U.S. patent application number 15/672021 was filed with the patent office on 2017-12-28 for systems and methods of aerosol delivery with airflow regulation.
The applicant listed for this patent is DARREN RUBIN. Invention is credited to DARREN RUBIN.
Application Number | 20170368273 15/672021 |
Document ID | / |
Family ID | 60675191 |
Filed Date | 2017-12-28 |
United States Patent
Application |
20170368273 |
Kind Code |
A1 |
RUBIN; DARREN |
December 28, 2017 |
SYSTEMS AND METHODS OF AEROSOL DELIVERY WITH AIRFLOW REGULATION
Abstract
Systems and methods are provided for aerosolizing and delivering
therapeutic substances in an electronic aerosol delivery device
with airflow regulation. Calibrated airflow resistance settings
enable adjustment and control of flow velocity and or flow volume
of air, aerosolized air, and or entrained aerosol particles,
through the device, for optimal aerosol delivery among diverse
conditions and applications.
Inventors: |
RUBIN; DARREN; (Largo,
FL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
RUBIN; DARREN |
Largo |
FL |
US |
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|
Family ID: |
60675191 |
Appl. No.: |
15/672021 |
Filed: |
August 8, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13969847 |
Aug 19, 2013 |
9757528 |
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15672021 |
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12806874 |
Aug 23, 2010 |
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13969847 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/3653 20130101;
A61M 2205/8268 20130101; A61M 2210/065 20130101; A61M 2016/0039
20130101; A61M 16/209 20140204; A61M 2210/1039 20130101; A61M 15/02
20130101; A61M 15/0093 20140204; A24F 47/008 20130101; A61M 16/204
20140204; A61M 2202/064 20130101; A61M 2205/505 20130101; A61M
11/06 20130101; A61M 15/0066 20140204; A61M 11/042 20140204; A61M
2205/52 20130101; A61M 2016/0033 20130101; A61M 2210/1035 20130101;
A61M 11/047 20140204; A61M 15/0095 20140204; A61M 16/0093 20140204;
A61M 2210/1028 20130101; A61M 2205/13 20130101; A61M 16/1055
20130101; A61M 2205/6072 20130101; A61M 11/005 20130101; A61M 15/06
20130101; A61M 15/025 20140204; A61M 15/0008 20140204; A61M 15/0085
20130101; A61M 15/0091 20130101; A61M 16/1065 20140204; A61M 16/14
20130101; A61M 16/0866 20140204; A61M 2205/8206 20130101; A61M
11/041 20130101; A61M 2210/0618 20130101; A61M 15/0028 20130101;
A61M 15/008 20140204; A61M 16/105 20130101; A61M 2210/1032
20130101; A61M 16/101 20140204; A61M 2016/0027 20130101; A61M
2205/6018 20130101; A61M 2205/8237 20130101; A61M 2205/6054
20130101; A61M 2202/30 20130101; A61M 2205/8262 20130101; A61M
11/007 20140204; A61M 15/002 20140204 |
International
Class: |
A61M 11/04 20060101
A61M011/04; A61M 16/10 20060101 A61M016/10; A61M 16/14 20060101
A61M016/14; A24F 47/00 20060101 A24F047/00; A61M 15/00 20060101
A61M015/00 |
Claims
1. An aerosol delivery device having a structure comprising a
housing, an at least one ambient/unaerosolized air inlet, an at
least one aerosolized air outlet, and an at least one airflow
passage therebetween/therein; said aerosol delivery device further
comprising an at least one aerosol generating element producing an
aerosol from an at least one aerosolizable substance or formulation
with the use of electrical energy and without the use of
compressed/pressurized gas; said aerosol delivery device further
having an at least one airflow through said housing produced by a
user inhaling from said aerosol delivery device and entraining said
aerosol when generated; wherein said at least one airflow is
controllable in velocity, volume, or a combination thereof as said
at least one ambient/unaerosolized air inlet, said at least one
aerosolized air outlet, said at least one airflow passage, or a
combination thereof undergoes an at least one physical change
selected from changes in size, angle, shape, biasing resistance to
flow, number of apertures, shunting of airflow, or a combination
thereof; said at least one physical change is modulated by
user/digital input to control said at least one airflow and to
regulate an at least one parameter selected from user inhalation
resistance, user inhalation duration, user inhalation rate, aerosol
delivery efficiency, targeting of aerosol to different user airway
regions, or a combination thereof.
2. The aerosol delivery device as set forth in claim 1 wherein said
user/digital input is selected from user inhalation, user touch,
user speech/sound, user programming, user selection, or a
combination thereof.
3. The aerosol delivery device as set forth in claim 1 further
comprising at least two physical change settings when said at least
one physical change is modulated by user/digital input.
4. The aerosol delivery device as set forth in claim 1 further
comprising marked/digitized indicia, preferably calibrated indicia,
adapted to be presented to the user and further representing said
at least one parameter selected from user inhalation resistance,
user inhalation duration, user inhalation rate, aerosol delivery
efficiency, targeting of aerosol to different user airway regions,
or a combination thereof.
5. The aerosol delivery device as set forth in claim 1 further
comprising an at least one airflow sensor, pressure sensor, or a
combination thereof.
6. The aerosol delivery device as set forth in claim 1 further
comprising an at least one airflow indicator, pressure indicator,
or a combination thereof.
7. The aerosol delivery device as set forth in claim 1 further
comprising an at least one airflow valve, pressure valve, or a
combination thereof.
8. The aerosol delivery device as set forth in claim 1 further
comprising said at least one aerosolizable substance or
formulation, said at least one aerosolizable substance or
formulation preferably comprising epinephrine, bronchodilator,
anticholinergic, nicotine, cannabinoid, opioid, insulin,
antibiotic, prostacyclin, interluekin, cytokine, vaccine,
immunosuppressant, immunomodulator, immunotherapy, chemotherapy, or
combination, analogue, or derivative thereof.
9. The aerosol delivery device as set forth in claim 1 further
comprising an at least one holding/storage area, chamber,
reservoir, or combination thereof for said at least one
aerosolizable substance or formulation.
10. The aerosol delivery device as set forth in claim 1 further
comprising an at least one power button/switch.
11. The aerosol delivery device as set forth in claim 1 further
comprising an at least one airflow filter.
12. The aerosol delivery device as set forth in claim 1 wherein
said at least one airflow through said housing produced by said
user inhaling from said aerosol delivery device interacts with at
least one additional airflow through said housing produced by said
user inhaling from said aerosol delivery device so that these
airflows meet in at least partially counterposing directions to at
least partially negatively interfere with each other; the resulting
at least partial negative interference adapted to change/control
the velocity and or trajectory of at least one of these
airflows.
13. The aerosol delivery device as set forth in claim 1 wherein
said at least one airflow through said housing produced by said
user inhaling from said aerosol delivery device interacts with at
least one additional airflow through said housing produced by said
user inhaling from said aerosol delivery device so that these
airflows meet in at least somewhat parallel directions to at least
partially positively interfere with each other; the resulting at
least partial positive interference adapted to enhance the velocity
and trajectory of at least one of these airflows.
14. The aerosol delivery device as set forth in claim 1 wherein an
at least one angle of incidence between at least two said at least
one airflow through said housing produced by said user inhaling
from said aerosol delivery device is modulated by user/digital
input to control said at least one airflow.
15. The aerosol delivery device as set forth in claim 1 wherein an
at least one angle of incidence between at least two said at least
one airflow through said housing produced by said user inhaling
from said aerosol delivery device is modulated automatically by
airflow, user inhalation rate, user inhalation force, airflow
sensor relay feedback or a combination thereof.
16. The aerosol delivery device as set forth in claim 1 wherein an
at least one angle of incidence between at least two said at least
one airflow through said housing produced by said user inhaling
from said aerosol delivery device is modulated to limit/restrict
airflow, airflow velocity, airflow volume, or a combination
thereof.
17. The aerosol delivery device as set forth in claim 1 wherein an
at least one angle of incidence between at least two said at least
one airflow through said housing produced by said user inhaling
from said aerosol delivery device is modulated to control/change
airflow, airflow velocity, airflow volume, or a combination
thereof.
18. The aerosol delivery device as set forth in claim 1 further
comprising an at least one dial, switch, valve, lever, or a
combination thereof to control said at least one airflow.
19. The aerosol delivery device as set forth in claim 1 further
comprising at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by said at least one
aerosol generating element.
20. The aerosol delivery device as set forth in claim 1 further
comprising at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by said at least one
aerosol generating element; the selection of said at least two
aerosol generating settings determined automatically by airflow,
user inhalation rate, user inhalation force, or a combination
thereof.
21. The aerosol delivery device as set forth in claim 1 further
comprising at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by said at least one
aerosol generating element; the selection of said at least two
aerosol generating settings determined automatically by airflow,
user inhalation rate, user inhalation force, type of said
aerosolizable substance/formulation, or a combination thereof, by a
relay/feedback from an at least one airflow sensor, pressure
sensor, reader, or a combination thereof.
22. The aerosol delivery device as set forth in claim 1 further
adapted to provide for a sustained maximal inhalation when a user
is able to sustain for a period of inhalation a negative pressure,
airflow rate, or a combination thereof that is at least as great as
the negative pressure threshold setting, airflow rate threshold
setting, or a combination thereof selected by said user/digital
input.
23. The aerosol delivery device as set forth in claim 1 further
adapted to provide strength training of the muscles involved in
respiration and help maintain lung elasticity.
24. The aerosol delivery device as set forth in claim 1 further
adapted to provide incentive inhalation feedback to said user; said
incentive inhalation feedback selected from visual incentive
signals, auditory incentive signals, vibrations, or a combination
thereof.
25. The aerosol delivery device as set forth in claim 1 further
adapted to only allow ambient/unaerosolized air to enter when said
user is inhaling or inhaling sufficiently from said aerosol
delivery device.
26. The aerosol delivery device as set forth in claim 1 wherein
aerosol generation is activated/actuated and coordinated with the
breathing cycle so that said aerosolizable substance or formulation
is conserved until/between periods of user inhalation.
27. The aerosol delivery device as set forth in claim 1 further
adapted to provide proper breathing technique/training for
optimized aerosol delivery.
28. The aerosol delivery device as set forth in claim 1 further
adapted to limit/constrain airflow, airflow velocity, airflow
volume, airflow rate, user inhalation rate, user generated negative
pressure, or a combination thereof to a range conducive for aerosol
delivery efficiency, accuracy and precision, and limiting or
preventing deviation; limiting or preventing intra-user and or
inter-user variability when using said aerosol delivery device.
29. The aerosol delivery device as set forth in claim 1 further
adapted to selectively target aerosols to one or more different
airway regions; one or more different airway regions comprising the
upper airways, upper respiratory tract, nasal cavity, pharynx,
larynx, lower airways, lower respiratory tract, trachea, bronchi,
lungs, bronchioles, deep lung, alveoli where systemic exchange
takes place, or a combination thereof.
30. The aerosol delivery device as set forth in claim 1 further
adapted to receive electrical energy from an electrical wall
socket/outlet, battery, rechargeable battery, or a combination
thereof to power said at least one aerosol generating element.
31. The aerosol delivery device as set forth in claim 1 further
adapted to receive electrical energy to recharge an at least one
associated battery that powers said at least one aerosol generating
element; said electrical energy is received via an at least one
power adapter, AC/DC power adapter, AC power connector, AC adapter
inlet/socket, AC adapter outlet, AC power adapter, AC adapter power
cord, AC power cord, DC power connectors, DC adapter inlet/socket,
DC adapter outlet, DC power adapter, DC adapter power cord, DC
power cord, male USB fitting, female USB fitting, USB adapter
inlet/socket, USB adapter outlet, USB power adapter, USB power
cord, USB cord, male micro-USB fitting, female micro-USB fitting,
micro-USB adapter inlet/socket, micro-USB adapter outlet, micro-USB
power adapter, micro-USB power cord, micro-USB cord, male mini-USB
fitting, female mini-USB fitting, mini-USB adapter inlet/socket,
mini-USB adapter outlet, mini-USB power adapter, mini-USB power
cord, mini-USB cord, fuel cell, micro-turbine, wireless power
transfer source, inductive coupling receiver, capacitive coupling
receiver, charging pad/surface, or a combination or derivative
thereof.
