UA71948C2 - Mobile heart-lung machine for maintaining blood circulation and respiration - Google Patents

Abstract

The invention relates to a mobile heart-lung machine for maintaining the blood circulation by taking over or supporting the cardiopulmonary function. Said machine comprises at least one venous tube (5), a blood pump (8), an oxygenator (9), an arterial filter (15), an arterial tube (4) and a tubular system for circulating the blood (7), an automatic control system (24) and a self-sufficient voltage supply. The aim of the invention is to provide a heart-lung machine that is easy to handle. To this end, the elements (4, 5, 6, 7, 8, 9, 15,18, 21) which circulate the blood, receive the biochemical and physiological signal and carry out the control commands on the one hand and the drive and automatic control elements (23, 24, 27, 28, 29, 30, 31, 32) on the other hand are arranged in two separate modules (2, 3) and can be combined to form one functional unit.

Description

Description of the invention

The invention relates to a mobile cardiopulmonary device for maintaining blood circulation. 2 In order to maintain blood circulation in a person in order to prevent or eliminate the stoppage of blood circulation or reduced blood supply during surgery, as a result of an accident or in case of other organic damage, with the help of a cardiopulmonary device, venous blood with a low oxygen content is taken with a cannula and fed into an oxygenator through a blood pump .

In the oxygenator, which takes over the function of an artificial lung, the blood is enriched with oxygen, and CO 5" is removed. 70 Then the oxygen-saturated arterial blood, after cleaning in the arterial filter, is returned to the patient's circulatory system through the cannula. Similar cardiopulmonary devices are used for stationary use in hospitals. So, for example, such a stationary cardiopulmonary apparatus is described in UUO99/59654 (SAKOIOMEMTIOM). It consists of a combined oxygenator-pump unit located in the sterile area next to the patient, as well as a control console connected to it through a connecting cable, which 72 is located outside the sterile area. The control console has controls and drives for the pump and oxygenator.

A cardiopulmonary device for mobile use is known from OEB4343334A1. It has a portable design with front and rear notches for carrying and feet on the bottom for installation.

Appropriate fasteners are provided for fixing the component parts of the cardiopulmonary apparatus. In this device, important functional elements are located with free access and are therefore not protected from damage that could affect the functioning. In addition, the device must always be carried by two people.

A cardiopulmonary apparatus is also known from OE19702098A1. It consists of a hose for supplying blood to the artery, a second hose for removing blood from the vein, as well as a venous reservoir, an oxygenator, a pump for pumping blood, which has the form of a circular pump, and an oxygen source in the form of an oxygen concentrator, c 22 z' connected to the pump on the drive side. The device has a regulator for the oxygen concentrator and for the power of the pump, as well as contacts for decentralized energy supply and/or for an electric battery.

Although this cardiopulmonary device is also designed for mobile use, it usually cannot be used by one person due to its size and weight. Due to the limited space in the ambulance, it is almost impossible to keep this device ready for use in the event of an accident. Long preparations of the 30 and adjustment in case of accidents are a big disadvantage. In addition, the mentioned cardio-pulmonary "And devices after use require a long cleaning and installation, to be ready for a new case.

Therefore, immediate re-application is impossible. at

From МЙ097/16213 (VAHTEK) a mobile cardiopulmonary device is already known, in which blood-conducting elements, including a pump, a heat exchanger and an oxygenator, are placed in a device designed for one-time use, and the pump motor is located in a node for multiple use. The device for - single use dynamically attached to the drive assembly by means of a connecting element protruding upwards from the drive assembly. Other fasteners serve to connect to individual drive, control and adjustment assemblies. Connection elements and contacts to connect the necessary hoses to the " device remain free and may, in particular, be damaged or open when using a mobile C 50. c Therefore, the task of the present invention is to create a mobile cardiopulmonary apparatus of the above-mentioned c" type, suitable for universal use and simple maintenance, in particular, carrying by one person.

