Flow measurement and flow control in the bronchus for local ventilation

Abstract

A medical device for treating a related patient includes an intratracheal sensor device configured to measure the fluid pressure within the trachea of the related patient, and an electronic controller configured to receive data of the fluid pressure from the intratracheal sensor device and calculate a measurement value of the fluid flow rate through the trachea based on the measured fluid pressure.

Description

Technical Field

[0001] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 346,341, filed May 27, 2022, under 35 U.S.C. § 119, the content of which is incorporated herein by reference.

[0002] The following generally relates to respiratory therapy techniques, mechanical ventilation techniques, mechanical ventilation control techniques, bronchial valve techniques, and related techniques.

Background Art

[0003] Invasive mechanical ventilation is an important element in the intensive care unit. There are several different ventilation methods, and these vary in several variables. Ventilation is distinguished by the way breathing is induced (pressure, volume, flow rate), by the limits that must not be exceeded (for volume, pressure, or flow rate), and by the cycle factors that end inspiration (again, pressure, volume, flow rate, time). There are volume-targeted ventilation modes, pressure-targeted modes, and combined modes. The amount of positive end-expiratory pressure (PEEP) is also an important factor. Thus, the intensivist has many ventilation parameters at hand to provide optimal treatment for individual patients.

[0004] However, all of these different ventilation modes and parameters provide air, pressure, volume, and flow through the patient's body, i.e., a single interface to the trachea and an endotracheal tube (ETT) in the trachea for invasive ventilation. The distribution of the amount of air blown into the lungs depends on the local airway resistance and local compliance of the respiratory system. In some diseases, one or both of the local airway resistance and local compliance are non-uniform, resulting in a non-uniform distribution of the amount of air blown in. This can lead to a situation where in some areas the PEEP value is too low for lung recruitment, while in other areas the pressure is too high, causing over-inflation of the lungs or cardiac complications. Specific examples are patients with lobar pneumonia, lobar emphysema, or other asymmetric lung disorders. For example, patients suffering from ARDS (acute respiratory distress syndrome) often develop edema, which leads to insufficient inflation or collapse of the lung units in the lower lung regions due to gravity-induced pressure.

[0005] Non-uniform inflation or deflation of the lungs also causes a dynamic pressure difference between regions, resulting in inter-regional air flow known as pendelluft (see Elliot E. Greenblatt et al., ’Pendelluft in the Bronchial Tree,’ Journal of Applied Physiology, 117.9 (2014), 979-88 https: / / doi.org / 10.1152 / japplphysiol.00466.2014). This is an important phenomenon contributing to local gas exchange, irreversible mixing, and aerosol deposition patterns within poorly ventilated regions of the lungs. It is more prominent in diseases with significant non-uniformity in both resistance and compliance.

[0006] In addition, COPD (Chronic Obstructive Pulmonary Disease) is a progressive lung disease associated with emphysema. Emphysema is characterized by air-filled spaces within the lungs and permanent damage to lung tissue. The emphysematous parts of the lungs may overinflate. As a result, the other healthy parts of the lungs have less space in the chest and thus cannot fully participate in gas exchange, leading to shortness of breath. Therefore, surgical removal of the most affected lung lobe of emphysema (lung volume reduction surgery) is an effective treatment for severe COPD.

[0007] The implantation of endobronchial valves is a minimally invasive alternative to lung volume reduction surgery and is also called bronchoscopic lung volume reduction (BLVR). One or more endobronchial valves are placed into one or more bronchi bronchoscopically (i.e., under visual control). These valves are simple one-way valves that allow air to be exhaled but not inhaled. After implantation, the targeted lung lobe rapidly collapses (if there is no pulmonary shunt), giving space to the healthy lung lobes. Several valve systems are commercially available (e.g., from Olympia Spiration, Pulmonx, etc.). Endobronchial valves can be easily placed and removed using a dedicated catheter that passes through the working channel of the bronchoscope.

