Lung airway clearance

Abstract

To provide a system for delivering treatment tailored to clear the lung airways. [Solution] A system comprising at least one pressure applicator 128 adapted to apply pressure at at least one specific location on the patient's torso when activated and to release the pressure when deactivated; a sensor for sensing patient-related signals; and a controller that communicates with the sensor and is adapted to analyze the signals and control the activation and deactivation of the at least one pressure applicator 128 based at least in part on the analysis of the signals. Related apparatus and methods are also described.

Description

TECHNICAL FIELD

[0001] Related applications This application is a PCT application claiming the priority benefit of U.S. Provisional Patent Application No. 63 / 013,614, filed on April 22, 2020.

[0002] The entire content of the above application is incorporated herein by reference as if set forth in full in this specification.

[0003] In some of its embodiments, the present disclosure relates to methods and systems for applying pressure to a patient's chest to clear the patient's airway and / or assist in removing secretions from at least one lung.

[0004] Respiratory failure is common among patients with severe pneumonia or pneumonitis caused by infections (e.g., viruses, bacteria, parasites). First-line treatment is based on oral therapy and optionally oxygen, but the final stage of treatment involves sedating the patient, intubating the patient, and ventilating the patient with a mechanical ventilator, thereby suppressing coughing, which is an important defense mechanism of the lungs. Mechanical ventilators supply the patient with a volume or pressure of air, typically enriched with oxygen, to enable gas exchange. The clinical characteristic of the lungs of patients with severe lower respiratory tract infection is usually heterogeneous injury, with areas of overinflation and areas of atelectasis (lung collapse), excessive secretions (sputum, pus) and airway narrowing (meaning higher airway resistance). Heterogeneous injury leads to heterogeneous air distribution. A mechanical ventilator supplies the patient with a volume of air that is typically no greater than resting tidal volume (typically 500 ml in adults). The amount of air supplied by the mechanical ventilator is usually sufficient during normal periods in healthy lungs, but during severe disease, most of the air remains in the large airways and barely reaches the periphery of the lungs. Therefore, in combination with airway narrowing and excessive sputum volume, the patient cannot expectorate, resulting in excessive ventilation perfusion (VP) mismatch that leads to prolonged duration of patient ventilation.

[0005] Other background technologies include Patent Documents 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12.

[0006] All disclosures of references mentioned above and throughout this specification, as well as all disclosures of references mentioned within those references, are incorporated herein by reference. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2016 / 0113839 [Patent Document 2] U.S. Patent Application Publication No. 2010 / 0326442 [Patent Document 3] U.S. Patent No. 10,555,870 [Patent Document 4] U.S. Patent No. 10,518,048 [Patent Document 5] U.S. Patent No. 9,687,415 [Patent Document 6] U.S. Patent No. 8,578,939 [Patent Document 7] U.S. Patent No. 7,909,034 [Patent Document 8] U.S. Patent No. 7,594,508 [Patent Document 9] U.S. Patent No. 6,461,315 [Patent Document 10] U.S. Patent No. 6,415,791 [Patent Document 11] U.S. Patent No. 4,928,674 [Patent Document 12] U.S. Patent No. 4,424,806 [Overview of the project] [Means for solving the problem]

[0008] This disclosure relates, in some embodiments thereof, to methods and systems for applying pressure to a patient's chest in order to clear the patient's airway and / or to help remove secretions in at least one lung, and in particular to a vest for applying pressure to the outside of a patient's chest.

[0009] In some embodiments, pressure is applied by a set of inflatable pouches or pillows placed on the patient's chest and enclosed by a vest.

[0010] In some embodiments, the vest pouch is inflated in a specific sequence, optionally synchronized with the patient's breathing and / or coughing and / or the patient's ventilation machine.

[0011] According to one aspect of several embodiments of the present disclosure, a system for clearing the lung airway is provided, which includes a vest for enclosing the patient's rib cage, and in some embodiments also for enclosing the area below the rib cage, and a plurality of inflatable pouches for being placed between the patient's torso or the area below it and the vest.

[0012] According to some embodiments of this disclosure, the material including the vest is rigid.

[0013] According to some embodiments of the present disclosure, a pocket for accommodating an inflatable bag is further included.

[0014] According to some embodiments of the present disclosure, a second inner soft vest further includes a pocket for placing an inflatable pouch.

[0015] According to some embodiments of the present disclosure, the inflatable pouch includes a hook-and-loop attachment to a corresponding hook-and-loop component included in a vest.

[0016] According to some embodiments of the present disclosure, the inflatable sac is configured to deflate in less than 0.5 seconds.

[0017] According to some embodiments of the present disclosure, the device further comprises individual inflation pipes connected to the respective input portions of each inflatable bladder.

[0018] According to some embodiments of the present disclosure, the device further comprises an inflation pump for inflating the inflatable bladder.

[0019] According to some embodiments of the present disclosure, the device further comprises a controller for controlling inflation of the inflatable bladder.

[0020] According to one aspect of some embodiments of the present disclosure, there is provided a method for clearing pulmonary airways, the method comprising: placing an inflatable bladder in a rigid vest surrounding a patient's torso; inflating the inflatable bladders in a specific order for a specific duration; and deflating the inflatable bladders.

[0021] According to some embodiments of the present disclosure, the inflating step and the deflating step are synchronized with the patient's breathing, whether assisted or unassisted.

[0022] According to some embodiments of the present disclosure, the inflating step and the deflating step are synchronized with the operation of a ventilator that ventilates the patient.

[0023] According to some embodiments of the present disclosure, one inflation cycle occurs over a plurality of inspiratory and expiratory cycles of the ventilator.

[0024] According to some embodiments of the present disclosure, one deflation cycle occurs in less than one inspiratory or expiratory cycle of the ventilator.

[0025] According to some embodiments of the present disclosure, the method further comprises generating a pressure lower than that inside the ventilator in the patient's lungs by rapid deflation of the inflatable bladder.

[0026] According to some embodiments of the present disclosure, the step of generating a lower pressure in the patient's lungs than in a ventilator by deflating an inflatable sac in less than 0.5 seconds is further included.

[0027] According to some embodiments of the present disclosure, the step of generating a lower pressure in the patient's lungs than in a ventilator by deflating an inflatable sac in less than 0.25 seconds is further included.

[0028] According to some embodiments of the present disclosure, the step of generating a lower pressure inside the patient's lungs than outside the patient's body by rapidly deflating an inflatable sac is further included.

[0029] According to some embodiments of this disclosure, the inflating and deflating steps are under the control of a programmable controller.

[0030] According to some embodiments of the present disclosure, the controller receives sensor measurement input and controls inflating and deflating steps based on the measurement.

[0031] According to some embodiments of this disclosure, the sensor is a microphone.

[0032] According to some embodiments of the present disclosure, the sensor is a microphone used for lung auscultation, and the controller is programmed to detect one or more conditions selected from the group consisting of air ventilation, wet crackle, dry crackle, fine crackle, secretion transport, wheezing, and cough.

[0033] According to some embodiments of this disclosure, the controller is programmed to select a treatment method based on sensor measurements.

[0034] According to some embodiments of the present disclosure, the sensor includes a plurality of sensors arranged symmetrically with respect to the vest. According to some embodiments of the present disclosure, the plurality of sensors includes at least three sensors on each side of the patient's torso.

[0035] According to some embodiments of this disclosure, the sensor is a volume meter that measures the volume of an adjacent space.

[0036] According to some embodiments of the present disclosure, the inflation and deflation steps are performed separately on each side of the patient's torso. According to some embodiments of the present disclosure, the inflation and deflation steps are performed separately in each inflatable sac.

[0037] According to some embodiments of this disclosure, the inflatable sac can be deflated in less than 0.5 seconds.

[0038] According to some embodiments of the present disclosure, the position for placing the inflatable sac within a rigid vest surrounding the patient's torso is determined by image processing of images of the patient's lungs.

[0039] According to some embodiments of the present disclosure, a program for inflating an inflatable sac in a specific order and for a specific duration, and for deflating the inflatable sac, is determined by image processing of images of the patient's lungs.

[0040] According to one aspect of several embodiments of the present disclosure, a system is provided for providing a treatment adapted to clear the lung airways, the system comprising: a plurality of pressure applicators adapted to apply pressure at a predetermined location on the patient's torso when activated and to release pressure when deactivated; a wearable component for positioning a first pressure applicator of the pressure applicators at a first position adjacent to the torso and a second pressure applicator of the pressure applicators at a second position adjacent to the torso; and a controller adapted to control the activation and deactivation of the pressure applicators.

[0041] According to some embodiments of the present disclosure, the first position is located in a higher part of the fuselage, and the second position is located in a lower part of the fuselage.

[0042] According to one aspect of several embodiments of the present disclosure, a system is provided for providing a treatment adapted to clear the lung airways, the system including at least one pressure applicator adapted to apply pressure at at least one specific location on the patient's torso when activated and to release the pressure when deactivated; a sensor for sensing patient-related signals; and a controller that communicates with the sensor and is adapted to analyze the signals and control the activation and deactivation of the at least one pressure applicator based at least in part on the analysis of the signals.

[0043] According to some embodiments of the present disclosure, the operation and deactivation of at least one pressure applicator include controlling the duration or amount of pressure applied by at least one pressure applicator, or a combination thereof.

[0044] According to some embodiments of the present disclosure, a wearable component is included, and the pressure applicator is of a size and shape that is mounted on the wearable component.

[0045] According to some embodiments of the present disclosure, the controller is adapted to operate and deactivate at least one of the pressure applicators independently of another pressure applicator.

[0046] According to some embodiments of this disclosure, the sensor includes a plurality of sensors.

[0047] According to some embodiments of the present disclosure, the sensor includes a sensor selected from the group consisting of pressure sensors, microphones, volumetric meters, impedance sensors, imaging systems, strain gauges, lung auscultation sensors, and combinations thereof.

[0048] According to some embodiments of this disclosure, the controller is adapted to detect the patient's physiological state based on the analysis of the signal.

[0049] According to some embodiments of the present disclosure, a physiological state is a physiological state selected from the group consisting of stages within a patient's respiratory cycle, a patient's cough, air ventilation, wet crackle, dry crackle, fine crackle, secretion transport, wheezing, coughing, and combinations thereof.

[0050] According to some embodiments of this disclosure, the controller is adapted to provide guidance to the patient about the desired breath pattern.

[0051] According to some embodiments of the present disclosure, the controller is adapted to select guidance from a group consisting of long, deep inhalation, shallow inhalation, sustained exhalation, sustained breathing, rapid exhalation, and combinations thereof.

[0052] According to some embodiments of this disclosure, the guidance is at least partially based on the operation and deactivation of at least one pressure applicator.

[0053] According to some embodiments of this disclosure, the guidance is at least partially based on sensing.

[0054] According to some embodiments of this disclosure, the guidance is selected from the group consisting of written instructions, voice instructions, sound instructions, sensory instructions, vibrations, visual instructions, and combinations thereof.

[0055] According to some embodiments of this disclosure, the location to which pressure is applied can be controlled by equipping a wearable component with at least one pressure applicator.

[0056] According to some embodiments of the present disclosure, at least one pressure applicator is selected from the group consisting of an inflatable bag, a fillable pad, an electrically actuated pad, a manually adjustable belt, an automatically adjustable belt, an extendable strap, and combinations thereof.

[0057] According to some embodiments of the present disclosure, the controller receives data from components selected from the group consisting of BiPAP devices, invasive ventilators, non-invasive ventilators, cough simulation devices, and combinations thereof.

[0058] According to some embodiments of the present disclosure, the controller synchronizes the operation and deactivation of at least one pressure applicator with the operation of the components.

[0059] According to some embodiments of this disclosure, the release of pressure from at least one pressure applicator is adapted to be provided in less than 0.5 seconds.

