Apparatus and method for alternating measurement of chest pressure and esophageal secretions seal

Abstract

The invention describes a device and a method for alternatingly measuring esophageal or thoracic pressure and for sealing the gastroesophageal or tracheal tube, wherein a balloon assembly of a tube or catheter placed in the trachea or esophagus is switched between two filling or functional states, wherein the filling state of the balloon assembly in the measuring mode assumes a relaxed, volume-constant volume definition value during the measurement, and the filling state of the balloon in the functional mode of sealing the esophagus or trachea maintains a constant sealing pressure preset by the user. An adjustment device connected to the tube or catheter unit ensures that the filling medium is rapidly moved into and out of the tube or catheter balloon in the state of sealing the esophagus or trachea, wherein the target pressure for sealing the trachea or esophagus is continuously maintained, in such a way that pressure fluctuations related to the respiratory mechanics in the balloon are compensated by continuously, compensatory moving the filling medium. In this case, the user can switch between the two functional states by means of a manual switching function or programmable time periods. In addition to being able to intermittently perform respiratory mechanics monitoring and continuously perform balloon tamponade in the manner of sealing the trachea or esophagus, the balloon placed in the trachea or esophagus can in both functional states lead out a respiratory mechanics trigger signal through the thorax, which can trigger a breathing stroke to assist the patient in a respirator connected to the device. Furthermore, the invention also describes structural and functional options for simultaneously leading out neuronal and / or muscle electrical signals from the diaphragm of a patient and respiratory mechanics signals based on thoracic or pleural pressure fluctuations led out from the trachea or esophagus.

Description

TECHNICAL FIELD

[0001] The invention relates to a device and a method for alternatingly, intermittently performing a measuring function mode, in particular for measuring esophageal or thoracic pressure, and a sealing function mode, in particular a transesophageal or intraluminal sealing with dynamic adaptation, comprising a catheter equipped with at least one measuring and / or sealing balloon assembly, which is switched between two filling states, wherein the filling state (i) of the balloon assembly has a relaxed, volumetrically defined static balloon filling in the measuring function mode and (ii) is adjusted, preferably in a pressure-controlled manner, in the sealing function mode in such a way that, by means of a regulator unit connected to the catheter unit, pressure fluctuations caused by the respiratory mechanics-related transmission of pressure from the thorax to the esophageal or tracheal sealing balloon are compensated by a corresponding displacement of the filling medium, thereby continuously maintaining a sealing target pressure preset by the user. BACKGROUND

[0002] In the case of mechanical ventilation of a patient, the problem often arises of transitioning from a ventilation mode that is completely controlled by the therapist to an assisted ventilation mode in which the patient's spontaneous breathing is supported. In the assisted ventilation mode, the breathing apparatus connected to the patient senses pressure fluctuations or volume movements that occur in the hose system connected to the patient. If, upon the patient's inspiration, the pressure in the inspiratory branch of the hose system decreases or a measurable movement of gas (flow) towards the patient is caused, the device supports the patient's breathing effort until the ventilation pressure or the end-tidal desired breathing effort volume (tidal volume) to be reached at the end of inspiration is reached, which is preset by the therapist.

[0003] The goal of assisted ventilation is generally to maintain the patient's ability to perform thoracic spontaneous breathing as much as possible in order to ensure that the patient can be smoothly and without difficulty detached from the device or the ventilation hose is removed (extubation) as required. After extubation, the patient should be able to perform a very adequate breathing effort without subsequently being exhausted in terms of respiratory mechanics.

[0004] In order to make the ability to breathe adequately autonomously measurable and assessable, a measuring catheter is used which is positioned in the patient's esophagus (esophagus) and is equipped with balloon assemblies which are filled with air in situ in a relaxed and stress-free manner. The so-called esophageal pressure present in the esophagus approximates the so-called intrathoracic pressure and is used as a standard for its clinical measurement. The best approximation of the pressure is achieved when the balloon assemblies of the measuring catheter are placed approximately in the transition area from the middle to the lower third of the esophagus.

[0005] The intrathoracic pressure, which is usually converted into an electrical signal by a pressure sensing element outside the patient's body, can be used as a coordinate system with respect to the volume of respiratory gas (flow) measured by the ventilator and simultaneously moved by the patient. In this case, the respiratory work performed by the patient maps an iterative circular curve. This enables an assessment of the patient's ability to breathe autonomously over time.

[0006] The present invention equips the oesophageal pressure measurement catheter with the ability to seal off the residual oesophageal lumen, which is adjusted around the catheter shaft, in order to reduce or, if possible, prevent gastric contents from rising into the patient's throat (gastro-pharyngeal reflux). The so-called aspiration of gastric contents into the throat is one of the known triggers for breathing-related pneumonia. The secretions that rise into the throat during aspiration enter from there deep into the respiratory tract, thus contributing to the development of inflammatory lung complications.

[0007] In order to reduce gastro-pharyngeal reflux, the patient's upper body is to be raised at an angle as far as possible, which has been clinically proven to reduce the incidence of breathing-related pneumonia. The present invention should be able to achieve the corresponding effect even if the patient has to remain in a medically indicated lying position. If the patient's chest is already in an upper body raised position, the anti-reflux effect can be further improved by the continuous balloon tamponade option of the oesophageal lumen, which is implemented within the scope of the present invention.

[0008] It is therefore desirable to be able to switch back and forth simply between the two filling states of the balloon element placed in the oesophagus.

[0009] In this case, on the one hand, there is a volume-controlled filling state, in which the balloon element is filled with a predetermined volume of filling medium, and, on the other hand, a pressure-controlled filling state, in which the filling pressure within the balloon element remains approximately constant.

[0010] Furthermore, on the one hand, the balloon should fulfil an oesophageal sealing function in order to inhibit or prevent the free rise of gastric secretions into the throat. This function can be optimally achieved in the case of a balloon adjusted to a pre-set filling pressure.

[0011] On the other hand, the balloon placed in the oesophagus should exhibit a defined filling state that allows the measurement of the intrathoracic pressure, so that the catheter is used to monitor the thorax with active breathing or mechanical assistance in a breathing-physiological manner on an intermittent basis. In this case, a pressure regulation would be counterproductive, because only a constantly maintained filling pressure would be measured, not the intrathoracic pressure.

[0012] The present invention therefore uses a switch of the control and regulation assembly, so that the filling pressure of the balloon is regulated as constantly as possible during the sealing state, whereas in the measurement state this pressure is not regulated constantly, but only a defined filling volume of filling medium is pushed into the balloon, which can then be said to be left to its own devices, so that it is susceptible to the thoracic pressure.

[0013] However, this requires a switch between two different operating modes. It is to be borne in mind in this case that the measurement operating mode should be repeated at certain time intervals in order to track the development of the patient's autonomous breathing capacity and to adapt the additional mechanical breathing stroke accordingly so that the patient can gradually resume pure autonomous breathing again.

[0014] However, in this case, the manual switch to adaptively adapt the mechanical breathing stroke to the gradually advancing patient autonomous breathing capacity requires the continuous presence of an operator in order to switch or program the system to the correct functional mode. SUMMARY

[0015] In view of the disadvantages of the prior art, the object of the present application is to find a solution that enables a patient who is being artificially ventilated to gradually resume autonomous breathing during the course of his recovery without the continuous care of an operator.

[0016] To achieve the above object, the present application proposes that the switch between the two functional states can be carried out manually and by means of programmable time periods.

[0017] This manual switch can be carried out on a regulator unit which uses the pressure in the catheter balloon either for an intermittent measurement function or, in a manner synchronized with the breath-physiologically generated chest pressure change, maintains this pressure with continuous secretion sealing. This device or regulation unit enables the manual switch, on the one hand, preferably in the form of a push button. This enables the doctor or other operator, for example, to switch to the measurement function mode at any time, to check the current autonomous breathing capacity of the patient and to adapt the ventilator manually if necessary.

[0018] However, the present application also proposes an automatic switch, in which the regulator unit switches back and forth between the two functional modes on its own on the basis of programmable time periods. On the basis of this functionality, the device according to the application can check the parameters of the mechanical assistance when using assisted breathing at regular time intervals and optimize or re-determine them if necessary in an adaptive manner. The device according to the application can therefore be used for lung inflammation prevention and respiratory planning.

[0019] It has proven to be advantageous if the catheter is a feeding catheter which can be inserted into the esophagus in a nasogastric or orogastric manner or which can be inserted via the stomach into the duodenum or the jejunum and / or a pressure reduction catheter.

[0020] In this case, the sealing balloon assembly can plug or seal the entire thoracic esophagus or only the upper or lower half of the thoracic esophagus.

[0021] It is proposed that the sealing and / or measuring balloon is pre-shaped with a diameter or circumference which is greater than the diameter or circumference of the respective lumen, in particular the esophageal lumen. The advantage resulting therefrom is that the relevant lumen can be packed in a stress-free, space-filling manner. In this regard, because the surface of the measuring balloon does not have to be stretched, the pressure inside the balloon element is equal to the pressure exerted on the outside of the balloon sheath, in this case the thoracic pressure in the region of the relevant, in particular esophageal, lumen.

[0022] Within the scope of the application, the sealing and optionally measuring balloon has a balloon tip which extends proximally towards the tip of the catheter and which exceeds the outer diameter of the catheter shaft carrying the balloon in terms of diameter and forms a clearance space through which the sealing balloon can be filled and pressurized. By fixing the relevant balloon to the catheter shaft only by means of its distal balloon tip, the introduction line to the balloon is obtained in the simplest manner in order to fill the balloon with a filling medium or to empty the balloon. The clearance space with a relatively large cross section even allows a relatively large flow to / from the balloon so that relatively fast regulation of dynamically, in particular breath-dynamically, induced pressure fluctuations is possible and an optimal sealing is always ensured.

[0023] The segments forming the balloon and / or the segments of the balloon forming the clearance space can have a partially collapsed, batten-like inner structure which at least partially keeps the introduction line to the balloon open. The permanently open fluid connection between the balloon placed in the esophagus in the body and the pressure regulator outside the body ensures that immediate regulation of dynamic pressure fluctuations is always possible.

[0024] The measuring balloon assembly should be arranged in such a way that it is located in the lower half of the thoracic esophagus, i.e. in the diaphragmatic region where the pressure fluctuations are strongest, when the catheter is positioned as intended.

[0025] In addition to the embodiment in which the same balloon is used for measurement and sealing, it can also be proposed that the sealing balloon and the measuring balloon are embodied as structurally independent and separately fillable assemblies. If these assemblies can be adjusted to different pressures or filling volumes, the sealing balloon can be permanently pressure-regulated, while the measuring balloon is permanently filled only to the relaxed shape.

[0026] With regard to the arrangement of the measuring balloon and the sealing balloon relative to each other, different solutions are possible. Within the scope of a first embodiment, the measuring balloon can be arranged concentrically within the sealing balloon.

[0027] On the other hand, the measuring balloon can also be arranged serially below or distally of the sealing balloon.

[0028] Radiopaque markings on the hose shaft of the catheter, in particular in the region of the proximal and / or distal end of the balloon assembly, allow the length and / or position of the associated balloon assembly to be visible by means of X-ray images. This enables the position of the oesophageal catheter according to the application in the patient's body to be corrected or optimised as appropriate in order to achieve maximum sensitivity for the pressure fluctuations or other signals to be recorded.

[0029] The control and / or regulator unit is connected or connectable to the measuring and / or sealing balloon assemblies of the catheter, the purpose of which is, on the one hand, to coordinate the different functional modes or the sequence thereof and, on the other hand, to be able to control the filling volume of the respective measuring balloon in the measuring functional mode in such a way that the balloon has a relaxed, stress-free shape on the basis of an incomplete, volume-defined filling, whereas in the sealing functional mode the filling state of the respective sealing balloon is regulated in a pressure-controlled manner.

[0030] The control and / or regulator unit according to the application can in particular be designed in such a way that at least three operating modes can be selected, namely a pure measuring functional mode, a pure sealing functional mode and an automatic operating mode in which the switching between the measuring functional mode and the sealing functional mode is triggered permanently by an automatic control, in particular on the basis of a programmable time period. Thus, there are only two different functional modes, namely the measuring functional mode with constant filling volume or the sealing functional mode with constant filling pressure. However, there is still a third operating mode in which the system switches back and forth between the two functional modes.

