WO2023003487A1

WO2023003487A1 - Device for automatic cyto- and plasmapheresis

Info

Publication number: WO2023003487A1
Application number: PCT/RU2021/000322
Authority: WO
Inventors: Лев Викторович ГРИГОРЬЕВ; Алексей Викторович ЦХЕ; Александр Сергеевич КАРАУЛОВ; Алексей Владимирович БАБЫШЕВ
Original assignee: Общество с ограниченной ответственностью "ПРОФИТ ФАРМ"
Priority date: 2021-07-19
Filing date: 2021-07-29
Publication date: 2023-01-26

Abstract

The invention relates to medicine, and more particularly to centrifuging and separating devices or similar devices for separating whole blood into plasma and cellular components (formed elements of blood). The technical result consists in increasing the operating efficiency of the device. This is achieved in that in the claimed device for automatic cyto- and plasmapheresis, comprising a container system for blood, a centrifuging means and an optical system coupled to a system for controlling the device, the optical system is disposed inside the centrifuging means and consists of an optical sensor with a monochromatic light source and a device for filtering monochromatic light radiation; further included is a video camera, wherein the data obtained from the optical system and the video camera are transmitted via a data processing device to a system control panel.

Description

Automatic Cytoplasmapheresis Device

The invention relates to medicine, in particular to devices for centrifugation and separation or similar devices for the purpose of separating whole blood into plasma and cellular components (blood cells).

The main components of blood are plasma and cellular components (erythrocytes, platelets and leukocytes). To separate them, centrifugal force is used, under the influence of which the blood is separated into plasma and cellular components in the form of layers on top of each other in accordance with the specific gravity. After centrifugation of blood, erythrocytes are at the very bottom, platelets and leukocytes (leukocyte layer) are in the middle, and the plasma rises to the top.

In medical practice, blood centrifugation is performed for the following purposes:

• preparation of material for the plasmapheresis procedure;

• separation of plasma for donor plasmapheresis;

• obtaining platelet-rich plasma for the needs of surgery, orthopedics, dentistry and cosmetology;

• obtaining platelet mass for blood transfusion;

• obtaining red blood cells for blood transfusion and treatment of systemic blood diseases

When carrying out transfusion of blood components, it is possible to reduce the load on the patient's circulatory system and reduce other side effects, while it becomes possible to effectively use donor blood and its components.

A centrifugal device for separating blood into components is known, containing a set of pumping and compression lines, including a pre-connected extracorporeal closed main circuit forming a donor line, a cassette assembly configured to interface with the pump elements of the centrifugal device, a separating node channel configured to interfacing with a centrifugal device, and a line containing a filter and a main loop made with the possibility of passing blood through it from a cassette node to the separation node and vice versa, and also containing a set of bags, made with the possibility of placing on a centrifugal device, and consisting of at least one bag for plasma, one bag for platelets and one bag with PAS (platelet storage solution)

(US Patent M> 8523750, publ. 09/03/2013)

A centrifugal device for separating blood into components is known, containing a pre-connected extracorporeal closed main circuit forming a donor line, a cassette assembly configured to interface with the pump elements of the centrifugal device, a channel of the separating unit configured to interface with the centrifugal device, and a line containing a filter and a main loop made with the possibility of passing blood through it from the cassette unit to the separating unit and back, and also containing a set of bags, made with the possibility of placing on a centrifugal device, while the cassette unit contains a filter, lines for connection with bags for blood components and a reservoir for collecting returnable blood components, and the donor line is configured to transfer blood from the donor along the line to the cassette assembly and back.

(Utility model patent of the Russian Federation а 184448, IPC А61М 1/38, publ. 12.11.2018, Bull. N° 32).

A centrifugal device for separating blood into components is known, having the shape of a box and including a container system for blood, which includes a composite bag and a cassette with a holder, a centrifuge drum (centrifugation tool) inside the device, which can be divided into several cavities or have a single cavity. The cassette is equipped with two tubes, includes a plate section mounted on the cassette holder, an arcuate section for connecting both end sections on the outside of the plate section, and a filter holder connected to the central section on the outer side of the arcuate section. The cassette holder includes a first sensor and a second sensor, each of which has a light emitting section and a light receiving section, and which are configured to determine the type of liquid passing between the light emitting section and a light receiving section, wherein the cassette has a sensor opening into which the first sensor and the second sensor are inserted, and the first tube is located so that it passes between the light emitting section and the light receiving section of the first sensor, while the second tube is located so that it passes between the light emitting section and a light-receiving section of the second sensor. This makes it possible to recognize the liquids present in the tubes. The central working part of the centrifuge drum has a holding lever, which is under the load of an elastic body and which holds the end portion of the cassette holder, the electrodes, the first rods and the second rods, as well as the clamping element. The centrifugal device is controlled based on the operations performed on the console section installed in front of the device, controlled by a microcomputer, and can display the set information on the monitor.

