DROPLET DELIVERY DEVICE FOR DELIVERY OF FLUIDS TO THE PULMONARY SYSTEM AND METHODS OF USE

• US 20170319797A1
• Filed: 05/16/2017
• Published: 11/09/2017
• Est. Priority Date: 05/03/2016
• Status: Active Grant

• Current Assignee: Pneuma Respiratory Inc.
• Original Assignee: Pneuma Respiratory Inc.
• Inventors: Germinario, Louis Thomas, Hebrank, John H., Hunter, Charles Eric, Hunter, Jack C., Li, Chengjie, Maurer, Christopher W.
• Granted Patent: US 9,962,507 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/002 by flow deviation causing inertial separation of transported particles
• CPC Class Codes: A61M 11/003 by passing the aerosol trough sieves or filters
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0035 Piercing means
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/021 : operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/022 : Control means therefor
• CPC Class Codes: A61M 16/024 : including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/10 : Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/107 : in the inspiratory path
• CPC Class Codes: A61M 16/1075 : by influencing the temperature A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/108 : before being humidified or mixed with a beneficial agent
• CPC Class Codes: A61M 16/14 : by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 16/142 : with semi-permeable walls separating the liquid from the respiratory gas
• CPC Class Codes: A61M 2016/0018 : electrical
• CPC Class Codes: A61M 2016/0021 : with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 : pressure meter
• CPC Class Codes: A61M 2016/0036 : in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 : in the inspiratory circuit
• CPC Class Codes: A61M 2205/0233 : Conductive materials, e.g. antistatic coatings for spark prevention
• CPC Class Codes: A61M 2205/0238 : the material being a coating or protective layer
• CPC Class Codes: A61M 2205/0294 : Piezoelectric materials
• CPC Class Codes: A61M 2205/103 : rotating
• CPC Class Codes: A61M 2205/27 : preventing use
• CPC Class Codes: A61M 2205/276 : preventing unwanted use
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3327 : Measuring
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/587 : Lighting arrangements
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2206/11 : Laminar flow
• CPC Class Codes: A61M 2207/00 : Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/40 : Respiratory characteristics
• CPC Class Codes: B05B 17/06 : using ultrasonic or other kinds of vibrations
• CPC Class Codes: B05B 17/0646 : Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto
• CPC Class Codes: B05B 7/0012 : Apparatus for achieving spraying before discharge from the apparatus
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A droplet delivery device and related methods for delivering precise and repeatable dosages to a subject for pulmonary use is disclosed. The droplet delivery device includes a housing, a reservoir, and ejector mechanism, and at least one differential pressure sensor. The droplet delivery device is automatically breath actuated by the user when the differential pressure sensor senses a predetermined pressure change within housing. The droplet delivery device is then actuated to generate a stream of droplets having an average ejected droplet diameter within the respirable size range, e.g, less than about 5 μm, so as to target the pulmonary system of the user.

Claims

1. An electronically actuated droplet delivery device for delivering a fluid as an ejected stream of droplets to the pulmonary system of a subject, the device comprising:

a housing;

a reservoir disposed within or in fluid communication with the housing for receiving a volume of fluid;

an electronically actuated ejector mechanism in fluid communication with the reservoir configured to generate an ejected stream of droplets;

at least one differential pressure sensor positioned within the housing;

the at least one differential pressure sensor configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the housing to thereby generate an ejected stream of droplets;

the ejector mechanism configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 10 microns, such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of a subject during use.

2. The droplet delivery device of claim 1, wherein the ejector mechanism comprises a piezoelectric actuator and an aperture plate, the aperture plate having a plurality of openings formed through its thickness and the piezoelectric actuator operable to oscillate the aperture plate at a frequency to thereby generate an ejected stream of droplets.

3. The droplet delivery device of claim 2, further comprising a surface tension plate between the aperture plate and the reservoir arranged in parallel orientation, wherein the surface tension plate is configured to increase contact between the volume of fluid and the aperture plate.

