11 and connected to the return line 7 to infuse a portion of the fresh dialysate into the blood circuit.

[0164] An auxiliary infusion pump 45 can be coupled to infusion line 11' to deliver the portion of fresh dialysate into the blood circuit.

[0165] Of course, the infusion line 11' may alternatively or additionally be connected to the blood collection line 6 (especially downstream of the blood pump 10) for pre-infusion of alternative fluids.

[0166] The ultrafiltration device is configured to remove fluid from the patient's body through a semi-permeable membrane 5 of the filtration unit 2. The ultrafiltration device includes a dialysis pump 30 located in the dialysis filtrate line 12. In a variant embodiment, a first dialysis pump is coupled to the dialysis supply line 11 and a second dialysis pump is coupled to the dialysis filtrate line 12. A first flow meter 31 operates in the dialysis supply line 11 and is positioned between the fluid monitoring mechanism 29 and the inlet 4a of the sub-chamber 4. A second flow meter 32 operates in the dialysis filtrate line 12 and is positioned between the outlet 4b of the sub-chamber 4 and the dialysis pump 30.

[0167] The infusion line 11' is connected to the dialysis supply line 11 between the first flow meter 31 and the inlet 4a of the sub-chamber 4. The first flow meter 31 and the second flow meter 32 are connected to the control unit 100 and are configured to determine the ultrafiltration rate (UFR).

[0168] The ultrafiltration rate (UFR) is the difference between the waste dialysate leaving outlet 4b of sub-chamber 4 and the prepared fresh dialysate, which is directed to inlet 4a of sub-chamber 4 and infused into the blood circuit via infusion line 11'. Figure 3 ).

[0169] like Figure 3 As shown, Q b1 The blood flow rate Q entering the main chamber 3 through entrance 3a. b2 Q is the blood flow rate leaving main chamber 3 through exit 3b. in The flow rate Q entering the secondary chamber 4 through inlet 4a is... inf It is the flow rate through the infusion line 11', where:

[0170] Q dial =Q in +Q inf

[0171] The first flow meter 31 and the second flow meter 32 provide the control unit 100 with their respective instantaneous flow values, enabling the control unit 100 to calculate the instantaneous ultrafiltration rate (UFR). Optionally, a differential sensor can be provided, operating on the dialysis supply line 11 and the dialysis outlet line 12, thus providing a signal directly related to the ultrafiltration rate (UFR). A balancing chamber can be operatively coupled to the dialysis circuit in place of the flow meters. The balancing chamber operates on the principle that the amount of fluid entering the first chamber on the dialysis supply line 11 is equal to the amount of fluid leaving the dialysis outlet line 12.

[0172] To achieve ultrafiltration, an ultrafiltration line (not shown) is added to the filtration line upstream of the equilibrium chamber. An ultrafiltration pump removes the desired amount of ultrafiltrate before the waste dialysate reaches the second equilibrium chamber, thus achieving the ultrafiltration volume. In this alternative embodiment, the second parameter is related to the volume of liquid removed through the ultrafiltration line, particularly to the ultrafiltration rate through the ultrafiltration line. Alternatively, the absolute volume change through the ultrafiltration line can also be measured.

[0173] The device 1 also includes a nutrient bag 33 containing nutrient solution and a nutrient tubing 34 having a first end in fluid communication with the nutrient bag 33 and a second end connected to a return line 7 for infusing the nutrient solution into the patient's vascular system via the return line 7. In an alternative embodiment, the nutrient solution can be directly infused into the patient's vascular system. An infusion pump 35 is coupled to the nutrient tubing 34 to deliver the nutrient solution through the nutrient tubing 34. A sensing element in the form of a weighing device 36 is configured to weigh the nutrient bag 33 during nutrient infusion and provide a first signal that allows the calculation of a first parameter W related to the weight of the nutrient bag 33 (and thus to the weight or volume of the nutrient solution contained in the nutrient bag). Typically, the weighing device 36 provides the change in bag weight over time, which is directly related to the actual flow rate of the nutrient solution through the nutrient tubing. In practice, since the control unit knows the cross-section of the nutrient tubing, the actual flow rate of the nutrient solution through the nutrient tubing can be easily and very accurately calculated from the measurement of the weight of the corresponding bag / the change in weight over time. Optionally, the first parameter is the weight of the nutrient bag 33 measured over time. Alternatively, a flow meter on the nutrient line can be used as a sensing element.