32. The aerosol delivery device as set forth in claim 1 wherein
said at least one ambient/unaerosolized air inlet, said at least
one aerosolized air out, and said at least one airflow passage
therebetween/therein are structurally associated with an at least
one aerosol chamber of said aerosol delivery device.
33. The aerosol delivery device as set forth in claim lfurther not
associated with nor having compressed/pressurized gas.
34. The aerosol delivery device as set forth in claim 1 further
comprising at least two different aerosolizable substances or
formulations and further aerosolizing said at least two different
aerosolizable substances or formulations separately, sequentially,
or simultaneously.
35. An aerosol delivery device having a structure comprising a
housing, an at least one air inlet, an at least one aerosolized air
outlet, and an at least one airflow passage therebetween/therein;
said aerosol delivery device further comprising an at least one
aerosol generating element producing an aerosol from an at least
one aerosolizable substance or formulation with the use of
electrical energy to produce vaporizing heat, vibration, or a
combination thereof, without the use of compressed/pressurized gas;
said aerosol delivery device further having an at least one airflow
through said housing produced by a user inhaling from said aerosol
delivery device and entraining said aerosol when generated; said
aerosol delivery device further having an at least one rechargeable
battery that at least powers the at least one aerosol generating
element; said at least one rechargeable battery receives electrical
energy via an at least one power adapter, AC/DC power adapter, AC
power connector, AC adapter inlet/socket, AC adapter outlet, AC
power adapter, AC adapter power cord, AC power cord, DC power
connectors, DC adapter inlet/socket, DC adapter outlet, DC power
adapter, DC adapter power cord, DC power cord, male USB fitting,
female USB fitting, USB adapter inlet/socket, USB adapter outlet,
USB power adapter, USB power cord, USB cord, male micro-USB
fitting, female micro-USB fitting, micro-USB adapter inlet/socket,
micro-USB adapter outlet, micro-USB power adapter, micro-USB power
cord, micro-USB cord, male mini-USB fitting, female mini-USB
fitting, mini-USB adapter inlet/socket, mini-USB adapter outlet,
mini-USB power adapter, mini-USB power cord, mini-USB cord, fuel
cell, micro-turbine, wireless power transfer source, inductive
coupling receiver, capacitive coupling receiver, charging
pad/surface, or a combination or derivative thereof.
36. An aerosol delivery device having a structure comprising a
housing, an at least one air inlet, an at least one aerosolized air
outlet, and an at least one airflow passage therebetween/therein;
said aerosol delivery device further comprising an at least one
aerosol generating element producing an aerosol from an at least
one aerosolizable substance or formulation with the use of
electrical energy and without the use of compressed/pressurized
gas; said aerosol delivery device further having an at least one
airflow through said housing produced by a user inhaling from said
aerosol delivery device and entraining said aerosol when generated;
said aerosol delivery device further having an adjustable airflow
restriction of said at least one airflow as said at least one air
inlet, said at least one aerosolized air outlet, said at least one
airflow passage, or a combination thereof undergoes an at least one
physical change selected from changes in size, angle, shape,
biasing resistance to flow, number of apertures, shunting of
airflow, or a combination thereof; said at least one physical
change is modulated by user/digital input to control said
adjustable airflow restriction and to regulate an at least one
parameter selected from user inhalation resistance, user inhalation
duration, user inhalation rate, aerosol delivery efficiency,
targeting of aerosol to different user airway regions, or a
combination thereof.
37. An aerosol delivery device having a structure comprising a
housing, an at least one air inlet, an at least one aerosolized air
outlet, and an at least one airflow passage therebetween/therein;
said aerosol delivery device further comprising an at least one
aerosol generating element producing an aerosol from an at least
one aerosolizable substance or formulation with the use of
electrical energy and without the use of compressed/pressurized
gas; said aerosol delivery device further having an at least one
airflow through said housing produced by a user inhaling from said
aerosol delivery device and entraining said aerosol when generated;
said aerosol delivery device further having an at least one
negative pressure within said housing produced by a user inhaling
from said aerosol delivery device; wherein said at least one
negative pressure is adjustable as said at least one air inlet,
said at least one aerosolized air outlet, said at least one airflow
passage, or a combination thereof undergoes an at least one
physical change selected from changes in size, angle, shape,
biasing resistance to flow, number of apertures, shunting of
airflow, or a combination thereof; said at least one physical
change is modulated by user/digital input to control said at least
one negative pressure and to regulate an at least one parameter
selected from user inhalation resistance, user inhalation duration,
user inhalation rate, aerosol delivery efficiency, targeting of
aerosol to different user airway regions, or a combination thereof.
Description
RELATED APPLICATION
[0001] The present application is a continuation-in-part of pending
U.S. patent application Ser. No. 13/969,847 filed on Aug. 19, 2013,
which is a continuation-in-part of U.S. patent application Ser. No.
12/806,874 filed on Aug. 23, 2010, now abandoned, the subject
matter of which applications is incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The present invention provides an aerosol delivery device
having structures and methods for providing controlled airflow and
aerosol entrainment through the device to optimize aerosol delivery
under a greater range of conditions.
BACKGROUND OF THE INVENTION
[0003] Aerosol delivery devices of known designs and configurations
previously devised and utilized for the purpose of administering
aerosolizable substances and medicament dosages through
conventional methods and apparatuses are known to consist basically
of familiar, expected, and obvious structural configurations,
notwithstanding the myriad of designs encompassed by the crowded
art which has been developed for the fulfillment of countless
objectives and requirements. Such aerosol delivery devices make it
possible to introduce substances to the respiratory system
generally via simple inhalation. Some aerosol delivery devices
utilize compressed air or pressurized gas, including jet nebulizers
and pressurized metered dose inhaler (MDI) canisters, while others,
like the present invention, do not; instead, relying on electrical
energy and vibrating/heating elements to aerosolize a substance for
inhalation.
[0004] As there is a myriad of ways to generate aerosol, there is
also a myriad of ways to store the medicament formulation,
including liquid reservoirs, pressurized canisters, cartridges, as
well as in blister strips or dosage packets.
[0005] The term "aerosol" is understood in the context of the
present invention to mean a preferably nebulous collection of
atomized liquid droplets, fine powder particles, or vapor, often
suspended in air, that can be available for inhalation. Aerosol
particles can be solid or liquid fine particles and come in a
variety of shapes. The term "aerosolizable substance" as used
herein means any substance, including, but not limited to aqueous
liquids, suspensions, and solids and those containing a
pharmacologically active ingredient, which is capable of becoming
an aerosol or having already become an aerosol. The term
"aerosolized therapy" as used herein means any aerosolized liquid
or powder, or the condensation aerosol that forms after
vaporization of a substance, regardless of whether it is
physiologically active. The expression "medicament formulation"
used in the present invention is understood to include, apart from
medicaments, also therapeutic agents or the like, in particular
therefore all types of agents for inhalation, including those which
are active and non-active ingredients. Aerosols may also comprise
water, saline, or flavoring agents. Some substances are
aerosolizable when placed in a liposomal formulation for
aerosolization.
[0006] In most instances, aerosol particles with a mass median
aerodynamic diameter (MMAD) between 0.5 and 5 micrometers are ideal
for lung delivery; whereas, aerosol particles with a MMAD of
greater than 5 micrometers have deposition in the upper airways
rather than the lungs. Aerosol particles with a MMAD of 2 to 5
micrometers have deposition in the bronchi and bronchioles, and
aerosol particles with a MMAD of less than 2 micrometers have
deposition in the alveoli, for deep lung and or systemic delivery.
Selection of MMAD is one method of targeting aerosols to different
airway regions.
[0007] Most aerosol delivery occurs through the mouth, such as via
a mouthpiece, hose, or facemask, but nasal delivery of aerosol is
also possible with a nosepiece or prongs. Some aerosol delivery
devices can also be placed in a respiratory circuit to provide
aerosols to patients on mechanical ventilation.
[0008] There are numerous limitations inherent in prior aerosol
delivery devices, including not being able to provide the optimal
amount of airflow regulation under all conditions of aerosol
delivery. Unlike the present invention, prior aerosol delivery
devices do not accomplish all of the following:
[0009] A) greater control over laminar flow and or flow velocity
and volume of aerosolized air for improved aerosol delivery to user
airways;
[0010] B) greater and longer expansion of user airways, such as
with positive pressure, so that airways are more receptive to
receiving aerosolized medicament formulations;
[0011] C) selective targeting of aerosols to different regions of
the airways, such as the upper airways, lower airways, and or
providing systemic delivery through the pulmonary route;
[0012] D) accommodation of the full range of varying degrees of
user lung function and or inspiratory ability, including, but not
limited to, pediatric patients with small lung volumes, chronic
obstructive pulmonary disease (COPD) patients with compromised lung
function, and adult patients with healthy lung function;
[0013] E) accommodation of more medicament formulations that have
potential for aerosolization; including liquids, suspensions and
solids, droplets and particles, of varying sizes, shapes, weights,
viscosities, and flow dynamic properties.
[0014] Therefore, prior aerosol delivery devices do not provide for
enhanced efficiency of aerosol delivery under a wide range of
medicament formulations, to a wide variety of users and patients,
and to various regions of the airways, as the present invention
does. The present invention, therefore, has the ability to improve
patient treatments for a multitude of ailments and diseases. The
present invention also has the ability to speed drug product
delivery research and development (R&D) time, and may reduce
costs associated with R&D.
[0015] In this respect, the aerosol delivery device according to
the present invention substantially departs from the conventional
concepts and designs of the prior art, and in doing so provides an
apparatus primarily developed for the purpose of providing
controlled airflow through the device to optimize aerosol delivery
under a greater range of conditions.
[0016] More pharmaceuticals are being made available for
inhalation. This includes pharmaceuticals that can be delivered to
the systemic circulation via the pulmonary route. As an improved
drug delivery device, the present invention can improve the
delivery dynamics and targeting of these drugs. Selective targeting
of aerosols to one or more different airway regions can aid in the
targeting of aerosolized chemotherapies against lung cancer.
Selective targeting of aerosols to one or more different airway
regions can also have profound military medicine applications,
including biodefense to counter bioterrorism, by coating upper
airways with antibiotics against anthrax or other infectious
agents, or by providing anticholinergic agents to the systemic
circulation via alveoli as an antidote to nerve agent exposure. The
present invention also has the potential to enhance the
deliverability of drug candidates in development, which has the
potential to reduce drug development costs.
[0017] Therefore, it can be appreciated that there exists a
continuing need for a new and improved aerosol delivery device
which can be used for providing controlled airflow through the
device to optimize aerosol delivery under a greater range of
conditions. In this regard, the present invention substantially
fulfills this need.
SUMMARY OF THE INVENTION
[0018] In view of the foregoing disadvantages inherent in the known
types of aerosol delivery devices of known designs and
configurations, the present invention provides an improved aerosol
delivery device. As such, the general purpose of the present
invention, which will be described subsequently in greater detail,
is to provide a new and improved aerosol delivery device and method
which has all the advantages of prior devices and none of the
disadvantages.
[0019] To attain this, the present invention essentially comprises
a housing with at least one airflow inlet, at least one airflow
outlet, and at least one airflow passage extending therebetween. A
medicinal, therapeutic, or other aerosolizable substance to be
inhaled is provided. Within this housing is at least one
site/element for producing and or dispensing an aerosol to be
entrained by airflow through the device. At least one calibrated
airflow resistance control element with adjustable settings allows
regulation of airflow into, through, and or out of the
invention.