Summary of the Invention

Problems to be Solved by the Invention

[0008] Thus, in the intensive care unit, there are many situations where it is preferable for ventilated patients to obtain the targeted ventilation volume for each region. However, with current ventilation systems, it is impossible to locally measure the pressure, flow rate, or volume reaching the lung sub-units (e.g., lung lobes or segments). Also, it is impossible to target parts of the lungs using dedicated parameter settings (e.g., pressure, volume, or flow rate) or dedicated pressure, flow rate, or volume curves.

[0009] The following discloses certain improvements to overcome these and other problems.

Means for Solving the Problem

[0010] In one aspect, a medical device for treating a related patient includes an intratracheal sensor device configured to measure the fluid pressure within the trachea of the related patient, and an electronic controller configured to receive data of the fluid pressure from the intratracheal sensor device and calculate a measured value of the fluid flow rate through the trachea based on the measured fluid pressure.

[0011] In another aspect, a medical device for treating a related patient includes an intratracheal sensor device disposed within the trachea of the related patient and configured to measure the fluid pressure within the trachea. The intratracheal sensor device includes a base portion, a membrane connected to the base portion, and a micro-robot (Micro-Bot) actuator connected to the membrane. The electronic controller is configured to receive data of the fluid pressure from the tracheal sensor device and calculate a measured value of the fluid flow rate through the trachea based on the distance between the membrane and the base portion measured by the micro-robot actuator.

[0012] One advantage is to provide the target ventilation volume for each region to patients undergoing mechanical ventilation therapy.

[0013] Another advantage is to provide a mechanical ventilation system capable of locally measuring the pressure, flow rate, or volume reaching the lung sub-units.

[0014] Another advantage is to target parts of the lung using dedicated parameter settings (e.g., pressure, volume, or flow rate) or dedicated pressure, flow rate, or volume curves for patients undergoing mechanical ventilation therapy.

[0015] Another advantage is to automatically adjust the settings of the mechanical ventilator to help the patient become less dependent on mechanical ventilation therapy.

[0016] A given embodiment may or may not provide any, one, two, more, or all of the aforementioned advantages, and / or may provide other advantages that will be apparent to those skilled in the art upon reading and understanding the present disclosure.

Brief Description of the Drawings

[0017] The present disclosure may take various components and combinations thereof, and various steps and arrangements thereof. The drawings are for illustrative purposes only of preferred embodiments and should not be construed as limiting the present disclosure.

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Modes for Carrying Out the Invention

[0018] In the specification, unless otherwise clearly stated in the context, even if not stated as being plural, it includes the case where there are a plurality thereof. In the specification, stating that two or more parts or components are "coupled", "connected", or "engaged" means that, as long as they are interlocked, these parts are joined, act, or cooperate either directly or indirectly, i.e., by any of one or more intermediate parts or components. In the specification, expressions of direction, for example, but not limited to, top, bottom, left, right, above, below, front, rear, and their derivatives, are related to the orientation of the elements shown in the drawings and do not limit the claims unless otherwise clearly stated. The terms "comprising" or "including" do not exclude the existence of elements or steps other than those described in the specification and / or listed in the claims. In a device having several means, some of these means may be embodied by one item of hardware.

[0019] To provide regional measurements of ventilation parameters to a patient undergoing mechanical ventilation, one or more measurement devices are disposed within a bronchus (i.e., with the aid of a bronchoscope) in one or more of a lobar bronchus, a segmental bronchus, or a smaller bronchus. The measurement device is disposed and fixed within the bronchus. It preferably includes one or more pressure sensors based on microbot technology (e.g., J Rahmer, C Stehning, and B Gleich, ‘Spatially Selective Remote Magnetic Actuation of Identical Helical Micromachines.,’ Science Robotics, 2.3 (2017)). This technology can be read out wirelessly and does not require an on-board power source (see, e.g., US2021 / 0244305, which is incorporated herein by reference in its entirety). The measurement device is based on Bernoulli's theorem, and the setting of the pressure sensor in this measurement device depends on the physical quantities to be measured, such as pressure and flow rate. Typically, the measurement device has some known constriction that imposes a defined resistance on the air flow. The pressure signal from the pressure sensor is read out and transmitted to a computer, which calculates regional curves, such as time-pressure curves, time-flow curves, and time-volume curves. Alternatively, with the aid of an imaging device, regional ventilation parameters can be evaluated.