According to the invention, this task is solved in a mobile cardiopulmonary apparatus for maintaining 45 blood circulation by replacing or maintaining cardiopulmonary function, which contains at least one venous 7 hose, a blood pump, an oxygenator, an arterial filter, an arterial hose, as well as a tubular blood-conducting - system, regulation and control device and autonomous power supply, due to the fact that the blood-conducting elements that perceive biochemical and physiological signals and execute control signals, on the one hand, and the elements of drive, control and regulation on the other hand, are placed in two separate modules made of the possibility of combining 20 "cars" into one functional unit, as well as the fact that it is made with the possibility of being carried by one person. The division into a module with elements that conduct blood, perceive biochemical and physiological signals and issue control signals ("disposable module") and a module with drive, control and regulation elements ("reusable module") allows for quick replacement of a disposable the use of a module that contains blood-conducting elements, after its use, as a result

HF) so that the cardiopulmonary apparatus is ready for use again very quickly. The division into modules also allows the production of ready-to-use modules in a compact form. In this way, a particularly high reliability of work is ensured, since there is no need to carry out complex operations for installation and maintenance in conditions of lack of time. An advantageous difference of the device corresponding to the invention is that it is made with the possibility of 60 transfer by one person.

In addition, due to the combination of blood-conducting elements in one compact module, the system of hoses and tubes for transporting blood between the individual elements has a particularly short length, as a result of which the filling volume can be reduced, which is favorable for the patient. In addition, the layout and structure of the blood vessels in this module can be accurately determined and calculated in the most advantageous way to make blood loss as small as possible. Yes, at the same time, for example, such standard elements as an oxygenator, a centrifugal pump head, a filter, etc. can be connected to each other by immovable paths for blood. The individual components of the single-use module, made in the form of a cartridge, can be easily interchanged or, if necessary, replaced.

Dependent clauses reproduce advantageous forms of implementation of the invention.

According to the invention, both modules can be easily assembled into one unit, since they are made with the possibility of being superimposed on each other and being connected to each other mechanically and electrically. Therefore, the cardiopulmonary apparatus can be easily used in mobile applications, and it can be carried by one person. This is also due to the fact that the blood pump is centrifugal. Circular pumps are usually used here. Due to the massiveness of the injection element, they have a lot of weight and require a lot of energy during operation. In contrast, centrifugal pumps especially save energy. In addition, they are characterized by a suction effect based on the created reduced pressure. In this way, blood in the volume necessary to supply the patient is sucked according to the performance of the pump, if a sufficient supply cannot be provided by the passive return flow of blood itself. This is especially important in /5 accidents where patient cannulation or hose placement cannot be optimally performed for external reasons.

According to the invention, the pump head, through which the blood passes, and the blood pump drive are placed in the corresponding modules. When installing the modules, the pump head and the drive are connected to each other using a coupling.

Since the elements in contact with the blood are located in a single disposable module, which has the appearance of a sterile node, the costs of manufacturing a single-use module, and thus the costs of using a mobile cardiopulmonary device, are kept low.

According to the preferred embodiment of the invention, connections between individual blood-conducting elements in order to optimize and standardize hemodynamics and increase internal rigidity consist of flexible and/or fixed tubes. The blood-conducting components of the extrapolar blood circulation and their connecting hoses or tubes are attached to the module body with the help of fastening or fixing means. Such a system is more reliable than purely hose connections and contributes to rigidity and better fixation of individual elements in a disposable module. and)

It has been found appropriate that at least part of the blood-conducting elements be manufactured monolithically with the module, for example by injection molding. If the blood supply system or, for example, the housings of other blood-conducting elements are an integrated component of a disposable module, then they may be subject to further reduction and integration during manufacture. It is also possible to manufacture a module body with blood-conducting elements and a blood supply system in the form of cartridges, into which standard blood-conducting elements, such as an oxygenator, a pump for He! blood, centrifugal pump head, arterial filter, etc. It is also possible to mount oxygenators, pumps, filters and other blood-conducting elements with their own blood paths, gas supply tubes, etc., designed specifically for the cardiopulmonary apparatus. in die-cast cartridges. Cha

Thanks to this, they achieve even greater integration and compactness of the disposable module.

So that the blood flow can be constantly monitored during the work of the cardiopulmonary apparatus, the body of the disposable module is made transparent.

