WO2012062266A1

WO2012062266A1 - Device and method for ventilation

Info

Publication number: WO2012062266A1
Application number: PCT/DE2011/001828
Authority: WO
Inventors: Sven Meissner; Christian Schnabel; Edmund Koch
Original assignee: Technische Universität Dresden
Priority date: 2010-10-11
Filing date: 2011-10-06
Publication date: 2012-05-18
Also published as: DE102010048916B4; DE102010048916A1

Abstract

The invention relates to a device (1) and a method for ventilation with gas (22) and/or with liquid (21), containing a ventilation tube (17) with an attached pressure sensor (3), an inspiration pump (6), which is attached to the tube (17) and is controlled by a motor controller (2), an expiration pump (7), which is attached to the tube (17) and is controlled by the motor controller (2), an oxygenator unit (101), which is connected at the inlet side to the expiration pump (7), a main container (15), which is connected to the inspiration pump (6) and of which the temperature is stabilized by a dedicated thermostat (14), an additional container (131) for liquid (21), which additional container (131) is arranged between the outlet of the oxygenator unit (101) and the inlet of the main container (15), a balance for determining the ventilated amount of liquid of the subject to be ventilated, and a control unit (18), which switches valves of the overall circuit (90) in order to perform the ventilation and is connected at least to motor controller (2) and sensors (5). Between the outlet side of the main container (15) and the inlet side of the oxygenator unit (101), a peristaltic pump (11) connecting the two is arranged for transporting the respective fluid from the main container (15) to the oxygenator (10) via hose lines (162, 161), wherein a valve (12) is connected to an additional container (20) for gas (22), and wherein the control unit (18) is designed at least with a first function block (40) for calculating ventilation parameters for the gas ventilation, for the total liquid ventilation and for the combination of the two fluid ventilations in a first function unit, with a second function block (41) for the motor control in a second function unit, and with a third function block (42) for data acquisition in a third function unit.

Description

Apparatus and method for ventilation

description

The invention relates to a device and a method for ventilation with gas and / or liquid, wherein the device contains

- a tube for ventilation with a connected pressure sensor,

An inspiratory pump connected to the tube via a tubing with a first valve and controlled by an engine monitor;

an expiratory pump connected to the tube via a hose line with a second valve and controlled by the motor controller,

an oxygenator unit which communicates with the exhalation pump on the input side via a hose controlled by the second valve, a main tank which is in communication with the inspiration pump via a hose controlled by the first valve and which is temperature-stabilized by a thermostat associated with it;

an auxiliary reservoir for liquid, which is connected via a third valve to a hose between the outlet of the oxygenator unit and the inlet of the main reservoir, the hose line system assisting to connect a total fluid path for the two fluids,

- A balance, which is connected to a pad for the person to be respirated, to determine the amount of ventilated fluid to be ventilated as well

- A control unit that switches the valves of the total knee run to perform the ventilation via data lines and is connected with motor bucklers and sensors. Research on fluid-based medical ventilation procedures and devices now includes differentiated surgical procedures. The invention relates to the further investigation of the effects of total liquid ventilation (TLV) on the respiratory organ lungs of small animals, whose body weight may be from 15 g to 5 kg. The body weight determines the maximum amount of fluid to be administered for ventilation.

The procedure is used when spontaneous breathing fails (apnea) or becomes insufficient.

The conventional technique of ventilation is over-pressure air ventilation by forcing air into the lungs by external overpressure.

In liquid ventilation, an oxygen-enriched liquid (family of perfluorocarbons) is used instead of breathing air.

A distinction is made between the following liquid respiratory conditions:

- the complete liquid ventilation (TLV) and

- partial liquid ventilation (PLV).

While the PLV is already in clinical use, significant medical development work is still required to use the full fluid ventilation (TLV) procedure. Partial liquid ventilation (PLV) and total liquid ventilation (TLV) are the two major forms of liquid ventilation.

Partial fluid ventilation is based on the replacement of the volume of residual functional capacity with perfluorocarbon. The actual breathing takes place with a standard ventilator and a gas-filled tubing system. Similarly, ventilation parameters of conventional gas ventilation are selected. The perfluorocarbon has, because of its low surface tension, mainly the task of keeping the lungs open to a to ensure the greatest possible gas exchange area. Since the respirator exhales some of the perfluorocarbons in this mode of ventilation, the loss reported in the literature in an adult male at 50-60 ml per hour according to http: // www. tnnovationsreport.de/html/berichte/medizin_gesundheit/bericht965.html be continuously balanced. The correct setting of the ventilation parameters and the effects of this combined ventilation mode on the lung dynamics are largely unknown, so that no standardized procedure has been established to date.

On the other hand, complete liquid ventilation is technically much more difficult to achieve. These include a fluid-filled tubing system, pumping units, oxygenator and valves that allow the application of liquid volumes. The perfiuorocarbon takes over the entire gas transport in and out of the lungs. The right choice of ventilation parameters, coupling and decoupling of the respirator, sufficient oxygenation and COa removal as well as the technical implementation are problems.

The substances used for liquid ventilation are perfluorocarbons, which have the property of having a very low surface tension. That is, the perfluorocarbons are very well spread in the lungs and are twice as heavy as water. The high specific gravity of the liquid substance and the high transport capacity for the respiratory gases form the basis of the liquid respiration process. A liquid-gas ventilation is described in the publication US 6 694 977 B1, in which the Perfiuorocarbon is used, which is enriched with gas, so here oxygen.

One problem is that in the specified method only liquid breaths are specified, wherein the gas is introduced into the liquid. From another point of view, various controls of the conventional ventilation methods in the publication Hullen: Biomedical Engineering, Therapy and Rehabilitation, Springer-Verlag, TÜV Rheinland, ISBN 3- 88585-901-7, 1992 are described, wherein with gases depending on the - Inhalation and exhalation by the device or the subject is worked:

- CMV-Controlled Mechanical Ventilation,

- AMV-Assisted mechanical ventilation

- DMV Demand Mechanical Ventilation.

Commercially available gas ventilators are powered electrically or pneumatically and are controlled by the parameters

- Flow

- Stroke volume

- Print

controlled.

A distinction is made between the selected Kontroflparameter in:

a flow-controlled ventilation (FC),

a volume-controlled ventilation (VCV),

- pressure-controlled ventilation (PCV).

One problem is that manually switching from one ventilator to another ventilator is always a risk factor. Since currently at least two different separately acting ventilators with different fluid are required, the cost burden is correspondingly higher.

In physiology, ventilation mechanics refers to the analysis and representation of static pressure-volume relationships (steady state) and pressure-volume relationships during a ventilation cycle, and only a portion of the gas mixture containing the lung after maximum inhalation may be ventilatory Physiological parameters of medicine always have high biological variability, and the size of the lung volumes also depends heavily on the individual anatomical conditions (especially atter, gender, height and weight). This fact must be taken into account, especially in the case of mechanical ventilation, by individually determining the parameters to be set in advance. The actual breathing takes place at the cellular level and only the pulmonary ventilation can be supported or taken over by apparative measures. Since the oxygenation of all body cells represents a vital function of the human organism, mechanical ventilation plays a prominent role in anesthetics and intensive therapy.

