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WO2016210266A1 - Appareil, systèmes et méthodes de dégagement acoustique des voies respiratoires - Google Patents

Appareil, systèmes et méthodes de dégagement acoustique des voies respiratoires Download PDF

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Publication number
WO2016210266A1
WO2016210266A1 PCT/US2016/039251 US2016039251W WO2016210266A1 WO 2016210266 A1 WO2016210266 A1 WO 2016210266A1 US 2016039251 W US2016039251 W US 2016039251W WO 2016210266 A1 WO2016210266 A1 WO 2016210266A1
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WIPO (PCT)
Prior art keywords
acoustic
patient
acoustic wave
wave
chest
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Ceased
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PCT/US2016/039251
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English (en)
Inventor
Manya DEEHR
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Dymedso Inc
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Dymedso Inc
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0218—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement
    • A61H23/0236—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement using sonic waves, e.g. using loudspeakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M16/0006—Accessories therefor, e.g. sensors, vibrators, negative pressure with means for creating vibrations in patients' airways
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A61H2201/501—Control means thereof computer controlled connected to external computer devices or networks
    • A61H2201/5012—Control means thereof computer controlled connected to external computer devices or networks using the internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5023—Interfaces to the user
    • A61H2201/5035—Several programs selectable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5097—Control means thereof wireless
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/08—Trunk
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/08—Trunk
    • A61H2205/084—Chest

Definitions

  • the embodiments described herein relate generally to apparatus, systems, and methods for treating cystic fibrosis and other respirator ⁇ ' pathologies.
  • Cystic fibrosis is a common fatal hereditary, single gene disease in North America and Europe. The average age of patients with cystic fibrosis at the time of their death is currently about 36 years old. Most of the morbidity and almost ail of the mortality are associated with respiratory lung diseases characterized by obstruction of the bronchial tubes by abundant thick infected mucus.
  • cystic fibrosis transmembrane conductance regulator CFTR
  • cystic fibrosis transmembrane conductance regulator CFTR is an anion channel allowing the passage of salt, bicarbonate and other negatively charged substances across the apical membranes of epithelial cells in the airways, pancreas, liver, intestinal tract and reproductive system.
  • the absence of CFTR in cystic fibrosis epithelia leads to a marked decrease of water and salt secretion which results in a characteristic increase in the viscosity of secretions. These secretions bind to the walls of the bronchial tubes and form tenacious plaques that cannot be carried up to the throat by cilia that line the airways.
  • inhaled bacteria become trapped in these secretions (or mucus), proliferate and initiate a cycle of events including aii'way tissue destruction, aii'way inflammation and the accumulation of even greater amounts of thick, adherent mucus. All of these events, which eventually can lead to respiratory insufficiency and death, are initiated by the lung's inability in the absence of CFTR to clear the viscous mucus from the airways. Correction of this basic defect in airway- clearance is the goal of many therapeutic developments aiming to control or cure cystic fibrosis.
  • autogenic drainage is a technique in which a superficial breathing pattern at low lung volumes is followed by huffing or forced expiratory bursts to move the mucus towards the throat and provoke a cough with expectoration.
  • PEP Positive Expiratory Pressure
  • Flutter is a simple device into which patients blow slowly and which creates a positive expiratory pressure much like the PEP mask. However, in addition, the Flutter creates a mild vibration at the mouth allowing adherent mucus to more readily be dislodged from the bronchial tubes.
  • the mechanical percussor is an electrical device based along the same principles as postural drainage with clapping, but the major advantage is that the patient can perform the treatments alone without the need of a therapist. However, the technique can be awkward since certain areas of the chest are more difficult to reach. Additionally, the technique can be uncomfortable since the percussion is repeated over a diseased chest.
  • the pneumatic vest is an inflatable vest connected to a pneumatic compressor allowing repeated mechanical compressions of the thorax at high frequencies.
  • an apparatus in some embodiments, includes a signal generator to generate an electrical signal.
  • the apparatus also includes a patient interface configured to be applied to at least a portion of a chest of a patient during use.
  • the patient interface includes an acoustic transducer operabiy coupled to the signal generator to convert the electrical signal into an acoustic wave.
  • the patient interface also includes an acoustic coupler operabiy coupled to the acoustic transducer to transmit the acoustic wave from the acoustic transducer toward at least one portion of the lungs of the patient.
  • the acoustic wave has a frequency from about 30 Hertz to about 120 Hertz.
  • a method includes generating an acoustic wave at a frequency from about 30 Hertz to about 120 Hertz. The method also includes transmitting the acoustic wave, via an acoustic coupler, toward at least one portion of a chest of the patient to promote expectoration of mucus from the lungs of the patient.
  • a method of treating a patient suffering from mucus obstruction of lungs includes generating an acoustic wave at a frequency of from about 30 Hertz to about 120 Hertz. The method also includes transmitting, via an acoustic coupler, the acoustic wave toward at least one portion of a chest of the patient.
