Device for eliminating obstruction of secretions from airway and removing said secretions

Abstract

An apparatus for eliminating obstruction of and removing secretions from airways, including small airways, by illustratively applying an oscillating airflow and acoustic vibrations according to a pre-programmed scheme defining at least one of a frequency, a waveform, a pressure amplitude, and an oscillation duration. In one illustrative embodiment, the device applies a combination of airflow oscillations and acoustic waves to facilitate separation of mucus from the airway wall by matching the resonance of particular airway sections and mucus, thereby enhancing the effect. For optimization, the algorithm illustratively matches the required frequency, amplitude, duty cycle and / or relative phase to specific patient and secretion characteristics.

Description

[0001] This application is a divisional application of a Chinese patent application with application number 201980008193.6, filing date January 11, 2019, and invention title "Device for Removing Obstruction of Secretions from the Airway and Removing Said Secretions".

[0002] Cross - Reference to Related Applications

[0003] This application claims the priority of U.S. Provisional Patent Application Serial No. 62 / 616,804, filed on January 12, 2018, the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION

[0004] The present invention relates to devices for assisting in the breakdown or expulsion of accumulated secretions in the airway, and more particularly to devices for treating respiratory diseases that assist in the breakdown or expulsion of accumulated secretions in the airway.

[0005] Respiratory inhalers are commonly used in the medical field to treat various upper respiratory diseases and conditions. Some upper respiratory diseases can be chronic and require lifelong treatment. It is well known that devices in the art assist in removing mucus and other solids and fluids from the airway, particularly for patients suffering from such lifelong chronic diseases. However, traditional secretion removal devices may be inefficient and less suitable for small airways.

[0006] For example, acute bronchiolitis is a common infant disease, usually caused by viral pathogens, characterized by thick inflammatory secretions obstructing and clogging the small airways of the infant. This can lead to respiratory distress or respiratory failure, thus requiring mechanical ventilation. Some treatment devices known in the art can worsen the condition of the infant, while other devices are unable to effectively clear the small airways. Similarly, patients with chronic obstructive pulmonary disease ("COPD") experience narrowing of the small airways, but available treatments typically do not effectively treat the small airways. This results in poor functional capacity and perceived health status in COPD patients. Therefore, there is a need for a non-invasive device for treating patients, and more particularly, a non-invasive device for removing obstructions of secretions in a patient's airway (especially small airways) and removing said secretions. SUMMARY OF THE INVENTION

[0007] The devices and methods of the present disclosure are configured to apply a combination of airflow oscillations and acoustic waves to facilitate the removal of mucus by disrupting or deagglomerating mucus plugs, separating the aggregated mucus plugs from the airway walls, and promoting clearance. For example, the disruption and detachment of mucus from the airway walls are achieved by a combination of oscillating airflow and acoustic pulses configured to match the resonance of a particular airway segment and the mucus, thereby enhancing the effect through the impedance matching principle. For example, an intrapulmonary percussion 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 an acoustic effect to the air pulsation causes the mucus to break down and the particles to move towards the patient's mouthpiece until the airway is almost completely cleared. For optimization, an algorithm can match the required frequencies, amplitudes, duty cycles, and relative phases of the oscillating airflow and acoustic pulses to the geometry of a particular patient and the particular secretions.

[0008] According to an illustrative embodiment of the present disclosure, a device for removing an obstruction of secretions from an airway and removing the secretions includes an airflow system and an acoustic system, the acoustic system being operably coupled to the airflow system. The airflow system includes a gas supply source, an electrically operable flow control valve, and a flow controller, the electrically operable flow control valve being in fluid communication with the gas supply source, and the flow controller being in electrical communication with the flow control valve. The acoustic system includes an acoustic pulse generator and an acoustic controller, the acoustic controller being in electrical communication with the acoustic pulse generator. An air flow passage 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 gas supply source to provide an oscillating airflow to the air flow passage, and the acoustic controller causes the acoustic pulse generator to provide acoustic vibrations to the oscillating airflow.

[0009] According to another illustrative embodiment, the flow controller includes a processor and a memory, the memory including software executed by the processor to define an 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.

[0010] According to another illustrative embodiment, the acoustic controller includes a processor and a memory, the memory including software executed by the processor to define acoustic vibrations at a defined acoustic vibration frequency and amplitude. In an illustrative embodiment, the defined acoustic vibration is between 295 Hertz (″Hz") and 500 Hz.

[0011] In an illustrative embodiment, a pressure sensor is operably coupled to the air flow passage and in communication with the main controller, and the main controller is configured to control the air flow system and the acoustic system in response to the air pressure detected by the pressure sensor.

[0012] According to another illustrative embodiment of the present disclosure, a device for removing an obstruction of secretions from an airway and removing the secretions includes an air flow passage, an air flow system, and an acoustic system. The air flow system is in communication with the air flow passage, and the acoustic system is in communication with the air flow passage. The air flow system includes a gas supply source and an electrically operable flow control valve that is in fluid communication with the gas supply source. The acoustic system includes a pulse generator configured to generate vibrations. A controller is operably coupled to the air flow system and the acoustic system, and 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 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.