[0020] In addition, the ventilation device can, overall, provide ventilation only to the lungs via the trachea. Thus, the ventilation device can ventilate only with a single time-pressure curve or time-volume curve. To supply individual pressures, volumes, or flow rates to different regions of the lungs (lobes, segments, or sub-segmental regions), one or more control devices are disposed within the bronchi. These control devices can shape ventilation parameters such as pressure, volume, or flow rate by adapting (typically increasing) the resistance of the airway or by functioning as a valve to completely close the airway.

[0021] The control device preferably includes one or more actuators based on microbot technology, which can be switched wirelessly without using an on-board power source (see, for example, Jurgen Rahmer, Christian Stehning, and Bernhard Gleich, ’Remote Magnetic Actuation Using a Clinical Scale System,’ PLOS ONE, 13.3(2018)). The switching or change in resistance is controlled by a computer. This controller may operate independently (sensing the operation of the ventilator) or may be digitally connected to a mechanical ventilator so that the timing and strength of the valve operation are synchronized with ventilation.

[0022] As disclosed herein, in a preferred embodiment, the measurement device and the control device are combined into one device that enables real-time measurement and formation of regional ventilation parameters. The system can operate in open-loop and closed-loop modes and can operate continuously or intermittently. Both the measurement device and the control device can be constructed based on microbot technology having a magneto-mechanical oscillator, which enables the construction of small (1-2 mm in length) wireless markers and sensors that can use a magnetic field to remotely interrogate (send a response signal). The microbots are constructed such that a physical quantity such as pressure, which can be detected externally, affects the oscillation frequency of the microbots. The microbots do not require a power source and are thus ideal for applications providing regional ventilation.

[0023] Referring to FIG. 1, a mechanical ventilator 2 for providing ventilation therapy to an associated patient P is shown. As shown in FIG. 1, this mechanical ventilator 2 includes an outlet 4 connectable to a patient breathing circuit 5 for delivering mechanical ventilation to patient P. The patient breathing circuit 5 includes typical components of a mechanical ventilator, such as an inhalation line 6, an optional exhalation line 7 (omitted if the ventilator uses a single-limb patient circuit), a connector or port 8 for connecting to an endotracheal tube (ETT) 16 inserted into the trachea of patient P (or alternatively, connecting to a tracheostomy tube not shown), and one or more respiratory sensors (not shown), such as a gas flow meter, a pressure sensor, and / or an end-tidal carbon dioxide (etCO2) sensor. The mechanical ventilator 2 is designed to deliver air, an air-oxygen mixture, or other breathable gas (not shown) to the outlet 4 at a programmed pressure and / or flow rate to ventilate the patient via the ETT. The mechanical ventilator 2 also includes an electronic controller 13 (e.g., an electronic processor or microprocessor), a display device 14, and a non-transitory computer-readable medium 15 storing instructions executable by the electronic controller 13. The instructions can include a method or process 100 for measuring a fluid (e.g., liquid or gas) flow rate.

[0024] FIG. 1 schematically shows patient P with an inserted ETT 16 (the lower part of the ETT is inside patient P, so its lower part is shown as a virtual line). The connector or port 8 is operably connected to the mechanical ventilator 2 to connect to the ETT 16 and deliver breathable air to patient P via the ETT 16. The mechanical ventilation supplied by the mechanical ventilator 2 via the ETT 16 is therapeutic for a wide range of diseases, such as various types of lung diseases, such as emphysema or pneumonia, viral or bacterial infections that affect breathing, such as COVID-19 infection or severe influenza, or cardiovascular diseases in which patient P receives an oxygen-enriched breathable gas.

