Modular respiratory device for the diagnosis and treatment of a patient's respiratory problems

Abstract

Modular respiratory device (1) for the diagnosis and treatment of a patient's respiratory problems, comprising a diagnostic module (2) with a housing (5), wherein a mainboard (6) is arranged inside the housing (5) and is connected to a screen (8) arranged in an outer wall (7) of the housing (5), a measuring module (3) with a flow channel (10) for guiding the patient's expiratory and / or inspiratory air, wherein the measuring module (3) is detachably coupled to the diagnostic module (2) and the measuring module (3) and / or the main board (6) have at least one sensor for measuring a flow rate or pressure of the expiratory and / or inspiratory air, wherein the at least one sensor is connected to the main board (6), a computing unit arranged on the mainboard (6) and designed to evaluate and process the measured values, wherein the processed values ​​can be displayed on the screen (8), a therapy module (4) with a second flow channel (18) for guiding the patient's expiratory and / or inspiratory air, which is detachably coupled to the diagnostic module (2), wherein the flow channel (10) of the measuring module (3) is fluidly connected to the second flow channel (18) of the therapy module (4) and the therapy module (4) has a control element (19, 25) for changing a process variable of the therapy module (4), wherein the control element (19, 25) can be controlled by means of the computing unit.

Description

[0001] The present invention relates to a modular respiratory device for the diagnosis and therapy of respiratory problems in a patient, comprising the features of claim 1.

[0002] Smartwatches and wearables are now widespread and, from a medical perspective, are primarily used for the continuous recording and analysis of physiological parameters. These devices enable, among other things, the monitoring of heart rate, heart rhythm, and oxygen saturation (SpO2). Beyond simply collecting data, smartwatches typically allow for two-way interaction with the user, for example, through acoustic or haptic signals, visual displays, reminders, or action recommendations. This allows users to be actively involved in monitoring and improving their health. However, such systems are solely for recording, displaying, and, if necessary, evaluating vital parameters. A diagnostic function for respiratory problems or diseases of the lungs and upper respiratory tract, and especially therapeutic intervention, is neither provided nor technically implemented in current systems.Smartwatches have neither functions to actively influence respiratory physiology nor mechanisms to treat or stabilize the airways.

[0003] In addition, portable devices are known that are used to treat specific respiratory diseases, such as chronic obstructive pulmonary disease (COPD), pulmonary emphysema, or cartilage softening of the airways (e.g., polychondritis). These so-called airway stabilizers exert a therapeutic effect by mechanically supporting or stabilizing the airways. However, they are each designed for a defined clinical indication and generally operate without active interaction with the patient. Specific adaptation to the current physiological state or feedback with continuous monitoring functions is not provided for in the known systems.

[0004] Based on this, the present invention aims to provide an improved respiratory device that is modular in design and is intended for both the diagnosis and diagnosis-dependent therapy of a patient's respiratory problems.

[0005] This problem is solved by a modular respiratory device for the diagnosis and therapy of respiratory problems in a patient, having the features of claim 1.

[0006] Advantageous further developments of the invention are the subject of the dependent claims.

[0007] The respiratory device according to the invention for the diagnosis and therapy of respiratory problems in a patient is modular in design and comprises a diagnostic module, a measuring module and a therapy module.

[0008] The diagnostic module has a housing. Inside the housing is a mainboard, which is connected to a screen located in an outer wall of the housing. The screen is visible to the user of the breathing apparatus.

[0009] The measuring module is detachably coupled to the diagnostic module. This allows the patient to disconnect and reconnect the measuring module, for example, for cleaning or replacement. The measuring module features a flow channel to guide the patient's exhaled and / or inspired air.

[0010] The measuring module and / or the mainboard includes at least one sensor for measuring the flow rate or pressure of exhaled and / or inhaled air. The sensors are connected to the mainboard.

[0011] The breathing device further includes a processing unit located on and connected to the mainboard. This processing unit comprises, in particular, a processor and software stored on the mainboard and is designed to evaluate and process the measured values, displaying the processed values ​​on the screen. The evaluation of the measured values ​​includes, in particular, the acquisition and aggregation of the measurement data, the derivation of a medical indication, and the determination of a corresponding therapy. The processing includes, in particular, the generation of a clear and concise representation of the acquired measured values, the derived medical indication, and / or the determined therapy, which is then displayed to the patient on the screen.

[0012] This allows the patient or user to be shown respiratory parameters and curves, such as a volume-time curve, a flow-volume curve, and / or the maximum expiratory flow. The flow-volume curve, for example, is a standardized display format in pulmonary function devices. Atypical values ​​or changes in this curve shape indicate respiratory tract disorders. Airway instability or asthma have specific patterns. In particular, depending on the evaluated and processed measurements, the patient can also be shown specific diagnoses, instructions for action, and / or warnings on the screen. The creation and display of therapy plans is also possible. The diagnostic module's screen thus provides the patient with detailed information regarding critical respiratory parameters, their significance, and information on the necessary therapy.The display also contributes to increased adherence, as patients tend to use the device for longer and more regularly when they can visually understand the operating process.

[0013] The therapy module is detachably coupled to the diagnostic module. The therapy module has a second flow channel which, when coupled, is fluidically connected to the flow channel of the measuring module. The patient's exhaled air is thus directed from the flow channel of the measuring module into the second flow channel of the therapy module. The process is reversed for inhaled air.

[0014] According to the invention, the therapy module further comprises a control element for changing a process parameter of the therapy module. The control element can be controlled by the processing unit. The controllable or changeable process parameter of the therapy module has, in particular, a direct or indirect influence on the patient's respiration.

[0015] Using the diagnostic module and its associated measurement module, a diagnosis of the patient's breathing pattern can be performed in a first step. This diagnosis, along with the corresponding processed measurement data, can be displayed on the screen for the patient. Due to the detachable connection between the diagnostic and therapy modules, the patient can select a suitable therapy module based on the displayed diagnosis and connect it to the diagnostic module. A process parameter relevant to the patient's treatment within the therapy module can be automatically controlled by the diagnostic module's processing unit based on the measured and processed breathing parameters. This control element can therefore be adaptive and performed in real time, enabling the therapy module to provide treatment for respiratory problems precisely tailored to the patient's individual health condition.