[0174] Finally, although not very precise, pump speed can be used to determine the flow rate through the nutrient line, which is monitored by a suitable sensor, such as a Hall sensor or a sensor sensitive to pump electrical parameters (such as resistance or power consumption).

[0175] likeFigure 1a As shown, device 1 includes: a main body 37 with a base located on the ground, supporting all components of device 1, namely: a filtration unit 2, a blood circuit, a blood pump 10, a dialysis circuit, a preparation device 13, a weighing device 36, a nutrition tubing 34, an infusion pump 35, and a control unit 100. The weighing device 36 is a weighing scale and is configured to suspend the nutrition bag 33.

[0176] The control unit 100 is housed in the main body 37. The infusion pump 35 and the blood pump 10 are peristaltic pumps supported by the main body 37. Each peristaltic pump includes an actuator or motor (not shown) connected to a rotor. The rotors of the infusion pump 35 and the blood pump 10 are positioned on the front of the main body 37.

[0177] The blood circuit and filtration unit 2 are disposable (i.e., they are disposed of after each blood processing) and are detachably coupled to the main body 37. The pump portion of the blood collection tubing 6 is detachably coupled to the rotor of the blood pump 10. The feeding tubing 34 is disposable and detachably coupled to the main body 37. The pump portion of the feeding tubing 34 is detachably coupled to the infusion pump 35.

[0178] Figure 1b An example of a disposable nutrient line 34 is shown. The nutrient line 34 includes: a pump section 39; a feed section 40 connected to the inlet of the pump section 39; and a delivery section 41 connected to the outlet of the pump section 39. Specifically, the pump section 39 may have a channel cross-section for the nutrient solution that is larger than the channel cross-section of the delivery section 41 and / or the feed section 40. Typically, the channel cross-section of the delivery section is equal to that of the feed section. At a first end for connecting to the nutrient bag (or the pipe connected to the nutrient bag), the feed section 40 includes a corresponding detachable connector 42, particularly a Luer connector. The other end engages with a rigid connector 44b associated with a rigid portion 44 of the nutrient line 34 supporting the pump section 39. Accordingly, the delivery section 41 includes a corresponding detachable connector 43, particularly a Luer connector, which can be connected to a corresponding reverse connector on the return line 7, for example at the degassing chamber 8. As described above, the nutrient pipeline also includes a rigid section 44 (which is more rigid than the flexible feed section 40 and delivery section 41), which includes: two pump connectors 44a for receiving opposite ends of the pump sections; a delivery section connector 44c for receiving one end of the delivery section 41; and a feed section connector 44b for receiving one end of the feed section 40.

[0179] The extracorporeal blood processing device body 37 includes a coupling device; a rigid body 44 is configured to couple with the device coupling device to position the nutrient tubing on the body in a specific arrangement relative to the infusion pump, such that the pump section can be precisely accommodated around the infusion pump rotor. Specifically, the coupling device is located on the front panel of the body 37.

[0180] The dialysis circuit is non-disposable and configured to be sterilized after each blood treatment. The tubing, pump, and sensors of the dialysis circuit are not configured for replacement after each treatment, but are only for maintenance purposes or replacement in case of failure. Therefore, the dialysis circuit is integrated into or fixedly mounted within the body 37. The dialysis pump 30 is a positive displacement pump through which the filtered fluid passes, and the dialysis pump is mounted within the body 37.

[0181] The control unit 100 is included in or supported by the main body 37. The control unit 100 is connected to the blood pump 10, the weighing device 36, the infusion pump 35, the injection pumps 22, 23, and 24 of the regulating device 14, the concentration or conductivity sensors 26, 27, and 28, the first flow meter 31, the second flow meter 32, the fluid monitoring mechanism 29, and the dialysis pump 30 of the ultrafiltration device. The control unit 100 controls the weighing device to measure instantaneous weight at, for example, 1 Hz. The control unit 100 is also connected to a display screen 38 mounted on the main body 37. Figure 1a )connect.