[0031] In order to define the current functional state of the system according to the application, i.e. the respective selected first or second functional mode, a selection module is provided, which has at least one logic output, the output signal of which is higher in one functional state and lower in the other functional state. In this case, the application benefits from the fact that the two possible functional states, namely the measuring functional mode and the sealing functional mode, can be shown by a single digital signal in such a way that the logic value high corresponds to the first functional state and the logic value low corresponds to the other functional state.

[0032] The selection module can be designed in the form of a flip-flop or bistable trigger circuit, with a set input at which the input signal is at the rising edge or high level, the output signal at the logic output is set to higher, and with a reset input at which the input signal is at the rising edge or high level, the output signal at the logic output is set to lower. By means of this bistable trigger circuit, a kind of "memory" is formed which remembers the respective last set functional mode and maintains this functional mode until a new, different manual or mechanical (switching) instruction occurs.

[0033] For manual input, the set input and / or the reset input of the selection module is coupled to a manual input member, such as a switch or a button.

[0034] Alternatively, the set input of the selection module can be coupled to a programmable dead time or delay module, which is activated in the case of a falling edge at the logic output or in the case of a rising edge at the inverted output and provides a rising edge at the set input after a programmed or programmable time interval; and / or the reset input is coupled to a programmable dead time or delay module, which is activated in the case of a rising edge at the logic output or in the case of a rising edge at the inverted output and provides a rising edge at the reset input after a programmed or programmable time interval. This enables a time-controlled switching back and forth between the two functional modes at any time.

[0035] If a plurality of input signals corresponding to the same set input or the same reset input are associated with one another via an OR gate, the one or more input signals of the at least one OR gate can be blocked or unblocked by one or more logic blocking and / or enabling signals, in particular by an AND gate. Furthermore, in a further development of the inventive concept, it can be proposed that the one or more logic blocking and / or enabling signals originate from another input option, in particular an input button.

[0036] A further feature of the invention is preferably a dynamically adaptive, transesophageal or intraluminal secretion seal, preferably by means of a regulating loop, in which the actual value of the filling pressure in the balloon assembly or in its introduction line is detected and maintained as constant as possible by regulating to a preset target value, in particular by means of a regulator unit configured as an electro-pneumatic or electronic-pneumatic regulator, which continuously maintains the target pressure preset by the user in the sealing balloon in the sealing functional mode, in particular in the state of the esophageal or tracheal seal, wherein pressure fluctuations in the sealing balloon, in particular breathing mechanics-related pressure fluctuations, i.e. pressure fluctuations occurring during the patient's spontaneous breathing, can be compensated for by correspondingly displacing the filling medium into or out of the balloon in order to maintain the seal.

[0037] Other advantages can be achieved in that the regulator unit connected to the balloon element for alternating measurement and sealing of the catheter has at least one electronic pressure regulating valve, which regulates the respective filling pressure in the balloon. In this case, the valve serves as an actuating element, on which the regulator acts according to a predetermined regulating algorithm, with the aim of maintaining the filling pressure in the balloon assembly that can be placed in the esophagus as constant as possible.

[0038] Furthermore, the control and / or regulation unit according to the application should have a valve function which leads into the balloon for feeding a volume to the balloon in a defined manner and in parallel thereto a valve function which leads out of the balloon for withdrawing a volume from the balloon. In this way, the constant filling volume of the balloon assembly can be regulated.

[0039] Another design specification states that one or both or all of the adjustable valve assemblies are designed as actuating elements which work in a piezoelectric manner. Since only very small filling volumes are required in the balloon which is placed in the esophagus, the solenoid valves are usually not fine enough, and therefore the application preferably uses piezoelectric actuating elements.

[0040] The application preferably a layout in which the pressure-regulating valve has an integrated or connected sensor function which measures the filling pressure in the balloon, in particular a sensor for the filling pressure in the balloon, wherein the valve regulates the pressure in the balloon in such a way that the preset filling pressure can be maintained in a continuous manner even in the presence of breathing mechanics-related pressure fluctuations in the balloon.

[0041] Upstream of the individual valves, a reservoir-like assembly can optionally be provided which holds an excess pressure or a negative pressure in reserve, or the valves are connected to one or more external pressure sources.

[0042] On the other hand, the regulator can have an assembly which applies a defined volume of air in the measurement balloon and optionally subsequently removes this volume of air from the balloon again.

[0043] A further preferred object of the control and regulation assembly according to the application is to generate a trigger signal for the connected breathing machine as early as possible. For this purpose, the aforementioned control and regulation assembly should have an adjustable function and / or assembly which recognizes a breathing mechanics-related pressure fluctuation measured in the thorax, in particular an initial intrathoracic pressure drop, as an indication that the thorax has started to actively breathe off. The advantage is that the esophageal pressure drop can be measured earlier and more reliably than the pressure drop in the ventilation hose system itself.

[0044] If the control and regulation assembly has recognized an initial intrathoracic pressure drop as an indication that the thorax has started to actively breathe off, a trigger signal for triggering a mechanically supported breathing stroke by the breathing machine can be generated on the basis of this intrathoracic pressure drop.

[0045] In order to be able to distinguish an initial breathing off of the thorax from random pressure fluctuations, a comparator module is provided which compares the pressure signal with a pressure drop value which is required for triggering a trigger pulse for the breathing machine. Such a comparator can receive the relevant pressure signal or a time derivative thereof at one input and a preset or adjustable target value at the other input.

[0046] On the other hand, in the case of assisted mechanical ventilation, the following effect regularly occurs: the sealing pressure is to be kept as constant as possible in the oesophageal balloon assembly, and a regulated pressure drop is hardly recognizable. The application therefore proposes that the control of the regulator assembly is programmed by means of a delay or dead time which allows a certain pressure drop in the sealing balloon to be achieved before volume compensation to the target value is carried out, in order to obtain a triggering option for the support mechanical breathing stroke.

[0047] Thus, in the case of a pressure drop occurring in the sealing balloon, the regulation loop is to remain interrupted until a triggering signal for the support mechanical breathing stroke is generated. The adaptive sealing function can then be employed again immediately.

[0048] Furthermore, the application allows a visualized, continuous thoracic pressure signal to be displayed on a display device in order to inform the physician or other operating personnel about the current state of the assisted ventilation.

[0049] Furthermore, one or more electrodes for receiving or leading out electrical signals of the patient can be arranged on the oesophageal catheter. By means of this, the application describes possible combinations of the oesophageal balloon catheter which optionally carries out measurements and / or sealing with electrode-like assemblies for leading out electrical signals from the diaphragm of the patient and the nerve structures which govern the diaphragm. Corresponding methods are known, for example, in the context of the so-called Edi catheter technology or NAVA ventilation method (neurally adjusted ventilatory assist). When the leading-out electrodes are correspondingly placed in the region of the oesophagus through the diaphragm, parameters are derived which are of greater importance for optimizing the synchronization of the breathing machine and the patient. Thus, the muscle action potentials of the diaphragm can identify, for example, the initial early beginning of the inspiratory effort of the patient and, when the patient has not yet generated a flow towards the patient in the connected ventilation hose system or the lungs of the patient have not yet expanded to a certain extent, trigger the mechanical support of the breathing stroke initiated by the patient, which triggers such a patient-oriented flow.

[0050] The application further proposes that the electrodes are arranged on the surface of the tube or catheter shaft, in particular distally of the balloon element or all balloon elements. While the sealing function of the balloon assembly preferably takes place in the upper region of the oesophagus, the electrodes are to be located as close as possible to the diaphragm, i.e. distally of the balloon element.

[0051] The arrangement of a plurality of electrodes on the surface of the catheter shaft distributed in the axial direction and spaced apart from one another has the advantage that a plurality of electrode signals are available, which can sense potential fluctuations in a larger region in the diaphragm environment and thus more reliably. For this purpose, it has proven advantageous to arrange a plurality of electrodes axially next to one another, similar to a square matrix extending in the longitudinal direction of the oesophagus, by means of which different phases of the potential can also be detected.

[0052] In this case, a reference electrode is preferably provided which provides a common reference potential, which is preferably arranged proximally or distally to all other electrodes.

[0053] The application also proposes that electrodes are arranged in the region of the catheter shaft which penetrates through the diaphragm when placed as intended in the esophagus, since the largest potential amplitudes occur naturally at this point.

[0054] The electrodes can be connected via a wireless connection, for example Bluetooth, to an extracorporeal amplification, analysis and / or monitoring module in order to transmit the digitized electrode signals as appropriate; however, a cable provides a less complex solution for the transmission of information, wherein each electrode is preferably contacted individually, in particular by means of a multicore cable having at least one conductor per individual terminal for each electrode.

[0055] Preferably, each electrode is contacted individually, in particular by means of a multicore cable having at least one conductor per individual terminal for each electrode, so that all phases can be analyzed individually and separately from one another.

[0056] A preferred further development of the application is that the extracorporeal amplification, analysis and / or monitoring module has a module or function for the autocorrelation of the electrode signals in order to identify periodically repeating sequences of the electrode signals, since only on the basis of such periodically repeating sequences can a reproducible statement be made about the current respiratory cycle.

[0057] Within the scope of such an implemented autocorrelation algorithm, a pattern sequence is correlated with a subsequent pattern sequence, wherein the degree of correlation or the coefficient required for pattern recognition can preferably be adjusted by means of an input element, for example by means of a rotary knob, preferably on a scale of -1 to +1. The period between two successive respiratory runs is not always exactly the same, so that for a typical pattern of respiratory cycles only such autocorrelation can be used for the identification.

[0058] Once a typical reference pattern of respiratory cycles has been found by means of such autocorrelation, another module or function can determine the correlation of one or more such reference electrode signals with the measured thoracic pressure fluctuations related to the respiratory mechanics, in particular with the initial thoracic pressure drop as an indicator of the onset of active breathing offset in the thorax, in order to identify the periodically repeating sequence of one or more electrode signals in the stored reference pattern as an indicator of the onset of neuromuscular respiratory activity or also to identify a typical relationship between two or more electrode phases for the onset of active breathing offset in the thorax. This process is preferably fully automated, so that no operating personnel are required to assist.

[0059] The pattern sequence or phase pattern sequence, which is typically identified as the onset of neuromuscular respiratory activity within the scope of the autocorrelation, can be stored as a reference sequence or a plurality of time-synchronous phase pattern sequences, which can then be used for real-time correlation with the currently measured electrode signals.

[0060] In the case of sufficient agreement between the currently measured electrode signals or the currently measured plurality of electrode phases and the typically stored reference sequence or the typically stored phase pattern sequence for the onset of neuromuscular respiratory activity, an early trigger signal for triggering an assisted mechanical breathing stroke by the breathing machine is generated.

[0061] Furthermore, according to the application, the degree of correlation or the coefficient required for the recognition of the agreement within the scope of the correlation algorithm between the currently measured electrode values, which are implemented in a module or as a function, and the typically stored pattern sequence for the onset of neuromuscular respiratory activity can be adjusted by an input element, for example by a rotary knob, preferably on a scale of -1 to +1.

[0062] In order to transmit the trigger signal for an additional mechanical breathing stroke generated by the system according to the application to the breathing machine, different solutions are provided. If the breathing machine has a corresponding logic input, it is most labor-saving to output the trigger signal as a pulse signal, for example as a voltage signal comprising 0 V corresponding to a low level and 5 V corresponding to a high level, or as a current signal comprising 4 mA corresponding to a low level and 20 mA corresponding to a high level.

[0063] In the case of a coupling of the control and regulation device according to the application to the breathing machine, the trigger signal can be transmitted as a short instruction sequence via a parallel or serial interface.

[0064] Such an instruction sequence can also be transmitted by radio, for example by Bluetooth.

[0065] As an alternative, the application proposes transmitting the trigger signal generated by the system according to the application to the breathing machine as a pressure signal in such a way that, by means of a pressure relief valve controlled by the control and / or regulation unit according to the application, air is discharged from the ventilation hose leading from the breathing machine to the patient in order to cause a pressure drop in the ventilation hose, which can be recognized by the breathing machine. By means of the breathing machine, a pressure drop is simulated in a manner recognizable by the breathing machine, which pressure drop is caused by a diaphragm contraction caused by the patient when starting spontaneous breathing, and which the breathing machine is already waiting for, but which can occur at a significantly earlier point in time compared to the case where the pressure drop has to be caused by the patient himself.

