RU2261118C2 - Artificial circulation of the blood mobile apparatus - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: apparatus has at least one vein tube, blood pump, oxygenator, arterial filter, and arterial tube, tube system to provide circulation of the blood, automatic control system and autonomous voltage source. Members providing circulation of the blood and reception of biochemical and physiological signals on one side and members of drive and automatic control on the other side, are disposed in two separate modules and they can integrated for forming single functional unit.

EFFECT: service comfort.

10 cl, 6 dwg

Description

This invention relates to a cardiopulmonary bypass device (heart-lung mobile device), designed to maintain blood circulation in accordance with the restrictive part of claim 1.

To maintain the blood circulation of a person, hypoxymic venous blood is released from this person by means of a cardiopulmonary bypass with a cannula and is pumped to an oxygenator by means of a pump for pumping blood to avoid or to prevent circulatory arrest or insufficient blood supply during surgery as a result of a heart attack or any other organ malfunction . In the oxygenator, which serves as an artificial respiration apparatus (artificial lung), the blood is enriched with oxygen and CO ₂ is removed from it. After that, oxygen-enriched arterial blood is supplied to the patient's blood circulation through the cannula after purification in the arterial filter. This type of heart-lung machine is used for stationary applications in hospitals. Such a stationary cardiopulmonary bypass device is described, for example, in WO 99/59654 (CARDIOVENTION). It contains an integrated oxygenator and pump unit located in the sterile area around the patient, and a control console outside this sterile area, connected to the mentioned unit via a connecting cable. The control console has control devices and drives for the pump and oxygenator.

DE 4343334 A1 discloses the essence of a cardiopulmonary bypass device for mobile use. It has a supporting structure, equipped with carrying handles front and rear and fixed supports protruding downward. In the case of this apparatus, functionally important elements are arranged so that they are freely accessible and therefore not protected against damage that could affect operability during operation. In addition, two people must always carry this unit.

The essence of the mobile cardiopulmonary bypass device is also disclosed in the publication DE 19702098 A1. It contains a circuit for supplying blood to the artery, a second circuit for draining blood from a vein, a venous reservoir, an oxygenator, a pump for pumping blood, made in the form of a vane pump, and an oxygen dispenser in the form of an oxygen concentrator connected to the discharge side of the pump. The device has a controller for controlling the oxygen concentrator and pump capacity, as well as connecting means for decentralized power supply and / or energy storage. Although this heart-lung machine is also designed for mobile use, given its size and weight, one person usually cannot handle it. Due to the limited space in the ambulance, it is almost impossible to take this device in a state of readiness for work on an ambulance call. The speed required for emergency calls makes long-term installation and preparation disadvantageous. In addition, each time they are used, the aforementioned cardiopulmonary bypasses have to be reconfigured and cleaned, performing a complex procedure before they can be used again. As a result, immediate reuse is not possible.

In the publication WO 97/16213 (BAXTER) the essence of a mobile cardiopulmonary bypass device has already been disclosed, in which the elements providing blood circulation, including a blood pump, a heat exchanger and an oxygenator, are assembled in a structure intended for use only once, and the pump motor enters the reusable drive unit. The structure, intended to be used only once, is connected to the drive unit by a power short circuit by means of a connecting part protruding high upward from said drive unit. There are additional means of connection with individual drive units and automatic control. The means for connecting the corresponding tubes to the structure are publicly available and can easily be damaged or open, in particular during mobile use.

Therefore, the objective of the present invention is to develop a mobile cardiopulmonary bypass device of the above type, providing universal use, as well as reliability and ease of use.

This problem is solved by the subject of the invention according to claim 1. Separation into a module with elements that provide blood circulation, reception of biochemical and physiological signals and the development of control signals ("one-time use module"), and a module with drive and automatic control elements ("reusable module") allows you to quickly replace the module after use, designed to be used only once, containing blood circulation elements so that this heart-lung machine can be used quickly again. Given this modularity, it is also possible to create appropriate modules in an already usable and compact form. This guarantees, in particular, high functional reliability in operation, since it is not necessary to take complex measures to start and configure in the limited time conditions typical of operation. In addition, the fact that the elements providing blood circulation are grouped in a compact module allows you to get a tube system that provides blood circulation between the individual elements having a specific short length, as a result of which it is possible to reduce the volume of filling, which is beneficial for the patient. Moreover, the routes and nature of the blood channels in this module can be precisely defined and developed to provide favorable blood flow conditions in order to reduce injuries associated with blood loss as much as possible. In this regard, it should be noted that it is possible, for example, to connect such industrially supplied components as an oxygenator, a centrifugal pump head, a filter, etc., with fixed blood channels. If necessary, the individual components of the disposable module, made in the form of a cartridge, can be easily removed and replaced with others.

