RU2706682C1 - Apparatus for monitoring and regulating the process of defrosting plasma and blood cells - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment and can be used in medical organizations having a transfusiology room, in quality control departments, blood preparation and blood transfusion station components, as well as in scientific research institutes. Device comprises a process chamber with a liquid heat carrier, a cover with a position sensor, an electric motor for reciprocating motion to a bracket, on which a removable membrane is attached, to accommodate a container with a blood component, a tube for removing air controlled by a vacuum pressure sensor from the membrane by a vacuum pump, a heat carrier level sensor, a tubular heating element, a circulating pump, temperature sensor connected to the program regulator of heat carrier temperature, a switching and control unit transmitting data for control of the technological process to a personal computer, a unit of sound and light signaling and a setting device of the value of mechanical and hydrodynamic actions.

EFFECT: accelerated process operation and improved safety of criterial parameters of quality of defrosted blood components.

1 cl, 1 dwg

Description

The invention relates to the field of medical equipment and can be used in medical organizations that include a transfusion cabinet, in the department of blood collection and its components and in the department of quality control of blood transfusion stations, as well as in research institutes.

Known devices for thawing cryopreserved blood products (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), which combines the use of a process chamber with a liquid coolant, the temperature of which is controlled by a system that maintains a given temperature and includes a circulation pump to increase speed and uniformity the volume of the chamber of heat transfer processes.

The disadvantage of the first (utility model RU 65760 U1, IPC A61K 35/14, 08/27/2007) and the second (invention EP 2510965 A1, IPC A61M 5/44, 10/17/2012) of analogues is the limited hydrodynamic effects that result from the operation of the pumps, on containers with blood components. In the third (invention RU 2329016 C1, IPC A61F 7/00, 07/20/2008) and the fourth (invention RU 2627462 C1, IPC A61J 3/00, 08/08/2017) analogs, containers with blood components undergo a combination of hydrodynamic and mechanical effects formed in as a result of the operation of the pumps and as a result of the reciprocating movements of the containers in the liquid coolant, thereby they surpass the first two analogues in speed and uniformity of heat transfer processes.

The disadvantage of the first, third and fourth analogues is the direct contact of containers filled with blood components with a liquid coolant. Damage that violates the tightness of one container will make it impossible to successfully complete the technological operation, and, consequently, will lead to damage to all simultaneously defrosted containers and require lengthy measures to prepare the device for subsequent operation. The second analogue does not have this drawback, since it provides for the defrosting of each container with the blood component separately, in a shell enclosing the coolant, the use of which reduces the rate of the heat exchange process in the technological operation.

A common drawback of the four analogues is the impossibility of individual actions for each individual container with a blood component in order to reduce the time of the technological operation, and therefore increase the safety of thermolabile blood components. In the second analogue, due to the separate placement of containers, it is possible to implement a separate beginning and end of the process for each container, however, changing the magnitude of the hydrodynamic effects is impossible, and there is a limitation in the operation of the device, which consists in the fact that the total temperature of the coolant in all tanks must be the same . Both of these circumstances are disadvantages. Empirically (Lemonjava V.N.The effect on the speed of the technological process of defrosting blood plasma of forced hydrodynamic and mechanical effects on a biological object // Biomedical Radioelectronics. 2018, No. 11, P. 48-55), the dependence of the duration of the technological process on the magnitude of the effects on a biological object in defrosting process. The effective values of the set of actions during thawing of blood plasma differ from the effective values of the set of actions for thawing the erythrocyte mass. For example, the magnitude of the mechanical effects leading to the hemolysis of red blood cells, and, consequently, to the damage of the prepared blood component, is less than the magnitude of the effects of permissible and more effective when thawing blood plasma.