[0013] According to an illustrative embodiment, the controller includes a processor and a memory operably coupled to the processor, and software stored in the memory is executed by the processor to define an air flow at a defined air flow frequency and amplitude and to define an acoustic vibration at a defined acoustic vibration frequency and amplitude. Illustratively, the defined air flow frequency is between 195 times per minute and 405 times per minute, the defined air flow amplitude is between 15 cmH2O and 45 cmH2O, the defined acoustic vibration frequency is between 295 hertz and 500 hertz, and the defined acoustic vibration amplitude is between 47 decibels and 109 decibels.

[0014] According to another illustrative embodiment of the present disclosure, a method for removing an obstruction of secretions from an airway and removing the secretions includes the steps of applying an oscillating air flow to an air flow passage containing secretions and applying an acoustic vibration to the air flow within the air flow passage. Illustratively, the oscillating air flow is controlled by pre-programmed executable instructions that define at least one of the frequency, waveform, pressure amplitude, and oscillation duration. Further illustratively, the acoustic vibration is controlled by pre-programmed executable instructions that define at least one of the frequency, amplitude, duty cycle, and relative phase. In an illustrative embodiment, the method further includes the steps of measuring the air pressure within the air flow passage and adjusting the oscillating air flow and the acoustic vibration in response to the measured air pressure.

[0015] According to an illustrative embodiment of the present disclosure, a device for removing an obstruction of secretions from an airway and removing the secretions provides treatment by applying oscillating air flow and acoustic vibrations according to a pre-programmed protocol, the pre-programmed protocol defining frequency, waveform, pressure amplitude, and / or oscillation duration through software control.

[0016] According to another illustrative embodiment of the present disclosure, a device for removing an obstruction of secretions from an airway and removing the secretions provides treatment by applying oscillating air flow and acoustic vibrations according to an algorithm stored in a memory as machine-readable instructions executed by a processor, which automatically matches the required frequency, amplitude, duty cycle, and / or relative phase with 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)).

[0017] Those skilled in the art will appreciate additional features and advantages of the present invention after considering the following detailed description of illustrative embodiments that exemplify the best mode currently understood for practicing the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] DETAILED DESCRIPTION OF THE DRAWINGS refers specifically to the drawings, in which:

[0019] Figure 1 is a schematic view of an illustrative device for removing an obstruction of secretions from an airway and removing the secretions, including a cross-sectional view of the device body and showing the air flow through the device to a patient mouthpiece;

[0020] Figure 2 is including Figure 1 a block diagram of an illustrative printed circuit board of a controller of the device;

[0021] Figure 3 is including Figure 1 a schematic view of an illustrative communication system of an illustrative device that provides transmission of information (e.g., customized prescriptions and / or effective treatment procedures) between a patient and a physician;

[0022] Figure 4 is for Figure 1 a schematic view of an illustrative test setup for experimental testing of an illustrative device, showing the air flow through the test setup to an artificial lung;

[0023] Figure 5A is Figure 4 a first perspective view of an illustrative test setup, showing components of the test setup such as a relay box, solenoid valve, upstream pressure transducer, downstream pressure transducer, breathing valve, speaker, test section, and artificial lung;

[0024] Figure 5B is Figure 4 a second perspective view of an illustrative test setup, showing the pressure regulator of the test setup relative to the components of the test setup shown in Figure 5A ;

[0025] Figure 6 is a flowchart showing the action steps and corresponding structures of the test setup in FIGS. Figure 4 , 5A and 5B in an experimental environment;

[0026] Figure 7A is a graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using only pneumatic oscillations in the illustrative test setup of Figure 4 , where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set to 30 cmH2O;

[0027] Figure 7B is a graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using only pneumatic oscillations in the illustrative test setup of Figure 4 , where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set to 40 cmH2O;

[0028] Figure 7C is a graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using only pneumatic oscillations in the illustrative test setup of Figure 4 , where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set to 50 cmH2O;

[0029] Figure 8A is a graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using a combination of acoustic supplementation and pneumatic oscillations in the illustrative test setup of Figure 4 , where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set to 30 cmH2O;

[0030] Figure 8B is a graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using a combination of acoustic supplementation and pneumatic oscillations in the illustrative test setup of Figure 4 , where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set to 40 cmH2O;

[0031] Figure 8Cshows the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using a combination of acoustic supplementation and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 50 cmH2O; Figure 4 and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 50 cmH2O;

[0032] Figure 9A is another graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using a combination of acoustic supplementation and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O; Figure 4 and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O;

[0033] Figure 9B is another graph showing the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using only pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O; Figure 4 and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Percussionaire intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O;

[0034] Figure 10A shows the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using a combination of acoustic supplementation and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Hill-Rom Metaneb intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O; Figure 4 and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Hill-Rom Metaneb intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O;

[0035] Figure 10B shows the results of removing simulated secretory obstructions or blockages from a simulated airway obtained using only pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Hill-Rom Metaneb intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O; Figure 4 and pneumatic oscillation in an illustrative test setup, where the breathing apparatus valve for test purposes is a Hill-Rom Metaneb intraluminal ventilator and the pneumatic pressure is set at 30 cmH2O;