It turned out to be beneficial for the elements that perceive biochemical and physiological signals to be sensors that "perceive, among others, such indicators as blood pH, blood pCO5, blood pO"o, temperature and flow rate of blood pt) with blood, RiO", temperature gas and gas flow rate, gas pOo, gas pCO»o, water temperature, pump rotation speed or flow to the pump drive. ;" Sensors for receiving parameters, for displaying and for applying acoustic, optical and acousto-optical warnings and for processing indicators for control purposes according to the invention are connected to a device for actuation, control and regulation. They, for example, regulate the drive of the blood pump and give acoustic, optical, and acoustic-optical warning signals when the blood flow deviates from the set value. In this way, functional disorders and/or changes in the patient's condition are visualized quickly and reliably, which allows appropriate actions to be taken. To control the flow of blood, a flow meter can also be placed in the working hose, which observes the quantitative parameters of the blood flow without coming into contact with the blood. The performance of the blood pump is suitable from 2L/min to 100/min and it can be adjusted by the control device smoothly or discretely. c According to another form of implementation of the invention, the reservoir for venous blood placed in front of the pump is provided with openings for filling and ventilation, which can be closed by an arterial filter and/or oxygenator and serviced externally, ensuring simple and perfect filling of the reservoir before starting the cardiopulmonary apparatus. In particular, they are used to supply a filling solution or medications, for example, heparin to reduce blood clotting. At the same time, the tank can have the shape of a bag. Such

F) the reservoir serves as a shock absorber to compensate for the difference between blood inflow and outflow. As a result of using the bag, the reservoir is easily adapted to the collected amount of blood.

According to the invention, a tempering device (for maintaining the temperature) can be provided on the oxygenator, such as a type of heat exchanger operating on water, through which the blood flows to bring the blood to the desired temperature before it is sent back to the patient.

With the help of a pre-filled filling solution, the cardiopulmonary apparatus is fully ventilated in the circulation mode before being connected to the patient and is maintained in immediate operational readiness. For this, the circulatory system has a bypass filter, which is connected between the arterial and venous hoses, 65 and through which the filling solution circulates before being applied to the patient. In addition, in the case of possible blockage of the arterial filter, blood circulation can be maintained with the help of an externally maintained bypass.

As a development of the idea of the invention, the regulating and controlling device can have an input and output unit for conducting a dialogue with the user, in particular a keyboard and/or display, as well as a program for initiating control of the work of the cardiopulmonary apparatus, which aims to provide simple maintenance.

The intended autonomous power supply according to the invention can be a battery and have an indicator for its charge. Therefore, the need to charge the battery is demonstrated in a timely manner, which makes it possible to take measures to obtain power from the outside. Meanwhile, the pump can be operated using a mechanical crank handle.

It is advantageous when the heart-lung machine also has a connection to an external power source, so that it is possible to 7/0, for example, charge the battery in an ambulance or to continue working with an empty battery.

The invention is explained by the implementation examples depicted in the drawings, namely:

Fig. 1 - a top view at an angle of a mobile cardiopulmonary apparatus with disconnected modules,

Fig. 2 - a view of the cardiopulmonary apparatus according to Fig. 1 with mounted modules,

Fig. 3 is a schematic representation of the blood-conducting elements of the cardiopulmonary apparatus according to Fig. 1,

Fig. A4 is a front view of the cardiopulmonary apparatus of Fig. 1, Fig. 5 is a top view of the cardiopulmonary apparatus of Fig. 1, and Fig. b is a side view of the cardiopulmonary apparatus of Fig. 1.

The mobile cardiopulmonary device 1 shown in Fig. 1 consists of two separate modules 2 and 3. In the first module, intended for single use, there are blood-conducting elements and elements for receiving biochemical and physiological signals, as well as elements for executing control signals, while the second module C houses the drive and control elements for reuse. Both modules 2 and 3 can be assembled into a single functional unit, and they are connected to each other by mounting or by means of non-illustrated fixing elements mechanically and simultaneously electrically (see Fig. 2). In the assembled state, the cardiopulmonary device is ready for use after step 2g5 Filling with the filling solution and can be connected to the patient's blood circulation with the help of arterial and venous hoses 4 and 5. and)

Based on the schematic image in Fig. 3, the structure and principle of operation of the disposable module 2 is explained.

