System and method for performing dialysis

Abstract

The group of inventions relates to medicine, and more particularly to devices for introducing drugs into the human body and withdrawing various media from the human body, and even more particularly to dialysis systems, as well as to catheters with various channel arrangements or shapes for fluid media, and can be used in infusion therapy, renal replacement therapy and gravity-assisted blood treatment to optimize the withdrawal and return of infusion solutions, blood, blood components and preparations. The technical result of the claimed group of inventions is that of providing broader functional capabilities, consisting in efficiently realizing the possibility of joining several accesses both into a single outflow and into a single inflow, with inclusion into an extracorporeal circuit, while also permitting variation of the linear and volumetric flow rate of the transported fluid and a reduction in the resistance of said fluid, with the distribution of the pressure of the fluid and automatic regulation of the pressure in the tubing circuit by virtue of a second point of access via a single system, as well as reducing patient emergency situations accompanied by activation alarms in extracorporeal treatment apparatus. To achieve this technical result, an extracorporeal treatment system and method are proposed.

Description

[0001] SYSTEM AND METHOD FOR CARRYING OUT DIALYSIS

[0002] The group of inventions relates to medicine, namely, to devices for introducing medicinal media into the human body and selecting various media from the human body, in particular, to dialysis systems, as well as to catheters with various placement or shape of channels for fluid media and can be used in infusion therapy, renal replacement therapy, and gravitational surgery to optimize the selection and return of infusion solutions, blood, its components and drugs.

[0003] A three-contact connecting system for feeding a reagent for a hemodialysis apparatus is known from the existing level of technology (Patent CA 2971041 A1, 23.04.2009, A61M1 / 16, A61M39 / 10, A61M60 / 113, A61M60 / 268, A61M60 / 37, A61M60 / 43, A61M60 / 508, A61M60 / 847, A61M60 / 849, A61M60 / 851), comprising: a first container including a bicarbonate material suitable for use in preparing a dialysate for the apparatus, wherein the container has a water supply line for feeding water into the first container and a bicarbonate supply line for feeding water and bicarbonate material from the first container; an acid supply line for feeding an acidic material suitable for use in preparing a dialysate; a connector comprising three parallel teeth, including first and second outer teeth, located in a common plane, and a bicarbonate supply line for supplying water and bicarbonate material from a first container;an acid feed line for feeding an acidic material suitable for use in preparing a dialysate, a central pin located above a common plane; a first pin smoothly connected to the bicarbonate feed line; a second pin smoothly connected to the acid feed line; a central pin smoothly connected to the water feed line, wherein the three parallel pins of the connector are arranged so as to ensure that the pins are connected to the corresponding receiving openings of the connection point of the hemodialysis device in only one orientation of the connector to prevent incorrect connection of the pins to the connection point.

[0004] Also known from the prior art is an apparatus for extracorporeal blood processing (Patent US 2022133975 A1, 05.05.2022, A61M1 / 36, A61M60 / 113, A61M60 / 279, A61M60 / 37) having a set of extracorporeal blood processing lines, an apparatus for extracorporeal blood processing comprising: an arterial blood line having a first distal access for the patient, a first proximal port of the device and a pump for supplying blood located between the first distal access for the patient and the first proximal port of the device, a pump for supplying blood from the patient to the device, a venous blood line having a second distal access for the patient and a second proximal port of the device, at least one fluid supply line that is connected to the arterial blood line in the passage part of the arterial blood line, wherein at leastone fluid supply line is located in front of the blood supply pump and includes a fluid container at one end and a fluid supply line valve assembly between at least one passage part and the fluid container, wherein the fluid supply line valve assembly is configured to regulate or control the flow of the supplied fluid, which is carried out exclusively using the suction pressure in at least one fluid supply line created by the blood flow in the arterial blood line.

[0005] The closest technical solutions selected as prototypes are the apparatus and method for treating renal failure (Patent US 2017216511 A1, 03.08.2017, A61M1 / 10, A61M1 / 16, A61M1 / 26, A61M1 / 28, A61M1 / 34, A61M1 / 36, B01D61 / 58).

[0006] A renal failure therapy apparatus comprising: a blood purification filter; a dialysis fluid circuit including a balancing chamber, the balancing chamber includes a compartment for fresh dialysis fluid configured to supply fresh dialysis fluid to the blood purification filter, and a compartment for used dialysis fluid configured to receive used dialysis fluid from the blood purification filter; a pipeline for fresh dialysis fluid fluid connected via fluid to the compartment for fresh dialysis fluid of the balancing chamber and the blood purification filter; and a flow restrictor connected via fluid to the blood purification filter, the flow restrictor is configured to supply fresh dialysis fluid to the blood purification filter.The dialysate fluid supplied from the fresh dialysis fluid compartment through the fresh dialysis fluid pipeline to the blood purification filter is compressed so that the first amount of fresh dialysis fluid performs convective clearance and the second amount of fresh dialysis fluid performs diffusion clearance.

[0007] A method for treating renal failure, comprising: supplying fresh dialysis fluid from a fresh dialysis fluid compartment of a balancing chamber to a blood purification filter; pumping used dialysis fluid from the blood purification filter to a used dialysis fluid compartment of the balancing chamber; restricting the flow to cause a first amount of fresh dialysis fluid to be squeezed through a membrane of the blood purification filter into an extracorporeal circuit, so that the first amount of fresh dialysis fluid performs convective clearance; and using a second amount of fresh dialysis fluid to clean the blood filter to perform diffusion clearance.

[0008] The disadvantages of known devices include the impossibility of simultaneous connection of several infusion sources with simultaneous administration of drugs.