  • a method of treating a patient suffering from cystic fibrosis includes generating an acoustic wave at a frequency of from about 30 Hertz to about 120 Hertz. The method also includes transmitting, via an acoustic coupler, the acoustic wave toward at least one portion of a chest of the patient to excite bronchial walls of the patient so as to dislodge obstructive fluid in lungs of the patient.
  • FIG. 1 illustrates a schematic of an apparatus for treating cystic fibrosis and other respiratory pathologies, according to embodiments.
  • FIG. 2 illustrates a schematic of an apparatus including a controller for clearing airways in lungs of a patient, according to embodiments.
  • FIG. 3 illustrates a perspective view of an apparatus for clearing airways in lungs of a patient according to embodiments.
  • FIG. 4 illustrates placement of a treatment interface of a device for clearing airways in lungs of a patient, according to embodiments.
  • FIG. 5 illustrates placement of a treatment interface of a device for clearing airways in a suspender, according to embodiments.
  • FIG. 6 illustrates a treatment protocol for treating cystic fibrosis and other respiratory pathologies, according to embodiments.
  • FIG. 7 illustrates a perspective view of a controller and a transducer, according to embodiments
  • FIG. 8 illustrates a method for treating for treating cystic fibrosis and other respiratory pathologies, according to embodiments.
  • FIG. 1 illustrates a schematic of an apparatus 100 for treating cystic fibrosis and other respiratory pathologies.
  • the apparatus 100 includes a main unit 1 10, which further includes an adjustable frequency generator 112 (sometimes also referred to as a function generator or a signal generator) configured to generate an electrical signal and an optional amplifier 114 configured to amplify the electrical signal.
  • the apparatus 100 also includes a treatment interface 120 that is operably coupled to the main unit 1 10.
  • the treatment interface includes an acoustic transducer 122 configured to convert the electrical signal provided by the main unit 110 into an acoustic wave (sometimes also referred to as a sound wave).
  • the acoustic wave has a frequency from about 30 Hertz to about 120 Hertz (e.g., about 30 Hertz, about 40 Hertz, about 50 Hertz, about 60 Hertz, about 70 Hertz, about 80 Hertz, about 90 Hertz, about 100 Hertz, about 1 0 Hertz, and about 120 Hertz, including all values and sub ranges in between).
  • the operation frequency of the frequency generator can be varied according to, for example, the selected site on the thorax and/or the patient's condition and body stracture, and (in some embodiments) can be adjustable by the patient according to his reaction to the effects of the waves. In generally, acoustic waves at lower frequencies can induce less pain or other discomfort.
  • An acoustic coupler 124 is coupled to the acoustic transducer 122 and configured to transmit the acoustic wave toward the lungs of a user.
  • the acoustic transducer 122 and the acoustic coupler 124 are enclosed in a casing 126.
  • the excitation of the bronchial walls by the propagated acoustic waves can dislodge viscous mucus, bronchial secretions, and/or other obstructive fluids so as to aid in the normal beating of the pulmonary cilia, helping the secretions follow their natural path towards the nostrils. This can eventually induce cough and then expectoration of the secretions.
  • the frequency generator 1 12 can include an analog frequency generator. In some embodiments, the frequency generator 1 12 can include a digital frequency generator. The frequency of the electrical signal generated by the frequency generator 1 12 can be adjustable so as to, for example, comply with different treatment protocols. In some embodiments, the output frequency of the frequency generator 1 12 can be set before each treatment. In some embodiments, the output frequency of the frequency generator 1 12 can be dynamically adjusted during treatment (e.g., using a feedback system to monitor the effect of treatment and adjust the output frequency based on the monitored effect).
  • the electrical signal generated by the frequency generator 112 can have various waveforms.
  • the frequency generator 1 12 can generate a sinusoidal wave.
  • the frequency generator 1 12 can generate a rectangular wave.
  • the duty cycle of the rectangular wave can be from about 0.1 to about 0.9 (e.g., about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, and about 0.9, including all values and sub ranges in between).
  • the frequency- generator 112 can generate a square wave.
  • the frequency generator 112 can generate a sawtooth wave.
  • the frequency generator 112 can include an arbitrary waveform generator (AWG) to generate an electrical signal having an arbitrary waveform.
  • AMG arbitrary waveform generator
  • the frequency generator 1 12 can operate in continuous mode.
  • the electrical signal generated by the frequency generator 1 12 can include a continuous wave, and the acoustic wave converted from this electrical signal can be continuous.
  • the frequency generator 112 can operate in pulsed mode, generating pulses of electrical signals, and the acoustic wave converted from this electrical signal can include a train of acoustic pulses.