Through the venous hose 5, the oxygen-depleted blood of the patient enters the module 2 with the blood-conducting elements of the cardio-pulmonary apparatus 1. The venous hose 5 can be connected to a closed reservoir, designed for receiving venous blood. Through the circulatory system 7, the reservoir 6 with the help of a pump 8, it is connected to the oxygenator 9 in order to saturate the blood with oxygen and remove hydrogen dioxide. The gas inlet 10" through the filter 11 is connected to the oxygenator 9 and serves to connect an external gas source. In this way, for gas exchange in the oxygenator U, it is possible turn to bottles with oxygen and hydrogen dioxide or to the hospital's oxygen supply network. In addition, on the oxygenator 9 there is a device 12 for -- c5 tempering, through which the tempered agent passes with the help of a circuit 13. For tempering the blood, the circulatory system 7 has a section 14 , which protrudes into the device 12. Behind the oxygenator 9 in the blood-conducting system 7 is an arterial f filter 15 for blood purification. A bypass 16 is provided around the arterial filter 15, which is serviced externally by means of a valve 17, so that blood circulation can be maintained even with possible blockages of the arterial filter 15. An arterial hose 4 is connected to the outlet of the arterial filter 15 for returning blood to the patient. For visual control of the blood flow on the arterial hose 4, a flow meter 18 is provided, which determines the blood flow and reports it to the control device 24. Figure A4 shows a front view of the cardiopulmonary apparatus 1 with a disposable module 2 having blood-conducting elements and a reusable module C having drive and control elements. At the bottom of the disposable module 2 there is an oxygenator 9 with a tempering device 12. A bag-shaped reservoir -I 6 for venous blood is located on top of the oxygenator 9 on an inclined support 19. Next to the oxygenator 9 at the bottom of the module 2 is a pump 8 for blood. It is designed as a centrifugal pump and has a head 21, which is connected through a coupling - 22 to the drive of the pump 23 located in the Z module. The coupling 22 is magnetic. Above the blood pump 8

Ge) there is an arterial filter 15, which is connected to the arterial hose 4, and on which there is a doro bypass 15 with a valve 17. Immediately before the exit of the arterial hose 4 from the module 2, a visual flow meter ve 18 is located. The tubes and hoses of the blood-conducting system 7 blood-conducting elements from connected to each other. c In the reuse module, there is an adjustment and control device 24 with keys 25 and a display 26. The keys 25 and the display 16 can have the form of Toysp-zsgeepz (touch screens). In addition to the regulating and controlling device 24 on the Z module, there is an indicator 27 for visualizing the charging status of the battery, a regulator 28 and a tachometer 29 for manually controlling the performance of the centrifugal pump 8, as well as a contact 30 for connecting an external voltage source. In addition, a central switch 31 (Ф) and a control lamp 32 are provided. In addition, module C has a battery (not shown) for autonomous power supply.

The disposable module 2 has a transparent housing 33, while the module C with drive and control elements 60 has an opaque housing 34. On the upper surface of the transparent housing 33 of the disposable module 2, there is a handle

Z5 for transfer.

Fig. 5 shows a top view of the blood-conducting elements of the disposable module 2. The venous hose 5 is connected to the reservoir 6. With the help of the blood-conducting system 7, the reservoir 6 through the pump 8 is connected to the (covered) oxygenator 9, the output of which is through the arterial filter 15 leads to the arterial hose 4. 65 Fig. b6 shows the cardiopulmonary apparatus 1 from the side of connecting the arterial and venous hoses.

The outputs of the circuit 13 in the tempering device 12 and the gas inlet 10 with the filter 11 are also visible.

The connecting tubes 36 with the bypass filter 37, with the venous hose 5, and with the arterial hose 4, shown schematically in Fig. 3, are not shown. By opening the shutters, not shown, which are operated from the outside, and simultaneously separating the hoses 4 and 5, it is possible to close the internal circuit in blood-conducting elements.

In such a circulation, before connecting the cardiopulmonary apparatus 1 to the patient, it is possible to completely ventilate the blood-conducting elements with the help of ventilation valves 38 and 40 on the tank 6. For this purpose, the ventilation hoses 39 are also connected to the arterial filter 15 and the oxygenator 9.