[0009] The disadvantages of the known methods are the simultaneous puncture into two veins through two separate systems, not one.

[0010] The technical result of the claimed group of inventions is the implementation of the possibility of combining several accesses, both into a direct single flow and into a reverse single flow, with inclusion in the dialysis circuit, as well as variability of the linear and volumetric flow rate of the liquid, reducing its resistance with the distribution of its pressure, automatic regulation of pressure in the main circuit due to the second access point through one system, as well as reducing emergency situations for patients due to alarms triggered in dialysis machines.

[0011] To achieve the specified technical result, a system and method for performing dialysis are proposed.

[0012] A dialysis system, designed in the form of a main tubular circuit with main clamps, contains a dialyzer with a venous main tubular side connected to it and an arterial main tubular side.

[0013] Moreover, one catheter port or one needle for vascular access puncture at one point of venous blood return of the patient is connected to the venous tubular trunk side, and two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture at two points of arterial blood collection of the patient are connected to the arterial tubular trunk side; or two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture at two points of venous blood return of the patient are connected to the venous tubular trunk side, and one catheter port or one needle for vascular access puncture at one point of arterial blood collection of the patient is connected to the arterial tubular trunk side;or two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle are connected to the venous tubular trunk side at two venous blood return points of the patient, and two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle are also connected to the arterial tubular trunk side at two arterial blood collection points of the patient;wherein the venous tubular trunk side comprises a venous tubular trunk along which the following are arranged in series from the dialyzer: an upper venous port for administering medicinal substances, a sensor for the air content in the returned blood, a lower venous port for administering medicinal substances and a venous end segment of the venous tubular trunk, and the arterial tubular trunk side comprises an arterial tubular trunk along which the roller pump, the arterial port for administering medicinal substances and the arterial end segment of the arterial tubular trunk are arranged in series from the dialyzer.

[0014] In particular, a catheter port or a needle for vascular access puncture at one point of venous return of the patient's blood can be connected to the venous end segment of the venous tubular line, and a Y-shaped connecting line is connected to the arterial end segment of the arterial tubular line through a port, the connectors of which are connected through two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture at two points of arterial blood collection of the patient.

[0015] In addition, a catheter port or a needle for vascular access puncture at one point of venous blood return of the patient can be connected to the venous end segment of the venous tubular line, one of two catheter ports or one of two needles for vascular access puncture at one of two points of arterial blood sampling of the patient can be connected to the arterial end segment of the arterial tubular line, and a Y-shaped connecting line can be connected to the arterial port for administering medicinal substances through one of the connectors, the other connector of which is connected to the second point of arterial blood sampling of the patient through the second catheter port or the second needle for vascular access puncture, and the port of which is designed with the function of administering medicinal substances.

[0016] Moreover, a catheter port or a needle for puncture of vascular access at one point of venous return of the patient's blood may be connected to the venous end segment of the venous tubular line, one of two catheter ports or one of two needles for puncture of vascular access at one of two points of arterial blood sampling of the patient may be connected to the arterial end segment of the arterial tubular line, and the second of two catheter ports or the second of two needles for puncture of vascular access at the second of two points of arterial blood sampling of the patient may be connected to the arterial port for administration of medicinal substances through the line for filling the overflow.

[0017] In this case, a catheter port or a needle for vascular access puncture can be connected to the arterial end segment of the arterial tubular line at one point of arterial blood collection from the patient, and a Y-shaped connecting line can be connected to the venous end segment of the venous tubular line through a port, the connectors of which are connected through two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture at two points of venous blood return from the patient.

[0018] In addition, a catheter port or a needle for puncture of vascular access at one point of arterial blood collection from the patient may be connected to the arterial end segment of the arterial tubular line, one of two catheter ports or one of two needles for puncture of vascular access at one of two points of venous blood return from the patient may be connected to the venous end segment of the venous tubular line, and the second of two catheter ports or the second of two needles for puncture of vascular access at the second of two points of venous blood return from the patient may be connected to the upper venous port for administration of medicinal substances through the blood transfusion system.

[0019] Moreover, the dialysis system can be designed with the possibility of vascular access through a vein, fistula or vascular prosthesis.

[0020] A method of performing dialysis, carried out using a dialysis system, according to which: connecting a patient to the venous tubular trunk side of the system via one catheter port or one vascular access puncture needle at one point of venous return of the patient's blood and connecting the patient to the arterial tubular trunk side of the dialysis system via two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle at two points of arterial blood collection of the patient;or connecting the patient to the venous tubular trunk side of the dialysis system via two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle at two venous blood return points of the patient, and connecting the patient to the arterial tubular trunk side of the dialysis system via one catheter port or one vascular access puncture needle at one arterial blood collection point of the patient; opening the trunk clamps, performing the circulation process with blood flow rate adjustment, stopping the circulation process with blood flow rate adjustment, closing the trunk clamps, disconnecting the patient from the dialysis system.