[0036] Figure 11 compares the results obtained from measuring the movement of simulated secretory obstructions or blockages in a simulated airway in the illustrative test setups of Figure 4 、 5A and 5B, where the results of the test setup using only pneumatic oscillation are compared with the results of the test setup using two pneumatic oscillations combined with acoustic supplementation;

[0037] Figure 12 compares the results obtained from measuring the movement of simulated secretory obstructions or blockages in a simulated airway in the illustrative test setups of Figure 4 、 5AGraph showing the measurement of results in the illustrative test setup of 5B, simulating the average dynamic viscosity of the simulated secretory obstruction or blockage in the airway, where the results of the test setup using only pneumatic oscillation are compared with the results of the test setup using two pneumatic oscillations combined with acoustic supplementation;

[0038] Figure 13 Is a comparison through Figure 4 、 5A Graph showing the results obtained by comparing the average air velocity in the test section of the illustrative test setup of 5B, where the results of the test setup using only pneumatic oscillation are compared with the results of the test setup using two pneumatic oscillations combined with acoustic supplementation;

[0039] Figure 14A Is a graph showing Figure 4 、 5A Results of the penetration time of the simulated secretory obstruction or blockage in the simulated airway obtained using combinations of different frequencies of pneumatic oscillation and different frequencies of acoustic supplementation in the illustrative test setup of 5B, where the air pressure is set to 20 cmH2O;

[0040] Figure 14B Is a graph showing Figure 4 、 5A Results of the penetration time of the simulated secretory obstruction or blockage in the simulated airway obtained using combinations of different frequencies of pneumatic oscillation and different frequencies of acoustic supplementation in the illustrative test setup of 5B, where the air pressure is set to 30 cmH2O;

[0041] Figure 14C Is a graph showing Figure 4 、 5A Results of the penetration time of the simulated secretory obstruction or blockage in the simulated airway obtained using combinations of different frequencies of pneumatic oscillation and different frequencies of acoustic supplementation in the illustrative test setup of 5B, where the air pressure is set to 40 cmH2O;

[0042] Figure 14D Is a graph showing Figure 4 、 5A Results of the penetration time of the simulated secretory obstruction or blockage in the simulated airway obtained using combinations of different frequencies of pneumatic oscillation and different frequencies of acoustic supplementation in the illustrative test setup of 5B, where the air pressure is set to 50 cmH2O;

[0043] Figure 15A Is a summary diagram showing the means for obtaining the Figure 15B And 15C Results shown in Figure 4 、 5AThe solenoid frequency (Hz) and speaker frequency (bpm) utilized in the illustrative test setups of 5B;

[0044] Figure 15B is a graph showing the Figure 4 and 5A penetration times of simulated secretory obstructions or blockages within the full-length simulated airway in the illustrative test setups of 5B at different speaker power fractions, solenoid frequencies, and speaker frequencies, where the air pressure is set to 40 cmH2O;

[0045] Figure 15C is a graph showing the Figure 4 and 5A penetration times of simulated secretory obstructions or blockages within the full-length simulated airway in the illustrative test setups of 5B at different speaker power fractions, solenoid frequencies, and speaker frequencies, where the air pressure is set to 50 cmH2O;

[0046] Figure 16A is a graph showing the Figure 4 and 5A penetration times of simulated secretory obstructions or blockages within the full-length or half-length simulated airway in the illustrative test setups of 5B at different speaker power fractions, where 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;

[0047] Figure 16B is a graph showing the Figure 4 and 5A penetration times of simulated secretory obstructions within the full-length or half-length simulated airway in the illustrative test setups of 5B at different speaker power fractions, where 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;

[0048] Figure 16C is a graph showing the Figure 4 and 5A penetration times of simulated secretory obstructions or blockages within the full-length or half-length simulated airway in the illustrative test setups of 5B at different speaker power fractions, where 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;

[0049] Figure 16D is a graph showing the Figure 4 and 5AGraph of the results of the penetration time of the simulated secretory obstruction or blockage in the full-length or half-length simulated airway in the illustrative test settings of 5B, where the air pressure is set at 40 cmH2O, the solenoid frequency is set at 400 bpm, and the speaker frequency is set at 400 Hz;

[0050] Figure 17A which shows the Figure 4 、 5A Graph of the results of the penetration time of the simulated secretory obstruction or blockage in the full-length or half-length simulated airway in the illustrative test settings of 5B, where the air pressure is set at 50 cmH2O, the solenoid frequency is set at 300 bpm, and the speaker frequency is set at 300 Hz;

[0051] Figure 17B which shows the Figure 4 、 5A Graph of the results of the penetration time of the simulated secretory obstruction or blockage in the full-length or half-length simulated airway in the illustrative test settings of 5B, where the air pressure is set at 50 cmH2O, the solenoid frequency is set at 300 bpm, and the speaker frequency is set at 400 Hz;

