RU2775883C1 - Method for preparation for transfusion of fresh frozen blood plasma and device for its implementation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: inventions group relates to medicine, namely to a method for preparing fresh frozen blood plasma for transfusion and a device for implementing this method. The method includes thawing and heating of blood plasma. According to the method, one container with blood plasma of a predetermined volume is placed in a technological container with water, the temperature of which exceeds the target blood plasma temperature and from which the container is separated by a membrane through which heat exchange occurs. As a result of a change in the mass of the technological container, measured by the strain gauge sensors of the device, the mechanical effects on the container are automatically triggered. The impacts lead to the joint movement of the container with the membrane, as a result of which they pass a distance of 24 mm, followed by a return to their original position, with a frequency of 60 to 180 cycles per minute, depending on the mass of the thawed and heated blood plasma. The movement leads to mixing of water in the container and blood plasma in the container, accompanied by a decrease in the water temperature to the target value of the blood plasma temperature, followed by thermal stabilization. The choice of the initial water temperature, the frequency and duration of mechanical effects is carried out by preliminary full-scale experiments with a simulation container with a volume equal to a predetermined volume of thawed and heated blood plasma according to the Gauss-Seidel method, in which successive advancement to the extremum is carried out by alternately varying the value of thermal and mechanical effects on the container during thawing.

EFFECT: reduction in the duration of the technological process is achieved.

2 cl, 1 dwg

Description

The invention relates to the field of medical technology and can be used in the subjects of the circulation of donor blood and its components, in particular, fresh frozen blood plasma in polymer containers in its preparation for transfusion.

Under the preparation for transfusion of fresh frozen blood plasma, we mean a process consisting of thawing and heating of blood plasma, as a result of which the temperature of blood plasma changes from the temperature of its storage in a frozen state to a target temperature value not exceeding 37°C.

Known methods of thawing blood plasma and devices for their implementation (invention RU 2280460 C2, IPC A61K 35/14, 10/20/2004, utility model RU 65760 U1, IPC A61K 35/14, 08/27/2007, invention EP 2510965 A1, IPC A61M 5 /44, 10/17/2012, invention RU 2329016 C1, IPC A61F 7/00, 07/20/2008, invention RU 2627462 C1, IPC A61J 3/00, 08/08/2017, invention US 5243833 A, IPC F25D 17/02, 14.09. 1993, invention US 20030082069 A1, IPC A01N 1/00, 05/01/2003, invention RU 2706682 C1, IPC A61J 3/00, 07/24/2019), which are combined by the presence of a process tank with a liquid heat carrier and the use of systems for maintaining the set value of the heat carrier temperature, a distinction is made between their methods and technical solutions, which make it possible to influence a container with blood plasma to change its temperature from the storage temperature to the target value.

The disadvantage of the first (invention RU 2280460 C2, IPC A61K 35/14, 10/20/2004), the second (utility model RU 65760 U1, IPC A61K 35/14, 08/27/2007) and the third (invention EP 2510965 A1, IPC A61M 5/44 , 10/17/2012) analogues is the absence of physical influences on the container with blood plasma, which lead to forced convection of the blood component inside the container. Such influences make it possible to reduce the duration of the technological process and increase the uniformity of changes in the blood plasma temperature.

The disadvantage of the first, second, fourth (invention RU 2329016 C1, IPC A61F 7/00, 07/20/2008) and the fifth (invention RU 2627462 C1, IPC A61J 3/00, 08/08/2017) analogs is the absence of membranes or shells into which place the container with blood plasma to prevent direct contact of the container with the coolant. They make it possible to exclude the ingress of a blood component into the coolant if the container is leaking and continue preparation for transfusion of fresh frozen blood plasma using a new container with a blood component and the old coolant.

The disadvantage of the first, second, third, fourth, fifth, sixth (invention US 5243833 A, IPC F25D 17/02, 09/14/1993) and the seventh (invention US 20030082069 A1, IPC A01N 1/00, 05/01/2003) analogues is the lack of by changing the value of the values of physical effects on the container with blood plasma, without leading to overheating of the blood plasma, controllable excess of the temperature of the coolant over the target temperature of the blood component to reduce the duration of the technological process, followed by a decrease in the temperature of the coolant and its thermal stabilization. Overheating means the excess of the blood plasma temperature of 37°C, leading to the loss of specific functions of some protein components due to the loss of native conformation. As a result of an experimental study (Lemondzhava V.N., Leushin V.Yu., Chechetkin A.V., Kasyanov A.D., Kiseleva E.A., Nazarov V.V., Gudkov G.A. Study of the influence of thermal parameters and mechanical influences on the duration of technological processes of defrosting cryopreserved thermolabile blood components // Biomedical Radioelectronics, 2020, No. 2, pp. 60-66) the possibility, in order to reduce the duration of the technological process of preparing for transfusion of fresh frozen blood plasma, the technical support of controlled excess of the temperature of the coolant is determined over the target temperature of the blood component using various combinations of thermal, mechanical and hydrodynamic effects on the container.