The dependent claims describe preferred specific embodiments of the invention.

According to the invention, both modules can be simply connected to each other to form one unit in which they can be mounted one on top of the other and can be mechanically and electrically connected to each other. Therefore, the heart-lung machine is easy to use in mobile applications, and it can be carried by one person. It is also possible to implement a pump for pumping blood in the form of a centrifugal pump. As pumps for pumping blood, slide valves are usually used. Given their massive plunger pair, they are heavy and require significant energy consumption during operation. On the other hand, in particular, centrifugal pumps are economical in terms of energy consumption. In addition, they are distinguished by a suction effect based on the resulting vacuum. As a result, the blood is absorbed to the extent necessary to supply the patient, and in accordance with the capacity of the (pump), if it is impossible to provide a passive reverse flow of the blood itself. This is important, in particular, when such pumps are used for emergency care, if the patient’s cannulation has not been done optimally or the tubes cannot be positioned optimally taking into account external circumstances.

According to the invention, the head of the pump through which blood flows and the drive of the pump — a pump for pumping blood — are respectively located in the respective modules. When the modules are connected to each other, the pump head and the pump drive are connected to each other by means of a coupling. Since the elements that come into contact with the blood are located in one single-use module designed as a sterile-packed unit, the costs of manufacturing a module designed for use only once can be kept low, which means the operational costs of a mobile heart-lung machine.

According to a preferred particular embodiment of the invention, the means of connection between the individual circulatory elements comprise flexible and / or rigid tubes for optimizing and standardizing hemodynamics and for increasing internal stiffness. Elements of the extracorporeal contour that provide blood circulation and the tubes connecting them are fixed in the module housing by means of fixing or fixing devices. Such a system is more reliable than connecting straight inserted tubes, and it provides rigidity and better preservation of individual elements in a disposable module.

It is proved that it is advisable to form at least some of the elements that provide blood circulation, as a whole with the module, for example, in the form of castings obtained by injection molding. If the system providing blood circulation, or, for example, the cases of other elements providing blood circulation in the module, are an embedded part of a disposable module, the latter can also be reduced in size and can be obtained in an embedded form. It is also possible to manufacture a module case with blood circulation elements and a blood circulation system in the form of a cassette into which industry-supplied blood circulation elements can be installed, such as an oxygenator, a blood pump, a pump head belonging to a centrifugal pump, an arterial filter and the like, using fasteners. Oxygenators, pumps, filters, or similar circulatory elements, with their own blood channels, gas lines, etc., specifically designed for use in a cardiopulmonary bypass device in accordance with the invention, can also be installed in a cassette made, for example, in in the form of castings obtained by injection molding. This ensures even greater integration and compactness of the reusable module.

To provide visual control of blood flow at any time during the operation of the heart-lung machine, the reusable module has a transparent body.

It has been proven that it is advantageous to have elements that receive biochemical and physiological signals in the form of sensors that measure, among other things, blood pH, blood pCO _2, blood temperature, blood flow rate, FiO ₂ , gas temperature, gas flow rate, gas pO ₂ , pCO ₂ gas, water temperature, pump speed or current flowing to the pump drive.

According to the invention, sensors for measuring parameters, for indicating loops and for use with the purpose of generating acoustic, optical or acousto-optic warnings and for processing values for control purposes are connected to a drive and automatic control system. They automatically control, among other things, the pump drive for pumping blood and, in the event of deviations from the value of the set blood flow setting, give acoustic, optical or acousto-optic warnings. Thus, any possible malfunctions and / or changes in the patient's condition are indicated quickly and reliably, so that the appropriate action can be taken. To monitor blood flow, you can also place a flow sensor on the arterial tube, which performs quantitative monitoring of blood flow without coming into contact with blood. The pumping speed of the pump for pumping blood is in the range between 2 l / min - 10 l / min and it can be controlled by changing continuously or by adding discrete increments through the automatic control system.

According to a further specific embodiment of the invention, closable filling and ventilation openings that can be operated externally are provided on a reservoir located upstream of the blood injection pump for receiving venous blood, on an arterial filter and / or on an oxygenator to ensure full and full and simple ventilation of the tank when the heart-lung machine is put into operation. They serve, in particular, to supply a primary solution or drugs, for example, such as heparin, to reduce coagulation. In this case, the tank may be made in the form of a bag. Such a reservoir serves as a buffer to compensate for the changing inflow and outflow of blood. The use of the bag provides a simple adaptation of the reservoir to the volume of the correspondingly received blood.