[0182] Control unit 100 may include a digital processor (CPU) with memory, analog circuitry, or a combination of one or more digital processing units and one or more analog processing circuits. As stated in this specification and claims, control unit 100 is "configured" or "programmed" to perform steps: this can be achieved in practice by any means capable of configuring or programming control unit 100. For example, in the case where control unit 100 includes one or more CPUs, one or more programs are stored in appropriate memory: said one or more programs contain instructions that, when executed by control unit 100, cause control unit 100 to perform steps described and / or required by control unit 100. Optionally, if control unit 100 is analog, the circuitry of control unit 100 is designed to include circuitry configured to process electrical signals in use, such as performing the steps of control unit 100 disclosed herein.

[0183] The control unit 100 is configured or programmed to receive signals from sensors and other inputs, and, based on said signals, command pumps and valves to perform blood processing and administer nutrients to the patient during blood processing. The control unit 100 is also configured or programmed to display data on display screen 38.

[0184] The nutrient solution contained in nutrient bag 33 comprises a mixture of amino acids, glucose or dextrose, and lipids. For example, the solution consists of 300 ml of 15% amino acids, 150 ml of 50% glucose, and 150 ml of 20% lipids. The amount of nutrient solution contained in nutrient bag 33 can be the total amount administered to the patient at the end of blood treatment, corresponding to 800 kcal or 200 kcal / h per treatment.

[0185] In alternative embodiments, such as Figure 4 As shown, multiple nutrient bags 33', 33"', and 33"' are provided, each containing one component of the nutrient solution. The first bag 33' contains an amino acid solution, the second bag 33"' contains a glucose or dextrose solution, and the third bag 33"' contains a lipid solution. The three nutrient bags 33', 33"', and 33"' are respectively hung on corresponding weighing scales 36', 36"', and 36"' and connected to a common nutrient line 34 of the infusion pump 35. In an alternative embodiment (not shown), each of the three nutrient bags 33', 33"', and 33"' can be coupled to a corresponding infusion pump.

[0186] Also according to the method of the present invention, the control unit 100 is programmed to receive a patient prescription for blood processing, namely, the target values ​​for blood processing and the target values ​​for nutrients to be administered to the patient. These target values ​​can be entered manually, for example, via a display touchscreen 38 or a keyboard placed on the main body 37 of the device 1. The prescription can also be read from a patient card or other type of storage media device, or received by the machine via a data transmission channel (wired or wireless).

[0187] Example ( Figure 5 )

[0188] Control unit 100 is programmed to receive the following target value as input:

[0189] Q b target The desired blood flow rate through the pump section of the blood collection tubing.

[0190] T Total processing time

[0191] WL target Target weight loss at the end of blood treatment

[0192] Q nutr target Target nutrient delivery rate

[0193] Q dial Flow rate of fresh dialysate

[0194] Control unit 100 is programmed to:

[0195] W(t) is the instantaneous weight of the nutrient bag received from the weighing device (first parameter).

[0196] The UFR receives the ultrafiltration rate (second parameter) from the first flow meter 31 and the second flow meter 32.

[0197] Control unit 100 is programmed for calculation:

[0198] Q nutr The nutrient delivery rate is calculated as dW(t) / dt based on W(t).

[0199] nUFR is the net ultrafiltration rate corresponding to the patient's weight loss rate (WLR) as nUFR = UFR - Q. nutr

[0200] nUFR target The desired net ultrafiltration rate during blood processing is such that patient weight loss at the end of blood processing matches total patient weight loss.

[0201] WL target =nUFR target *T

[0202] UFR target The target ultrafiltration rate during blood processing ensures that the patient's weight loss at the end of blood processing matches the total patient weight loss: WLR*T = nUFR*T = WL(T) = WL target

[0203] WL target =nUFR target *T=UFR target *TQ nutr target *T

[0204] UFR target =((WL target ) / T)+Q nutr target

[0205] Control unit 100 is programmed to control:

[0206] Blood pump 10 enables Q b =Q b target

[0207] Infusion pump 35, so that Q nutr =Q nutr target

[0208] The ultrafiltration unit (dialysis pump 30) makes UFR = UFR targetOr nUFR = nUFR target

[0209] Specifically, the control unit 100 is programmed to control the ultrafiltration device (dialysis pump 30) so that the flow rate Q of the waste dialysate is... eff equals Q eff target ,in

[0210] Q eff target =UFR target +Q dial =((WL target ) / T)+Q nutr target +Q dial

[0211] Numerical Examples

[0212] T 4 hours

[0213] WL target 3.5kg = 3500ml (blood density is very close to water density)

[0214] Q nutr target 150ml / hour = 2.5ml / min

[0215] Q dial 500ml / min

[0216] Q eff target =((WL target ) / T)+Q nutr target +Q dial =517ml / min

[0217] According to other embodiments, the target value directly input into the control unit 100 can be the desired net ultrafiltration rate nUFR. target (corresponding to the target weight loss rate WLR) target (not the target weight loss rate WLR) target .