[0016] The controllable process parameter of the therapy module is preferably the free flow cross-section within the second flow channel. This allows the therapy module to directly influence the patient's breathing behavior during both inhalation and exhalation.

[0017] The breathing device is designed to be portable. Portable, as defined in the invention, means that the patient can carry and use the breathing device without additional equipment, for example, in a patient's bag. The dimensions of the breathing device are thus designed to be manageable, so that even elderly and ill patients can operate the device without difficulty.

[0018] In an advantageous embodiment of the invention, the screen is arranged on the mainboard and is particularly preferably round. The combination of mainboard and screen is most preferably a core module for a smartwatch. Such core modules have the advantage that a large number of sensors are already arranged on the mainboard or connected to it via interfaces, which are designed for acquiring body and environmental data. These sensors are, in particular, an accelerometer, a gyroscope, a magnetometer, a barometer, a PPG sensor (photoplethysmography), a temperature sensor, and / or an EDA sensor (electrodermal activity). Furthermore, the core modules already include communication interfaces such as a microphone and speaker, GPS chips, NFC chips, and / or Bluetooth, WLAN, and LTE modules. Another advantage of using such core modules is that they are inexpensive to manufacture or purchase.The health-related data, such as the patient's activity level, which is collected by the sensors of the smartwatch's core module in the usual way, can be taken into account in diagnosis and determining the necessary therapy. In addition, the patient can be reminded to take medication or use metered-dose inhalers via a calendar or timer function.

[0019] The screen features a touch interface, allowing the patient or user to access different views and control basic functions of the breathing device via the touch interface.

[0020] The measuring module preferably features a ventilation access point that is fluidically connected to the flow channel and, in particular, is detachable. The ventilation access point can be, for example, a mouthpiece, an endotracheal tube, or a breathing circuit. Expiring air is directed from the patient into the flow channel via the ventilation access point, and inspiratory air is directed from the flow channel to the patient. The detachable connection allows for easy cleaning of the ventilation access points or the use of disposable items. The ventilation access point can also be designed as an adapter connected to the flow channel, which can be coupled with breathing or nasal masks. This enables the measurement, diagnosis, and treatment of respiratory disorders originating in the nasopharynx or paranasal sinuses. The measuring module can also be connected to stationary devices such as oxygen concentrators, oscillating devices, cough suppressants, or compressors using an adapter.

[0021] If the sensor for measuring the flow rate of exhaled and / or inspired air is located in the measuring module, it is preferably a thermal flow sensor, such as those used in anesthesia machines. A thermal flow sensor is a flow sensor that determines the volumetric flow rate based on the heat dissipated from a heated element by the flowing medium. The resulting temperature-dependent signal change serves as a direct measure of the flow velocity. The thermal flow sensor is preferably connected to the processing unit via an I2C (Inter-Integrated Circuit) interface.

[0022] Alternatively or additionally, a differential pressure sensor can be mounted on the mainboard to measure the pressure of the exhaled and / or inspired air. The processing unit can evaluate the measured differential pressure and calculate the corresponding volume flow rate of the exhaled and / or inspired air in the flow channel.

[0023] To determine the differential pressure, a resistance element is preferably arranged within the flow channel. Furthermore, preferably two pressure channels are formed between the measuring module and the diagnostic module, which are coupled to the differential pressure sensor. One pressure channel is coupled to a flow channel section upstream of the resistance element, and the other pressure channel is coupled to a flow channel section downstream of the resistance element.

[0024] The measuring module and / or the mainboard specifically include a sensor for measuring the CO2 content of the expiratory and / or inspirational air. When using respiratory support devices, there is a risk of hyperventilation in the patient due to excessively rapid or deep breathing, which causes the carbon dioxide level in the blood to drop. If a drop in the CO2 level is detected, a warning message can be sent to the patient and / or the airflow through the breathing device can be reduced, for example, by increasing the flow resistance via the actuator. Furthermore, the end-tidal carbon dioxide content (etCO2) of the expiratory air can be displayed on the screen. The breathing device thus also functions as a capnometer.

[0025] Furthermore, the measuring module and / or the mainboard may include a humidity sensor. This sensor can determine the humidity level of the patient's exhaled air and / or the humidity level of the ambient air. The corresponding measurements can then be taken into account by the processing unit for diagnosis and determining the necessary therapy. This allows the therapy, particularly the prescribed duration of inhalation, to be adjusted, for example, in dry winter air.

[0026] In addition to differential pressure, determining the absolute pressure within the flow channel is often necessary for adaptive patient therapy. Therefore, an absolute pressure sensor is preferably mounted on and connected to the mainboard. To determine the absolute pressure, a passageway is formed between the flow channel of the measuring module or the second flow channel of the therapy module and the interior of the diagnostic module. This ensures that the same absolute pressure prevails in the flow channel and the interior of the diagnostic module.

[0027] In a further advantageous embodiment, the flow channel or ventilation access has a translucent window. This translucent window can also simply be an opening within a wall of the flow channel or ventilation access. The translucent window faces the diagnostic module. The diagnostic module has an optical pulse sensor that faces the translucent window. The pulse sensor is preferably integrated into an outer wall of the diagnostic module. The patient can insert a finger into the flow channel or ventilation access until it is level with the translucent window. The light emitted by the pulse sensor strikes the patient's finger, thus enabling the measurement of the pulse or heart rate. The finger is held in place without pressure and shielded from ambient light, making the measurement particularly reliable.In this way, the breathing device fulfills the function of a pulse oximeter.

[0028] The mainboard is connected to an inductively rechargeable battery. The battery is preferably located on the underside of the diagnostic module within the housing. The electrical components of the therapy module and / or the measurement module are also preferably powered by the battery located in the diagnostic module. The inductive charging capability facilitates use for elderly or seriously ill patients.