[0020] The present invention is an aerosol delivery device having a
structure comprising a housing, an at least one (ambient) air
inlet, an at least one aerosolized air outlet, and an at least one
airflow passage (extending) therebetween/therein. The aerosol
delivery device further comprises an at least one aerosol
generating element producing an aerosol from an at least one
aerosolizable substance or formulation with the use of electrical
energy and without the use of compressed/pressurized gas. The
aerosol delivery device further has an at least one airflow through
its housing produced by a user inhaling from this aerosol delivery
device and entraining aerosol when generated. The at least one
airflow is controllable in velocity, volume, or a combination
thereof as the at least one air inlet, the at least one aerosolized
air outlet, the at least one airflow passage, or a combination
thereof undergoes an at least one physical change selected from
changes in size, angle, shape, (biasing) resistance to flow, number
of apertures, or a combination thereof. The at least one physical
change is modulated by user/digital input to control the at least
one airflow and or entrained aerosolized air and to regulate an at
least one parameter selected from user inhalation resistance, user
inhalation duration, user inhalation rate, aerosol delivery
efficiency, targeting of aerosol to different user airway regions,
or a combination thereof. In different embodiments, the aerosol
delivery device has an adjustable airflow restriction of the at
least one airflow through the housing, and or an adjustable
negative pressure through the housing, experienced when the user
inhales through the aerosol delivery device. The user can modulate
the at least one physical change of the device by the act of
inhaling itself when the device adjusts automatically in a
non-electric analog manner, such as with valves; or automatically
via sensors, circuitry, and motors. Or, the user can modulate the
at least one physical change of the device by manually moving a
dial, lever, or setting with the user's fingers or hand. Or, the
user can modulate the at least one physical change of the device
via a digital control unit by pressing a button or dial, or by
voice activation, or via software programming or algorithms, or via
a Smartphone or other electronic device.
[0021] There has thus been outlined, rather broadly, the more
important features of the invention in order that the detailed
description thereof that follows may be better understood and in
order that the present contribution to the art may be better
appreciated. There are, of course, additional features of the
invention that will be described hereinafter and which will form
the subject matter of the claims attached.
[0022] In this respect, before explaining at least one embodiment
of the invention in detail, it is to be understood that the
invention is not limited in its application to the details of
construction and to the arrangements of the components set forth in
the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein are for the purpose
of descriptions and should not be regarded as limiting.
[0023] As such, those skilled in the art will appreciate that the
conception, upon which this disclosure is based, may readily be
utilized as a basis for the designing of other structures, methods
and systems for carrying out the several purposes of the present
invention. It is important, therefore, that the claims be regarded
as including such equivalent constructions insofar as they do not
depart from the spirit and scope of the present invention.
[0024] It is therefore an object of the present invention to
provide a new and improved aerosol delivery device which has all of
the advantages of the prior art aerosol delivery devices of known
designs and configurations and none of the disadvantages.
[0025] It is another object of the present invention to provide a
new and improved aerosol delivery device which may be easily and
efficiently manufactured and marketed.
[0026] An even further object of the present invention to provide a
new and improved aerosol delivery device which is of durable and
reliable constructions.
[0027] Lastly, it is an object of the present invention to provide
a new and improved aerosol delivery device for providing controlled
airflow through the device to optimize aerosol delivery under a
greater range of conditions.
[0028] These together with other objects of the invention, along
with the various features of novelty which characterize the
invention, are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages and the
specific objects attained by its uses, reference should be had to
the accompanying drawings and descriptive matter in which there is
illustrated preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The invention will be better understood and objects other
than those set forth above will become apparent when consideration
is given to the following detailed description thereof. Such
description makes reference to the annexed drawings wherein:
[0030] FIG. 1 is a side cross-sectional view of an improved aerosol
delivery device according to the invention that serves as a
portable, sensor activated, electronic aerosol generating device
having a liquid aerosolizable substance or formulation reservoir, a
calibrated airflow resistance control element adjustable by hand,
along with digital inputs and display.
[0031] FIG. 2 is a side view of the aerosol delivery device
described in FIG. 1 showing indicia or calibrated indicia of
airflow resistance settings and or inhalation resistance settings
associated with an airflow path lever. Also shown is a USB power
adapter with cord that plugs into the USB port of the device to
provide electrical energy.
[0032] FIG. 3 is a side cross-sectional view of an alternate
improved aerosol delivery device according to the invention that
serves as a portable, sensor activated, electronic aerosol
generating device having a preformed blister pack, or other
medicament cartridge or packaging, filled with an aerosolizable
substance or formulation instead of having a reservoir. The device
is powered by battery with electronically controlled calibrated
airflow resistance control element, airflow sensors, and digital
auditory and visual outputs.
[0033] FIG. 4 is a side view of the aerosol delivery device
described in FIG. 3 showing user grips for holding the device. Also
shown is a micro/mini-USB power adapter with cord that plugs into
the micro/mini-USB port of the device to provide electrical energy
and or recharge the battery. Calibrated settings can show on the
digital display.
[0034] FIG. 5A shows an outline of an aerosol delivery device
housing according to the invention with several ambient air inlets
having a resilient biasing member that covers them and gradually
opens upon the user exceeding a threshold negative pressure from
inhalation, to automatically adjust airflow through the housing and
user inhalation resistance.
[0035] FIG. 5B shows an alternate outline of an aerosol delivery
device housing according to the invention with several ambient air
inlets, but with no resilient biasing member that covers them.
Instead, a sliding, calibrated resistance control element is
manually adjusted by the user with the digits of the user's fingers
according to calibrating indicia to cover one or more ambient air
inlets to control the airflow through the device housing and other
parameters of inhalation. A USB fitting is shown for which
electrical energy can be received.
[0036] FIG. 6 shows an airflow control diagram outline of a method
for controlling airflow through an aerosol delivery device
according to the invention utilizing the interference of multiple
airflow paths. By changing the angle of incidence of these airflow
paths, the velocity and trajectory of these airflows can be
manipulated to effect aerosol entrainment, aerosol delivery, and
other parameters of user inhalation.
[0037] The same reference numerals refer to the same parts
throughout the various Figures.
DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
[0038] With reference now to the drawings, the preferred
embodiments of the new and improved systems and methods of aerosol
delivery with airflow regulation embodying the principles and
concepts of the present invention will be described in the
following preferred aerosol delivery device embodiments. Wherever
possible, the same reference numbers will be used throughout the
drawings to refer to the same or like parts.
[0039] FIG. 1 shows a side cross-sectional view of a preferred
embodiment example of an aerosol delivery device 1 according to the
invention having a structure comprising a housing 10, an at least
one (ambient) air inlet 19, an at least one aerosolized air outlet
20, and an at least one airflow passage (extending)
therebetween/therein 16. The aerosol delivery device further
comprises an at least one aerosol generating element (11,12,13)
producing an aerosol with the use of electrical energy and without
the use of compressed/pressurized gas. The aerosol delivery device
further has an at least one airflow 27 through its housing 10
produced by a user inhaling from this aerosol delivery device and
entraining aerosol when generated. The at least one airflow 27 is
controllable in velocity, volume, or a combination thereof as the
at least one air inlet 19, the at least one aerosolized air outlet
20, the at least one airflow passage 16, or a combination thereof
undergoes an at least one physical change selected from changes in
size, angle, shape, biasing resistance to flow, number of
apertures, shunting of airflows/airflow paths, or a combination
thereof. This will be described later in further detail.
[0040] The at least one physical change is modulated by
user/digital input to control the at least one airflow and or
entrained aerosolized air and to regulate an at least one parameter
selected from user inhalation resistance, user inhalation duration,
user inhalation rate, aerosol delivery efficiency, targeting of
aerosol to different user airway regions, or a combination thereof.
In various embodiments, the aerosol delivery device has an
adjustable airflow restriction of the at least one airflow through
the housing, and or an adjustable negative pressure through the
housing, experienced when the user inhales through the aerosol
delivery device.
[0041] The aerosol delivery device 1 embodiment of FIG. 1 has an at
least one aerosol generating element (11,12,13), which includes a
vibratable, porous membrane 11 that is caused to oscillate at a
desired frequency by piezoelectric motor assembly 12,13 in response
to an electric drive signal, as will later be explained. The
piezoelectric motor assembly is comprised of a support unit 12 and
a piezoelectrical conversion unit 13, both containing or comprised
of electrically conductive material. Both support unit 12 and
piezoelectrical conversion unit 13 are attached to each other, and
both are attached to vibratable membrane 11.
[0042] The oscillation of vibratable membrane 11, which may include
bending oscillations, causes a liquid aerosolizable substance or
formulation 14, stored within a liquid reservoir 15, to be
atomized/nebulized as this liquid is forced through small pores of
membrane 11. The formulation may be that of an active ingredient in
liposomes. The resulting nebulized aerosol travels into, and
diffuses within, the internal chamber or aerosol holding chamber 5.
Optionally or alternatively, a liquid containing-cartridge or vial
can be placed within the liquid reservoir 15 or take the place of
or serve as the liquid reservoir (not shown).
[0043] One-way valves 17 and 18, preferably duckbill valves, trap
the nebulized aerosol within the device until vacuum pressure, or a
significant threshold vacuum pressure, generated from user
inhalation, is able to open said one-way valves 17 and 18.
Nebulized aerosol is thusly contained in reserve chamber 5 until
airflow 27, originating at one or more airflow inlets 19, carries
the aerosol through the device and out to the end user through the
airflow outlet end 20 of the device.
[0044] Calibrated airflow resistance control element 21, in this
embodiment, consists of a user controlled airflow resistance dial
with one or more supplemental apertures 22. The user controlled
airflow resistance dial 21 is flush with the airflow inlet end of
the device. Rotation of dial 21 aligns supplemental aperture(s) 22
with one or more airflow inlet passages 19, thereby controlling the
amount of airflow 27 allowed to enter the device and travel through
these passages 19, having the affect of controlling the velocity
and or volume of airflow through the device. Therefore, the number
of different apertures 19, 22 is controlled and adjusted by user
input. The airflow resistance settings of this device may also
provide an auditory signal to the user, such as a whistle sound
caused by air passing through the airflow control element.
[0045] Furthermore, the pitch of this whistle sound may vary
between different airflow resistance settings and may allow the
user to distinguish between such settings. Furthermore, the
auditory signal may indicate for user to adjust his or her
inhalation rate.
[0046] The airflow outlet end of the device may contain a
mouthpiece 23 that contours to the user's lips, allowing for an
airtight seal. Said mouthpiece 23 may contain an exhaust port 24,
comprised of an elastomeric one-way, flap, valve, which vents user
exhalation, while one-way valve 18 prevents exhalation from
entering the interior of the device. An optional and or removable
filter housing assembly 40 may be aligned with exhaust port 24, to
allow exhaled air to pass through a filter element 41, and out of
the filter housing 40 (not shown). A preferred filter element 41
may be a 3M filtrate filter, or other HEPA filter, able to capture
infectious particles and aerosol particles larger than 0.3
micrometers in diameter from exhalation, thereby preventing cross
contamination to nearby individuals. A contaminated filter element
may be cleaned or replaced as necessary. Other user interfaces
other than the mouthpiece can be envisioned, including adapters for
a respiratory circuit to provide aerosols to patients on mechanical
ventilation.
[0047] The interior walls of the device, such as along reserve
chamber 5, may be curved and or contain spiral baffles 229 (not
shown) or other baffles to generate a rotational flow of
aerosolized air that enters the device. Said rotational airflow may
surround the aerosol and may more efficiently carry the aerosol out
of the device, while reducing impaction or adhesion of aerosol with
the inner walls of the device. Other baffle designs can be used in
conjunction or alternatively to allow only smaller particles, with
a mass median aerodynamic diameter, MMAD, more ideal for
inhalation, to exit the device.
[0048] The device also comprises an electronic drive means 28 that
sends an electric drive signal through signal lines 29a and 29b to
the piezoelectrical conversion unit 13 and conductive support unit
12, of the piezoelectric motor assembly 12,13. A power source 30,
preferably a rechargeable battery with micro-USB power (cord) port
or USB power (cord) port 37, provides the electrical energy for the
electronic drive means 28. The aerosol delivery device is
preferably a rechargeable device with USB, micro-USB, or mini-USB
power adapter or cord. The device may further comprise a digital
control unit 31, with user inputs 32, and a digital display 33,
such as LCD or LED, and or electroacoustic transducer speaker (not
shown). The digital control unit 31 operates the electronic drive
means 28 through circuit lines 34a and 34b. The digital control
unit may also contain a microprocessor or microelectronic circuit
that can perform one or more functions, such as: setting the
intensity of the electric drive signal, providing visual and or
auditory feedback to the user and or health care worker, providing
an alarm function to signal when a treatment is due, a timer
function to measure the duration of treatment and or to turn off
operation after a certain treatment duration, a counting function
to determine the number of treatments, a function to keep track of
the airflow resistance settings during treatment, a time/date
function to track the treatments of one or more different
medicament formulations, along with any other functions obvious to
the use of this device. Furthermore, the digital control unit may
utilize the USB port 37 and or memory card so that data can be
interfaced with a computer or respiratory instrument.