[0218] According to other embodiments, the control unit 100 is programmed to receive the total amount W of nutrient solution administered to patient P at the end of treatment time T. nutr target Instead of the desired nutrient delivery rate target Q nutr target This serves as input. The control unit 100 is programmed to calculate the desired nutrient delivery rate target Q. nutr target As Wnutr target / T or calculate the target nutrient delivery rate Q as it varies over time during treatment. nutr target (t), and make Q nutr target The integral of (t) over time T equals W nutr target .

[0219] According to other embodiments, the control unit is programmed to integrate the ultrafiltration rate (UFR) (a second parameter) received from the first flow meter 31 and the second flow meter 32, and calculate the patient weight loss (WL(t)) at time t by subtracting the weight W(t) of the nutrient bag (a first parameter) from the integrated ultrafiltration rate UFR. The calculated patient weight loss (WL(t)) at time t is then compared with the target total weight loss WL at the end of blood treatment. target For comparison, when the patient's weight loss equals WL target Processing will stop when the time is right.

[0220] According to some embodiments, the nutrient delivery rate Q nutr Ultrafiltration rate (UFR(t)), net ultrafiltration rate (nUFR(t)), and other relevant values ​​change over time during blood processing.

[0221] According to some embodiments, the nutrient solution feed rate Q nutr Ultrafiltration rate (UFR(t)), net ultrafiltration rate (nUFR(t)), and other relevant values ​​can be controlled to vary over time during blood processing. For example, the net ultrafiltration rate (nUFR(t)) (or weight loss rate (WLR)) is greater at the beginning of blood processing (when patient P releases more fluid) than at the end. For example, the target nutrient delivery rate Q... nutr The volume is larger at the end of blood processing than at the beginning, and at the end of blood processing, the nutrient solution is more likely to be discharged without passing through the blood.

[0222] The control unit 100 can be programmed to change the nutrient solution feed rate Q by controlling the infusion pump 35. nutr And / or by controlling the dialysis pump 30 to change the ultrafiltration flow rate UFR(t).

[0223] The control unit 100 can also be programmed to store data related to the nutrient solution administered during blood treatment and to display said data along with other values ​​related to blood treatment on a display screen. For example, the data may include at least one of the following: the weight of at least one nutrient bag, the feed rate Q. nutr The amount of nutrient solution applied instantly, the total amount of nutrient solution to be applied, and the composition of the nutrient solution.

[0224] While the invention has been described in conjunction with embodiments that are presently considered to be the most practical and preferred, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover various modifications and equivalent arrangements within the scope of the appended claims.