[0066] However, the pressure relief valve must be closed as soon as possible after the ventilator has initiated a supportive mechanical breathing cycle, so that the breathing cycle does not escape through the pressure relief valve, but rather reaches the patient's lungs. For this reason, a pressure sensor is arranged on the ventilation hose, which is connected or connectable to the control and / or regulation unit, in order to signal to the control and / or regulation unit that the ventilator has triggered a supportive mechanical breathing cycle.

[0067] The sensor can also be used to sense the extent of the pressure drop caused by the pressure relief valve, so that it can be identified whether the pressure drop that has occurred is sufficient to activate the ventilator. The pressure relief valve can then be closed for a short time, and if the subsequent pressure increase can identify that the mechanical breathing support has actually been initiated, the pressure relief valve is kept closed; otherwise, the pressure relief valve can be opened again in order to increase the pressure drop in the ventilation hose system.

[0068] The pressure relief valve and / or the pressure sensor can be arranged on the Y-connection, at which the common ventilation hose of the endotracheal tube divides into the inspiratory and expiratory tubes connected to the ventilator, or on the tubular connection, which is preferably connected directly to the ventilator.

[0069] A further feature of the application is an endotracheal tube, comprising a tube body, which is penetrated by a lumen, and a cuff surrounding the tube body, the proximal end of which can be connected to a ventilator by one or more ventilation hoses.

[0070] The cuff can be connected to a control and regulation device by a connection line, in particular by a hose line, via which the cuff is in communication with the control and regulation device. In this way, the cuff can be filled or (partially) emptied with respect to the control and regulation device in accordance with a preset and implemented algorithm.

[0071] In a further development of the idea of the application, a module or function for dynamically self-adapting the cuff sealing with respect to the trachea can be provided in the control and regulation unit, in which the actual value of the filling pressure in the cuff or in its introduction line is detected and kept as constant as possible by adjusting to a preset target value. In this way, pressure fluctuations in the cuff, in particular breathing mechanics-related pressure fluctuations, i.e. pressure fluctuations occurring during the patient's spontaneous breathing, can be compensated for by correspondingly moving the filling medium into or out of the cuff, in order to dynamically maintain the sealing.

[0072] The application can also be further improved by a signal input on the control and regulation device for receiving data of the ventilator, in particular the volume flow from or to the patient and / or the pleural pressure.

[0073] This information can be combined with information generated by the control and regulation unit itself and, for example, shown visually, preferably in the form of an iterative pie chart or as a respiration work curve plotted on the volume flow from or to the patient including the continuously measured chest or pleural pressure signal. For this purpose, a graphic display device, for example in the form of an LCD display, is used.

[0074] A method for switching a balloon assembly of a tube or catheter unit between two filling states (i) a first filling state of the balloon assembly in a measuring function mode, in which the balloon assembly is in a relaxed state and has a filling which is statically adjusted in a volume-defined manner, and (ii) a second filling state of the balloon assembly in a sealing function mode, in which the filling of the balloon assembly is dynamically adjusted in a pressure-controlled manner in that pressure fluctuations transmitted to the balloon assembly are compensated by a corresponding displacement of the filling medium by means of a regulator unit connected to the catheter unit, so that a sealing target pressure preset by a user is continuously maintained, the method being characterized in that a third function mode is permanently triggered by an automatic control, in particular based on a programmable time period, in which a switching between the measuring function mode and the sealing function mode takes place.

[0075] In one aspect, in the case of a selection of the measuring function mode, a volume of the filling medium, which brings the balloon to a balloon sheath relaxed and unexpanded filling state, is injected into the balloon after the balloon has been initially emptied.

[0076] In another aspect, in the case of a selection of the sealing function mode, a volume is fed to the balloon or removed from the balloon by the regulation module in order to achieve and continuously maintain a set sealing pressure target value.

[0077] In this case, a relatively early trigger signal for triggering an auxiliary mechanical breathing stroke can also be derived in a roughly time-offset manner by measuring or sensing a chest pressure fluctuation, wherein a pressure curve is detected by means of a pressure-absorbing balloon or cuff placed in the esophagus or trachea of the patient, is converted into an electrical signal by the control and regulation unit or a connected breathing machine (artificial respirator), is visualized and is processed in a regulated manner by controlling the electrical signal.

[0078] The present invention proposes in particular the combination of the continuous derivation of an electrical signal with the continuous or intermittent derivation of a mechanical signal of the thorax. While the electrical signal does not provide immediate information about the actual degree of development of the respiratory excursion of the thorax of a patient, the respiratory-physiological success of the respiratory effort can be detected by means of a curve of the thoracic pressure or the pleural pressure, shown in the curve, analyzed for the device control and used by the user for the continuous ventilation plan. The combination of the two methods described within the scope of the present invention is in particular capable of:

[0079] - verifying whether the derived electrical signal actually belongs to a mechanical diaphragm action;

[0080] - determining the actual point in time at which the electrical signal is converted into a change in the pleural pressure that can be measured in the thorax and the quantitative correlation of the electrical signal strength and the corresponding mechanical response strength;

[0081] - enabling the continuous correlation of the electrical signal strength and the respiratory-physiological response strength;

[0082] - triggering the connected artificial respirator, optionally as early as possible, in the case that no measurable mechanical diaphragm action has occurred, in order to provide respiratory support to the patient as early as possible;

[0083] - continuously monitoring the respiratory physiology of the patient, wherein a periodically iterated respiratory work curve generated by the patient can be generated on the basis of the continuous measurement of the pleural pressure in the ventilation hose system and the volume flow towards and away from the patient;

[0084] - performing a control in which the gas balloon of the esophagus can be switched from a measurement filling state to a continuously sealing, inhibiting or avoiding filling state that suppresses or avoids the regurgitation of the gastric contents towards the larynx. BRIEF DESCRIPTION OF DRAWINGS

[0085] Further features, characteristics, advantages and effects of the present invention are based on the following description of preferred embodiments of the present invention and the attached drawings. Therein:

[0086] Figure 1 is a general view of the device, which comprises a catheter unit, an introduction line and connection elements for connecting the different functional components of the catheter unit and the regulating and control unit;

[0087] Figure 2a is a cross-sectional view of a gas balloon catheter in the gas balloon carrying section of the catheter shaft portion with the gas balloon in a relaxed packing state according to the present invention;

[0088] Figure 2b shows a gas balloon body with a balloon tip shaped over the shaft portion dimension towards the proximal (oral) direction for coaxial filling or pressurization of the gas balloon;

[0089] Figure 2c A special shaft profile of the catheter is shown, which serves to ensure an uninterrupted, continuously maintained volume flow between the oesophageal balloon and an external volume reservoir or an external pressure or volume source;

[0090] Figure 3a A further embodiment of a catheter unit with two oesophageal balloons arranged concentrically is shown;

[0091] Figure 3b An improved embodiment of a catheter unit with two oesophageal balloons arranged in series is shown;

[0092] Figure 4 A catheter unit is shown, which is supplemented by electrodes integrated in the catheter shaft for leading out the electrical signal of the diaphragm and / or for leading out the electrical signal of the efferent nerve to the diaphragm;

[0093] Figure 5 Two module units are shown, which work in conjunction with the catheter unit described in Figure 4 for visualizing and processing the patient's led-out electrical signals and for synchronous monitoring of the corresponding respiratory response of the patient;

[0094] Figure 6 Switching logic is shown, which serves to optionally switch to a measuring function mode or to a sealing function mode, so that the automatic control is not switched off, but only interrupted;

[0095] Figure 7 A further embodiment of the switching logic is shown, in which a switch-over between an automatic function mode and a manual function mode can take place by means of a selection switch, wherein in the manual function mode a manual measuring function mode and a manual sealing function mode can then be selected;

[0096] Figure 8 A further improved embodiment of the invention is shown, in which a switch-over directly between a pure measuring function mode and a pure sealing function mode and an automatic function mode is possible, in which in the automatic function mode a permanent time-controlled switch-over between the measuring function mode and the sealing function mode takes place;

[0097] Figure 9a A further improved embodiment of the invention is shown, in which a trigger signal is transmitted by means of a valve to a ventilation hose, which then further transmits the trigger signal as a pressure signal to a breathing machine via the hose;

[0098] Figure 9b An embodiment of the invention is shown, which is similar to the system shown in Figure 9a but with a different type of valve;

[0099] Figure 10a An enlarged view of the valve assembly shown in Figure 9a ;

[0100] Figure 10b is Figure 9b an enlarged view of the valve assembly shown in

[0101] Figure 11 is a timing diagram comprising the pressure curve within the ventilation hose, the filling pressure within the balloon element placed in the esophagus and the cuff pressure within the endotracheal tube's cuff plotted over two breathing cycles in the case of mechanical assisted ventilation, wherein Figure 11 the left side shows the case of triggering the mechanical breathing stroke in accordance with the pressure curve within the ventilation hose, whereas Figure 11 the right side illustration shown in

[0102] Figure 12 is a timing diagram with corresponding pressure curves corresponding to Figure 11 , wherein Figure 12 the left side again shows the case of triggering the mechanical breathing stroke in accordance with the pressure curve within the ventilation hose, whereas Figure 12 the right side illustration shown in DETAILED DESCRIPTION

[0103] The drawings illustrate the application exemplarily in connection with an esophageal sealing catheter 1. However, this does not conceal the fact that almost all aspects of the application are also applicable to endotracheal tubes with a tracheal sealing balloon element in the form of a cuff.

[0104] Figure 1The individual components of the device are described, which are exemplarily connected according to the functional principle of the application. The catheter unit 1 is equipped in the thoracic section of the esophagus 3 with a balloon element 1a, which has been shaped to its required working dimensions during manufacture. The catheter itself corresponds in its preferred embodiment to the typical construction form of a nasogastric decompression tube or feeding tube. The catheter extends with its distal end 4a into the stomach of the patient, but in alternative embodiments it can also extend beyond the stomach into the duodenum and the jejunum in the case of so-called enteral feeding. At the proximal, extracorporeal end of the catheter unit 1, the catheter shaft 4 has a lead-in and lead-out lumen which is adjoined by a conventional connector 4b for the lead-in of a nutrient fluid and / or for the decompression or evacuation of the stomach contents. At the proximal end of the catheter unit 1, this has a hose-like connection 1b which adjoins distally a lead-in lumen through which the balloon element 1a is filled with a preferably gaseous medium or pressurized. The lead-in lumen can be integrated, for example extruded, into the wall of the catheter shaft 4 or formed as a film hose-like shaft tube which sheathes the extension of the proximal balloon end. The connection hose is closed at the end by means of a connector 1c which allows a non-confusing coupling with a regulator unit 5 located extracorporeally via a further hose line 1d as appropriate.

[0105] The hose lead-in line 1d from the regulator 5 to the connector 1c should have a circular lumen with a diameter of at least 5 mm in order to avoid flow-related pressure losses and damping effects between the balloon and the regulator as far as possible. Upstream of the lead-in line 1d, two flow or pressure regulating valve units D and U are provided, wherein unit D regulates the inflow to the patient and unit U regulates the outflow or volumetric output to the environment. The valves D and / or U are preferably based on a piezoelectric structure and working principle and are therefore particularly low-noise and energy-efficient. Upstream of both valves D and U, storage chambers PD and PU are provided which hold a specific pressure (PD) or negative pressure (PU) as a preset target value in reserve. The valves D and U are in communication with the respective associated storage chambers PD and PU. As an alternative, the pressure or negative pressure can be achieved by a corresponding connection to an external power supply unit ZV.

[0106] The module 5 also has a component Z for the volumetric injection into the balloon element 1a of the catheter 1. A defined amount of air can be moved from a gas cylinder into the balloon element 1a or into the lumen 1b, 1d to be led into the balloon element 1a by means of a device KZ, for example in the form of a cylinder. This is particularly important for the measuring function of the device, since the measurement itself, in particular the constant reproducibility of the measurement, requires a relaxed filling of the balloon element 1a with a defined volume of filling medium.

[0107] The volume injection is preferably carried out by the control software of the module with a fixed set pre-set value, but can also be variably adjusted by the user. Other mechanisms can also be employed as a non-adjustable variant, for example a hose nipple which ensures spontaneous elastic straightening, which is mounted in a rigid cylinder which surrounds the hose element, wherein the cylinder is pressurized during the injection, thereby pressing the contents of the hose nipple towards the catheter balloon la, which again automatically straightens elastically upon de-pressurization of the cylinder.

[0108] At the instant of switching from the sealing function to the measuring function of the device, the balloon is emptied by opening the negative pressure valve U. Subsequently, the valve U is closed and a specific amount of filling medium is conducted from the injection unit Z via the bypass ZB to the input of the pressure valve D, which is closed in the open state towards the balloon la. Valve D is then closed.