[0060] According to some embodiments of the present disclosure, the system is configured to assist coughing by stopping the operation of at least one of at least one pressure applicator.

[0061] According to some embodiments of this disclosure, two of the pressure applicators overlap at least partially.

[0062] According to some embodiments of this disclosure, at least one pressure applicator is configured to be placed on the abdomen of a patient.

[0063] According to some embodiments of this disclosure, a database for storing data related to a sensed signal is included.

[0064] According to some embodiments of the present disclosure, the data are selected from the group consisting of the patient's breath pattern, the trend of the breath pattern, the eigenvectors of the breath pattern, the shape of at least a portion of the breath pattern, the area under at least a portion of the breath pattern, the derivative of at least a portion of the breath pattern, the number of coughs during treatment, the cough pattern during treatment, overall compliance, the number of treatments the patient received over a certain period of time, and combinations thereof.

[0065] According to one aspect of several embodiments of the present disclosure, a method is provided for providing a treatment adapted to clear the lung airways, the method comprising the steps of: a. placing at least one pressure applicator on the torso of a patient; b. sensing a signal related to the patient; c. analyzing the signal; and d. performing a treatment protocol, the treatment protocol comprising the steps of activating and deactivating at least one pressure applicator to apply and release pressure to the torso, at least in part based on the step of analyzing the signal, thereby providing a treatment to clear the lung airways.

[0066] According to some embodiments of this disclosure, the treatment protocol includes the step of synchronizing it with the patient's physiological state.

[0067] According to some embodiments of the present disclosure, the steps of performing a treatment protocol include activating and deactivating at least one pressure applicator for a specific duration of time, or using a specific amount of pressure, or a combination thereof.

[0068] According to some embodiments of this disclosure, the steps of performing a treatment protocol include activating and deactivating pressure applicators in a specific sequence.

[0069] According to some embodiments of the present disclosure, the step of activating at least one pressure applicator includes the step of activating a fixed pressure for a duration longer than the time period corresponding to one of a group selected from the patient's inhalation, the patient's exhalation, and one of the patient's breathing cycles.

[0070] According to some embodiments of this disclosure, the treatment protocol enables autonomous sputum clearance.

[0071] According to some embodiments of the present disclosure, the step of providing guidance to a patient in order to instruct the patient on a desired breath pattern is included.

[0072] According to some embodiments of this disclosure, the guidance is based on the step of activating and deactivating at least one pressure applicator.

[0073] According to some embodiments of this disclosure, the guidance is based on sensing.

[0074] According to some embodiments of the present disclosure, the guidance includes breath-holding instructions to the patient, selected from the group consisting of long, deep inhalation, shallow inhalation, sustained exhalation, sustained breathing, rapid breath-holding, and combinations thereof.

[0075] According to some embodiments of the present disclosure, at least one of the pressure applicators is deactivated when a cough or urge to cough is detected.

[0076] According to some embodiments of this disclosure, the treatment protocol includes the step of synchronizing the treatment protocol with the patient's breathing cycle.

[0077] According to some embodiments of this disclosure, a patient's urge to cough or cough is automatically detected based on an analysis of input from a sensor.

[0078] According to some embodiments of this disclosure, the procedure includes a step of automatically adjusting the treatment protocol based on sensing.

[0079] According to some embodiments of the present disclosure, sensing includes data provided by a device selected from the group consisting of BiPAP devices, invasive ventilators, non-invasive ventilators, cough stimulation devices, and combinations thereof.

[0080] According to some embodiments of this disclosure, a treatment protocol is synchronized with a device based at least in part on data.

[0081] According to some embodiments of this disclosure, the procedure includes selecting a treatment protocol based at least partially on images of the patient's lungs.

[0082] According to some embodiments of the present disclosure, the steps include placing at least one pressure applicator at a specific location on the patient's torso based at least partially on an image of the patient's lungs.

[0083] According to some embodiments of the present disclosure, the first step is to activate at least one of the pressure applicators to sense a signal.

[0084] According to some embodiments of the present disclosure, a treatment protocol includes the steps of activating and applying pressure to at least one pressure applicator located next to the upper part of the patient's torso, and activating and applying pressure to at least one pressure applicator located next to the lower part of the patient's torso.

[0085] According to some embodiments of the present disclosure, the further step includes deactivating at least one pressure applicator located next to the lower part of the patient's torso to release pressure from it.

[0086] According to some embodiments of the present disclosure, the process includes repeatedly activating and deactivating at least one pressure applicator located next to the lower part of the patient's torso.

[0087] According to some embodiments of the present disclosure, the procedure includes the steps of: activating at least one pressure applicator located next to the upper part of the patient's torso to apply pressure thereto; activating at least one pressure applicator located next to the lower part of the patient's torso to apply pressure thereto; deactivating at least one pressure applicator located next to the lower part of the patient's torso to remove pressure therefrom; repeating the steps of activating and deactivating at least one pressure applicator located next to the lower part of the patient's torso multiple times; deactivating all pressure applicators; and repeating the above multiple times.

[0088] According to some embodiments of the present disclosure, the step of increasing the transpulmonary pressure gradient in a patient's lungs by rapidly stopping the operation of at least one pressure applicator is included.

[0089] According to some embodiments of this disclosure, sensing includes the step of performing a lung auscultation.

[0090] According to some embodiments of this disclosure, the steps include storing data from sensing in a database.

[0091] According to some embodiments of the present disclosure, the steps include: analyzing data; providing guidance to a patient based at least in part on the analysis step; and adjusting a protocol based at least in part on the analysis step.

[0092] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as that generally understood by a person skilled in the art with ordinary art in the field to which this disclosure relates. Similar or equivalent methods and materials to those described herein may be used in the practice or testing of embodiments of this disclosure, but exemplary methods and / or materials are described below. In case of any conflict, the patent specification, including the definitions, shall prevail. In addition, the materials, methods and examples are for illustrative purposes only and are not necessarily intended to be limiting.

[0093] As will be understood by those skilled in the art, some embodiments of the present disclosure may be embodied as systems, methods, or computer program products. Accordingly, some embodiments of the present disclosure may take the form of entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, all of which may be commonly referred to herein as “circuits,” “modules,” or “systems.” Furthermore, some embodiments of the present disclosure may take the form of computer program products embodied in one or more computer-readable media on which computer-readable program code is embodied. Embodiments of methods and / or systems of some embodiments of the present invention may include performing and / or completing selected tasks manually, automatically, or in combination thereof. Furthermore, according to the actual equipment and facilities of some embodiments of methods and / or systems of the present disclosure, some selected tasks may also be performed by hardware, by software or firmware, and / or in combination thereof, for example, using an operating system.

[0094] For example, hardware for performing selected tasks according to some embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to some embodiments of the present invention may also be implemented as a set of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform, for executing a set of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, such as a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, network connectivity is also provided. A display and / or a user input device such as a keyboard or mouse is also optionally provided.

[0095] Any combination of one or more computer-readable media may be used for some embodiments of this disclosure. A computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples (exemplary enumeration) of computer-readable storage media may include an electrical connection having one or more wires, a portable computer diskette, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, compact disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In the context of this specification, a computer-readable storage medium may be any tangible medium that contains or can store programs for use by or in connection with an instruction execution system, apparatus, or device.

[0096] A computer-readable signal medium may include, for example, a propagating data signal in which computer-readable program code is embodied. Such a propagating signal may take any of a variety of forms, including but not limited to electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium, rather than a computer-readable storage medium, that can communicate, propagate, or transfer a program for use by or in connection with an instruction execution system, apparatus, or device.

[0097] Program code and / or data used thereby, embodied in a computer-readable medium, may be transmitted using any suitable medium, including but not limited to wireless, wireline, fiber optic cable, RF, or any suitable combination thereof.

[0098] Computer program code for performing operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages ​​such as Java®, Smalltalk, C++, etc., and conventional procedural programming languages ​​such as the C programming language or similar programming languages. The program code may run entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including the user's local area network (LAN) or wide area network (WAN), or it may be connected to an external computer (for example, via the Internet using an Internet service provider).

[0099] Some embodiments of the present invention are described below with reference to flowcharts and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the present invention. It will be understood that each block in the flowchart and / or block diagram, as well as combinations of blocks within the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a dedicated computer, or another programmable data processing device to generate a machine, such that instructions executed via the processor of the computer or other programmable data processing device produce means for performing one or more functions / actions specified in the flowchart and / or block diagram.

[0100] These computer program instructions may be stored on a computer-readable medium that can instruct a computer, other programmable data processing device, or other device to function in a particular manner, such that the instructions stored on the computer-readable medium generate a product containing instructions that perform functions / actions specified in one or more blocks of a flowchart and / or block diagram.

[0101] Computer program instructions can also be loaded into a computer, another programmable data processing device, or another device to generate a process to be executed by the computer, such that the instructions executed on the computer or other programmable device provide a process for performing one or more functions / actions specified in one or more blocks of a flowchart and / or block diagram, causing the computer, another programmable device, or another device to perform a series of operational steps.

[0102] Some of the methods described herein are generally designed for computer use only and may not be feasible or practical to be performed purely manually by human professionals. Human professionals who wish to perform similar tasks manually, such as physicians or medical technicians, may be expected to use entirely different methods, such as leveraging their expertise and / or the pattern recognition capabilities of the human brain, which would be far more efficient than manually going through the steps of the methods described herein.

[0103] With reference to the accompanying drawings, several embodiments of the present invention are described herein merely as examples. With regard to detailed specific references to the drawings herein, it is emphasized that the details shown are illustrative and intended to illustrate embodiments of the present invention. In this regard, the description, understood together with the drawings, will make it clear to those skilled in the art how embodiments of the present invention may be put into practice. [Brief explanation of the drawing]

[0104] [Figure 1A] This is a simplified diagram of a conventional system. [Figure 1B] This is a simplified diagram of a system that can be constructed and operated according to an exemplary embodiment. [Figure 1C] This is a simplified diagram of a system that can be constructed and operated according to an exemplary embodiment. [Figure 2A-C] This is a simplified diagram of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment. [Figure 2D] This is a simplified graph illustrating an exemplary embodiment of autogenic drainage (AD) airway clearance therapy. [Figure 2E] This is a simplified graph illustrating the application of pressure by a vest chamber synchronized with the breath cycle according to an exemplary embodiment. [Figure 2F] This is a simplified flowchart of a treatment cycle according to an exemplary embodiment. [Figure 2G]This is a simplified flowchart of a treatment method according to an exemplary embodiment. [Figure 2H] This is a simplified flowchart of a treatment method according to an exemplary embodiment. [Figure 2I-K] This is a simplified flowchart of a treatment method according to an exemplary embodiment. [Figure 3A-D] This is a simplified graphical diagram of breathing and pressure in three pairs of inflatable sacs according to an exemplary embodiment. [Figure 4A-D] This is a simplified graphical diagram of breathing and pressure in three pairs of inflatable sacs according to an exemplary embodiment. [Figure 5] This is a simplified graphical diagram of breathing and pressure in three inflatable bags according to exemplary embodiments. [Figure 6] This is a simplified schematic diagram of a system constructed according to an exemplary embodiment. [Figure 7] This is a simplified flowchart of a method for clearing the lung airways according to an exemplary embodiment. [Figure 8A-C] This is a simplified diagram of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment. [Figure 9A-C] This is a simplified diagram of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment. [Figure 10] This is a simplified flowchart of a method for providing a treatment adapted to clear the lung airways according to an exemplary embodiment. [Figure 11] This is a simplified block diagram of a system for providing a treatment adapted to clear the lung airways according to an exemplary embodiment. [Modes for carrying out the invention]

[0105] This disclosure relates, in some embodiments thereof, to methods and systems for applying pressure to a patient's chest in order to clear the patient's airway, and in particular to, but not limited to, a vest for applying pressure to the outside of a patient's chest.