[0049] The aerosol delivery device may also contain one or more
conductivity sensing leads or panels, touch panels 36, as an
integral component of the mouthpiece that forms a switching circuit
with the digital control unit 31 via circuit leads 35. Conductivity
sensing touch panels 36 receive bioelectricity through a living
being in contact with the touch panel to complete this switching
circuit, which may signal the digital control unit 31 to activate
electronic drive means 28 so that the device may generate or
dispense aerosol only when the user is able to receive such aerosol
delivery. Said touch panels may, therefore, prevent aerosol loss
when the user is not able to receive aerosol. The switching circuit
may include one or more resistors, transistors, grounds,
capacitors, and or any other circuit components necessary for the
function of this circuit. Touch panels 36 may also or instead be
pressure sensing panels that detect user contact with the device.
Alternatively, airflow sensors and or pressure sensors/pressure
transducers, could be used in place of, or in addition to, touch
panels 36, to detect changes in airflow and negative pressure
caused by user inhalation. Likewise, airflow sensors and or
pressure sensors would detect and or monitor user inhalation and
provide such information to the digital control unit 31 that can
interpret the data so as to activate and or regulate aerosol
generation via electronic drive means 28, and or to provide visual
and or auditory feedback to the user and or health care worker.
[0050] Airflow 27 and or entrained aerosolized air passes through
the device housing 10 and internal chamber 5, through an at least
one airflow passage therein 16. This airflow path or passage 16
can, in some embodiments, be adjustable as well. As shown in FIG.
1, the aerosol delivery device 1 can include airflow path lever 25
that can slide and or tilt to change the size, angle, and shape of
the airflow passage 16. Airflow path lever 25 can also include
apertures in it (not shown). Additionally, a biasing member 26,
such as a resilient coil or membrane, can provide resistance to the
movement of the airflow path lever 25 and provide resistance to
airflow 27. The biasing force of biasing member 26 may be linear or
exponential; meaning as the airflow path lever tilts from airflow
27 pushing into it, resistance to tilting may increase linearly or
exponentially with each incremental or continuous movement. As the
airflow path lever 25 tilts with increasing inhalation effort and
increasing airflow 27, it regulates at least one parameter selected
from user inhalation resistance, user inhalation duration, user
inhalation rate, aerosol delivery efficiency, targeting of aerosol
to different user airway regions, or a combination thereof.
[0051] It is to be understood that parameters for controlling
aerosol generation timing and duration, aerosol generation amount,
airflow velocity, airflow volume, airflow restriction, negative
pressure, user inhalation resistance, user inhalation duration,
user inhalation rate, aerosol delivery efficiency, targeting of
aerosol to different user airway regions, physical changes of the
device, or a combination thereof may be optionally performed or
indicated by the digital control unit, and any microprocessor,
electronic chip or circuit thereof, via one or more pre-programmed
and or programmable algorithms stored in the device or optionally
accessible via wireless or blue-tooth from a software application
("app") on a computer, Smartphone, tablet, or diagnostic device. In
certain embodiments, the aerosol delivery device utilizes "machine
learning" of an aerosolizable substance's properties and or a
user's breathing pattern to fine-tune and adjust the algorithm(s)
of the aerosol delivery device to optimize performance and aerosol
delivery, and in a sense, customize that device to a specific
aerosolizable substance and or specific user or patient. In some
embodiments, algorithm(s) and or data generated can be stored in
the device or sent via wireless internet or blue-tooth from an
"app" on a computer, Smartphone, or tablet for users, patients, and
their trainers or physicians to monitor the use and progress on the
device. Therefore, devices of the present invention optionally have
wireless and or blue-tooth connectivity microchips and hardware
(not shown). In other embodiments, wireless connectivity is not
present, and instead the device optionally provides data to an
"app" on a computer, Smartphone, or tablet via a USB cable or
memory card or thumb drive.
[0052] FIG. 2 shows a side view of the aerosol delivery device 1
depicted in the previous figure. Indicia or calibrated indicia 38
of airflow resistance settings and or inhalation resistance
settings are shown associated with airflow path lever 25. User
input of turning the dial or calibrated airflow resistance control
element 21 also influences and modulates airflow 27 and acts on and
effects the optional airflow path lever 25 and its biasing member
26. To the right of the device is an alternating current (AC) wall
socket outlet 52, which the device's USB (AC/DC) power adapter 50
plugs into. A USB charging cable 51 plugs into USB power adapter 50
on one end and plugs into micro-USB power (cord) port 37, or other
format of port, of the device on the other end. The combination of
50, 51, 52, and 37 can power the aerosol delivery device directly,
or recharge its battery or batteries 30, and at least in some
instances, even when the device is in use.
[0053] In an alternative embodiment of the invention, airflow
sensors 36 may also provide feedback of airflow and or breathing
pattern data to a digital control unit, or microprocessor 31, which
can interpret the data and can adjust airflow resistance by sending
an electronic signal to an electric motor controlling a calibrated
airflow resistance control element, such as that described in the
next figure.
[0054] In other embodiments, the piezoelectric motor assembly may
also serve as, or include, or be accompanied by, or be replaced by,
a heat generating element/means to raise the temperature of the air
and or aerosolized liquid droplets within the device to promote
reduced particle size and convection. Electrical resistance
preferably provides the heat energy for the heat generating means,
and so the heat generating element is foremost an electrically
resistive heating element. Furthermore, this heat generating
element may serve as a vaporizing element to vaporize a liquid or
other substance into a condensation aerosol available for
inhalation, and may be used with, or instead of,
ultrasonic/vibrating mesh nebulization, or be a hybrid among them.
Therefore, at least one aerosol generating element (11,12,13) may
also be or instead be a heating or vaporizing element to produce
and deliver aerosols of liquid medicament, e.g., flavored nicotine
solutions and cannabis oils, etc. Electricity can be used to
generate aerosol by vaporizing a medicament formulation with heat
from an electrically resistive heating element, electrothermal
transducer, or thermo-electrical converter, and allowing that
vaporized substance to condense or react in the airflow of the
device. The present invention provides structures, elements, and
methods for vaporization to take place.
[0055] FIG. 3 shows a side cross-sectional view of an alternate
preferred embodiment example of an aerosol delivery device
according to the invention comprising a horn-shaped, first chamber
210. An optional piezoelectric transducer 211 that is made to
oscillate, vibrate, while in contact with the proximal end of first
chamber 210, such as to send vibrations to that chamber 210. A
heating element 212 can be comprised of an electrically resistive
heating support or resistor, and is located in close communication
with the proximal end of first chamber 210, such as to send heat to
that first chamber, including sending heat to an aerosolizable
substance or medicament. The piezoelectric transducer 211 and
heating element 212 may be housed together. A preformed blister
pack 213, or other aerosolizable substance or formulation cartridge
or packaging, filled with a preferably liquid aerosolizable
substance or formulation, but also a gel or solid aerosolizable
substance or formulation, can be housed on a slidable structure,
slide, strip, 214, that can be inserted into first chamber 210,
such as along or near its proximal end. Slide 214 can optionally
contain a coded tag 215, such as a bar code, microchip,
transmitter, radio-frequency identification tag, or other means,
that can be detected and or analyzed by an electronic tag reader
216. Optional tag reader 216 is able to detect the presence of the
blister pack and slide. The coded information detected may also
include the type of aerosolizable substance or medicament and or
also its dosage and or its serial number. If the aerosol delivery
device is to nebulize and or vaporize a non-medicinal substance,
such as a flavored nicotine-containing liquid, the coded tag may
not be necessary. However, if the device is nebulizing and or
vaporizing a prescription drug, such as an opioid or cannabinoid or
other controlled substance or analogue or derivative, then a coded
tag may provide essential information, such as to monitor use and
prevent abuse of the drug products. In some states, cannabinoids or
marijuana or marijuana-derived substances may be used medicinally
or recreationally, in which case, aerosol delivery with this device
would be ideal and optimized. Other ideal drugs for treating
symptoms, conditions, and or diseases can include aerosolized
diabetic drugs such as aerosolized insulin, aerosolized epinephrine
for treating allergic reactions and anaphylaxis/anaphylactic shock,
other bronchodilators for treating asthmatic symptoms, aerosolized
antibiotics for treating infection, aerosolized analgesics for
treating pain, aerosolized prostacyclins and prostacyclin analogues
for treating pulmonary arterial hypertension, immunomodulators for
treating asthma, and aerosolized chemotherapies for treating
cancers including lung cancer. Orphan drug products for treating
cystic fibrosis and organ transplant rejection can also be
delivered efficaciously with this device. Vaccines and other
immunotherapies can also be delivered in this manner. Some
aerosolizable substances can be nebulized and vaporized, while
other aerosolizable substances may be better suited for
vaporization or nebulization due to viscosity or heating
degradation. The present invention allows for all three conditions
to be satisfied and opens the potential to aerosolize virtually all
substances.
[0056] The tag reader 216 may send information through an
electronic circuit 217, preferably wired to a digital control unit
218, with user inputs 219, and a digital display 220, such as LCD
or LED. The digital control unit 218 controls the operation of the
piezoelectric transducer 211 and or heating element 212, using
power from one or more batteries or rechargeable batteries 221.
Preferably, a micro or mini-USB power (cord) port or USB power
(cord) port 260, provides the interface for external electrical
energy for generating aerosol with this device, and or for
recharging batteries 221. In this case, an alternating current (AC)
wall socket outlet 52, which the device's USB (AC/DC) power adapter
50 plugs into would be utilized. Also utilized is a USB charging
cable 51 which plugs into USB power adapter 50 on one end and plugs
into micro-USB power (cord) port 260, or other format of port, of
the device on the other end. The combination of 50, 51, 52, and 260
can power the aerosol delivery device directly, or recharge its
battery or batteries 221, and at least in some instances, even when
the device is in use.
[0057] The detection and or analysis of the coded medicament
information 215, by the reading device 216, may allow the digital
control unit 218 to turn the piezoelectric transducer 211 and or
heating element 212 on for certain durations, and or may determine
the desired power and frequency to operate the piezoelectric
transducer 211, and may determine the desired power and temperature
to heat the heating element 212, for proper delivery
characteristics of that particular medicament code.
[0058] When medicament slide 214 is inserted into the aerosol
delivery device, through the medicament port channel 222, an
optional piercing means or mechanism 223 can remove or cause
openings 224 on the top of blister packaging 213, by which
medicament can be released into the first chamber 210. When
activated, heating element 212 is able to vaporize the medicament
substance from medicament slide 214 by sending thermal energy to
the substance by conduction and or convection. In other
embodiments, heating element 212 can be located on medicament slide
214 as an electrically resistive heating support, such as a metal
foil support, which may even be part of blister packaging 213. As
such, an aerosolizable substance or formulation or medicament may
be coated on this metal foil support. After vaporization,
preferably with minimal degradation products of medicament, the
vapor can cool and condense to form a condensation aerosol
available for inhalation. As will next be described, this vapor can
be efficiently carried to an aerosol holding chamber 225 where the
particles can cool further.
[0059] First chamber 210 is connected to a second chamber 225 via a
narrow orifice or channel 226. Vibration of the proximal end of
first chamber 210 by the vibrations caused by the optional
piezoelectric transducer 211, sets up pressure variations, as well
as standing waves and or acoustic waves, within the first chamber,
causing air in the first chamber 210 to move back and forth through
channel 226, while vortices of air are formed at channel 226,
leading to second chamber 225. A synthetic jet of air 227 is thus
created by these vortices, resulting in the net flow of air from
first chamber 210 into second chamber 225. Vapor and condensation
aerosol is entrained in this airflow and evacuated from first
chamber 210, and carried to the second chamber 225, by a synthetic
jet 227 via channel 226. When the aerosolizable substance is a dry
powder, and the heating element does not vaporize some or all of
the powder, such as when the heating element is not activated or
when the heat transfer is less than 100% efficient, piezoelectric
transducer 211 can still vibrate and mix air in the first chamber
to disaggregate the dry powder released from blister pack 213, to
form an aerosol. The aerosolized dry powder is entrained in the air
and evacuated from first chamber 210, and carried to the second
chamber 225, by a synthetic jet 227 via channel 226. As such, this
aerosol delivery device can serve as a dry powder inhaler. In most
embodiments, the aerosol delivery device is preferably a vaporizer
and or nebulizer. In other words, the device can be a hybrid
between vaporization and nebulization (hybrid vaporizer/nebulizer).