[0109] Valve D and / or valve U have a pressure measuring function, which continuously detects the pressure in the balloon and in the introduction line leading to the balloon during the phase of the esophageal pressure measurement and exports it as a signal for monitoring the pressure curve. The measurement of the esophageal pressure is preferably carried out with the aid of a gaseous medium, the volume of which is dimensioned in conjunction with the carrier medium volume of the catheter unit 1 so that the balloon element la transitions into a relaxed filling, in order to avoid in any case a stretching of the balloon sheath which would impair the measurement quality. The unstretched state of the balloon sheath ensures that any deviations of the pressure in the esophagus can be detected or that values which cannot be measured with respect to a stretched balloon sheath can be detected.

[0110] After the measurement phase, valve D is opened, the pressure in the balloon element la is adjusted to the sealing pressure DP selected by the user and is continuously maintained there during the subsequent adjustment sealing phase. The regulation is achieved in an ideal form by the interaction of the active feeding of the filling medium into the catheter balloon la and the active removal of the filling medium.

[0111] The above-mentioned regulation can be carried out with the aid of a programmable control unit, logic unit and / or regulation unit, wherein a superordinated control logic SL can be used in order to switch back and forth between the measurement function mode FM, in which the filling state of the balloon element la is controlled to a constant filling volume, and the sealing function mode FS, in which the filling state of the balloon element la is regulated to a constant filling pressure.

[0112] The superordinated control device SL has an input scheme which comprises at least two options, which switch the system into the functional state FS of the sealing (button S, seal) or the functional state FM of the measurement (button M, monitor). On the other hand, the switching between the two functional states can also be preset automatically or by a control algorithm, for which a button A (automatic) can be provided.

[0113] The upper control device SL can, for example, be as follows: Figure 6 The circuit is constructed as shown. Preferably, it includes a bistable trigger circuit 22 with a non-inverting output Q1, which is set by a high level at input S1 and reset by a high level at input R1. The bistable trigger circuit 22 is preferably edge-triggered, meaning that the rising edge of the input signal at inputs S1 and R1 triggers the setting or reset process, while the other signal curve at the relevant input remains inactive until the next rising edge is reached. Output terminal It always has an inverted signal at the output terminal Q1.

[0114] When a high level is applied to the output terminal Q1, the system according to the present invention will operate in measurement function mode FM, wherein the filling state of the airbag element 1a is controlled to a constant filling volume; simultaneously, the output terminal It is a low level.

[0115] Conversely, if at the output end When a high level is applied, the system according to the invention will operate in a sealed function mode FS, wherein the filling state of the airbag element 1a is adjusted to a constant filling pressure; at the same time, the output terminal Q1 is at a low level.

[0116] The output of the first OR gate 23 is connected to the setting input S1; the OR gate has two inputs, one of which can be connected to a high level via button M, and otherwise has a low level. If button M is pressed, the high level reaches the input of the OR gate 23 and is further transmitted from there to the setting input S1 of the bistable trigger circuit 22; setting the output Q1 to a high level, the system immediately enters the measurement function mode FM.

[0117] Furthermore, the output of the second OR gate 24 is connected to the reset input R1 of the bistable trigger circuit 22; this OR gate also has two inputs, one of which can be connected to a high level via button S, and otherwise has a low level. If button S is pressed, the high level reaches the input of the OR gate 24 and is further transmitted from there to the reset input R1 of the bistable trigger circuit 22; the output Q1 is set to a low level, and alternatively, the inverted output is... Set to high level; the system immediately enters the sealed function mode FS.

[0118] from Figure 6 It can also be seen that the inverting output terminal of the bistable trigger circuit 22 Feedback is sent to the second input of OR gate 23 via the first timer or delay module T1. Therefore, the output of the bistable trigger circuit 22... The positive edge, i.e. the switching from low to high level, at the output Q1 of the flip-flop 22 reaches the OR gate 23 in a time-delayed manner by the adjustable time T1 and is immediately transmitted there from the flip-flop 22 to the set input S1 of the flip-flop 22, whereupon the automatic change of the output signal Q1 from low to high level is triggered. At this point in time, the system switches automatically from the sealing function mode FS to the measuring function mode FM after the time T1.

[0119] In addition, there is a second feedback from the non-inverted output Q1 of the flip-flop 22 via a second timer or delay module T2 to the second input of the OR gate 24. The positive edge, i.e. the switching from low to high level, at the output Q1 of the flip-flop 22 thus reaches the OR gate 24 in a time-delayed manner by the adjustable time T2 and is immediately transmitted there from the flip-flop 22 to the reset input R1 of the flip-flop 22, whereupon the automatic change of the output signal Q1 from high to low level is triggered, while the inverted output is alternatively switched to high level; at this point in time, the system switches automatically from the measuring function mode FM to the sealing function mode FS after the time T2.

[0120] Thus, the automatic control is permanently switched off and the system is in the manual control state. The manual control state is maintained as long as the switch S or M is closed. If the switch S is closed, the system is in the sealing function mode FS. If the switch M is closed, the system is in the measuring function mode FM. If the switch S or M is opened, the system switches automatically from the sealing function mode FS to the measuring function mode FM or vice versa after the time T1 or T2. Figure 6 The illustrated switching logic SL shows the performance of a permanent, non-switchable automatic control, in which a temporary override function is triggered by the pushbutton M or S, i.e. a time-limited switching to a manually selectable state, which then remains active for the time interval T1 or T2; the system then returns to the automatic state again by itself and time-controlledly switches back and forth between the two function states FM, FS.

[0121] Figure 7 The illustrated upper control logic SL' provides the possibility of completely switching off the automatic control. For this purpose, a switch A with two stable switching states is provided. If the switch A is closed, the system is in the automatic control state, i.e. a high level at the input of the switch A reaches any of the inputs of the AND gates 25, 26. By this, the two AND gates can be said to be transparent and immediately react to a rising edge at their respective other input. At the other input of the AND gate 25, the output signal of the timer module T1 is applied, which in turn switches the rising edge at the non-inverted output Q1 in a time-delayed manner by the time T1, as in the control logic SL. And at the other input of the AND gate 26, the output signal of the timer module T2 is applied, which in turn switches the rising edge at the non-inverted output Q1 in a time-delayed manner by the time T2. Thus, in this automatic circuit state, a time-controlled mode switching is permanently implemented, i.e. a time-controlled constant switching back and forth between the two function modes FM, FS.

[0122] In contrast, if the switch A is closed, a low level is applied at either input of the two AND gates 25, 26 and these two gates 25, 26 are thereby blocked, i.e. they do not react at their outputs to the output signals of the timer modules Tl, T2 - the automatic control is switched off.

[0123] As an alternative, a high level reaches via the inverting module 27 to either input of the two further AND gates 28, 29, whereby these two AND gates become transparent or sensitively react to the signals at their respective further input. There, the AND gate 28 is connected with the button M and the AND gate 29 with the button S. Both buttons M, S have their inputs at a high level and switch a high level to the respective AND gate 28, 29 upon manual actuation of the relevant button M, S. Then, the relevant AND gate 28, 29 generates a high level at its output as well, which is further transferred at the AND gate 28 to the OR gate 23 and at the AND gate 29 to the OR gate 24. This has the effect that upon pressing the button M the output Ql of the bistable flip-flop 22 is set and the system immediately enters the measuring function mode FM, while upon pressing the button S the inverting output Q2 of the bistable flip-flop 22 is set and the system immediately enters the sealing function mode FS. The setting to a high level and the system immediately enters the sealing function mode FS.

[0124] Once the automatic control is switched off, the system remains in the last selected function mode FM, FS until another function mode FS, FM is selected or the automatic control is switched on by closing the switch A.

[0125] Thus, in the control logic SL' each selected function mode FM, FS, including the automatic control, is stable until a new input is made. However, for the manual selection of a function mode FM, FS it is necessary to first switch off the automatic control and then in a second action to select the respective function mode FM, FS by pressing the button M, S. In contrast, pressing the button M, S directly without switching off the automatic control has no effect.

[0126] This can lead to misunderstandings of the respective active operating mode by laymen. In order to avoid the above-mentioned situation, there is another embodiment of the upper control logic SL" as shown in Figure 8

[0127] Here, the function of the switch A is handed over to a second bistable flip-flop circuit 30. Figure 7

[0128] ​​The non-inverted output Q2 of this second bistable trigger circuit is connected to any input of two AND gates 28, 29, the other input of which is connected to the push button M or to the push button S. Thus, in the case of the output Q2 being at a high level, the AND gates 28, 29 are transparent, and by pressing the push button M or S the set input S1 is activated via the downstream OR gates 23, 24 in order to select the function mode FM, or the reset input R1 is activated in order to select the function mode FS.

[0129] On the other hand, the inverted output Q2 of the bistable trigger 30 is connected to the other input of the two AND gates 25, 26, the other input of which is connected to the push button A. At the same time, the bistable trigger 30 is in the low level, and thus the two AND gates 25, 26 connected to this inverted output are blocked and thus prevent the automatic operation by means of the timer modules T1, T2.

[0130] From this state, the bistable trigger 30 can be reset by pressing the push button A, and thus the two AND gates 25, 26 connected to the inverted output Q2 of the bistable trigger 30 are made transparent and react to the delayed edges at the output Q1 of the bistable trigger 22 by means of the timer modules T1, T2, so that the two function modes FM, FS are switched back and forth permanently, which corresponds to the automatic operation. Figure 8 It can also be seen that at the set input S2 of the bistable trigger 30 there is connected the output of a further OR gate 31, the two inputs of which are connected to the outputs of the switches M or S, respectively. That is to say, upon actuation of one of the push buttons M or S, an upstroke always reaches the set input S2 of the bistable trigger 30 and brings it into the aforementioned state with a high level at the output Q2, which in turn makes the two AND gates 28, 29 transparent.

[0131] As long as the push button A is not pressed, the bistable trigger 30 cannot be reset and remains in this state, which can be called manual operation, and in which one of the two manually selectable function modes FM or FS is executed, between which two function modes FM, FS a switch can be made at any time by pressing the respective other push button S, M.

[0132] In contrast thereto, if the push button A is pressed, the bistable trigger 30 is reset and then a high level is applied at the inverted output Q2, so that the two AND gates 25, 26 connected with this output are made transparent and react to the delayed edges at the output Q1 of the bistable trigger 22 by means of the timer modules T1, T2, so that the two function modes FM, FS are switched back and forth permanently, which corresponds to the automatic operation. In other words, pressing the push buttons M, S, A enters the respective working mode FM or FS or the automatic working mode immediately, and the respective working mode remains active until the respective other push button M, S, A is pressed.

[0133] In other words, pressing the push buttons M, S, A enters the respective working mode FM or FS or the automatic working mode immediately, and the respective working mode remains active until the respective other push button M, S, A is pressed.

[0134] ​​The measured pressure values can be monitored in different ways. For example, the pressure signal is displayed as a continuous absolute value. In addition, it can also be displayed as an iterative circular curve KK in combination with the volume (flow) actively moved by the patient, so that the respiratory work of the patient can be shown in a time curve. In addition, the so-called transpulmonary pressure can be determined, which is derived from the so-called alveolar pressure minus the pleural pressure.

[0135] As a further application option, the unit can also be used in both functional states to trigger a mechanically assisted breathing stroke. The respective shift in the intrathoracic pressure or the pleural pressure is related in time to the start of a mechanical respiration of the patient's chest, even before a measurable movement of the respiratory gas in the patient- connected hose system occurs. In this case, as a trigger threshold, a certain intrathoracic or pleural pressure drop to be generated by the patient is preset by the user, wherein the respective pressure difference can be adjusted, for example, steplessly or grid-like, by a rotary knob or a rotary knob T.

[0136] Figure 2a The balloon catheter 1 in the functional state of the oesophagus sealing with tamponade according to the application is shown schematically. The lumen of the oesophagus OE is shown in the shown organ cross-section as a star-creased invaginated space F. The balloon sheath BH, which has been completely formed in the manufacturing process, lies stress-free in the form of a relaxed mantle against the folds of the organ mucosa. In particular in the functional state of the balloon tamponade sealing the oesophagus in the long term, a stretching of the balloon sheath should be avoided, since the exposed mucosa is very sensitive to pressure on the one hand and a stimulating bolus feeling should be avoided on the other hand for the patient.

