RU-2024132944-A - A method for obtaining donor cryoprecipitate in a flow mode and an automatic apparatus for its implementation

Inventors

• Асатуров Богдан Иванович

Assignees

• Асатуров Богдан Иванович

Dates

Publication Date

20260504

Application Date

20241101

Claims (6)

1. 1. A method for producing cryoprecipitate by collecting donor blood, separating and freezing the plasma, followed by slow defrosting and separating the cryoprecipitate, characterized in that the donor blood is separated into blood plasma and formed elements on a plasma filter, after which the blood plasma enters a cryoprecipitation chamber, where it is cooled in a flow mode at a rate of, preferably, 15 ml per minute at a temperature of -10 ° C, with the formation of cryoprecipitate at the outlet, which, together with the plasma, enters a filtration chamber, where the cryoprecipitate is separated from the plasma and enters a cryoprecipitate accumulation chamber, and the filtered plasma passes into a heating chamber, where it is heated in a flow mode at a temperature of 38 ° C and enters a mixing chamber, where it is mixed with formed elements entering in a flow mode from the plasma filter, after which the blood, restored to a high-quality composition, is reinfused donor, and the process of collecting blood from the donor and reinfusing his blood occurs simultaneously, and the resulting native cryoprecipitate is used for its intended purpose, primarily for ex temporaneous administration to the patient.
2. 2. A method for obtaining cryoprecipitate according to paragraph 1, characterized in that the native cryoprecipitate isolated from the donor undergoes clarification and sterilizing filtration and is administered ex temporaneously to the patient for medical reasons.
3. 3. The method for obtaining cryoprecipite according to paragraph 1, characterized in that the separation of blood into plasma and formed elements is carried out by any method that allows obtaining blood plasma in a volume and qualitative composition suitable for the implementation of subsequent stages of the claimed method.
4. 4. The method for producing cryoprecipitate according to paragraph 1, characterized in that the entire technological process of the claimed method for producing cryoprecipitate is controlled by temperature and liquid level sensors connected to an electronic control unit, which makes it possible to maintain a given temperature regime and the rate of processing of blood plasma.
5. 5. A device for cryophoresis by separating blood into plasma and formed elements, separating the plasma into a sealed plastic bag, cooling the plasma to -10°C, separating cryoprecipite from the plasma by centrifugation, characterized in that the donor's blood is preliminarily separated by plasma filtration into formed elements and blood plasma, which is fed through a line from the plasma filter passing through a peristaltic pump with an adjustable capacity, preferably 10 ml per minute, to a cooling unit, which consists of a cooling unit and a cryoprecipitation chamber installed horizontally and perpendicular to the vertical axis of the device, which is made of an elastic plastic material, preferably polycarbonate, with an external size of preferably 200x80x5 mm, in the internal space of which there is a spiral channel of rectangular cross-section, the preferred size being 10 mm in width and 3 mm in height, and in the initial and final sections of the spiral channel two nozzles are installed, one of which is connected to the line blood plasma input, and the second is connected to the blood plasma and cryoprecipitate output line formed in the flow-through cooling of the blood plasma in the cryoprecipitation chamber, wherein the flow-through cooling is carried out by using four thermoelectric elements in the cooling unit connected to an electronic control unit, each of which is preferably 40x40 mm in size and preferably 5 mm thick, wherein all thermoelements are mounted on the surface of the outer wall of the metal frame sequentially along its length, with the cooling surface inward, and the metal frame itself is made, preferably of copper, with dimensions of 210x100x20 mm, fits tightly with its back wall to the outer wall of the cryoprecipitation chamber, and fans are mounted above the thermoelements for air cooling of their heating outer surface, as a result of which blood plasma and cryoprecipitate cooled to -4°C are supplied to the outlet of the cryoprecipitation chamber, which are directed into a filtration chamber installed vertically and parallel to the vertical axis of the apparatus, made of elastic plastic material, preferably polycarbonate, having a square cross-section measuring preferably 40 mm in width and 60 mm in height, with a wall thickness of preferably 2 mm, wherein the filtration chamber is hermetically sealed at the top and bottom with upper and lower covers, and in the center of the lower cover there is a nozzle for introducing into the filtration chamber plasma with cryoprecipitate, coming through the line from the cryoprecipitation chamber, wherein the filtration chamber is provided inside with a filtration cell, installed horizontally and perpendicular to the vertical axis of the filtration