In some embodiments, a switch can determine when the aerosol
generating element performs vaporization or vibrational
nebulization. In other embodiments, the digital control unit 218 or
microprocessor automatically determines the amount of heating or
vibrating for vaporization and or nebulization, which may also tie
into information about the specific aerosolizable substance
inputted by the user or obtained from the coded tag 215 and tag
reader 216. Only electrical energy, and not compressed
air/pressurized gas produces aerosols with this device by providing
kinetic energy to heat or vibrate molecules of aerosolizable
substance.
[0060] Second chamber 225 can serve as an aerosol reserve, holding,
chamber. Airflow enters device chamber 225 through inlet passage
228, where it may be vortexed by the curved interior walls or
spiral baffles 229 of this chamber, before exiting the device via
outlet end 230. Airflow outlet end 230 can consist of a user
mouthpiece 231 that contours to the user's lips, allowing for an
airtight seal. Said mouthpiece 231 may optionally contain an
exhaust port 232, comprised of an elastomeric one-way, flap, valve,
which vents user exhalation, while optional one-way valve 233,
preferably a duckbill valve, prevents exhalation from entering the
interior of the device. The outlet end 230 may have interchangeable
mouthpieces of different sizes to change airflow through it, or may
have a mechanism to be turned to adjust airflow by modulating
airflow restriction (not shown). Other user interfaces other than a
small mouthpiece can be envisioned, including a hose, hose with
mouthpiece, facemask, oxygen mask, nosepiece or nasal prong can be
used alternatively.
[0061] The aerosol delivery device may also contain one or more
airflow sensors 234, that forms a switching circuit with the
digital control unit 218 via circuit leads 235. Detection of user
airflow may signal the digital control unit 218 to activate and or
regulate piezoelectric transducer 211 and or heating element 212
for aerosol delivery. Airflow sensors may also provide feedback of
airflow and or breathing pattern data to a digital control unit, or
microprocessor, 218, which can interpret the data and can adjust
airflow resistance by sending an electronic signal to an electric
motor 236, controlling a calibrated airflow resistance control
element 237 by means of gears 238 and 239. The acoustic horn shape
of this embodiment, along with its associated synthetic jet, is
preferred, although one can envision other embodiments where the
acoustic horn is not used. The main feature of these embodiments
are, however, a calibrated airflow resistance control element 237
that controls the velocity and or volume of airflow through the
device. There exist many ways to achieve this calibrated airflow
resistance control element, and one such way is way is with an
inhalation threshold resistance valve which regulates airflow
entering chamber 225 via inlet 228, thereby, effecting the airflow
through the device 27.
[0062] The airflow resistance valve assembly is comprised of a
rotatable cap 240 with an integrally formed cylindrical wall
slidably received through a cylindrical housing 241. Gear 239 is
connected to, or forms the top of, rotatable cap 240. Gear 239, and
or the top of cap 240, contains one or more air inlet ports 242
that allow airflow to enter airflow resistance control element 237,
which allows airflow to enter chamber 225 via inlet 228, when this
valve is open. Rotatable cap 240 also has a tubular guide 243
extending through it. The tubular guide has female threads 244 that
is designed to receive the male threads of a thin rod 245. A load
calibrated, coiled spring 246, or other resilient or biasing
member, is positioned inside of the rotatable cap 240, around the
tubular guide 243 and thin rod 245. A circular disc 247, along thin
rod 245, is located within a chamber region 248, adjacent to
reserve chamber 225, and serves as the actuator piston of threshold
resistance valve 237. As spring 246 puts outward pressure on
rotatable cap 240, circular disc 247 is pulled against the proximal
surface of chamber 248, thereby blocking this chamber's proximal
aperture 249, which in some embodiments can serve as a Venturi or
Venturi-like structure or function.
[0063] Upon inhalation, when a threshold level of negative
pressure, vacuum pressure, is applied on the valve assembly, the
threshold valve will open as the spring compresses and the actuator
piston moves away from its resting position. Cap 240 is able to
slide within cylindrical housing 241, commensurate with gear 239
being able to slide along gear 238. When the threshold valve is
open, ambient air enters the device through air inlets 242, and
passes through chamber 248 and reserve chamber 225, entraining
aerosolized particles, and carrying these particles out of the
device through outlet 230. The threshold valve closes when negative
pressure within chamber 225, and chamber 248, can no longer
overcome the tension of the spring. The threshold valve 237 also
serves as a calibrated airflow resistance control element. As
electric motor 236 turns gears 238 and 239, cap 240 is rotated like
a dial. When the cap is rotated, the distance that the thin rod 245
screws into the tubular guide 243 of the cap also changes, thereby
affecting the space between the cap 240 and the cylindrical housing
241, and thus, the compression of the spring 246. By varying the
tension of the spring, one can control inhalation resistance,
negative pressure, and the velocity and or volume of airflow
through the device, which may allow for aerosol delivery with
sustained maximal inspiration/inhalation. The number of partial or
full revolutions that the electric motor 236 must spin in order to
turn gears 238 and 239, and thus, cap 240, necessary to adjust the
tension of load calibrated spring 246, is programmed into the
digital control unit 218. Thus, digital control unit 218 can
automatically adjust airflow resistance settings based on user
inputs 219, or from data signals generated from airflow sensor 234.
Other embodiments may utilize a manual means for adjusting
calibrated airflow resistance settings.
[0064] The digital control unit 218 may also contain a
microprocessor that can perform one or more functions, such as:
providing an alarm function to signal when a treatment is due, a
timer function to measure the duration of treatment and or to turn
off operation after a certain treatment duration, a counting
function to determine the number of treatments, a function to keep
track of the airflow resistance settings during treatment, a
time/date function to track the treatments of one or more different
medicament formulations, the ability to store settings for
different medicament formulations, along with any other functions
obvious to the use of this device. The digital control unit 218 may
have an electronic speaker 250 that provides auditory feedback to
the user regarding the user's progress and or to adjust the user's
inhalation rate or breathing pattern, and or to provide the user
with incentive. The electronic speaker may provide human sounding
words to provide such auditory feedback, and may also voice aloud
device settings and functions. The aerosol delivery device can
train the user on proper inhalation technique for optimized aerosol
delivery efficiency, or overcome any incorrect inhalation
technique. The digital control unit may contain a memory card (not
shown) so that data can be interfaced with a computer or
respiratory instrument.
[0065] This embodiment utilizes a medicament strip with a single
medicament blister. One can envision other embodiments where
multiple blisters are housed on the strip, or a device that can
hold and use multiple unit dosages of medicament(s), sequentially.
Other embodiments can include cartridges. Some embodiments can
include at least two different aerosolizable substances or
formulation dosages that can be aerosolized separately and or
simultaneously with this device. Some of these embodiments have
control or selection means to control or select which of these at
least two different aerosolizable substances or formulations are to
be aerosolized and delivered at any given time or times; selected
manually or by digital control. This is desirable when having two
or more life saving emergency drugs, such as epinephrine and an
anticholinergic such as atropine, such as if a soldier is exposed
to nerve agent or anaphylaxis causing agent.
[0066] It is to be understood that parameters for controlling
aerosol generation timing and duration, aerosol generation amount,
airflow velocity, airflow volume, airflow restriction, negative
pressure, user inhalation resistance, user inhalation duration,
user inhalation rate, aerosol delivery efficiency, targeting of
aerosol to different user airway regions, physical changes of the
device, or a combination thereof may be performed by the digital
control unit, and any microprocessor, electronic chip or circuit
thereof, via one or more pre-programmed and or programmable
algorithms stored in the device or optionally accessible via
wireless or blue-tooth from an software "app" on a computer,
Smartphone, tablet, or diagnostic device. In certain embodiments,
the aerosol delivery device utilizes "machine learning" of an
aerosolizable substance's properties and or a user's breathing
pattern to fine-tune and adjust the algorithm(s) of the aerosol
delivery device to optimize performance and aerosol delivery, and
in a sense, customize that device to a specific aerosolizable
substance and or specific user or patient. In some embodiments,
algorithm(s) and or data generated can be stored in the device or
sent via wireless internet or blue-tooth from an "app" on a
computer, Smartphone, or tablet for users, patients, and their
trainers or physicians to monitor the use and progress on the
device. Therefore, devices of the present invention optionally have
wireless and or blue-tooth connectivity microchips and hardware
(not shown).
[0067] FIG. 4 shows a side view of the aerosol delivery device
depicted in the previous figure. Hand or finger grips 270 are
shown, as well as the power adapter and cord for the device's port
260. Medicament port channel 222 is accessible externally to slide
a cartridge or strip of aerosolizable substance into the device.
Airflow 27 enters from the left and travels through the device and
exits to the right.
[0068] Other embodiments may rely on one or more solenoid valves
under the control of a digital control unit. These other
conceivable embodiments are not shown and are not meant to be
limiting.
[0069] FIG. 5A shows an outline of an aerosol delivery device
housing according to the invention with housing 400 having four
ambient air inlets 401, 402, 403, and 404, each having a resilient
biasing member 410 that covers them by pressing against the air
inlets in a valve-like manner. When a user inhales through the
aerosolized air outlet 20 via mouthpiece 23 with significant
inhalation effort and negative pressure, different negative
pressures above 1 centimeter of water, and preferably above 3
centimeters of water, the resilient biasing members are gradually
and or sequentially pulled away from covering air inlets 401-404.
The greater the inhalation effort and negative pressure generated
by the user which overcomes the thresholds of these valve-like
structures, the more the air inlets are uncovered. The opening of
one or more of these air inlets is a physical change which lets
ambient airflow into the housing, which causes the housing to lose
negative pressure inside, which increases the difficulty of the
user trying to generate negative pressure. In this configuration,
the device automatically in an analog manner adjusts the airflow
through the device and user inhalation resistance and other
parameters as well. The faster and or stronger the inhalation
effort from the user, the more the device adjusts to increase
inhalation resistance. The biasing member force of these resilient
biasing members 410 can be selected at the time of manufacture to
obtain the desired biasing member force for certain user abilities.
Other embodiments can include structures to dial the desired
biasing member force setting for similar valves (not shown).
[0070] FIG. 5B shows a similar outline of an aerosol delivery
device housing as in FIG. 5A, but with housing 400' and no
resilient biasing members 410 covering ambient air inlets 401',
402', 403', and 404'. Instead a sliding, calibrated resistance
control element 420 is manually adjusted by the user with the
digits of the user's fingers according to calibrating indicia 425
to cover one or more ambient air inlets, thus, control the at least
one airflow through the device housing and an at least one
parameter selected from user inhalation resistance, user inhalation
duration, user inhalation rate, aerosol delivery efficiency,
targeting of aerosol to different user airway regions, or a
combination thereof. Note that both FIG. 5A and FIG. 5B show a male
USB fitting 430 distal to the mouthpiece end. The mini, micro, or
standard male USB fitting 430 (in other embodiments mini, micro, or
standard female USB fitting) supplies electrical power directly to
the aerosol generating element or other internal circuitry, or to a
rechargeable battery thereof via a power cord and or USB power
adapter. In other embodiments, the USB interface may configure the
settings of the aerosol generating element (not shown). The
rechargeable battery can be internal or external, and in some
embodiments, detachable and or replaceable.