[0106] Introduction For example, some diseases, such as acute or chronic lung disease, and even chronic lung disease caused by the 2020 global COVID-19 pandemic, can cause severe lung damage that potentially spreads unevenly throughout the lungs, obstructing the movement of air in and out of the lungs. Mucus accumulates in the lungs. There is a desire to cough to clear the mucus.

[0107] According to one aspect of several embodiments of the present disclosure, a system is provided for providing a treatment adapted to clear the lung airway, the system is a. At least one pressure applicator adapted to apply pressure to at least one predetermined location on the patient's torso when activated and to remove the pressure from the at least one predetermined location when deactivated, b. At least one sensor for sensing at least one parameter related to at least one physiological state of the patient, c. A controller that communicates with the at least one sensor, adapted to control the activation and deactivation of the at least one pressure applicator based on information received from the at least one sensor in accordance with a predefined treatment protocol, so as to synchronize the activation and deactivation of the at least one pressure applicator with the at least one parameter relating to the at least one physiological state of the patient. Includes.

[0108] It should be noted that the physiological state of the patient is selected from a group including at least one stage in the patient's breath cycle, lung auscultation, the patient's cough, and any combination thereof.

[0109] According to one aspect of some embodiments of the present disclosure, a method is provided for providing a treatment adapted to clear the lung airways, the method comprising (a) placing at least one pressure applicator at a predetermined position on the torso of a patient, and (b) operating and deactivating the at least one pressure applicator in a particular sequence and for a particular duration to apply and release pressure to the torso, thereby clearing the lung airways.

[0110] According to one aspect of several embodiments of the present disclosure, a system is provided for providing a treatment adapted to clear the lung airways, the system comprising: (a) at least one inflatable sac adapted to apply pressure to at least one predetermined location on the patient's torso when inflated and to remove the pressure from the at least one predetermined location when deflated; (b) at least one sensor for sensing at least one parameter relating to at least one physiological condition of the patient; and a controller communicating with the at least one sensor, adapted to control the inflation and deflation of the at least one inflatable sac based on information received from the at least one sensor in accordance with a predefined treatment protocol, so as to synchronize the inflation and deflation of the at least one pressure applicator with the at least one parameter relating to the at least one physiological condition of the patient.

[0111] It should be noted that the physiological state of the patient is selected from the group consisting of at least one stage in the patient's breath cycle, lung auscultation, the patient's cough, and any combination thereof.

[0112] According to one aspect of some embodiments of the present disclosure, a method is provided for providing a treatment adapted to clear the lung airways, the method comprising (a) placing at least one inflatable sac at a predetermined location on the torso of a patient, and inflating and deflating the at least one inflatable sac in a particular sequence over a particular duration to apply and release pressure to the torso, thereby applying pressure to the predetermined location and clearing the lung airways.

[0113] According to one aspect of several embodiments of the present disclosure, a medical device is provided that enables airway clearance in patients with acute or chronic lung disease.

[0114] In some embodiments, the device is a vest positioned over the patient's upper body and integrated with one or more actuators to apply pressure to a predetermined location on the vest over a predetermined time period. For example, the vest may be in the shape of a simple belt such that its tightening results in the application of pressure to the predetermined location on the patient's upper body. According to such embodiments, strain gauge sensors are optionally used to quantify the amount of pressure in the lungs and the amount of pressure applied to (or released from) the torso.

[0115] In some embodiments, an integration of multiple electrically actuated elements (e.g., pads, pistons, etc.) is provided within a wearable vest so that one, more, or all of the elements can be operated independently to apply pressure.

[0116] In some embodiments, as described herein, there may be one or more belts or straps that are manually and / or automatically extendable to apply pressure to the patient's torso when positioned over the patient's torso and extended.

[0117] In some embodiments, as described herein, an integration of multiple fillable elements is provided within a wearable vest so that one, more, or all of the elements can be activated to, for example, be filled with liquid and pressurized.

[0118] In some embodiments, the device is a vest placed over the patient's upper body and includes several inflatable sacs inside the vest, which are arbitrarily and automatically controlled by an envelope and a controller. The inflatable sacs can be voluntarily inflated and deflated to potentially apply pressure to various areas of the patient's upper body to help remove phlegm.

[0119] Other examples of applying pressure to various areas of a patient's upper body include: Expansion of the bag due to a fluid (e.g., water), Shortening of the straps surrounding the patient's upper body, and Mechanical operation of pads on the patient's upper body It could be due to this.

[0120] In some embodiments, the physiological principle on which some methods are based is breath at different lung volumes to move secretions along the bronchial tree, and such techniques are called autonomous sputum clearance.

[0121] In some embodiments, secretions are removed from the lungs and potentially clear the airway by applying constant / dynamic pressure at a predetermined position on the patient's upper body according to a predetermined protocol (e.g., the duration and amount of pressure applied).

[0122] According to some embodiments, a sensor is provided for sensing at least one parameter related to one or more of a patient's breath cycle, lung auscultation, and the patient's cough.

[0123] According to one aspect of several embodiments of the present disclosure, the application of such pressure is combined with the provision of breath instructions (hereinafter referred to as “guidance” or “instructions” to the patient). In some embodiments, such guidance is optionally provided to support an autonomous sputum clearance airway clearance technique. In some embodiments, the guidance is optionally synchronized with patient breath data received from a sensor.

[0124] According to some embodiments, the vest is integrated with at least one control unit adapted to control the operation of the pressure applicator (and / or vest). In other words, the control unit may be adapted to control the amount of pressure applied, its timing, and the location (on the patient's body) to which the pressure is applied.

[0125] In some embodiments, the controller synchronizes with the ventilation machine when the patient is being ventilated.

[0126] In some embodiments, the controller synchronizes with the patient's breathing cycle. In some embodiments, the best is independent of patient interaction and does not require, for example, patient cooperation. In some embodiments, the controller uses algorithms based on physiological principles and the experience of respiratory physiotherapists.

[0127] In some embodiments, the system may optionally provide the patient with guidance on how to breathe, based on data provided by sensors, thereby enabling the patient to cooperate with and / or assist in the treatment provided. The guidance may take one or more forms of displaying instructions (e.g., written and / or graphical diagrams), providing audio instructions (e.g., voice commands or any acceptable sound that provides instructions), providing sensible instructions (e.g., vibration of at least one element selected from the group consisting of a wearable vest and any device that communicates with the vest), and displaying visual instructions of a desired type of breathing guidance to the patient about how to breathe.

[0128] It should be noted that, according to some embodiments, various biofeedback mechanisms may be employed. Biofeedback can be used to sense (by any sensor communicating with the patient's body) and / or to provide feedback (guidance) to the patient based on the sensed information, or both.

[0129] The terms “bladder,” “pillow,” and “pad” are used interchangeably throughout this specification and the claims in all their grammatical forms to mean a bladder that can be inflated or pressurized by filling it with a fluid or gas and deflated or depressurized by emptying it with a fluid or gas.

[0130] In some embodiments, the “bag,” “pillow,” or “pad” may refer to an electrically actuated element (e.g., by an electric motor) for applying mechanical pressure to the patient’s upper body. In another embodiment, the element is a hydraulically actuated element.

[0131] The term “contract” is used throughout this specification and the claims in all its grammatical forms to mean opening a valve that allows for the release of pressure and / or actually pumping gas or fluid to deflate an inflatable sack and / or releasing pressure applied by an electrically or hydraulically actuated element.

[0132] One potential solution to improve airway ventilation could be increasing ventilatory pressure. However, doing so would expose the patient to the risk of barotrauma and other pressure disorders, which could potentially lead to a significant increase in the duration of ventilation.

[0133] In some embodiments, effective airway clearance can potentially serve as a complementary therapy, reducing VP (ventilation-perfusion) mismatch and potentially shortening the duration of ventilation for the patient. Ventilation and perfusion are optionally coordinated with each other to enable adequate oxygenation of the blood.

[0134] In some embodiments, the vest and / or pressure application method (e.g., inflation and deflation elements) is intended to allow airway clearance in a ventilated patient, in which case the patient may potentially use feedback and / or instructions from the system to alter their breath accordingly.

[0135] In some embodiments, the vest and / or pressure application method (e.g., inflation and deflation elements) is intended to enable airway clearance in a ventilated patient without the patient's cooperation.

[0136] In some embodiments, the vest and / or pressure application method (e.g., inflation and deflation elements) is intended to enable airway clearance in patients with acute or chronic lung diseases such as chronic obstructive lung disease (COPD), cystic fibrosis (CF), and bronchiectasis, optionally including ventilated patients with coronavirus pneumonitis. In some embodiments, the device does not require patient cooperation, and therefore the device is also suitable for sedated ventilated patients. In some embodiments, the vest is optionally placed on the patient's torso. In some embodiments, the vest is optionally synchronized with a ventilation machine. In some embodiments, the purpose of the vest is to potentially enable airway clearance in patients having one or more pulmonary debilitation conditions such as pneumonia, pneumonitis, and ARDS (Acute Respiratory Disease Syndrome).

[0137] In some embodiments, the device potentially enables expectoration in sedated patients by ventilating the distal and closed regions of the lungs without potentially increasing ventilation pressure.

[0138] According to some embodiments, the patient's orientation is selected from a group including sitting, standing, lying down (e.g., supine, prone, and lateral), and any combination thereof.

[0139] The term “ventilator” is used interchangeably with the terms “PAP (Positive Airway Pressure) device,” “BiPAP device,” and “cough simulation device” and their corresponding grammatical forms throughout this specification and the claims, in all its grammatical forms.

[0140] The term "ventilator" in all its grammatical forms throughout this specification and the claims, Invasive and non-invasive ventilators (NIVs) (examples of NIVs include PAP devices, BiPAP devices, mechanical supply-exhaust devices, and cough stimulators), as well as Positive pressure devices and negative pressure devices such as suction devices It is used to mean [something].

[0141] To better understand some embodiments of this disclosure shown in Figure 1B and subsequent drawings, we first refer to the structure and operation of a simplified diagram of a prior art system shown in Figure 1A. Figure 1A shows a non-limiting example of a best and best inflatable system to set up the various descriptive situations provided herein.

[0142] Figure 1A shows a vest 102 that opens at the front and a strap 108 for closing the vest 102.

[0143] Figure 1A also shows the inflator 104 or inflation pump 104, and a pipe 106 which appears to be a single pipe connecting to each side of the vest.

[0144] Before describing in detail at least one embodiment of this disclosure, it should be understood that the applications of this disclosure are not necessarily limited to the structural and deployment details of the components and / or methods shown in the following description and / or drawings and / or examples. This disclosure can be practiced or carried out in other embodiments or in various ways.

[0145] Before describing in detail at least one embodiment of this disclosure, it should be understood that the applications of this disclosure are not necessarily limited to the details described below or illustrated by the embodiments. This disclosure can be practiced or carried out in other embodiments or in various ways.

[0146] By generating pressure on the patient's torso, air may potentially move from healthier areas of the lungs to more diseased areas, potentially clearing the airways by causing, for example, opening narrowed airways and / or air movement, movement of secretions and / or clearing secretions from the airways by causing coughing or suctioning to remove secretions.

[0147] Here, we refer to Figure 1B, a simplified diagram of a system constructed and operational according to an exemplary embodiment.

[0148] Figure 1B shows non-limiting examples of the best 122 and best pressure applicator 128.

[0149] In various embodiments, the pressure applicator 128 may be an electrically driven mechanical pad, a pneumatically driven pad or inflatable bag, or a hydraulically driven pad or inflatable bag.