chamber, consisting of lower and upper meshes made of plastic threads based on, preferably, nylon, with an internal lumen size between the threads of, preferably, 500 μm, wherein both meshes are fixed in plastic frames, which, in turn, are attached to the inner walls of the filtration chamber in the upper third of its height, wherein the distance between the surfaces of the meshes is, preferably, 20 mm, wherein the internal space between the meshes is filled with a bead polymer gel, preferably based on polyacrylamide, with a pore size that allows substances with a molecular weight of preferably 20 kDa to pass through, and in the middle part of the space between the grids on one of the walls, a nozzle is installed on the outside for introducing a beaded polymer into this space, wherein the outer part of the nozzle is provided with a plug, in addition to this, in the center of the lower cover on the outside, a nozzle is installed, connected to a line that goes through an electromagnetic valve to the cryoprecipitate accumulation chamber, which, after opening the electromagnetic valve, enters the cryoprecipitate accumulation chamber, which is a sealed container of cylindrical shape, with a diameter of preferably 40 mm, a height of preferably 60 mm, with a wall thickness of preferably 2 mm, wherein the cryoprecipitate accumulation chamber is hermetically closed at the top and bottom with upper and lower covers, and in the center of the lower cover of the cryoprecipitate accumulation chamber a T-shaped nozzle is installed, one branch of which is intended for introducing concentrate into its container cryoprecipitate from the lower section of the filtration chamber, and the other outlet is designed to remove the obtained cryoprecipitate and is closed with a plug before use, at the same time, in the center of the upper cover of the cryoprecipitate accumulation chamber, on the outside, an air filter is installed for releasing air as the accumulation chamber is filled with cryoprecipitate, in addition to this, in the center and on the outer surface of the upper cover of the plasma filtration chamber, a nozzle is installed for removing blood plasma purified from cryoprecipitate, connected to a line going to the heating unit, including a heating chamber, which is made of an elastic plastic material, preferably polycarbonate, with an outer size, preferably 100x80x5 mm, in the inner space of which there is a spiral channel of rectangular cross-section, the preferred size is 10 mm in width and 3 mm in height, and in the initial and final sections of the spiral channel, two nozzles are installed, one of which is connected to the blood plasma input line from the filtration chamber, and the second is connected to a blood plasma output line reheated in a flow mode to a temperature of preferably 38°C, for which purpose two thermoelectric elements are used, having a square shape, with a size of preferably 40x40 mm and a thickness of preferably 5 mm, connected to an electronic control unit, which are installed with the heating surface inside and on the same axis along the length of the metal frame, and at the same time tightly contact the heating surface with the outer surface of one of its walls, and the metal frame itself is made, preferably of copper, with dimensions of 110x100x20 mm, serves to heat the chamber to a temperature of preferably 38°C, as a result of which the blood plasma purified from cryoprecipitate and heated enters the mixing unit through the line, consisting of a mixing chamber made of a transparent elastic material, preferably polycarbonate, having a square cross-section, with a size of preferably 40 mm in width and 60 mm in height, with a wall thickness of preferably 2 mm, while the housing of the mixing chamber is hermetically closed at the top and bottom upper and lower covers, and in the center of the side wall of the mixing chamber there is a nozzle for introducing plasma from the heating unit, and below this nozzle along one axis there is a nozzle for introducing formed elements of the blood along the line going from the plasma filter through the peristaltic pump into the mixing chamber, and on its outer side surface in the lower part at the level of the bottom of the mixing chamber there is a nozzle for removing the mixed mixture of formed elements and blood plasma purified from cryoprecipitate and heated, while for mixing the mixture a magnetic stirrer equipped with an external electric motor is adjacent to the outer surface of the lower cover of the mixing chamber, and the magnetic stirrer in a plastic housing is located inside the mixing chamber, as a result of which the reconstituted blood of the donor enters through the line passing through a peristaltic pump with a capacity of, preferably, 15 ml per minute, regulated by an electronic control unit, for reinfusion to the donor.
6. 6. An apparatus for obtaining cryoprecipitate according to paragraph 5, characterized in that all disposable plastic devices and lines of the apparatus are sterilized and installed in compliance with aseptic techniques to maintain sterility and prevent microbial contamination of the obtained cryoprecipitate, as well as the plasma and formed elements of the donor's blood.