The iron lung is the first widespread use of ventilation technology. The entire body, with the exception of the head, is located in a pressure chamber, the seal being made via a rubber neck cuff. In the chamber, negative pressure is generated periodically, whereby the thorax expands. As a result, air flows through the mouth / nose into the lungs. The expiration takes place by the change from negative pressure to overpressure in the chamber. This type of ventilation is passive and is the gentlest ventilation option, as it resembles the physiological spontaneous breathing. Due to the high technical effort, the increasing demand for respirators in the intensive care and home care sector and the low quality of life when using the vacuum chambers, together with the development of intubation technology actively ventilating devices have become increasingly prevalent and today form the standard of modern ventilation technology. The ventilation takes place here by generating an overpressure, whereby the corresponding respiratory volume is applied to the patient. Expiration occurs spontaneously and passively by contracting the stretched thorax.

The goal of every ventilation concept is reliable support or respiration. An additional role, especially in intensive care long-term treatment, is the weaning from mechanical ventilation to spontaneous spontaneous breathing during the recovery process. Various ventilation modes are available for this, whereby the parameters pressure, volume, volume flow, respiratory rate and gas composition must be individually adjusted. Basically, ventilatory techniques can be classified as controlled ventilation (volume-controlled or pressure-controlled) and assisted spontaneous breathing with mixed forms derived therefrom. Controlled ventilation is primarily used when the respiratory muscles and / or respiratory drive are too weak to sustain spontaneous breathing.

In volume-controlled ventilation, a set tidal volume is applied during inspiratory time, regardless of intrapulmonary pressure. Depending on the resistance and compliance of the lung tissue and the respiratory tract, the resulting pressures can be very high, so that an overpressure valve on the ventilator is opened when the adjustable alarm limit is reached.

During pressure-controlled ventilation, air is forced into the lungs during the inspiratory cycle until the set peak pressure is reached. The administered volume may vary greatly depending on the tissue condition and there is a risk that the minute ventilation will be too high or too low. Exhalation occurs passively in both ventilation modes after opening the expiratory valve.

A conventional ventilator is specified in the lecture series Prof. Ralf Hinderen Therapeutic Technique, WS 2009/2010, Hochschule Mittweida, which contains

- Lines for power supply, oxygen and compressed air,

a gas mixing and metering device for generating the inspiration gas with an oxygen concentration between 21 and 100% by volume and providing the required gas quantities,

a respiratory gas humidifier for heating and humidifying the inspiration gas,

- a (nascent tube and an expiratory tube,

- an expiratory valve closed during the inspiratory phase while the expiratory phase is open, a PEEP valve whereby, if the expiratory valve is not kept open until the end of the expiration, a positive end-expiratory pressure is reached,

a flow sensor that measures the flow of exspiraton gas.

The gas mixing and dosing system is often implemented as a closed or semi-open system, as the respiratory gas is often added anesthetics and drugs that should not be released to the environment. The expired breathing gas is cleaned in filters, carbon dioxide CO2 is bound by absorber material and fresh oxygen is periodically added to the system from pressurized bottles. The narcotic is also extracted, then re-liquefied and can be reused.

A pressure-controlled, timed fluid ventilation system is disclosed in Kenichi atsuda, MD; Shigeki Sawada, MD; Robert H. Bartlett, MD; Ronald B. Hirschl, MD: Effect of ventilatory variables on gas exchange and modynamics during total liquid ventilation in a rat modef, Crit Care Med 2003 Vol. 31, no. 7, wherein the structure consists of two height-adjustable reservoirs, a heat exchanger, a peristaltic pump, an oxygenator and condenser unit, as well as the hose system and an electromechanical valve.

The peristaltic pump pumps the perfiuorocarbon from the lower reservoir through the heat exchanger into the upper reservoir. The heating takes place on physiological 37T. The oxygenation takes place in the upper reservoir through a bubble oxygenator. Via an overflow the perfiuorocarbon flows back into the lower reservoir, the evaporated perfiuorocarbon is recovered via a condenser. Inspiration and expiration are realized by a timed electromechanical valve. The inspiratory pressure and the expiratory pressure are regulated by the set height of both reservoirs. The ventilated volume is controlled by the level in both reservoirs and by the balance.

A volume-controlled and time-controlled ventilation system is described in the document Stefano Tredici MD; Eisaku Komori MD; Akio Funakubo PhD; David O. Brant MS; Joseph L. Bull PhD; Robert H. Bartlett MD; Ronald B. Hirschl MD: A prototype of a liquid ventilator using a novel hoilow-fiber oxygenator in a rabbit model, Cht Care Med 2004 Vol. 32, no. 10 described, wherein in the ventilation system, a controlled piston pump forms the core. The perfluorocarbon is pumped through the oxygenator directly through the endotracheal tube (ETT) into the lungs of the respirator. During expiration, the volume is actively aspirated and passed through a bubble trap and a heat exchanger back into the cylinder. The oxygenation is carried out in countercurrent with 100% oxygen in the membrane oxygenator. The thereby emerging Perfiuorocarbon- steam is liquefied via a condenser and collected in a collecting container. This loss of perfluorocarbon is compensated by appropriate addition in Exsptrationsschenkel. The applied Ttdalvolumen and the end-expiratory and endinspiratorischen volumes are determined by a balance. One-way valves are used to control the flow direction.

Another volume-controlled and timed system is James Courtney Parker; Nobility Sakla; Francis M. Donovan; David Beam; Annu Chekuri; Mohammad Al-Khatib; Charles R. Hamm; Fabten G. Eyal: A microprocessor-controlled tracheal insufflation-assisted total liquid ventilation system, Med Bio! Eng Comput, 2009, 47: 931-939, the structure being mainly differentiated by the use of a double-lumen endotracheal tube, which allows different modes of ventilation to be realized. A first mode is purely time-controlled. A first pump rotates continuously and transports the perfluorocarbon used. Two valves control the flow direction and switch between inspiration and expiration. The first mode is used during filling of the lung with perfluorocarbon. Then the second mode is activated and the tidal volume is increased. The second mode is controlled by the end-expiratory reservoir pressure measured by a first pressure sensor to make volume corrections. The valve opening times can be manually overridden to ensure a constant inflow and outflow. The third mode is equivalent to the second mode except that end-expiratory pressure control is performed directly at the endotracheal tube. In addition to the old three modes, two additional pumps can be time-controlled. In addition to all three modes, two additional pumps can be time-controlled. Additional volume is applied via the second channel of the double-lumen tube through the second pump, which is removed again with the third pump. This pump principle allows for better mixing with freshly oxygenated perfluorocarbon as well as the leaching of the dead space volume and is thus intended to promote gas exchange. The system also includes the oxy genator as well as a condenser and a temperature control unit. Before each breathing cycle, a control unit calculates the required times and ventilated volumes depending on adjustable parameters. If the measured dextranspiratory reservoir pressure or lung pressure deviates from the set pressure, a differential pressure is determined and converted directly into a volume which additionally has to be applied or removed in the next respiratory cycle. Although end-tidal pressure is used to control breathing cycles, it is a volume-controlled system because the pressure differences are converted directly into volumes to ventilate a constant, adjustable volume.

Another volume controlled and timed system is in the book Raymond Robert; Philippe Micheau; Herve Waith A supervisor for volume-controlled tidal liquid ventilator using independent piston pumps, Biomedical Signal Processing and Controi 2, 2007, 267-274, which differs from the aforementioned respiratory systems by the use of two independently controllable piston pumps for inspiration and expiration , Thus, corrections of the applied and removed volumes can be individually implemented and the dynamics of the respiratory cycle are increased. Furthermore, two interconnected oxygenators, heat exchanger, reservoir and condenser are integrated in the circuit. The valves control the flow direction and are timed addressed. For the measurement of pulmonary pressure, a pressure sensor is used on the endothracheal tube, the measurement taking place in the end-inspiratory and end-expiratory pauses by closing certain valves. A valve is closed during the preparation phase in order to oxygenate and temper the perfluorocarbon used in the cyclic circulation. The volume control is carried out on the other hand via a level indicator on the reservoir, on the other hand, the displaced volume is detected in the piston pumps by means of potentiometers. The valve opening times and the motor control commands are calculated from this according to the set parameters.