[0025] Figure 1 shows an intratracheal sensor 10 disposed within a bronchus (not shown) of the lung 18 of a patient P schematically shown. This sensor 10 has an intratracheal sensor device 10 configured to measure the fluid pressure within the bronchus of the patient P. Embodiments of the intratracheal sensor device 10 are described herein. Figure 1 also shows a magnetomechanical intratracheal valve 20 disposed in the same or a different bronchus of the lung 18 of the patient P (also schematically shown as a rectangle in Figure 1). Embodiments of the intratracheal valve 20 are also described herein.

[0026] The non-transitory computer-readable medium 15 of the mechanical ventilator 2 stores instructions executable by the electronic controller 13 of the mechanical ventilator 2 for performing a measurement method or process 100. To do so, the measurement method 100 performed by the electronic controller 13 includes receiving data of the fluid pressure from the intratracheal sensor device 10 and calculating a measured value of the fluid flow rate through the bronchus based on the measured fluid pressure. In one embodiment, an indication of the measured value of the fluid flow rate is displayed on the display device 14 of the mechanical ventilator 2. In another embodiment, the measured value of the fluid flow rate is input into the electronic controller 13 and controls the operation of the mechanical ventilator in the delivery of mechanical ventilation therapy to the patient P. For example, when the measured value of the fluid flow rate is below a predetermined fluid flow rate threshold, the mechanical ventilator 2 is controlled to supply additional air to the patient P, while when the measured value of the fluid flow rate is equal to or exceeds the predetermined fluid flow rate threshold, the mechanical ventilator 2 is controlled to supply a lesser amount of air to the patient P.

[0027] The non - transitory computer - readable medium 15 of the mechanical ventilator 2 optionally further stores instructions executable by the electronic controller 13 of the mechanical ventilator 2 for performing a ventilation control method or process 200. To do so, the control method 200 performed by the electronic controller 13 receives the measured value of the fluid flow rate calculated by the measurement process 100 and, based on that measured value, generates a control signal 21 for controlling the mechanical ventilation of the patient, together with other information such as, for example, the settings of the mechanical ventilator 2, the measured value of the overall ventilation flow rate obtained by a gas flow sensor, a pressure sensor, an etCO2 sensor, or other sensors of the ventilator 2. In one example, at least one setting of the mechanical ventilator 2 is controlled based on the measured value of the fluid flow rate through the bronchus obtained by the method 100. For example, if the measured value of the fluid flow rate indicates that the gas flow received by a part of the lung 18 may be too high, the settings of the ventilator 2 are adjusted to reduce the gas flow measured by the method 100 until the gas flow reaches the target level. In another example, if the gas flow measured by the method 100 is too high, the in - bronchus valve 20 (which is in the same bronchus as the sensor 10 in this example) operates to close (either fully or partially, depending on the type of valve), thereby reducing or eliminating the gas flow through that bronchus. In other examples, at least one setting of the mechanical ventilator 2 is controlled based on one or more of the measured fluid pressure in the bronchus, the measured value of the calculated fluid flow rate through the bronchus, the determined volume of the fluid in the bronchus, and other measured or derived parameters.

[0028] Referring continuously to FIGS. 2 - 5, some non - limiting exemplary embodiments of the sensor 10 will be described.

[0029] Figure 2 shows an example of the intrabronchial sensor device 10. As shown in Figure 2, the intrabronchial sensor device 10 is disposed within the bronchus B of the patient P. In one example, the intrabronchial sensor device 10 includes a stent 30 having a diameter smaller than the diameter of the bronchus B. The pressure sensors 32, 34 are disposed proximate to both ends of this stent 30. Each of the pressure sensors 32, 34 has a magnetomechanical oscillator device (i.e., a microbot). The electronic controller 13 is configured to calculate a measured value of the fluid flow rate based on the diameter of the stent 30 and the pressure data measured by each of the pressure sensors 32, 34. The stent 30 becomes a constriction in the airway of the bronchus B. According to Bernoulli's theorem, the flow rate can be calculated from the pressure difference measured across a known resistance, in this case the stent 30 having a known diameter. In another example, the stent 30 has a diameter slightly larger than the diameter of the bronchus B such that when this stent 30 is inserted into the bronchus B, it expands this bronchus B.