According to the invention, a temperature control device may be provided on the oxygenator, for example, in the form of a heat exchanger that can operate on water and through which blood flows to control the temperature of the blood, if desired, before being returned to the patient.

The pre-filled primary solution gives the effect that the heart-lung machine is fully ventilated and maintained in immediate readiness before connecting to the patient during surgery to support blood circulation. To this end, the circulatory system has a preliminary shunt filter that is connected to the shunt between the arterial tube and venous tube and through which the primary solution circulates before the device is connected to the patient. In addition, blood circulation can be maintained through a shunt, which can be used externally in the event of a clogged arterial filter.

To develop the concept of the invention, it should be added that the automatic control system has an input unit and an output unit for dialogue with the user, in particular buttons, and / or controls, and / or a display, as well as a program for initialization and functional control during operation of the apparatus cardiopulmonary bypass to guarantee easy control by the operator.

In accordance with the invention, the provided self-contained power source can be made in the form of a battery and have an indicator of its charged state. Therefore, the approaching discharge of the battery can be detected in due time so that, if necessary, measures can be taken to provide an external power source. Incidentally, the pump could be driven by a mechanical handle.

The heart-lung machine also has a means of connection for an external voltage source to provide charging of the battery, for example, in an ambulance or working with an external power source after the battery is discharged.

The following is a more detailed explanation of the invention based on a possible specific embodiment shown in the drawings, where

figure 1 depicts an acute angle view from above of a mobile cardiopulmonary bypass device according to the invention, with modules separated from each other,

figure 2 depicts a view of the heart-lung machine shown in figure 1, with modules connected to each other,

figure 3 depicts a schematic representation of the elements that provide blood circulation, cardiopulmonary bypass, presented in figure 1,

figure 4 depicts a front view of the heart-lung machine corresponding to figure 1,

figure 5 depicts a top view of the heart-lung machine shown in figure 1, and

Fig.6 depicts a side view of the heart-lung machine corresponding to Fig.1.

The mobile cardiopulmonary bypass device 1 shown in Fig. 1 contains two separate modules 2 and 3. Inside the first module 2 (the “single use module”), intended for use only once, the elements are enclosed that provide blood circulation, biochemical and physiological reception signals and the execution of control commands, and the second module 3 reusable enclosed elements of the drive and control. Both modules 2 and 3 can be connected to each other to form one functional unit, mounted one on top of the other and connected mechanically and simultaneously electrically to each other by means of fixing elements (not shown) (see figure 2). In the connected state, the cardiopulmonary bypass device 1 is ready for use after filling with the primary solution and can be connected via the arterial and venous tubes 4 and 5, respectively, to the circulatory organs of the patient who needs to be given blood.

The design and operation mode of the disposable module 2 is illustrated based on the schematic representation shown in FIG. 3. The patient's hypoxymic blood is passed through a venous tube 5 into module 2 of the cardiopulmonary bypass apparatus 1, which contains blood circulation elements. The venous tube 5 in this case can be connected to a closed reservoir 6 for receiving venous blood. Through the system 7, providing blood circulation, the reservoir 6 is connected through a pump 8 for pumping blood with an oxygenator 9 for enriching blood with oxygen and for the removal of carbon dioxide. The gas connection 10 is open to the oxygenator 9 through the filter 11 and serves to connect an external gas source. Therefore, it is possible to use mobile cylinders with oxygen and carbon dioxide or a stationary hospital oxygen supply system for gas exchange in the oxygenator 9. A temperature control device 12 is also located on the oxygenator 9, through which the temperature control medium flows through circuit 13. To control the blood temperature, system 7, which provides blood circulation, has a part 14 protruding into the temperature control device 12. Downstream of the oxygenator 9 in the blood circulation system 7 is an arterial filter 15 for purifying the blood. Around the arterial filter 15, a shunt 16 is provided, which can be activated externally by a valve 17 to maintain blood circulation even in the event of a clogged arterial filter 15. An arterial tube 4 is connected to the outlet of the arterial filter 15 to return blood to the patient. For the purpose of contactless monitoring of blood flow on the arterial tube 4, a flow sensor 18 is provided, which detects the blood flow and reports about it to the automatic control system 24.