[0052] Figure 17C which shows the Figure 4 、 5A Graph of the results of the penetration time of the simulated secretory obstruction or blockage in the full-length or half-length simulated airway in the illustrative test settings of 5B, where the air pressure is set at 50 cmH2O, the solenoid frequency is set at 400 bpm, and the speaker frequency is set at 300 Hz;

[0053] Figure 17D which shows the ​ 、 5A Graph of the results of the penetration time of the simulated secretory obstruction or blockage in the full-length or half-length simulated airway in the illustrative test settings of 5B, where the air pressure is set at 50 cmH2O, the solenoid frequency is set at 400 bpm, and the speaker frequency is set at 400 Hz;

[0054] ​ Graph of the results of removing the simulated secretory obstruction or blockage from the simulated airway over time using a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and an air pressure of 30 cmH2O at full speaker power, half speaker power, and zero speaker power;

[0055] ​ which is at half speaker power ​A pixelated snapshot of the secretion removal results;

[0056] ​ It uses zero speaker power. ​ A pixelated snapshot of the secretion removal results;

[0057] ​ 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;

[0058] ​ It uses half the speaker power. ​ A pixelated snapshot of the secretion removal results;

[0059] ​ 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;

[0060] ​ yes ​ Pixelated snapshot of secretion removal results using half speaker power with full secretion volume;

[0061] ​ yes ​ Pixelated snapshot of secretion removal results using zero speaker power with half the secretion volume;

[0062] ​ 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;

[0063] ​ It shows ​ A graph of the results;

[0064] ​ 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

[0065] ​ It shows ​ Graph of the results. DETAILED DESCRIPTION

[0066] 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. Instead, the embodiments described herein enable those skilled in the art to practice the present disclosure.

[0067] First referring to ​ , an illustrative device 10 for removing obstructions from an airway and removing the secretions 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. ​ The device body 12 of

[0068] is shown in cross-section to illustrate the contents of the device body 12.

[0069] Further referring to ​ , an air inlet 20 is fluidly coupled to an airflow system 22 to provide an airflow to the device 10. The airflow 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 respiratory valve 30) is illustratively coupled to the air supply source 24. As described in further detail herein, the respiratory valve 30 can be defined by an intrapulmonary percussive ventilator (″IPV"). The air inlet 20 can be removably coupled to the distal end of the device body 12 through an air inlet connector 31, thereby allowing the airflow to enter an internal air duct or passage 34.

[0070] 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 can 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.

[0071] Device 10 is illustratively powered by a rechargeable battery pack 49. When the battery runs out, the user can charge the battery pack 49 by connecting it to an off-the-shelf external battery charger. The battery pack 49 illustratively includes a protection circuit that protects the battery pack 49 from overcharging, over-discharging, maximum battery voltage, and minimum battery voltage.

[0072] Referring again to ​ and 2 , the air inlet 20 is fluidly coupled to an air supply source 24 to supply air to the body 12 of the device 10. In an illustrative embodiment, the air supply source 24 (such as a blower) can generate air at a pressure of at least 100 pounds per square inch. Illustratively, the air inlet 20 is detachably coupled to the distal end of the device body 12 through an air inlet connector 31, thereby allowing air flow to enter the internal air duct 34. In an 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.

[0073] When air moves through the device body 12, the processor 44 illustratively operates the air pressure regulator 26 and the solenoid control valve 28 according to a pre-programmed scheme or algorithm stored in the memory 46 of the controller 42 as machine-readable instructions (e.g., software). First, the air pressure regulator 26 illustratively regulates the pressure of the air flow from the air supply source 24 to an operable level provided by a pre-programmed scheme or algorithm executed by the controller 42, such as between 25 pounds per square inch and 30 pounds per square inch. Then, the air moves from the air pressure regulator 26 to the solenoid control valve 28, which illustratively opens and closes at a given frequency provided by a pre-programmed scheme or algorithm executed by the controller 42, such as 100 to 300 cycles per minute.

[0074] Then, the air enters the breathing valve 30 from the device body 12 via the internal air duct 34. The breathing valve 30 can illustratively be an IPV, such as a Frequency Modulated Tube IPV (Phasitron IPV) manufactured by Percussionaire Corporation of Sandpoint, Idaho, or a Metaneb IPV manufactured by Hill-Rom, Inc. of Batesville, Indiana. In another illustrative embodiment, the breathing valve 30 can include a Venturi valve connected to a T-adapter that can be used as an inhalation and exhalation valve. Illustratively, the solenoid valve 28 and / or the pressure regulator 26 can be incorporated within the breathing valve 30.

[0075] In an illustrative embodiment, the airflow system 22 is operatively coupled to the acoustic system 33. More specifically, the breathing valve 30 of the airflow system 22 is operatively coupled to the 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 breathing valve 30. More specifically, the speaker amplifier 56 may be disposed within the device body 12 and may be operatively coupled to the controller 42 (either directly or via the data acquisition unit 41). The speaker 58 and the amplifier 56 may include a compression driver unit SD-210R 100W (neodymium driver) available from Sanming Sound, Huntington Beach, California, or another acoustic device (such as a speaker and an 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 may be set to approximately 100 Hz, approximately 200 Hz, approximately 300 Hz, approximately 400 Hz, approximately 500 Hz, or approximately 600 Hz. The maximum acoustic frequency effect has been shown to occur at, for example, approximately 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.