[0021] In particular, a method for performing dialysis that can be implemented using a dialysis system, and according to which: connecting a patient to a venous end segment of a venous tubular line via one catheter port or one vascular access puncture needle at one point of venous blood return of the patient, connecting the patient to an arterial end segment of the arterial tubular line via a port of a Y-shaped connecting line, the connectors of which are connected at two points of arterial blood collection of the patient via two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle, opening the trunk clamps and the clamps of the Y-shaped connecting line, performing a circulation process with blood flow rate adjustment, stopping the circulation process with blood flow rate adjustment,close the main line clamps and Y-connection line clamps, disconnect the patient from the dialysis system,

[0022] In this case, the method of performing dialysis, which can be implemented using a dialysis system, and according to which: the patient is connected to the venous end segment of the venous tubular line via one catheter port or one needle for vascular access puncture at one point of venous blood return of the patient, the patient is connected to the arterial end segment of the arterial tubular line via one of two catheter ports or one of two needles for vascular access puncture at one of two points of arterial blood collection of the patient, the patient is connected to the arterial port for administering medicinal substances through one of the connectors of the Y-shaped connecting line, the other of the connectors of which is connected to the second of the points of arterial blood collection of the patient via the second catheter port or the second needle for vascular access puncture,open the main clamps and the clamps of the connectors of the Y-shaped connecting line, carry out the circulation process with the regulation of the blood flow rate, stop the circulation process with the regulation of the blood flow rate, close the main clamps and the clamps of the connectors of the Y-shaped connecting line, and disconnect the patient from the dialysis system.,

[0023] In addition, through the port of the Y-shaped connecting line, it is possible to administer medicinal preparations with the possibility of dosing and / or closing them using a clamp located on the main tube of the port of the Y-shaped connecting line.

[0024] Moreover, the method of performing dialysis, which can be implemented using a dialysis system, and according to which: connecting the patient to the venous end segment of the venous tubular line via one catheter port or one needle for vascular access puncture at one point of venous blood return of the patient, connecting the patient to the arterial end segment of the arterial tubular line via one of two catheter ports or one of two needles for vascular access puncture at one of two points of arterial blood collection of the patient, connecting the patient to the arterial port for administering medicinal substances through the line for filling the overflow via a second catheter port or a second needle for vascular access puncture of the second of two points of arterial blood collection of the patient, opening the line clamps, performing the circulation process with regulation of the blood flow rate,stop the circulation process with regulation of blood flow rate, close the main clamps, disconnect the patient from the dialysis system,

[0025] In this case, the method of performing dialysis, which can be implemented using a dialysis system, and according to which: the patient is connected to the arterial end segment of the arterial tubular line via one catheter port or one needle for vascular access puncture at one point of arterial blood collection of the patient, the patient is connected to the venous end segment of the venous tubular line via a port of a Y-shaped connecting line, the connectors of which are connected at two points of venous blood return by means of two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture, the main clamps and the clamps of the Y-shaped connecting line are opened, the circulation process is carried out with blood flow rate regulation, the circulation process is stopped with blood flow rate regulation,close the main line clamps and Y-connection line clamps, disconnect the patient from the dialysis system,

[0026] In addition, a method for performing dialysis that can be implemented using a dialysis system, and according to which: connecting a patient to an arterial end segment of an arterial tubular line via one catheter port or one needle for vascular access puncture at one point of arterial blood collection of the patient, connecting the patient to a venous end segment of a venous tubular line via one of two catheter ports or one of two needles for vascular access puncture at one of two points of venous blood return of the patient, connecting the patient to an upper venous port for administering medicinal substances through a blood transfusion system via a second catheter port or a second needle for vascular access puncture of the second of two points of venous blood return of the patient, opening the trunk clamps, performing a circulation process with regulation of the blood flow rate,stop the circulation process with regulation of blood flow rate, close the main clamps, disconnect the patient from the dialysis system,

[0027] Moreover, a vein, fistula, or vascular prosthesis can be used as vascular access.

[0028] The essence of the invention is explained by drawings, which show a particular case of the implementation of the claimed group of inventions: Figure 1 shows a general view of a Y-shaped connecting line; Figure 2 is a schematic general view of a system for performing dialysis with a two-point connection of a patient via arterial blood sampling to the arterial end segment of the arterial line through a port of a Y-shaped connecting line, the connectors of which are connected through ports of catheters or needles for vascular access puncture at two points of arterial blood sampling of the patient;in figure 3 - a schematic general view of a system for performing dialysis with a two-point connection of a patient via arterial blood sampling, in the case where one of two catheter ports or one of two needles for vascular access puncture can be connected to the arterial end segment of the arterial line at one of the two points of arterial blood sampling of the patient, and a Y-shaped connecting line is connected to the arterial port for administering medicinal substances through one of the connectors, the other of the connectors of which is connected through the second catheter port or the second needle for vascular access puncture to the second of the points of arterial blood sampling of the patient, and the port of which is designed with the function of administering medicinal substances;in figure 4 - a schematic general view of a system for performing dialysis with a two-point connection of the patient via the arterial collection of his blood, in the case when one of two catheter ports or one of two needles for vascular access puncture at one of two points of arterial blood collection of the patient can be connected to the arterial end segment of the arterial line, and the second of two catheter ports or the second of two needles for vascular access puncture at the second of two points of arterial blood collection of the patient can be connected to the port for administering medicinal substances; in figure 5 - a schematic general view of a system for performing dialysis with a two-point connection of the patient via the venous return of his blood to the venous end segment of the venous line through a port of a Y-shaped connecting line, the connectors of which are connected via catheter ports or needles for vascular access puncture at two points of venous return of the patient's blood;in figure 6 - a schematic general view of a system for performing dialysis with a two-point connection of the patient along the venous return of his blood, in the case when one of two catheter ports or one of two needles for puncture of vascular access at one of two points of venous return of the patient's blood can be connected to the venous end segment of the venous trunk line, and the second of two catheter ports or the second of two needles for puncture of vascular access at the second of two points of venous return of the patient's blood can be connected to the upper venous port for the introduction of drugs through the blood transfusion system; in figure 7 - an example of implementing the system and method for performing dialysis according to the diagram of figure 2 using a catheter with two ports (arterial and venous); in figure 8 - an example of implementing the system and method for performing dialysis according to the diagram of figure 5 using a catheter with two ports (arterial and venous), where:;