  • the temporal pitch of the pulses train (i .e., time delay between adjacent acoustic pulses) can be, for example, from about 0.1 second to about 2 seconds (e.g., about 0.1 second, about 0.2 second, about 0.3 second, about 0.4 second, about 0.5 second, about 0.6 second, about 0.8 second, about 1.0 second, about 1.2 second, about 1.4 second, about 1.6 second, about 1.8 second, and about 2.0 seconds, including all values and sub ranges in between).
  • the acoustic transducer 122 can be based on various mechanisms.
  • the acoustic transducer 122 can include an electro-dvnamic transducer, which can include a coil of wire suspended in a magnetic field.
  • an alternating electrical current is passed through the coil, mechanical forces can be developed between the coil's electromagnetic field and the field in which it is mounted (sometimes also referred to as an external field).
  • the coil of wire is usually rigidly connected to a radiating diaphragm that is in turn resiliently mounted to an enclosure. This can hold the coil within the external field, but allows it to freely vibrate within this external field.
  • the mechanical force developed between the coil's electromagnetic field and the external field can then cause the coil to move back and forth, vibrating the diaphragm and generating sound.
  • the acoustic transducer 122 can include a magnetostrictive material for transduction.
  • a magnetostrictive material When a magnetostrictive material is placed in a magnetic field, its mechanical dimensions can change as a function of the strength of the magnetic field, which in turn can be used to generate sound.
  • the acoustic transducer 122 can use a piezoelectric crystal, including but is not limiting to, Quartz, Rochelle Salt, and Ammonium Dihydrogen Phosphate (ADP), for transduction.
  • Piezoelectric crystals can develop an electric charge between two surfaces of the crystals when the crystals are mechanically compressed, and they expand and contract in size in the presence of an applied electrical field. Therefore, by applying an external electrical field, the piezoelectric crystals can contract and expand, thereby causing, for example, a diaphragm to generate sound waves.
  • the acoustic transducer 122 can include electrostrictive ceramics (sometimes also referred to as piezoelectric ceramics) for transduction. Electrostrictive materials, such as Barium Titinate and Lead Zirconate Titanate, can produce an electric charge when a mechanical stress is applied. Conversely, an electric field applied over piezoelectric ceramics can cause a change of physical dimensions of the piezoelectric ceramics, thereby generating acoustic waves.
  • electrostrictive ceramics sometimes also referred to as piezoelectric ceramics
  • the acoustic transducer 122 generates an acoustic wave having a power from about 5 Watts to about 50 Watts (e.g., about 5 Watts, about 10 Watts, about 15 Watts, about 20 Watts, about 25 Watts, about 30 Watts, about 35 Watts, about 40 Watts, about 45 Watts, and about 50 Watts, including all values and sub ranges in between),
  • the total duration of the acoustic waves can be from about 10 minutes to about 40 minutes (e.g., 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, and 40 minutes, including ail values and sub ranges in between).
  • each treatment can be divided into several sections or phases and each section or phase can have a duration of about 10 seconds to about 10 minutes (e.g., 10 seconds, about 20 seconds, about 30 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 5 minutes, about 7 minutes, about 10 minutes, about 20 minutes, about 40 minutes, about 1 hour, about 2 hours, including all values and sub ranges in between).
  • the duration of treatment can depend on, for example, the selected site on the thorax where the acoustic coupler 124 is placed.
  • the duration can also depend on the patient's condition and body structure, and can be adjusted by the patient according to his or her reaction to the effects of the waves.
  • the acoustic coupler 124 in operation, is placed in close proximity of the chest wail of the patient.
  • the acoustic coupler 124 can include soft materials to increase comfort level for the patient during treatment.
  • the exterior shape of the acoustic coupler 124 can substantially match the general contour of the chest of the patient.
  • the exterior surface of the acoustic coupler 124 can include a memon,' material such as memory foam, a shape-memory polymer, and/or the like, to improve and/or enhance the surface area of the matching between the acoustic coupler 124 and the chest of the patient during treatment.
  • the acoustic coupler 124 in operation, creates a gap (i.e., via the thickness of the acoustic coupler 124) between the acoustic transducer 122 and the chest of the patient.
  • the size of the gap can influence the power directed to the lungs of the patient. In general, a larger gap can lead to a lower level of acoustic power that can be deposited into lungs of the patient and used for clearing airways.
  • the gap has a size of about 0.5 inch to about 5 inches (e.g., about 0.5 inch, about 1 inch, about 1.5 inch, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, about 4 inch, about 4.5 inches, and about 5 inches, including all values and sub ranges in between).
  • the acoustic coupler 124 can include a chamber (sometimes also referred to as an acoustic coupling chamber) made of materials that can be sterilized.
  • the acoustic coupler 124 can include a chamber filled with fluid (e.g., water or any other appropriate fluid).
  • the acoustic coupler 124 is detachably coupled to acoustic transducer 122 such that different acoustic couplers 124 can be used for different patients or for different treatment protocols. For example, different acoustic couplers 124 can have different transmission or focusing of acoustic waves.