[0030] Figure 3 shows another example of the intrabronchial sensor device 10. As shown in Figure 3, the intrabronchial sensor device 10 is disposed within the bronchus B of the patient P. The intrabronchial sensor device 10 includes a tube 36 extending from one end of the stent 30 to a constriction (with respect to the air flow) in this stent 30. A single magnetomechanical oscillator device 32 (although more than one can be included) is shown and is configured to measure the pressure difference across the constriction in the stent 30. When the magnetomechanical oscillator device 32 is disposed in the tube 36 from one non-constricted end of the stent 30 to the center of the constriction, this magnetomechanical oscillator device 32 measures the difference in static pressure between the inside and the outside of the constriction with respect to the flow rate. This is an embodiment in which the intrabronchial sensor device 10 serves as a venturi meter.

[0031] Figure 4 shows another example of the intrabronchial sensor device 10. As shown in Figure 4, the intrabronchial sensor device 10 is disposed within the bronchus B of the patient P. The intrabronchial sensor device 10 includes a deflecting membrane 38 that is attached to the stent 30 and configured to move based on a change in the fluid flow rate within the bronchus B. A magnet (i.e., permanent magnet 40) is disposed on this deflecting membrane 38. Each magnetomechanical oscillator device 32 is configured to measure a pressure difference based on the measured distance between each magnetomechanical oscillator device 32 and the magnet 40 during the movement of the deflecting membrane 38 regarding the fluid flow rate in the bronchus B (see, e.g., US2020 / 0400509, which is hereby incorporated by reference in its entirety).

[0032] Yet another method is a configuration similar to a Pitot tube where one microbot pressure sensor is used to measure the stagnation pressure (or total pressure) and another microbot pressure sensor measures the static pressure. From Bernoulli's equation, the dynamic pressure that depends on the flow velocity, and thus the flow velocity, can be calculated.

[0033] Figures 2 - 4 show the intrabronchial sensor device 10 as a flow measurement device or a volume measurement device. For mechanical ventilation, it is important to measure the volume supplied to a region of the patient B or the lungs. If the time - flow curve is measured as continuously as possible with the help of a flow measurement device, this flow is integrated over time to obtain the added volume.

[0034] FIG. 5 shows an embodiment of an intrabronchial sensor device 10 configured to control or vary fluid flow rate. As shown in FIG. 5, the intrabronchial sensor device 10 includes a base portion 42, a membrane 44 hinge-connected to the base portion 42, and an actuator 46 connected to the membrane 44. The membrane 44 and the actuator 46 can operate to create a variable constriction and thus a variable sensor. The electronic controller 13 is configured to calculate the fluid flow rate based on the distance between the membrane 44 and the base portion 42 measured by the actuator 46. In some examples, the actuator 46 has a magnet (i.e., a rotating magnet actuated by a spatially rotating field with a simple gear mechanism to adjust the opening size of the constriction), and the electronic controller 13 is configured to calculate the fluid flow rate based on the magnetic field generated by the magnet 46. The actuator 46 can also be controlled, for example, by the measured fluid pressure in the bronchus, the measured value of the calculated fluid flow rate through the bronchus, the determined volume of the fluid in the bronchus, the ventilation parameters of the mechanical ventilator (2), and other measured or determined parameters.

[0035] Referring to FIGS. 6A and 6B, some exemplary embodiments of the intrabronchial valve 20 will be described. In some embodiments, the intrabronchial valve 20 can have an "active" intrabronchial valve by controlling a portion of the fluid flowing to the patient P.