[0076] Still referring to ​ , an air tube or air flow path 60 schematically provides an airflow from the breathing valve 30 to the patient interface 62 (such as a detachable face mask or mouthpiece). The detachable face mask is configured to be placed over the patient's nose and mouth during use. Another embodiment may utilize a detachable mouthpiece 62, which is configured for use only in the mouth. Free airflow is permitted from the air conduit 34 along an internal air passage through the mouthpiece 62. A patient using the mouthpiece 62 may breathe normally while being provided with the oscillating air pressure frequency generated by the solenoid valve 28 and the acoustic frequency provided by the speaker 58. In an illustrative embodiment, the device 10 may also include a nebulizer to deliver medication through the patient's respiratory system while the patient uses the device 10 to breathe.

[0077] When the patient exhales into the patient interface 62, the patient is free to exhale into the interface. During exhalation, the device 10 generates an exhalation pressure due to a pneumatic pulse controlled by the solenoid valve 28. In one illustrative embodiment, the patient can release air from a mouthpiece outlet valve coupled to a pressure sensor 48 supported by a printed circuit board 40. The pressure sensor 48 can include an upstream pressure transducer 64 operatively coupled to the air flow path 60 for measuring the pressure of the outlet air flow. The pressure transducer 64 can include a pressure transducer available from Kulite of Leonia, New Jersey.

[0078] In another illustrative embodiment, the active controller within the mouthpiece 62 includes at least one pressure sensor and at least one flow rate sensor, and the mouthpiece measures the airway resistance, thereby providing feedback to the controller 42. More specifically, the measured pressure and flow rate allow a pre-programmed scheme 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).

[0079] In another illustrative embodiment, the processor 44 of the device 10 applies the scheme or algorithm in the memory 46 to personalize and adjust the air oscillations and acoustic pulsations of the device based on the responses recorded in the memory 46 of the controller 42 during use. 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, thereby optimizing the effectiveness of secretion removal. The secretion characteristics can include volume, depth, rheological properties (e.g., viscosity and / or elasticity), and surface properties (e.g., surface tension, cohesion, and / or adhesiveness).

[0080] ​ An illustrative communication system incorporating the device 10 is shown. For example, the sensor 202 measures the respiratory response from the patient 204 and transmits the response to a handheld device 206 owned by the patient 204, such as a tablet computer or a smartphone, using a graphical user interface application 207. The handheld device 206 can also transmit the response to a cloud-based system 208, thereby allowing the physician 210 to access the recorded response and communicate an effective treatment 212 to the patient 204.

[0081] ​ and 5A-5B shows a test setup 101 that can be used to test the efficiency and effectiveness of the device 10. The test setup 101 includes many of the same components as the device 10, although these components are not necessarily enclosed within the device body 12. Likewise, similar components include similar reference numbers. 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 Corporation of Leonia, New Jersey.

[0082] Now refer to ​ , showing the display ​ The test sequence of the function of test setup 101. For example, refer to ​ , a user can 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 can 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 offset the effects of the speaker 58' and the respirator valve 28', respectively. The data acquisition unit 41' transmits the electromagnetic valve signal (generated in the function block 162) to the relay 41' ( ​ ) 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).

[0083] Further references ​, a gas supply source 24' supplies air to the test setup 101; illustratively, the gas supply source 24' supplies an air flow at a gas pressure of about 100 pounds per square inch (″psi″) or about 7030.7 centimeters of water column (″cmH2O″). The air flows through a pressure regulator 26', which, as described above, regulates the pressure of the air flow to an operable level. Then, the air flows from the pressure regulator 26' to a solenoid valve 28' operating as described above, and then into a breathing valve 30' schematically coupled to a T-adapter. The air is acoustically enhanced by a speaker 58' coupled to the breathing valve 30', which operates as described above. Then, the air freely enters a test section 166 (including an artificial airway 103 containing an obstruction 105 including a simulated secretion), and an artificial lung 107 is coupled to the distal end of the artificial airway 103 opposite the breathing valve 30'.

[0084] An upstream pressure transducer 64' and a downstream pressure transducer 109 measure the upstream gas pressure in a functional block 170 and the downstream gas pressure in a functional block 172, respectively, and transmit the measured pressure data to a data acquisition unit 41'. The data acquisition unit 41' then transmits the measured pressure and time stamps to a data file in a memory 46 of a controller 42 for later analysis and utilization as shown in a functional block 174.

[0085] For testing purposes, natural human secretions including mucus (e.g., the obstruction 105) can be modeled with a simulated material. The simulated material is illustratively selected based on the nature of the behavior that produces behavior mimicking the secretion (e.g., viscosity and surface tension). Various secretion characteristics can include volume, depth, rheological properties (e.g., viscosity and / or elasticity), and surface properties (e.g., surface tension, cohesiveness, and / or adhesiveness).