The principle of action of the cardiopulmonary device 1 described above:

During the operation of the cardiopulmonary apparatus 1, oxygen-depleted blood flows through the venous hose 5 to the reservoir 6. Through the ventilation valves 38, 40 on the venous hose 5 and/or the reservoir, it is possible to supply the filling solution, medications, etc. From the reservoir b, the blood is pumped to the oxygenator 9 by a ventral pump 8, where it is enriched with oxygen. During gas exchange in the oxygenator U, the blood passes through the tempering device 12, where the tempering of the blood can be carried out. In addition, a tempering agent, preferably water, can be directed to the tempering device 12 from the outside. Through the gas inlet 10 oxygen or oxygen /5 The mixture enters the oxygenator 9. After enriching the blood with oxygen, it passes through the arterial filter 15, which is equipped with a bypass 16, for the purpose of purification. If the arterial filter is clogged during operation, then a bypass can be used to maintain the patient's blood circulation 16 open manually.

Then the blood through the arterial hose 4 again flows to the patient, passing the flow meter 18.

The flow meter 18 measures the blood flow in the arterial hose 4 and is connected to the regulating and controlling device 24 of the cardiopulmonary apparatus 1 through an electrical plug contact 20 (see Fig. 1). Depending on the measured flow, the regulating and controlling device 24 controls the drive 23 of the pump . After reaching critical values, the device 24 issues appropriate acoustic, optical and acoustic-optical warning signals.

In addition, the disposable module 2 provides other, not shown, sensors for receiving biochemical or physiological signals that serve to control the operation of the cardiopulmonary apparatus 1. Sensor signals through the sch 25 contacts, similar to the plug contact 20, are sent to the regulating and controlling device, and all contacts can also be assembled into a multi-pin plug. This facilitates the mounting of both modules 2 and 3. i)

In the disposable module 2 can also be placed elements that give control signals, such as, for example, electrically adjustable valves, and Through electrical contacts, actuate from the regulating and controlling device 24. so z To make the patient wean from the cardiopulmonary apparatus 1 the performance of the pump 8 is gradually reduced with the help of the regulating and controlling device 24, constantly monitoring and coordinating - the filling of the heart. b

Cardiopulmonary device 1 can only be disconnected if the patient is in a stable condition. After disconnection, by separating the fixing elements of the disposable module 2 with -- 35 blood-conducting elements, you can separate the module 2 from the module C with the driving and regulating elements and replace it with a new sterile module 2. After closing the fixing elements and filling the filling solution, the cardiopulmonary apparatus 1 ready to use again.

In this way, a mobile cardiopulmonary apparatus 1 is created, which, based on a modular design consisting of a disposable module 2 and a reusable module C, can, thanks to the compactness of both modules 2 and C, be quickly serviced by one person and is therefore suitable for accidents. With the condition of connecting aspiration and cardiology equipment for various heart injuries, such a mobile cardiopulmonary device 1 is also suitable for stationary use in hospitals, for example, with cardiac operations.

List of positional designations 45 1 mobile cardiopulmonary apparatus -I 2 module with blood-conducting elements

C module with drive and control elements - 4 arterial hose SO 5 venous hose 9 tank 50 7 circulatory system TE 8 blood pump SO 9 oxygenator inlet for gas supply 11 filter 55 12 tempering device 13 circulation circuit iF) 14 protrusion ko 15 arterial filter 16 bypass in 17 valve 18 flow meter 19 support plug contact 21 pump head 65 22 coupling 23 pump drive

24 adjustment and control device 25 keys 26 display 27 indicator 28 regulator 29 tachometer

ZO connecting contact

C1 switch 70 32 control lamp 33 transparent module housing 34 module housing

C5 handle for transportation 36 connecting tubes 37 bypass filter 38 hole or valve for ventilation 39 ventilation hoses 40 hole or valve for ventilation 35 in st

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Claims (1)

