Device for deobstructing and removing secretions from the airway

Abstract

A device for deobstructing and removing secretions from airways, including small airways, by applying oscillating airflow and acoustic vibrations illustratively according to a preprogrammed protocol that defines at least one of frequency, waveform, pressure amplitude, and oscillation duration. In one illustrative embodiment, the device applies a combination of airflow oscillations and acoustic waves to promote the separation of mucus from airway walls by matching the resonance of specific airway segments and mucus, thereby enhancing the effect. For optimization, the algorithm illustratively matches the desired frequency, amplitude, duty cycle, and / or relative phase to the specific patient and secretion characteristics.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 616,804, filed on January 12, 2018, the disclosure of which is expressly incorporated herein by reference. Background Art

[0003] The present invention relates to a device for helping to decompose or discharge accumulated secretions in the airway, and more particularly to a device for helping to decompose or discharge accumulated secretions in the airway for treating respiratory diseases.

[0004] Respiratory inhalers are commonly used in the medical field to treat various upper respiratory tract diseases and disorders. Some upper respiratory tract diseases may be chronic and require lifelong treatment. It is well known that devices in the art help remove mucus and other solids and fluids from the airways, especially for patients suffering from such lifelong chronic diseases. However, traditional secretion removal devices may be inefficient and are not well suited to small airways.

[0005] For example, acute bronchiolitis is a common infant disease, usually caused by viral pathogens, characterized by thick inflammatory secretions that block and obstruct the small airways of infants. This may lead to respiratory distress or respiratory failure, thereby requiring mechanical ventilation. Some therapeutic devices known in the art can worsen the condition of infants, while other devices cannot effectively clear the small airways. Similarly, patients with chronic obstructive pulmonary disease ("COPD") experience small airway stenosis, but available treatments are generally not effective in treating the small airways. This makes the functional ability and perceived health of COPD patients poor. Therefore, a non-invasive device for treating patients is needed, more specifically, a non-invasive device for eliminating the obstruction of secretions in the patient's airways (especially the small airways) and removing the secretions is needed. Summary of the invention

[0006] The devices and methods of the present disclosure are configured to apply a combination of airflow oscillations and sound waves to promote the removal of mucus by breaking up or deagglomerating mucus clumps, separating aggregated mucus clumps from the airway walls, and promoting clearance. For example, the breaking up and detaching of mucus from the airway walls is achieved by a combination of oscillating airflow and acoustic pulses configured to match the resonance of a specific airway segment and mucus, thereby enhancing the effect through the principle of impedance matching. For example, an intrapulmonary percussive ventilation ("IPV") system working alone tends to push and spread mucus on the airway walls while opening a hole in the middle of the mucus. Adding acoustic effects to the air pulsations causes the mucus to break up and move the particles toward the patient's mouthpiece until the airway is almost completely cleared. For optimization, the algorithm can match the desired frequency, amplitude, duty cycle, and relative phase of the oscillating airflow and acoustic pulses to the geometry and specific secretions of a specific patient.

[0007] According to an illustrative embodiment of the present disclosure, a device for eliminating secretion obstruction from an airway and removing the secretion includes an airflow system and an acoustic system, and the acoustic system is operably coupled to the airflow system. The airflow system includes an air supply source, an electrically operable flow control valve, and a flow controller, the electrically operable flow control valve is in fluid communication with the air supply source, and the flow controller is in electrical communication with the flow control valve. The acoustic system includes an acoustic pulse generator and an acoustic controller, and the acoustic controller is in electrical communication with the acoustic pulse generator. The airflow path is in fluid communication with the airflow system and in acoustic communication with the acoustic system. The flow controller causes the flow control valve and the air supply source to provide an oscillating airflow to the airflow path, and the acoustic controller causes the acoustic pulse generator to provide acoustic vibrations to the oscillating airflow.

[0008] According to another illustrative embodiment, the flow controller includes a processor and a memory, the memory including software executed by the processor to define the airflow at a defined airflow frequency and amplitude. In an illustrative embodiment, the defined airflow frequency is between 195 beats per minute ("bpm") and 405 bpm, and the defined airflow amplitude is between 15 centimeters of water column ("cmH2O") and 55 cmH2O.

[0009] According to another illustrative embodiment, the acoustic controller includes a processor and a memory, the memory including software executed by the processor to define the acoustic vibration at a defined acoustic vibration frequency and amplitude. In one illustrative embodiment, the defined acoustic vibration is between 295 Hertz ("Hz") and 500 Hz.

[0010] In one illustrative embodiment, a pressure sensor is operably coupled to the air flow passageway and in communication with the main controller, the main controller being configured to control the air flow system and the acoustic system in response to air pressure detected by the pressure sensor.

[0011] According to another illustrative embodiment of the present disclosure, a device for eliminating obstruction of secretions from an airway and removing the secretions includes an airflow path, an airflow system and an acoustic system, wherein the airflow system is in communication with the airflow path, and the acoustic system is in communication with the airflow path. The airflow system includes an air supply source and an electrically operable flow control valve, wherein the electrically operable flow control valve is in fluid communication with the air supply source. The acoustic system includes a pulse generator configured to generate vibrations. A controller is operably coupled to the airflow system and the acoustic system, wherein the controller is configured to control at least one of the frequency, waveform, pressure amplitude and oscillation duration of the air provided by the flow control valve, and wherein the controller is configured to control at least one of the frequency, amplitude, duty cycle and relative phase of the vibrations generated by the pulse generator.

[0012] According to an illustrative embodiment, the controller includes a processor and a memory, the memory being operably coupled to the processor, wherein software stored in the memory is executed by the processor to define airflow at a defined airflow frequency and amplitude and to define acoustic vibrations at a defined acoustic vibration frequency and amplitude. Illustratively, the defined airflow frequency is between 195 and 405 times per minute, the defined airflow amplitude is between 15 and 45 cmH2O, the defined acoustic vibration frequency is between 295 and 500 Hz, and the defined acoustic vibration amplitude is between 47 and 109 decibels.