[0086] For example, one of the mock materials used can be mayonnaise. In other embodiments, the mock material can be a thixotropic material. For example, the volume of one cup of such thixotropic material can include: 1) one-third cup of a glycerol-water mixture of 40 - 60; 2) one-half cup of a lubricating gel such as Lubri Gel or K-Y Gel; 3) five teaspoons of a powder having nanoparticles sized 20 to 50 microns, such as 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 additional embodiments, for testing purposes, guar gum, borate, or locust bean gum can be used in place of mucus. Galactomannan (a substance derived from locust bean, including galactose and mannose, with a ratio of galactose to mannose of one galactose unit per four mannose units) and scleroglucan (a substance obtained by aerobic fermentation of the fungus Sclerotium rolfsii) can additionally be used for testing purposes in place of mucus or other secretions.

[0087] The viscosity of the mock material can be changed by varying the size of the powder, while paraffin oil can be used to reduce the surface tension. There is also a strong correlation between surface tension, viscosity, and temperature. The illustrative contact angle of the mock material is about 75 degrees, which can be measured by taking a drop of the mock material with a diameter of about two millimeters and measuring the side height. Alternatively, an optical viscometer can be used.

[0088] During illustrative testing, videos of the airway simulator can be recorded to post-process and quantify the secretions in the airway simulator based on the test duration and the direction of secretion movement. Referring ​ , preliminary results are given. The results show that flow rate, flow pulsation, and acoustic frequency affect the removal of the mock substance (blockage) in the mock airway and should not be interpreted as indicating a positive or negative trend. Specifically referring ​ and 8A - 8C, data from test setups using the Percussionaire IPV-1C unit are given. ​ 、 7B and 7C show the percentage of mock secretions remaining in the mock airway when tested without acoustic action and with air pressures of 30 cmH2O, 40 cmH2O, and 50 cmH2O respectively. Meanwhile, ​ 、 8B and 8C show the percentage of mock secretions remaining in the mock airway when tested with acoustic action. By comparing ​ and ​ 、 ​ and ​ etc., it can be seen that the acoustic enhancement of the airflow enables faster removal of the mock secretions from the mock airway.

[0089] In ​ and 9B additional graphical comparisons of the amount of simulated secretions in a simulated airway of a test setup of a Percussionaire IPV system using a set air pressure of 30 cmH2O are shown. ​ The percentage of simulated secretions remaining in the simulated airway using an acoustic enhancement system over time is shown, while ​ the percentage of simulated secretions remaining in the simulated airway over time when using a standard system (i.e., no acoustic effect) is shown. As shown, the enhanced system can clear secretions significantly faster than the standard system.

[0090] Alternatively, ​ and 10B additional graphical comparisons of the amount of simulated secretions in a simulated airway of a test setup of the Vyaire MetaNeb IPV system using a set air pressure of 30 cmH2O are shown. ​ The percentage of simulated secretions remaining in the simulated airway using an acoustic enhancement system over time is shown, while ​ the percentage of simulated secretions remaining in the simulated airway over time when using a standard system (i.e., no acoustic effect) is shown. As shown, the enhanced system clears secretions significantly faster than the standard system.

[0091] Now referring to ​ , additional data is depicted to show the different effects of airflow pulsations with acoustic enhancement compared to those without acoustic enhancement. In each of ​ , line 302 shows the effect of acoustically enhanced air pulsations while line 304 shows the effect of air pulsations without acoustic enhancement. Specifically, ​ the movement of simulated secretion obstructions within the simulated airway during the test is measured. As shown, the acoustically enhanced air pulsations can move the secretion obstructions more effectively compared to air pulsations without acoustic enhancement.

[0092] Now referring to ​ , the relative viscosity of the simulated secretions used during the test is measured in a system using acoustically enhanced air pulsations compared to a system using air pulsations without acoustic enhancement. As the secretion viscosity becomes lower, it is easier to penetrate and also more effective to move within the airway using air pulsations, thus facilitating the removal of secretions from the airway. As shown, the viscosity of the secretions in the system using acoustic enhancement is significantly lower compared to the system not using the acoustic effect.

[0093] ​Shows the average airflow velocity of air entering the artificial lung in the test setup. In airways with secretory obstructions, the airflow into the lung is less than that in airways without secretory obstructions. The air velocity of acoustically enhanced air pulsations is higher than that of air pulsations without acoustic enhancement. In addition, acoustic enhancement generates airflow oscillations, which have a significant impact on simulating secretions.

[0094] In the case where the airway is completely blocked by secretions, it is desired to penetrate the obstruction caused by the secretion to allow the user to breathe and use device 10( ​ ) to better facilitate the removal of secretions from the airway. ​ Depicts a diagram showing the ability of device 10( ​ ) to penetrate the secretory obstruction at a consistent solenoid pressure and speaker power percentage. When the penetration time reaches or exceeds 300 seconds, it is assumed that the secretory obstruction was not penetrated before being pushed into the artificial lung for testing. For example, ​ Shows that when the speaker frequency is between 400 Hz and 500 Hz and the constant air pressure is 20 cmH2O, the secretory obstruction was not penetrated before being pushed into the artificial lung. Observing together ​ , the middle range of frequencies (e.g., 300 - 490 Hz) penetrates the secretory obstruction faster than the top or bottom ranges of the frequencies tested. In addition, a higher solenoid pressure penetrates the secretory obstruction more consistently and at a faster rate than a lower supply pressure.