  • a kit can include the apparatus 100 with a set of different acoustic couplers, each acoustic coupler having different transmission characteristics than each other acoustic coupler.
  • the apparatus 100 can further include a focusing or diverging element to adjust the power directed toward the lungs of the patient.
  • the apparatus 100 can include the focusing or diverging element between the acoustic transducer 122 and the acoustic coupler 124 (not shown).
  • the apparatus 100 can include the focusing or diverging element between the acoustic coupler 124 and the chest of the patient.
  • various lenses e.g., a curved lens to focus acoustics or disperse acoustics
  • various fluid mediums e.g., liquid, oil, gel, water or polymer
  • the focusing or diverging element can include a chamber filled with a gas, such as a balloon or other pliable containers filled with air.
  • the gas can be heavier than air, such as carbon dioxide, oxygen, propane, xenon, radon, krypton, or any other suitable gas.
  • the focusing or diverging element can van,' the depth of the acoustic waves, focus the sound on a specific area or component (e.g., mucus plug), or diverge the acoustic impact over a wider area.
  • a water layer between the acoustic transducer 122 and the patient can serve as a suitable medium for conducting sound into the patient. By varying the water path for focused transducers, one can control the depth of the sound that is focused within the patient.
  • the acoustic transducer 122 can have a curved piezoelectric element.
  • the acoustic transducer 22 can have a curved lens. In such embodiments, the acoustic transducer 122 can produce a focused sound beam.
  • the focusing or diverging element can be part of the acoustic coupler 124.
  • the acoustic coupler 124 can include a chamber filled with fluid such as water, oil, gel, or polymer, which is configured to focus or diverge acoustic waves.
  • the focusing or diverging element can be part of the acoustic transducer 122, In some embodiments, the shape and length of the transducer can be configured to focus or diverge acoustic waves.
  • the acoustic transducer 122 can include a phased array.
  • a phased array usually includes an array of piezoelectric elements, each of which can convert electrical signals into acoustic waves. These piezoelectric elements are individually excited by electric pulses at programmed delay times and the individual acoustic wave generated by the piezoelectric elements can interference with each other (also referred to as coherent with each other) before converging into a single output acoustic beam. The interference among these individual output acoustic waves allows electronic and dynamic beam control.
  • the setting of timing at each individual piezoelectric element can direct the output acoustic beam toward a designated direction (i.e., direction control). In some embodiments, the setting of timing at each individual piezoelectric element can focus or diverge the output acoustic beam.
  • the apparatus 100 can include a cooling head disposed in the treatment interface 120 so as to dissipate heat generated by the acoustic transducer 122.
  • the apparatus 100 can include a seal that can conformally couple the acoustic coupler 124 to the chest of the patient.
  • the apparatus 100 can include a noise reduction element to reduce noise level and increase comfort level for the patient during treatment.
  • the apparatus 100 can further includes a processor (not shown in FIG. 1) to analyze data such as, for example, attributes of the acoustic wave applied to the patient (e.g., frequency, amplitude, power, duration, etc.), measurement of respiratory activities of the patient, and/or the monitoring of possible mucus excess in the lungs via ultrasonic imaging or other methods.
  • the processor is further configured to control the operation of the apparatus 100 based on the analyzed data.
  • the processor is configured to control the operation of components in the apparatus 100, such as to control the operation of the frequency generator 112, the amplifier 114, and/or the acoustic transducer 122.
  • the apparatus 100 can further include a power source (not shown in FIG. 1), such as, but not limited to, replaceable batteries such as button cells, an integrated battery, a rechargeable battery (including an inductively-rechargeable battery), capacitors, super-capacitors, and/or the like.
  • a power source such as, but not limited to, replaceable batteries such as button cells, an integrated battery, a rechargeable battery (including an inductively-rechargeable battery), capacitors, super-capacitors, and/or the like.
  • the apparatus 100 can further include a memory (not shown in FIG 1 ), and optionally a database.
  • the memory can independently be, for example, a random access memory (RAM), a memory buffer, a hard drive, a database, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), Flash memory, and/or so forth.
  • RAM random access memory
  • EPROM erasable programmable read-only memory
  • EEPROM electrically erasable read-only memory
  • ROM read-only memory
  • Flash memory Flash memory
  • the processor can be, for example, a general pote processor, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and/or the like.
  • the processor can be configured to run and/or execute application processes and/or other modules, processes and/or functions associated with the apparatus 100.
  • the processor can include one or more components/modules (not shown), where each can independently be a hardware component/module and/or a software component/module.
  • each of the components/modules can be operatively coupled to each other.
  • the functionality of one or more of the components/modules can be combined and/or overlap.
  • the functionality of one or more components/modules and/or the interaction between the components/modules can be based on regulatory requirements for data processing, storage, integrity, security, and/or the like.