Another method similar to the above-mentioned method for ventilation is described in the document EP 1 424 090 B1, wherein a system for complete liquid ventilation with a solution for oxygen enrichment in the liquid is specified.

The problems are that the two systems have a large component cost.

The invention is therefore based on the object to provide a device and a method for ventilation, which are designed so suitable that a ventilation with gas and / or liquid can be carried out in each case pressure-controlled and volume-controlled. In addition, the artificial and controlled combined ventilation with gas and liquid to be realized with only a single device. Furthermore, a performance of a complete liquid ventilation and a normal mechanical ventilation with gas to be achieved, so that a cost and saving can be achieved.

The object is solved by the features of claims 1, 10, 11, 12. A device for ventilation

containing gas and / or liquid,

- a tube for ventilation with a connected pressure sensor,

an inspiratory pump connected to the tube with a first valve and controlled by a motor controller,

an expiratory pump connected to the tube via a hose line with a second valve and controlled by the motor controller, an oxygenator unit which communicates with the exhalation pump on the input side via a hose line controlled by the second valve,

a main tank communicating with the inspiration pump via a hose controlled by the first valve and temperature-stabilized by a thermostat associated therewith,

an auxiliary container for liquid, which is connected via a third valve with a hose between the outlet of the oxygenator unit and the inlet of the main container, the hose system supporting a Gesamtkreisfauf connecting the two fluids,

- a control unit which switches the valves of the complete circuit for the execution of the respiration via data lines and is connected with motor controllers and sensors,

wherein according to the characterizing part of patent claim 1

between the main reservoir on the output side and the oxygenator unit on the input side a peristaltic pump connecting both for transporting the respective fluid from the main reservoir via hose lines to the oxygenator, the third valve being connected to an additional reservoir for gas, the control device having functional units and at least following program-technical function blocks:

a first functional block for calculating ventilation parameters,

- A second function block for engine control and

- a third function block for data acquisition

is trained.

The peristaltic pump has a direction of rotation which moves the respectively applied fluid in the tubing between the main container and the oxygenator unit.

The inspiration pump can consist at least of a first syringe containing a first piston, a first linear motor connected to the first piston and the motor controller. The expiratory pump may consist at least of a second syringe containing a second piston, a second linear motor connected to the second piston and the motor controller.

The oxygenator unit may include an internal gas exchange circuit including an oxygenator, a gas diaphragm pump, and a soda lime container connected in series in the gas loop. The fluid-carrying and / or gas-carrying lines of the entire circuit can form a hose line system.

The provided for a respiration with gas and / or liquid and back to the gas back main container may be embedded in an ambient container that belongs to the thermostat, which adjusts a constant temperature of the fluid in the main container and temperature-stabilized the fluid in the main container.

In the hose line connecting the oxygenator on the outlet side and the main container on the inlet side, the third valve is provided, which communicates with the additional container for liquid and the additional container for gas and is optionally manually operable or shadable controlled by the control unit.

The switchable, convertible third valve may consist of two switchable three-way valves, wherein the first three-way valve and the additional reservoir for gas are connected to a first three-way valve and the first three-way valve and the hose are connected to a Zwet tes three-way valve, the third valve optionally can be connected to the control unit via a signal line switchable.

At least most of the valves can be pinch valves for the respective continuous lines of the inspiratory pump and the (expiratory pump). With the device according to the invention, ventilation with gas without a change to liquid ventilation according to the characterizing part of patent claim 10 can be carried out with the following steps:

A. Intake of the device with 100% oxygen for expelling residual nitrogen from the lungs of the respirator,

B. Setting the ventilation parameters for the air ventilation and

C. Carrying out conventional air ventilation.

With the method for ventilation with liquid and a change to the final gas ventilation can with the use of the aforementioned device according to the characterizing part of claim 11

following steps are performed:

A. Interior of the device with 100% oxygen for expelling residual nitrogen from the lungs of the respirator,

D. change to liquid ventilation,

01. setting the ventilation parameters to fluid ventilation,

D2. Circulation of the fluid in the entire cycle,

D3. Filling the inspiratory syringe with liquid,

D4. Pumping the fluid into the lungs,

D5. Air extraction via the expiration unit,

E. change from liquid ventilation to air ventilation,

E1. Opening of the entire cycle,

E2. Pumping the liquid into the auxiliary container,

E3. Replacing the liquid with air in the syringes,

E4. Setting ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

With the method for ventilation with gas and liquid with a final change to the gas ventilation can be carried out using the aforementioned device according to the characterizing part of patent claim 12

following steps are performed:

A. Intake of the device with 100% oxygen for expelling residual nitrogen from the lungs of the respirator, B. Setting the ventilation parameters for the air ventilation and

C. Carrying out the conventional air ventilation,

D. change to liquid ventilation,

Dl Setting the ventilation parameters for liquid ventilation, D2. Circulation of the fluid in the entire cycle,

03. filling the inspiratory syringe with liquid,

D4. Pumping the fluid into the lungs,

D5. Air extraction via the expiration unit,

E. change from liquid ventilation to air ventilation,

E. Opening of the entire cycle,

E2. Pumping the liquid into the auxiliary container,

E3. Replacing the liquid with air in the syringes,

E4. Conversion of ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

The program-technical means of the control program used are divided into three separate function blocks, which are assigned to hardware-based functional units, which are executed in parallel as required and whose processing time per cycle is not interdependent, being stored in the control unit:

a first function block for calculating the ventilation parameters, which performs a setting, modification, display and calculation of the ventilation parameters for gas ventilation or liquid ventilation or for the combination of the two ventilations,

a second function block for controlling the engine, which takes over the values determined in the first function block and is responsible for controlling the motors via the motor controller and for switching the valves, and

- a third function block for data acquisition, which continuously reads the collected measurement data of the pressure sensor and the force transducer of the balance from the USB-6009 measuring module and displays the measured data,

wherein the measurement data of the pressure sensor signal is transmitted to the second function block to stop engine movements when reaching limit pressures. A repeated execution of the function blocks can be carried out until the completion of the respective ventilation program, wherein the engine initialization, the status request and the measurement module initialization are executed once each at the program start and the user interface is constantly queried and updated during the program execution, so that value changes to the function blocks Transfer and display data from the function blocks via a display, eg via a user interface of the control unit. Engine initiation establishes communication between the control unit and the engine front end by passing the settings for the RS-232 interface.

The status polling is a first safety feature for the device, with engine limit switches being executed when the motor controllers are turned on to determine the zero position and maximum displacement.

The measurement module initialization performs communication between the control unit and the USB 6009 measurement module by creating the functions for the data channels.

Basis of the present invention with a total gas ventilation and total liquid ventilation and with a combined total gas ventilation and total Fiüssigkettsbeatmung is the Reaiisierung the four forms of ventilation in the device according to the invention:

- ventilation with gas / air - pressure controlled,

- Ventilation with gas / air - controlled by the vofum,

- ventilation with fluid - pressure controlled,

- Ventilation with fluid - Volume controlled.

Each mode of ventilation (gas or liquid) can be performed with two ventilation modes (pressure-controlled or volume-controlled) stored in the control unit. Depending on whether the device is filled with liquid or gas, is ventilated with the appropriate fluid. For the change between air and liquid, the fluid is simply exchanged during operation.