[0029] 1 - Y-shaped tubular main tee of Y-shaped connecting main;

[0030] 2 - main pipes of the Y-shaped connecting line;

[0031] 3 - main pipe of the Y-shaped connecting line port;

[0032] 4 - port with a female adapter of the Y-shaped connecting line; 5 - main tubes of the connectors of the Y-shaped connecting line;

[0033] 6 - connectors with pin adapters of Y-shaped connecting line;

[0034] 7 - clamps of Y-shaped connecting line;

[0035] 8 - dialyzer;

[0036] 9 - venous tubular main side;

[0037] 10 - arterial tubular main side;

[0038] 11 - catheter ports or needles for puncture of vascular access (eg, vein, fistula, or vascular prosthesis);

[0039] 12 - tubular lines of the dialysis solution filtration circuit;

[0040] 13 - venous tubular trunk line;

[0041] 14 - upper venous port for administration of medicinal substances of the venous tubular line;

[0042] 15 - air content sensor in the returning blood of the venous tubular line;

[0043] 16 - lower venous port for the introduction of medicinal substances into the venous tubular line;

[0044] 17 - venous end segment of the venous tubular trunk;

[0045] 18 - arterial tubular line;

[0046] 19 - roller pump of arterial tubular line;

[0047] 20 - arterial port for the introduction of medicinal substances of the arterial tubular line;

[0048] 21 - arterial terminal segment of the arterial tubular trunk;

[0049] 22 - overflow filling line;

[0050] 23 - blood transfusion system.

[0051] A particular case of the implementation of a system for conducting dialysis and a method for conducting dialysis can be implemented as follows: The Y-shaped connecting line is made in the form of a Y-shaped tubular main tee 1 with communicating main pipes 2 at the ends.

[0052] Moreover, one of the branch pipes 2 of the tee 1 is connected to the main tube 3, at the other end of which there is a port 4 with a socket adapter (luer-lock female adapter), and the other two branch pipes 2 of the tee 1 are connected to the main tubes 5, at the other ends of which there are connectors 6 with pin adapters (luer-lock male adapter), and on all the main tubes 3, 5 there is at least one clamp 7 (Fig. 1). The dialysis system, made in the form of a main tubular circuit with main clamps (not shown in the figures), contains a dialyzer 8 with a venous tubular main side 9 and an arterial tubular main side 10 connected to it.

[0053] Moreover, one port 11 of a catheter or one needle 11 for puncture of vascular access at one point of venous return of the patient’s blood, or two ports 11 of catheters, or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access at two points of venous return of the patient’s blood are connected to the venous tubular trunk side 9; and one catheter port 11 or one needle 11 is connected to the arterial tubular trunk side 10 for puncture of vascular access at one point of arterial blood collection of the patient, or two catheter ports 11, or two needles 11 for puncture of vascular access, or one catheter port 11 and one needle 11 for puncture of vascular access at two points of arterial blood collection of the patient, wherein if one catheter port 11 or one needle 11 is connected to the venous tubular trunk side 9 for puncture of vascular access at one point of venous blood return of the patient,then two catheter ports 11, or two needles 11 for vascular access puncture, or one catheter port 11 and one needle 11 for vascular access puncture at two points of arterial blood collection from the patient are connected to the arterial tubular trunk side 10, and if one catheter port 11 or one needle 11 is connected to the arterial tubular trunk side 10 for vascular access puncture at one point of arterial blood collection from the patient, then two catheter ports 11, or two needles 11 for vascular access puncture, or one catheter port 11 and one needle 11 for vascular access puncture at two points of venous blood return from the patient are connected to the venous tubular trunk side 9.

[0054] The dialyzer 8 can be made with tubular lines 12 of the filtration circuit of the dialysate solution, the venous tubular line side 9 can contain a venous tubular line 13, along which from the dialyzer 8 the following are arranged in series: an upper venous port 14 for administering medicinal substances, a sensor of the air content 15 in the returned blood, a lower venous port 16 for administering medicinal substances and a venous end segment 17 of the venous tubular line 13, and the arterial tubular line side 10 - an arterial tubular line 18, along which from the dialyzer 8 the following are arranged in series: a roller pump 19, an arterial port 20 for administering medicinal substances and an arterial end segment 21 of the arterial tubular line 18 (Fig. 2-8).

[0055] In this case, a port 11 of a catheter or a needle 11 for puncture of vascular access at one point of venous return of the patient's blood can be connected to the venous end segment 17 of the venous tubular line 13, and a Y-shaped connecting line is connected to the arterial end segment 21 of the arterial tubular line 18 through port 4, the connectors 6 of which are connected through two ports 11 of catheters or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access at two points of arterial blood collection from the patient (Fig. 2 and Fig. 7).

[0056] In addition, a port 11 of a catheter or a needle 11 for puncture of vascular access at one point of venous return of the patient's blood can be connected to the venous end segment 17 of the venous tubular line 13, one of the two ports 11 of the catheters or one of the two needles 11 for puncture of vascular access at one of the two points of arterial blood sampling of the patient can be connected to the arterial end segment 21 of the arterial tubular line 18, and a Y-shaped connecting line can be connected to the arterial port 20 for introducing medicinal substances through one of the connectors 6, the other of the connectors 6 of which is connected through the second port 11 of the catheters or the second needle 11 for puncture of vascular access to the second of the points of arterial blood sampling of the patient, and the port 4 of which is designed with the function of introducing medicinal substances (Fig. 3).