  • the modules can be implemented in the processor, while in other embodiments, the components/modules, or a portion thereof, can be distributed, and implemented in other processors and/or network devices.
  • processors and/or network devices can be communicatively coupled via, for example, a network.
  • FIG. 2 illustrates a schematic of an apparatus 200 including a controller for clearing airways in lungs of a patient.
  • the apparatus 200 includes a main unit 210 to provide an electrical signal, a treatment interface 220 to convert the electrical signal into acoustic waves and direct the acoustic waves toward the lungs of one or more patients, and a feedback system 230 to monitor the effects of the treatment and adjust the operation of the main unit 210 and the treatment interface 220 accordingly.
  • the main unit 210 includes a microcontroller 215 (e.g., structurally and/or functionally similar to the processor described for FIG. 1) with associated memory 216 (e.g., similar to the memory described for FIG. 1) to digitally generate the electrical signals, which are then converted into analog signals and provided to an amplifier 214.
  • the patient or the therapist can communicate with the apparatus 200 via a user interface 217, such as a keypad, keyboard, touchscreen, and/or the like.
  • An optional display unit 219 such as a LCD, can display information about the treatment.
  • the information can include, for example, the power, frequency, amplitude, or duration of the acoustic waves.
  • the information can also include remaining treatment time and/or any other relevant information of the treatment.
  • the memory 216 can be used by the microcontroller 215 to store historical data on the frequencies, amplitudes, duration, time, and date of each individual treatment sessions.
  • the data in the memory 216 can be transferred to, for example, a portable computer or any other such device, via an Input/Output port 218 and/or a wireless link (not shown),
  • the user interface 217 and the display 219 can be combined into a touchscreen.
  • a patient or operator can use the touchscreen to control the operation of the apparatus 200.
  • the treatment interface 220 includes an acoustic transducer 222 to convert electrical signals into acoustic waves and an acoustic coupler 224 to transmit the generated acoustic waves toward lungs of the patient.
  • the acoustic transducer 222 and the acoustic coupler 224 can be substantially the same as the acoustic transducer 22 and the acoustic coupler 124 as shown in FIG. I and described above and therefore are not described in detail here.
  • the feedback system 230 can include a detector to monitor the treatment and provide control signal to the main unit 210 and the treatment interface 220 based on the monitored treatment activities.
  • the feedback system 230 can include a detector to monitor the acoustic waves applied to the patient, such as the power, frequency, amplitude, and duration of the acoustic waves.
  • the monitored information can be compared to a preset protocol to generate a control signal for the main unit 210 to adjust the application of acoustic waves accordingly.
  • the feedback system 230 can monitor the acoustic waves by measuring the pressure in the acoustic coupler 224.
  • the acoustic coupler 224 can include liquid inside a chamber. The compression or expansion of the liquid can change the distance between the acoustic transducer 222 and the patient, thereby changing the power level of the acoustic waves applied to the patient.
  • the feedback system 230 can derive the power level of the acoustic waves.
  • the feedback system 230 can include an ultrasound feedback component (sometimes also referred to as an ultrasonic feedback component).
  • the acoustic transducer 224 can be configured to generate ultrasonic waves directed to lungs of the patient.
  • the main unit 210 can provide an electrical signal at ultrasonic frequencies (e.g., greater than 20 KHz) and the acoustic transducer 223 can be configured to convert this electrical signal into ultrasonic waves.
  • the feedback system 230 can detect possible locations of mucus "plugs" or heavy impacts in the lungs. This monitoring can allow the patient or operator to determine whether the acoustic coupler 224 is applied at the optimal location on the check of the patient and make adjustment accordingly.
  • the main unit 210 can include a SBC0386EX microcontroller 215 from Micro/Sys®, Flash memory 216, a keypad 217, a RS-232 interface 218, a LCD display 219, and an audio amplifier 214.
  • the treatment interface 210 can include a 3.5 inch woofer model RS400 acoustic transducer 222 from Bazooka® and an acoustic coupling chamber 224 creating a gap of about 1.5 inches between the acoustic transducer 222 and the chest wall of the patient.
  • Microcontroller 215 can digitally generate a sinusoidal electrical signal, which is converted into an analog signal by the internal Digital to Analog Converter (DAC) in the microcontroller's 215 and then provided to audio amplifier 214. The amplifier 214 then feeds the treatment interface 220, which is applied to the patient.
  • DAC Digital to Analog Converter
  • Some embodiments described herein relate to a computer storage product with a non-transitory computer-readable medium (also can be referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations.
  • the computer-readable medium (or processor- readable medium) is non -transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable).
  • the media and computer code also can be referred to as code) may be those designed and constructed for the specific purpose or purposes.
  • non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tape, optical storage media such as Compact Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices.
  • ASICs Application-Specific Integrated Circuits
  • PLDs Programmable Logic Devices
  • ROM Read-Only Memory
  • RAM Random-Access Memory
  • Examples of computer code include, but are not limited to, micro-code or microinstructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter.