An analogue having the closest set of features in essence is the invention RU 2706682 C1, IPC A61J 3/00, 07/24/2019. The device for control and regulation of the technological process of thawing plasma and blood cells allows you to set the amount of thermal, mechanical and hydrodynamic effects on the container with the blood component. The ability to set individual exposure values for each new processed container with a blood component is an advantage of the invention, since when preparing fresh frozen blood plasma obtained from donated blood after centrifugation, the fullness of containers with the same maximum capacity can differ significantly. For example, 215 ml and 275 ml of blood plasma can be stored in two identical polymer containers. As a result of an experimental study (Lemondzhava V.N. Effect of forced hydrodynamic and mechanical effects on a biological object on the rate of the technological process of blood plasma defrosting // Biomedical radioelectronics. 2018, No. 11, pp. 48-55) it was found that with a known volume of the contents of the container at Using an installation that ensures the repeatability of the totality of physical effects on the container in the technological process, it is possible, by preliminary field experiments, to determine the duration of thawing of the sample and the duration of reaching the target temperature for a given volume. Adjusting the duration of the technological process depending on the fullness of the container allows it to be optimized in order to reduce the inevitable decrease in the value of factor VIII and other heat-labile blood plasma components in the considered technological process. The first disadvantage of the invention RU 2706682 C1 is the lack of automated start of the process. The description of the operation of the device indicates that after the container with the blood component is immersed in the membrane and before the start of the thermal effects of the first of the two modes and, accordingly, the countdown of the first mode, the operator of the device must, depending on the circumstances, perform from one to three manipulations with the device. If it is necessary to perform all of the possible manipulations, the operator will have to respond to the alarm about the error of closing the technological chamber cover and close it, then to the alarm about the error in setting the exposure values that do not correspond to the volume of the blood component, and correct the impact value, then start the first thermal exposure mode . In this case, heat exchange of the coolant with the thawing blood plasma will occur from the moment the container is immersed in the membrane with an intensity depending on the temperature of the coolant in the process chamber. Due to the above possible interactions between the operator and the device, due to operator errors, an excessive duration of exposures for a container with blood plasma will be carried out and, as a result, a decrease in the safety of hemostatic parameters of blood plasma. The second disadvantage is the lack of technical support for controlling the surface temperature of the container with blood plasma placed in the membrane. The invention provides only a coolant temperature sensor, which is installed on the wall of the technological chamber and according to the logged data of which it is possible to determine only the change in the coolant temperature during operation of the device. The third disadvantage is the absence of a maximum limitation of filling the process chamber with coolant. When implementing individual actions for each new container with blood plasma, the duration of which is determined in advance, among other things, it is necessary to ensure the repeatability of the technological process, one of the factors of which is the constancy of the volume of the coolant in the technological chamber. The fourth disadvantage of the invention is the lack of a description of the determination of the optimal process parameters for containers of different filling.

The problem to be solved by the invention is to increase the safety of thermolabile parameters of blood plasma.

The technical result to which the invention is directed is to eliminate the above disadvantages of methods for preparing fresh frozen blood plasma for transfusion and devices for their implementation in order to ensure more efficient operation.

The specified technical result is achieved by the fact that the use of the device proposed in the invention, which does not have the above disadvantages, makes it possible to implement a method for preparing fresh frozen blood plasma for transfusion, which consists in the fact that one container with blood plasma of a predetermined volume is placed in the technological container of the device with water, the value temperature of which exceeds the target temperature of the blood plasma and from which the container is separated by a membrane through which heat exchange takes place, and as a result of a change in the mass of the process container, measured by strain gauge sensors of the device, mechanical effects on the container are automatically triggered, leading to its joint movement with the membrane, in as a result of which they pass a distance equal to 24 mm, followed by a return to their original position, with a frequency of 60 to 180 cycles per minute, depending on the mass of the thawed and heated blood plasma, leading to mixing water in the container and blood plasma in the container, accompanied by a decrease in the water temperature to the target temperature of the blood plasma, followed by thermal stabilization, while the choice of the initial water temperature, frequency and duration of mechanical effects is carried out by preliminary field experiments with a simulation container with a volume equal to a certain volume of thawed and heated blood plasma, according to the Gauss-Seidel method, in which successive advancement to the extremum is carried out by alternately varying the magnitude of thermal and mechanical effects on the container during thawing. The implementation of thawing and heating of blood plasma in this way allows, taking into account the volume of plasma, to provide automated start and stop of individual effects for each container, the value of which changes in the described process, allowing a controlled excess of the coolant temperature over the target blood plasma temperature, thereby significantly reducing the duration of the technological process. process, without leading to local excesses of the target temperature of the blood plasma inside the container.

In FIG. 1 shows a diagram of a device for preparing fresh frozen blood plasma for transfusion.

The device for preparing fresh frozen blood plasma for transfusion contains a technological container (1) filled with distilled water (2), an electric motor (3) connected to levers (4) connected to a bracket (5) on which a cassette (6) is fixed, in which a polymer membrane (7) is installed in the form of a bag to accommodate a container (8) filled with blood plasma (9), strain gauge sensors in the legs of the device (10), a minimum water level sensor (11), a maximum water level sensor (12) , water temperature sensor fixed on the technological vessel wall (13), upper (14) and lower (15) membrane surface temperature sensors, heating element (16), time relay (17), software water temperature controller (18), switching unit and control (19), a personal computer (20), a sound and light signaling unit (21) and a container impact generator (22).