[0071] FIG. 6 is an airflow control diagram outline of an aerosol
delivery device according to the invention with an aerosol chamber
300 that receives aerosol from an aerosol generating element (not
shown). Line segment arrows A, A', B, B' show ambient airflow
entering the device, device housing, and or aerosol chamber. Line
segment arrows A and A', as well as, B and B' in the current
configuration intersect at oblique right angles to each other to
slow their airflow velocity. The resulting airflows, line segment
arrows C and C', entrain aerosol and also intersect perpendicularly
at right angles to each other. The final resulting aerosolized
airflow, line segment arrow D, exits out the aerosol chamber 300
and or aerosol outlet of the device. All these airflow line segment
arrows comprise the overall airflow 27 through the device. The
diagram of FIG. 6 also shows a method of controlling airflow
through an aerosol delivery device by having two or more airflows
or airflow paths interact or interfere with each other at oblique
and or non-oblique angles. The angles of intersection among these
different airflow paths, namely angles (a), (b), and (c) in the
diagram, can be changed by one or more different means, under
manual analog or digital control, such as by tilting or bending one
or more of these airflow paths of A, A', B, B', C, and C'. When the
angle of incidence between two or more airflows/airflow paths is
more than 90 degrees, velocity is decreased more as components of
their vectors of momentum cancel each other out more. When the
angle of incidence is less than 90 degrees, velocity is not
decreased as much or is increased. If airflow paths approach
becoming close to parallel to each other in the same direction,
velocity between them will be nearly additive. This method employs
airflow vector addition and subtraction to control airflow through
the device and inhalation parameters experienced by the user.
Turbulence and other fluid dynamics of these airflows also come
into play. This diagram and method is not mean to be limiting, and
instead, is intended to broaden the horizons of what is possible
through the Applicant's inventive device; aerosol delivery
properties and parameters of inhalation of aerosolized airflow can
now be controlled in profound ways. The velocity of aerosol
discharge and or entrained aerosol airflows can be reduced or
manipulated with airflow and or aerosol paths angled toward one
another. Alternatively or in addition, airflow control can also
include the shunting of one or more airflow paths. These other
conceivable embodiments are not shown and are not meant to be
limiting.
[0072] The embodiments presented and other conceivable embodiments
can include a threshold that either lets airflow into the device or
aerosol chamber or some other airflow path, and or lets airflow out
of the device or aerosol chamber or some other airflow path. When
the threshold is overcome, the airflow path opens. It is desirable
to have an adjustable airflow resistance and or negative pressure
threshold. It may also be desirable to have a threshold associated
with inhalation and or exhalation that actuates or activates
aerosol generation or aerosol discharge of the device. The present
invention can accomplish this with structures, functions,
properties, and methods amenable to do so.
[0073] Increased airflow resistance and or increased negative
pressure settings of this invention require an increased inhalation
effort (negative pressures above 1 cm of water, and preferably
above 3 cm of water) and can provide exercise to the muscles
involved in respiration. The breathing exercise therapy provided by
this device can also help maintain lung elasticity. Some
embodiments can have the ability to bypass or remove or nearly
remove airflow resistance or negative pressure resistance
thresholds.
[0074] Embodiments of this invention may utilize flow throttling
structures, and flow throttling structures that indicate airflow
and or inhalation is taking place, and even to what extent. Such
flow throttling structures, such as a Venturi, ball, disc, flap,
weight, impeller, springs, compressible materials, or moveable
baffle can serve as inhalation and or exhalation incentive, and
could conceivably take the place of an incentive spirometer if
calibrated with indicia and can be visualized.
[0075] Other embodiments can be adapted to provide positive
expiratory pressure (PEP) therapy, such as with an exhalation
threshold resistance valve or PEP valve.
[0076] Some embodiments can include a vibratable/oscillatable
aperture mesh/membrane, to atomize/nebulize aerosol from a liquid
substance, such as when said liquid comes in contact with/passes
through the mesh, the source of vibration/oscillation being chosen
from vibratory means chosen from the class of electro-mechanical
vibratory means including, but not limited to, piezoelectric
elements, including piezoelectric transducers, piezoelectric pumps,
and piezoelectric motors, the vibratory mesh element including
regions of one or more different curvatures and pores of one or
more different sizes, oscillations including bending oscillations,
such as of the vibratable mesh. Oscillations can be adapted to
occur at ultrasonic frequencies.
[0077] Some embodiments are adapted to force a liquid through at
least one small orifice, such as part of a spray nozzle, ejection
actuator, or aperture mesh, to cause aerosolization of that liquid,
the means for moving the liquid is chosen from physical means
chosen from the class of mechanical/electro-mechanical means
including, but not limited to, pumps, such as electric pumps,
hydraulic pumps, and piezoelectric pumps, pistons, injectors,
piezoelectric elements, piezo-inkjets, thermal inkjets, thermal
bubble jets, synthetic jets, solenoids, and valves.
[0078] Some embodiments are adapted to control the activity of at
least one aerosol generating element, chosen from among aerosol
generating elements, including, but not limited to, spray nozzles,
ejection actuators, aperture meshes, vibratable plates, and
heating/vaporizing elements.
[0079] The settings of most embodiments are adapted to be
adjustable and adjusted by any physical means, including, but not
limited to, rotatable means, slidable means, manual means,
mechanical means, electro-mechanical means, including electric
motors, analog control means, digital control means, and
microprocessor control means.
[0080] Some embodiments include an aerosol delivery device with an
at least one controller/microprocessor adapted to adjust airflow
resistance settings, such as by electric motorized means, the
controller/microprocessor adapted to adjust the airflow resistance
settings based on input received from at least one electronic
sensor, being chosen from the class of electronic sensors,
including, but not limited to, pressure transducers, piezoelectric
sensors, and other airflow sensors, such sensors adapted to provide
the controller/microprocessor with at least some user or patient
information chosen from the class of breathing information,
including, but not limited to, inhaled air volume, exhaled air
volume, inhaled airflow rate, exhaled airflow rate, breathing cycle
patterns, and other lung function parameters of spirometry, such as
tidal volume, forced vital capacity, and lung capacity, in this
manner, the device is able to adjust to the properties of the user,
such as for optimized aerosol delivery, the device is adapted to
display these measured parameters allowing the device to serve as a
pulmonary diagnostic tool/instrument.
[0081] Some embodiments include an aerosol delivery device with an
at least one controller/microprocessor adapted to modulate the
operation of at least one aerosol generating element, the
controller adapted to modulate the operation of the at least one
aerosol generating element based on input received from at least
one electronic sensor, being chosen from the class of electronic
sensors, including, but not limited to, conductivity sensing leads,
pressure transducers, piezoelectric sensors, and other airflow
sensors, such sensors adapted to provide the
controller/microprocessor with at least some user or patient
information chosen from the class of breathing information,
including, but not limited to, inhaled air volume, exhaled air
volume, inhaled airflow rate, exhaled airflow rate, breathing cycle
patterns, and other lung function parameters of spirometry, such as
tidal volume, forced vital capacity, and lung capacity, in this
manner, the device is able to adjust to the properties of the user,
such as for optimized aerosol delivery, the device also allows
aerosol generation to be breath/touch activated and synchronized
with portions of the breathing cycle.
[0082] Some embodiments are adapted to modulate aerosol particle
size, such as by modulating the size and number of nozzle/mesh
orifices and or oscillations, and or as well as temperature.
[0083] Some embodiments are adapted to modulate aerosol particle
size by modulating the operation of at least one aerosol generating
element, including, but not limited to, its frequency and
intensity, aerosol generating elements are chosen from among sites
of aerosol generation, including, but not limited to, spray
nozzles, ejection actuators, aperture meshes, vibratable plates,
and vaporizing elements.
[0084] Some embodiments include a heating element that raises the
temperature of the air and aerosol within the device, such as above
that of ambient air, said heating element adapted to help evaporate
aerosol droplets to reduce particle size, said heating element also
produce convection currents that are adapted to help move
aerosolized air, the activity and temperature of the heating
element adapted to be controlled by electronic means as the heating
element is adapted to be an electrically resistive heating
element.
[0085] Some embodiments can include a valved aerosol holding
chamber to retain aerosol within the device until/between periods
of user inhalation, the chamber/region also being valved to prevent
user exhalation from entering far into the interior of the device,
valves chosen from fluid regulating devices chosen from the class
of valves including, but not limited to, elastomeric valves,
one-way valves, flap valves, duckbill vales, pistons, and threshold
valves.
[0086] Some embodiments include vaporization means to vaporize a
therapeutic substance to produce a condensation aerosol available
for inhalation, vaporization means chosen from the class of
vaporization elements including, but not limited to, electrically
resistive heating elements, electrostatic chargers, elements
producing thermal radiation, elements that transfer thermal energy
by conduction, elements that transfer thermal energy by convection,
elements releasing exothermic energy from chemical reactions, laser
producing elements, and elements producing electromagnetic
radiation, such as microwaves, radio frequency waves, and infrared
waves.
[0087] Some embodiments include means to electronically store data,
algorithms, and or programs, the electronically stored data is
chosen from the types of electronic data including, but not limited
to data records, such as time, date, time and or date of treatment,
treatment duration, airflow resistance settings, flow rate, flow
volume, number of dosages used and unused, dosage amounts,
medicament information, such as name and serial number, breathing
pattern information, user's progress, device program information,
such as device temperature settings, frequency settings, airflow
settings, timing settings, aerosolization settings for a particular
type of medicament, and other user settings, such as alarm settings
and password protection, said electronic data is adapted to be
stored and accessed from an Electrically Erasable Programmable
Read-Only Memory, EEPROM, and flash memory chips, and or USB ports
or other ports.
[0088] Most embodiments will conserve the aerosolizable substance
or formulation by incorporating a pump or drive system or aerosol
generating element that is breath-activated, and may be turned on
and off depending on the stage in the user's breathing cycle. The
breathing cycle includes the stages of inhalation, pause, and
exhalation.
[0089] The purpose is for the device to be responsive to
inhalation, that it may activate the pump, drive, or aerosol
generating element during inhalation, and inactivate the pump,
drive, or aerosol generating element when inhalation is no longer
detected, i.e., during exhalation, or with a timer.
[0090] The invention is an aerosol delivery device having a
structure comprising a housing, an at least one
ambient/unaerosolized air inlet, an at least one aerosolized air
outlet, and an at least one airflow passage therein the device or
housing and or extending at least partially therebetween the at
least one ambient/unaerosolized air inlet and the at least one
aerosolized air outlet. The aerosol delivery device further
comprises an at least one aerosol generating element that produces
an aerosol from an at least one aerosolizable substance or
formulation with the use of electrical energy and without the use
of compressed/pressurized gas. The aerosol delivery device further
has an at least one airflow through its housing produced by a user
inhaling from the aerosol delivery device and entraining the
aerosol when generated; wherein the at least one airflow is
controllable in velocity, volume, or a combination thereof as the
at least one ambient/unaerosolized air inlet, the at least one
aerosolized air outlet, the at least one airflow passage, or a
combination thereof undergoes an at least one physical change
selected from changes in size, angle, shape, biasing resistance to
flow, number of apertures, shunting of airflow, or a combination
thereof. The at least one physical change is modulated by
user/digital input to control the at least one airflow and to
regulate an at least one parameter selected from user inhalation
resistance, user inhalation duration, user inhalation rate, aerosol
delivery efficiency, targeting of aerosol to different user airway
regions, or a combination thereof.
[0091] In preferred embodiments, the user/digital input is selected
from user inhalation, user touch, user speech/sound, user
programming, user selection, or a combination thereof.
[0092] In preferred embodiments, the aerosol delivery device
further comprises at least two physical change settings when the at
least one physical change is modulated by user/digital input.
[0093] In preferred embodiments, the aerosol delivery device
further comprises marked/digitized indicia, preferably calibrated
indicia, adapted to be presented to the user and further
representing the at least one parameter selected from user
inhalation resistance, user inhalation duration, user inhalation
rate, aerosol delivery efficiency, targeting of aerosol to
different user airway regions, or a combination thereof.
[0094] In preferred embodiments, the aerosol delivery device
further comprises an at least one airflow sensor, pressure sensor,
or a combination thereof.
[0095] In preferred embodiments, the aerosol delivery device
further comprises an at least one airflow indicator, pressure
indicator, or a combination thereof.
[0096] The aerosol delivery device generally comprises an at least
one airflow valve, pressure valve, or a combination thereof.
[0097] In preferred embodiments, the aerosol delivery device
further comprises an at least one aerosolizable substance or
formulation or liposomal formulation, said at least one
aerosolizable substance or formulation preferably comprises
epinephrine, bronchodilator, anticholinergic, nicotine,
cannabinoid, opioid, insulin, antibiotic, prostacyclin,
interluekin, cytokine, vaccine, immunosuppressant, immunomodulator,
immunotherapy, chemotherapy, or combination, analogue, or
derivative thereof.