  • embodiments may be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and/or development tools.
  • Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.
  • FIG. 3 illustrates a perspective view of a portable device/apparatus 300 for clearing airways in lungs of a patient, according to embodiments.
  • the apparatus 300 includes a main unit 310 (e.g., similar to the main unit 210 and a treatment interface 320 (e.g., similar to the interfaces 120 and 220 shown in FIG. 1 and FIG. 2, respectively).
  • the main unit 310 includes a keypad 317 and a display 319 for a user to control the operation of the device 300.
  • the main unit 310 also includes an I/O interface 318 to transmit data to external devices or to receive data (e.g., treatment protocol) from external devices.
  • the apparatus 300 is configured as a handheld device such that users or patients can conveniently carry out the treatment.
  • the main unit 310 and the treatment interface 320 are connected via a cable (e.g., as shown in FIG. 3 ).
  • the main unit 310 and the treatment interface 320 are connected via a wireless link, such as Bluetooth, WiFi, Infrared communication, 3G network, 4G network, LTE network, or any other method known in the art.
  • the treatment interface 320 (sometimes also referred to as a head) can be removable from the main unit 310.
  • the same main unit 320 can provide electrical signals to multiple treatment interfaces 320.
  • these multiple treatment interfaces 320 can have different settings, such as the thickness of the acoustic coupler, the focal length of possible focusing elements, or different types of acoustic transducers.
  • a user can apply different treatment protocols by placing different treatment interfaces 320 to a same main unit 310.
  • FIG. 4 illustrates placement of a treatment interface 420 of an apparatus (e.g., any of the apparatuses 100, 200, 300) for clearing airways in lungs of a patient, according to embodiments.
  • a treatment interface 420 is placed in specifically positioned pockets 432a and 432b (collectively referred to as pockets 432) on a vest 430 or other clothing apparel.
  • the pockets 432 can be disposed at various locations on the vest or other apparel.
  • the pockets 432a can be placed near the chest of the patient.
  • the pockets 432b can be placed near the abdomen of the patient.
  • FIG. 5 illustrates placement of a treatment interface 520 of an apparatus in a suspender.
  • a treatment interface 520 can be held by some sort of support about the chest of the patient.
  • the treatment interface 520 can be placed in an elastic band 534 held by suspenders 536 and placed across the torso of the patient.
  • FIG. 6 illustrates locations on the chest where acoustic waves can be applied to clear airways in lungs, according to example, non-limiting embodiments.
  • an acoustic wave can be applied to six different locations 610, 620, 630, 640, 650, and 660 on the chest. These locations are generally above or near the lungs.
  • acoustic waves can be applied to one or more of these locations.
  • acoustic waves can be applied from location 610 to location 660 following a clockwise order using, for example.
  • acoustic waves can be applied from location 610 to location 660 following a counterclockwise order.
  • acoustic waves can be applied only on a subset of the six locations 610 to 660 based on an arbitrary pattern, a user-defined pattern, and/or the like.
  • a feedback system e.g., 230 shown in FIG. 2
  • subsequent treatment can be applied on locations where mucus plugs are found.
  • the locations 610 to 660 are located on the front side of the patient (e.g., on the chest). In some embodiments, the locations 610 to 660 can be located on the back of the patient.
  • FIG. 7 illustrates a treating system 700 including a controller 710 and a treatment head 720.
  • the system 700 includes a single transducer assembly 720a configured and/or customized to a single patient.
  • the system 700 includes a transducer assembly 720b configured for use with multiple different patients.
  • the transducer assembly 720b can include one or more modular, replaceable components as illustrated herein such as, for example, a liner, a filter, a diaphragm, a membrane, and/or the like.
  • any of the transducers 720a, 720b and/or the controller 710 can interface with a smart phone, a tablet, or other portable wireless device.
  • the controller 710 is configured to communicate with and control multiple transducers 720 so as to apply treatment protocols for multiple patients.
  • the controller 710 can be configured to control other devices such as a nebulizer to apply medicines.
  • the application of medicine can be based on, for example, treatment effects of the device 700,
  • the controller 710 can include a touchscreen for a user or an operator to control the operation of the system 700.
  • the system 700 can include a compliance tracking or monitoring component.
  • the controller 710 can operate all of the patient's devices (e.g., other treatment devices, nebulizer, etc.) and automatically transmit the treatment information into the wireless controller.
  • the compliance component can also store protocol information and prevent inadvertent operation of the user, if the intended operation is different than the desired operation specified in the protocol.
  • the treatment interfaces 720a, 720b can be configured to apply the acoustic waves through mouth, instead of through the chest cavity,
  • the system 700 can include a device that tests and records lung function before and after airway clearance therapy.
  • the device can test forced expiratory volume (FEV) of the lungs.