By exchanging only one fluid, it is possible to realize the complete liquid ventilation and the complete air ventilation of the respirator in the corresponding weight limits.

Furthermore, the possibility exists by a corresponding control loop of a feedback ventilation, e.g. perform at respiratory support.

The evaluation of the effects of complete fluid ventilation (TLV) on the surface of the lung can be done with optical coherence tomography (OCT).

With the help of the device according to the invention of hoses, valves, pumps, sensors ventilation is realized via an inspiratory circuit and an expiratory cycle. When the device is filled with fluid, liquid ventilation is performed and, accordingly, when the device is filled with air, normal ventilation with air. Furthermore, the device contains an oxygenator, with which the medium in the geschiossenen device (state) is enriched with oxygen. A soda lime container eliminates the resulting carbon dioxide from the device in a circuit.

There may be a combination of alternating mechanical ventilation with air and with fluid in the device. In liquid-chain ventilation, the functional residual capacity of the lung (i.e., the volume that normally remains air-filled after exhalation) is filled with perfluorocarbon and, as in conventional gas-breathing, gas tidal volumes are applied to the intra-per- petal perfluorocarbon level.

The advantages of the invention are:

Use of a single device with fluid exchange during operation,

Variation of the operation pressure-controlled and volume-controlled,

- Complete liquid ventilation or normal mechanical gas ventilation are possible - The test subjects to be examined may preferably have a weight of 15 g to 5 kg and

- a cost reduction. Regulating respiration should, depending on the metabolic condition, i. both at rest and under load - a customized ventilation to be ensured.

The invention thus makes it possible to perform a mechanical ventilation with at least two fluids, in particular with air and with fluid with one and the same device both pressure-controlled and volume-controlled.

Further developments and further embodiments of the invention are specified in further subclaims. The invention will be explained in more detail by means of an embodiment with reference to several drawings.

It shows:

Fig. 1 is a schematic representation of the device according to the invention for

Ventilation with gas and / or liquid,

Fig. 2 is a circuit diagram of a circuit electronics of the valve control and

Pressure sensor electronics with external connection bending and a schematic representation of the program structure and the data exchange between the function blocks in functional units of the control unit.

Hereinafter, FIGS. 1 and 3 are considered together.

In Fig. 1, a device 1 for respiration with gas 22 and liquid 21 and is shown, wherein the device 1 contains

a tube 17 for ventilation with a connected pressure sensor 3, an inspiratory pump 6 which is connected via a hose 164 with a first valve 71 to the tube 17 and is controlled by a motor controller 2,

- An expiratory pump 7, which is connected via a hose 165 with a second valve 72 to the tube 17 and the motor controller

2 is controlled

an oxygenator unit 101, which communicates with the exhalation pump 7 on the input side via a hose line controlled by the second valve 72,

a main reservoir 15 which communicates with the inspiration pump 6 via a hose line controlled by the first valve 71 and which is temperature-stabilized by a thermostat 14 associated therewith,

an auxiliary tank 131 for liquid 21 which is connected via a third vent 12 to a hose 163 between the outlet of the oxygenator unit 101 and the inlet of the main tank 15, the hose line system 16 supporting a total circulation 90 for the two fluids 21, 22,

- A control unit 18, which connects via data lines at least the valves 71, 72 of the overall circuit 90 for carrying out the ventilation and is in communication with the motor controller 2 and at least with the pressure sensor 3.

According to the invention, between the main tank 15 on the outlet side and the oxygenator unit 101 on the input side a peristaltic pump 11 connecting both for transporting the respective fluid from the main tank 15 via hose lines 162, 161 to the oxygenator 10 of the oxygenator unit 101, the third valve 12 having an additional tank 20 for gas 22 and wherein the control unit 18 with hardware-functional units and at least with the following, shown in Fig. 3, program-technical function blocks: a first functional block 40 for calculating ventilation parameters for the gas ventilation, for the complete liquid ventilation and for the combination of the two ventilations in a first functional unit,

a second function block 41 for controlling the engine in a second functional unit and

- A third function block 42 for data acquisition in a third functional unit

is trained. The peristaltic pump 11 has a direction of rotation which moves the respectively applied fluid in the hose lines 164, 165 between the main container 15 and the oxygenator unit 101.

The inspiration pump 6 may consist at least of a first syringe 61 containing a first piston 63, a first linear motor 2 connected to the first piston 63, and the motor controtout 2.

The expiratory pump 7 may consist at least of a second syringe 62 containing a second piston 64, a second linear motor 19 connected to the second piston 64 and the motor controller 2.

The oxygenator unit 101 has a gas circulation run 23, which includes at least one oxygenator 10, a gas diaphragm pump 9 and a soda lime tank 8, which are arranged in series in the inner gas exchange circuit 23.

The liquid and / or gas-carrying lines 161, 162, 163 and 164, 165 of the overall circuit 90 form a hose line system 16.

The main receptacle 15 provided for receiving the fluid 21, 22 may be embedded in a cup-like surrounding container 13 belonging to the thermostat 14, which sets a constant temperature of the fluid 21, 22 in the main receptacle 15. In the connecting hose 163, the third valve 12 may be provided, which is in communication with the additional tank 131 with liquid 21 and an additional tank 20 with gas 22 and is controlled by the control unit 18 from switchable.

The third valve 12 may, as shown in Fig. 1, consist of two Dreiwegeventiien 121 and 122, wherein the first three-way valve 121, the auxiliary tank 131 with liquid 21 and the auxiliary tank 20 are connected to gas 22 and the second three-way valve 122 the first three-way valve 121 and the hose 163 are connected, wherein the valve 12 is selectively manually operable or connected to the control unit 18 via a signal line (not shown) switchable.

At least the valves 71, 72 may constitute pinch valves for the continuous hose lines of the inspiration pump 6 and the expiratory pump 7.

With the method for respiration with gas 22 and with liquid 21 with a final change to gas ventilation, the following steps can be carried out using the above-mentioned device 1:

A. Internal filling of the apparatus 1 with 100% oxygen for expelling residual nitrogen from the lung of the respirator,

B. Setting the ventilation parameters for the air ventilation and

C. Carrying out the conventional air ventilation,

D. change to liquid ventilation,

D1. Setting the ventilation parameters for liquid ventilation, D2. Circulation of the liquid 21 in the entire cycle 90,

D3. Filling the inspiratory syringe 61 with liquid 21,

D4. Pumping the fluid 21 into the lungs,

D5. Air extraction via the expiratory pump 7,

E. change from liquid ventilation to air ventilation,

E1. Opening of the entire circuit 90,

E2. Pumping the liquid 21 into the auxiliary tank 131, E3. Replacing the liquid 21 by air 22 in the syringes 61, 62, E4. Setting ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

With the method for ventilation with liquid 21 and a change to the final gas ventilation, the following steps can be carried out using the aforementioned device 1:

A. internal filling of the device 1 with 100% oxygen for the escape of residual nitrogen from the lung of the respirator,

D. change to liquid ventilation,

D1. Setting the ventilation parameters to flow-rate ventilation,

D2. Circulation of the liquid 21 in the entire cycle 90,

D3. Filling the inspiratory syringe 61 with liquid 21,

D4, pumping the fluid 21 into the lungs,

D5. Air extraction via the expiratory pump 7,

E. change from liquid ventilation to air ventilation,

E1. Opening of the entire circuit 90,

E2. Pumping the liquid 21 into the auxiliary tank 131,

E3. Replacing the liquid 21 by air 22 in the syringes 61, 62, E4. Setting ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

With the device 1 according to the invention, however, ventilation with gas 22 without a change to liquid ventilation can also be carried out with the following steps:

B. Classification of ventilation parameters for ventilation and

C. Carrying out conventional air ventilation.

Based on the listed ventilators of the prior art, major components have been found to be essential for successful liquid ventilation. This includes a pumping device for actively transporting the tidal volume into and out of the lungs, an oxygenator unit to oxygenate the perfiuorocarbon and dissolve carbon dioxide, a heat exchanger to heat the perfluorocarpone to physiological 37 ^e C, preventing the body core temperature from dropping, and flow control valves and a suitable control routine that allows the user to actively access the ventilation parameters and map appropriate feedback from the device. 1 shows a schematic overview of the arrangement of the components and the volume flow of the perfluorocarbon during ventilation. The description of the operation is initially based on the beginning of a breathing cycle with the inspiration. The device 1 should be completely filled with Perfiuorocarbon for the description, the principle of operation is independent of Perfiuorocarbon or of the air. Extraordinary conditions, such as filling the perfiuorocarbon device and changing the ventilation medium during operation, are explained after the description of the continuous ventilation mode. The mode of operation is that, during the ventilation, the peristaltic pump 1 1 continuously conveys perfiuorocarbon 21 out of the main container 15 through the oxygenator unit 101 with 15 ml / min in order to bind sufficient oxygen in the perfiuorocarbon 21 and to detach bound carbon dioxide CO 2 from the perfiuorocarbon 21. For this, conventional soda lime is used in a soda lime tank 8 and a perfusate oxygenator 10 with a filling volume of 19 ml. The heating of Perfiuorocarbon to 37 "C in the main tank 15 takes place in doppelwandtgen reservoir with a cup container 13 by means of the thermostat 14. Starting with the inspiration of the first piston 63 a first syringe 61 (depending on the ventilated Tidaivolumen) is moved by motor, so that Perfiuorocarbon 21 is pushed into the lungs, whereas the solenoid valve 71 opens the inspiratory branch 70, whereas the solenoid valve 72 keeps the expiratory branch 80 closed, the volume being dependent on the propulsion of the motors 24, 19, the propulsion in the lungs Control program is calculated according to the syringe size and the set ventilation parameters. Time-controlled, the inspiration is terminated and the valve 71 closes the inspiratory branch 70, the valve 72 simultaneously opens the expiratory branch 80. With incipient expiration, the second piston 64 of a second syringe 62 is also moved by motor, so that the applied volume is actively pumped out of the lungs , Simultaneously with the expiration, the inspiratory syringe 61 attracts oxygenated perfluorocarbon 21 from the main reservoir 15, whereas during the inspiratory period the expiratory syringe 62 returns a portion of its volume to the overall circuit 90 via the oxygenator unit 101. The pulmonary pressure is meanwhile continuously measured by means of differential pressure sensor 3 directly on the pulmonary tube 17. This results in a precise timing of the engine control and valve control and the differences in pressure or volume controlled ventilation modes.

As the liquid 21 can be selected from the group of perfluorocarbons perfluorodecalin (C10F18), whose chemical properties are explained in more detail below. These are also listed in Table 1 in comparison to other perfluorocarbons and other medically relevant media.

Perfluorodecalin 21 consists of fully fluorinated ten atomic carbon chains, is colorless and odorless, and biologically, thermally and chemically inert.

The high boiling point of 142 ° C is advantageous, as a result of which the evaporation rate at room temperature can be kept low. The high density of 1.917 kg / l, in conjunction with the surface tension of 15 mN / m, ensures a good distribution of perfluorocarbons within the lung solely due to gravity. The gaseous oxygen binding capacity is 49 ml per 100 ml of liquid and for gaseous carbon dioxide 140 ml per 100 ml of liquid. This means that almost three times as much gas can be bound as the same amount of blood can transport.

An essential advantage for the imaging of lung surfaces to be examined and ventilated by means of optical coherence tomography is the optical index of n - 1, 31. The small difference to the refractive index of the surrounding tissue (n = 1.33) minimizes the scattering losses on the path of the near-infrared radiation through the tissue and the artifacts in the subsequent bit-rotation construction.

The respiration according to the invention always begins according to the method with a conventional gas ventilation with 100% oxygen. The ventilation parameters are set accordingly and the ventilation is carried out. The change to the liquid ventilation takes place with the aid of an additional container 131 with liquid 21, which can be switched on via the valve 12 to the entire circuit 90. The liquid addition tank 131 is mounted above the double-walled liquid reservoir 13 so that the perfluorodecalin used as the liquid flows in due to gravity. The peristaltic pump 11 circulates the perfluorodecaline in the overall circulation 90, care being taken to ensure that sufficient liquid 21 is available, since a volume of 19 ml alone is required for filling in the oxygenator 10. The ventilation parameters are switched to liquid ventilation and a filling sequence is started, whereby the inspiratory syringe 61 is filled with enough perfluorodecalin 21. In the further course, only perfluorodecalin 21 is pumped into the lungs and the remaining air in the hose line system 16 is gradually removed via the exhalation pump 9.

The use of 100% oxygen 22 at the beginning of ventilation has two advantages:

On the one hand, nitrogen is flushed out of the lung, which can not be bound in perfluorodecalin 21,

on the other hand, the oxygen 22 is gradually dissolved in the perfluorodecalin 21, so that a complete filling of the tubing 16 is possible.

If oxygen scavenging is discontinued at the beginning, air bubbles may form, which stick due to the small inner tube diameter. If this occurs exactly in front of the endotracheal tube 17, these air bubbles are additionally pressed into the lungs, which causes the liquid to breathe can disturb. The change from the liquid ventilation to the air ventilation takes place by opening the entire circuit 90. As a result, the perfluorodecalin 21 is not pumped back into the main container 15 by the peristaltic pump 11, but into a collecting container 131. By starting the filling sequence, remaining liquid 21 is removed from the syringes 61.62 pressed and replaced by air 22. Subsequently, the conversion of the ventilation parameters and the conventional ventilation with air 22 can be started. The change from gas ventilation to liquid ventilation takes about 3 minutes and the change from 21 to 22 back to gas / air ventilation for about 5 minutes.

The use of two separate syringes 61, 62 for inspiration and expiration has the great advantage that occurring volume differences are processed individually. In addition, various ventilation modes can be realized, which are technically difficult to implement with just one pump unit. These include, for example, different inspirations regarding exhaled pregnancies and different positive and negative flow phases within a respiratory cycle.

In contrast to the ventilators presented in the prior art, a condenser unit for the recovery of gaseous perfluorocarbon was omitted in the construction of the prototype, since previous respirations have shown no significant loss of perfluorocarbon over the ventilation period of up to two hours. This is justified on the one hand by the high boiling point of the Perftuorocarbons used with 142 ° C, on the other hand by the saturation vapor pressure at 37 ° C of 14 mmHg. To control the amount of ventilated fluid and remaining in the lung functional residual capacity a pad 4 is mounted on a force sensor 5, the signal is transmitted via a data acquisition card to the control unit 18. Decisive for the liquid ventilation is the gas transport medium.

Other components are hardware components that are used in the device 1 according to the invention, the respirator. These include the drive motors 24, 19 for the syringes 61, 62. At the same time, the motors 24, 19 provide a reproducible positioning accuracy of ± 5 m and an axial tensile or compressive force of 15 N. With a maximum adjustment speed of 15 ~ are the

Motors 24,19 sufficiently dimensioned for the common ventilation frequencies.

For the engine control corresponding routines are provided, which can be integrated directly into the programmatic means of the control program. The communication between motor controller 2 and the control unit 18 in the form of a personal computer is optionally via USB or RS-232 interface.