[0029] Preferably, a photoplethysmographic sensor connected to the mainboard is arranged within a side wall of the diagnostic module. The sensor allows the patient's pulse rate and oxygen saturation (SpO2) to be determined. The measured values ​​can be used by the processing unit to optimize the diagnosis and determine the necessary therapy.

[0030] Furthermore, an acoustic membrane connected to the mainboard can be positioned in a side panel of the diagnostic module. This membrane can detect both ambient sounds and, when placed on the patient's body, respiratory sounds. This allows the module to be used both as a cough recorder and as a stethoscope.

[0031] The diagnostic module and the therapy module are preferably coupled via a magnetic connector. This allows for easy, detachable connection between the modules, so that even elderly or seriously ill patients can disconnect and reconnect the modules. The magnetic connector also ensures that the diagnostic and therapy modules are correctly aligned with each other.

[0032] In particular, the magnetic connector includes conductive contact pins for transmitting control signals and power between the diagnostic module and the therapy module. The mechanical coupling between the modules also provides the electrical connection between them. Alternatively, signal and power transmission between the diagnostic and therapy modules can also occur via a separate interface between the two modules.

[0033] The therapy module, which is detachably coupled with the diagnostic module, can be configured differently depending on the therapy needs determined by the diagnostic module. In particular, the patient has several different therapy modules to choose from. The modular design of the respiratory device allows the patient to couple the diagnostic module with a therapy module tailored to their specific acute respiratory condition.

[0034] In one version of the therapy module, the control element is an actuator for changing the flow resistance of the second flow channel. This actuator allows, in particular, the free flow cross-section within the second flow channel to be altered. If, for example, the expiratory flow rate measured in the sensor module is too low, this may indicate airway collapse. In this case, the processing unit sends a signal, specifically an electrical signal, to the actuator, which then increases the flow resistance in the second flow channel. This, in turn, leads to an increase in pressure within the patient's airways, thus reopening the collapsed or constricted airways. As the expiratory flow rate increases again, the flow resistance can be reduced once more.

[0035] Based on the measurement of the tidal volume flow determined by the measuring module, the evaluation and control unit uses the actuator to adjust the optimal flow resistance to prevent airway collapse. Because the flow resistance is adjusted according to the patient's current breathing pattern via a correlation stored in the processing unit, the modular respiratory device can deliver improved therapeutic outcomes regardless of the patient's age, physical condition, or the severity of their tendency to collapse. When the patient inhales through the airway stabilizer, this is registered by the measuring module, and the actuator opens the flow channel, preventing the generation of additional flow resistance.

[0036] In another embodiment, the control element can be an oscillating element. This oscillating element sets the expiratory or inspiratory air into oscillation or vibration, continuously varying the inspiratory or expiratory resistance through oscillation, particularly rotation, of the oscillating element at a frequency specified by the processing unit. The oscillating element can be used, in particular, to loosen and remove secretions from the patient's airways.

[0037] In a preferred embodiment, the therapy module can include both an actuating element and an oscillating element. The elements are arranged sequentially in the second flow channel, with the actuating element first in the direction of exhalation, followed by the oscillating element. This has the advantage that the basic flow resistance can be adaptively adjusted using the actuating element, thus keeping the patient's airways open regardless of the patient's respiratory effort. Simultaneously, the oscillating element can be used to loosen secretions.

[0038] Preferably, one wall of the second flow channel has an opening in the area of ​​the actuator. In this case, the actuator is preferably designed such that a certain proportion of the patient's exhaled air can be discharged into the environment through the opening. This allows for the setting of a defined percentage distribution between free breathing and oscillation. For example, the actuator can be set so that 70% of the patient's exhaled air is discharged into the environment, while 30% of the exhaled air is directed through the oscillation element. This allows for optimal adaptation of the therapy to the individual needs of the patient.

[0039] The measuring module can also detect whether the patient is currently inhaling or exhaling. During inhalation, the actuator can be controlled in such a way that the free cross-section of the second flow channel, and thus the flow resistance, is not reduced. The oscillation frequency of the oscillation element can also be adjusted depending on the direction of breathing. For example, a gentle oscillation of 20 Hz can be used during inhalation to liquefy the patient's secretions, and an oscillation of 12 Hz during exhalation to facilitate the removal of secretions.

[0040] Both the actuating element and the oscillating element can have a cylindrical body. The elements are specifically removable and rotatable within the second flow channel.

[0041] The actuator is preferably connected to a first drive unit, which is in particular a servo motor. The servo motor allows the actuator to be rotated into a position specified by the processing unit.

[0042] The oscillating element is preferably connected to a second drive unit, which is in particular a DC motor. The DC motor can drive the oscillating element at a rotational frequency specified by the processing unit.

[0043] Particularly in the case of a combination of actuator and oscillator, the use of a servo motor for the actuator and a DC motor for the oscillator has proven advantageous, since the servo motor allows for targeted positioning of the actuator, while the DC motor can be used to drive the oscillator at a frequency determined by the computing unit.

[0044] Preferably, the actuator and / or oscillator is detachably connected to the respective drive units via a magnet. This ensures rotational stability and correct orientation of the elements. Furthermore, the patient can easily clean and replace the elements. Specifically, the patient can select an actuator and / or oscillator suitable for their acute respiratory condition and position it within the second flow channel. Additionally, the magnetic connection prevents accidental blockage of the drive units. Ideally, the screen can display to the patient which control element promises the best therapeutic results for their specific respiratory condition.

[0045] The actuating element and / or the oscillating element preferably have a recess, wherein the free flow cross-section of the second flow channel () can be adjusted by means of a rotation of the oscillating element () and / or the actuating element ().

[0046] The recess is in particular a through-hole or an asymmetrical cutout, preferably a triangular cutout. The degree of resistance change can be determined by the size or area of ​​the recess or hole. In the case of a hole or cutout with an asymmetrical shape, the rate of resistance change also changes. For example, a triangular cutout leads to a slow increase in the flow of expiratory or inspiratory air with an abrupt stop. Within the scope of the invention, it has been found that an asymmetrical shape of the cutout leads to better liquefaction of the secretions located in the patient's airways.