An analogue having the closest combination of features in essence is a device for thawing frozen transfusion material (invention US 5243833 A, IPC F25D 17/02, 09/14/1993). It allows defrosting of only one container with a blood component protected from contact with the coolant membrane. Hydrodynamic effects are carried out as a result of a pulsed supply of the coolant through the jet nozzles in the direction of the geometric center of the container, which leads to intense heat transfer inside the polymer container by forced convection. The first drawback is that the temperature of the coolant in any technological operation is equal to the target temperature of the defrosted blood component. For example, in the second analogue, the coolant temperature is higher than the target, which allows to increase the speed of the technological operation, but leads to the need for additional measures of protection against overheating of blood components, which can lead to the loss of specific functions of some protein components due to loss of native conformation. The second disadvantage is the impossibility of changing the magnitude of the impact, the significance of which is explained above. The third drawback is the lack of technical conditions for the same and uniform effect on the formation of forced convection inside containers of various sizes and shapes.

The problem to which the invention is directed, is to increase the safety of criteria for quality indicators of defrosted blood components.

The technical result to which the invention is directed is to eliminate the above disadvantages and create a device that provides more highly efficient operation.

The specified technical result is achieved by providing for each container with a blood component individual capabilities, in contrast to the prototype, taking into account the type and volume of the blood component, as well as the shape of the container, the magnitude of the effects possible due to the fact that the device for monitoring and regulating the technological process of defrosting the plasma and blood cell contains a process chamber with a liquid coolant, a cover of the process chamber with a position sensor, a rod mounted in the guide and driven an electric motor for transmitting reciprocating movements to a bracket fixed on it, on which a removable membrane in the form of a bag is fixed, for placing a polymer container containing a blood component, a tube fixed in the bracket to remove air controlled by a vacuum pressure sensor from the membrane by a vacuum pump, coolant level sensor, tubular heating element, circulation pump with exhaust pipe and suction pipe connected to it, temperature sensor, sub accessed to a software proportional-integral-differentiating temperature controller with a built-in timer, a switching and control unit that transmits data for process control and subsequent logging via an interface signal converter to a personal computer, an audio and light alarm unit, and a mechanical and hydrodynamic impact unit. The use of empirically obtained dependences of the influence of a combination of thermal, hydrodynamic and mechanical influences on the duration of thawing of different types of blood components, different volumes and different shapes of polymer containers, and, therefore, the surface area through which heat transfer is carried out, allows the invention to carry out controlled excess of the coolant temperature over the target temperature of the blood component, in a limited period of time, with p following a reduction to the target without leading to overheating of components of blood, but significantly reducing the time of technological operations.

In FIG. 1 shows a diagram of a device for monitoring and regulating the technological process of thawing plasma and blood cells.

A device for monitoring and regulating the technological process of defrosting plasma and blood cells contains a process chamber (1) with a liquid coolant (2), a cover (3) of the process chamber with a position sensor (4), a rod (5) installed in the guide (6) and driven by an electric motor (7) for transmitting reciprocating movements to an arm (8) fixed to it, on which a removable membrane (9) is attached in the form of a bag, for placing a polymer container (10) containing a blood component (11), a tube ( 12), fix wash in the bracket to remove air controlled by a vacuum pressure sensor (13) from the membrane with a vacuum pump (14), a coolant level sensor (15), a tubular heating element (16), a circulation pump (17) with an exhaust pipe connected to it ( 18) and a suction pipe (19), a temperature sensor (20) connected to a software proportional-integral-differentiating temperature regulator of the coolant with a built-in timer (21), a switching and control unit (22) that transmits data for process control process and subsequent recording through a signal converter of the interfaces (23) to a personal computer (24), a sound and light signaling unit (25), and a set point for the magnitude of mechanical and hydrodynamic effects (26).

A device for monitoring and regulating the technological process of thawing plasma and blood cells works as follows.