For flow direction regulation, two magnetically operated micro-Schiauchquetschventile with a DC power supply voltage of 12 V are selected as valves 71, 72. The pinch valves 71, 72 withstand a differential pressure of 0.8 bar and are also impermeable to gas in the closed state when using silicone tubing 16 of the maximum hardness of 50 Shore. The valves 71,72 have short switching times and a low minimum waiting time between the switch-on in the desired working range. The advantages of these pinch valves 71, 72 are the separation of the fluid-carrying parts of the mechanism, the avoidance of additional dead space and the possibility of flow in both directions. The term 3/2-way valve means that there are two switching states and three process connections. In the case of the pinch valves 71, 72 used two hoses 16 can be inserted and during operation, one port is always open and the other is closed. For the fluid-carrying Schlauchte iteration system 16, a commercially available silicone hose is selected, for example, with an inner diameter of 1, 98 mm, an outer diameter of 3.18 mm and a hardness of 50 Shore. The maximum outer diameter and the maximum hardness are determined by the valve selection. ned. With the given inner diameter results for a hose length of 10 cm dead space volume of 308 μ (which must be considered especially in the dimensioning of the connecting paths between syringes 61,62 and Lungentubus 17 and has a non-negligible influence in the ventilation of small Tidalvoiumina.

The connection of the tubes 16 with other components and the connection with each other preferably takes place via Luer-lock connections and miniature hose connectors.

For the inspiration unit 6 and the expiration unit 7, depending on the desired tidal vofumen, perfusion syringes or fine dosage syringes with a central luer or luer lock connection are used. The filling volume varies from 1 ml to 50 ml, which is crucial for the design of syringe holder units.

The inserted pressure sensor 3 is operated at 5 V and converts the difference between system pressure and ambient pressure into a voltage signal which is detected and is a measure of the pulmonary pressure.

For the circulation of the perfluorocarbon in Gesamtkretslauf 90 a conventional peristaltic pump 11 is used with a maximum of two delivery channels.

The used for the temperature control of the perfluorocarbon Thermostat 14 is equipped with a 10 liter water tank and a pump unit and it can be reached temperatures of up to 160 ° C. The thermostat connection is made via two water hoses to the double-walled reservoir 13. The temperature control to the desired 37 "C takes place in less than 10 minutes and is kept constant over the entire time of ventilation.

For the volume control, a force transducer 5 is provided. It is equally suitable for tensile and compressive loads and measures forces up to 50 N with a relative characteristic deviation of 0.2%. The tip of the force transducer 5 is the correctly measured vertically and therefore forms one of three structurally provided supports the pad 4. Two additional bearings are located on a bracket at a distance of 14 cm. The triangular arrangement of the supports allows the horizontal and tilt-free storage of the pad 4 without additional adjustment. The correction of the measurement signal takes place as a function of the distance of the lung to the support of the force sensor 5 via the lever law. The correction is made by program means after the distance is measured and entered.

For the oxygenation of the perfluorocarbon and the carbon dioxide elimination a Hohifaser membrane oxygenator 10 is used, as it is used in neonatal cardiovascular machines. The gas exchange takes place in the countercurrent process, with a total exchange area of 0.25 m ^{2 being} available. The individual fibers have an inner diameter of 250 pm and a length of 140 mm. This results in the Gesamtkreisfauf 90 an additional volume of 19 ml. To avoid air bubbles and their circulation, therefore, even at low tidal volumes of, for example, 0.2 ml, a total liquid volume of at least 30 ml is used. In the connected gas exchange circuit is a soda lime container 8 with soda lime, in which the carbon dioxide CO2 is chemically bonded. The attainment of the saturation limit of the soda lime is recognized by a color change from white to pink

It is a support unit for the different types of syringe 61, 62 provided, the positive connection of the syringe plunger with the carriage of the linear motors 24,19 and the storage of the base. 4

For the flexible use of the device 1 according to the invention, the ventilator, different syringes 61, 62 are used in the ventilator and their change made user-friendly. Available are perfusion syringes with 1, 3, 5, 10, 20 and 50 ml filling volumes. Due to the three-part design, consisting of cylinder, punch and rubber seal, a low-friction long-term operation is possible. The standardized centric Luer connection provides for the uncomplicated connection and termination of the hose line system 16 and serves as a constant unilateral clamping. In contrast, depending on the filling volume, the syringe length and the diameter change, so that the second clamping must be made adaptable to the size of the syringe to fix its size. Since the pistons 63, 64 of the syringes 61, 62 likewise have different dimensions, their fixation on the carriages of the linear motors 24, 19 is also correspondingly constructed. For this purpose, a form-fit connection was selected in order to avoid the play of motion and to transmit the motor movement to the piston movement without path differences, so that the reproducible movement accuracy only depends on the positioning accuracy of the motors 24, 19.

The pad 4 is pivotally connected to the overall structure of the device 1, since frequent rotation of the pad 4 is necessary.

The force transducer 5 is fastened in the middle of the mounting unit. His to be loaded sensor tip forms one of three support points of the base 4. The other two support points are formed by two mutually perpendicular V-grooves of the support unit. The pad 4 is modified so that three triangularly arranged ball tips are mounted, which can be inserted into the bearing points of the attachment and the force sensor 5, whereby a adjustment-free handling is made possible.

The device 1 includes the thermostat 14 with a pump to heat the liquid, for example, the perfluorocarbon, to 37 ° C. To shorten the time required for this, the temperature is controlled at the double-walled reservoir. The double-walled reservoir used consists of a 50 ml syringe as Haupthöhöiter 5 inside a cup container 13 with 500 ml filling volume. The syringe 15 is modified with a port at the top through which the perfluorocarbon 21 can flow into the syringe 15. The drain is via the standard outlet at the bottom. The inlet and outlet hose is guided through holes in the cup container 13 to the syringe 15. The holes, as well as the connections to the syringe 15 and its pistons are sealed with epoxy resin to prevent the ingress of water. For the connection of the Thermostatic pump hoses are glued two additional hose connector with a corresponding diameter in the wall of the cup container 13. With this structure, the perfluorocarbon 21 in the main tank 15 can be heated by circulating the warm water of the thermostat 14 around the main tank 15.

In the control unit 18, a circuit electronics shown in Fig. 2 25 may be present and there are programmatic means for controlling the associated circuit electronics 25 is stored.

The electronic circuit 25 essentially fulfills three tasks.

This includes

Switching through and blocking the 12 V power supply at least for the solenoid valves 71, 72 by means of an external signal,

- A continuous power supply of the pressure sensor 3 with 5 V and

- The amplification of pressure measuring signals.

Fig. 2 shows the schematic circuit diagram of the electronic circuit 25, the layout is implemented on a standard breadboard.

The power supply for the entire circuit electronics 25 via a 12 V DC power supply 26, wherein the circuit electronics 25 is connected via the switch 27 on the housing. To protect the circuit electronics 25 from possible voltage peaks, a fuse 28 is provided in series with the switch 27. The smoothing of the input voltage is effected by means of 1 mF capacitor 29. Parallel to this, a light-emitting diode 30 is connected with a corresponding series resistor 31, which visualizes the switched-on operating state. The two solenoid valves 71, 72 used are switched via two MOS field effect transistors 32, 33 by changing the gate voltages. For switching through the 12 V supply voltage for the operation of the valves 71, 72, a 5 V DC voltage signal is applied to the gate input of the transistors for this purpose. The signal is generated via the digital ports of the external USB 6009 measuring card 48 according to the control routine of the PC program, whereby the different valve opening times are realized. The remaining part of the circuit electronics 25 provides the voltage supply of the pressure sensor 3 and the amplification of the differential pressure signal. By means of a constant voltage converter 34, the 12 V are transformed to an output voltage of 5 V, by means of which the pressure sensor is operated. The differential pressure signal is fed in the form of a voltage difference between the terminals "signal +" and "signal -" in an amplifier circuit. The operational amplifier 35 used is operated with +6 V and -6 V. Both voltages are created by splitting the 12 V supply voltage by means of the two gletch-dimensioned RC elements 36, 37 whose connection point serves as virtual ground for the operational amplifier 35. Due to the selected series resistors 38,39 can be achieved with the electronic circuit 25 a thousandfold amplification of the Differenzspannungsstgnals of mV to volts, so that a measurement via an analog input of the USB 6009 card is possible.