[0036] The endobronchial valve 20 is typically configured to occlude a portion of a lung region by blocking an endobronchial tube that conveys a portion of the air delivered by the mechanical ventilator 2 to a region of the lung. As shown in FIGS. 6A and 6B, the endobronchial valve 20 can include a base portion having a first strip 48 and a second strip 50 configured to be disposed on opposing walls of the bronchus B. The membrane 52 is pivotally connected to the first strip 48. The actuator 54 (i.e., a magnetomechanical oscillator device or other magnetomechanical actuator) is connected to hold the valve in the open position by contacting and holding the membrane 52 proximate to the second strip 50 as shown in FIG. 6A, and is operable to release the membrane 52 to close the valve in response to a magnetic control signal to close the valve as shown in FIG. 6B. In some examples, the actuator 54 can hold the membrane 52 in the open position (FIG. 6A) until the airflow pushes the actuator 54 against the second strip 50 (FIG. 6B). When this control device is combined with a pressure sensor, a flow sensor, or a volume sensor, it is used to limit the maximum pressure, maximum flow, or maximum volume to the lung region of interest. Appropriate safety mechanisms can ensure that the valve does not accidentally close. The exemplary valve 20 is a two-position valve and in the closed position (FIG. 6B), the airflow can be completely blocked (e.g., if the released membrane 52 completely closes the lumen) or only partially blocked (e.g., if the membrane 52 has some openings or slits that allow some air to pass through). It should be noted that the exemplary endobronchial valves 20 of FIGS. 6A and 6B are merely non-limiting exemplary examples and other designs may be contemplated. For example, two or more (e.g., N) membranes 52 can be provided with individual actuators for each membrane, presenting different levels of gas flow resistance, such that an N-membrane valve can generate a variety of different discrete flow resistance values.

[0037] FIG. 7 shows an example of the magnetomechanical oscillator device 32. As shown in FIG. 7, the magnetomechanical oscillator device 32 includes a resonator 60 having a passive device with a fixed magnet 62 and a suspended permanent magnet 64, and the suspended permanent magnet 64 performs rotational vibration in response to a magnetic field pulse from the fixed magnet 62. The magnetomechanical oscillator device 32 also includes a detection system 66 configured to generate an excitation pulse (transmission channel, Tx) and a received signal (Rx) from an array of up to 16 coils. The detection system 66 can also apply a magnetic field sequence (e.g., a rotating magnetic field for a screw-based actuator) to control the magnetic drive actuator.

[0038] In some embodiments, the intubation sensor device 10 can include an adjustable magnetomechanical oscillator device having a diaphragm and a simple gear mechanism used to form a valve that acts as a pressure regulator. This control device automatically adjusts its aperture to limit the pressure to one or more parts of the patient P's lungs. When a measurement device combined with the control device is placed intratracheally under bronchoscopy, these devices are controlled in real time with the help of a transceiver system to communicate with the magnetomechanical oscillator device. Signals from the measurement device are analyzed with the help of a computer program that calculates pressure, flow rate, and volume. These values are input into a model of the patient's lungs based on either individual CT scans or general knowledge of human anatomical structures.

[0039] The operator of the device 10 can adjust the maximum pressure, maximum flow rate, maximum volume, etc. for each of the control devices within the lung region of interest. In addition, the computer program controls the settings of a mechanical ventilator that supplies pneumatic pressure, air flow, and air volume through the trachea. For example, dynamic control of the device to address dynamic ventilation problems such as pendelluft is particularly interesting by ensuring that only air flows out during exhalation and only air flows in during inhalation.

[0040] As an exemplary use case, alveolar overdistension is a condition that can lead to persistent lung injury after mechanical ventilation. To protect the lungs, the plateau pressure applied to the peripheral airways and alveoli during positive pressure ventilation should be limited. The intrabronchial sensor device 10 enables a clinician to measure the local pressure within one or more bronchi B of a patient P.

[0041] Since the local pressure is not necessarily the same as the pressure applied by the mechanical ventilator 2 in the endotracheal tube 16, the local pressure measurement can be used to limit the local plateau pressure, for example, by changing the overall settings of the mechanical ventilator 2 such that the overall plateau pressure in the endotracheal tube 16 is reduced. When using this technique, not only the average plateau pressure (measured by the mechanical ventilator 2) but also the local plateau pressure does not exceed a predetermined threshold. For example, the maximum value of the local pressure measurement can be used to determine the optimal overall pressure by adapting (increasing or decreasing) the actual overall pressure until the maximum value of this local pressure measurement has a specific target value.