[0057] Moreover, a port 11 of a catheter or a needle 11 for puncture of vascular access at one point of venous return of the patient's blood can be connected to the venous end 17 segment of the venous tubular line 13, one of two ports 11 of catheters or one of two needles 11 for puncture of vascular access at one of two points of arterial blood sampling of the patient can be connected to the arterial end segment 21 of the arterial tubular line 18, and the second of two ports 11 of catheters or the second of two needles 11 for puncture of vascular access at the second of two points of arterial blood sampling of the patient can be connected to the arterial port 20 for administration of medicinal substances through the line for filling the overflow 22 (Fig. 4).

[0058] In this case, a port 11 of a catheter or a needle 11 for puncture of vascular access at one point of arterial blood collection of the patient can be connected to the arterial end segment 21 of the arterial tubular line 18, and a Y-shaped connecting line can be connected to the venous end segment 17 of the venous tubular line 13 through port 4, the connectors 6 of which are connected through two ports 11 of catheters, or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access at two points of venous blood return of the patient (Fig. 5 and Fig. 8).

[0059] In addition, port I of a catheter or needle I for puncture of vascular access at one point of arterial blood collection of the patient can be connected to the arterial end segment 21 of the arterial tubular line 18, one of two ports 11 of catheters or one of two needles 11 for puncture of vascular access at one of two points of venous blood return of the patient can be connected to the venous end segment 17 of the venous tubular line 13, and the second of two ports 11 of catheters or the second of two needles 11 for puncture of vascular access at the second of two points of venous blood return of the patient can be connected to the upper venous port 14 for administration of medicinal substances through the blood transfusion system 23 (Fig. 6).

[0060] Moreover, a vein, fistula, or vascular prosthesis can be used as vascular access.

[0061] The method for performing dialysis consists of the following steps: connecting the patient to the venous tubular main line side 9 of the dialysis system by means of one catheter port 11 or one needle 11 for vascular access puncture at one point of venous blood return of the patient, or two catheter ports 11, or two needles 11 for vascular access puncture, or one catheter port 11 and one needle 11 for vascular access puncture at two points of venous blood return of the patient; connecting the patient to the arterial tubular main line side 10 of the dialysis system by means of one catheter port 11 or one needle 11 for vascular access puncture at one point of arterial blood collection of the patient, or two catheter ports 11, or two needles 11 for vascular access puncture, or one catheter port 11 and one needle 11 for vascular access puncture at two points of arterial blood collection of the patient; opening of main clamps (not shown in the figures);implementation of the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures); disconnecting the patient from the system for dialysis (Fig. 2-8).;

[0062] The method for performing dialysis may consist of the following steps: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of a catheter or one needle 11 for puncture of vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 through a port of a Y-shaped connecting line, the connectors 6 of which are connected at two points of arterial blood collection by means of two ports 11 of catheters, or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access; opening the trunk clamps (not shown in the figures) and the clamps 7 of the Y-shaped connecting line; performing the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate;closing the main clamps (not shown in the figures) and clamps 7 of the Y-shaped connecting line; disconnecting the patient from the dialysis system (Fig. 2 and Fig. 7).;

[0063] In this case, the method for performing dialysis may consist of the following stages: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of the catheter or one needle 11 for puncture of the vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of the vascular access at one of the two points of arterial blood collection of the patient; connecting the patient to the arterial port 20 for administration of medicinal substances through one of the connectors 6 of the Y-shaped connecting line, the other of the connectors 6 of which is connected to the second of the points of arterial blood collection of the patient by means of the second port 11 of the catheters or the second needle 11 for puncture of the vascular access;opening the main clamps (not shown in the figures) and clamps 7 of the connectors 6 of the Y-shaped connecting line; carrying out the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures) and clamps 7 of the connectors 6 of the Y-shaped connecting line; disconnecting the patient from the system for dialysis (Fig. 3).;

[0064] In addition, depending on the need during the circulation process, medicinal preparations can be administered through port 4 of the Y-shaped connecting line with the possibility of dosing and / or closing them by means of clamp 7 located on main tube 3 of port 4 of the Y-shaped connecting line (Fig. 3). Moreover, the method for performing dialysis can consist of the following stages: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of the catheter or one needle 11 for puncture of vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of vascular access at one of the two points of arterial blood collection of the patient;connecting the patient to the arterial port 20 for administering medicinal substances through the overflow filling line 22 by means of the second port 11 of the catheters or the second needle I for puncture of the vascular access of the second of the two points of arterial blood collection of the patient; opening the main clamps (not shown in the figures); carrying out the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures); disconnecting the patient from the system for performing dialysis (Fig. 4).;

[0065] In this case, the method for performing dialysis may consist of the following stages: connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one port I of a catheter or one needle I for puncture of vascular access at one point of arterial blood collection from the patient; connecting the patient to the venous end segment 17 of the venous tubular line 13 through port 4 of the Y-shaped connecting line, the connectors 6 of which are connected at two points of venous blood return by means of two ports 11 of catheters, or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access; opening the trunk clamps (not shown in the figures) and the clamps 7 of the Y-shaped connecting line; performing the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate;closing the main clamps (not shown in the figures) and clamps 7 of the Y-shaped connecting line; disconnecting the patient from the dialysis system (Fig. 5 and Fig. 8);

[0066] In addition, the method for performing dialysis may consist of the following steps: connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one port 11 of the catheter or one needle 11 for puncture of vascular access at one point of arterial blood collection from the patient; connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of vascular access at one of the two points of venous return of the patient's blood; connecting the patient to the upper venous port 14 for the administration of medicinal substances through the blood transfusion system 23 by means of the second port 11 of the catheter or the second needle 11 for puncture of vascular access at the second of the two points of venous return of the patient's blood; opening the trunk clamps (not shown in the figures); performing the circulation process with regulation of the blood flow rate;stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures); disconnecting the patient from the system for dialysis (Fig. 6).;

[0067] Moreover, a vein, fistula, or vascular prosthesis can be used as vascular access.