The ventilation parameters can also be set with the stored program-technical means and the engine control and valve opening times can be realized accordingly. In addition, the representation of the measured endotracheal pressure signal and various control parameters takes place. The implementation was carried out with a data flow oriented programming system. Due to the separate hierarchy levels of this type of programming, a user-friendly user interface can be created, which is free of the actual wiring and the mathematical calculation algorithms and thus allows a largely intuitive handling. The design of the user interface and the control elements displayed on it are based on the design and setting options of conventional ventilators. To better understand the following, once again the adjustable parameters are listed in tabular form as a function of pressure- or volume-oriented ventilation modes. Table 1

Adjustable parameters depending on pressure-controlled or volume-controlled ventilation (+ means, the parameter is adjustable, - not adjustable)

The units of the setting parameters can not be changed and serve as a conversion basis in the given calculation steps, ie a preset value of the tidal volume, for example, must be entered in ml in order to correctly carry out the spraten-type dependent conversion into a required engine-facilitating path.

- syringe type: corresponds to the syringe size used 1, 3, 5 and 50 ml,

Tidal volume (ml): corresponds to the ventilated volume per cycle,

- Peak pressure (mbar): maximum pressure up to which is inspired

- Respiration Rate (bpm): number of breaths per minute,

- Flow (ml / min): volume flow per minute; results in the vofumen-controlled ventilation, the time within which the set tidal volume is inspired,

- Ramp rise: varies the rise of the applied pressure signal in the pressure-controlled ventilation; the steeper, the faster the set peak pressure is reached,

- Insp./Esxp. Ratio: ratio of inspiratory time to expiration time; adjustable are 1: 1, 1: 2 and 1: 4,

- PEEP (mbar): pressure at which expiration ends, - hold inspirations: the inspiration break is extended as long as this button is pressed, only then the expiration takes place,

- Exsp. hold: the expiration pause is extended as long as this button is pressed, only then is the inspiration

- pos. Flow (sec): sets inspiratory time for pressure-controlled ventilation while volume can be applied; the increase is determined by the Ramp increase button,

- Exsp. Pause (sec): Time after active expiration, after which inspiration begins again; A corresponding inspiration pause results from the other ventilation parameters and is calculated automatically.

The data flow-oriented program-technical means offer a multiplicity of finished program modules for the solution of individual problems. For this, existing basic elements are wired together to create more complex program functions. However, data flow oriented programming means that elements of the program can only be executed if all required data is available at the input. The advantage lies in the parallel processing of elements that are not interdependent. In addition, the processing time plays a crucial role, so some program parts must wait until others have been processed.

Therefore, program-technical means of the control program used are subdivided into three separate function blocks 40, 41, 42, which can be executed in parallel and whose processing time per cycle is not dependent on one another. The basic functional block structure is shown in FIG. The first function block 40 for calculating the ventilation parameters deals with the setting, modification, display and calculation of respiration parameters for the gas ventilation, for the complete liquid ventilation and for the combination of the two ventilations.

The second motor control function block 41 adopts the values determined in the first functional block 40 and is responsible for controlling the motors 24, 19 and switching at least the valves 71, 72. The third function block 42 for data acquisition continuously reads the collected measurement data from the pressure sensor 3 and the force transducer 5 from the USB 6009 measurement module 48 and displays the measurement data to the user.

In addition, the measured data of the pressure sensor signal are transferred to the second function block 41 in order to stop the motor movement when limit pressures are reached.

The cycle symbol 43 means the repeated execution of the function blocks 40, 41, 42 until the end of the program. The arrows indicate the data transfer from one function block to other function blocks. The engine initialization 44, the status query 45 and the measurement module initialization 46 are executed once at program start. The user interface 47 is permanently queried and updated during program execution, so that value changes to the function blocks 40, 41, 42 can be transferred and data from the function blocks 40, 41, 42 are displayed.

The engine initialization 44 establishes communication between the controller 18, particularly the PC and the engine controller 2, by passing the settings for the RS-232 interface 48 (shown in FIG. 1). The settings are made especially for the measuring station computer 18 and have to be adapted for every other PC.

The status query 45 is the first safety feature for the ventilator 1. If the motor controller 2 is turned on, the Endschaiterfahrten the motors 24, 19 must be performed so that the zero position and the maximum displacement can be determined. Failure to do so could cause the motors 24, 19 to be damaged as the carriages strike unrestrained or traverse the maximum travel and fall out of the guide. The status inquiry 45 detects whether the limit switch travel has been executed and, if necessary, prevents the start of the ventilation until the travel limits have been determined. The measurement module initialization 46 establishes communication between personal computer 18 and the USB 6009 measurement module 48 by creating the tasks and functions for the data channels. Currently, 240 measurement points per second are determined per data channel. Data line: channel one 49 (shown in FIG. 1), the force sensor signal, data line: channel two 50 (shown in FIG. 1) provides the pressure signal.

Regulating respiration should, depending on the metabolic condition, i. both at rest and under load - a customized ventilation can be ensured.

The invention thus makes it possible to carry out a mechanical ventilation with at least two different fluids, in particular with air / gas and with liquid with one and the same device 1 both pressure-controlled and volume-controlled.

LIST OF REFERENCE NUMBERS

1 device

2 motor controllers

3 pressure sensor

4 base

5 force sensor

6 inspiration pump

7 expiratory pump

8 soda lime container

9 gas diaphragm pump

10 oxygenator

101 oxygenator unit

1 1 peristaltic pump

12 third valve

121 first three-way valve 122 second three-way valve

13 cup containers

131 Additional container for liquid

14 thermostat

15 main tanks

16 hose line system

161 Hose line

162 hose line

163 Hose line

164 Hose line

165 hose line

17 tube

18 control unit

19 second engine

20 additional tank for gas

21 liquid

22 gas

23 gas exchange cycle 24 first engine

25 circuit electronics

26 DC power supply

27 switch S1

28 fuse

29 capacitor

30 LED

31 resistor

32 first MOS-FET

33 second MOS-FET

34 constant voltage transformers

35 operational amplifiers

36 first RC element

37 second RC element

38 resistor

39 Resistance

40 first function block for calculating ventilation parameters

41 second function block for engine control

42 third function block for data acquisition

43 cycle icon

44 engine initialization

45 status query

46 Measurement module initialization

47 user interface

48 RS-232 interface / USB

49 data line: channel one

50 data line: channel two

61 first syringe

62 second syringe

63 first piston

64 second piston

70 Inspiration branch

71 first valve 72 second valve 80 expiratory branch 90 total circuit

Claims

claims

1. Device (1) for ventilation

with gas (22) and / or with liquid (21) containing

a tube (17) for ventilation with a connected pressure sensor (3),

an inspiratory pump (6) which is connected via a hose line (164) with a first valve (71) to the tube (17) and is controlled by a motor controller (2),