(Patent RF JVb 2486922, IPC A61M 1/36, publ. 10.07.2013, Bull. M> 19)

Known centrifugal device for separating blood into components, including a container system for blood and centrifugation means in the form of a centrifuge bell. The centrifuge bell inside has an upper inner member and a lower inner member. The upper inner element can be rotatable with the outer housing and coaxial with it. The lower inner member may have a lower wall and a proximally extending wall which extends from the lower wall and is positioned radially outward from a portion of said upper inner member. On the intermediate part of the outer housing of the centrifuge bell there is an optical system that controls the interface between the first blood component and the second blood component. The optical system may include an LED that emits a beam that illuminates a small area of the intermediate portion. In addition, the optical system may also include an optical sensor, which is focused on the illuminated area of the intermediate part of the bell. The optical sensor controls the operation of the pump for the first blood component based on the position of the interface. The optical system is in communication with the control system of the device for separating blood into components,

(RF Patent

2662856, IPC A61M 1/36, publ. 07/31/2018, Bull. JFS 22) However, these devices have a low efficiency in the extraction of cellular blood components, low speed and, as a result, a high burden on the donor.

The objective of the invention is to create an effective device for automatic cytoplasmapheresis, with sufficient mechanical strength, ease of use, reliability of operation and speed of the procedure for separating blood cells, which makes it possible to evaluate the appearance of a platelet mass in a rotating centrifuge bell and determine its volume to obtain platelets with a given concentration, as well as measure light transmission (turbidity) of blood components during centrifugation.

The technical result is to increase the efficiency of the device.

This is achieved by the fact that in the claimed device for automatic cytoplasmapheresis, including a container system for blood, a centrifugation tool and an optical system associated with the device control system, according to the invention, the optical system is located in the centrifugation tool and consists of an optical sensor with a monochrome light source and a filtering device monochrome light emission; a video camera is also additionally installed, while the data received from the optical system and the video camera are transmitted through the information processing device to the system control panel.

To perform the process of thrombopheresis through blood centrifugation, it is necessary to control the appearance/presence of a layer of platelets, as well as to give a quantitative forecast for the volume of released platelet mass. Platelet mass in density is intermediate between the erythrocyte mass and plasma. During centrifugation, a white layer of platelet mass is formed in the container, which is necessary for moving to a separate container. The layer has fairly clear boundaries, and is visually distinguishable from plasma (plasma is yellow, is located above the white platelet layer during centrifugation) and erythrocyte mass (has a dark red color, is located below the platelet layer during centrifugation). During centrifugation, plasma, as a lighter component, rises along the walls a sealed centrifuge bell with translucent walls and tubes for inlet and outlet of fluid, after which it moves through the tubes into a special bag to collect the blood component. Following the plasma along the walls of the bell, the platelet mass begins to rise - the target product of the thrombopheresis process. When a platelet mass appears in the bell, it is necessary, by adding plasma to the bell, to create a sufficient amount of liquid in the bell to wash out the platelet layer. As it was established experimentally, the rate of plasma inflow to wash out the platelet layer depends on the volume of platelet mass present in the bell, as well as the centrifuge rotation speed and hemotocrit. Thus, there is a need to evaluate the appearance of a platelet mass in a rotating centrifuge bell and determine its volume.

Due to the fact that each blood component has not only its own density value, but also its own turbidity value (an indicator of a decrease in the transparency of a liquid due to the presence of fine particles in it), and the design of the bell is made of glass and a plastic rod-core, then to detect blood component is the need to measure the turbidity of blood components during centrifugation. That is, to use the effect of the relationship between the density of a blood component and its turbidity.

In this regard, an optical system was developed that allows solving the tasks set. The optical system includes an optical sensor with a monochrome light source (hereinafter referred to as the optical sensor) and a device for filtering monochrome light radiation; as well as a video camera. Data from the optical system is fed to the control panel through an information processing device.

An optical sensor with a monochrome light source is a monochrome light source with a strictly specified wavelength, which is directed to a predetermined position in the bell with the help of optical waveguides, and the sensor is also directed to the position where monochrome light is illuminated by means of an optical waveguide. Light generated by a monochrome source travels through the liquid in the rotating bell and is reflected off the core of the bell. The amplitude of the returned (reflected) wave indicates the degree of light transmission of the liquid through which the light has passed. Application A monochrome light source makes it possible to calculate the current blood component with a high probability, and, in fact, to determine the boundaries of blood components under the illumination conditions that are present in laboratories and at blood transfusion stations.

Due to the filtering device, all frequencies that do not coincide with the frequency of a monochrome source are filtered out, which makes it possible to use the system in various lighting conditions.