[0013] According to another illustrative embodiment of the present disclosure, a method for eliminating secretion obstruction from an airway and removing the secretion includes the following steps: applying an oscillating airflow to an airflow pathway containing secretions, and applying acoustic vibrations to the airflow within the airflow pathway. Illustratively, the oscillating airflow is controlled by preprogrammed executable instructions that define at least one of frequency, waveform, pressure amplitude, and oscillation duration. Further illustratively, the acoustic vibrations are controlled by preprogrammed executable instructions that define at least one of frequency, amplitude, duty cycle, and relative phase. In an illustrative embodiment, the method further includes the following steps: measuring the air pressure within the airflow pathway and adjusting the oscillating airflow and the acoustic vibrations in response to the measured air pressure.

[0014] According to an illustrative embodiment of the present disclosure, a device for deobstructing and removing secretions from an airway provides therapy by applying oscillating airflow and acoustic vibrations according to a preprogrammed regimen that defines frequency, waveform, pressure amplitude, and / or oscillation duration through software control.

[0015] According to another illustrative embodiment of the present disclosure, a device for deobstructing and removing secretions from an airway provides therapy by applying oscillating airflow and acoustic vibrations according to an algorithm stored in a memory as machine-readable instructions executed by a processor that automatically matches the desired frequency, amplitude, duty cycle, and / or relative phase to specific patient parameters (e.g., height, weight, geometry, etc.) and / or specific secretion characteristics (e.g., volume, depth, rheological properties (e.g., viscosity and / or elasticity), and / or surface properties (e.g., surface tension).

[0016] Additional features and advantages of the present invention will become apparent to those skilled in the art after considering the following detailed description of illustrative embodiments which illustrate the best mode presently understood of carrying out the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The detailed description of the drawings makes particular reference to the accompanying drawings, in which:

[0018] Figure 1 is a schematic diagram of an illustrative device of the present disclosure for deobstructing and removing secretions from an airway, including a cross-sectional view of the device body, and showing airflow through the device to a patient's mouthpiece;

[0019] Figure 2 Yes Figure 1 a block diagram of an illustrative printed circuit board of a controller of a device;

[0020] Figure 3 is included Figure 1 and providing a schematic diagram of an illustrative communication system for transmitting information (e.g., a customized prescription and / or an effective treatment program) between a patient and a physician;

[0021] Figure 4 is used for Figure 1 A schematic diagram of an illustrative test setup for experimental testing of an illustrative apparatus showing airflow through the test setup to an artificial lung;

[0022] Figure 5A yes Figure 4 a first perspective view of an illustrative test setup showing components of the test setup, such as a relay box, a solenoid valve, an upstream pressure transducer, a downstream pressure transducer, a ventilator valve, a speaker, a test section, and an artificial lung;

[0023] Figure 5B yes Figure 4 A second perspective view of an illustrative test setup showing the pressure regulator of the test setup relative to Figure 5A Components of the test setup shown;

[0024] Figure 6 It is demonstrated in an experimental environment Figure 4 , 5A and a flowchart of the action steps and corresponding structures of the test setup of 5B;

[0025] Fig. 7A It is shown in Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using only air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes is a Percussionaire intra-lung ventilator and the air pressure is set to 30 cmH2O;

[0026] Figure 7B It is shown in Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using only air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes is a Percussionaire intra-lung ventilator and the air pressure is set to 40 cmH2O;

[0027] Figure 7C It is shown in Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using only air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes is a Percussionaire intra-lung ventilator and the air pressure is set to 50 cmH2O;

[0028] Fig. 8A It is shown in Figure 4 A graph showing the results of removing a simulated secretion obstruction or blockage from a simulated airway using a combination of acoustic supplementation and air pressure oscillations in an illustrative test setup of wherein the ventilator valve used for testing purposes was a Percussionaire intra-lung ventilator and the air pressure was set to 30 cmH2O;

[0029] Figure 8B It is shown in Figure 4 A graph showing the results of removing a simulated secretion obstruction or blockage from a simulated airway using a combination of acoustic supplementation and air pressure oscillations in an illustrative test setup of wherein the ventilator valve used for testing purposes was a Percussionaire intra-lung ventilator and the air pressure was set to 40 cmH2O;

[0030] Figure 8CIt is shown in Figure 4 A graph showing the results of removing a simulated secretion obstruction or blockage from a simulated airway using a combination of acoustic supplementation and air pressure oscillations in an illustrative test setup of wherein the ventilator valve used for testing purposes was a Percussionaire intra-lung ventilator and the air pressure was set to 50 cmH2O;

[0031] Fig. 9A is another demonstration of Figure 4 A graph showing the results of removing a simulated secretion obstruction or blockage from a simulated airway using a combination of acoustic supplementation and air pressure oscillations in an illustrative test setup of wherein the ventilator valve used for testing purposes was a Percussionaire intra-lung ventilator and the air pressure was set to 30 cmH2O;

[0032] Fig. 9B is another demonstration of Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using only air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes is a Percussionaire intra-lung ventilator and the air pressure is set to 30 cmH2O;

[0033] Fig. 10A It is shown in Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using a combination of both acoustic supplementation and air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes was a Hill-Rom Metaneb intrapulmonary ventilator and the air pressure was set to 30 cmH2O;

[0034] Fig. 10B It is shown in Figure 4 A graph of the results of removing a simulated secretion obstruction or blockage from a simulated airway using only air pressure oscillations in an illustrative test setup of , wherein the ventilator valve used for testing purposes is a Metaneb intra-lung ventilator and the air pressure is set to 30 cmH2O;

[0035] Fig.11 It is relatively Figure 4 , 5A and 5B, a graph of results obtained from measuring movement of a simulated secretion obstruction or blockage within a simulated airway in an illustrative test setup, wherein the results of a test setup using air pressure oscillations alone are compared to the results of a test setup using both air pressure oscillations combined with acoustic supplementation;