[0047] The shape of the oscillation element allows for targeted control of the generated oscillation characteristics. A sudden increase in back pressure causes a rapid outward movement of the tracheal and bronchial walls, which loosens adhering secretions and facilitates expectoration. Furthermore, by varying the design of the recesses or bores and, if necessary, by adjusting the frequency, the rheology, i.e., the flowability, of the bronchial secretions can be altered.

[0048] Preferably, the direction of rotation of the oscillating element can be changed very quickly by the drive unit. In conjunction with the recess, particularly an asymmetrical recess, this results in the free flow cross-section, and thus the volume flow of the expiratory and / or inspirational air passing through the second flow channel, gradually increasing and then abruptly decreasing, or vice versa. This allows secretions in the patient's airways to be loosened and coughed up very effectively.

[0049] This effect is preferably achieved by reversing the polarity of the supply voltage to the drive unit, particularly the DC motor, using an H-bridge circuit integrated into the drive unit's control electronics. An H-bridge circuit is an electronic circuit that allows the direction of rotation of a DC motor to be reversed electronically without requiring manual polarity reversal. The H-bridge circuit preferably comprises four electronic switches, such as transistors or MOSFETs, arranged to form the shape of the letter "H". By selectively controlling these switches, the current flow through the motor can be directed in either direction, thus enabling a rapid change in the direction of rotation of the oscillating element.

[0050] In another embodiment, the therapy module can include a jet nozzle. The jet nozzle is preferably positioned within the second flow channel such that one opening of the jet nozzle is directed towards the flow channel of the measuring module. The jet nozzle can be connected to a compressor or an oxygen cylinder. Active respiratory support can be provided during the inhalation phase by injecting the aerosol. The jet nozzle is controlled, in particular, by the processing unit. To counteract airway obstruction due to collapse, the flow generated by the jet nozzle can also be applied during the exhalation phase. Furthermore, the continuous monitoring of airway pressure and airflow by the measuring module prevents dangerous pressure spikes from occurring.The jet nozzle can be designed as a standalone control element or can be arranged in the therapy module in addition to other control elements, for example together with an actuating element and an oscillation element.

[0051] The breathing device can be connected to external devices such as smartphones, computers, or tablets, preferably via a wired or wireless interface. These external devices can provide the patient with additional data and information derived from the recorded measurements, which would be difficult to display on the smaller screen of the diagnostic module. The interface also allows for the offloading of computationally intensive processes, which the diagnostic module's processing unit cannot handle, to the external devices.

[0052] The software stored on the mainboard is primarily installed on the mainboard's memory. The software can be individually configured for the patient via an app. For example, depending on the severity of the patient's illness, different time intervals or threshold values ​​can be specified, which are then taken into account by the processing unit during therapy and when controlling the system's functions.

[0053] The patient can also control the breathing device in real time via an app installed on their smartphone. In this case, the app or smartphone is connected to the mainboard. For example, the app can display certain parameters of the current therapy to the patient via a visual representation on their smartphone. If certain parameters, such as the measured tidal volume flow, exceed specific limits, the patient receives a corresponding warning on their smartphone. The patient can then use an input function provided by the app on their smartphone to make an adjustment to the controls.

[0054] Preferably, additional active modules can be detachably connected to the breathing device. Possible additional modules include a medication nebulizer, a nebulizer, or an oxygen generator. These additional active modules can be detachably connected to the breathing device, particularly using an adapter.

[0055] In principle, within the scope of the invention, it is possible for several therapy modules or additional active modules to be detachably coupled in series or in a cascade with the diagnostic module.

[0056] In a further advantageous embodiment, an additional circuit board, in particular a driver board, can be connected to the main board. This board is also located within the housing of the diagnostic module. Drivers, for example for the drive units, additional sensors, or even the battery can be integrated into the diagnostic module via this additional board. The control electronics of the drive units, and especially the H-bridge circuit, are also preferably located on the driver board. The interfaces to the sensors located in the measuring module or to the pressure channels arranged in the measuring module can also be connected to the main board via this board.

[0057] An accelerometer mounted on the mainboard allows for the recording of not only the patient's steps but also vibrations of the breathing device itself. Correct use of the device causes it to vibrate. The recorded vibration signals can be analyzed and processed by the processing unit. This data allows conclusions to be drawn about the patient's usage patterns. In particular, it is possible to determine the duration and frequency of use of the breathing device, enabling, for example, a precise assessment of the therapy's success by the treating physician.

[0058] The invention particularly includes a modular respiratory device system comprising a measuring module, a diagnostic module, and at least one therapy module. Preferably, the system comprises several therapy modules, in particular a therapy module with an actuator, a therapy module with an oscillation element, a therapy module with an actuator and an oscillation element, and / or a therapy module with an actuator, an oscillation element, and a jet nozzle. The specific configuration of the respective modules can be carried out according to the previously described embodiments. The system may also preferably include a selection of ventilation access points.