[0042] Instead of measuring the local pressure, it is also possible to use the intrabronchial sensor device 10 to measure the local flow rate and (for example, by integrating the flow rate over time) measure the local tidal volume. Thus, it is possible to measure the local tidal volume for each lung region equipped with the intrabronchial sensor device 10 within the corresponding bronchus B. When the local tidal volume exceeds a predetermined threshold, the overall tidal volume applied by the mechanical ventilator 2 is reduced until all measured local tidal volumes are below their thresholds.

[0043] To protect the lungs from local alveolar overinflation, one or more endobronchial valves 20 are disposed within the bronchi in different bronchi B. These endobronchial valves 20 include a microbot actuator 54 configured to close the corresponding bronchi B that is actuated by an external signal applied to the microbot actuator 54. In addition, the endobronchial valves 20 can include one or more microbot sensors 32, 34 that measure local pressure and local flow rate.

[0044] The optimal local tidal volume corresponding to the lung region controlled by the endobronchial valve 20 can be determined based on a computed tomography (CT) scan or a digital model of the patient P's lungs. These optimal local tidal volumes are a part (i.e., a percentage) of the total tidal volume delivered by the mechanical ventilator 2 in the endotracheal tube 16. When the total tidal volume increases or decreases, these optimal local tidal volumes also change proportionally.

[0045] During inhalation, if the measured value of the volume in one of the endobronchial valves 20 exceeds the optimal local tidal volume, the microbot actuator 54 operates to close the endobronchial valve 20. Thereafter, the remaining portion of the total tidal volume delivered by the mechanical ventilator 2 is distributed to other lung regions that have not yet reached their optimal tidal volume. This procedure is repeated with the remaining endobronchial valves 20 until all lung regions behind the endobronchial valve 20 receive their optimal tidal volume at the end of inhalation (i.e., when the total tidal volume is delivered by the mechanical ventilator 2).

[0046] In some embodiments, instead of embedding an active control device, a passive resistor or valve can be used. For example, a passive resistor is a simple stent with a stenosis of a defined diameter. These stenoses must be constructed with a fixed diameter or a resistance of the appropriate diameter must be selected. Alternatively, a resistor with an adjustable stenosis (and thus an adjustable resistance) can be constructed. Their characteristics are set prior to implantation and, being passive devices, remain fixed until explantation. In another example, passive valves are similar to passive resistors. These valves open and close at a fixed (or adjustable and then fixed) pressure or flow rate.

[0047] In some embodiments, a computer program (e.g., a model with a patient's Digital Twin) can be used to estimate the optimal selection or setting of a passive control device.

[0048] In some embodiments, feedback can be provided to the clinician, such as, for example, feedback from functional imaging to adapt the control device and / or feedback from a wearable or patient monitor (e.g., a vital sign measurement device) to adapt the control device.

[0049] This disclosure has been described with reference to preferred embodiments. Others may envision modifications and variations upon reading and understanding the detailed description above. Exemplary embodiments are intended to include all such modifications and variations as long as they fall within the scope of the appended claims or their equivalents.

Claims

1. A medical device for treating a related patient, the medical device comprising: An intratracheal sensor device configured to measure the fluid pressure within the trachea of the related patient, and An electronic controller The electronic controller is configured to: Receive data of the fluid pressure from the intratracheal sensor device, and Calculate a measured value of the fluid flow rate through the trachea based on the measured fluid pressure A medical device so configured.

2. The tracheal sensor device has a stent, and the stent is provided with pressure sensors arranged close to both ends thereof, The electronic controller is configured to calculate the measured value of the fluid flow rate based on the diameter of the stent and the pressure data measured by each of the pressure sensors, The medical device according to claim 1.