[0137] With regard to the described combination measuring and sealing balloon 1a, the application proposes a balloon body which is substantially cylindrical, has a diameter of 15 to 35 mm, preferably 25 to 30 mm, and a length of 6 to 12 cm, preferably 8 to 10 cm. The balloon 1a should be composed of a thin-walled material with a low volume extensibility. Polyurethane with a Shore hardness of 90A to 95A or a hardness of 55D is preferably used. The wall thickness of the balloon body 1a is in the range of 5 to 30 μm, preferably 10 to 15 μm. The sealing pressure set in the balloon 1a is usually in the range of 5 to 30 mbar, preferably in the range of 15 to 25 mbar, in order to avoid a gastro- pharyngeal reflux.

[0138] Figure 2bOne special construction of a balloon 1 a combined with the sealing and measurement of the esophagus is shown, wherein the balloon is fixed at the distal end 1 e directed towards the stomach on the hose shaft portion SS and tapers at the proximal end 1 f, so that a gap space SR is formed between the surface of the hose shaft portion SS and the balloon end 1 f, through which the balloon can be filled from the outside or the filling pressure can be applied to the balloon. Thus, the gap space SR enables the filling of the filling balloon 1 a independently of the filling lumen pressed into the wall of the hose shaft portion SS, which on the one hand enables a particularly large cross section of the introduction or introduction catheter lumen in communication with the digestive tract and on the other hand allows a particularly high efficient cross section in terms of throughput when introducing the filling medium into the balloon 1 a and removing the filling medium from the balloon.

[0139] Figure 2c One special embodiment of the catheter shaft portion SS in the region above the sealing balloon 1 a as a lateral cut plane [2c] is shown. In this case, the hose shaft portion SS is surrounded by a profile structure 6, which remains open using the remaining space 7 for the movement of the filling medium in the case of forces acting from the outside on the catheter 1, for example peristaltic contractions, so that an interruption of the communication of the balloon 1 a with the outside regulating unit 5 can be avoided. The profile 6 is preferably made of an elastic, self-straightening material, for example polyurethane. The profile extends from the proximal balloon end 1 f into the transition region from the hose shaft portion to the introduction line 1 b. In an alternative embodiment, the profile also extends towards the distal into the region of the sealing balloon body or through the lower fixing point of the balloon 1 a on the catheter shaft portion SS.

[0140] Figure 3a One alternative embodiment of the catheter unit 1 is shown, wherein the catheter is equipped with two balloons 8, 9 concentric to each other, and wherein the inner balloon 9 has a measuring function and the outer balloon 8 seals the esophagus in an organ-compatible manner with a tamponing. The two balloons are filled by separate introduction lines 10 and 11 and connected to the regulator 5 modified by means of a respective inlet. In this case, the introduction line filling the measuring balloon is directly connected to the volume syringe Z.

[0141] The measuring balloon 9 preferably has a diameter of 8 to 12 mm, which is likewise composed of a preferably low-volume-elasticity soft film and for example made of PUR with a (Shore) hardness of 95 A. The sealing tamponing balloon 8 corresponds in its dimensions and the material used to the previously described embodiments for the sealing of the esophagus.

[0142] Figure 3b An alternative sequential arrangement of the two balloon bodies is shown, wherein the measuring balloon 9 is preferably arranged distally, so that it can preferably be placed in the transition of the lower third to the middle third of the esophagus, preferably for detecting the thoracic pressure. The sealing balloon 8 is positioned in the region of the upper half of the thoracic portion of the esophagus.

[0143] The operation is constituted by the catheter unit 1 and the regulator module 5 shown, which optionally have the features of the catheter unit 1 according to one or more of the Figure 1 The method of the system with the features of the catheter unit 1 according to one or more of the Figures 2a to 3b The method of the system with the features of the catheter unit 1 according to one or more of the

[0144] The catheter unit 1 is generally positioned in the nasogastric. The correct positioning of the catheter balloon la, which is filled and sealed between the upper and lower sphincter muscles of the esophagus, is confirmed by X-ray images of the thorax, where the upper and lower ends of the balloon la are highlighted by the corresponding pairs of markers 14 on the hose shaft SS of the catheter 1.

[0145] After the position check of the balloon la and the fixation of the catheter 1 in the region of the nostrils, the catheter is connected together with the regulator unit 5.

[0146] As a first functional step of the regulator unit 5, the valve U is opened, so that the balloon body la is emptied to the greatest extent. After the closure of the valve U, a predetermined volume of filling medium is guided through the volume injection unit Z directly to the open valve D and moved beyond this valve into the catheter balloon. The valve D is closed and the filling pressure in the balloon la is measured as a continuous value by a pressure absorption function, which is preferably integrated in the valve, which is very close to the intrathoracic pressure. A first visualization of the intrathoracic pressure is then realized as a continuous pressure curve or as a continuous iterative pie chart of the respiratory effort diagram. The correct positioning of the balloon la is confirmed by the typical image of the esophageal pressure curve.

[0147] The user checks the typical reductions of the continuous intrathoracic pressure signal, which are triggered by the autonomous breathing of the thorax of the patient. In the case of sufficiently clear images, these reductions can be used to trigger mechanically assisted breathing strokes. In this case, the trigger threshold or pressure difference to be reached can be adjusted by the user by rotating the regulator T.

[0148] In the measurement mode, the user can view the intrathoracic pressure as a continuous curve / signal, can show an iterative pressure / volume curve (respiratory effort curve) or can also show the calculated so-called transpulmonary pressure.

[0149] The transition from the measurement to the sealing mode is realized by the user by a manual switch (button S). At this point, the pressure reservoir PD is connected with the valve P and the negative pressure reservoir PU is connected with the valve U. Volumes are fed to the balloon or removed from the balloon in order to reach or continuously maintain the respective set esophageal sealing pressure target value DP.

[0150] In order to obtain a triggering option for triggering the mechanical assisted breathing stroke, the control of the regulator can be programmed with a certain delay which allows a certain pressure drop in the balloon volume before a volume displacement towards the balloon occurs which holds the sealing target value.

[0151] By manipulating the M button, a switch from the sealing mode to the measurement mode or vice versa can be triggered or the above-mentioned switch can also be implemented within a user preset period.

[0152] Figure 4 A catheter unit 1 according to the application is shown, which has additional derivation electrodes 12 for the electrical action potentials of the diaphragm ZF and / or the nerve structures which innervate the diaphragm. The electrodes 12 are arranged on the surface of the catheter shaft 4 in an axially distributed manner at a distance from one another, preferably on the distal catheter tip 13 which is remote from the balloon 1a or the balloon assemblies 8, 9. These electrodes are arranged below or distally of the oesophageal balloon assembly 8 or 9, in a preferred embodiment, these electrodes detect the area above and below the diaphragm. The individual electrodes 12 are derived from the catheter shaft by a full-phase bundle cable 12a in the area of the extracorporeal catheter tip. The connection to the connected hardware is achieved by a corresponding multipolar connector 12b. The electrodes 12 are connected to a reference electrode 12c respectively or all together during derivation.

[0153] The distal end 13 of the catheter is optionally embodied such that it communicates with the stomach of the patient, or it extends through the stomach into the duodenum, or it extends through the duodenum into the jejunum of the patient.

[0154] Figure 5 An exemplary layout of the modules 15, 18 for receiving, processing and evaluating the signals is shown, which allow the user to use the synchronous derivation of electrical and mechanical respiration-related signals modularly accordingly.

[0155] On the one hand, an amplification and monitoring module 15 is shown, on the other hand a respiratory mechanics module 19. In this case, the respiratory mechanics module 19 contains, in addition to the functions and elements described below, the functions and elements mentioned above for the regulator module 5, in particular the valves D and / or U, the pressure reservoirs PD and / or PU, the assembly Z for injecting a volume into the balloon element 1a of the catheter 1, the control logic SL, the input elements M and S for manually selecting the measurement function or the sealing function and, if appropriate, the knobs DP, T for inputting the oesophageal sealing pressure target value or the triggering threshold.

[0156] The amplification and monitoring module 15 is connected to the one or more electrodes 12, 12c via the cables 12a, 12d and preferably detachable plug-in connections 12b, 12b' and enables continuous visualization of the electrical diaphragm activity in the form of a continuous signal curve 16. By means of a corresponding analysis algorithm of the signal, specific periodically recurring segments of the signal can be identified and marked as effective start of the "neuromuscular" respiratory activity. The point in time 17 at which the patient generates a neuromuscular activity can be transmitted to the patient's ventilator (artificial respirator) V, at which point in time the assisted breathing stroke is triggered, which is temporally earlier than the point in time at which the effective spontaneous breath of the patient triggers the volume flow to the patient, i.e. in the state of "isometric" patient breathing, the breathing stroke optimally assists the patient's spontaneous breathing attempt at an early stage, in which the thorax has not yet increased in size or only slightly or the elastic recoil force of the lungs has not yet been overcome. This option of early assistance is particularly important for many patients. In order to prevent respiratory system failure due to the patient's frustrating non-delivered volume breathing efforts, which often cause the patient to return from the assisted ventilation mode to the controlled ventilation mode, the patient with weak respiratory mechanics can be weaned from the artificial respirator more quickly with better efficiency and more targeted ventilation planning.

[0157] The calculation and triggering of the signal recognition or trigger pulse can be implemented, for example, by means of a self-correlation algorithm which associates a pattern action with a subsequent action. The degree of correlation or coefficient required for the triggering can be adjusted by the user by means of a manual input on an input element, such as a rotary knob 18a, preferably on a scale of -1 to +1.

[0158] In parallel to the electrical signal, a mechanical signal is derived from the patient's chest, wherein the current thoracic pressure is absorbed by the esophageal balloon 8, 9, la and conducted to the respiratory mechanics module 19 by means of one or more hose-like introduction lines 1b, 1d and preferably by means of detachable plug-in connections or screw connections 1c, 1c'. In the respiratory mechanics module 19, the thoracic or costal membrane pressure curve is displayed, for example, as a continuous pressure curve. This curve enables the user to track the thoracic capacity of the patient's spontaneous breathing over time.

[0159] The relative shift of the pressure curve to the negative can be interpreted by means of a recognized correlation algorithm as the start of a mechanical breathing action and transmitted as a trigger pulse to the artificial respirator V. The calculation and triggering of the signal recognition or trigger pulse can be implemented, for example, by means of a self-correlation algorithm which associates a pattern course of the pressure curve with a subsequent signal curve of the pressure curve. The degree of correlation or coefficient required for the triggering can be adjusted by the user by means of a manual input on an input element, such as a rotary knob 18b, preferably on a scale of -1 to +1.

[0160] In addition to continuously displaying the pleural pressure, it can be visualized in the respiratory mechanics module 19 as an iterative pie chart or a work of breathing curve 20 plotted as a function of the volumetric flow rate moved by the patient. The number of iterations of the work of breathing curve 20 to be displayed on the screen can be manually entered by the user at an input option, such as on the input knob 21.

[0161] The respiratory mechanics module 19 interacts with the ventilator V in two directions: it receives the current flow value measured by the ventilator V and transmits control or trigger pulses to the ventilator.

[0162] The described combination of electrical and mechanical signals specifically enables the correlation between neuromuscular electrical activity and the effective, mechanically performed work of breathing, and allows users to identify electrical signals with mechanical responses as belonging to each other. Furthermore, the analysis algorithm for the two signals can correlate the corresponding signal intensities. Additionally, the electrical signals can be distinguished into incoming motor efferent neuron signals and subsequent muscle action potentials. Users can further verify whether the neuronal efferent electrical signals translate into muscle action potentials or determine the strength of the potentials. Users can determine, in a corresponding manner, whether and at what strength, the muscle action potentials translate into mechanical contraction of the diaphragm.

[0163] In all preferred embodiments of the balloon catheter 1, the flexible tube stem SS is provided with a radiopaque marker 14, which makes the upper and lower ends of the balloon 1a or balloon devices 1a, 8, 9 located in the esophagus visible in X-ray images. In principle, the balloons 1a, 8 should achieve a sealing effect throughout the entire region between the upper and lower esophageal sphincter. In this case, the positioning of the annular marker 14 on the flexible tube stem SS preferably corresponds approximately to the corresponding sphincter.

[0164] The present invention also describes a method for mechanically ventilating a patient in a manner that minimizes backflow and prevents pneumonia, wherein the user can switch from a mode of dynamically sealing the esophagus to a mode of statically measuring the esophagus during ventilation.