Figure 4 depicts a front view of the cardiopulmonary bypass device 1 with a disposable module 2 having blood circulation elements and a reusable module 3 with drive and control elements. Based on the replaceable module 2, there is an oxygenator 9 with a temperature control device 12. A bag 6 for receiving venous blood made in the form of a bag is located above the oxygenator 9 on an inclined support 19. Together with the oxygenator 9, a pump 8 for pumping blood is located on the base of module 2. This pump for pumping blood is made in the form of a centrifugal pump and has a pump head 21, which is connected by a sleeve 22 to the pump drive 23 located in the refillable module 3. Clutch 22 is a magnetic clutch. Above the pump 8 for pumping blood is an arterial filter 15, which is connected to the arterial tube 4 and on which there is a shunt 16 with valve 17. Directly in front of the place where the arterial tube 4 exits module 2, there is a non-contact flow sensor 18. Elements that provide blood circulation are connected to each other by tubes of the system 7, providing blood circulation.

In the reusable module 3, an automatic control system 24 with buttons 25 and a display 26 is located. Buttons 25 and display 26 can also be made in the form of a touch screen. In addition to the automatic control system 24, in module 3 there is an indicator 27 for indicating the charged state of the battery, a controller 28 and a rotation speed indicator 29 for manually controlling the pumping speed of the centrifugal pump 8, as well as connection means 30 for connecting an external voltage source. A central “on” and “off” state switch 31 and a signal light 32 are also provided. In addition, module 3 has a battery (not shown) as a stand-alone voltage source.

The disposable module 2 has a transparent module case 33, while the reusable module 3 with drive and control elements has an opaque case 34. A carrying handle 35 is attached to the upper surface of the transparent case 33 of the module 2 intended for single use.

Figure 5 depicts in a plan view the elements that provide blood circulation in the module 2 disposable. The venous tube 5 is connected to the reservoir 6. By means of a blood circulation system 7, the reservoir 6 is connected via a pump 8 for pumping blood with an oxygenator 9 (which is not visible in this figure), the outlet of which is connected through the arterial filter 15 to the arterial tube 4.

6, the cardiopulmonary bypass device 1 is shown in a side view showing the connections for the arterial and venous tubes 4 and 5. Here you can also see the outlet openings of the circuit 13 of the temperature control device 12, as well as the gas connection 10 with the filter 11. The connection is not shown tube 36, conventionally shown in figure 3, with a preliminary shunt filter 37 between the venous tube 5 and arterial tube 4. Opening the covers, which are not shown in the drawing and which can be reached from the outside, and at the same time removing presses with tubes 4 and 5 can be closed internal circuit elements providing circulation. In the process of such work of the blood circulation circuit, before connecting the cardiopulmonary bypass apparatus 1 to the patient, it is possible to completely ventilate the blood circulation elements by means of valves 38 and 40 on the reservoir 6. To this end, ventilation tubes 39 are also connected to the arterial filter 15 and oxygenator 9.

The mode of operation of the above-described apparatus 1 cardiopulmonary bypass is as follows.

During the operation of the cardiopulmonary bypass apparatus 1, hypoxic venous blood flows through the venous tube 5 into the reservoir 6. The supply of the primary solution, drugs, etc. possible through ventilation valves 38, 40 on the venous tube 5 and / or on the reservoir 6. From the reservoir 6, the blood is pumped by a centrifugal pump 8 to the oxygenator 9, in which it is enriched with oxygen. During gas exchange in the oxygenator 9, blood flows through a temperature control device 12, in which blood temperature can be controlled. For this purpose, a temperature control medium from circuit 13 can be supplied to the temperature control device 12. Oxygen or an oxygen mixture is introduced into the oxygenator 9 through the gas connection 10. Immediately after oxygen enrichment, blood is passed for purification through the arterial filter 15, which is equipped with a shunt 16. If the arterial filter 15 becomes clogged during operation, you can manually open the shunt to maintain the patient's blood circulation. Then the blood is again supplied to the patient through the arterial tube 4, passing the flow sensor 18.

The flow sensor 18 measures the blood flow in the arterial tube 4 and is connected to the automatic control system 24 of the cardiopulmonary bypass device 1 by means of an electric plug contact 20 (see, for example, FIG. 1). In accordance with the measured flow rate, the automatic control system 24 controls the pump drive 23. Upon reaching critical values, the automatic control system 24 generates appropriate acoustic, optical, or acousto-optic warnings.