[0036] Fig.12 It is relatively Figure 4 , 5Aand 5B , a graph of the results obtained from measuring the average dynamic viscosity of a simulated secretion obstruction or blockage within a simulated airway in an illustrative test setup, wherein the results of a test setup using air pressure oscillations alone are compared to the results of a test setup using both air pressure oscillations combined with acoustic supplementation;

[0037] Fig.13 It is compared through Figure 4 , 5A and 5B , a graph of results obtained for the average velocity of the airflow in a test section of an illustrative test setup, wherein the results of a test setup using air pressure oscillations alone are compared to the results of a test setup using two air pressure oscillations combined with acoustic supplementation;

[0038] Fig.14A It is shown in Figure 4 , 5A and 5B , a graph of results of penetration times of simulated secretion obstructions or blockages within a simulated airway obtained using a combination of air pressure oscillations of different frequencies and acoustic supplementation of different frequencies in an illustrative test setup, wherein the air pressure was set to 20 cmH2O;

[0039] Fig. 14B It is shown in Figure 4 , 5A and 5B are graphs of results of penetration times of simulated secretion obstructions or blockages within simulated airways obtained using a combination of air pressure oscillations of different frequencies and acoustic supplementation of different frequencies in illustrative test tissue, wherein the air pressure was set at 30 cmH2O;

[0040] Fig. 14C It is shown in Figure 4 , 5A and 5B are graphs of results of penetration times of simulated secretion obstructions or blockages within simulated airways obtained using a combination of air pressure oscillations of different frequencies and acoustic supplementation of different frequencies in illustrative test tissues, wherein the air pressure was set at 40 cmH2O;

[0041] Fig.14D It is shown in Figure 4 , 5A and 5B are graphs of results of penetration times of simulated secretion obstructions or blockages within simulated airways obtained using a combination of air pressure oscillations of different frequencies and acoustic supplementation of different frequencies in illustrative test tissue, wherein the air pressure was set at 50 cmH2O;

[0042] Fig.15A is an overview diagram showing the methods used to obtain Fig. 15B and 15C The results shown in Figure 4 , 5Aand 5B, the solenoid frequency (Hz) and speaker frequency (bpm) utilized in the illustrative test setup;

[0043] Fig. 15B The results obtained at different loudspeaker power fractions, solenoid frequencies, and loudspeaker frequencies are shown. Figure 4 , 5A and 5B are graphs of the results of penetration time of a simulated secretion obstruction or plug within a full length simulated airway in an illustrative test setup, wherein the air pressure was set to 40 cmH2O;

[0044] Fig. 15C The results obtained at different loudspeaker power fractions, solenoid frequencies, and loudspeaker frequencies are shown. Figure 4 , 5A and 5B are graphs of the results of penetration time of a simulated secretion obstruction or plug within a full length simulated airway in an illustrative test setup, wherein the air pressure was set to 50 cmH2O;

[0045] Fig.16A is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 40 cmH2O, the solenoid frequency is set to 300 bpm, and the speaker frequency is set to 300 Hz;

[0046] Fig. 16B is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of penetration time of a simulated secretion obstruction in a full-length simulated airway or a half-length simulated airway in an illustrative test setup, wherein the air pressure is set to 40 cmH2O, the solenoid frequency is set to 300 bpm, and the speaker frequency is set to 400 Hz;

[0047] Fig. 16C is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 40 cmH2O, the solenoid frequency is set to 400 bpm, and the speaker frequency is set to 300 Hz;

[0048] Fig.16D is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5Aand 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 40 cmH2O, the solenoid frequency is set to 400 bpm, and the speaker frequency is set to 400 Hz;

[0049] Fig.17A is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 50 cmH2O, the solenoid frequency is set to 300 bpm, and the speaker frequency is set to 300 Hz;

[0050] Fig. 17B is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 50 cmH2O, the solenoid frequency is set to 300 bpm, and the speaker frequency is set to 400 Hz;

[0051] Fig. 17C is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 50 cmH2O, the solenoid frequency is set to 400 bpm, and the speaker frequency is set to 300 Hz;

[0052] Fig.17D is a graph showing the power obtained at different loudspeaker power fractions. Figure 4 , 5A and 5B , a graph of the results of the penetration time of a simulated secretion obstruction or blockage within a full-length simulated airway or a half-length simulated airway in the illustrative test setup, wherein the air pressure is set to 50 cmH2O, the solenoid frequency is set to 400 bpm, and the speaker frequency is set to 400 Hz;

[0053] Fig.18A is a graph showing results obtained at full speaker power, half speaker power, and zero speaker power for removing a simulated secretion obstruction or blockage from a simulated airway over time using a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and an air pressure of 30 cmH2O;

[0054] Fig.18B It uses half the speaker power. Fig.18APixelated snapshot of secretion removal results;

[0055] Fig. 18C It uses zero speaker power. Fig.18A Pixelated snapshot of secretion removal results;

[0056] Fig.19A is a graph showing results of removing a simulated secretion obstruction or blockage from a simulated airway over time using a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and an air pressure of 50 cmH2O at full speaker power and half speaker power;

[0057] Fig.19B It uses half the speaker power. Fig.19A Pixelated snapshot of secretion removal results;

[0058] Fig. 20A is a graph showing results of removing a simulated secretion obstruction or blockage from a simulated airway over time using a solenoid frequency of 300 bpm, a speaker frequency of 490 Hz, and an air pressure of 40 cmH2O at half speaker power with full secretion volume and zero speaker power with half secretion volume;

[0059] Fig. 20B yes Fig. 20A Pixelated snapshot of secretion removal results using half speaker power with full secretion volume;

[0060] Fig. 20C yes Fig. 20A Pixelated snapshot of secretion removal results using zero speaker power with half secretion volume;

[0061] Fig.21A is a pixelated snapshot showing the results of removing a simulated secretion obstruction from a simulated airway obtained without acoustic enhancement using a solenoid frequency of 400 bpm and an air pressure of 50 cmH2O;

[0062] Fig.21B It is shown Fig.21A A graph of the results;

[0063] Fig.22A is a pixelated snapshot showing the results of removing a simulated secretion obstruction from a simulated airway using a solenoid frequency of 400 bpm and an air pressure of 50 cmH2O with increased acoustic enhancement and a speaker frequency of 490 Hz; and

[0064] Fig. 22B It is shown Fig.22A Graph of the results. DETAILED DESCRIPTION

[0065] The embodiments of the present disclosure described herein are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed. Rather, the embodiments described herein enable those skilled in the art to practice the present disclosure.