[0059] The invention can further be described as follows: 1. Procedure for diagnosing and treating a patient's respiratory problems, comprising the following procedural steps: • Provision of a diagnostic module with a housing, wherein a mainboard is arranged inside the housing and connected to a screen located in an outer wall of the housing, • Detachable coupling of the diagnostic module with a measuring module, wherein the measuring module has a flow channel for guiding the patient's expiratory and / or inspiratory air, and the measuring module and / or the mainboard has at least one sensor for measuring a flow rate or pressure of the expiratory and / or inspiratory air, wherein the sensors are connected to the mainboard, • Inhalation and exhalation of the patient through the flow channel of the measuring module, • Measurement of the flow rate or pressure, in particular differential pressure, of expiratory and inspiratory air, • Evaluation and processing of the measured values ​​by a computing unit located on the mainboard, • Display of the processed measurement data on the screen, • Detachable coupling of the diagnostic module with a therapy module, wherein the selection of the therapy module is made by the patient based on the displayed and processed measured values, and the therapy module has a second flow channel for guiding the patient's expiratory and / or inspiratory air, wherein the flow channel of the measuring module is fluidly connected to the second flow channel of the therapy module by the coupling, and the therapy module has a control element. • Inhalation and exhalation of the patient through the flow channel of the measuring module, • Measurement of the flow rate or pressure, especially differential pressure, of expiratory and inspiratory air, • Evaluation and processing of the measured values ​​by a computing unit located on the mainboard, • Control of the control element by means of the computing unit depending on the processed measured values, whereby a process parameter of the therapy module, in particular a free flow cross-section of the second flow channel, is adjusted by the control element. 2. Procedure according to point 1, wherein at least two therapy modules are provided and, based on the displayed and processed measured values, a therapy module for detachable coupling with the diagnostic module is selected by the patient. 3. Procedure according to point 2, wherein at least one therapy module includes an adjusting element. 4. Procedure according to point 2 or 3, wherein at least one therapy module includes an oscillation element. 5. Procedure according to one of points 2 to 4, wherein at least one therapy module includes a jet nozzle.

[0060] All training courses disclosed for the modular respiratory device can be applied analogously to the procedure for diagnosing and treating a patient's respiratory problems.

[0061] Further advantages, features, and properties of the present invention are described in the following figures. The figures are schematic representations intended to facilitate understanding of the invention. They show: Fig. 1 a modular breathing apparatus in a first design variant in a side view, Fig. 2. A diagnostic module detachably coupled with a measurement module in a first perspective, Fig. 3. The diagnostic module and the measurement module from a second perspective. Fig. 4 a modular breathing apparatus in a second version variant in a side view, Fig. 5 a modular breathing apparatus in a third design variant in a side view, Fig. 6. A housing of the diagnostic module in one perspective, Fig. 7 a measuring module in a sectional view in side view, Fig. 8 a measuring module with side connection in a sectional view in side view, Fig. 9 a measuring module in a sectional view in side view, Fig. 10 a therapy module in a side view, Fig. 11a-c Detailed views of control elements, secondary flow channels and drive units, Fig. 12a-e Detailed views of controls with cutouts, Fig. 13a, b Detailed views of control elements with different recesses in different rotational positions and Fig. 14 a driver board in perspective.

[0062] The same reference symbols are used for identical or corresponding parts or components, even if a repeated description is omitted for the sake of simplicity.

[0063] The Fig. Figure 1 shows a modular respiratory device 1 for the diagnosis and treatment of a patient's respiratory problems. The respiratory device 1 comprises a diagnostic module 2, a measurement module 3, and a therapy module 4. The measurement module 3 and the therapy module 4 are each detachably coupled to the diagnostic module 2. Fig. Figure 1 shows the therapy module 4 in a state not fully coupled with the diagnostic module 2, in order to make the respective interfaces between modules 2 and 4 visible.

[0064] The breathing device 1 is designed to be portable and easy to use. It has a length (L) of approximately 10 cm and a height (H) of approximately 6 cm. Therefore, even elderly and ill patients can easily operate the breathing device 1.

[0065] Diagnostic module 2 and measurement module 3 are located in the Fig. 2 and Fig. Figure 3 shows in more detail. The diagnostic module 2 has a housing 5. A mainboard 6 is located inside the housing 5. The mainboard 6 is connected to a screen 8 located in an outer wall 7 of the housing 5. The screen 8 is round, has a capacitive touch function, and is located directly on the mainboard 6. The combination of mainboard 6 and screen 8 constitutes a core module for a smartwatch. Such core modules have the advantage that a large number of sensors are already arranged on the mainboard 6 or connected to it via interfaces, which are designed for acquiring body and environmental data. Another advantage of using such core modules is that they are inexpensive to manufacture or purchase.

[0066] The measuring module 3 is detachably coupled to a top surface 9 of the housing 5 by means of a retaining clip 29. This detachable coupling allows for cleaning and easy replacement of the measuring module 3. The measuring module 3 can be a single-use item. The measuring module 3 has a flow channel 10 for guiding the patient's expiratory and inspiratory air. A ventilation access 12 in the form of a mouthpiece is fluid-conductingly connected to the flow channel 10 at a front section 11. The patient can breathe in and out via the ventilation access 12 using the breathing device 1. Alternatively, other ventilation accesses 12, such as an endotracheal tube or a breathing circuit, can be connected to the flow channel 10 instead of the mouthpiece.

[0067] The mainboard 6 has a sensor (not shown) for measuring pressure, in this case differential pressure, of the exhaled and / or inspired air. The sensor is connected to the mainboard 6.

[0068] Furthermore, a processing unit (not shown) is located on the mainboard 6. This unit is designed to evaluate and process the measured values, which can then be displayed on screen 8. This allows the patient to see respiratory parameters and curves, such as a volume-time curve, a flow-volume curve, and / or the maximum expiratory flow. In particular, specific diagnoses, instructions, and / or warnings can also be displayed to the patient on screen 8, depending on the evaluated and processed measurements. The creation and display of therapy plans is also possible.

[0069] The mainboard 6 is connected to an inductively rechargeable battery 13. The battery 13 is connected to an inductive charging coil 14, which is located on the underside 15 of the housing 5. The inductive charging function allows for easy handling and charging of the breathing apparatus 1. Furthermore, no additional connections are required.

[0070] An acoustic membrane 17, connected to the main circuit board 6, is located on the rear surface 16 of the housing 5. The membrane 17 can detect both ambient sounds and, when placed on the patient's body, respiratory sounds. This allows the breathing device 1 to be used both as a cough recorder and as a stethoscope. The patient's additional health parameters thus recorded can be taken into account by the processing unit for diagnosis and for the resulting therapy.

[0071] Using diagnostic module 2 and the coupled measurement module 3, a diagnosis of the patient's breathing pattern can be performed in a first step. This diagnosis, along with the corresponding processed measurement data, can be displayed to the patient on screen 8. Due to the detachable connection between diagnostic module 2 and therapy module 4, the patient can select a suitable therapy module 4 based on the displayed diagnosis and connect it to diagnostic module 2.