[0150] Figure 1B shows a vest 122 that opens at the front and a zipper 118 for closing the vest 122, in a non-limiting example of Figure 1B. Note that in other embodiments, the vest may open at the back, or at one or both sides.

[0151] Figure 1B also shows the power supply unit 124 and the power supply pipe or wire 116.

[0152] In some embodiments, the power supply unit 124 may also be a power source and / or controller 124, and Figure 1B also shows any electrical wires 126 connected to a power supply 122.

[0153] In some embodiments, the power supply unit 124 may also be a pneumatic source and / or controller 124, and Figure 1B also shows a pipe or tube 126 leading to a vest 122.

[0154] In some embodiments, the power supply unit 124 may also be a hydraulic source and / or pump and / or controller 124, and Figure 1B also shows any pipes or tubes 126 leading to a vest 122.

[0155] Figure 1B shows multiple wires / tubes 126. The number of wires / tubes is not limited to the 6 shown in Figure 1B.

[0156] In some embodiments, one or more pressure applicators 128 may be present in the vest. In some embodiments, the number of wires / tubes 126 may be the same as the number of pressure applicators 128 in the vest.

[0157] In some embodiments, a single wire / tube may power one associated pressure applicator 128. In some embodiments, a single wire / tube may power multiple pressure applicators 128.

[0158] Figure 1B shows two wire / tube groups, one on each side of the vest 122. However, it should be noted that the same wire / tube group may be for both sides of the vest.

[0159] In some embodiments, the power supply unit 124 may also be a liquid storage unit 124, and the tubes / pipes 126 lead the liquid (e.g., water or oil) to the vase 122.

[0160] Here, we refer to Figure 1C, a simplified diagram of a system constructed and operational according to an exemplary embodiment.

[0161] Figure 1C shows a non-limiting example of an air-driven vest and vest inflation system.

[0162] Figure 1C shows a vest 112 that opens at the front and a zipper 118 for closing the vest 112, in a non-limiting example of Figure 1C. Note that in other embodiments, the vest may open at the back, or at one or both sides.

[0163] Figure 1C also shows the inflator 114 or inflation pump 114 and the pipe 116 leading to the vest 112.

[0164] Figure 1C shows multiple pipes 116. The number of pipes is not limited to the six pipes shown in Figure 1C. In some embodiments, one or more inflatable bags may be inside the vest. In some embodiments, the number of pipes 116 may be the same as the number of inflatable bags inside the vest. In some embodiments, one pipe may supply air to one associated inflatable bag. In some embodiments, one pipe may supply air to multiple inflatable bags.

[0165] Figure 1C shows two sets of pipes, one on each side of the Best 112.

[0166] The guidance or release of air to inflate the pouch may be performed by valves under the control of the controller, and / or by valves associated with pipes to one or more pouches and optionally pipes also under the control of the controller.

[0167] Overview of some exemplary embodiments One aspect of several embodiments relates to a personalized thoracic physiotherapy system designed to provide efficient airway clearance to patients with chronic lung disease in a clinical or hospital setting, or independently at home.

[0168] In some embodiments, the device is a vest placed over the patient's upper body and is a means for applying pressure to a predetermined location on the vest over a predetermined period of time. For example, the vest may be in the shape of a simple belt such that the tightening results in the application of pressure to the predetermined location on the patient's upper body.

[0169] In some embodiments, as described herein, the integration of multiple electrically actuated elements within a wearable vest is included so that each element can be actuated independently to apply pressure.

[0170] In some embodiments, the application of pressure to various areas of the patient's upper body is performed. Expansion of the bag due to a fluid (e.g., water), Shortening of the straps surrounding the patient's upper body, and Mechanical operation of pads on the patient's upper body It can be added by...

[0171] According to some embodiments, the system includes a vest equipped with independently inflatable air chambers that deliver a series of chest compressions to facilitate breathing at different lung volumes and positions.

[0172] In some embodiments, a sensor integrated with the system synchronizes its operation with the patient's breathing cycle and / or the use of invasive or non-invasive ventilation. In a non-limiting example, such non-invasive ventilation may be a BiPAP device.

[0173] In some embodiments, synchronization is optionally performed by pressure sensors that track the pressure in one or more designated air chambers. Potential pressure changes in the chambers result from chest movements during breathing, and the user's breathing pattern is optionally detected based on the sampled pressure signals.

[0174] In some embodiments, breath cycle detection potentially allows for the synchronization of pressure application (e.g., expansion and contraction of the vest chamber) with inhalation and exhalation.

[0175] In some embodiments, breath cycle detection potentially allows for the detection of when a patient coughs.

[0176] In some embodiments, breath cycle detection may potentially allow detection when a patient removes their breath mask, such as a BiPAP mask.

[0177] In some embodiments, the vest is optionally controlled to deflate and pause treatment when it is detected that the patient has removed the breathing mask or has started a coughing cycle.

[0178] In some embodiments, the patient can optionally have their cough assisted by the timing of inflation and / or deflation of an air bladder inside the vest.

[0179] In some embodiments, the system optionally provides feedback and / or guidance during treatment to instruct the patient on a desired breathing pattern in accordance with a treatment algorithm, and in non-limiting examples, it may guide the patient on when to take long, deep inhalations rather than shallow inhalations, when to sustain exhalations, when to sustain inhalations, and when to perform rapid exhalations.

[0180] Herein, we refer to Figures 2A-2C, which show simplified diagrams of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment.

[0181] Figures 2A–2C show non-limiting examples of a patient and one or more inflatable sacs to set up the various explanatory situations provided herein.

[0182] Figures 2A-2C do not show a vest (as shown in Figures 1B and 1C) so that the vest does not obstruct the view of the pouch.

[0183] Figure 2A shows a lateral view of the skeleton 202 representing the patient and an inflatable sac 204 positioned in a primary exemplary location on one side of the patient.

[0184] Figure 2B shows a posterior view of the skeleton 202 representing the patient, and two inflatable sacs 206 positioned in two exemplary locations on each side of the patient's back.

[0185] Figure 2C shows a frontal perspective view of the patient's skeleton 202 and six inflatable sacs 208 positioned in six exemplary locations on the anterior side of the patient.

[0186] It should be noted that the sac may be placed in a position selected by a physician and / or physiotherapist and / or medical technician, as is optional, according to the location chosen to apply pressure to the section of the lung where secretions should be cleared and / or the airway should be cleared.

[0187] In some embodiments, a section of the lung is optionally selected based on imaging of the patient's lungs.

[0188] In some embodiments, the pouch is placed in an arbitrary fixed position, and several models or examples of vests with pouches are provided for a physician to select for a patient based on the patient's size, sex, and further physical considerations.

[0189] Please note that the locations of the sacs shown in Figures 2A-2C are intended as non-limiting examples, not as definitive representations.

[0190] One aspect of several embodiments involves the use of a vest to apply pressure to the outside of the patient's chest.

[0191] The vest includes at least one element adapted to apply pressure to the patient's body.

[0192] As described above, the application of pressure can be, for example, an inflatable sac (which applies pressure when inflated with air), a fluid-fillable element (which applies pressure when filled with liquid), a mechanically operated element, or a simple belt that is attached to the patient's torso and stretched to apply pressure.

[0193] In some embodiments, the vest is optionally used in conjunction with ventilation of the patient's lungs.

[0194] In some embodiments, the vest is optionally used in conjunction with collateral ventilation of the lungs.

[0195] Various descriptions in this specification refer to inflatable / deflated bags. However, other pressure applications may be used as described herein.

[0196] According to some embodiments, the system includes a control unit equipped with an air compressor and an inflatable vest connected to the air compressor. The inflatable vest includes one or more air chambers connected to the air compressor by a pneumatic tube.

[0197] In some embodiments, the air chamber is sequentially inflated to apply local external pressure to the patient's chest to facilitate breathing at arbitrarily different lung volumes.

[0198] In some embodiments, adjusting the depth and / or position of lung volume during respiration potentially generates airflow-induced shear forces, which potentially relax and / or mobilize and / or move secretions from the peripheral to the central airways. Once secretions or mucus have moved into wider airways, they can potentially be expelled by coughing.

[0199] In some embodiments, the vest includes a zipper on the front. In some embodiments, the vest includes hook-and-loop fasteners for adjusting the fit.

[0200] In some embodiments, the system is optionally connected to an application for control via a computer, tablet, smartphone, etc., by wireless (e.g., Bluetooth) and / or wired communication.

[0201] In some embodiments, the application optionally includes visual and / or audible and / or verbal and / or perceptible (e.g., vibration) feedback for therapeutic purposes and for device use.

[0202] In some embodiments, feedback is used to guide the patient on how to breathe and potentially enhance the efficacy of the treatment.

[0203] As a non-limiting example, there may be six independent pressure applicators positioned relative to the lung lobes, designed to apply localized external pressure to the chest (e.g., six inflatable chambers on the front side of a vest). In some embodiments, the pressure applicators may be operated independently according to a predefined inflation sequence.

[0204] Please note that the number six is ​​not intended as a limitation. Any integer up to any size may be used to position the pressure on the patient's body. The number of inflatable sacs may be in the range of 1 to 40 or 100.

[0205] In some embodiments, the number of pressure applicators (e.g., inflatable chambers) may be even, and the inflatable chambers may be symmetrically positioned on the right and left sides of the patient's upper body.

[0206] In some embodiments, the number of pressure applicators (e.g., inflatable chambers) does not have to be even, and the inflatable chambers may be positioned asymmetrically with respect to the right and left sides of the patient's upper body.

[0207] In some embodiments, one or more pressure applicators (e.g., inflatable chambers) may be positioned centrally in relation to the right and left sides of the patient's upper body. In some embodiments, one or more inflatable chambers may be positioned next to the patient's diaphragm and / or sternum and / or back.

[0208] In some embodiments, the vest may be rigid, providing a hard surface that a pressure applicator (e.g., an inflatable sac) can press against, thereby applying pressure to the patient's torso. Furthermore, when the pressure applicator is deactivated (e.g., deflated), rapid release of the compressed lung is possible.

[0209] In some embodiments, the vest may be flexible and provide a flexible surface that can be pressed by a pressure applicator (e.g., an inflatable sac), thereby applying pressure to the patient's torso.

[0210] In some embodiments, the vest may be flexible and stretchable, and stretching may release some pressure, but some pressure may still remain to be applied to the patient's torso.

[0211] Location of pressure applicator (single or multiple) In some embodiments, the pressure applicator is placed in a pocket of the vest and / or integrated into the pocket.

[0212] In some embodiments, a second internal flexible, possibly fabric vest, is placed over the patient's torso. In some embodiments, pockets are sewn into the second internal vest, which is placed beneath the outer vest and in contact with the patient's torso. In some embodiments, the pockets of the internal vest determine the potential location of a pressure applicator (e.g., an inflatable pouch).

[0213] In some embodiments, the pressure applicator (e.g., inflatable sac) optionally includes a hook-and-loop fastener on one side, such as Velcro®, and best includes a hook-and-loop fastener on the other side, potentially allowing flexibility for physicians / physiotherapists / technicians to place the inflatable sac wherever they desire.

[0214] A pressure applicator (e.g., an inflatable bag) is, Covering one lung lobe, Covering each lung lobe, The number of sacs in each lung lobe varies arbitrarily, covering the lung lobe. At each location where pressure is planned, there should be at least one applicator (e.g., an inflatable sac), and Multiple applicators (e.g., inflatable pouches) can be arbitrarily placed at each location where pressure is planned, so that two or more applicators can potentially be stacked to press on a single location. It can be placed.

[0215] In some embodiments, the number of pressure applicators (e.g., inflatable sacs) is arbitrarily derived from their anatomical location in the lung lobes.

[0216] In some embodiments, if the pressure applicator is an inflatable pouch, the pouch is inflated with gas, such as air.