[0066] First reference Figure 1 , an illustrative device 10 for deobstructing and removing secretions from an airway is shown. The illustrative device 10 can be used to treat a variety of respiratory diseases, such as chronic obstructive pulmonary disease, acute bronchiolitis, cystic fibrosis, and other diseases. The illustrative device 10 includes a device body 12, which also serves as a handle for the device 10, thereby allowing a patient to hold the device 10 with one hand during use. Figure 1 The device body 12 is shown in cross section to show the contents of the device body 12.

[0067] In one illustrative embodiment, the user places the device 10 into an operational mode through user input, for example, by pressing a button 14 on the exterior of the device body 12. In another illustrative embodiment, the user operates the device 10 using a graphical user interface ("GUI") 16 supported on a surface of the device body 12. The user may recognize that the device 10 is operational through auditory means or visual means, for example, text or backlighting on the GUI 16, an operation light on the device body 12, etc.

[0068] Further references Figure 1 , the air inlet 20 is fluidly coupled to an air flow system 22 to provide air flow to the device 10. The air flow system 22 illustratively includes an air supply source 24, a pressure regulator 26, and a control valve 28. The control valve 28 is illustratively an electrically operable valve, such as a solenoid valve. A flow controller (schematically a ventilator valve 30) is illustratively coupled to the air supply source 24. As further described in detail herein, the ventilator valve 30 can be defined by an intrapulmonary percussion ventilator ("IPV"). The air inlet 20 can be removably coupled to the distal end of the device body 12 via an air inlet connector 31, thereby allowing air flow to enter an internal air conduit or passage 34.

[0069] like Figure 2 As shown, a printed circuit board 40 is schematically disposed within the device body 12, and in the illustrative embodiment, it supports a main controller 42 defined by a processor 44 and a memory 46. The main controller 42 schematically includes a flow controller 42a and an acoustic controller 42b. A pressure sensor 48, an auditory output device 50 (e.g., a buzzer), a real-time clock 52, and a backup battery 54 for the real-time clock 52 may also be supported by the printed circuit board 40 and are in electrical communication with the main controller 42. In addition, a data acquisition unit 41 illustratively transmits feedback from the pressure sensor 48 to the main controller 42 during use of the device 10.

[0070] The device 10 is illustratively powered by a rechargeable battery pack 49. When the battery is depleted, the user can recharge the battery pack 49 by connecting it to an external, off-the-shelf battery charger. The battery pack 49 illustratively contains protection circuits that protect the battery pack 49 from overcharging, overdischarging, maximum battery voltage, and minimum battery voltage.

[0071] Reference again Figure 1 and 2 , the air inlet 20 is fluidly coupled to an air supply source 24 to provide air to the body 12 of the device 10. In the illustrative embodiment, the air supply source 24 (e.g., a blower) can generate air at a pressure of at least 100 pounds per square inch. Schematically, the air inlet 20 is removably coupled to the distal end of the device body 12 via an air inlet connector 31, thereby allowing air flow into the internal air duct 34. In the illustrative embodiment, the connection between the air inlet 20 and the air inlet connector 31 is configured to provide a minimal amount of air pressure loss.

[0072] As air moves through the device body 12, the processor 44 illustratively operates the air pressure regulator 26 and the solenoid controlled valve 28 according to a preprogrammed scheme or algorithm stored as machine-readable instructions (e.g., software) in the memory 46 of the controller 42. First, the air pressure regulator 26 illustratively adjusts the pressure of the air flow from the air supply 24 to an operable level provided by the preprogrammed scheme or algorithm executed by the controller 42, such as between 25 and 30 pounds per square inch. Then, the air moves from the air pressure regulator 26 to the solenoid controlled valve 28, which illustratively opens and closes at a given frequency provided by the preprogrammed scheme or algorithm executed by the controller 42, such as 100 to 300 cycles per minute.

[0073] Air then passes from the device body 12 through the internal air conduit 34 into the respirator valve 30. The respirator valve 30 may illustratively be an IPV, such as the Phasitron IPV manufactured by Percussionaire, Inc. of Sandpoint, Idaho, or the Metaneb IPV manufactured by Hill-Rom, Inc. of Bartlesville, Indiana. In another illustrative embodiment, the respirator valve 30 may include a venturi valve connected to a T-adapter that may be used as an inhalation and exhalation valve. Illustratively, the solenoid valve 28 and / or the pressure regulator 26 may be incorporated into the respirator valve 30.

[0074] In the illustrative embodiment, the airflow system 22 is operably coupled to the acoustic system 33. More specifically, the ventilator valve 30 of the airflow system 22 is operably coupled to an acoustic device or speaker 58 of the acoustic system 33 via a speaker / valve adapter 32. The speaker 58 provides acoustic enhancement to the air within the ventilator valve 30. More specifically, a speaker amplifier 56 can be disposed in the device body 12 and can be operably coupled to the controller 42 (directly or via the data acquisition unit 41). The speaker 58 and amplifier 56 can include a compression driver unit SD-210R 100W (neodymium driver) available from Sanming Sound, Inc. of Huntington Beach, California, or another acoustic device (e.g., speaker and amplifier) ​​capable of delivering an acoustic amplitude of up to at least 133 decibels ("dB") between frequencies of at least 180 Hertz ("Hz") and 7000 Hz. Illustratively, the controller 42 causes the speaker amplifier 56 to generate an acoustic vibration frequency according to a pre-programmed scheme or algorithm stored in the memory 46. The acoustic vibration frequency can be set to about 100 Hz, about 200 Hz, about 300 Hz, about 400 Hz, about 500 Hz, or about 600 Hz. It has been demonstrated that the maximum acoustic frequency effect occurs at, for example, about 400 Hz. The speaker amplifier 56 transmits the acoustic vibration frequency to the speaker 58, thereby adding the vibration frequency to the oscillating air pressure at the adapter 32.