The video camera is aimed at the upper part of the bell, performs an auxiliary role and serves to detect the fact of separation of blood into components, as well as to determine the amount of platelet mass located in the bell, and in fact - to determine the thickness of the leukocyte layer, that is, the number of platelets. Using the video camera, it is possible to determine the time when the valve cuts off the liquid leaving the bell, i.e. to identify the presence of the moment of completion of the washing out of the leukocyte layer, in order to prevent the entry of erythrocytes into the container with platelets. Data from the video camera is transmitted to the monitor located on the system control panel.

The information processing device calculates the obtained value of light transmission (turbidity) based on the amplitude of the filtered signal of the light-sensitive point light sensor, and calculates the current blood component based on pre-set values (permissible turbidity limits for each blood component).

The main effect - in contrast to existing solutions - is the ability to obtain platelets with a given concentration, minimizing the time of the procedure for separating blood cells, eliminating the reflux of erythrocytes into a container with platelets. The ratio of the thickness of the layers is displayed on the display screen through the information processing device.

The claimed device for automatic cytoplasmapheresis is illustrated by drawings.

Fig. 1 - general view of the centrifuge;

Fig. 2 is a close-up of the optical system showing the direction of the beam from the spotlight device;

Fig. 3: For - the location of the elements of the optical system;

36 - arrangement of elements of the optical system, side view.

Fig. 4 - monitor on the control panel of the device for separating blood into components. where 1 - centrifuge; 2 - optical system; 3 - optical sensor with a monochrome light source, 4 - movable bracket for optical sensor 3; 5 - video camera; 6 - device for filtering monochrome light radiation; 7 - fixing screw of the optical sensor 3.

In the upper part of the centrifuge bowl 1, there is an optical system 2, which includes an optical sensor 3 with a monochrome light source on a movable bracket 4, with which you can set the direction of the beam and fix it with a screw 7; a device 6 for filtering monochrome light radiation and a video camera 5. The beam is directed to the core of the bell (not shown) and from it the optical sensor 3 measures the optical reflection during the passage of various blood components in front of the optical beam. Optical sensors for measuring the light transmission of a liquid provide a transparency measurement time of no more than 1 second.

The device for separating blood into components operates as follows.

The device takes the amount of blood set by the program, safe for the donor, which is subjected to centrifugation. The final collected volume of the product is set by the operator, the number of cycles is determined by software using the built-in hemocalculator. In the centrifugal separation chamber, called the bell, the blood components are separated, in accordance with the difference in their specific gravity. Readings are transmitted to the monitor on the control panel from the optical system of the centrifuge, which continuously measures the density of the plasma in anticipation of the approach of the buffy coat. After some time, the approached leukocyte layer is detected by an optical sensor of monochrome light and a video camera. Optical sensors for measuring liquid transparency provide a transparency measurement time of no more than 1 second.

After the optical system determines the leukocyte layer, a delay phase is formed for the concentration of the leukocyte layer, and to a greater extent platelets in the upper part of the bell. Based on the video camera readings, the width of the platelet layer is estimated based on their assessment of the width of the color the boundaries of the blood components separated during centrifugation, after which, based on the geometric parameters of the separation chamber, their volume is calculated. Based on the data on the number (volume) of platelets and setting the concentration of received platelets and plasma in the bag with platelets, as well as the donor's blood hemotocrit, the flow rate of the washing out plasma increases in proportion to the volume of platelets in the chamber and a corresponding change in the speed of rotation of the centrifuge.

The current readings of the optical system are recorded and then the leukocyte layer concentrated in the upper part of the bell is squeezed out into the drain tube after the centrifuge.

Upon completion of the platelet collection process, the platelet collection line valve closes and the transfer pump stops. The air collection bag valve opens to relieve excess pressure in the centrifuge. The centrifuge stops. The return of blood and excess plasma to the donor begins.

In addition, the use of an optical system with a video camera makes it possible to assess the degree of contamination of the optical part of the photosensitive element, which, in turn, may hinder the effective operation of the system. The information processing device, by comparing the readings of the optical sensor and the video camera, diagnoses the state of the optical elements; the level of contamination is automatically assessed by the device after the separation chamber is installed in the centrifuge and before it is filled with blood. At the same time, the readings of the optical sensor and the video camera (in the part of the image aimed at the place where the optical sensor is focused) are compared, and in case of a discrepancy between the signal values, a warning is issued to the control panel.

Claims

Claim

An automatic cytoplasmpheresis device, including a container system for blood, a centrifugation means and an optical system associated with the device control system, characterized in that the optical system is located in the centrifugation means and consists of an optical sensor with a monochrome light source and a monochrome light radiation filtering device; in addition, a video camera is additionally installed, which makes it possible to evaluate the volume of platelets, on the basis of which the control system sets the speed of rotation of the centrifuge and the volume of plasma supplied to wash out the platelets; in this case, the data received from the optical system and the video camera are transmitted through the information processing device to the system control panel.