In addition, in the module 2 disposable provides additional sensors (not shown in the drawing) for receiving biochemical or physiological signals, which are used to monitor the functioning of the apparatus 1 of cardiopulmonary bypass. The signals of these sensors are transmitted through contacts similar to the male contact 20, to the automatic control system 24, and all these contacts can be grouped into a multi-pin plug. This makes it easy to connect both modules 2 and 3 to each other. Elements that implement control signals can also be located in the disposable module 2, and the automatic control system 24 can switch these elements through electrical contacts.

In order to disconnect the patient from the cardiopulmonary bypass apparatus 1, the pumping speed of the blood pump 8 is gradually reduced by the automatic control system 24 and adapted to the perceived state of the heart. Only after this can the heart-lung machine 1 be turned off, provided that the patient is again in a stable state. After disconnection, the disposable module 2 with the blood circulation elements can be easily disconnected from the reusable module 3 with the drive and control elements, opening the locking elements, and can be replaced with a new sterile disposable module 2. After the locking elements are closed and the primary solution is filled, the cardiopulmonary bypass apparatus 1 is immediately ready for reuse.

This provides a cardiopulmonary bypass apparatus 1, which, taking into account its modular design, comprising a disposable module 2 and a reusable module 3, can be quickly put into operation and taking into account the compactness of both modules 2 and 3 can be transferred by the efforts of one person; therefore, this device is suitable, in particular, for emergency calls.

Adding a system of suction devices and / or assistance with cardioplegia (cardiac arrest), intended for ventilation, absorption, and stabilization of the heart, it is possible to make the mobile heart-lung machine 1 suitable for stationary use in hospitals, for example, during heart surgery.

Notation list

1. Mobile heart-lung machine

2. Module with blood circulation elements

3. Module with drive and control elements

4. Arterial tube

5. Venous tube

6. The reservoir

7. The system that provides blood circulation

8. Blood injection pump

9. Oxygenator

10. Gas connection

11. Filter

12. Temperature control device

13. The circuit

14. Part

15. Arterial filter

16. Shunt

17. Valve

18. Flow sensor

19. Support

20. Fork contact

21. Pump head

22. Coupling

23. Pump drive

24. Automatic control system

25. Buttons

26. Display

27. Indicator

28. Controller

29. Speed indicator

30. Connection tool

31. The state switch "on" and "off"

32. Warning light

33. Transparent module housing

34. Module housing

35. Carrying handle

36. Connecting tube

37. Pre-shunt filter

38. Air vent or valve

39. Ventilation tubes

40. Air vent or valve

Claims (10)

1. A mobile cardiopulmonary bypass device designed to maintain blood circulation by taking over or maintaining cardiopulmonary function with at least one venous tube, a blood pump, an oxygenator, an arterial filter, an arterial tube, and a tube system that provides blood circulation, an automatic control system and an autonomous voltage source, characterized in that the arterial and venous tubes, a reservoir for receiving venous blood, a system of tubes, ensure circulating blood circulation, head for pumping blood, oxygenator, arterial filter, on the one hand, and pump drive, automatic control system, indicator for indicating the charged state of the battery, controller, rotation speed indicator, connection means for connecting an external voltage source, status switch “on” and “off” and the signal light, on the other hand, are located in two separate modules - disposable and reusable, respectively, made with possible awn mechanical and electrical connection with each other to form a functional unit provided with a carrying handle. 2. The mobile device according to claim 1, characterized in that the modules connected to each other are mounted one on top of the other and a carrying handle is attached to the housing of the disposable module. 3. The mobile device according to claim 1, characterized in that the constituent elements providing blood circulation to the extracorporeal circuit and the tubes connecting them are located and / or fixed in the module body by means of fixing or fixing devices. 4. The mobile device according to claim 1, characterized in that at least some of the elements that provide blood circulation are made integrally with a disposable module, in particular, in the form of an integral cast obtained by injection molding. 5. The mobile device according to claim 1, characterized in that the disposable module has a transparent body. 6. The mobile device according to claim 1, characterized in that the non-contact flow sensor is connected to an automatic control system. 7. The mobile device according to claim 1, characterized in that the filling and ventilation holes are provided on the reservoir located upstream of the pump for pumping blood to receive venous blood, on an arterial filter and / or on an oxygenator. 8. The mobile device according to claim 1, characterized in that the blood circulation system has a preliminary shunt filter that is connected to the shunt between the venous tube and the arterial tube leading to the patient. 9. The mobile device according to claim 1, characterized in that the automatic control system is equipped with an input unit and an output unit for dialogue with the user, made in particular in the form of buttons and / or control elements and / or display. 10. The mobile device according to claim 1, characterized in that the autonomous power source contains a battery and a charged state indicator.

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