[0217] In some embodiments, the gas does not leave the system when the bag is deflated and is drawn into a gas chamber for reuse in a closed system, if desired.

[0218] In some embodiments, the bag is inflated with a fluid, such as water or oil.

[0219] In some embodiments, when the sac is inflated with fluid, the fluid does not leave the system when the sac is deflated and is drawn into a fluid container for reuse in a closed system, if desired.

[0220] A potential advantage of exemplary embodiments in which a gas or fluid is used in a closed system is that the air around the patient is not pumped into the bag, potentially does not go to a different patient, and potentially does not escape at the location of that different new patient. Such systems may be potentially suitable for use in environments with infectious diseases, such as COVID-19.

[0221] Data Analysis According to some embodiments, the system is integrated with sensors (e.g., pressure sensors for sensing at least one pressure of the pressure applicator, strain gauges, at least one microphone for performing lung auscultation) for sensing at least one parameter related to at least one physiological state of the patient (e.g., at least one stage in the patient's breathing cycle, lung auscultation, the patient's cough, etc.).

[0222] According to some embodiments, the system further includes feedback adapted to provide guidance during the treatment to instruct the patient on the required breathing pattern.

[0223] In some embodiments, such guidance is based on the perception of at least one of the physiological conditions of the patient.

[0224] According to some embodiments, the system communicates with a communicable and readable database for collecting and storing such data from one or more sensors. The database optionally includes one or more parameters, including the patient's breath pattern, the trend of the breath pattern, the eigenvectors of the breath pattern, the shape of at least a portion of the breath pattern, the area under at least a portion of the breath pattern, any derivative of at least a portion of the breath pattern, the number of coughs during treatment, the cough pattern, overall compliance with the treatment protocol, the duration of treatment, and the number of treatments the patient received in a given time period (e.g., weeks, months, etc.).

[0225] In some embodiments, the database is analyzed and the guidance (and / or treatment) is adjusted accordingly.

[0226] In some embodiments, patient guidance (i.e., instructions on how to breathe) may be based on (a) the patient's perceived parameters (one or more), (b) a statistical analysis (or arbitrary data analysis) of data collected from multiple patients stored in the database, and (c) any combination thereof.

[0227] In some embodiments, machine learning (ML) and / or artificial intelligence (AI) algorithms are used.

[0228] The terms "machine learning (ML)" or "artificial intelligence (AI)" refer, below, to the study of computer algorithms that automatically improve through experience and the use of data. Machine learning algorithms build models based on sample data known as "training data" so that they do not have to be explicitly programmed to make predictions or decisions. Machine learning algorithms are commonly used when it is difficult or impossible to develop conventional algorithms to perform the required task.

[0229] Such ML and / or AI can be used to analyze collected data and provide suggestions for better patient guidance to enhance the effectiveness of treatment.

[0230] In some embodiments, by utilizing Neural Network Analysis (NNA) based on machine learning capabilities, the analysis of the database continuously improves with each additional performance improvement as the database grows. Thus, better guidance (i.e., breath guidance) that is more relevant to the purpose can be provided. Such a learning process (by ML, AI, or NNA) can be optionally used to "educate" the data analysis to include more variation in its solution space.

[0231] According to some embodiments, the system defined above optionally includes two operating modes: (a) a learning phase and (b) an operation phase.

[0232] One object of this disclosure is to provide a system defined above in which, during the learning phase, a machine learning model is trained to analyze at least one parameter (as described above) in a database, the treatment applied thereto, and the clinical outcome in order to generate information that directs the guidance for providing the treatment and / or enhanced treatment.

[0233] In some embodiments, such information includes a treatment protocol and corresponding clinical outcomes obtained from such a treatment protocol.

[0234] According to some embodiments, the data collected in the database is either supervised data or unsupervised data.

[0235] According to some embodiments, during the operation phase, the system is adapted to provide suggestions and / or advice on various treatment protocols based on the analysis.

[0236] Washable and sterilizable One aspect of several embodiments includes the fact that the surfaces of the system components are washable and / or sterilizable to medical standards.

[0237] In some embodiments, a replaceable and / or disposable outer vest cover is optionally used to keep the vest clean, and is replaced when replacement is justified and / or when it is transferred from one patient to another.

[0238] Programmed timing of expansion and / or contraction One aspect of several embodiments involves programming a specific sequence of pressure applications (e.g., inflation and / or deflation of one or more inflatable sacs).

[0239] In some embodiments, the timing of pressure application (e.g., expansion / contraction) is optionally synchronized with the operation of a ventilator that ventilates the patient. In some embodiments, the timing is optionally synchronized with spontaneous breathing. In some embodiments, synchronization with breathing is optionally based on the detection of inhalation / exhalation by sensors, as described elsewhere in this specification.

[0240] In some embodiments, the application of pressure is maintained over multiple inspiratory / expiratory cycles of the patient, continuing over multiple breathing cycles of the patient.

[0241] In some embodiments, the patient's readiness and / or urge to cough is optionally detected, and the timing of pressure application (e.g., expansion / contraction) is optionally synchronized with that detection.

[0242] In some embodiments, the patient can optionally have their cough assisted by the timing of pressure application (e.g., inflation / deflation).

[0243] console In some embodiments, the console optionally includes one or more electronic modules of the system, one or more control units, a power supply, an optional source for applying pressure (e.g., an air compressor, a pneumatic system), an optional display screen, and operating buttons.

[0244] In some embodiments, when an inflatable bag is used, the pneumatic system includes an air compressor connected via piping to a set of solenoid valves used to direct compressed air to a desired air pocket.

[0245] In some embodiments, a pressure sensor is used to regulate the pressure within the chamber, and a pressure relief valve is optionally used to prevent pressure overload.

[0246] Smart, adaptive One aspect of several embodiments involves programming a controller to change the order of operation of a pressure applicator (e.g., inflation and / or deflation of one or more inflatable bags).

[0247] In some embodiments, program changes are optionally entered by a physician.

[0248] In some embodiments, program modifications are optionally based on the measurement of physiological parameters related to the measurement and analysis of the patient's breath.

[0249] In some embodiments, the position for placing the pressure applicator (e.g., an inflatable sac) is arbitrarily and automatically generated based on image analysis of the patient's lungs. In a non-limiting example, the pressure applicator (e.g., an inflatable sac) may be arbitrarily placed over a lung lobe showing signs of secretion, potentially applying pressure to that lobe. In some embodiments, the pressure applicator may be placed over a lung lobe showing signs of being clear or relatively clear, potentially applying pressure to that lobe.

[0250] In some embodiments, a program for inflating the inflatable sac is optionally generated automatically based on image analysis of the patient's lungs.

[0251] Closing the device's control loop One aspect of several embodiments includes the steps of collecting sensor measurements and determining a treatment program based on the measurements.

[0252] One aspect of several embodiments includes the steps of collecting sensor measurements and activating a best operation based on the measurements.

[0253] In some embodiments, multiple types of sensors may be used, and the inputs from these multiple sensors may be arbitrarily combined to determine a treatment program.

[0254] In some embodiments, the sensor is one or more microphones that may be optionally inserted into or attached to the vest. The microphones perform auscultation to detect lung parameters such as air ventilation, or, if there is no air ventilation, detect wet crackles, dry crackles, fine crackles, secretion transport, wheezing, and coughing.

[0255] In some embodiments, breath sensing and / or testing is optionally performed by using a dedicated pouch or pillow within the vest.

[0256] In some embodiments, sensing is performed by using a pressure sensor that senses a dedicated sac / pillow. In some embodiments, the dedicated sac can be inflated at a different time from other sacs to enable pressure sensing independent of the use of other sacs for applying pressure to a patient's lungs. In some embodiments, the dedicated sac can be inflated before other sacs. In some embodiments, the dedicated sac may or may not be contracted when other sacs are contracted.

[0257] In some embodiments, sensing is performed by using a microphone that senses with a dedicated sac / pillow.

[0258] In some embodiments, breathing sensing and / or testing is optionally performed by using a strap or belt around the patient's chest that includes a strain gauge. The strain gauge provides a signal that is optionally used to estimate changes in chest circumference related to breathing and / or related to pressure applied between the strap and the chest.

[0259] In some embodiments, the sensor(s) is / are one or more volumeters, potentially enabling estimation of lung expansion and / or contraction and / or lung compliance. In some embodiments, the sensor(s) can measure the volume of adjacent space. Such a sensor potentially enables measurement of lung expansion and / or contraction.

[0260] In some embodiments, the sensor(s) is / are one or more pressure sensors.

[0261] In some embodiments, the sensor(s) is / are one or more impedance sensors.

[0262] In some embodiments, the sensor(s) is / are optionally provided symmetrically with respect to the vest.

[0263] In some embodiments, the sensor is one or more imaging systems that optionally provide one or more images of the patient's lungs, which are optionally used to determine the position of a pressure applicator (e.g., an inflatable bladder) and / or which (e.g., inflatable bladder to be inflated / deflated) is to be actuated.

[0264] Target group Non-limiting examples of populations in which the exemplary embodiments may potentially be used include patients with cystic fibrosis (CF), COPD, bronchiectasis, asthma, and lung diseases involving secretion problems, and patients with neuromuscular diseases that affect the ability to cough effectively.

[0265] Clearing the patient's airway, or ventilating the patient, or both. The above description of "closed loop" optionally relates to providing therapy to clear a patient's airway based on sensor measurements and / or image processing, and optionally relates to combining patient airway clearance and patient ventilation.

[0266] Negative pressure One aspect of some embodiments includes potentially generating a negative pressure condition within a patient's lungs. In some embodiments, the pressure applied by a pressure applicator (e.g., an inflatable bladder) is rapidly released, by way of non-limiting example, in less than 0.5 seconds, or less than 0.25 seconds. The patient's torso potentially recoils, generating a rapid drop in pressure within the patient's lungs, or at least at the position where the pressure applicator (e.g., the inflatable bladder) is deactivated. The pressure drop can optionally induce air to enter the patient's lungs.

[0267] In some embodiments, the system described herein can potentially improve mucus transport and potentially improve the efficacy of suction.

[0268] In some embodiments, the system described herein potentially assists a device that generates negative pressure.

[0269] In some embodiments, the systems described herein potentially assist a person using a positive expiratory pressure (PEP) device. The PEP device allows air to flow freely as the patient inhales, but not as freely as the patient exhales. The patient exhales more forcefully against the resistance. In some embodiments, a vest assists the patient in exhaling by pressing against the patient's body.

[0270] Here, we provide a more detailed description of some non-limiting examples of embodiments.

[0271] In some embodiments, a pneumatic vest having one or more of the following features is placed on the patient's torso. a. The vest may have an optionally robust envelope. b. At least one pressure applicator (e.g., inflatable pouch), any number of which may be 2, 3, 4, 5, 6, 7, 8, 9, 10, and up to 40 or 50. c. The system potentially increases the resistance of the chest in the over-inflation area. d. The system potentially directs airflow to the closed peripheral regions of the lungs. The system potentially increases the effective volume of the lungs by increasing airflow in potentially narrowed airways. f. The system potentially enables secretion clearance by delivering secretions to larger airways. g. The system can be synchronized with the ventilation machine as needed.

[0272] In some embodiments, the system includes one or more sensors, as described elsewhere in this specification.

[0273] In some embodiments, the system includes a controller, as described elsewhere in this specification.

[0274] In some embodiments, the controller is configured to provide feedback and / or guidance to the patient and / or caregiver, as described elsewhere herein.

[0275] In some embodiments, at least two pressure applicators overlap in position to better apply pressure to the patient's torso.

[0276] In some embodiments, by way of non-limiting example, as shown in FIGS. 9A to 9C, the first pair of inflatable bladders is U-shaped and covers the upper lobe region, the second pair of inflatable bladders is disposed immediately below the first pair and is also U-shaped, and the third pair is the same.