[0075] Still reference Figure 1 , an air tube or airflow passage 60 schematically provides airflow from the ventilator valve 30 to a patient interface 62 (such as a removable mask or mouthpiece). The removable mask is configured to be placed over the patient's nose and mouth during use. Another embodiment may utilize a removable mouthpiece 62 that is configured for oral use only. Free airflow is allowed from the air conduit 34 along the internal air passage through the mouthpiece 62. A patient using the mouthpiece 62 can breathe normally while being provided with an oscillating air pressure frequency generated by the solenoid valve 28 and an acoustic frequency provided by the speaker 58. In one illustrative embodiment, the device 10 may also include a nebulizer to deliver medication through the patient's respiratory system while the patient is breathing using the device 10.

[0076] When the patient exhales into the patient interface 62, the patient can freely exhale into the interface. During exhalation, the device 10 generates exhalation pressure due to the air pressure pulses controlled by the solenoid valve 28. In an illustrative embodiment, the patient can release air from the mouthpiece outlet valve coupled to the pressure sensor 48 supported by the printed circuit board 40. The pressure sensor 48 can include an upstream pressure transducer 64 operably coupled to the airflow passage 60 for measuring the pressure of the outlet airflow. The pressure transducer 64 can include a pressure transducer available from Kulite of Leonia, New Jersey.

[0077] In another illustrative embodiment, the active controls within the mouthpiece 62 include at least one pressure sensor and at least one flow rate sensor, and the mouthpiece measures airway resistance, thereby providing feedback to the controller 42. More specifically, the measured pressure and flow rate allow a pre-programmed protocol or algorithm within the memory 46 executed by the processor 44 to optimize the parameters of the device 10 and personalize the parameters for each patient based on, for example, the patient's age and size and the nature of the disease or secretions (i.e., mucus).

[0078] In another illustrative embodiment, the processor 44 of the device 10 applies a protocol or algorithm in the memory 46 to personalize and adjust the air oscillations and acoustic pulsations of the device according to the responses recorded during use by the memory 46 of the controller 42. The algorithm can also use specific patient parameters (e.g., height, weight, airway geometry, etc.) and specific secretion characteristics to match the desired frequency, amplitude, duty cycle, and relative phase of the device 10 to optimize the effectiveness of secretion removal. Secretion characteristics can include volume, depth, rheological properties (e.g., viscosity and / or elasticity), and surface properties (e.g., surface tension, cohesion, and / or adhesion).

[0079] Figure 3 An illustrative communication system is shown that includes device 10. For example, sensor 202 measures breathing responses from patient 204 and transmits the responses to a handheld device 206, such as a tablet or smartphone, owned by patient 204 using a graphical user interface application 207. Handheld device 206 can also transmit the responses to a cloud-based system 208, allowing physician 210 to access the recorded responses and communicate effective treatment 212 with patient 204.

[0080] Figure 4 and 5A-5B shows a test setup 101 that can be used to test the efficiency and effectiveness of the setup 10. The test setup 101 includes many of the same components as the device 10, although these components are not necessarily enclosed in the device body 12. Likewise, similar components include similar reference labels. In addition, the test setup 101 includes a simulated airway 103, a simulated secretion obstruction 105 within the simulated airway 103, and a simulated or artificial lung 107 (e.g., a flexible air bag). A downstream pressure sensor or transducer 109 is located between the simulated airway 103 and the artificial lung 107 and is used to measure the effectiveness of the device 10 by measuring the air pressure downstream of the simulated secretion obstruction 105 under different device settings. Similar to the upstream pressure transducer 64, the downstream pressure transducer 109 can include a pressure transducer available from Colette, Inc. of Leonia, New Jersey.

[0081] Reference now Figure 5A-6 , showing the display Figure 4 The test sequence of the functions of the test setup 101. For example, refer to Figure 6 , a user may enter a desired or defined speaker frequency into the memory 46 of the controller 42′ at input box 150, a desired or defined speaker amplitude into the memory at input box 152, and a desired or defined speaker phase into the memory at input box 154 via the GUI 16. The software in the memory 46 illustratively generates a speaker signal at function box 160, which is then transmitted to the data acquisition unit 41′. The user may also enter a desired or defined solenoid valve frequency into the software at input box 156 and a desired or defined solenoid valve phase into the software at input box 158 to generate a solenoid valve signal at function box 162, which is also transmitted to the data acquisition unit 41′. Changing the speaker phase at input box 154 and the solenoid valve phase at input box 158 allows the user to cancel the effects of the speaker 58′ and the ventilator valve 28′, respectively. The data acquisition unit 41′ transmits the solenoid valve signal (generated at function box 162) to the relay 41′ ( Figure 5A-5B ) to operate the solenoid valve 28' according to the solenoid valve signal (generated at function block 162). The data acquisition unit 41' also amplifies the speaker signal (generated at function block 160) through the speaker amplifier 56' to operate the speaker 58' according to the speaker signal (generated at function block 160).

[0082] Further references Figure 5A-6, an air supply 24′ provides air to the test setup 101; illustratively, the air supply 24′ provides the air flow at an air pressure of approximately 100 pounds per square inch (“psi”) or approximately 7030.7 centimeters of water column (“cmH2O”). The air flows through a pressure regulator 26′, which adjusts the pressure of the air flow to an operable level as described above. The air then flows from the pressure regulator 26′ to a solenoid valve 28′, which operates as described above, and then enters a ventilator valve 30′, which is schematically coupled to a T-adapter. The air is acoustically enhanced by a speaker 58′ coupled to the ventilator valve 30′, which operates as described above. The air then freely enters the test section 166 (containing a simulated airway 103 containing an obstruction 105 including simulated secretions), and an artificial lung 107 is coupled to the distal end of the simulated airway 103 opposite the ventilator valve 30′.