The method of preparation for transfusion of fresh frozen blood plasma through the described device is carried out as follows. Technological container 1 is filled with distilled water 2 to the mark above the minimum water level sensor 11 and below the maximum water level sensor 12. Replaceable polymer membrane 7 is installed in the cassette 6, which is then fixed on the bracket 5. The device is connected to the AC mains and switched on, after which, in case of insufficient or excessive water level, the signal from the water level sensors 11 and 12 is transmitted through the switching and control unit 19 to the sound and light alarm unit 21 to signal an error. With a sufficient water level, simultaneously with turning on the device, the program water temperature controller 18 starts to work, which ensures its preheating to a temperature of 37°C and thermal stabilization. The software water temperature controller 18 through the switching and regulation unit 19, based on the signals of the water temperature sensor mounted on the wall of the technological vessel 13, controls the on and off of the heating element 16. Before preparing for the transfusion of fresh frozen blood plasma, on the software water temperature controller 18, the action generator on container 22 and time relay 17, respectively, set the values of water temperature, frequency and duration of mechanical impacts on container 8 for thawing fresh-frozen blood plasma 9. These values depend on the volume and temperature of blood plasma, the shape of the polymer container, as well as the thickness of its walls and are determined preliminarily by thawing and heating simulation samples. The determination of the optimal values of water temperature at the time of immersion of the container 8 filled with blood plasma 9, the frequency and duration of mechanical effects is carried out according to the Gauss-Seidel method, in which successive advancement to the extremum is carried out by alternately varying the magnitude of thermal and mechanical effects during thawing. It is optimal to determine such a combination of desired values, in which the duration of reaching the target temperature of the simulated sample will be minimal in the absence of local excesses of the sample temperature of 37°C. After the temperature of the water in the process tank reaches the value set on the program controller 18 and its thermal stabilization, the container 8 with freshly frozen blood plasma 9 is placed in the polymer membrane 7. The change in the mass of the process tank 2, caused by the placement of the container 8 and measured by strain gauges in the legs of the device 10, triggers the time relay. At the same time, logging on the pre-enabled personal computer 20 of temperature sensor data begins, and the electric motor 3 is started, which sets in motion the levers 4 connected to it. bracket 5, on which the cassette 6 is fixed with a polymer membrane 7 installed. At the same time, the temperature of the water in the process tank 2 decreases as a result of heat exchange with the container 8 of the blood plasma 9 through the membrane 7 until the water temperature reaches 37°C, after which thermal stabilization is carried out water with a program controller 18. The control of the magnitude of thermal effects on the container 8 filled with blood plasma 9 is carried out using the upper 14 and lower 15 membrane surface temperature sensors. At the end of a period of time equal to the duration of mechanical effects on the container set on the time relay 17, the electric motor 3 is turned off and a signal is transmitted to the sound and light alarm unit 21 to signal the end of the process of preparation for transfusion of fresh frozen blood plasma, after which the container 8 is removed from the membrane 7.

Claims (2)

1. A method for preparing fresh frozen blood plasma for transfusion, including its thawing and heating, characterized in that one container with blood plasma of a predetermined volume is placed in a technological container with water, the temperature of which exceeds the target blood plasma temperature and from which the container is separated by a membrane , through which heat exchange occurs, and as a result of a change in the mass of the process vessel, measured by strain gauges, mechanical effects on the container are automatically triggered, leading to its joint movement with the membrane, as a result of which they pass a distance equal to 24 mm, followed by a return to the original position, with a frequency of 60 to 180 cycles per minute, depending on the mass of the thawed and heated blood plasma, leading to mixing of water in the container and blood plasma in the container, accompanied by a decrease in the water temperature to the target value of the blood plasma temperature with subsequent thermal stabilization, while the choice of the initial water temperature, frequency and duration of mechanical influences is carried out by preliminary full-scale experiments with a simulation container with a volume equal to a predetermined volume of thawed and heated blood plasma, according to the Gauss-Seidel method, in which successive advancement to extremum is carried out by alternately varying the value of thermal and mechanical effects on the container during thawing. 2. The device for preparing fresh frozen blood plasma for transfusion contains a technological container filled with distilled water, an electric motor connected to levers connected to a bracket on which a cassette is fixed, in which a polymer membrane is installed, having the shape of a package, to accommodate a container filled with blood plasma , strain gauge sensors in the legs of the device, a minimum water level sensor, a maximum water level sensor, a water temperature sensor mounted on the technological vessel wall, upper and lower membrane surface temperature sensors, a heating element, a software water temperature controller, a switching and control unit, a personal computer , a unit of sound and light signaling, a setter of effects on the container and a time relay, which is configured to operate as a result of a change in the mass of the technological container caused by the placement of the container with blood plasma and measured by tensometric and sensors in the legs of the device.

Images