[0277] In some embodiments, the first pair contacts the lower portion of the patient's torso, the second pair is located higher up above the first pair along the torso toward the patient's head, and the third pair is located even higher up above the second pair further along the torso toward the patient's head.

[0278] In some embodiments, the controller potentially controls activation and / or deactivation of pressure applicators, controls inflation and / or deflation of inflatable bladders, in the case of inflatable bladders, optionally controlling the inflation and deflation of each inflatable bladder separately, operates in synchronization with a ventilator, optionally controls inflation by measuring the inflation pressure of the inflatable bladders to prevent high pressure from potentially causing damage to the lungs, includes algorithms for monitoring the system.

[0279] In various embodiments, the vest operates in conjunction with devices other than ventilators, for example BiPAP devices and / or cough stimulation devices.

[0280] In various embodiments, the vest operates in conjunction with positive pressure devices, such as BiPAP devices, and / or negative pressure devices.

[0281] An example of a pressure limit per inflatable sac is arbitrarily approximately 50–150 millibars. The controller will arbitrarily control and block pressures above this limit.

[0282] In some embodiments, the system is optionally interfaced with a ventilation system. In some embodiments, a connection is made to the ventilation pipe of a ventilation machine. In some embodiments, the connection is optionally configured so as not to move air out of the ventilation pipe.

[0283] In some embodiments, the system is packaged as a sealed package that can be washed and / or sterilized.

[0284] In some embodiments, the system generates noise of 60 dB or less at a distance of 0.5 meters.

[0285] In some embodiments, the system is not dependent on electricity and is powered, for example, by a battery.

[0286] In some embodiments, the system uses ambient air, for example, optionally unfiltered local room air, for expansion.

[0287] In some embodiments, a portion of the system placed on the patient weighs 8 kilograms or less.

[0288] Some of the best features of exemplary embodiments include: a. The vest is easy for the patient to put on and take off at will. b. The vest is optionally comfortable in contact with the patient's skin and optionally placed in direct contact with the patient's skin. c. The vest can be closed in a variety of ways, such as zippers, straps, hook-and-loops, and buckles. In some embodiments, the closure is adjustable, such as by using a cinch and / or strap and / or buckle and / or hook-and-loop (Velcro) closure. d. The vest is constructed so as not to shift excessively on the patient's torso after being closed, i.e., not to shift more than 1-3 centimeters vertically and / or more than 1-3 centimeters horizontally. The vest is designed not to expand under arbitrary pressure, allowing the pressure to be directed to the patient. f. Each pressure applicator (e.g., an inflatable bag) may be operated independently, or some (or all) pressure applicators may be operated simultaneously. g. The vest is arbitrarily lightweight for easy hand-carrying from patient to patient. The vest is made from medical-grade materials that can be sterilized, for example, by concentrated alcohol solution.

[0289] Some features of exemplary embodiments of the controller include: a. Release the pressure from the inflatable sac between 0.25 and 0.5 seconds. b. The controller is, Power on / off, High pressure, The pressure of each pressure applicator (e.g., inflatable bag), Low pressure per pressure applicator (e.g., inflatable bag), Stopped operation (e.g., deflated) state for each pressure applicator (e.g., inflatable sac), The selected operating program, and Time and / or date Optionally includes one or more instructions or warnings.

[0290] In some embodiments, the release of pressure from the inflatable sac is a release to a lower pressure, not necessarily a release to zero positive pressure.

[0291] In some embodiments, pressure release is achieved by opening a valve that allows for pressure release. The pressure does not necessarily have to drop to ambient pressure or zero, but it does decrease relative to the pressure previously present and applied to the patient's upper body.

[0292] In some embodiments, the controller performs system testing during initial operation.

[0293] In some embodiments, the controller may optionally deactivate the pressure applicator (e.g., deflating the inflatable sac) when the system determines that the patient is coughing or about to cough.

[0294] In some embodiments, the controller optionally detects that a patient is beginning to cough or preparing to cough by measuring the pressure either within the ventilation system or within the inflatable sac caused by coughing or preparation for coughing.

[0295] In some embodiments, the controller is calibrated to optionally detect coughing by setting pressure levels and / or duration for each patient.

[0296] In some embodiments, the controller is calibrated to optionally set the duration and / or rate of contractions for coughing, with the duration of contractions for coughing set optionally for each patient.

[0297] In some embodiments, records of expansion and contraction times are optionally maintained.

[0298] In some embodiments, the expansion and contraction of the pouch are optionally synchronized with the ventilator.

[0299] In various embodiments, the best operates in conjunction with non-invasive ventilators, such as BiPAP devices and / or cough stimulators.

[0300] In various embodiments, the vest operates in conjunction with an invasive ventilator.

[0301] In various embodiments, the vest operates in conjunction with the patient's spontaneous breathing without the use of a ventilation device.

[0302] In some embodiments, the user interface allows setting and / or selecting pressure-activated / deactivated (e.g., inflation / deflation) programs (sequences and / or durations per pouch, etc.).

[0303] In some embodiments, the controller runs a program that inflates all inflatable sacs gradually over 3-4 breathing cycles and then deflates all inflatable sacs at once.

[0304] In some embodiments, the systems described herein are based on autonomous sputum clearance (AD) airway clearance therapy. Such therapeutic methods aim to generate expiratory flow at various bronchial bifurcations.

[0305] In some embodiments, this therapy aims to generate an expiratory flow simultaneously with active but unforced exhalation.

[0306] By breathing with a lower lung volume, secretions are systematically transported from the periphery to the more central airways, where an effective cough can expel them.

[0307] Typically, an AD (Airborne Discharge) procedure involves three breath phases: detachment, collection, and elimination.

[0308] During the separation phase, breathing is done in small, low-volume breaths, which affects the peripheral airways in the chest. This slow, deep movement of air potentially relieves peripheral secretions.

[0309] During the collection phase, moderate-sized breaths are taken, which affect the more proximal airways in the chest, and secretions from the central airways are potentially collected by breathing with low to moderate lung volume.

[0310] During the elimination phase, deep breaths are taken with moderate to high lung volume to expel secretions from the central airways. In some embodiments, the breath is slow. By adjusting the depth and position of lung volume during respiration, airflow-induced shear forces are potentially generated, which relax, mobilize, and move secretions from the periphery to the central airways, from where they can be expelled by coughing.

[0311] In some embodiments, the vest inflation sequence is designed to mimic the breath-taking phase of AD airway clearance therapy. The vest applies localized external pressure to the chest in a stepwise manner to facilitate breath-taking at different lung volumes and in different regions of the lungs.

[0312] In some embodiments, the top air chamber of the vest is inflated first, followed by the chambers at the next level, and so on.

[0313] Next, for the "separation" phase, all chambers are inflated. In some embodiments, the patient is instructed to breathe with a low lung volume at this time.

[0314] Next, the bottom row of chambers is alternately contracted and expanded over several cycles, transitioning from the separation phase to the collection phase.

[0315] Once complete, all best chambers will deflate simultaneously, enabling the "elimination" phase.

[0316] The above sequence can be repeated.

[0317] In some embodiments, the operation of the vest is combined with positive airway pressure (PAP) provided by the ventilator to potentially allow air to ventilate more distal areas within the bronchial tree.

[0318] In some embodiments, positive expiratory pressure helps the patient balance expiratory force during treatment, resulting in longer and deeper exhalations and potentially preventing smaller airway collapses.

[0319] Here, we refer to Figure 2D, a simplified graph of an exemplary embodiment of autonomous sputum clearance (AD) airway clearance therapy.

[0320] Figure 2D shows a graph 220 with time on the X axis 224 and breath volume on the Y axis 222.

[0321] Figure 2D shows an example of an AD treatment cycle that includes several breath cycles.

[0322] Figure 2D shows the low-volume breathing stage for mobilizing secretions from the peripheral airways, qualitatively corresponding to the separation phase of Stage 1 254-AD treatment cycle; the medium-volume or tidal-volume breathing stage for collecting mucus from the middle airways, qualitatively corresponding to the collection phase of Stage 2 256-AD treatment cycle; and the larger-volume breathing stage for enabling expectoration from the central airways, qualitatively corresponding to the elimination phase of Stage 3-AD treatment cycle.

[0323] Figure 2D shows line 232 of the volume of air in the patient's lungs over time.

[0324] Stage 1 254 involves several cycles of breathing at a low volume, followed by Stage 2 256 which involves several cycles of breathing at a higher volume, and then Stage 3 258 which involves several cycles of breathing at an even higher volume.

[0325] In some embodiments, an optional abrupt contraction occurs after step 3 (not shown in Figure 2D).

[0326] Figure 2D shows line 232 in relation to several physiological features typically associated with a patient's lungs: TLC (Total Lung Capacity) 242, FRC (Functional Residual Capacity) 244, TV (Tidal Volume) 243, and RV (Residual Volume) 245.

[0327] In some embodiments, the pressure applicator (e.g., an inflatable sac) is activated and deactivated in synchronization with the patient's natural exhalation and inhalation, respectively. The patient's breathing cycle is optionally tracked, and transitions between stages are optionally activated according to a “cycle interval” setting.

[0328] As one non-limiting example, in a 3-cycle "cycle interval" setting, after the upper chamber reaches full inflation and the 3-breath cycle is complete, a continuous level of chamber inflation occurs when the user exhales.

[0329] In some embodiments, when a coughing session is detected, the pressure applicator (e.g., inflatable pouch) in the vest is automatically deactivated (e.g., deflated). In some embodiments, this may also be done by receiving a signal from the patient that they wish to cough. In some embodiments, detection of a coughing session may be done automatically, for example, by monitoring pressure and detecting a change from a regular breath pattern or noise in the regular breath monitoring signal.

[0330] According to some embodiments, at least one microphone is used to perform pulmonary auscultation so that air ventilation, wet crackles, dry crackles, fine crackles, secretion transport, wheezing, coughing, and any combination thereof can be detected.

[0331] In some embodiments, the pressure applicator (e.g., an inflatable sac) can be activated (i.e., inflated) while the patient exhales.

[0332] In some embodiments, the pressure applicator (e.g., an inflatable sac) can be deactivated (i.e., deflated) while the patient inhales.

[0333] Here, we refer to Figure 2E, a simplified graph of pressure application by the vest chamber synchronized with the breath cycle according to an exemplary embodiment.

[0334] Figure 2E shows a graph 260 with time on the X axis 262 and pressure on the Y axis 261.

[0335] Graph 260 shows line 263 representing the patient's intrapulmonary pressure over time, which can serve as an indicator of the breath pattern. Reference numbers 268 and 267 refer to exhalation and inhalation, respectively.

[0336] Graph 260 shows an example of a treatment cycle that includes several breathing cycles involving the application and removal of pressure (e.g., by the inflation and deflation of an inflatable sac).

[0337] Graph 260 shows any initial time period 264 in which the patient's breath is monitored and / or detected.

[0338] In some embodiments, the patient's breath is monitored by a microphone sensor.

[0339] In some embodiments, the patient's breath is monitored by a pressure sensor. In some embodiments, the patient's breath is monitored by one of the pressure applicators (e.g., inflatable sacs). For example, one or more inflatable sacs are inflated, or one or more inflatable sacs are already inflated, so that the pressure in the patient's lungs can be monitored by measuring the relevant pressure in one or more inflatable sacs positioned in contact with the patient's upper body.

[0340] Figure 2E shows an additional time period of 265 during which a pressure applicator (e.g., an inflatable sac) is activated (e.g., inflated) to provide an AD treatment cycle.

[0341] During the additional time period 265, the inflatable sac located in contact with the upper part of the patient's torso is inflated (269A), and at the end of the additional time period 265, the inflatable sac located in contact with the upper part of the patient's torso is deflated (269D).