Formula of the invention -I - 1. Mobile cardiopulmonary apparatus for maintaining blood circulation by replacing or maintaining cardiopulmonary function, which contains at least one venous hose (5), blood pump (8), oxygenator (9), arterial filter (15), arterial a hose (4), as well as a tubular blood-conducting system (7), - a regulating and controlling device (24) and an autonomous power supply, which differs in that blood-conducting elements (4, 5, 6, 7, 8, 9, 15, 18 , 21), which perceive biochemical and physiological signals and perform control signals - on the one hand, and drive, control and regulation elements (23, 24, 27, 28, 29, 30, 31, 32) - on the other hand, are placed in two separate modules (2, 3), made with the possibility of combining into ONE functional node, as well as the fact that it is made with the possibility of being carried by one person. 2. Mobile cardiopulmonary device according to claim 1, which is characterized by the fact that the assembled modules (2, 3) (Ф) are made with the possibility of being installed on one another with the provision of mechanical and electrical connection. GI Z. Mobile cardiopulmonary device according to claims 1 or 2, which is characterized by the fact that the blood-conducting parts of the blood pump (8), in particular the head (21) of the centrifugal pump, are integrated into the module (2) (disposable module), which contains blood-conducting elements (4, 5, 6, 7, 8, 9, 15, 18, 21), which perceive biochemical and physiological signals and perform control signals, - ("disposable module"), and the pump drive (23) is integrated into the module (3) (reusable module), which contains the elements (23, 24, 27, 28, 29, 30, 31, 32) of the drive, control and regulation, and in the assembled position the module (2, C) with connected to each other by a coupling (22). 65 4. Mobile cardiopulmonary device according to one of claims 1-3, which is characterized by the fact that the connections between individual blood-conducting elements are made of flexible and/or fixed tubes. 5. A mobile cardiopulmonary device according to one of claims 1-4, which is characterized by the fact that the blood-conducting components of the extrapolar circulation and the hoses or tubes connecting them are placed in the module body and attached with the help of fixing and fastening devices. 6. Mobile cardiopulmonary apparatus according to one of claims 1-5, which is characterized by the fact that at least one part of the blood-conducting elements (4, 5, b, 7, 8, 9, 15, 21) is made monolithically with a disposable module (2) , in particular by the method of injection molding. 7. Mobile cardiopulmonary apparatus according to one of claims 1-6, which is characterized in that the disposable module (2) has a transparent case (33). 70 8. Mobile cardiopulmonary device according to one of claims 1-7, which is characterized by the fact that the elements that perceive biochemical and physiological signals are sensors that, along with others, perceive such parameters as pH of blood, pCO» of blood, pO» o blood, blood temperature and flow rate, RiO", gas temperature and gas flow rate, pO" gas, pCO" gas, water temperature, pump rotation speed or flow to the pump drive. 9. A mobile cardiopulmonary device according to one of the previous items, which differs in that sensors 7/5. (18) for determining parameters, for visualizing and using acoustic, optical and acoustic-optical warning signals and for processing values for control are connected to the device for drive, control and regulation (24). 10. The mobile cardiopulmonary device according to one of the preceding points, which is characterized by the fact that the reservoir (6) for venous blood located in front of the blood pump (8), the arterial filter (15) or the oxygenator (9) has openings ( 38, 40) for ventilation and refueling, which can be closed and serviced from the outside. 11. The mobile cardiopulmonary apparatus according to one of claims 1-10, characterized in that the blood-conducting system (7) has a bypass filter (37) which is connected between the venous hose (5) and the arterial hose (4) leading to patient, and through which the filling solution circulates before use on the patient. high school 12. The mobile cardiopulmonary device according to one of the points 1-11, characterized in that the adjustment and control device (24) has an input and output unit for conducting a dialogue with the user, and) in particular, keys/controller (25, 28) and/or display (26), as well as a program for initialization and adjustment of work during operation of the cardiopulmonary apparatus (1). 13. The mobile cardiopulmonary device according to one of items 1-12, which is characterized in that the autonomous power supply unit includes a battery and an indicator (27) of the state of charge. 14. The mobile cardiopulmonary device according to one of the points 1-13, which is characterized by the fact that it has a connecting contact (30) for external power supply. Gee! Official bulletin "Industrial Property". Book 1 "Inventions, useful models, topographies of integrated circuits", 2005, M 1, 15.01.2005. State Department of Intellectual Property of the Ministry of Education and Science of Ukraine. - . and? -i - se) sh» IR e) ime) 60 b5