- an expiratory pump (7) which is connected via a hose line (165) with a second valve (72) to the tube (17) and is controlled by the motor controller (2),

an oxygenator unit (101) which communicates with the exhalation pump (7) on the input side via a hose line controlled by the second valve (72),

a main container (15) which communicates with the inspiration pump (6) via a hose line controlled by the first valve (71) and which is temperature-stabilized by a thermostat (14) associated with it,

- An additional container (131) for liquid (21) which is connected via a third valve (12) with a hose line (163) between the outlet of the oxygenator unit (101) and the input of the main container (15), wherein the Schiauchleitungssystem (16 ) supporting an overall circuit (90) for the two fluids (21, 22),

- a balance, which is connected to a pad (4) for the person to be respirated, to determine the amount of ventilated fluid to be ventilated and

a control unit (18) which switches the valves of the overall circuit (90) for carrying out the ventilation via data lines and is connected at least to the motor controller (2) and sensors (5),

characterized,

in that, on the output side, between the main container (15) and the oxygenator unit (101), there is a peristaltic pump (11) connecting both for transporting the respective fluid from the main container (15) Hose lines (162,161) to the oxygenator (10) is arranged, wherein the third valve (12) with an additional container (20) for gas (22) is in communication and wherein the control unit (18) with hardware functional units and at least with the following programmatic function blocks: o a first functional block (40) for calculating ventilation parameters for the gas ventilation, for the complete liquid ventilation and for the combination of the two fluid ventilations in a first functional unit,

o a second function block (1) for controlling the engine in a second functional unit and

o a third function block (42) for data acquisition in a third functional unit

is trained.

Device according to claim 1,

characterized,

in that the peristaltic pump (11) has a direction of rotation which moves the respectively applied fluid in the hose lines (164, 165) between the main container (15) and the oxygenator unit (101).

Device according to claim 1,

characterized,

in that the inspiration pump (6) comprises at least one first syringe (61) containing a first piston (63), a first linear motor (12) connected to the first piston (63) and the motor controller (2).

4. Apparatus according to claim 1,

characterized,

in that the expiratory pump (7) comprises at least one second syringe (62) containing a second piston (64), a second linear motor (19) connected to the second piston (64) and the motor controller (2).

5. Apparatus according to claim 1,

characterized,

in that the oxygenator unit (101) has an internal gas exchange circuit (23) in which an oxygenator (10), a soda lime container (8) and a gas diaphragm pump (9) are integrated, which in series in the gas exchange circuit (23) are arranged connected.

6. Apparatus according to claim 1,

characterized,

in that the fluid-carrying and / or gas-carrying lines (161, 162, 163, 164, 165) of the overall circuit (90) form a hose-line system (16).

7. Apparatus according to claim 1,

characterized,

in that the main container (15) is embedded in an ambient container (13) belonging to the thermostat (14), which sets a constant temperature of the respective fluid (21, 22) inside the main container (15).

8. Apparatus according to claim 1,

characterized,

in that the third valve (12) consists of two three-way valves (121, 122), to which the first three-way valve (121) the additional container (131) for liquid (21) and the additional container (20) for gas (22) are connected and to the second three-way valve (122), the first three-way valve (121) and the hose line (163) are connected, wherein the third valve (12) is selectively operable manually or switchably connected to the control unit (18) via a signal line.

9. Apparatus according to claim 1,

characterized,

that at least the valves (71, 72) pinch valves for each continuous Schiauchleitungen the inspiratory pump (6) and the Exspirati- onspumpe (7) represent.

10. Method of ventilation

gas (22) using the device (1) according to claims 1 to 9, having the following steps:

Internal filling of the device (1) with 100% oxygen for expelling the remaining nitrogen from the lung of the respirator,

B. Setting the ventilation parameters for the air ventilation and

C. Carrying out conventional air ventilation. 1 1. Procedure for ventilation

with liquid (21) and a change to the final gas ventilation using the aforementioned device (1) according to claims 1 to 9, comprising the following steps:

Amenbefüliung the device (1) with 100% oxygen for expelling the remaining nitrogen from the lungs of the respirator,

D. change to liquid ventilation,

Dl Setting the ventilation parameters for liquid ventilation, D2. Circulation of the fluid (21) in the entire circuit (90),

D3. Filling the inspiratory syringe (61) with liquid (21),

D4. Pumping the fluid (21) into the lungs,

D5. Air extraction via the expiratory pump (7),

E. change from liquid ventilation to air ventilation,

El opening the entire circuit (90),

E2, pumping the liquid (21) into the auxiliary container (131),

E3. Replacing the liquid (21) with air (22) in the syringes (61, 62),

E4. Setting ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

12. Method of ventilation

with gas (22) and with liquid (21) with a final change to

Gas ventilation using the aforementioned device (1) according to claims 1 to 9 with the following steps: A. interior filling of the device (1) with 100% oxygen for expelling the remaining nitrogen from the lung of the respirator,

B. Setting the ventilation parameters for the air ventilation and

C. Carrying out the conventional air ventilation,

D. change to liquid ventilation,

D1. Setting the ventilation parameters for liquid ventilation, D2. Circulation of the fluid (21) in the entire circuit (90),

D3. Filling the inspiratory syringe (61) with liquid (21),

D4. Pumping the fluid (21) into the lungs,

D5. Air extraction via the expiratory pump (7),

E. change from liquid ventilation to air ventilation,

E1. Opening of the complete circuit (90),

E2. Pumping the liquid (21) from the syringes (61,62) in the

Additional container (131) for liquid (21),

E3. Replacing the liquid (21) with air (22) in the syringes (61, 62),

E4. Setting ventilation parameters for air ventilation and

E5. Start and implementation of conventional air ventilation.

13. Method according to claims 10 to 12,

characterized,

the program-technical means of the control program used are subdivided into three separate function blocks (40, 41, 42), which are optionally executed in parallel and whose bear-bed duration per cycle is not interdependent, wherein the control unit (8) stores:

o a first function block (40) for calculating the ventilation parameters, which performs an adjustment, modification, display and calculation of ventilation parameters for a gas ventilation, for a complete liquid ventilation and for a combination of the two fluid ventilations gene.

o a second function block (41) for controlling the engine, which takes over the values determined in the first function block (40) and is used for triggering tion of the motors (24,19) and for the switching of the valves (71,72) is responsible, and

o a third function block (42) for data acquisition, which continuously reads the collected measurement data of the pressure sensor (3) and of the grip receiver (5) from the interface (48) and displays the measurement data,

wherein the measurement data of a pressure sensor signal to the second function block (41) are passed to the motor control to stop the motor movement when reaching limit pressures.

14. The method according to claim 13,

characterized,

the processing of the function blocks (40, 41, 42) is carried out until the completion of the ventilation program, the engine initialization (44), the status request (45) and the measurement module initialization (46) being executed once at the program start and the user interface (47) during the program execution is constantly queried and updated, so that value changes to the function blocks (40,41,42) passed and data from the Funktionsbiöcken (40,41, 42) are displayed.

15. The method according to claim 14,

characterized,

in that the engine initialization (44) establishes the communication between the control unit (18) and the engine controller (2) by passing over the settings for the interface (48).

16. The method according to claim 14,

characterized,

in that the status query (45) is a first safety feature for the device (1), whereby when the motor controller (2) is switched on, the limit switch trips of the motors (24, 19) are carried out in order to determine the zero position and the maximum adjustment path.

17. The method according to claim 14,

characterized,

in that the measurement module initialization (46) establishes the communication between the control unit (18) and the interface (48) by creating the functions for the data channels (49, 50).