[0072] As in the Fig. As shown in Figure 1, the diagnostic module 2 and the therapy module 4 are coupled by means of a magnetic connector 23. This allows for easy, detachable coupling between modules 2 and 4, so that even elderly or seriously ill patients can disconnect and reconnect the modules. The magnetic connector 23 also ensures that the diagnostic module 2 and the therapy module 4 are correctly aligned with each other.

[0073] Therapy module 4 has a second flow channel 18, which, when coupled, is fluidically connected to the flow channel 10 of measuring module 3. The patient's exhaled air is thus directed from flow channel 10 of measuring module 3 into the second flow channel 18 of therapy module 4. The process is reversed for inspiratory air.

[0074] Therapy module 4 includes a control element 19 for changing a process parameter of therapy module 4. In the Fig. In the embodiment shown in Figure 1, the control element 19 is an actuating element with a cylindrical body, which is removable and rotatably arranged within the second flow channel 18. The control element 19 has recesses 20, whereby a process parameter of the therapy module 4, here the free flow cross-section of the second flow channel 18, can be adjusted by means of a rotation of the control element 19.

[0075] The control element 19 is detachably connected to a first drive unit 21, in this case a servo motor. The drive unit 21, and thus the control element 19, can be controlled by the processing unit. When the diagnostic module 2 and the therapy module 4 are coupled, an electrically conductive interface 22 is formed between modules 2 and 4. Control signals can be transmitted from the processing unit to the first drive unit 21 via interface 22. The first drive unit 21 is also supplied with power from the battery 13 via interface 22. Consequently, a process parameter of the therapy module 4 relevant to the patient's treatment can be automatically controlled by the processing unit of the diagnostic module 2, depending on the measured and processed respiratory parameters.The control element 19 can thus be adaptive and performed in real time, enabling therapy module 4 to provide treatment for respiratory problems precisely tailored to the patient's individual health condition. In the... Fig. In the embodiment shown in Figure 1, the control element 19 can be rotated by means of the first drive unit 21 so that a specific flow cross-section in the second flow channel 18 is fluid-permeable. Thus, the flow resistance of the second flow channel 18 can be adjusted. For example, increasing the breathing resistance can prevent lung collapse.

[0076] For the adaptive therapy of the patient, it is often necessary to determine the absolute pressure within the flow channel 10. Therefore, an absolute pressure sensor (not shown) is located on and connected to the main board 6. To determine the absolute pressure, a passage channel 24 is formed between the section of the second flow channel 18 of the therapy module 4 adjacent to the flow channel 10 and the interior of the diagnostic module 2. This ensures that the same absolute pressure prevails in the flow channel 10 and the interior of the diagnostic module 2, which can be measured by the sensor located on the main board 6.

[0077] The Fig. Figure 4 shows a breathing device 1 with an alternative version of the therapy module 4. This module features, in addition to the one already shown in the Fig. A control element 19, configured as an actuator, is connected to a second control element 25, configured as an oscillation element. The control elements 19 and 25 are arranged one behind the other in the second flow channel 18. The oscillation element 25 is also rotatable and detachable within the flow channel and, analogous to the actuator, has a cylindrical body with a recess 20. The control element 25 is detachably connected to a second drive unit 26, which is configured as a DC motor. The second drive unit 26 is also connected to the main board 6 and the battery 13 and can be controlled via the processing unit. By means of the oscillation element, the exhaled or inhaled air can be set into oscillation or vibration, whereby the exhaled or inhaled air is...Inhalation resistance is continuously varied by an oscillation, specifically a rotation of the oscillating element, at a frequency and direction of rotation specified by the processing unit. This oscillating element can be used to loosen and remove secretions, particularly those located in the patient's airways.

[0078] The combination of the two control elements 19, 25 has the advantage that the basic flow resistance can be adaptively adjusted by means of the actuating element, so that the patient's airways are kept open regardless of how much respiratory effort the patient can exert. At the same time, secretions can be loosened by means of the oscillating element.

[0079] To regulate the flow resistance, the second flow channel 18 also has an opening 27 in the area of ​​the actuator. The measuring module 3 can also detect whether the patient is currently inhaling or exhaling. During inhalation, the actuator can be controlled so that the opening 27 of the second flow channel 18 is open. In this state, the patient does not have to inhale against resistance.

[0080] The Fig. Figure 5 shows a breathing apparatus 1 with another alternative embodiment of the therapy module 4. The therapy module 4 shown here has a jet nozzle 28. The jet nozzle 28 is arranged within the second flow channel 18 and has an opening directed towards the flow channel 10 of the measuring module 3. An aerosol, in particular air or oxygen, can be introduced into the second flow channel 18 via the jet nozzle 28. Active respiratory support can be provided during the inhalation phase by injecting the aerosol. The jet nozzle 28 is also controlled by the processing unit. To counteract airway obstruction due to collapse, the flow generated by the jet nozzle 28 can also be applied during the exhalation phase. In this case, the controllable process variable of the therapy module 4 is the timing and quantity of the aerosol injection.

[0081] The Fig. Figure 6 shows a housing 5 of the diagnostic module 2. Two pressure channels 30, 31 are formed within the retaining clip 29 of the housing 5. In the coupled state, the pressure channels 30, 31 connect the measuring module 3 and the diagnostic module 2.

[0082] The pressure channels 30, 31 are coupled to the differential pressure sensor located on the main board 6.

[0083] The Fig. Figure 7 shows the cross-section of a variant of the measuring module 3. A resistance element 33 is arranged within the flow channel 10 of the measuring module 3. To determine the differential pressure before and after the resistance element 33, a pressure channel 30 upstream of the resistance element 33 and a pressure channel 31 downstream of the resistance element 33 are connected to the flow channel 10. If the measuring module 3 is coupled to the diagnostic module 2, the pressure channels 30 and 31 of the measuring module 3 are fluidly connected to the pressure channels 30 and 31 of the diagnostic module 2.