Claims

1. An extracorporeal blood processing device for chronic treatment, comprising: Main body (37); The filter unit (2) has a main chamber (3) and a secondary chamber (4) separated by a semi-permeable membrane (5); A blood circuit, coupled to the filter unit (2) and including a blood collection line (6) and a return line (7), the blood collection line (6) being connected to the inlet (3a) of the main chamber (3) and the return line (7) being connected to the outlet (3b) of the main chamber (3), the blood collection line (6) and the return line (7) being configured to connect to the patient’s cardiovascular system; A blood pump (10), which is supported by the body (37) and configured to be coupled to the pump portion of the blood circuit; The dialysis circuit includes a dialysis supply line (11) for fresh dialysis fluid and a dialysis filtration line (12) for waste dialysis fluid, the dialysis supply line (11) being connected to the inlet (4a) of the sub-chamber (4) and the dialysis filtration line (12) being connected to the outlet (4b) of the sub-chamber (4). A preparation device (13) for preparing the fresh dialysate, wherein the preparation device (13) includes a preparation line connected to a liquid source and at least one concentrate container, wherein the container is located on a pre-set corresponding infusion line to supply substances to the preparation line, wherein the preparation device (13) is connected to the dialysate supply line (11) and includes an adjustment device (14) for adjusting the composition of the fresh dialysate. Nutrient solution, which contains a mixture of protein, carbohydrates and fat; At least one nutrient bag (33) containing the nutrient solution. The nutrition tubing (34) has a first end and a second end, the first end being in fluid communication with the nutrition bag (33), and the second end being used to infuse the nutrient solution into the return blood line (7) or directly into the patient's vascular system; Infusion pump (35), coupled to the nutrient line (34) to deliver the nutrient solution via the nutrient line (34) at a feed rate (Q). nutr ), wherein the infusion pump is attached to the main body (37); At least one sensing element (36) is a weighing device configured to provide the weight of the at least one nutrient bag (33) and configured to provide a first signal related to the actual flow rate in the nutrient pipeline; An ultrafiltration device (30) is configured to remove fluid from the patient through the semipermeable membrane (5); At least one sensor (31, 32) comprising at least one flow meter placed on at least one of the dialysis supply line (11) and the dialysis filtration line (12), the at least one sensor (31, 32) being configured to provide a second signal related to the ultrafiltration rate (UFR) and to detect one of the following: The difference between the amount or flow rate of fresh dialysate prepared by the preparation device (13) and entering the filtration unit (2) and the amount or flow rate of waste dialysate leaving the filtration unit (2); The difference between the amount or flow rate of fresh dialysate prepared by the preparation device (13) and infused into the blood circuit and the amount or flow rate of waste dialysate leaving the filtration unit (2); and The difference between the amount or flow rate of fresh dialysate prepared by the preparation device (13) and entering the filtration unit (2) and the blood circuit, and the amount or flow rate of waste dialysate leaving the filtration unit (2), The blood circuit, the nutrition tubing (34) and the filter unit (2) are disposable and are detachably coupled to the main body (37). The blood circuit and the nutrition tubing (34) are coupled to the blood pump (10) and the infusion pump (35) respectively. The dialysis circuit is non-disposable and integrated into the main body (37); A control unit (100), which is contained in or supported by the body (37), and is connected at least to the ultrafiltration device (30), the infusion pump (35), the sensing element (36), and the at least one sensor (31, 32), and is programmed to: Receive patient prescriptions that include two of the following parameters: Total patient weight loss (WL) to be achieved at the end of blood treatment target ); Total processing time (T); and The ultrafiltration rate (UFR); The weight signal is received from the weighing device, and a first parameter (W) related to the actual flow rate in the nutrient pipeline is determined. A second signal is collected from the at least one sensor (31, 32), and the second parameter (FR) is determined to be the ultrafiltration rate (UFR). Control the infusion pump (35); The ultrafiltration device (30) is controlled based on the first parameter (W) and the second parameter (FR) to achieve the patient prescription, such that the patient weight loss (WL) at the end of the blood treatment is equal to the total patient weight loss (WL) to be achieved at the end of the blood treatment. target (matches) 2. The device according to claim 1, wherein, The control unit (100) is programmed to calculate and / or store data related to the nutrient solution applied during the extracorporeal blood treatment.

3. The device according to claim 1 or 2, wherein, The nutrient solution delivery rate (Q) during blood processing nutr The flow rate is between 50 ml / h and 500 ml / h.

4. The device according to claim 1 or 2, wherein, The first parameter (W) is the instantaneous weight (W(t)) of the nutrient bag (33); wherein the second parameter (FR) is the ultrafiltration rate (UFR).

5. The device according to claim 3, wherein, The first parameter (W) is the instantaneous weight (W(t)) of the nutrient bag (33); wherein the second parameter (FR) is the ultrafiltration rate (UFR).

6. The device according to claim 4, wherein, Net ultrafiltration rate (nUFR) is calculated by measuring the nutrient solution feed rate (Q) based on the weight (W(t)) of the nutrient bag (33). nutr ) and by subtracting the feed rate (Q) from the ultrafiltration rate (UFR). nutr The calculation is performed using the ultrafiltration device (30), which is controlled such that the net ultrafiltration rate (nUFR) is equal to the desired net ultrafiltration rate (nUFR). target )match.

7. The device according to claim 4, wherein, The instantaneous patient weight loss (WL(t)) is calculated by integrating the instantaneous ultrafiltration rate (UFR) and subtracting the instantaneous weight of the nutrient bag (33) (W(t)) from the integrated rate (UFR); wherein the ultrafiltration device (30) is controlled such that the patient weight loss (WL) at the end of the blood treatment is equal to the total patient weight loss (WL). target )match.