[0095] Using ​ 's legend shows ​ the effect of reducing the speaker power on the ability of device 10( ​ ) to penetrate the secretory obstruction. If no points are plotted on the graph or arrows are used instead of points, it is assumed that no penetration occurs before the obstruction is pushed into the artificial lung for testing. Specifically, in ​ , the points plotted on the graph show the penetration times at varying solenoid frequencies and speaker frequencies at a consistent air pressure of 40 cmH2O within the range of speaker power fractions. Alternatively, ​ represents the same data at a consistent solenoid pressure of 50 cmH2O. The air pressures of 40 cmH2O and 50 cmH2O were selected because of the performance of device 10( ​ ) at these pressures in previous tests( ​ ). As ​Shown, a reduction in speaker power generally results in an increase in penetration time. However, any power reduction between 40% and 80% generally results in a faster penetration time than without acoustic assistance, where penetration occurs after a significantly longer time or does not occur at all. This range of speaker power allows for variability in speaker power in several different situations where different sound levels are required.

[0096] Now referring to ​ and ​ , the effect of tube length on secretory obstruction removal is depicted. In these figures, the triangular plotting points represent the time taken for penetration using a tube that is half the length of the full-length tube used in the previous experiment, while the circular plotting points represent the time taken for penetration using the full-length tube. Specifically, ​ the effect of tube length on different speaker power fractions was tested at a pneumatic pressure of 40 cmH2O with a consistent solenoid frequency and a consistent speaker frequency. Additionally, ​ the effect of tube length on different speaker power fractions was also tested at a pneumatic pressure of 50 cmH2O with a consistent solenoid frequency and a consistent speaker frequency. Many of these tests showed little difference between the half-length tube and the full-length tube, while other tests showed a transition between the half-length tube and the full-length tube in terms of the length of the penetration time. Thus, it can be concluded that the length of the tube has little effect on the time taken for the device 10 ( ​ ) to reach the secretory obstruction, making the device 10 ( ​ ) suitable for both children and adults.

[0097] In ​ and 19A - 19B, data from the secretion clearance tests can be seen. Specifically, ​ shows the amount of secretion over time at a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and a pneumatic pressure of 30 cmH2O. ​ The test results using full speaker power (104 dB), half speaker power (52 dB), and zero speaker power were compared. A pixelated snapshot of the 52 dB case can be seen in ​ , while a pixelated snapshot of the zero power case is shown in ​ . For the pixelated snapshots here and below, the video data is line-of-sight data, which means that if the secretion is smeared across the entire test section, the video will not see anything behind the secretion and it is assumed that the test section is completely filled. Thus, at the start of each test, the secretion mimic is increased as the secretion is penetrated and smeared on the inner wall of the tube. The mouth side is on the left of each snapshot, while the lung side is on the right of the image, and time progresses forward from top to bottom. As ​Shown, the test section one secretion mimetic without acoustic enhancement was never penetrated, but only pushed into the artificial lung for testing.

[0098] ​ Shows the change in the amount of secretions in the simulated airway over time at a solenoid frequency of 400 bpm, a speaker frequency of 490 Hz, and a pneumatic pressure of 50 cmH2O at half power and full power. In ​ a pixelated snapshot of the half-power case can be seen.

[0099] Now refer to ​ , which depicts a comparison of the amount of secretions that can be removed from the airway by the device 10 ( ​ ) and a standard IPV without acoustic enhancement. A consistent speaker frequency of 490 Hz, a consistent solenoid frequency of 300 bpm, and a consistent pneumatic pressure of 40 cmH2O are used. Specifically, ​ shows the amount of remaining secretions in the simulated airway over time when using a standard IPV without acoustic enhancement and half of the initial amount of secretions compared to the amount of remaining secretions in the simulated airway over time when using the device 10 ( ​ ) with half-power acoustic action and the full amount of secretions. ​ provides a pixelated snapshot of the half-power case, while ​ provides a pixelated snapshot of the zero-power case. As shown, acoustic enhancement allows twice the amount of secretions to be penetrated in almost the same amount of time as the standard IPV, and is also able to remove secretions in a shorter amount of time than the standard IPV.

[0100] Now refer to ​ and 21B , which depicts the time to remove simulated secretions from the simulated airway without using acoustic enhancement. A consistent solenoid frequency of 400 bpm, and a consistent pneumatic pressure of 50 cmH2O are used. Specifically referring to ​ , the dimensionless dispersion of the relevant experimental simulated plug over time is plotted. The dimensionless value is defined as the ratio of the number of pixels associated with the simulated secretions at a given time to the number of pixels associated with the simulated secretions at the start of the experiment. For example, the value "1" represents the start of the experiment, where the simulated secretions are undisturbed, while the value "0" represents the end of the test, where the simulated secretions have been removed. In the case of pure volume movement, the numerical value remains below "1"; if the simulated secretions deposit on the inner surface of the simulated airway, the value exceeds "1".