[0165] The present invention also describes a method of applying catheter unit 1 in a manner that alternately measures and seals the esophagus, wherein neuromuscular electrical signals of the patient's diaphragm are detected by a transdiaphragmatic or proximal diaphragmatic electrode device 12. Catheter unit 1 accordingly has a structural combination of a catheter balloon 1a positioned in the esophagus for measurement and / or sealing, and an electrical discharge electrode 12.

[0166] Operating catheter unit 1 and by Figure 4 The method of the system consisting of modules 15 and 18 shown is set in the following order:

[0167] The catheter unit 1 is usually positioned in the nasogastric tract. The correct positioning of the catheter balloon 1a, which is filled and sealed in the upper esophageal sphincter and the lower esophageal sphincter and is measured, is confirmed by means of an X-ray image of the thorax, in which the upper end and the lower end of the balloon 1a are highlighted by means of the corresponding pairs of markers 14 on the soft tube shaft SS of the catheter 1. The probe-like catheter 1 has the function of a nasogastric feeding catheter, which enables gastric decompression and gastric feeding of the patient.

[0168] The lead-out electrodes 12, which are positioned distally of the balloon assembly 1a, are preferably positioned such that they are located on both sides of the diaphragm, i.e. transdiaphragmatically.

[0169] After the position of the balloon 1a has been checked and the catheter 1 has been fixed in the region of the nostrils, the lead-out electrodes 12 are connected to the amplification and monitoring module 15, for example by means of the cable lead-through lines 12a, 12b, 12b' and 12d, and the balloons 1a, 8, 9 are connected to the respiratory mechanics module 19 by means of the soft tube lead-through lines 1b, 1c, 1c' and 1d.

[0170] In this case, the total potential of the plurality of individual electrodes 12 or the signal of one or more individual electrodes 12 can be mapped as a continuous signal curve 16 in the display of the monitoring module 15. The conduction takes place relative to the signal of the reference electrode 12c, which is also arranged on the catheter shaft SS. A control algorithm integrated in the module determines the identified spike 17 in the signal 16 as early as possible by comparing a plurality of potential cycles, the specific form of which is associated with the subsequent potential of the cycle. The accuracy of the correlation can be adjusted by the user by inputting the correlation factor required to identify the signal spike. If such a pattern spike is identified in the signal, the module sends a trigger pulse to the ventilator V connected to the patient, which informs the device of the beginning of the electrical diaphragmatic activity. The trigger pulse can be used by the ventilator V to trigger a breathing cycle that assists the patient's breathing effort.

[0171] The respiratory mechanics module 19 visualizes the curve of the thoracic or pleural pressure in the display as a continuous curve or as an iterative loop. The continuous loop is established in that the flow of respiratory gas to and from the patient is continuously determined by the ventilator V and is transferred as a corresponding electronic signal, for example as a voltage curve, to the respiratory mechanics module 19, which plots it on the continuously determined thoracic pressure.

[0172] The combination of the two modules 15, 19 enables the association of the onset of the muscular action (diaphragmatic action potential) with the onset of a diaphragm-related, breathing-physiologically effective contraction of the diaphragm and the associated shift or reduction of the thoracic pressure in the best possible manner for the ventilation plan of the user. In particular, the auxiliary volume support for supporting the respiratory journey or the inspiratory effort of the patient can be initiated on the basis of the triggering by the diaphragm-derived electrical potential, even if the patient has not yet exerted any mechanical respiratory effort or has only exerted a slight mechanical respiratory effort. This is crucial for certain patients who are not able to produce a sufficient thoracic pressure drop by means of autonomous breathing to overcome the corresponding elasticity of the patient's lungs or to expand the lungs within the thorax, in order to regulate the volume flow towards the patient within the ventilation hose system. Such patients can adopt an assisted ventilation mode by means of the described method and remain permanently and assistedly ventilated there without repeated respiratory muscle fatigue.

[0173] As an alternative to the implementation of the "early" triggering by means of an electrical signal, the user can switch to a triggering by means of a "late" thoracic mechanical signal, wherein the triggering signal is determined by a thoracic rest pressure according to a specific, adjustable thoracic pressure shift or reduction. Depending on the preset value of the pressure shift required for the triggering signal, the patient can contribute more or less of an autonomous component to achieve a specific tidal volume. This preset value can thus enable an optimized respiratory "respiratory system training" without the patient developing respiratory fatigue and without the patient having to be relieved of the assisted autonomous breathing.

[0174] If the breathing-physiological module 19 has already integrated or has the functions and elements of the regulator module 5, the soft tubular introduction line 1 b leading to the catheter balloon 1 a can also be connected to the module 5 showing the thoracic pressure curve in parallel or as an alternative to the connection of the catheter balloon 1 a to the breathing-physiological module 19, which can provide, in addition to the option of intermittent measurement of the thoracic pressure, the option of continuous pressure control with a sealing tampon effect in the catheter balloon 1 a, wherein the sealing balloon pressure is adjusted dynamically and compensates for thoracic pressure fluctuations caused by the patient's autonomous breathing. In the case of this combination of the modules, the breathing machine assisting the patient's breathing can be triggered continuously by the action potential of the diaphragm independently of the primarily sealing pressure situation, which can be regulated with respect to the target value, and / or independently of the esophageal measurement function in the esophageal balloon. The point in time of the device triggering can again be used for the insertion of the electrical diaphragm signal, which can be adjusted by the user, with a certain time offset with respect to the respiratory training or the respiratory plan.

[0175] Figure 9a Another example of how the triggering signal generated by the control and regulator unit 5 is passed on to the breathing machine V.

[0176] To this end, the adapter 33 is connected via a cable 32a to the control and regulator unit 5, which in turn is connected with a ventilation hose 34a of the ventilator V, for example via a Y-connection 35 as shown in Figure 9a which on the one hand is connected or connectable with the proximal end of the ventilation hose 34a leading to the patient and on the other hand with two separate hoses 34b for inhalation and exhalation.

[0177] In the embodiment shown in Figure 9b the adapter 33 is arranged directly on a tubular connection 36, which in turn can be connected directly on the ventilator V.

[0178] The main component of the adapter 33 is a pressure relief valve 37, which is opened and closed by a magnet 38, which in turn is controlled by the control and regulator unit 5 via the cable 32a.

[0179] As soon as a trigger signal is generated by the control and regulator unit 5, i.e. an assisted mechanical breathing stroke is requested by the ventilator to the control and regulator unit 5, this trigger signal has to be transmitted to the ventilator V. For this purpose, the trigger signal is connected via the cable 32a to the magnet 38 in a suitably amplified form and causes the magnet to open the pressure relief valve 37. In this way, air can escape from the ventilation hoses 34a, 34b, which are in communication with each other, and / or from the Y-distributor 35 or the tubular connection 36. The resulting pressure drop in the ventilation hose 34b leading to the ventilator V is sensed by the ventilator V and interpreted as an attempt by the patient to lift his chest in order to suck air into his lungs by means of the negative pressure, whereupon the ventilator V triggers the desired assisted mechanical breathing stroke.

[0180] The pressure relief valve 37 should remain open until the desired assisted mechanical breathing stroke is triggered. Subsequently, the pressure relief valve 37 should be closed as quickly as possible so that the overpressure generated by the ventilator V does not escape, but reaches the patient's lungs. Therefore, it is further proposed according to the invention to arrange a pressure sensor 39 in the region of the pressure relief valve 37, which is connected via a cable 32b with the control and regulator unit 5, which allows to recognize a pressure increase in the ventilation hose 34b due to the working ventilator V and to close the pressure relief valve 37 immediately.

[0181] In the layout shown in Figure 9a a catheter unit 1 without electrodes as shown in Figure 1 and Figure 4The catheter unit 1 shown, in which the electrodes 12, 12c are arranged in the region of the distal end 4a of the catheter shaft, is connected to a control and regulation unit 5, in this case preferably also having the functions of a monitoring module 15 and a respiratory mechanics module 19 or can be connected with these functional modules, by means of the cable connections 12a, 12b, 12d. In this case, the trigger signal can be derived not only from the oesophageal pressure within the balloon element 1a, but also from the signals of the electrodes 12, 12c, which directly pick up the action potentials of the diaphragm from the patient.

[0182] Figure 9a A ventilation cannula or endotracheal cannula 40 is also shown. This comprises an actual tube 41 and a cuff 42a surrounding this tube. The ventilation hose 34a can be connected at the proximal or extracorporeal end 43 of the ventilation cannula 40.

[0183] The cuff 42a of the ventilation cannula 40 is also affected by a similar sealing problem as the balloon element 1a of the oesophageal catheter 1. This sealing problem is based on the fact that the intrathoracic pressure is subject to regular fluctuations within the respiratory cycle of the patient, which can cause the cuff 42a, as well as the balloon element 1a, to no longer seal completely, in particular in the case of temporary pressure reductions.

[0184] In order to reduce the above-mentioned effects to a minimum, the application, as for the balloon element 1a placed in the oesophagus, also proposes an adaptive pressure regulation for the cuff 42a of the ventilation cannula 40, so that the cuff 42a is permanently sealed during the entire respiratory cycle, without this causing non-traumatic injuries in the case of long-term presence in the patient.

[0185] In other words, the pressure within the cuff 42a is measured directly within the cuff 42a itself or in its introduction lines 42b, 42c, 42d, and the measured pressure is then regulated by the control and regulation unit 5 to the preset target value as far as possible. The same regulation algorithm as for the balloon element 1a placed in the oesophagus can be used here, the only difference being that in the cuff 42a there is no need to switch to a measurement function mode.

[0186] Figure 11 and 12 Different modes of action of the application are shown. In both figures, the curve a represents the temporal pressure curve within the ventilation hose 34a, 34b during mechanical assisted ventilation, which is measured by the ventilator V in the inspiration phase 44 and the expiration phase 45 of the respiratory cycle 46, 47', 47", but is also influenced. In this case, the pressure in mbar along the ordinate is plotted as the abscissa on the time axis t.

[0187] In the case of a conventional triggering by the ventilator V, the triggering takes place in the breathing cycle 46 in conjunction with the pressure curve placed in the balloon element 1a in the esophagus, in the breathing cycle 47' and in conjunction with the potential curve measured on the diaphragm ZF by means of the electrodes 12, 12c on the shaft 4a of the catheter 1 placed in the esophagus, in the breathing cycle 47".

[0188] All breathing cycles 46, 47', 47" have in common that at the end of the preceding complete expiration phase 45, the pressure in the ventilation hose 34a, 34b drops to a nearly constant value 48, which is referred to as positive end-expiratory pressure (PEEP) and is approximately +5 mbar.

[0189] In the case of a conventional triggering, as soon as the patient, consciously or unconsciously, requires another breathing cycle 46, the corresponding stimulus reaches the diaphragm ZF via the phrenic nerve. The diaphragm then begins to contract - at least in the case of a patient who has at least a basic autonomous breathing capacity. After a certain time, the diaphragm deforms approximately conically, and the pleural cavity expands. As soon as the pleural cavity has significantly enlarged, the pressure in the ventilation hose system 34a, 34b drops slightly according to curve a. This pressure drop 49 is referred to as initial respiratory pressure drop (IRPD). As soon as the pressure drop 49 reaches an order of magnitude of approximately 2 to 3 mbar below the positive end-expiratory pressure level 48, this pressure drop is recognized by the ventilator V and is considered to be an inspiration phase 44 as desired by the patient, and the ventilator V increases the pressure in the ventilation hose system 34a, 34b in order to additionally press air into the patient's lungs. In this case, the pressure in the ventilation hose system 34a, 34b rises according to curve a to a peak pressure value 50 (PEAK) of typically approximately 35 mbar. As the lungs gradually fill up, this value drops to an elevated inspiratory pressure plateau 51 (PLATEAU) of approximately 25 mbar. Then there is again an expiration phase 45, during which curve a returns to the initial positive end-expiratory PEEP pressure level 48.