The process chamber 1 is filled with liquid coolant 2 (distilled water is used as the coolant) up to a mark above the coolant level sensor 15. Install a removable membrane in the form of a bag in the bracket 8, which is an assembly unit and has two positions: closed and open. The bracket is mounted on a rod 5 installed in the guide 6. The rod will be driven by an electric motor 7 after starting the process. The device is plugged in. If the coolant level does not correspond to the permissible level, then the signal from the coolant level sensor 15 is transmitted through the switching and regulation unit 22 to the sound and light signaling unit 25 to alert service personnel. If the coolant level is sufficient, then at the same time the device is turned on, the circulation pump 17 starts to work, which, through the suction pipe 19 and the exhaust pipe 18, circulates the coolant in the process chamber. Then set the temperature of the coolant on a software proportional-integral-differentiating regulator of the temperature of the coolant with a built-in timer 21 and start the heating process on it. This value will exceed the target temperature of the defrosted blood component 11 and will depend on the type and volume of the blood component, as well as the shape of the polymer container 10. The temperature of the coolant is controlled by a temperature sensor 20. The program proportional-integral-differentiating regulator of the coolant temperature through the switching and regulation unit 22 controls turning on and off the tubular heating element 16. After reaching the temperature of the coolant, the set value on the task e values of hydrodynamic and mechanical effects 26 establish acceptable and effective for the type and volume of the blood component planned for thawing, as well as the shape of the polymer container, the value of the frequency of the reciprocating movements of the stem 5, and therefore the polymer container 10 with the blood component, as well as the value coolant circulation speeds. The temperature and time values for the two modes of thermal effects are set on the heat carrier temperature controller. For the first mode, the temperature value coincides with the temperature value of the already heated coolant, and the value for the second mode will coincide with the target temperature of the blood component planned for thawing. The value of the time period for each mode is set depending on the type and volume of the blood component, as well as the shape of the polymer container. On the included personal computer 24 run pre-installed software for monitoring and recording the process. From this moment, the data received through the signal converter of the interfaces 23 will be displayed in real time on a computer monitor and a protocol will be generated at the end of the process. A polymer container with a frozen blood component is removed from the storage device and immersed in the membrane 9, mounted on the bracket 8, in the open position. Then the bracket is moved to the closed position, in which the tube 12 for removing air is fixed in a certain position inside the membrane. On the setpoint hydrodynamic and mechanical stresses trigger the corresponding effects. If the lid 3 of the process chamber is open at this moment, then the signal from the position sensor 4 of the lid is transmitted through the switching and regulation unit 22 to the sound and light signaling unit 25 to alert service personnel and no effects will be triggered. If the cover is closed, then the start of actions will begin by removing the air controlled by the vacuum pressure sensor 13 from the membrane by the vacuum pump 14. In this case, the pressure data is transmitted to the switching and regulation unit 22. If, for a certain time, depending on the setting of the setpoint, the hydrodynamic and mechanical values effects, and therefore, depending on the type and volume of the blood component, as well as the shape of the polymer container, the required pressure is not reached, the signal from the switching and regulation unit 22 before etsya in sound and light alarm unit 25 to alert maintenance personnel and run effects will not occur. This may indicate: a violation of the integrity of the membrane or the polymer container with the blood component, the absence of a polymer container with the blood component in the membrane, or the presence in the membrane of the container with the type or volume of the blood component to which the specified effects cannot be applied. If the launch of hydrodynamic and mechanical effects has been successfully completed, then two established modes of thermal effects are launched. After the set time of the two modes of thermal effects, the hydrodynamic and mechanical effects are stopped, the lid is opened, the bracket 8 is moved to the open position and the polymer container with the blood component is removed.

Claims (1)

A device for monitoring and regulating the technological process of defrosting plasma and blood cells contains a technological chamber with a liquid coolant, a lid of the technological chamber with a position sensor, a rod installed in the guide and driven by an electric motor for transmitting reciprocating movements to an arm mounted on it a removable membrane in the form of a bag for placement of a polymer container containing a blood component, a tube fixed in an arm for removal I of air controlled by a vacuum pressure sensor, from a membrane by a vacuum pump, a coolant level sensor, a tubular heating element, a circulation pump with an exhaust pipe and a suction pipe connected to it, a temperature sensor connected to a software proportional-integral-differentiating temperature controller with a built-in timer , a switching and control unit transmitting data for process control and subsequent logging through p a signal converter of interfaces to a personal computer, a sound and light signaling unit, and a setpoint for the magnitude of mechanical and hydrodynamic effects.

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