[0098] In preferred embodiments the aerosol delivery device further
comprises an at least one holding/storage area, chamber, reservoir,
or combination thereof for the at least one aerosolizable substance
or formulation.
[0099] In most embodiments, the aerosol delivery device further
comprises an at least one power button/switch.
[0100] In some embodiments, the aerosol delivery device further
comprises an at least one airflow filter.
[0101] In some embodiments of the aerosol delivery device, the at
least one airflow through the device housing produced by the user
inhaling from the aerosol delivery device interacts with at least
one additional airflow through the device housing produced by the
user inhaling from said aerosol delivery device so that these
airflows meet in at least partially counterposing directions to at
least partially negatively interfere with each other; the resulting
at least partial negative interference is adapted to change/control
or reduce the velocity and or trajectory of at least one of these
airflows.
[0102] In some embodiments of the aerosol delivery device, the at
least one airflow through the device housing produced by the user
inhaling from the aerosol delivery device interacts with at least
one additional airflow through the device housing produced by the
user inhaling from the aerosol delivery device so that these
airflows meet in at least somewhat parallel directions to at least
partially positively interfere with each other; the resulting at
least partial positive interference adapted to enhance the velocity
and trajectory of at least one of these airflows; and in some
embodiments serves as a "turbo boost" to aerosol entrainment and
delivery.
[0103] In some embodiments of the aerosol delivery device, an at
least one angle of incidence between at least two of the at least
one airflow through the device housing produced by the user
inhaling from the aerosol delivery device is modulated by
user/digital input to control the at least one airflow.
[0104] In some embodiments of the aerosol delivery device, an at
least one angle of incidence between at least two of the at least
one airflow through the device housing produced by the user
inhaling from the aerosol delivery device is modulated
automatically by airflow, user inhalation rate, user inhalation
force, airflow sensor relay feedback or a combination thereof.
[0105] In some embodiments of the aerosol delivery device, an at
least one angle of incidence between at least two of the at least
one airflow through the device housing produced by the user
inhaling from the aerosol delivery device is modulated to
limit/restrict airflow, airflow velocity, airflow volume, or a
combination thereof.
[0106] In some embodiments of the aerosol delivery device, an at
least one angle of incidence between at least two of the at least
one airflow through the device housing produced by the user
inhaling from the aerosol delivery device is modulated to
control/change airflow, airflow velocity, airflow volume, or a
combination thereof.
[0107] Most embodiments of the aerosol delivery device further
comprising an at least one dial, switch, valve, lever, or a
combination thereof to control the at least one airflow through the
device and or aerosol chamber.
[0108] Some embodiments of the aerosol delivery device further
comprise at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by the at least one
aerosol generating element.
[0109] Some embodiments of the aerosol delivery device further
comprise at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by the at least one
aerosol generating element; the selection of the at least two
aerosol generating settings determined automatically by airflow,
user inhalation rate, user inhalation force, or a combination
thereof.
[0110] Some embodiments of the aerosol delivery device further
comprise at least two aerosol generating settings to vary the
amount and or properties of aerosol generated by the at least one
aerosol generating element; the selection of the at least two
aerosol generating settings determined automatically by airflow,
user inhalation rate, user inhalation force, type of said
aerosolizable substance/formulation, or a combination thereof, by a
relay/feedback from an at least one airflow sensor, pressure
sensor, (substance ID) reader, or a combination thereof.
[0111] Some embodiments of the aerosol delivery device are further
adapted to provide for a sustained maximal inhalation when a user
or patient is able to sustain for a period of inhalation a negative
pressure, airflow rate, or a combination thereof that is at least
as great as the negative pressure threshold setting, airflow rate
threshold setting, or a combination thereof selected by the
user/digital input.
[0112] Some embodiments of the aerosol delivery device are further
adapted to provide strength training of the muscles involved in
respiration and help maintain lung elasticity.
[0113] Some embodiments of the aerosol delivery device are further
adapted to provide incentive inhalation feedback to the user; the
incentive inhalation feedback is selected from visual incentive
signals, auditory incentive signals, vibrations, or a combination
thereof.
[0114] Preferred embodiments of the aerosol delivery device are
further adapted to only allow ambient/unaerosolized air to enter
when the user is inhaling or inhaling sufficiently or inhaling
above a threshold from the aerosol delivery device.
[0115] Preferred embodiments of the aerosol delivery device have
aerosol generation that is activated/actuated and coordinated with
the breathing cycle so that the aerosolizable substance or
formulation is conserved until/between periods of user
inhalation.
[0116] Some embodiments of the aerosol delivery device are further
adapted to provide proper breathing technique training for
optimized aerosol delivery.
[0117] Preferred embodiments of the aerosol delivery device are
further adapted to limit/constrain airflow, airflow velocity,
airflow volume, airflow rate, user inhalation rate, user generated
negative pressure, or a combination thereof to a range conducive
for aerosol delivery efficiency, accuracy and precision, and
limiting or preventing deviation; limiting or preventing intra-user
and or inter-user variability when using said aerosol delivery
device.
[0118] Preferred embodiments of the aerosol delivery device are
further adapted to selectively target aerosols to one or more
different airway regions; one or more different airway regions
comprising the upper airways, upper respiratory tract, nasal
cavity, pharynx, larynx, lower airways, lower respiratory tract,
trachea, bronchi, lungs, bronchioles, deep lung, alveoli where
systemic exchange takes place, or a combination thereof.
[0119] Different embodiments of the aerosol delivery device are
further adapted to receive electrical energy from an electrical
wall socket/outlet, battery, rechargeable battery, or a combination
thereof to power said at least one aerosol generating element.
[0120] Most embodiments with at least one rechargeable battery are
further adapted to receive electrical energy to recharge the at
least one associated battery, such as a lithium battery (a
non-limiting example) that powers the at least one aerosol
generating element. The electrical energy is received via an at
least one power adapter, AC/DC power adapter, AC power connector,
AC adapter inlet/socket, AC adapter outlet, AC power adapter, AC
adapter power cord, AC power cord, DC power connectors, DC adapter
inlet/socket, DC adapter outlet, DC power adapter, DC adapter power
cord, DC power cord, male USB fitting, female USB fitting, USB
adapter inlet/socket, USB adapter outlet, USB power adapter, USB
power cord, USB cord, male micro-USB fitting, female micro-USB
fitting, micro-USB adapter inlet/socket, micro-USB adapter outlet,
micro-USB power adapter, micro-USB power cord, micro-USB cord, male
mini-USB fitting, female mini-USB fitting, mini-USB adapter
inlet/socket, mini-USB adapter outlet, mini-USB power adapter,
mini-USB power cord, mini-USB cord, fuel cell, micro-turbine,
wireless power transfer source, inductive coupling receiver,
capacitive coupling receiver, charging pad/surface, or a
combination or derivative thereof.
[0121] In preferred embodiments, the at least one
ambient/unaerosolized air inlet, the at least one aerosolized air
out, and the at least one airflow passage therebetween/therein are
structurally associated with an at least one aerosol chamber of the
aerosol delivery device. Some embodiments of the device can have at
least two aerosol chambers.
[0122] The aerosol delivery device is not associated with nor
having compressed/pressurized gas.
[0123] In some embodiments, the aerosol delivery device comprises
at least two different aerosolizable substances or formulations (or
dosages thereof) and is able to aerosolize these at least two
different aerosolizable substances or formulations separately,
sequentially, or simultaneously. The selection of aerosolization of
one or both of these two different aerosolizable substances or
formulations (or dosages thereof) can be selected by user/digital
input, such as providing signal to an at least one aerosol
generating element and or blister strip, packaging, vial,
reservoir, or cartridge that contains or releases said at least one
aerosolizable substance or formulation (or dosage thereof).
[0124] The invention is also an aerosol delivery device having a
structure comprising a housing, an at least one air inlet, an at
least one aerosolized air outlet, and an at least one airflow
passage therebetween/therein. The aerosol delivery device further
comprises an at least one aerosol generating element producing an
aerosol from an at least one aerosolizable substance or formulation
with the use of electrical energy to produce vaporizing heat,
vibration, or a combination thereof, without the use of
compressed/pressurized gas. The aerosol delivery device further has
an at least one airflow through its housing produced by a user
inhaling from the aerosol delivery device, preferably its
mouthpiece, and entraining the aerosol when generated. The aerosol
delivery device further has an at least one rechargeable battery
that at least powers the at least one aerosol generating element.
The at least one rechargeable battery receives electrical energy
via an at least one power adapter, AC/DC power adapter, AC power
connector, AC adapter inlet/socket, AC adapter outlet, AC power
adapter, AC adapter power cord, AC power cord, DC power connectors,
DC adapter inlet/socket, DC adapter outlet, DC power adapter, DC
adapter power cord, DC power cord, male USB fitting, female USB
fitting, USB adapter inlet/socket, USB adapter outlet, USB power
adapter, USB power cord, USB cord, male micro-USB fitting, female
micro-USB fitting, micro-USB adapter inlet/socket, micro-USB
adapter outlet, micro-USB power adapter, micro-USB power cord,
micro-USB cord, male mini-USB fitting, female mini-USB fitting,
mini-USB adapter inlet/socket, mini-USB adapter outlet, mini-USB
power adapter, mini-USB power cord, mini-USB cord, fuel cell,
micro-turbine, wireless power transfer source, inductive coupling
receiver, capacitive coupling receiver, charging pad/surface, or a
combination or derivative thereof.
[0125] The invention is also an aerosol delivery device having a
structure comprising a housing, an at least one air inlet, an at
least one aerosolized air outlet, preferably with user interface
such as a mouthpiece, and an at least one airflow passage
therebetween/therein. The aerosol delivery device further comprises
an at least one aerosol generating element producing an aerosol
from an at least one aerosolizable substance or formulation with
the use of electrical energy and without the use of
compressed/pressurized gas. The aerosol delivery device further has
an at least one airflow through its housing produced by a user
inhaling from the aerosol delivery device and entraining the
aerosol when generated. The aerosol delivery device further has an
adjustable airflow restriction of the at least one airflow as the
at least one air inlet, the at least one aerosolized air outlet,
the at least one airflow passage, or a combination thereof
undergoes an at least one physical change selected from changes in
size, angle, shape, biasing resistance to flow, number of
apertures, shunting of airflow, or a combination thereof; said at
least one physical change is modulated by user/digital input to
control the adjustable airflow restriction and to regulate an at
least one parameter selected from user inhalation resistance, user
inhalation duration, user inhalation rate, aerosol delivery
efficiency, targeting of aerosol to different user airway regions,
or a combination thereof.
[0126] The invention is also an aerosol delivery device having a
structure comprising a housing, an at least one air inlet, an at
least one aerosolized air outlet with user interface, and an at
least one airflow passage therebetween/therein. The aerosol
delivery device further comprises an at least one aerosol
generating element producing an aerosol from an at least one
aerosolizable substance or formulation with the use of electrical
energy and without the use of compressed/pressurized gas. The
aerosol delivery device further has an at least one airflow through
the housing produced by a user inhaling from the aerosol delivery
device and entraining aerosol when generated. The aerosol delivery
device further has an at least one negative pressure within the
device housing produced by a user inhaling from the aerosol
delivery device; wherein the at least one negative pressure is
adjustable as said at least one air inlet, said at least one
aerosolized air outlet, said at least one airflow passage, or a
combination thereof undergoes an at least one physical change
selected from changes in size, angle, shape, biasing resistance to
flow, number of apertures, shunting of airflow, or a combination
thereof; said at least one physical change is modulated by
user/digital input to control the at least one negative pressure
and to regulate an at least one parameter selected from user
inhalation resistance, user inhalation duration, user inhalation
rate, aerosol delivery efficiency, targeting of aerosol to
different user airway regions, or a combination thereof.