[0084] The Fig. Figure 8 shows another embodiment of the measuring module 3. The ventilation access 12, here designed as a mouthpiece, has an additional side port 34. External devices such as cough generators or CPAP machines can be connected to the measuring module 3 via the side port 34.

[0085] A cough generator can be used to apply a short negative pressure pulse to assist in coughing up secretions from the patient's airways. Preferably, the inlet of the cough generator is equipped with a solenoid valve. A vacuum line is connected to this valve and fluidically linked to the side port 34. Control electronics release the vacuum line for a short period during the patient's expiratory phase, creating a brief negative pressure that elicits an airflow similar to a cough. The control electronics can be connected to the processing unit of the respiratory device 1. During the artificially generated cough, the control elements 19 and 25 of the therapy module are positioned to create a defined negative pressure phase.This is made possible by the measuring module 3 detecting a corresponding negative pressure and moving the control elements 19, 25 into a closed position by means of the computing unit, in which the free flow cross-section of the second flow channel 18 is as small as possible.

[0086] The CPAP machine can generate a constant positive pressure, thus keeping the patient's airways open.

[0087] The Fig. Figure 9 shows an alternative embodiment of the measuring module 3. Here, the volume flow rate of the exhaled and / or inhaled air is determined not by differential pressure measurement, but by means of a thermal flow sensor (not shown in detail). A thermal flow sensor is a flow sensor that determines the volume flow rate based on the heat dissipation from a heated element by the flowing medium. The resulting temperature-dependent signal change serves as a direct measure of the flow velocity. The thermal flow sensor is preferably connected to the processing unit via an I2C (Inter-Integrated Circuit) interface. Furthermore, the measuring module 3 can include a CO2 sensor (also not shown in detail) which is connected to the processing unit.

[0088] The Fig. Figure 10 shows another embodiment of the therapy module 4. The therapy module 4 shown here comprises a combination of a control element 19 designed as an actuating element and a jet nozzle 28. The therapy module 4 also has a connection port 32 for connecting the jet nozzle 28 to a gas cylinder or compressor (not shown).

[0089] The Fig. Figures 11 a) to c) show different embodiments of the control elements 19, 25, as well as the associated design of the second flow channels 18 and the drive units 21, 26 detachably connected to the control elements 19. The control elements shown can be used both as actuators and as oscillators.

[0090] The Fig. Figures 11 a) and b) show that the recess 20 of the control elements 19, 25 can be a through-hole. If the control element 19, 25 with a through-hole is set in rotation, the free flow cross-section changes such that a sinusoidal change in resistance occurs. If the control element 25 is used as an oscillation element in the therapy module 4, the oscillation frequency is determined by the rotational frequency of the second drive unit 26. With two lateral bores, the oscillation frequency doubles at the same rotational speed. The area of ​​the recess 20, here a bore, determines the degree of resistance change.

[0091] The Fig. Figure 11 c) shows a control element 19, 25 with a triangular recess 20. With corresponding non-symmetrical recesses 20, the rate of change in resistance changes. For example, with a triangular recess, there is a slow increase in the free flow cross-section followed by an abrupt change to a complete blockage of the second flow channel 18.

[0092] The Fig. Figures 12 a) to e) show control elements 19, 25 with different triangular recesses 20.

[0093] The Fig. Figures 13 a) and b) further show the free flow cross-section of different control elements 19, 25 with different recesses 20 in two different rotational positions within the flow channel. The control elements 19, 25 of the Fig. 13 b) are in relation to the corresponding controls 19, 25 of the Fig. 13 a) rotated a further 45°. It is evident that, due to the different design and dimensions of the recesses, 20 different magnitude differences between the free flow cross-sections are formed.

[0094] The characteristics of the generated oscillation can be specifically influenced by the design of the flow path and the geometry of the control elements 19, 25 and their recess 20. A sudden increase in back pressure causes a rapid outward movement of the walls of the trachea and bronchi. This loosens adhering secretions from the airway walls, making them easier to transport or cough up. Furthermore, the rheology, i.e., the flow properties of the bronchial secretions, can be influenced by varying the oscillation shape and, if necessary, the oscillation frequency.

[0095] The Fig. Figure 14 shows a driver board 35, which can be arranged inside the housing 5 of the diagnostic module 2 and connected to the main board 6. Preferably, the driver board 35 is arranged on the main board 6. The sensors and interfaces provided by the main board 6 can be further expanded via the driver board 35. The sensors and interfaces of the main board 6 described above can thus also be outsourced to the driver board 35. The Fig. The driver board 35 shown in Figure 14, for example, includes a differential pressure sensor 36 and an absolute pressure sensor 37. Furthermore, the driver board 35 can be connected to mass flow sensors and CO2 sensors integrated in the measuring module 3. The driver board 35 can also include the drivers for the drive units 21 and 26, an H-bridge circuit, and a charging converter. Reference symbol: 1 breathing apparatus 2 Diagnostic module 3 measuring module 4 Therapy Module 5 cases 6 Mainboard 7 Exterior wall 8-inch screen 9 Top 10 Flow channel 11 front area of ​​9 12. Ventilation access 13 Battery 14 Induction charging coil 15 Underside 16 Back 17 Membran 18 second flow channel 19 Control element 20 Exclusion 21 first drive unit 22 Interface 23 magnetic connectors 24 Passage channel 25 second control element 26 second drive unit 27 Opening 28 jet nozzle 29 retaining clip 30 Pressure channel 31 Pressure channel 32 connection spigots 33 Resistance element 34 Side connection 35 driver board 36 Differential pressure sensor 37 Absolute pressure sensor Length L H height