[0190] The pressure curve b is measured in the cuff 42 of the endotracheal tube 40 in a manner that is synchronized in time with the pressure curve a in the ventilation hose system 34a, 34b according to the curve a. This pressure curve has reached a constant pressure value 52 of approximately 25 mbar at the end of the expiration phase 45. The onset of patient breathing (OPB) can be identified by a slight pressure drop 53 in the cuff 42 as soon as the diaphragm ZF starts to contract. The pressure drop 53 is only approximately 2 to 3 mbar below the initial constant pressure value 52 of approximately 25 mbar. In the case of mechanical assisted breathing, the pressure drop 53 remains approximately constant until the ventilator V is activated and air is pressed into the lungs. In this case, the cuff pressure b also rises approximately to the peak or PEAK value 50 and then follows the pressure curve a in the ventilation hose system 34a, 34b to the somewhat elevated inhalation pressure level 51 (PLATEAU) of approximately 25 mbar, which is close to the initial pressure value 52 of the curve b of approximately 25 mbar, which the curve c finally again strives to achieve in the expiration phase 45.

[0191] Similarly, the pressure curve c can be measured in a manner that is synchronized in time with the pressure curves a and b in the balloon element 1 a of the catheter unit 1 placed in the esophagus. This pressure curve reaches a constant pressure value 54 of approximately 15 mbar at the end of the expiration phase 45. The onset of patient breathing OPB can again be identified by a pressure drop 55 in the esophageal balloon assembly 1 a as soon as the diaphragm ZF starts to contract. However, the pressure drop 55 at the curve c is more pronounced than the pressure drop at the curve b and is typically approximately 6 to 7 mbar below the initial constant pressure value 54 of approximately 15 mbar. In the case of mechanical assisted breathing, the pressure drop 55 remains approximately constant or drops slightly further until the ventilator V is activated and air is pressed into the lungs. In this case, the pressure c of the balloon element 1 a placed in the esophagus also rises approximately to the peak or PEAK value 50, i.e. to approximately 45 mbar, and then follows the pressure curve a in the ventilation hose system 34a, 34b to the somewhat elevated inhalation pressure level 51 (PLATEAU) of approximately 25 mbar in order to finally return again to the initial pressure value 52 of approximately 15 mbar in the expiration phase 45.

[0192] The pressure drop 55 in the balloon element 1 a placed in the esophagus is more pronounced than the approximately simultaneous pressure drop 53 in the cuff 42a on the endotracheal tube 40 when the patient starts to breathe, so that the pressure drop 55 can be more easily and quickly identified by the control and / or regulation unit 5 according to the application than the pressure drop 53 in the cuff 42a and can be used to generate a trigger signal for the ventilator V.

[0193] In Figure 11The left side in Fig. 1 shows a breathing cycle 46 when a pressure drop 49 (IRPD) in the ventilation hose system 34a, 34b is triggered in a conventional manner. This pressure drop 49 (IRPD) is recognized by the ventilator V at a point in time 56 and the mechanical assisted breathing stroke 44 is then initiated or triggered.

[0194] As shown on the left side in Fig. 1, since the onset 57 of the muscular action of the diaphragm ZF (BIMO), a non-negligible time interval 58 has already elapsed. Figure 11

[0195] In contrast to this, in the case of the method shown on the right side in Fig. 1, instead of waiting for the pressure drop 49 in the pressure curve a of the ventilation hose system 34a, 34b, triggering is carried out on the basis of the pressure drop 55 in the balloon assembly 1 a placed in the esophagus according to curve c. This curve is more pronounced and thus can be reliably used as a basis for generating a triggering pulse. It can be seen that the triggering point in time 56' is closer to the onset 57 of the muscular action of the diaphragm ZF than the triggering point in time 56 determined by the ventilator V in a conventional manner. Thus, the time interval 58' between the onset 57 of the muscular action of the diaphragm ZF (BMO) and the assisted switching on by the ventilator V is significantly shorter than the corresponding time interval 58 in the case of triggering of the ventilator in a conventional manner. Figure 11

[0196] Figure 12 The output signal of the electrodes 12, 12c in connection with the catheter shaft 4a placed in the esophagus 1 is also shown as a further scenario for triggering.

[0197] Since the esophagus 3, OE, passes through the diaphragm ZF at the hiatus oesophageus (esophageal hiatus), the electrodes 12 can be in direct contact with the diaphragm ZF in order to measure the electrical muscular activity of the diaphragm in the range of electromyography (EMG), in particular if the electrode array 12 is positioned approximately half on the distal side of the catheter shaft 4a and half on the proximal side of the diaphragm ZF. This positioning can be ensured by means of possible additional marker elements 14 on the catheter shaft 4a, for example at the proximal and distal end of the electrode array 12.

[0198] In this case, it is thus no longer necessary to put the diaphragm ZF into action in order to determine the triggering point in time 56". This is particularly important because it is often very difficult for elderly and / or particularly weak people to cause a measurable pressure drop 49 in the ventilation hose system 34a, 34b due to the muscular contraction of the diaphragm ZF. Even if a pressure drop 55 is generated in the balloon element 1 a placed in the esophagus, which is usually easy to perceive, a very weak patient needs to make a relatively large effort, which increases the burden and fatigue of such a patient.

[0199] ​​Thus, in triggering to the onset 57" (BMO) of the diaphragm ZF's muscle activity, which is interpreted from the sensible electrode signal in terms of the a priori correlation of the curve c to the esophageal pressure signal, the triggering point in time 56" can be determined before the occurrence of the esophageal pressure drop 55, i.e. immediately following the point in time 57". It can be seen in Figure 12 that at the beginning of the inhalation phase 44, before the rising edges of all curves a-c, no pressure drop 49, 53, 55 can be recognized anymore. Furthermore, the two points in time 56", 57" coincide, the reaction time interval 58" is zero.

[0200] Legend

[0201] 1 catheter unit

[0202] 1a balloon element

[0203] 1b introduction line

[0204] 1c connector

[0205] 1c' connector

[0206] 1d introduction line

[0207] 1e distal end

[0208] 1f proximal end

[0209] 1g connector

[0210] 1h connector

[0211] 2 thorax

[0212] 3 esophagus

[0213] 3a stomach

[0214] 4 catheter shaft

[0215] 4a distal end

[0216] 4b connector

[0217] 5 regulator unit

[0218] 6 profile structure

[0219] 7 residual space

[0220] 8 external balloon

[0221] 9 measuring balloon

[0222] 10 introduction line

[0223] 11 introduction line

[0224] 12 electrode

[0225] 12a cable

[0226] 12b connector

[0227] 12b' connector

[0228] 12c reference electrode

[0229] 12d cable

[0230] 13 distal catheter tip

[0231] 14 marker

[0232] 15 monitoring module

[0233] 16 signal curve

[0234] 17 identification spike

[0235] 18a input knob

[0236] 18b input knob

[0237] 19 respiratory mechanics module

[0238] 20 respiratory work curve

[0239] 21 input knob

[0240] 22 bistable flip-flop

[0241] 23 OR gate

[0242] 24 OR gate

[0243] 25 AND gate

[0244] 26 AND gate

[0245] 27 NOT gate

[0246] 28 AND gate

[0247] 29 AND gate

[0248] 30 bistable flip-flop

[0249] 31 OR gate

[0250] 32a cable

[0251] 32b cable

[0252] 33 adapter

[0253] 34a breathing hose

[0254] 34b breathing hose

[0255] 35 Y-connector

[0256] 36 Tubular connector

[0257] 37 Pressure relief valve

[0258] 38 Magnet

[0259] 39 Pressure sensor

[0260] 40 Endotracheal tube

[0261] 41 Tubing

[0262] 42a Cuff

[0263] 42b Introduction line

[0264] 42c Connector

[0265] 42d Introduction line

[0266] 43 Proximal end

[0267] 44 Inhalation phase

[0268] 45 Exhalation phase

[0269] 46 Respiratory cycle

[0270] 47' Respiratory cycle

[0271] 47" Respiratory cycle

[0272] 48 Pressure level

[0273] 49 Pressure drop

[0274] 50 Peak

[0275] 51 Elevated pressure level

[0276] 52 Constant pressure value

[0277] 53 Pressure drop

[0278] 54 Constant pressure value

[0279] 55 Pressure drop

[0280] 56 Triggering time point

[0281] 56' Triggering time point

[0282] 56" Triggering time point

[0283] 57 Onset of diaphragmatic activity

[0284] 57' Onset of diaphragmatic activity

[0285] 57” The onset of diaphragmatic activity

[0286] 58 Reaction time interval

[0287] 58' reaction time interval

[0288] 58” reaction time interval

[0289] a curve

[0290] Button A: "Auto Mode"

[0291] curve b

[0292] BH Airbag Sheath

[0293] c-curve

[0294] D valve unit

[0295] DP sealing pressure

[0296] F fold indentation

[0297] FM Function Mode "Monitoring"

[0298] FS Function Mode "Sealed"

[0299] KK Circular Curve

[0300] KZ Piston Cylinder Assembly

[0301] M button "Monitoring Mode"

[0302] OE esophagus

[0303] PD storage container

[0304] PU storage container

[0305] Q1 Output

[0306] Q2 Output Terminal

[0307] R1 Reset Input Terminal

[0308] R2 Reset Input Terminal

[0309] S button "Sealed Mode"

[0310] SL Programming Unit

[0311] SR gap space

[0312] SS rod hose

[0313] S1 Set Input Terminal

[0314] S2 Set Input Terminal

[0315] T rotary adjuster

[0316] U valve unit

[0317] V ventilator

[0318] Z injection unit

[0319] ZB bypass

[0320] ZF diaphragm

[0321] ZV external power source

[0322] Z volumetric injection assembly

Claims

1. A device for alternating pressure measurement and secretion sealing in the esophagus (3, OE), comprising a catheter unit (1) having a cuff assembly (1a) capable of being placed in the esophagus, wherein the cuff assembly (1a) of the catheter unit (1) is switchable between two filling states: (i) a first filling state of the cuff assembly (1a) in a measurement function mode (FM) for measuring esophageal or thoracic pressure, wherein the cuff assembly (1a) is in a relaxed state and has statically adjusted filling in a volume-defined manner; and (ii) a second filling state of the cuff assembly (1a) in a sealing function mode (FS) for esophageal sealing, wherein the filling of the cuff assembly (1a) is dynamically adjusted in a pressure-controlled manner by means of a regulator unit (5) connected to the catheter unit (1) compensating for respiratory mechanics-related pressure fluctuations of the cuff assembly (1a) transmitted from the chest to the sealed esophagus by a corresponding displacement of the filling medium, thereby continuously maintaining a user-preset sealing target pressure, characterized in that, It can trigger the switching between two functional modes (FM, FS) through a programmable time period.

2. The apparatus according to claim 1, characterized in that, The catheter (1) is a feeding catheter and / or decompression catheter that can be inserted into the esophagus (3, OE) via the nasogastric or oropharyngeal route or into the duodenum or jejunum via the stomach (3a).

3. The apparatus according to claim 1 or 2, characterized in that, The airbag assembly (1a, 8) of the sealing function mode (FS) fills or seals the entire thoracic esophagus (3, OE) or only the upper or lower half of the thoracic esophagus (3, OE).

4. The apparatus according to claim 1, characterized in that, The airbag assembly (1a, 8) of the sealing function mode (FS) is pre-formed with a diameter or circumference greater than the diameter or circumference of the corresponding esophageal lumen, thereby enabling stress-free, space-filling sealing of the lumen.

5. The apparatus according to claim 1, characterized in that, The airbag assembly (1a, 8) of the sealed function mode (FS) has an airbag end that extends proximally toward the end of the extracorporeal catheter. The airbag end exceeds the outer diameter of the catheter rod (4) that carries the airbag assembly (1a, 8) and forms a gap space (SR) through which the airbag assembly (1a, 8) of the sealed function mode (FS) can be filled and pressurized.

6. The apparatus according to claim 1, characterized in that, The segment (1f) forming the gap space (SR) of the airbag assembly (1a, BH) and / or the airbag assembly (1a, BH) has a partially collapsed, strip-shaped internal structure that at least partially keeps the inlet line leading to the airbag assembly (1a, BH) open.

7. The apparatus according to claim 1, characterized in that, The balloon assembly (1a, 9) of the measurement function mode (FM) is located in the lower half of the thoracic esophagus (3, OE).

8. The apparatus according to claim 7, characterized in that, The airbag assembly (8) in the sealing function mode (FS) and the airbag assembly (9) in the measurement function mode (FM) are implemented as structurally independent components that can be filled individually.

9. The apparatus according to claim 8, characterized in that, The measuring airbag (9) is concentrically arranged inside the sealing airbag (8).

10. The apparatus according to claim 8, characterized in that, The airbag assembly (9) of the measurement function mode (FM) is arranged in series below or distal to the airbag assembly (8) of the sealing function mode (FS).