8. The device according to claim 1 or 2, wherein, The at least one sensor (31, 32) includes at least one flow meter, which is placed on at least one of the dialysis supply line (11) and the dialysis filter line (12); wherein the second signal is a signal from the at least one flow meter.

9. The device according to claim 1 or 2, wherein, The nutrient pipeline includes: a pump section (39), a feed section (40) connected to the inlet of the pump section (39), a delivery section (41) connected to the outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) including two pump connectors (44a) for receiving opposite ends of the pump section (39), a delivery section connector (44c) for receiving one end of the delivery section (41), and a feed section connector (44b) for receiving one end of the feed section (40). The feed section and / or delivery section includes a corresponding detachable connector (42, 43), and the detachable connector (43) of the delivery section (41) can be connected to a corresponding reverse connector on the degassing chamber (8) on the return line (7).

10. The device according to claim 3, wherein, The nutrient pipeline includes: a pump section (39), a feed section (40) connected to the inlet of the pump section (39), a delivery section (41) connected to the outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) including two pump connectors (44a) for receiving opposite ends of the pump section (39), a delivery section connector (44c) for receiving one end of the delivery section (41), and a feed section connector (44b) for receiving one end of the feed section (40). The feed section and / or delivery section includes a corresponding detachable connector (42, 43), and the detachable connector (43) of the delivery section (41) can be connected to a corresponding reverse connector on the degassing chamber (8) on the return line (7).

11. The device according to claim 4, wherein, The nutrient pipeline includes: a pump section (39), a feed section (40) connected to the inlet of the pump section (39), a delivery section (41) connected to the outlet of the pump section (39), and at least one rigid portion (44), the at least one rigid portion (44) including two pump connectors (44a) for receiving opposite ends of the pump section (39), a delivery section connector (44c) for receiving one end of the delivery section (41), and a feed section connector (44b) for receiving one end of the feed section (40). The feed section and / or delivery section includes a corresponding detachable connector (42, 43), and the detachable connector (43) of the delivery section (41) can be connected to a corresponding reverse connector on the degassing chamber (8) on the return line (7).

12. The device according to claim 2, comprising a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed to display data related to the nutrient solution on the display screen (38).

13. The device according to claim 5, wherein, Net ultrafiltration rate (nUFR) is calculated by measuring the nutrient solution feed rate (Q) based on the weight (W(t)) of the nutrient bag (33). nutr ) and by subtracting the feed rate (Q) from the ultrafiltration rate (UFR). nutr The calculation is performed using the ultrafiltration device (30), which is controlled such that the net ultrafiltration rate (nUFR) is equal to the desired net ultrafiltration rate (nUFR). target )match; The device includes a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed to display data related to the nutrient solution on the display screen (38).

14. The device according to claim 5, wherein, The instantaneous patient weight loss (WL(t)) is calculated by integrating the instantaneous ultrafiltration rate (UFR) and subtracting the instantaneous weight of the nutrient bag (33) (W(t)) from the integrated rate (UFR); wherein the ultrafiltration device (30) is controlled such that the patient weight loss (WL) at the end of the blood treatment is equal to the total patient weight loss (WL). target )match; The device includes a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed to display data related to the nutrient solution on the display screen (38).

15. The device of claim 10, comprising a display screen (38) connected to the control unit (100), wherein the control unit (100) is programmed to display data related to the nutrient solution on the display screen (38).

16. The device according to claim 1 or 2, wherein, The infusion pump (35) and the blood pump (10) are peristaltic pumps.

17. The device according to claim 1 or 2, wherein, The ultrafiltration device (30) includes at least one dialysis pump coupled to a dialysis supply line (11) and / or a dialysis filtration line (12); wherein the at least one dialysis pump is mounted on the body (37).

18. The device according to claim 1 or 2, wherein, The sensors (31, 32) used to provide a second signal related to the ultrafiltration rate (UFR) take into account the net volume / flow rate of the fresh dialysate prepared by the preparation device (13), without taking into account the fresh dialysate fed to the filtration unit, removed from the filtration unit and infused into the blood circuit.

19. The device according to claim 1 or 2, wherein, The device includes an infusion line (11') branching from the dialysis supply line (11) to infuse fresh dialysate into the blood circuit, and sensors (31, 32) configured to provide a second signal related to the ultrafiltration rate (UFR), the sensors (31, 32) operating at least upstream of the branch of the infusion line (11') to take into account the fresh dialysate fed through the dialysis supply line (11) to the filtration unit (2) and / or through the infusion line (11') to one or both of the blood circuit.