[0342] During another time period 266, an inflatable sac located in contact with the lower part of the patient's upper body is inflated (269B), and at the end of that other time period 266, the inflatable sac located in contact with the lower part of the patient's upper body is deflated (269C).

[0343] In some embodiments, the inflation and deflation of the vest's air bladder are optionally synchronized with the patient's natural exhalation and inhalation, respectively. The patient's breathing cycle is optionally tracked, and transitions between stages are optionally actuated according to a “cycle interval” setting.

[0344] In some embodiments, the pressure applicator (e.g., an inflatable sac) is activated (e.g., inflated) while the patient exhales.

[0345] In some embodiments, the pressure applicator (e.g., an inflatable sac) can be deactivated (deflated) while the patient inhales.

[0346] In some embodiments, the vest automatically retracts when a coughing session is detected.

[0347] Here, we refer to Figure 2F, a simplified flowchart of the treatment cycle according to an exemplary embodiment.

[0348] Figure 2F shows, Steps to initiate treatment (272), Step (274) of applying pressure (e.g., inflating) using a pressure applicator (e.g., an inflatable bag) located on top, Step (276) of applying pressure (e.g., inflating) using a pressure applicator (e.g., an inflatable bag) located at the bottom, The step (278) of releasing (e.g., deflating) the pressure applied by a pressure applicator (e.g., an inflatable sac) located at the bottom, Step (280) is to arbitrarily repeat the steps of (276) activating (e.g., inflating) a pressure applicator (e.g., an inflatable bag) located on the lower upper part (e.g., deflating) (278) for N cycles, Step (282) to release all pressure and This shows the process that includes this.

[0349] In some embodiments, the step of releasing all pressure (282) includes the step of releasing all pressure except the pressure in one or more pressure applicators that may be used for sensing.

[0350] Here, we refer to Figure 2G, a simplified flowchart of the treatment method according to an exemplary embodiment.

[0351] Figure 2G shows, Steps to initiate treatment (290), Step (291) of inflating one or more monitoring chambers. In some embodiments, one or more chambers are used to monitor the patient's lungs and / or breath on the vest, and one or more monitoring chambers may optionally be inflated before other chambers. Step (292) of inflating the upper chamber, Step (293) of inflating the lower chamber, Step (294) of retracting the lower chamber, The steps of inflating the lower chamber (293) and deflating the lower chamber (294) are repeated arbitrarily for N cycles (295), Step (296) to deflate all chambers and This shows the process that includes this.

[0352] In some embodiments, the step of deflating all chambers (296) includes the step of releasing all pressure except for the pressure in one or more chambers that may be used for sensing.

[0353] In some embodiments, the patient's breath is monitored after the step of inflating one or more monitoring chambers (291).

[0354] In some embodiments, the pressure in one or more monitoring chambers may be monitored. In some embodiments, the pressure signal may be optionally analyzed to detect the patient's breathing cycle. The pressure signal may be used to detect where the patient is in the breathing cycle at a given time.

[0355] In some embodiments, microphones adjacent to one or more monitoring chambers may be monitored. In some embodiments, sound may be optionally analyzed to detect the patient's breathing cycle. Sound may be used to detect where the patient is in the breathing cycle at a given time.

[0356] In some embodiments, the system arbitrarily controls inflation and deflation based on where the patient is in the breathing cycle at a given time.

[0357] In some embodiments, the system optionally provides the patient with guidance on how to breathe based on monitoring, thereby enabling the patient to cooperate with and / or assist in the treatment provided.

[0358] Guidance may take one or more forms, including written instructions for the desired type of breath, verbal instructions, sound instructions, sensory instructions such as vibration, and visual instructions.

[0359] In some embodiments, monitoring may be used to detect coughing. In some embodiments, the inflatable sac is deflated when coughing is detected.

[0360] Explanation of illustrative algorithms In some embodiments, the system tracks the pressure in one or more designated air chambers using pressure sensors. Pressure changes within the chambers result from chest movements during breathing, and the user's breathing pattern is detected based on the sampled pressure signals. Detection of the breathing cycle potentially allows for the inflation and deflation of the vest's chambers to be synchronized with the patient's exhalation and inhalation, respectively.

[0361] Here, we refer to Figure 2H, a simplified flowchart of the treatment method according to an exemplary embodiment.

[0362] The method shown in Figure 2H is: Step (284) involves inflating one or more inflatable sacs located next to the upper part of the patient's torso, Step (285) involves inflating one or more inflatable sacs located next to the lower part of the patient's torso, Step (286) of deflating one or more inflatable sacs located next to the lower part of the patient's torso, The step (287) involves repeatedly inflating and deflating one or more inflatable sacs located next to the lower part of the patient's torso, Step (288) to deflate all inflatable sacs and Includes.

[0363] Here, we refer to Figure 2I, a simplified flowchart of the treatment method according to an exemplary embodiment.

[0364] The method shown in Figure 2I is Step (342) of sensing signals related to the patient's breath, Step (344) of analyzing the signal, Steps (346) include providing guidance to the patient to control the patient's breath and Includes.

[0365] Here, we refer to Figure 2J, a simplified flowchart of the treatment method according to an exemplary embodiment.

[0366] The method shown in Figure 2J is: Step (352) of sensing signals related to the patient's breath, Step (354) of analyzing the signal, The steps (356) involve activating or deactivating the pressure applicator based on the analysis, and Includes.

[0367] In some embodiments, the step of activating the pressure applicator includes the step of changing the amount of pressure applied to the patient's lungs.

[0368] In some embodiments, the step of activating a pressure applicator includes the step of changing the location of the pressure applied to the patient's lungs by arbitrarily controlling which pressure applicator is activated.

[0369] In some embodiments, the step of changing the location and / or amount of pressure applied to the patient's lungs includes the step of changing the inflation and / or deflation of one or more inflatable sacs positioned to apply pressure to the patient's lungs and / or abdomen.

[0370] Here, we refer to Figure 2K, a simplified flowchart of the treatment method according to an exemplary embodiment.

[0371] The method shown in Figure 2K is: Step (362) of activating or deactivating a pressure applicator on the patient's torso, Steps (364) include sensing and analyzing signals related to the patient's breath, Steps (368) include providing guidance to the patient to control the patient's breath and Includes.

[0372] In some embodiments, the sensing and analysis step includes a control 366 of the step (362) of activating or deactivating a pressure applicator on the patient's torso.

[0373] In some embodiments, the method shown in Figure 2K also includes the step of changing the location and / or amount of pressure applied to the patient's lungs.

[0374] In some embodiments, the step of changing the location and / or amount of pressure applied to the patient's lungs includes the step of changing the inflation and / or deflation of one or more inflatable sacs positioned to apply pressure to the patient's lungs and / or abdomen.

[0375] Exemplary User Interface In some embodiments, a display screen and / or control buttons on the console are used to adjust therapy settings and manage the operation of the device.

[0376] In some embodiments, the display screen and / or control buttons are located on a console optionally packaged with the air compressor. In some embodiments, the display screen and / or control buttons are located on a console optionally mounted on a vest.

[0377] In some embodiments, the display screen and / or control buttons are optionally located on a smartphone or tablet or other type of mobile computing device.

[0378] The patient or caregiver may choose the pressure level, duration of treatment, and treatment protocol necessary to comply with the prescribed therapy ordered by the physician.

[0379] In some embodiments, during therapy, the patient may press a “cough rest” that contracts, allowing the user to cough to clear secretions.

[0380] In some embodiments, the user interface may include patient breath guidance as one or more of the following: displaying written instructions for a desired type of breath, providing voice instructions, providing audio instructions, and displaying visual instructions.

[0381] Here, we refer to Figures 3A to 3D, which are simplified graphical diagrams of breathing and pressure in three pairs of inflatable sacs according to exemplary embodiments.

[0382] Figures 3A to 3D are all graphs, where x-axis 304, 314, 324, and 334 represent qualitative time, the unit for x-axis 304 represents inhalation or breath, and y-axis 302, 312, 322, and 332 represent unitless qualitative pressure.

[0383] Figures 3A–3D show an exemplary program for inflating an inflatable bag, optionally synchronized with a ventilation machine.

[0384] Figure 3A shows the first line 306 indicating the air pressure inside the ventilation machine.

[0385] Figures 3B-3D show lines indicating the pressure supplied to the inflatable sac.

[0386] Figure 3B shows the second line 316, which indicates the pressure supplied to the first inflatable bag pair.

[0387] Figure 3C shows the third line 326, which indicates the pressure supplied to the second inflatable bag pair.

[0388] Figure 3D shows the fourth line 336, which indicates the pressure supplied to the third inflatable bag pair.

[0389] Figures 3A–3D show exemplary programs for progressively inflating an inflatable sac over several (3–4) breathing cycles of a ventilation machine. While the above disclosure refers to an inflatable sac, it should be noted that in some embodiments this may relate to an electro-operated mechanical pad or any other pressure-applying means.

[0390] Here, we refer to Figures 4A to 4D, which are simplified graphical diagrams of breathing and pressure in three pairs of inflatable sacs according to exemplary embodiments.

[0391] Figures 4A to 4D are graphs, where x-axis 404, 414, 424, and 434 represent qualitative time, and y-axis 402, 412, 422, and 432 represent qualitative pressure.

[0392] The description of the drawings relates to an inflatable bag, but may also relate to an electro-operated mechanical pad or any other pressure-applying means.

[0393] Figures 4A–4D show an exemplary program for inflating an inflatable bag, optionally synchronized with a ventilation machine.

[0394] Figure 4A shows the first line 406 indicating the air pressure inside the ventilation machine.

[0395] Figures 4B-4D show lines indicating the pressure supplied to the inflatable sac.

[0396] Figure 4B shows the second line 416, which indicates the pressure supplied to the first inflatable bag pair.

[0397] Figure 4C shows the third line 426, which indicates the pressure supplied to the second inflatable bag pair.

[0398] Figure 4D shows the fourth line 436, which indicates the pressure supplied to the third inflatable bag pair.

[0399] Figures 4A–4D show an exemplary program for progressively inflating the inflatable sacs over several (3–4) breathing cycles of the ventilation machine, starting with one sac pair, then the second sac pair, then the third sac pair, and so on.

[0400] Here, we refer to Figure 5, a simplified graphical diagram of breathing and pressure in three inflatable pouches according to an exemplary embodiment.

[0401] The explanation in Figure 5 relates to an inflatable bag, but it could also relate to an electro-operated mechanical pad or any other pressure-applying means.

[0402] Figure 5 is a graph, where the x-axis 504 represents qualitative time and the y-axis 502 represents qualitative pressure.

[0403] Figure 5 shows an exemplary program for inflating an inflatable bag, optionally synchronized with a ventilation machine.

[0404] Figure 5 shows the first horizontal bar 505, where the white section represents inhalation and the black section represents exhalation.

[0405] Figure 5 shows lines indicating the pressure supplied to the inflatable sac.

[0406] Figure 5 shows the first line 506 indicating the pressure supplied to the first inflatable sac, the second line 507 indicating the pressure supplied to the second inflatable sac, and the third line 508 indicating the pressure supplied to the third inflatable sac.

[0407] Figure 5 also shows the fourth line 510, which indicates PIP (Positive Inspiratory Pressure).

[0408] Figure 5 shows that the pressure supplied to the inflatable sac increases until it exceeds the PIP pressure. As a non-limiting example, the supplied pressure is in the range of approximately 20–40 cmH₂O.

[0409] In some embodiments, one side of the lung may be healthy or more healthy, while the other side may be diseased or more diseased.