11. The apparatus according to claim 1, characterized in that, The radiopaque markings on the flexible stem (SS) of the catheter (1) allow the length and / or position of the associated balloon assembly (1a) or balloon assembly (8, 9) to be reproduced by X-ray imaging.

12. The apparatus according to claim 1, characterized in that, Control and / or regulator units (5, 19, SL, SL', SL'') for controlling and / or adjusting different functional modes are connected to the balloon assemblies (1a, 8) of the sealing function mode (FS) and / or the balloon assemblies (1a, 9) of the measurement function mode (FM) of the catheter (1), wherein the control and / or regulator units (5, 19, SL, SL', SL'') are designed such that, in the measurement function mode (FM), the balloon assemblies (1a, 9) of the corresponding measurement function mode (FM) present a relaxed shape with incomplete, volume-defined filling, while in the sealing function mode (FS), the filling state of the balloon assemblies (1a, 8) of the corresponding sealing function mode (FS) is adjusted in a pressure-controlled manner.

13. The apparatus according to claim 1, characterized in that, The control and / or regulator unit (5, 19, SL, SL', SL'') is configured to enable selection of at least three operating modes: a pure measurement function mode (FM), a pure sealing function mode (FS), and an automatic function mode, in which automatic control permanently triggers the switching between the measurement function mode (FM) and the sealing function mode (FS).

14. The apparatus according to claim 1, characterized in that, A selection module is defined for the selected first or second functional mode (FM, FS), which has at least one logic output terminal (Q1), wherein the output signal of the output terminal is high in one functional state and low in another functional state.

15. The apparatus according to claim 14, characterized in that, The selection module is constructed in the form of a trigger or a bistable trigger circuit (22). The selection module has a setting input terminal (S1), which sets the output signal at the logic output terminal (Q1) to a higher level when the input signal at the input terminal (S1) is at a rising edge or a high level. The selection module also has a reset input terminal (R1), which sets the output signal at the logic output terminal (Q1) to a lower level when the input signal at the reset input terminal (R1) is at a rising edge or a high level.

16. The apparatus according to claim 15, characterized in that, The setting input terminal (S1) and / or the reset input terminal (R1) are coupled to a manual input component or to a switch or button (M, S).

17. The apparatus according to claim 15 or 16, characterized in that, The setting input terminal (S1) is coupled to a programmable dead time or delay module, and the output signal at the logic output terminal (Q1) is at a falling edge or at the inverting output terminal ( When the output signal at the terminal is at a rising edge, the dead time or delay module is activated, and a rising edge is provided at the setting input (S1) after a programmed or programmable time interval (T1).

18. The apparatus according to claim 15 or 16, characterized in that, The reset input (R1) is coupled to a programmable dead time or delay module, and the output signal at the logic output (Q1) is either at a rising edge or at the inverting output ( When the output signal at the terminal is at a rising edge, the dead time or delay module is activated, and a rising edge is provided at the reset input (R1) after a programmed or programmable time interval (T2).

19. The apparatus according to claim 15 or 16, characterized in that, Multiple input signals corresponding to the same setting input terminal (S1) or the same reset input terminal (R1) are associated with each other through their respective OR gates (23, 24).

20. The apparatus according to claim 19, characterized in that, One or more input signals of at least one OR gate (23, 24) can be latched or unlocked by one or more logic blocking and / or enabling signals.

21. The apparatus according to claim 20, characterized in that, One or more logic blocking and / or enabling signals originate from another input option or input button (A).

22. The apparatus according to claim 1, characterized in that, A dynamic, adaptive, transesophageal or intraesophageal secretion seal is achieved by means of an adjustment circuit, wherein the actual value of the filling pressure in the cuff assembly (1a) or its inlet lines (1b, 1c, 1d) is detected and maintained as constantly as possible by adjusting to a preset target value. In the sealing function mode (FS), under esophageal sealing, the user-preset target pressure is continuously maintained within the cuff assembly (1a, 8) in the sealing function mode (FS). Pressure fluctuations in the cuff assembly (1a, 8) in the sealing function mode (FS), including pressure fluctuations related to respiratory mechanics, i.e. pressure fluctuations occurring during the patient's spontaneous breathing, are compensated for by correspondingly moving the filling medium into or out of the cuff assembly (1a, 8) to maintain the seal.

23. The apparatus according to claim 1, characterized in that, The regulator unit (5), which is connected to the airbag assemblies (1a, 8, 9) that are alternately measured and sealed with the conduit (1), has at least one electronic pressure regulating valve assembly (D, U) that regulates the corresponding filling pressure in the airbag assemblies (1a, 8, 9).

24. The apparatus according to claim 1, characterized in that, The regulator unit (5) has a valve assembly (D) introduced into the airbag assembly (1a, 8, 9) for feeding volume into the airbag assembly (1a, 8, 9) and a valve assembly (U) parallel thereto derived from the airbag assembly (1a, 8, 9) for extracting volume from the airbag assembly (1a, 8, 9).

25. The apparatus according to claim 23 or 24, characterized in that, One or both of the valve assemblies (D, U) consist of a piezoelectric regulating element.

26. The apparatus according to claim 23 or 24, characterized in that, The valve assembly (D) has an integrated or connected sensor function for measuring the filling pressure in the airbag assembly (1a, 8, 9), wherein the valve assembly (D) regulates the pressure in the airbag assembly (1a, 8, 9) so that a preset filling pressure can be maintained continuously even when there are respiratory mechanics-related pressure fluctuations in the airbag.

27. The apparatus according to claim 23 or 24, characterized in that, Upstream of each valve assembly (D, U) is a reservoir-like component (PD, PU) that reserves overpressure or negative pressure, or the valve assembly (D, U) is alternatively connected to one or more external pressure sources (ZV).

28. The apparatus according to claim 23 or 24, characterized in that, The regulator unit (5) has a component (KZ) that applies a defined air volume to the airbag assembly (1a, 9) of the measurement function mode (FM) and optionally subsequently removes the air volume from the airbag assembly (1a, 9) of the measurement function mode (FM).

29. The apparatus according to claim 23 or 24, characterized in that, The regulator unit (5) has adjustable functions (T) and / or components that identify respiratory mechanics-related pressure fluctuations measured in the thoracic cavity (2) as an indication that the thoracic cavity (2) has begun active respiratory shift.

30. The apparatus according to claim 29, characterized in that, The regulator unit (5) uses the initial intrathoracic pressure drop, which is identified as an indication that the thoracic cavity (2) has begun to deviate from active breathing, as a trigger signal to trigger a mechanical breathing journey supported by a ventilator (V).

31. The apparatus according to claim 1, characterized in that, A comparator module is used to compare a pressure signal with the pressure drop value required to trigger a trigger pulse for a ventilator (V).

32. The apparatus according to claim 1, characterized in that, The control of the regulator unit (5) is programmed with a delay or dead time that allows a certain pressure drop in the airbag assembly (1a, 9) in the sealed function mode (FS) before volume compensation to the target value is performed, so as to obtain the triggering option for the supportive mechanical breathing stroke.

33. The apparatus according to claim 32, characterized in that, In the event of a pressure drop in the sealed airbag (1a), the regulating circuit remains interrupted until a trigger signal is generated for the supportive mechanical breathing stroke.

34. The apparatus according to claim 1, characterized in that, A display device for visualizing continuous intrathoracic pressure signals.

35. The apparatus according to claim 1, characterized in that, One or more electrodes (12, 12c) are arranged on the catheter (1) for receiving or exporting the patient's electrical signals.

36. The apparatus according to claim 35, characterized in that, The electrodes (12, 12c) are arranged on the surface of the guide rod (4), distal to the airbag assembly (1a) or all airbag assemblies (8, 9).

37. The apparatus according to claim 35 or 36, characterized in that, Multiple electrodes (12, 12c) are arranged axially on the surface of the guide rod (4) and spaced apart from each other.

38. The apparatus according to claim 35 or 36, characterized in that, A reference electrode (12c) is arranged near or far from all other electrodes (12).

39. The apparatus according to claim 35 or 36, characterized in that, The electrodes (12, 12c) are arranged in the region of the catheter rod (4), which passes through the diaphragm (ZF) when placed in the esophagus (3, OE) as intended.

40. The apparatus according to claim 35 or 36, characterized in that, Each electrode (12, 12c) is individually contacted via a multi-core cable (12a, 12d) with at least one wire at a single terminal for each electrode (12, 12c).

41. The apparatus according to claim 35 or 36, characterized in that, The electrodes (12, 12c) can be connected to an external amplification, analysis and / or monitoring module (15) via cables (12a, 12d), wherein each electrode (12, 12c) is individually contacted.

42. The apparatus according to claim 41, characterized in that, The in vitro amplification, analysis and / or monitoring module (15) has a module or function for autocorrelation of the electrode signals in order to identify periodically repeating sequences of the electrode signals.

43. The apparatus according to claim 42, characterized in that, Within the scope of the implemented autocorrelation algorithm, a pattern sequence is correlated with subsequent pattern sequences, where the correlation or coefficient required for pattern recognition can be adjusted.

44. The apparatus according to claim 42 or 43, characterized in that, The module or function that uses the initial intrathoracic pressure drop, which is used to identify the initiation of active respiratory deviation in the thoracic cavity (2), associates one or more electrode signals with the measured pressure fluctuations in the thoracic cavity (2) related to respiratory mechanics, so that a periodically repeating sequence of one or more electrode signals is identified as an indicator of the initiation of neuromuscular respiratory activity.

45. The apparatus according to claim 44, characterized in that, Pattern sequences typically identified as the initiation of neuromuscular respiratory activity within the associated range are stored as reference sequences and used to correlate with currently measured electrode signals in real time, so as to generate an early trigger signal for triggering assisted mechanical breathing via a ventilator (V) when sufficient consistency between the measured electrode signals and the reference sequences is identified.

46. ​​The apparatus according to claim 45, characterized in that, Within the scope of the implemented correlation algorithm, the correlation or coefficient required to identify the onset of neuromuscular respiratory activity can be adjusted.

47. The apparatus according to claim 1, characterized in that, The trigger signal generated by the system according to the invention for additional mechanical breathing stroke is transmitted as an electrical signal to the ventilator (V) via one or more cables, or the trigger signal is transmitted as a radio signal to the ventilator.

48. The apparatus according to claim 1, characterized in that, The trigger signal for additional mechanical breathing stroke generated by the system according to the invention is transmitted as a pressure signal to the ventilator (V) by means of a pressure relief valve (37) controlled by the device according to the invention, air is vented from the ventilation tubing (34a, 34b) of the ventilator (V) to the patient, so as to cause a pressure drop in the ventilation tubing (34a, 34b) that can be detected by the ventilator.

49. The apparatus according to claim 48, characterized in that, Pressure sensors (39) are arranged on the ventilation hoses (34a, 34b), which are connected to or can be connected to the control and / or regulation unit (5) to send a signal to the control and / or regulation unit (5) to indicate that the ventilator (V) has triggered an assisted mechanical breathing stroke.

50. The apparatus according to claim 48 or 49, characterized in that, The pressure relief valve (37) and / or the pressure sensor (39) are arranged on the Y-shaped connector (35) or the tubular connector (36).

51. The apparatus according to claim 1, characterized in that, An endotracheal tube (40) includes a tube body (41) through which a lumen is passed and a cuff (42a) surrounding the tube body (41), the proximal end of which can be connected to a ventilator (V) via one or more ventilation hoses (34a, 34b).

52. The apparatus according to claim 51, characterized in that, The sheath (42a) is connected to the control and regulator unit (5) via connecting lines (42b, 42c, 42d).

53. The apparatus according to claim 52, characterized in that, The control and regulator unit (5) is provided with a module or function for dynamically and adaptively sealing the cuff (42a) relative to the trachea, wherein the actual value of the filling pressure in the cuff (42a) or its inlet lines (42b, 42c, 42d) is detected and the actual value is kept as constant as possible by adjusting to a preset target value, wherein the pressure fluctuations in the cuff (42a) related to respiratory mechanics, i.e. pressure fluctuations that occur during the patient’s spontaneous breathing, are compensated for by correspondingly moving the filling medium into or out of the cuff (42a) to maintain the seal.

54. The apparatus according to claim 1, characterized in that, Signal input terminal used to receive data from the ventilator (V).

55. The apparatus according to claim 54, characterized in that, A display device for visualizing a continuous pleural or pleural pressure signal in the form of an iterative pie chart or as a work of breathing curve (20) on the volumetric flow rate from or to the patient.

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