3. Each of the pressure sensors has a magnetomechanical oscillator device, the medical device according to claim 2.

4. Further having a tube extending from one end of the stent to a stenosis within the stent, The magnetomechanical oscillator device is configured to measure the pressure difference between both ends of the stenosis within the stent, the medical device according to claim 3.

5. The medical device further comprises: A deflection membrane attached to the stent and configured to move based on a change in the fluid flow rate within the trachea, and A magnet disposed on the deflection membrane Each of the magnetomechanical oscillator devices is configured to measure a pressure difference based on the distance between each of the magnetomechanical oscillator devices and the magnet while the deflection membrane is moving, the medical device according to claim 3.

6. The intratracheal sensor device comprises: A base portion, A membrane hinge-connected to the base portion, and An actuator connected to the membrane The electronic controller is configured to calculate the measured value of the fluid flow rate based on the distance between the membrane and the base portion measured by the actuator, the medical device according to claim 1.

7. The actuator has a magnet, and the electronic controller is configured to calculate the measured value of the fluid flow rate based on the magnetic field generated by the magnet, the medical device according to claim 6.

8. The medical device further comprises: ​ ​ A base portion having first and second strips configured to be disposed on opposing walls of a bronchus, a membrane pivotally connected to the first strip, and a magnetomechanical actuator connected to the membrane The medical device according to claim 1, further comprising an in-bronchus valve, wherein the magnetomechanical actuator is configured to hold the valve in an open position by contacting and holding the membrane close to the second strip, and to close the valve by releasing the second strip in response to a magnetic actuation signal.

9. The medical device further comprises a mechanical ventilation device configured to deliver mechanical ventilation to the associated patient, at least one setting of the mechanical ventilation device is the measured fluid pressure in the bronchus, a measured value of the calculated fluid flow rate through the bronchus, and a determined volume of fluid in the bronchus The medical device according to claim 1, which is controlled based on at least one of them.

10. A medical device for treating an associated patient, the medical device comprising an in-bronchus sensor device for placement within the bronchus of the associated patient, the in-bronchus sensor device being configured to measure the fluid pressure within the bronchus, and an electronic controller The in-bronchus sensor device has a base portion, a membrane connected to the base portion, and a microbot actuator connected to the membrane The electronic controller is configured to receive data of the fluid pressure from the bronchus sensor device, and calculate a measured value of the fluid flow rate through the bronchus based on the distance between the membrane and the base portion measured by the microbot actuator A medical device configured as such.

11. The medical device further comprises an in-bronchus valve, the in-bronchus valve comprising a base portion having first and second strips configured to be disposed on opposing walls of the bronchus, a membrane pivotally connected to the first strip, and a microbot actuator connected to hold the membrane when the in-bronchus valve is in an open position and operable to release the membrane in response to a magnetic control signal for closing the valve to close the valve The medical device according to claim 10.

12. The medical device is A deflection membrane attached to the base portion and configured to move based on a change in the fluid flow rate within the bronchus, and A magnet disposed on the deflection membrane The medical device according to claim 10, further comprising, wherein each microbot device is configured to measure a pressure difference based on the distance between each microbot device and the magnet while the deflection membrane is moving.

13. The medical device according to claim 10, further comprising a tube extending from one end of the stent to a constricted portion within the stent, wherein the magnetomechanical oscillator device is configured to measure a pressure difference between both ends of the constricted portion within the stent.

14. The microbot actuator has a magnet, the electronic controller is configured to calculate a measured value of the fluid flow rate based on a magnetic field generated by the magnet, and the microbot actuator is The measured fluid pressure within the bronchus, The calculated measured value of the fluid flow rate through the bronchus, The determined volume of fluid within the bronchus, and Ventilation parameters of a mechanical ventilator The medical device according to claim 10, which is controlled based on at least one of them.

15. The medical device according to claim 11, further comprising a mechanical ventilator configured to deliver mechanical ventilation to the associated patient, wherein at least one setting of the mechanical ventilator is controlled based on a measured value of the fluid flow rate through the bronchus.

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