[0083] The upstream pressure transducer 64' and the downstream pressure transducer 109 measure the upstream air pressure at function block 170 and the downstream air pressure at function block 172, respectively, and transmit the measured pressure data to the data acquisition unit 41'. The data acquisition unit 41' then transmits the measured pressure and time stamp to a data file in the memory 46 of the controller 42 for later analysis and utilization as shown in function block 174.

[0084] For testing purposes, naturally occurring human secretions (e.g., obstruction 105) including mucus can be modeled by simulated materials. Simulated materials are illustratively selected based on properties (e.g., viscosity and surface tension) that produce behavior that mimics the behavior of secretions. Various secretion properties can include volume, depth, rheological properties (e.g., viscosity and / or elasticity), and surface properties (e.g., surface tension, cohesion, and / or adhesion).

[0085] For example, one of the simulated materials used may be mayonnaise. In other embodiments, the simulated material may be a thixotropic material. For example, a cup of such a thixotropic material may include: 1) one-third cup of a 40-60 glycerol-water mixture; 2) half a cup of a lubricating gel, such as Lubri Gel or KY Gel; 3) five teaspoons of a powder having nanoparticles of 20 to 50 microns in size, such as a water-soluble poly(ethylene) oxide polymer (Polyox), alumina, salt and talc; 4) five to 10 cc of food coloring or two teaspoons of instant coffee. In other embodiments, guar gum, tetraborate or locust bean gum may be used instead of mucus for testing purposes. Galactomannan gum (a substance derived from locust beans, including galactose and mannose, with a ratio of galactose and mannose of one galactose unit for every four mannose units) and scleroglucan (a substance obtained by aerobic fermentation of sclerotium fungi) may be used in addition to replace mucus or other secretions for testing purposes.

[0086] The viscosity of the simulated material can be changed by changing the size of the powder, and paraffin oil can be used to reduce the surface tension. Surface tension, viscosity and temperature also have a strong correlation. An illustrative contact angle of the simulated material is about 75 degrees, which can be measured by taking a drop of the simulated material with a diameter of about two millimeters and measuring the side height. Alternatively, an optical viscometer can be used.

[0087] During illustrative testing, a video of the airway simulator can be recorded to post-process and quantify secretions in the airway simulator based on the test duration and direction of secretory movement. Figures 7A-10B , presents preliminary results. The results indicate that flow rate, flow pulsation, and acoustic frequency affect the removal of simulated material (blockage) in the simulated airway and should not be interpreted as indicating a positive or negative trend. Figures 7A-7C and 8A-8C, present data from a test setup utilizing a Percussionaire IPV-1C unit. Fig. 7A , 7B 7C show the percentage of simulated secretions remaining in the simulated airway when no acoustic effect was used and the test was performed using air pressures of 30 cmH2O, 40 cmH2O, and 50 cmH2O, respectively. Fig. 8A , 8B Figures 8 and 8C show the percentage of simulated secretions remaining in the simulated airway when tested using acoustic stimulation. Fig. 7A and Fig. 8A , Figure 7B and Figure 8B It can be seen that the acoustic enhancement of airflow resulted in faster removal of simulated secretions from the simulated airway.

[0088] exist Fig. 9A and 9B An additional graphical comparison of the amount of simulated secretions in the simulated airway of a test setup using the Percussionaire IPV system with a set air pressure of 30 cmH2O is shown in FIG. Fig. 9A Figure 2 shows the percentage of simulated secretions remaining in the simulated airway using the acoustic enhancement system over time. Fig. 9B The percentage of simulated secretions remaining in the simulated airway is shown over time when the standard system is used (ie, no acoustic effect). As shown, the enhanced system can clear secretions significantly faster than the standard system.

[0089] Alternatively, Fig. 10A and 10B An additional graphical comparison of the amount of simulated secretions in the simulated airway of a test setup using the MetaNeb IPV system with a set air pressure of 30 cmH2O is shown in FIG. Fig. 10A Figure 2 shows the percentage of simulated secretions remaining in the simulated airway using the acoustic enhancement system over time. Fig. 10B The percentage of simulated secretions remaining in the simulated airway is shown over time when the standard system is used (ie, no acoustic effect). As shown, the enhanced system clears secretions significantly faster than the standard system.

[0090] Reference now Figure 11-13 , additional data are presented to demonstrate the different effects of air flow pulsation without acoustic enhancement compared to air flow pulsation with acoustic enhancement. Figure 11-13 In each of the examples, line 302 illustrates the effect of acoustically enhanced air pulsation, while line 304 illustrates the effect of air pulsation without acoustic enhancement. Specifically, Fig.11 The movement of a simulated secretion obstruction within a simulated airway during the test was measured. As shown, the secretion obstruction was more effectively moved by acoustically enhanced air pulsation than without acoustic enhancement.

[0091] Reference now Fig.12 The relative viscosity of the simulated secretions used during testing was measured in a system using acoustically enhanced air pulsation compared to a system using air pulsation without acoustic enhancement. As the viscosity of the secretions becomes lower, they are more easily penetrated by air pulsation and also more effectively moved within the airway, thereby facilitating the removal of secretions from the airway. As shown, the viscosity of the secretions in the system using acoustic enhancement decreased significantly compared to the system without acoustic enhancement.

[0092] Fig.13The average airflow velocity of the air entering the artificial lung of the test setup is shown. In airways with secretion obstructions, the airflow into the lung is less than in airways without secretion obstructions. The air flow velocity with acoustically enhanced air pulsation is higher than the air flow velocity without acoustic enhancement. In addition, acoustic enhancement produces airflow oscillations, which have a significant effect on simulating secretions.