[0068] The proposed group of inventions is used as follows.

[0069] In order to carry out the process of dialysis depending on variable situations (in gravitational surgery, renal replacement therapy, for example, in hemodialysis and hemofiltration), the system for dialysis is first configured (in accordance with the variants of the systems described above), using the dialyzer 8, lines 19, 18, ports 11 of catheters or needles 11 for puncture of vascular access (for example, a vein or fistula, vascular prosthesis), plugs, a Y-shaped connecting line, a blood transfusion system 23, as well as a line for filling the overflow 22.In this case, the Y-shaped connecting line is made in the form of a Y-shaped tubular main tee 1 with communicating main pipes 2 at the ends, wherein one of the pipes 2 of the tee 1 is connected to the main tube 3, at the other end of which a port 4 with a female adapter (luer-lock female adapter) is located, and the other two pipes 2 of the tee 1 are connected to the main tubes 5, at the other ends of which connectors 6 with pin adapters (luer-lock male adapter) are located, and on all main tubes 3, 5 at least one clamp 7 is located. And the venous tubular main side 9 and the arterial tubular main side 10 are connected to the dialyzer 8.Moreover, the dialyzer 8 can be made with tubular lines 12 of the filtration circuit of the dialysate solution, the venous tubular line side 9 can contain a venous tubular line 13, along which from the dialyzer 8 the following are sequentially located: an upper venous port 14 for administering medicinal substances, a sensor of the air content 15 in the returned blood, a lower venous port 16 for administering medicinal substances and a venous end segment 17 of the venous tubular line 13, and the arterial tubular line side 10 - an arterial tubular line 18, along which from the dialyzer 8 the roller pump 19, the arterial port 20 for administering medicinal substances and the arterial end segment 21 of the arterial tubular line 18 are sequentially located.In this case, if the patient has an arteriovenous fistula (an artery sewn together with a vein or an artificial vessel sewn in), from where blood is collected, and if the patient also has a double-lumen catheter installed in a vein, then, accordingly, blood can be collected either from vascular access or from one port 11 of the catheter or completely from the catheter.

[0070] After that, the actual process of dialysis is carried out depending on the variable situations using various methods in accordance with the customizable systems for dialysis as follows.

[0071] The first method of performing dialysis may consist of the following steps: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of the catheter or one needle 11 for puncture of vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 through a port of the Y-shaped connecting line, the connectors 6 of which are connected at two points of arterial blood collection by means of two ports 11 of the catheters, or two needles 11 for puncture of vascular access, or one port 11 of the catheter and one needle 11 for puncture of vascular access; opening the trunk clamps (not shown in the figures) and the clamps 7 of the Y-shaped connecting line; performing the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate;closing the main clamps (not shown in the figures) and clamps 7 of the Y-shaped connecting line; disconnecting the patient from the dialysis system (Fig. 2 and Fig. 7).;

[0072] The second method of performing dialysis may consist of the following steps: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of the catheter or one needle 11 for puncture of the vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of the vascular access at one of the two points of arterial blood collection of the patient; connecting the patient to the arterial port 20 for administration of medicinal substances through one of the connectors 6 of the Y-shaped connecting line, the other of the connectors 6 of which is connected to the second of the points of arterial blood collection of the patient by means of the second port 11 of the catheters or the second needle 11 for puncture of the vascular access;opening the main clamps (not shown in the figures) and clamps 7 of the connectors 6 of the Y-shaped connecting line; carrying out the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures) and clamps 7 of the connectors 6 of the Y-shaped connecting line; disconnecting the patient from the dialysis system. Depending on the need during the circulation process, medications can be administered through port 4 of the Y-shaped connecting line with the possibility of dosing and / or closing them by means of clamp 7 located on the main tube 3 of port 4 of the Y-shaped connecting line (Fig. 3).;

[0073] The third method of performing dialysis may consist of the following steps: connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one port 11 of the catheter or one needle 11 for puncture of the vascular access at one point of venous return of the patient's blood; connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of the vascular access at one of the two points of arterial blood collection from the patient; connecting the patient to the arterial port 20 for administration of medicinal substances through the line for filling the overflow 22 by means of the second port 11 of the catheters or the second needle 11 for puncture of the vascular access of the second of the two points of arterial blood collection from the patient; opening the line clamps (not shown in the figures); performing the circulation process with regulation of the blood flow rate;stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures); disconnecting the patient from the system for dialysis (Fig. 4).;

[0074] The fourth method of performing dialysis may consist of the following steps: connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one port 11 of a catheter or one needle 11 for puncture of vascular access at one point of arterial blood collection from the patient; connecting the patient to the venous end segment 17 of the venous tubular line 13 through port 4 of the Y-shaped connecting line, the connectors 6 of which are connected at two points of venous blood return by means of two ports 11 of catheters, or two needles 11 for puncture of vascular access, or one port 11 of a catheter and one needle 11 for puncture of vascular access; opening the trunk clamps (not shown in the figures) and the clamps 7 of the Y-shaped connecting line; performing the circulation process with regulation of the blood flow rate; stopping the circulation process with regulation of the blood flow rate;closing the main clamps (not shown in the figures) and clamps 7 of the Y-shaped connecting line; disconnecting the patient from the dialysis system (Fig. 5 and Fig. 8);