  • FEV forced expiratory volume
  • the treatment protocol can be adjusted accordingly.
  • the user can adjust the power, amplitude, frequency of the acoustic waves.
  • FIG. 8 illustrates a method 800 of treating cystic fibrosis and other respiratory pathologies, according to embodiments.
  • an acoustic wave is generated.
  • the acoustic wave has a frequency from about 30 Hertz to about 120 Hertz (e.g., about 30 Hertz, about 40 Hertz, about 50 Hertz, about 60 Hertz, about 70 Hertz, about 80 Hertz, about 90 Hertz, about 100 Hertz, about 110 Hertz, and about 120 Hertz, including all values and sub ranges in between).
  • the acoustic wave is transmitted to a chest of a patient, via an acoustic coupler, to promote expectoration of secretions from the lungs of the patient so as to treat cystic fibrosis and other respiratory pathologies.
  • the method 800 can include an adaptive treatment protocol.
  • the method 800 can further include monitoring a respiratory parameter of the patient and adjusting the parameters) of the acoustic wave applied to the patient based on the measured respirator ⁇ ' parameter.
  • the respiratory parameter can include a forced expiratory volume (FEV) of the patient.
  • FEV forced expiratory volume
  • the patient or another operator can adjust the frequency, amplitude, power, duration, or any other parameter of the acoustic wave applied to the patient so as to optimize the treatment.
  • the adaptive treatment protocol can include detecting possible mucus plugs in the lungs of the patient using ultrasonic waves.
  • the ultrasonic waves can be generated by the same acoustic transducer that generates the acoustic waves.
  • the patient or another operator can adjust the subsequent treatment, such as adjusting the location on the patient's chest where acoustic waves are applied and the parameters of the acoustic waves (e.g., frequency, power, amplitude, duration, etc.).
  • generating the acoustic wave at step 810 of the method can be achieved by converting an electrical signal generating by a frequency generator into an acoustic wave using an acoustic transducer.
  • the acoustic transducer can include a piezoelectric acoustic transducer that can have small size and low power consumption.
  • Some embodiments are directed to a method for treating a patient suffering from cystic fibrosis.
  • the method includes generating an acoustic wave at a frequency of from about 30 Hertz to about 120 Hertz and transmitting, via an acoustic coupler, the acoustic wave toward at least one portion of a chest of the patient to excite bronchial walls of the patient so as to dislodge obstructive fluid in lungs of the patient.
  • the obstructive fluid that can be dislodged can include viscous mucus and/or bronchial secretions.
  • the acoustic wave is configured to propagate in the lungs of the patient to promote expectoration of the secretions.
  • the method 800 can further include monitoring a respiratory parameter of the patient and adjusting at least one attribute of the acoustic wave transmitted toward the at least- one portion of the chest of the patient based on the respiratory parameter.
  • the respirator ⁇ ' parameter can be the forced expiratory volume (FEV) and the attribute of the acoustic wave that can be adjusted includes, but are not limited to, the frequency of the acoustic wave, the amplitude of the acoustic wave, and the duration of the acoustic wave.
  • FEV forced expiratory volume
  • the acoustic wave can be generated as described herein.
  • An electrical signal including at least one of a sinusoidal wave, a square wave, a triangle wave, and a sawtooth wave can be generated (e.g., using a frequency generator).
  • An acoustic transducer such as a piezoelectric acoustic transducer, can convert the electrical signal into the acoustic wave.
  • the generated acoustic wave can be continuous wave (C W).
  • the acoustic wave can include a train of acoustic pulses having a repetition rate of about J Hz (sometimes also referred to as pulsed acoustic wave),
  • the method can further include generating an ultrasonic wave toward the chest of the patient to detect mucus plugs in the lungs of the patient.
  • the ultrasonic waves can be generated by the same acoustic transducer that generates the acoustic waves.
  • the method 800 further includes detecting at least a portion of the ultrasonic wave reflected by the patient, and identifying existence of one or more mucus plugs in the lungs of the patient based on the reflected portion of the ultrasonic wave.
  • Some embodiments are directed to a method for treating a patient suffering from mucus obstruction of lungs.
  • the method can include generating an acoustic wave at a frequency of from about 30 Hertz to about 120 Hertz and transmitting, via an acoustic coupler, the acoustic wave toward at least one portion of a chest of the patient,
  • the acoustic wave is configured to propagate in the lungs of the patient to excite bronchial walls of the patient so as to dislodge the mucus obstruction. In some embodiments, the acoustic wave is configured to propagate in the lungs of the patient to promote expectoration of the mucus obstruction.
  • the method can further include monitoring a respiratory parameter of the patient and adjusting at least one attribute of the acoustic wave transmitted toward the at least one portion of the chest of the patient based on the respiratory parameter.