[0093] In the event that the airway is completely blocked by secretions, it is desirable to penetrate the blockage caused by the secretions to allow the user to breathe and the device 10 ( Figure 1 ) to better facilitate the removal of secretions from the airways. Figures 14A-14D The device 10 ( Figure 1 ) is a graphical representation of the ability to penetrate a secretion obstruction at consistent solenoid pressure and speaker power percentage. When the penetration time reaches or exceeds 300 seconds, it is assumed that the secretion obstruction was not penetrated before being pushed into the artificial lung for testing. For example, Fig.14A It was demonstrated that when the speaker frequency was between 400Hz and 500Hz and the air pressure was constant at 20cmH2O, the secretion obstruction was not penetrated before being pushed into the artificial lung. Figures 14A-14D , mid-range frequencies (e.g., 300-490 Hz) penetrate secretion obstructions faster than the top or bottom ranges of the frequencies tested. In addition, higher solenoid pressures more consistently penetrate secretion obstructions at a faster rate than lower supply pressures.

[0094] use Fig.15A The legend of Figures 15B-15C The effect of speaker power reduction on the device 10 ( Figure 1 ) is affected by the ability of the test lung to penetrate a secretory obstruction. If no points are drawn in the figure, or if arrows are used in place of points, it is assumed that penetration will not occur before the obstruction is pushed into the artificial lung used for testing. Fig. 15B In the figure, the points plotted on the graph show the breakthrough time at a consistent air pressure of 40 cmH2O at varying solenoid valve frequencies and speaker frequencies over a range of speaker power fractions. Fig. 15C The same data is shown with a solenoid pressure of 50 cmH2O. The pressures of 40 cmH2O and 50 cmH2O were chosen because in previous tests ( Figures 14A-14D ) in device 10( Figure 1 ) performance under these pressures. Figures 15B-15CAs shown, a reduction in loudspeaker power generally results in an increase in breakthrough time. However, any power reduction between 40% and 80% generally produces a faster breakthrough time than without the acoustic aid, where breakthrough occurs after a significantly longer time or does not occur at all. This range of loudspeaker power allows for variability in loudspeaker power in several different situations where different sound levels are required.

[0095] Reference now Figures 16A-16D and Figures 17A-17D , depicting the effect of tube length on secretion obstruction removal. In these figures, the triangular plot points represent the time taken to penetrate using a tube that is half the length of the full-length tube used in the previous experiments, while the circular plot points represent the time taken to penetrate using the full-length tube. Specifically, Figures 16A-16D The effect of tube length on different speaker power fractions at a constant solenoid frequency and a constant speaker frequency at an air pressure of 40 cmH2O was tested. Figures 17A-17D The effect of tube length on different speaker power fractions at a consistent solenoid frequency and a consistent speaker frequency but at an air pressure of 50 cmH2O was also tested. Many of these tests showed little difference between half-length and full-length tubes, while others showed a switch between half-length and full-length tubes in terms of length of penetration time. Therefore, it can be concluded that the length of the tube has an important effect on the performance of the device 10 ( Figure 1 ) has little effect on the time it takes to penetrate the secretion obstruction, which makes the device 10 ( Figure 1 ) is suitable for children and adults.

[0096] exist Figures 18A-18C Data from secretion clearance studies can be seen in Figures 19A-19B and 19A-19B. Specifically, Figures 18A-18C The secretion volume over time is shown at a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and an air pressure of 30 cmH2O. Fig.18A The test results using full speaker power (104dB), half speaker power (52dB) and zero speaker power were compared. Fig.18B A pixelated snapshot of the 52 dB case can be seen in , while a pixelated snapshot of the zero power case is shown in Fig. 18C For the pixelated snapshots here and below, the video data is line-of-sight data, meaning that if secretions were coated across the entire test segment, the video would not see anything behind the secretions and assume the test segment was completely full. Therefore, at the beginning of each test, there was an increase in secretion simulant as secretions penetrated and coated the inner wall of the tube. The left side of each snapshot is the mouth side, while the lung side is on the right side of the image, with time progressing forward from top to bottom. Fig. 18CShown, the test section without acoustic enhancement—the secretion simulant was never penetrated but simply pushed into the artificial lung used for testing.

[0097] Fig.19A The change in the amount of secretions in the simulated airway over time at half power and full power with a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and an air pressure of 50 cmH2O is shown. Fig.19B A pixelated snapshot of the half-power situation can be seen in .

[0098] Reference now Figures 20A-20C , depicting the device 10( Figure 1 ) compared to the amount of secretions that can be removed from the airway with standard IPV without acoustic enhancement. A consistent speaker frequency of 490 Hz, and a consistent solenoid frequency of 300 bpm and a consistent air pressure of 40 cmH2O were used. Specifically, Fig. 20A The device 10 ( Figure 1 ) compared to the simulated amount of secretions remaining in the airway over time when using standard IPV without acoustic enhancement and using half the initial amount of secretions. Fig. 20B provides a pixelated snapshot of the half-power condition, while Fig. 20C A pixelated snapshot of the zero power condition is provided. As demonstrated, acoustic enhancement allows penetration of twice the amount of secretions in almost the same amount of time as standard IPV, and is also able to remove secretions in a shorter amount of time than standard IPV.

[0099] Reference now Fig.21A and 21B , plots the time to remove simulated secretions from a simulated airway without the use of acoustic enhancement. A consistent solenoid frequency of 400 bpm and a consistent air pressure of 50 cmH2O were used. Fig.21B , the dimensionless dispersion of the simulated blockage of the relevant experiment is plotted over time. The dimensionless value is defined as the ratio of the number of pixels associated with simulated secretions at a given time to the number of pixels associated with simulated secretions at the beginning of the experiment. For example, a value of "1" represents the beginning of the experiment, where the simulated secretions are undisturbed, while a value of "0" represents the end of the test, where the simulated secretions have been removed. In the case of pure volumetric movement, the values ​​remain below "1"; if simulated secretions are deposited on the inner surface of the simulated airway, the values ​​exceed "1".