[0075] The fifth method of performing dialysis may consist of the following steps: connecting the patient to the arterial end segment 21 of the arterial tubular line 18 by means of one port 11 of the catheter or one needle 11 for puncture of vascular access at one point of arterial blood collection of the patient; connecting the patient to the venous end segment 17 of the venous tubular line 13 by means of one of the two ports 11 of the catheters or one of the two needles 11 for puncture of vascular access at one of the two points of venous return of the patient's blood; connecting the patient to the upper venous port 14 for administration of medicinal substances through the blood transfusion system 23 by means of the second port 11 of the catheter or the second needle 11 for puncture of vascular access at the second of the two points of venous return of the patient's blood; opening the trunk clamps (not shown in the figures); performing the circulation process with regulation of the blood flow rate;stopping the circulation process with regulation of the blood flow rate; closing the main clamps (not shown in the figures); disconnecting the patient from the system for dialysis (Fig. 6).;

[0076] The specified technical result is achieved due to the fact that the structural implementation of the Y-shaped connecting line in the form of a Y-shaped tubular main tee with communicating main pipes at the ends and its use in various variations for dialysis systems, as well as the structural implementation of the possibility in dialysis systems of simultaneous connection of several infusion sources with one-stage administration of drugs and one-stage puncture into two veins through one separate system, fully ensure the effective implementation of the possibility of combining several accesses, both into a direct single flow and into a reverse single flow, with inclusion in the dialysis circuit, as well as the variability of the linear and volumetric speed of the liquid flow, a decrease in its resistance with the distribution of its pressure, automatic regulation of pressure in the line circuit due to the second access point through one system,and reducing emergency situations for patients due to alarms triggered in dialysis machines. In addition, connecting a Y-shaped connecting line to a standard infusion system to create a flushing system allows for the simultaneous administration of drugs from two different sources (e.g., a solution bag and a drug dispenser).

[0077] No technical solutions have been identified that coincide with the set of essential features of the claimed group of inventions, which allows us to conclude that the claimed group of inventions meets the patentability requirement of “novelty”.

[0078] The claimed essential features that predetermine the achievement of the specified technical result do not clearly follow from the state of the art, which allows us to conclude that the claimed group of inventions meets such a patentability condition as “inventive step”.

Claims

FORMULA OF INVENTIONS SYSTEM AND METHOD FOR PERFORMING DIALYSIS 1. A system for performing dialysis, made in the form of a main tubular circuit with main clamps, containing a dialyzer with a venous tubular main line side connected thereto and an arterial tubular main line side, characterized in that one catheter port or one needle for puncture of vascular access at one point of venous return of the patient's blood is connected to the venous tubular main line side, and two catheter ports, or two needles for puncture of vascular access, or one catheter port and one needle for puncture of vascular access at two points of arterial blood collection of the patient are connected to the arterial tubular main line side;or two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle are connected to the venous tubular trunk side at two venous return points of the patient's blood, and one catheter port or one vascular access puncture needle is connected to the arterial tubular trunk side at one arterial blood collection point of the patient; or two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle are connected to the venous tubular trunk side at two venous return points of the patient's blood, and two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle are also connected to the arterial tubular trunk side at two arterial blood collection points of the patient;wherein the venous tubular trunk side comprises a venous tubular trunk along which the following are arranged in series from the dialyzer: an upper venous port for administering medicinal substances, a sensor for the air content in the returned blood, a lower venous port for administering medicinal substances and a venous end segment of the venous tubular trunk, and the arterial tubular trunk side comprises an arterial tubular trunk along which the following are arranged in series from the dialyzer; a roller pump, an arterial port for the administration of medicinal substances and an arterial end segment of the arterial tubular line are located.

2. The system according to claim 1, characterized in that a catheter port or a needle for puncture of vascular access at one point of venous return of the patient's blood is connected to the venous end segment of the venous tubular line, and a Y-shaped connecting line is connected to the arterial end segment of the arterial tubular line through a port, the connectors of which are connected through two catheter ports, or two needles for puncture of vascular access, or one catheter port and one needle for puncture of vascular access at two points of arterial blood collection from the patient.

3. The system according to claim 1, characterized in that a catheter port or a needle for puncture of vascular access at one point of venous return of the patient's blood is connected to the venous end segment of the venous tubular line, one of two catheter ports or one of two needles for puncture of vascular access at one of two points of arterial blood sampling of the patient is connected to the arterial end segment of the arterial tubular line, and a Y-shaped connecting line is connected to the arterial port for administering medicinal substances through one of the connectors, the other of the connectors of which is connected through the second catheter port or the second needle for puncture of vascular access to the second of the points of arterial blood sampling of the patient, and the port of which is designed with the function of administering medicinal substances.

4. The system according to claim 1, characterized in that a catheter port or a needle for puncture of vascular access at one point of venous return of the patient's blood is connected to the venous end segment of the venous tubular line, one of two catheter ports or one of two needles for puncture of vascular access at one of two points of arterial blood collection from the patient is connected to the arterial end segment of the arterial tubular line, and the second of two catheter ports or the second of two needles for puncture of vascular access at the second of two points of arterial blood collection from the patient is connected to the arterial port for administering medicinal substances through the line for filling the overflow.

5. The system according to claim 1, characterized in that a catheter port or a needle for puncture of vascular access at one point of arterial blood collection from the patient is connected to the arterial end segment of the arterial tubular line, and a Y-shaped a connecting line whose connectors are connected through two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle at two points of venous return of the patient's blood.