[0101] Now refer to ​, when the simulated secretions move into a previously clear simulated airway region, the algorithm used to generate Figure 21B also produces white pixels. Otherwise, when the simulated secretions leave a previously clear region of the simulated airway, black pixels are produced. Grey pixels represent the spatial regions of the simulated airway that do not undergo any change throughout the experiment. As ​ shown, in the test setup without using acoustic enhancement, the simulated airway obstruction continuously moves downstream towards the lung and does not penetrate and remove towards the mouth.

[0102] Now refer to ​ , an experiment identical to the above was reproduced, but additionally using acoustic enhancement with a speaker frequency of 490 Hz. As ​ shown, the obstruction with a significant surface deposition undergoes an initial downstream movement, which is related to the penetration of the plug. The acoustic enhancement is then able to break the obstruction into much smaller fragments, which can then gradually pulse upstream towards the mouth.

[0103] As detailed herein, an illustrative device for removing obstructions and removing secretions from the airway provides treatment by applying oscillating airflows and acoustic vibrations according to a pre-programmed scheme, the pre-programmed scheme defining frequency, waveform, pressure amplitude, and / or oscillation duration through software control. The illustrative device includes an airflow system for applying oscillating airflows, an acoustic system for applying acoustic vibrations, and a controller operably coupled to the airflow system and the acoustic system, the controller being configured to match frequency, amplitude, duty cycle, and relative phase to the geometry of a particular patient and a particular secretion.

[0104] 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. An apparatus for removing an obstruction of secretions from an airway and removing the secretions, the apparatus comprising: An airflow system including a gas supply source, an electrically operable flow control valve, and a flow controller, the electrically operable flow control valve being in fluid communication with the gas 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 including an acoustic pulse generator and an acoustic controller, the acoustic controller being in electrical communication with the pulse generator; And An air flow passage in fluid communication with the airflow system and in acoustic communication with the acoustic system; A main controller defining the flow controller and the acoustic controller, the main controller including a processor and a memory, the memory being operably coupled to the processor; A pressure sensor operably coupled to the air flow passage and in communication with the main controller, the main controller being configured to control the airflow system and the acoustic system in response to the air pressure detected by the pressure sensor; Wherein the flow controller causes the flow control valve and the gas supply source to provide an oscillating air flow to the air flow passage, and the acoustic controller causes the acoustic pulse generator to provide acoustic vibrations to the oscillating air flow.

2. The apparatus according to claim 1, wherein the flow controller includes a processor and a memory, the memory including software executed by the processor to define an air flow at a defined air flow frequency and amplitude.

3. An apparatus for removing an obstruction of secretions from an airway and removing the secretions, the apparatus comprising: An air flow passage; An airflow system in communication with the air flow passage, the airflow system including a gas supply source and an electrically operable flow control valve, the electrically operable flow control valve being in fluid communication with the gas supply source; An acoustic system in communication with the air flow passage, the acoustic system including a pulse generator configured to generate vibrations; A controller operably coupled to the airflow 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 air 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; And A pressure sensor operably coupled to the air flow passage and in communication with the controller, the controller being configured to adjust at least one of the air flow frequency, air flow amplitude, acoustic vibration frequency, and acoustic vibration amplitude in response to the air pressure detected by the pressure sensor, 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.

4. The apparatus according to claim 3, wherein the controller includes a processor and a memory, the memory being operably coupled to the processor; and software stored in the memory is executed by the processor to define an air flow with a defined air flow frequency and amplitude and to define an acoustic vibration with a defined acoustic vibration frequency and amplitude.

5. A method of removing an obstruction of secretions from an airway and removing the secretions, the method comprising the steps of: Applying an oscillating air flow to an air passage containing the secretions; And Applying an acoustic vibration to the air flow within the air passage.

6. The method according to claim 5, wherein the oscillating air flow is controlled by pre-programmed executable instructions that define at least one of a frequency, a waveform, a pressure amplitude, and an oscillation duration.

7. The method according to claim 6, wherein the defined oscillating air flow frequency is between 195 times per minute and 405 times per minute.

8. The method according to claim 6, wherein the defined air flow pressure amplitude is between 15 cmH2O and 55 cmH2O.

9. The method according to claim 5, wherein the acoustic vibration is controlled by pre-programmed executable instructions that define at least one of a frequency, an amplitude, a duty cycle, and a relative phase.

10. The method according to claim 9, wherein the defined acoustic vibration frequency is between 295 Hz and 500 Hz.

11. The method according to claim 5, wherein the step of applying the oscillating air flow includes the step of providing an air flow system that includes 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.

12. The method according to claim 5, wherein the step of applying the acoustic vibration includes the step of providing an acoustic system that is operably coupled to the air flow system, the air flow system including an acoustic pulse generator and an acoustic controller, the acoustic controller being in electrical communication with the pulse generator.

13. The method according to claim 5, further comprising the following steps: Measuring the air pressure within the air passage and adjusting the oscillating air flow and the acoustic vibration in response to the measured air pressure.

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