20. The device according to claim 1 or 2, wherein, The at least one sensor includes: A flow meter placed on the dialysis supply line and another flow meter placed on the dialysis filtration line; the control unit is configured to receive signals from both flow meters to determine the flow difference between the dialysate supplied to the supply line and the dialysate removed using the dialysis filtration line; or A differential flow meter is placed on the dialysis supply line and the dialysis filter line to detect the flow difference between the dialysis supply line and the dialysis filter line.

21. The device according to claim 1 or 2, further comprising: A balancing chamber, which is operatively coupled to the dialysis circuit, to precisely balance the fresh dialysate prepared by the preparation device with the waste dialysate leaving the filtration unit; as well as An ultrafiltration line and a pump for removing waste dialysate upstream of the equilibrium chamber in the dialysis filtration line; the at least one sensor detects the amount of waste dialysate removed by the ultrafiltration pump, wherein the second parameter is the flow rate in the ultrafiltration line or the volume of liquid removed through the ultrafiltration line.

22. The device according to claim 21, wherein, The ultrafiltration device includes at least one dialysis pump coupled to the dialysis supply line and / or the dialysis filtration line.

23. The device according to claim 21, wherein, The first balancing chamber operates on the dialysis supply line and the second balancing chamber operates on the dialysis filtration line.

24. The device according to claim 1 or 2, wherein, The control unit is programmed to receive the following as prescription input: Desired blood flow rate (Q) b target ); Target nutrient delivery rate (Q) nutr target ) or the total amount (W) of the nutrient solution applied at the end of the treatment time (T). nutr target ); Total patient weight loss (WL) target and total treatment time (T) or desired net ultrafiltration rate (nUFR) target ); The command instructs the blood pump to operate according to the desired blood flow rate (Q). b target ) Pump blood or reach the total amount (W) of the applied nutrient solution at the end of the total treatment time (T). nutr target ); The command infusion pump is set according to the nutrient delivery rate target (Q). nutr target ) deliver the nutrient solution; The command instructs the ultrafiltration device to achieve the total patient weight loss (WL). target ) or the desired net ultrafiltration rate (nUFR) target ).

25. The device according to claim 1 or 2, wherein, The control unit is programmed to receive the total amount (W) of nutrient solution to be applied at the end of the total treatment time (T). nutr target ) as prescription input to determine the nutrient delivery rate target (Q nutr target The total amount (W) of the nutrient solution delivered no later than the end of the total processing time (T) nutr target ), to command the infusion pump according to the nutrient delivery rate target (Q) nutr target ) to deliver the nutrient solution.

26. The device according to claim 1, wherein, The at least one sensing element (36) is a weighing scale.

27. The device according to claim 1, wherein, The first parameter is the actual flow rate in the nutrient pipeline.

28. The device according to claim 2, wherein, The data includes at least one of the following: the weight of the at least one nutrient bag (33), the feed rate (Q) of the nutrient solution through the nutrient pipeline (34). nutr The amount of nutrient solution applied instantaneously, the total amount of nutrient solution to be applied, and the composition of the nutrient solution.

29. The device according to claim 3, wherein, The nutrient solution delivery rate (Q) during blood processing nutr The flow rate is between 100 ml / h and 200 ml / h.

30. The device according to claim 3, wherein, The nutrient solution delivery rate (Q) during blood processing nutr The flow rate is 150 ml / h.

31. The device according to claim 9, wherein, The feed section and / or the delivery section include corresponding Luer connectors.

32. The device according to claim 17, wherein, The at least one dialysis pump is a volumetric pump.

33. The device according to claim 1, wherein, The patient prescription is the total patient weight loss (WL) to be achieved at the end of blood treatment. target The patient prescription is the ultrafiltration rate (UFR) and total processing time (T), or the patient prescription is the ultrafiltration rate (UFR) and total processing time (T).

34. The device according to claim 22, wherein, The at least one dialysis pump includes a first dialysis pump coupled to the dialysis supply line and a second dialysis pump coupled to the dialysis filter line.

35. The device according to claim 1, wherein, The infusion pump is placed on the front panel of the main body.

Images