4. The droplet delivery device of claim 3, wherein the surface tension plate is located within 2 mm of the aperture plate so as to create sufficient hydrostatic force to provide capillary flow between the surface tension plate and the aperture plate.

5. The droplet delivery device of claim 2, wherein the aperture plate comprises a domed shape.

6. The droplet delivery device of claim 2, wherein the aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), Ni, NiCo, Pd, Pt, NiPd, metal alloys, and combinations thereof.

7. The droplet delivery device of claim 2, wherein one or more of the plurality of openings have different cross-sectional shapes or diameters to thereby provide ejected droplets having different average ejected droplet diameters.

8. The droplet delivery device of claim 2, further comprising a laminar flow element located at the airflow entrance side of the housing and configured to facilitate laminar airflow across the exit side of aperture plate and to provide sufficient airflow to ensure that the ejected stream of droplets flows through the droplet delivery device during use.

9. The droplet delivery device of claim 8, further comprising a mouthpiece coupled with the housing opposite the laminar flow element.

10. The droplet delivery device of claim 1, wherein the ejector mechanism is orientated with reference to the housing such that the ejected stream of droplets is directed into and through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing.

11. The droplet delivery device of claim 1, wherein the reservoir is removably coupled with the housing.

12. The droplet delivery device of claim 1, wherein reservoir is coupled to the ejector mechanism to form a combination reservoir/ejector mechanism module, and the combination reservoir/ejector mechanism module is removably coupled with the housing.

13. The droplet delivery device of claim 1, further comprising a wireless communication module.

14. The droplet delivery device of claim 13, wherein the wireless communication module is a Bluetooth transmitter.

15. The droplet delivery device of claim 1, wherein the device further comprises one or more sensors selected from an infer-red transmitter, a photodetector, an additional pressure sensor, and combinations thereof.

20. A method of filtering large droplets from an aerosolized plume using inertial forces, the method comprising:

generating an ejected stream of droplets using the droplet delivery device of claim 1,

wherein the ejector mechanism is orientated with reference to the housing such that the ejected stream of droplets is directed into and through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing; and

wherein droplets having an diameter greater than about 5 μ

m are deposited on the sidewalls of the housing due to inertial forces, without being carried in entrained airflow through and out of the droplet delivery device to the pulmonary system of the subject.

16. A breath actuated droplet delivery device for delivering a fluid as an ejected stream of droplets to the pulmonary system of a subject, the device comprising:

a housing;

a combination reservoir/ejector mechanism module in fluid communication with the housing for receiving a volume of fluid and generating an ejected stream of droplets;

the ejector mechanism comprising a piezoelectric actuator and an aperture plate comprising a domed shape, the aperture plate having a plurality of openings formed through its thickness and the piezoelectric actuator operable to oscillate the aperture plate at a frequency to thereby generate the ejected stream of droplets;

at least one differential pressure sensor positioned within the housing;

the at least one differential pressure sensor configured to activate the ejector mechanism to generate the ejected stream of droplets upon sensing a pre-determined pressure change within the housing when a subject applies an inspiratory breath to an airflow exit side of the housing;

the ejector mechanism configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 10 microns, such that at least about 50% of the mass of the ejected stream of droplets is delivered in a respirable range to the pulmonary system of the subject during use.

17. The droplet delivery device of claim 16, wherein the domed-shape aperture plate is composed of a material selected from the group consisting of poly ether ether ketone (PEEK), polyimide, polyetherimide, polyvinylidine fluoride (PVDF), ultra-high molecular weight polyethylene (UHMWPE), Ni, NiCo, Pd, Pt, NiPd, metal alloys, and combinations thereof.

18. The droplet delivery device of claim 16, further comprising a laminar flow element located at an airflow entrance side of the housing and configured to facilitate laminar airflow across the exit side of aperture plate and to provide sufficient airflow to ensure that the ejected stream of droplets flows through the droplet delivery device during use.

19. The droplet delivery device of claim 16, further comprising a mouthpiece coupled with the housing opposite the laminar flow element.