[0100] Reference now Fig.21AThe algorithm used to generate Figure 21B also produces white pixels when simulated secretions move into previously clear regions of the simulated airway. Otherwise, black pixels are produced when simulated secretions leave previously clear regions of the simulated airway. Gray pixels represent spatial regions of the simulated airway that did not undergo any changes throughout the experiment. Fig.21A As shown, in the test setup without the use of acoustic enhancement, the simulated airway obstruction continued to move downstream toward the lungs and did not penetrate and dislodge toward the mouth.

[0101] Reference now Figures 22A to 22B , the same experiment as above was reproduced, but with the additional use of acoustic enhancement with a loudspeaker frequency of 490 Hz. Fig.22A As shown, an initial downstream movement of an obstruction with considerable surface deposits occurs, which is associated with penetration of the obstruction. Acoustic enhancement is then able to break up the obstruction into much smaller fragments, which can then gradually pulse upstream towards the oral cavity.

[0102] As detailed herein, an illustrative device for deobstructing secretions from an airway and removing the secretions provides therapy by applying an oscillating airflow and acoustic vibrations according to a preprogrammed protocol that defines the frequency, waveform, pressure amplitude, and / or oscillation duration through software control. The illustrative device includes an airflow system that applies the oscillating airflow, an acoustic system that applies the acoustic vibrations, and a controller operably coupled to the airflow system and the acoustic system, the controller being configured to match the frequency, amplitude, duty cycle, and relative phase to a specific patient geometry and specific secretions.

[0103] Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the spirit and scope of the invention as described and defined in the following claims.

Claims

1. A device for removing secretions from an airway and removing the secretions, the device comprising: An air flow system, the air flow system comprising an air supply source, an electrically operable flow control valve and a flow controller, the electrically operable flow control valve being in fluid communication with the air supply source, and the flow controller being in electrical communication with the flow control valve; an acoustic system operably coupled to the airflow system, the acoustic system comprising an acoustic pulser and an acoustic controller in electrical communication with the pulser; as well as an air flow pathway in fluid communication with the air flow system and in acoustic communication with the acoustic system; The invention is characterized in that the flow controller is configured to make the flow control valve and the air supply source provide an oscillating airflow to the airflow passage, and the acoustic controller is configured to make the acoustic pulse generator provide acoustic vibration to the oscillating airflow. wherein the defined air flow frequency is between 195 times per minute and 405 times per minute, and wherein the defined acoustic oscillation frequency is between 295 Hz and 500 Hz, The airflow amplitude is limited to between 15cmH2O and 55cmH2O. The acoustic vibration amplitude is defined as between 47 decibels and 109 decibels.

2. The apparatus of claim 1, wherein the flow controller comprises a processor and a memory, the memory comprising software that, when executed by the processor, defines the airflow to define the airflow frequency and amplitude.

3. The apparatus of claim 1, wherein the acoustic controller comprises a processor and a memory, the memory comprising software executed by the processor to define acoustic vibrations at defined acoustic vibration frequencies and amplitudes.

4. The device of any one of claims 1-3, further comprising a rechargeable battery in electrical communication with the airflow system and the acoustic system.

5. The apparatus of claim 1, wherein the flow controller and the acoustic controller are defined by a master controller, the master controller comprising a processor and a memory, the memory being operably coupled to the processor.

6. The device according to claim 5 further comprises a pressure sensor, which is operably coupled to the airflow passage and communicates with the main controller, and the main controller is configured to control the airflow system and the acoustic system in response to the air pressure detected by the pressure sensor.

7. The device of any one of claims 1-3, further comprising a patient interface in fluid communication with the airflow pathway.

8. A device for deobstructing and removing secretions from an airway, the device comprising: Airflow pathways; an air flow system, the air flow system being in communication with the air flow passage, the air flow system comprising an air supply source for providing gas to the air flow passage and an electrically operable flow control valve, the electrically operable flow control valve being in fluid communication with the air supply source; an acoustic system in communication with the gas flow path, the acoustic system comprising a pulse generator configured to generate vibrations to provide the gas to the gas flow path; as well as a controller operably coupled to the gas flow system and the acoustic system, the controller being configured to control at least one of the frequency, waveform, pressure amplitude, and oscillation duration of the gas provided by the flow control valve, and the controller being configured to control at least one of the frequency, amplitude, duty cycle, and relative phase of the vibrations generated by the pulse generator, wherein the defined air flow frequency is between 195 times per minute and 405 times per minute, and wherein the defined acoustic oscillation frequency is between 295 Hz and 500 Hz, The airflow amplitude is limited to between 15cmH2O and 55cmH2O. The acoustic vibration amplitude is defined as between 47 decibels and 109 decibels.

9. The device of claim 8, wherein the controller is defined by a flow controller and an acoustic controller, the flow controller being in electrical communication with the flow control valve, and the acoustic controller being in electrical communication with the pulse generator.

10. An apparatus according to claim 8 or 9, wherein the controller comprises a processor and a memory, the memory being operably coupled to the processor; and software stored in the memory being executed by the processor so as to limit the airflow at a defined airflow frequency and amplitude and to limit the acoustic vibration at a defined acoustic vibration frequency and amplitude.

11. The apparatus of claim 9, further comprising an intrapulmonary percussion ventilator defining the flow controller and the flow control valve and / or wherein the pulse generator comprises an acoustic speaker and a speaker amplifier.

12. The apparatus of claim 8 or 9, further comprising a patient interface in fluid communication with the airflow pathway.

13. The device according to claim 8 further comprises a pressure sensor, which is operably coupled to the airflow passage and connected to the controller, and the controller is configured to adjust at least one of the airflow frequency, airflow amplitude, acoustic vibration frequency and acoustic vibration amplitude generated by the device in response to the air pressure detected by the pressure sensor.

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