  • the respiratory parameter can be the forced expiratory volume (FEV) of the patient and the attribute of the acoustic wave that can be adjusted includes, but are not limited to, the frequency of the acoustic wave, the amplitude of the acoustic wave, and the duration of the acoustic wave.
  • FEV forced expiratory volume
  • the acoustic wave can be generated via a two-step process.
  • the process can include generating an electrical signal including at least one of a sinusoidal wave, a square wave, a triangle wave, and a sawtooth wave at a first step.
  • the process can also include a second step to convert the electrical signal into the acoustic wave using an acoustic transducer, such as a piezoelectric acoustic transducer.
  • the acoustic wave can be generated by a phased array, which can generate a focused acoustic wave toward the chest of the patient.
  • the acoustic wave can include continuous wave.
  • the acoustic wave can include a train of acoustic pulses having a repetition rate of about 1 Hz.
  • the acoustic wave can include a mixture of continuous wave and pulsed wave.
  • the method can further include generating an ultrasonic wave toward the chest to detect mucus plugs in the lungs of the patient.
  • the ultrasonic wave can be generated by the same acoustic transducer that generates the acoustic wave, or by another ultrasonic wave source.
  • the method can further include detecting at least a portion of the ultrasonic wave reflected by the patient and identifying existence of one or more mucus plugs in the lungs of the patient based on the reflected portion of the ultrasonic wave.
  • inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein.
  • any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.
  • a computer may be embodied in any of a number of forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computer may be embedded in a device not generally regarded as a computer but with suitable processing capabilities, including a Personal Digital Assistant (PDA), a smart phone or any other suitable portable or fixed electronic device.
  • PDA Personal Digital Assistant
  • a computer may have one or more input and output devices. These devices can be used, among other things, to present a user interface. Examples of output devices that can be used to provide a user interface include printers or display screens for visual presentation of output and speakers or other sound generating devices for audible presentation of output. Examples of input devices that can be used for a user interface include keyboards, and pointing devices, such as mice, touch pads, and digitizing tablets. As another example, a computer may receive input information through speech recognition or in other audible format.
  • Such computers may be interconnected by one or more networks in any suitable form, including a local area network or a wide area network, such as an enterprise network, and intelligent network (IN) or the Internet.
  • networks may be based on any suitable technology and may operate according to any suitable protocol and may include wireless networks, wired networks or fiber optic networks.
  • the various methods or processes may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and/or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.
  • inventive concepts may he embodied as a computer readable storage medium (or multiple computer readable storage media) (e.g., a computer memory, one or more floppy discs, compact discs, optical discs, magnetic tapes, flash memories, circuit configurations in Field Programmable Gate Arrays or other semiconductor devices, or other non-transitory medium or tangible computer storage medium) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods that implement the various embodiments of the invention discussed above.
  • the computer readable medium or media can be transportable, such that the program or programs stored thereon can be loaded onto one or more different computers or other processors to implement various aspects of the present invention as discussed above.
  • program or “software” are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects of embodiments as discussed above. Additionally, it should be appreciated that according to one aspect, one or more computer programs that when executed perform methods of the present invention need not reside on a single computer or processor, but may be distributed in a modular fashion amongst a number of different computers or processors to implement various aspects of the present invention.
  • Computer-executable instructions may be in many forms, such as program modules, executed by one or more computers or other devices.
  • program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types.
  • functionality of the program modules may be combined or distributed as desired in various embodiments.
  • data structures may be stored in computer-readable media in any suitable form.
  • data structures may be shown to have fields that are related through location in the data structure. Such relationships may likewise be achieved by assigning storage for the fields with locations in a computer-readable medium that convey relationship between the fields.
  • any suitable mechanism may be used to establish a relationship between information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish relationship between data elements.
  • inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
  • a reference to "A and/or B", when used in conjunction with open- ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
  • the phrase "at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
  • This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those elements specifically identified.
  • “at least one of A and B" can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.

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Abstract

La présente invention concerne un appareil comprenant un générateur de signaux destiné à générer un signal électrique. L'appareil comprend également une interface patient configurée pour être appliquée à au moins une partie de la poitrine d'un patient pendant l'utilisation. L'interface patient comprend un transducteur acoustique couplé fonctionnellement au générateur de signaux pour convertir le signal électrique en une onde acoustique. L'interface patient comprend en outre un coupleur acoustique couplé fonctionnellement au transducteur acoustique pour émettre l'onde acoustique du transducteur acoustique vers au moins une partie de la poitrine du patient. L'onde acoustique a une fréquence d'environ 30 Hertz à environ 120 Hertz.
PCT/US2016/039251 2015-06-24 2016-06-24 Appareil, systèmes et méthodes de dégagement acoustique des voies respiratoires Ceased WO2016210266A1 (fr)

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EP4304546A4 (fr) * 2021-04-27 2025-01-22 Woojer Ltd Système et procédé de déplacement ou de reformation d'une masse au sein d'un milieu corporel
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