6. The system according to claim 1, characterized in that a catheter port or a needle for puncture of vascular access at one point of arterial blood collection from the patient is connected to the arterial end segment of the arterial tubular line, one of two atheter ports or one of two needles for puncture of vascular access at one of two points of venous blood return from the patient is connected to the venous end segment of the venous tubular line, and the second of two atheter ports or the second of two needles for puncture of vascular access at the second of two points of venous blood return from the patient is connected to the upper venous port for the introduction of medicinal substances through the blood transfusion system.

7. The system according to paragraphs 1-6, characterized in that it is designed with the possibility of vascular access through a vein, fistula or vascular prosthesis.

8. A method for performing dialysis, carried out using a dialysis system according to paragraphs 1-6, in accordance with which: the patient is connected to the venous tubular trunk side of the system by means of one catheter port or one needle for vascular access puncture at one point of venous return of the patient's blood and the patient is connected to the arterial ribbed trunk side of the dialysis system by means of two catheter ports, or two needles for vascular access puncture, or one atheter port and one needle for vascular access puncture at two points of arterial blood collection of the patient;or connecting the patient to the venous tubular trunk side of the dialysis system by means of two catheter ports, or two vascular access puncture needles, or one catheter port and one vascular access puncture needle at two venous return points of the patient's blood, and connecting the patient to the arterial tubular trunk side of the dialysis system by means of one catheter port or one vascular access puncture needle at one arterial blood collection point of the patient; opening the trunk clamps, performing the circulation process with blood flow rate adjustment, stopping the circulation process with blood flow rate adjustment, closing the trunk clamps; disconnect the patient from the dialysis system.

9. The method according to claim 8, characterized in that the patient is connected to the venous end segment of the venous tubular line by means of one catheter port or one needle for vascular access puncture at one point of venous blood return of the patient, the patient is connected to the arterial end segment of the arterial tubular line through a port of a Y-shaped connecting line, the connectors of which are connected by means of two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture at two points of arterial blood collection of the patient, the trunk clamps and the clamps of the Y-shaped connecting line are opened, the circulation process with blood flow rate adjustment is carried out, the circulation process with blood flow rate adjustment is stopped, the trunk clamps and the clamps of the Y-shaped connecting line are closed, the patient is disconnected from the dialysis system.

10. The method according to claim 8, characterized in that the patient is connected to the venous end segment of the venous tubular artery by means of one catheter port or one needle for puncture of the vascular access at one point of venous return of the patient's blood, the patient is connected to the arterial end segment of the arterial ribbed trunk line by means of one of two catheter ports or one of two vascular access puncture needles at one of two points of arterial blood sampling of the patient, the patient is connected to the arterial port for administration of medicinal substances through one of the connectors of the Y-shaped connecting trunk line, the other connector of which is connected to the second point of arterial blood sampling of the patient by means of the second catheter port or the second needle for puncture of vascular access, the trunk clamps and the clamps of the connectors of the Y-shaped connecting trunk line are opened, the circulation process is carried out with regulation of the blood flow rate,stop the circulation process by regulating the blood flow rate, close the main line clamps and the Y-line connector clamps and disconnect the patient from the dialysis system.

11. The method according to item 10, characterized in that medicinal preparations are administered through the port of the Y-shaped connecting line with the possibility of dosing and / or closing them by means of a clamp located on the main tube of the port of the Y-shaped connecting line.

12. Method according to p.8, characterized in that the patient is connected to the venous end segment of the venous tubular arterial line by means of one catheter port or one needle for puncture of the vascular access at one point of venous return of the patient's blood, the patient is connected to the arterial end segment of the arterial ribbed trunk line by means of one of two catheter ports or one of two needles for puncture of the vascular access at one of the two points of arterial blood sampling of the patient, the patient is connected to the arterial port for administration of medicinal substances through the trunk line for filling the overflow by means of a second catheter port or a second needle for puncture of the vascular access of the second of the two points of arterial blood sampling of the patient, the trunk clamps are opened, the circulation process is carried out with regulation of the blood flow rate, the circulation process is stopped with regulation of the blood flow rate, the trunk clamps are closed, the patient is disconnected from the system for performing dialysis.

13. The method according to claim 8, characterized in that the patient is connected to the arterial end segment of the arterial ribbed line by means of one catheter port or one needle for vascular access puncture at one point of arterial blood collection of the patient, the patient is connected to the venous end segment of the venous tubular line through a port of a Y-shaped connecting line, the connectors of which are connected at two points of venous blood return of the patient by means of two catheter ports, or two needles for vascular access puncture, or one catheter port and one needle for vascular access puncture, open the main clamps and the clamps of the Y-shaped connecting line, carry out the circulation process with regulation of the blood flow rate, stop the circulation process with regulation of the blood flow rate, close the main clamps and the clamps of the Y-shaped connecting line, disconnect the patient from the dialysis system.

14. The method according to claim 8, characterized in that the patient is connected to the arterial end segment of the arterial ribbed trunk line by means of one catheter port or one needle for vascular access puncture at one point of arterial blood collection from the patient, the patient is connected to the venous end segment of the venous tubular trunk line by means of one of two catheter ports or one of two needles for vascular access function at one of two points of venous blood return of the patient, the patient is connected to the upper venous port for administration of medicinal substances through the blood transfusion system by means of the second catheter port or the second needle for vascular access puncture of the second of two points of venous blood return of the patient, the trunk clamps are opened, the circulation process is carried out with blood flow rate regulation, the circulation process is stopped with blood flow rate regulation, the trunk clamps are closed, the patient is disconnected from the system for performing dialysis.

15. The method according to paragraphs 8-14, characterized in that a vein, or fistula, or vascular prosthesis is used as vascular access.

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