Claims

[1] Modular respiratory device (1) for the diagnosis and treatment of a patient's respiratory problems, comprising a diagnostic module (2) with a housing (5), wherein a mainboard (6) is arranged inside the housing (5) and is connected to a screen (8) arranged in an outer wall (7) of the housing (5), a measuring module (3) with a flow channel (10) for guiding the patient's expiratory and / or inspiratory air, wherein the measuring module (3) is detachably coupled to the diagnostic module (2) and the measuring module (3) and / or the main board (6) have at least one sensor for measuring a flow rate or pressure of the expiratory and / or inspiratory air, wherein the at least one sensor is connected to the main board (6), a computing unit arranged on the mainboard (6) and designed to evaluate and process the measured values, wherein the processed values ​​can be displayed on the screen (8), a therapy module (4) with a second flow channel (18) for guiding the patient's expiratory and / or inspiratory air, which is detachably coupled to the diagnostic module (2), wherein the flow channel (10) of the measuring module (3) is fluidly connected to the second flow channel (18) of the therapy module (4) and the therapy module (4) has a control element (19, 25) for changing a process variable of the therapy module (4), wherein the control element (19, 25) can be controlled by means of the computing unit. [2] Modular breathing apparatus (1) according to claim 1, characterized by , that the variable process variable of the therapy module (4) is a free flow cross-section of the second flow channel (18). [3] Modular breathing apparatus (1) according to claim 1 or 2, characterized by , that the screen (8) is located on the mainboard (6). [4] Modular breathing apparatus (1) according to any one of claims 1 to 3, characterized by , that the measuring module (3) has a ventilation access (12), in particular a mouthpiece, which is fluidly and in particular detachably connected to the flow channel (10). [5] Modular breathing apparatus (1) according to any one of claims 1 to 4, characterized by , that the sensor arranged in the measuring module (3) for measuring the flow rate of the expiratory air and / or inspirational air is a thermal flow sensor. [6] Modular breathing apparatus (1) according to any one of claims 1 to 5, characterized by , that the sensor arranged on the main board (6) for measuring the pressure of the exhaled air and / or inspired air is a differential pressure sensor. [7] Modular breathing apparatus (1) according to any one of claims 1 to 6, characterized by, that a resistance element (33) is arranged in the flow channel (10). [8] Modular breathing apparatus (1) according to claims 6 and 7, characterized by , that between the measuring module (3) and the diagnostic module (2) two pressure channels (30, 31) are formed which are coupled to the differential pressure sensor, wherein one pressure channel (30) is coupled to the flow channel (10) in front of the resistance element (33) and one pressure channel (31) is coupled to the flow channel (10) behind the resistance element (33). [9] Modular breathing apparatus (1) according to any one of claims 1 to 8, characterized by , that a pressure sensor for measuring an absolute pressure is arranged on and connected to the main board (6). [10] Modular breathing apparatus (1) according to any one of claims 1 to 9, characterized by , that the measuring module (3) and / or the main board (6) have a sensor for measuring the CO2 content of the exhaled air and / or the inhaled air. [11] Modular breathing apparatus (1) according to any one of claims 1 to 10, characterized by , that the flow channel (10) or the ventilation access (12) has a translucent window, in particular an opening, wherein the translucent window faces the diagnostic module (2), and the diagnostic module (2) has an optical pulse sensor facing the translucent window. [12] Modular breathing apparatus (1) according to any one of claims 1 to 11, characterized by , that the mainboard (6) is connected to an inductively rechargeable battery (13), wherein the battery (13) is arranged on a bottom side (15) of the diagnostic module (2) inside the housing (5). [13] Modular breathing apparatus (1) according to any one of claims 1 to 12, characterized by , that a photoplethysmographic sensor connected to the main board (6) is arranged within a side wall of the diagnostic module (2). [14] Modular breathing apparatus (1) according to any one of claims 1 to 13, characterized by , that an acoustic membrane (17) connected to the main board (6) is arranged in a rear wall (16) of the diagnostic module (2). [15] Modular breathing apparatus (1) according to any one of claims 1 to 14, characterized by , that the diagnostic module (2) and the therapy module (4) are coupled by means of a magnetic connector (23). [16] Modular breathing apparatus (1) according to claim 15, characterized by , that the magnetic connector (23) includes conductive contact pins for transmitting the control signals between the diagnostic module (2) and the therapy module (4). [17] Modular breathing apparatus (1) according to any one of claims 1 to 16, characterized by , that the control element (19) of the therapy module (4) is an actuating element for changing the flow resistance of the second flow channel (18). [18] Modular breathing apparatus (1) according to any one of claims 1 to 17, characterized by, that the control element (25) of the therapy module (4) is an oscillation element for dynamically changing the flow resistance of the second flow channel (18). [19] Modular breathing apparatus (1) according to any one of claims 1 to 18, characterized by , that the therapy module (4) comprises a jet nozzle (28), wherein an opening of the jet nozzle (28) is arranged within the second flow channel (18) and is directed towards the flow channel (10) of the measuring module (3). [20] Modular breathing apparatus (1) according to claims 17 to 19, characterized by , that the therapy module (4) comprises an actuating element, an oscillating element and a jet nozzle (28). [21] Modular breathing apparatus (1) according to any one of claims 17 to 20, characterized by that the actuating element and / or the oscillating element have a cylindrical body and are in particular removable and rotatable within the second flow channel (18). [22] Modular breathing apparatus (1) according to any one of claims 17 to 20, characterized by that the actuating element is connected to a first drive unit (21), in particular a servo motor. [23] Modular breathing apparatus (1) according to any one of claims 18 to 20, characterized by , that the oscillating element is connected to a second drive unit (26), in particular a DC motor. [24] Modular breathing apparatus (1) according to claim 21, characterized by , that the oscillation element and / or the actuating element have a recess (20) wherein the free flow cross-section of the second flow channel (18) can be adjusted by means of a rotation of the oscillation element and / or the actuating element. [25] Modular breathing apparatus (1) according to claim 24, characterized by , that the recess (20) is a through hole and / or a triangular recess. [26] Modular breathing apparatus (1) according to any one of claims 1 to 25, characterized by, that the main board (6) includes a pedometer, a position sensor and / or a humidity sensor. [27] Modular breathing apparatus (1) according to any one of claims 1 to 26, characterized by , that the diagnostic module (2) can be paired with an end device, in particular with a computer, smartphone and / or tablet.

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