[0410] Table 1 below represents a program, method, or algorithm for the treatment of a patient's lungs. Table 1 shows the timing of activation and deactivation (e.g., inflation and deflation) of a pressure applicator (e.g., an inflatable sac) in relation to the patient's breathing cycle. Table 1 uses "+" to mark pressure activation of the pressure applicator (e.g., the inflatable sac being inflated) and "-" to mark pressure deactivation of the pressure applicator (e.g., the inflatable sac being uninflated). The columns in Table 1 represent the inspiratory (Ins) and expiratory (Exp) cycles, and the rows in Table 1 represent one of the three inflatable sacs "H1", "H2", and "H3" on the healthy or more healthy side of the lung, as well as one of the three inflatable sacs "S1", "S2", and "S3" on the diseased or more diseased side of the lung. The method in Table 1 is referred to herein as the "healthy-disease" algorithm. [Table 1]

[0411] Table 2 below represents a program, method, or algorithm for treating a patient's lungs, where "+" marks pressure operation of the pressure applicator (e.g., the inflatable sac is inflated), "++" marks a state where more pressure is applied (i.e., more inflated), "+++" marks a state where even more pressure is applied (i.e., more inflated), and "-" marks the deactivation of pressure operation of the pressure applicator (e.g., pressure is released from the inflatable sac). The columns in Table 2 represent the inspiratory and expiratory cycles, and the rows in Table 2 represent the state of one of the three right-side inflatable sacs "R1", "R2", and "R3" and the three left-side inflatable sacs "L1", "L2", and "L3". The method in Table 2 is referred to herein as "stepped compression shift". [Table 2]

[0412] Table 3 below represents a program, method, or algorithm for treating a patient's lungs, where "+" indicates the inflated state of the inflatable sac, "++" indicates a more inflated state, "+++" indicates an even more inflated state, and "-" indicates a non-inflated state of the inflatable sac. The columns in Table 3 represent the inspiratory and expiratory cycles, and the rows in Table 3 represent the state of one of the three right-side inflatable sacs "R1", "R2", and "R3" and the three left-side inflatable sacs "L1", "L2", and "L3". The methods in Table 3 are referred to herein as "lower lobe ventilation". [Table 3]

[0413] In some embodiments, each "+" in the table above represents a pressure of approximately 5 to 15 cmH2O.

[0414] Here, we refer to Figure 6, which is a simplified schematic diagram of a system constructed according to an exemplary embodiment.

[0415] Figure 6 shows a basic embodiment including a vest 602 and a pressure applicator (e.g., an inflatable sac) 604, qualitatively positioned on a diagram of a patient's torso 606.

[0416] Here, we refer to Figure 7, a simplified flowchart of a method for clearing the lung airways according to an exemplary embodiment.

[0417] Figure 7 shows a flowchart of the method according to a basic embodiment.

[0418] The method shown in Figure 7 is, The steps include (702) placing a pressure applicator (e.g., an inflatable sack) inside a vest that surrounds the patient's torso, Step (704) of operating (e.g., inflating) a pressure applicator (e.g., an inflatable bag) in a specific sequence for a specific duration, Step (706) to stop the operation (e.g., deflate) of the pressure applicator (e.g., an inflatable bag) and Includes.

[0419] Here, we will describe the other locations and deployments of the inflatable pouch.

[0420] Herein, we refer to Figures 8A-8C, which show simplified diagrams of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment.

[0421] Figures 8A–8C show non-limiting examples of patients and pressure applicators (e.g., inflatable sacs).

[0422] Figures 8A-8C do not show a vest (as shown in Figure 1) so that the vest does not obstruct the view of the pouch.

[0423] Figure 8A shows a lateral view of the skeleton 802 representing the patient, and inflatable sacs R1 804A R2 804B R3 804C placed in an exemplary position on the patient's right side. Marks R1, R2, and R3 are used to indicate the exemplary position on the patient's right side.

[0424] Figure 8B shows a posterior view of the skeleton 802 representing the patient, the location of the inflatable sacs on the patient's back, L1 806A L2 806B L3 806C on the left side of the patient's back, and R1 808A R2 808B R3 808C on the right side of the patient's back.

[0425] Figure 8C shows a frontal perspective view of skeleton 802 representing the patient, the location of the inflatable sac on the anterior side of the patient, R1 810A R2 810B R3 810C on the right side of the anterior side of the patient, and L1 812A L2 812B L3 812C on the left side of the anterior side of the patient.

[0426] In some embodiments, the pressure applicator (e.g., an inflatable pouch) is optionally shaped as a U-shaped pouch.

[0427] In some embodiments, the pressure applicator (e.g., an inflatable sac) is optionally positioned to start at the front of the patient, continue along the periphery of the patient's torso to the sides, and then continue to the rear of the patient.

[0428] Herein, we refer to Figures 9A-9C, which show simplified diagrams of one or more inflatable sacs in relation to a patient in a system constructed and operable according to an exemplary embodiment.

[0429] Figures 9A–9C provide additional abdominal pressure applicators (e.g., inflatable pouches). Such abdominal pressure applicators potentially enable the treatment of patients with neuromuscular diseases and spinal cord injuries in which the expiratory muscles are impaired.

[0430] Figures 9A–9C show an exemplary abdominal inflatable sac and several crescent-shaped or U-shaped inflatable sacs.

[0431] Figures 9A–9C show non-limiting examples of patients and inflatable sacs. Figures 9A–9C do not show vests (as shown in Figure 1) so that the vest does not obstruct the view of the sac.

[0432] Figure 9A shows a side view of the skeleton 902 representing the patient, and the inflatable pouches R1 904A R2 904B R3 904C placed in an exemplary position on the right side of the patient, and the abdominal inflatable pouch 905 placed in contact with the patient's abdomen.

[0433] Figure 9B shows a posterior view of the skeleton 902 representing the patient, the location of the inflatable sacs on the patient's back, L1 906A L2 906B L3 906C on the left side of the patient's back, and R1 908A R2 908B R3 908C on the right side of the patient's back.

[0434] Figure 9C shows a frontal perspective view of the skeleton 902 representing the patient, the positions of the inflatable pouches on the anterior side of the patient, R1 910A R2 910B R3 910C on the right side of the anterior side of the patient, L1 912A L2 912B L3 912C on the left side of the anterior side of the patient, and the abdominal inflatable pouch 911 placed in contact with the patient's abdomen.

[0435] In some embodiments, the inflatable pouch is optionally shaped as a U-shape or crescent-shaped pouch.

[0436] In some embodiments, an abdominal pouch, marked "A" in Figures 9A and 9C, is positioned anteriorly on the upper abdomen, arbitrarily between the rib cage and the navel. The abdominal pouch potentially supports the abdominal organs and potentially improves oxygenation by mimicking the prone position.

[0437] Herein, we refer to Figure 10, a simplified flowchart of a method for providing a treatment adapted to clear the lung airways according to an exemplary embodiment.

[0438] The method shown in Figure 10 is a. The step of placing at least one pressure applicator on the patient's torso (1002), b. A step of sensing a signal related to the patient (1004), c. The step of analyzing the signal (1006), d. A step of performing a treatment protocol, the treatment protocol comprising the step of activating and deactivating the pressure applicator to apply and release pressure to the torso based at least in part on the step of analyzing the signal, step (1008) Includes.

[0439] Herein, we refer to Figure 11, a simplified block diagram of a system for providing treatment adapted to clear the lung airways according to an exemplary embodiment.

[0440] The system in Figure 11 is At least one pressure applicator 1102, adapted to apply pressure at at least one specific location on the torso of patient 1105 when activated and to release the pressure when deactivated, A sensor 1104 for sensing signals related to the patient 1105, A controller 1106 is configured to communicate with the sensor 1104, analyze the signal, and control the operation and deactivation of the pressure applicator 1102 at least partially based on the analysis of the signal. Includes.

[0441] As used herein with respect to quantity or value, the terms “about” or “approximately” mean “within ±20% of ~.”

[0442] The terms "to include," "to contain," and "to possess," as well as their conjugations, all mean "to include but not limited to."

[0443] The term "consisting of" is intended to mean "including and being limited to."

[0444] The term "essentially derived from" means that a composition, method, or structure may include additional components, steps, and / or parts, but only if such additional components, steps, and / or parts do not substantially alter the basic and novel features of the claimed composition, method, or structure.

[0445] As used herein, the singular forms “a,” “an,” and “the” refer to multiple things unless otherwise specified by the context. For example, the terms “unit” or “at least one unit” may refer to multiple units, including combinations thereof.

[0446] The terms “example” and “exemplary” are used herein to mean “serving as an example, case, or illustration.” Any embodiment described as “example” or “exemplary” should not be construed as necessarily being preferable or advantageous to other embodiments, and / or excluding the incorporation of features from other embodiments.

[0447] The term “optional” is used herein to mean “provided in some embodiments, but not in other embodiments.” Any particular embodiment of this disclosure may include several “optional” features, provided that such features do not conflict.

[0448] Throughout this application, various embodiments of the disclosure may be presented in scope form. It should be understood that scope form is for convenience and conciseness only and should not be interpreted as an inflexible limitation on the scope of the disclosure. Therefore, a scope description should be considered to specifically disclose all possible sub-ranges and individual numbers within that range. For example, a scope description such as 1 to 6 should be considered to specifically disclose sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, and individual numbers within those ranges, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the size of the scope.

[0449] Whenever a numerical range is indicated herein (e.g., "10 to 15", "10 to 15", or any other pair of numbers linked by such range indications), unless the context makes it more clear to otherwise, it means that the range includes any number (decimals or integers) within the indicated range limit, including the range limit. The phrases "range / ranging / ranges between" and "range / ranging / ranges to, up to, until or through" (or other such range indicators) are used interchangeably herein and mean that the first and second indications, as well as all decimals and integers between them, are included.

[0450] Unless otherwise indicated, the numbers used herein and any number ranges derived therefrom are approximations within reasonable measurement and rounding error tolerances as understood by those skilled in the art.

[0451] As used herein, the term “method” means a method for accomplishing a given task, including but not limited to methods, means, techniques and procedures that are known or readily developed from known methods, means, techniques and procedures by practitioners of chemistry, pharmacology, biology, biochemistry and medical technology.

[0452] As used herein, the term “treat” includes inhibiting, substantially inhibiting, slowing or reversing the progression of a condition, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of clinical or aesthetic symptoms of a condition.

[0453] Certain features of this disclosure are described in the context of separate embodiments for clarity, but are understood to also be provided in combination in a single embodiment. Conversely, various features of this disclosure are described in the context of a single embodiment for brevity, but are also provided separately, in any suitable subcombination, or as suitable for any other described embodiment of this disclosure. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiments are inoperable without those elements.

[0454] While this disclosure is described with respect to its specific embodiments, it will be obvious to those skilled in the art that numerous alternatives, modifications, and variations will be apparent. Therefore, it is intended to encompass all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0455] All publications, patents, and patent applications referenced herein are incorporated herein by reference in whole to the same extent as any individual publication, patent, or patent application is specifically and individually incorporated herein by reference. In addition, any citation or specification of any reference in this application shall not be construed as an admission that such reference is available as prior art of this disclosure. Where section headings are used, they shall not necessarily be construed as limitations. In addition, any priority document(s) of this application are incorporated herein by reference, both in whole and in part.

Claims

[Claim 1] A method for generating a treatment protocol adapted to clear the lung airways, a. A step of receiving patient-related signals, b. The step of analyzing the signal, c. A step of generating a treatment protocol for treating the patient, the treatment protocol comprising, at least in part, the step of analyzing the signal, providing commands to activate and deactivate at least one pressure applicator for applying and releasing pressure, The command for activating and deactivating at least one pressure applicator to apply and release pressure is configured to restrict the patient's respiration to different lung volumes in different respiratory cycles, so that the patient breathes with a lower lung volume in one stage of treatment and with a higher lung volume in another stage of treatment.

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