[0127] For patients with adequate lung function that can achieve
greater inhalation effort, the different airflow resistance
settings and or different negative pressure settings of this novel
aerosol delivery device can have profound effects on aerosol
delivery dynamics. Aerosol generation and aerosol delivery occur
when enough negative pressure builds within the device to cause
actuation. After building up the necessary negative pressure
required for valve actuation, aerosol is generated at the precise
moment that the valve opens to allow a rapid stream of ambient air
into the device for entraining and efficiently carrying out this
aerosol as a bolus. Choosing different settings can allow this
bolus to be sustained as a stream over different lengths of
inhalation time corresponding to different airflow resistance
settings and or different negative pressures that can be sustained
and selected by the user or patient. Moreover, by having actuation
of aerosolization and aerosol entrainment associated with different
airflow resistance settings and or different negative pressure
settings, this novel aerosol delivery device can be used to
selectively target aerosols to one or more different airway
regions. In effect, aerosol actuation, entrainment, and delivery
occur when one or more different airways are optimally expanded
with the desired pressure for enhanced drug targeting and delivery
efficiency. The aerosol delivery device is thus adapted to
selectively target aerosols to one or more different airway regions
by selecting different negative pressure threshold settings of
actuation of aerosolization. The one or more different airway
regions are chosen from the regions, including, but not limited to,
the upper airways, upper respiratory tract, nasal cavity, pharynx,
larynx, lower airways, lower respiratory tract, trachea, bronchi,
lungs, bronchioles, deep lung, and alveoli where systemic exchange
takes place.
[0128] More pharmaceuticals are being made available for
inhalation. This includes pharmaceuticals that can be delivered to
the systemic circulation via the pulmonary route, such as insulin.
As an improved drug delivery device, the present invention can
improve the delivery dynamics and targeting of these drugs.
Selective targeting of aerosols to one or more different airway
regions can aid in the targeting of aerosolized chemotherapies
against lung cancer, including targeting an airway region having a
tumor. Selective targeting of aerosols to one or more different
airway regions can also have profound lifesaving and medical
military applications, including biodefense to counter
bioterrorism, by coating upper airways with antibiotics against
anthrax or other infectious agents, or by providing anticholinergic
agents to the systemic circulation via alveoli as an antidote to
nerve agent exposure. The present invention also has the potential
to enhance the deliverability of drug candidates in development,
which has the potential to reduce drug development costs.
Therefore, the present invention fulfills important unmet other
needs, and has applications that transcend beyond medication
delivery to asthma, COPD, and cystic fibrosis patients that have
trouble breathing, and opens the way for treating countless other
patients, including those with the ability to generate greater
negative pressures.
[0129] The present invention is able to deliver aerosols of various
substances that include, but are not limited to: unformulated
active pharmaceutical ingredient, formulated active pharmaceutical
ingredient, pharmaceutical inactive or excipient ingredient,
non-biological materials, biological materials, plant material or
extracts, animal material or extracts, cellular material or
extracts, cultured cell line material or extracts, cells, stem
cells, bacterial material or extracts, fungal material or extracts,
viral material or extracts, peptides, polypeptides, recombinant
proteins, glycoproteins, sugars, monosaccharides, disaccharides,
and polysaccharides, lipids, fatty acids and prostaglandins,
prostacyclins and prostacyclin analogues, cholesterol,
lipoproteins, vesicles, liposomes, nutrients/supplements, holistic
substances, antibodies/immunoglobulins and or fragments thereof,
immunosuppressants, immunotherapies, water, water soluble
substances, antipsychotics, water insoluble substances, vitamins,
coenzymes, enzymes, substrates, inhibitors, hormones, steroids,
amino acids, neurotransmitters, cell signaling molecules,
antibiotics, NSAIDs, cellular receptors and or receptor fragments,
ion channels/ion channel fragments, ligands/ligand fragments,
single stranded/double stranded nucleotides, deoxyribonucleic acids
and or ribonucleic acids, small interfering RNA, siRNA,
transcription factors, transcription inhibitors, translation
factors, translation inhibitors, vaccines, antihistamines,
anti-inflammatory substances, cytotoxic substances, anti-toxins,
anti-venoms, anticoagulants, vasodilators, bronchodilators,
stimulants, anti-depressants, analgesics, anesthetics, therapeutic
gases, including, but not limited to nitric oxide, nitrous oxide,
hydrogen sulfide, carbon monoxide, carbon dioxide, nitrogen,
cyclopropane, helium, and oxygen, diatomic molecules and gases,
electrolytes, ionic substances, non-ionic substances, minerals,
salts, hydrates, anhydrates, naturally occurring non-organic
molecules or compounds, synthetic/modified non-organic molecules or
compounds, naturally occurring organic molecules or compounds,
synthetic/modified organic molecules or compounds,
medical/diagnostic probes/tracers, fluorescent substances, magnetic
substances, radioisotopes or radioactive substances, nanoparticles,
from any phase of any of these aforementioned materials, solid
phases, liquid phases, gaseous phases, polymers of any of these
aforementioned materials, precursors of any of these aforementioned
materials, derivatives of any of these aforementioned materials,
enantiomers of any of these aforementioned materials, stereoisomers
of any of these aforementioned materials, hybrid molecules of any
of these aforementioned materials, combinations of any of these
aforementioned materials, suspensions, mixtures/solutions of any of
these aforementioned materials.
[0130] Examples of pharmaceutical aerosols that can be delivered by
the present invention include, but are not limited to: acebutolol,
acetaminophen, adrenaline (epinephrine), alprazolam, amantadine,
amiloride, amitriptyline, amoxicillin, anticholinergic agent,
apomorphine diacetate, apomorphine hydrochloride, atropine,
azatadine, betahistine, brompheniramine, bumetanide, buprenorphine,
bupropion hydrochloride, butalbital, butorphanol, carbinoxamine
maleate, celecoxib, chlordiazepoxide, chlorpheniramine,
chlorzoxazone, ciclesonide, ciclosporin, citalopram, clomipramine,
clonazepam, clozapine, codeine, cyclobenzaprine, cyproheptadine,
dapsone, dextran sulfate, diazepam, diclofenac ethyl ester,
diflunisal, disopyramide, doxepin, estradiol, ephedrine, estazolam,
ethacrynic acid, fenfluramine, fenoprofen, flecainide,
flunitrazepam, galanthamine, granisetron, haloperidol,
hydromorphone, hydroxychloroquine, hyoscyamine, ibuprofen,
imipramine, indomethacin ethyl ester, indomethacin methyl ester,
insulin, interleukin, isocarboxazid, ketamine, ketoprofen,
ketoprofen ethyl ester, ketoprofen methyl ester, ketorolac ethyl
ester, ketorolac methyl ester, ketotifen, lamotrigine, lidocaine,
loperamide, loratadine, loxapine, maprotiline, memantine,
meperidine, metaproterenol, methoxsalen, metoprolol, mexiletine
HC1, midazolam, mirtazapine, morphine, nalbuphine, naloxone,
naproxen, naratriptan, nicotine, norepinephrine, nortriptyline,
olanzapine, orphenadrine, oxycodone, paroxetine, pergolide,
phenytoin, pindolol, piribedil, pramipexole, procainamide,
prochloperazine, propafenone, propranolol, pyrilamine, quetiapine,
quinidine, racepinephrine, rizatriptan, ropinirole, sertraline,
selegiline, sildenafil, spironolactone, tacrine, tadalafil,
terbutaline, testosterone, thalidomide, theophylline, tocainide,
toremifene, trazodone, triazolam, trifluoperazine, valproic acid,
venlafaxine, vitamin E, zaleplon, zotepine, amoxapine, atenolol,
benztropine, caffeine, doxylamine, estradiol 17-acetate,
flurazepam, flurbiprofen, hydroxyzine, ibutilide, indomethacin
norcholine ester, ketorolac norcholine ester, melatonin,
metoclopramide, nabumetone, perphenazine, protriptyline HCl,
quinine, triamterene, trimipramine, zonisamide, bergapten,
chlorpromazine, colchicine, diltiazem, donepezil, eletriptan,
estradiol-3,17-diacetate, efavirenz, esmolol, fentanyl,
flunisolide, fluoxetine, hyoscyamine, indomethacin, isotretinoin,
linezolid, meclizine, paracoxib, pioglitazone, rofecoxib,
sumatriptan, tetrahydrocannabinol, tolterodine, tramadol,
tranylcypromine, trimipramine maleate, valdecoxib, vardenafil,
verapamil, zolmitriptan, zolpidem, zopiclone, bromazepam,
buspirone, cinnarizine, dipyridamole, naltrexone, sotalol,
telmisartan, temazepam, albuterol, apomorphine hydrochloride
diacetate, carbinoxamine, clonidine, diphenhydramine, thambutol,
fluticasone proprionate, fluconazole, lovastatin, lorazepam
N,O-diacetyl, methadone, nefazodone, oxybutynin, promazine,
promethazine, sibutramine, tamoxifen, tolfenamic acid,
aripiprazole, astemizole, benazepril, clemastine, estradiol
17-heptanoate, fluphenazine, protriptyline, ethambutal,
frovatriptan, pyrilamine maleate, scopolamine, tacrolimus,
triamcinolene acetonide, epinephrine, and any analogues,
derivatives, and combinations thereof.
[0131] Antibiotic active pharmaceutical ingredient examples for
aerosolization with this device, include, but are not limited to:
polyketide antibiotics; macrolide antibiotics, including, but not
limited to, clarithromycin, erthythromycin, azithromycin,
dirithromycin, roxithromycin, telithromycin, carbomycin A,
josamycin, kitasamycin, midecamycin, oleandomycin, solithromycin,
spiramycin, troleandomycin; beta-lactam antibiotics; penicillin
drugs including, but not limited to amoxicillin, ampicillin,
talampicillin, bacampicillin, lenampicillin, mezlocillin,
sultamicillin, temocillin; cephem/cephalosporin antibiotics
including, but not limited to, cefaclor, cefadroxil, cefalexin,
cefpodoxime proxetil, cefixime, cefdinir, ceftibuten, cefotiam
hexetyl, cefetamet pivoxil, cefuroxime axetil; penem antibiotics
including, but not limited to, faropenem, ritipenem; monobactam
antibiotics; sulfonamide antibiotics; lincosamide antibiotics
including, but not limited to, lincomycin or clindamycin;
aminoglycoside antibiotics including, but not limited to amikacin,
tobramycin, paromomycin; tetracycline antibiotics including, but
not limited to, tetracycline, minocycline, doxycycline; quinolone
antibiotics including, but not limited to, ofloxacin, levofloxacin,
norfloxacin, enoxacin, ciprofloxacin, lomefloxacin, tosufloxacin,
fleroxacin, sparfloxacin, temafloxacin, nadifloxacin,
grepafloxacin, baloflaxacin, prulifloxacin, pazufloxacin;
nitroimidazole antibiotics including, but not limited to,
metronidazole, tinidazole; nitrofuran antibiotics including, but
not limited to, nitrofurantoin, furazolidone, nifurtoinol;
rifamycin antibiotics including, but not limited to, rifampicin,
rifabutin, rifapentine, rifaximin; glycopeptide antibiotics
including, but not limited to vancomycin, ramoplanin; and any
salts, solvates, polymorphs, racemic mixtures, enantiomers,
derivatives, mixtures and combinations thereof.
[0132] Other embodiments of aerosol delivery devices within the
scope of the present invention include motorized or electronic
controlled adjustable negative pressure threshold valves of
actuation, which employ the use of solenoid valves and pressure
sensors and the necessary circuitry, buttons, and power elements to
accomplish this. Even further conceivable aerosol delivery device
embodiments can include a moveable seal that exists in a position
that allows aerosol delivery to occur until moved out of position
by actuation of the valve during inhalation, so that aerosolization
does not occur during inhalation, but occurs during exhalation.
These other conceivable embodiments are not shown and are not meant
to be limiting.
[0133] There are methods for using the aerosol delivery device
disclosed in the present invention, as well as, methods to produce
the desired aerosolized therapies and aerosol delivery dynamics
when using the present invention.
[0134] As to the manner of usage and operation of the present
invention, the same should be apparent from the above description.
Accordingly, no further discussion relating to the manner of usage
and operation will be provided.
[0135] With respect to the above description then, it is to be
realized that the optimum dimensional relationships for the parts
of the invention, to include variations in size, materials, shape,
form, function and manner of operation, assembly and use, are
deemed readily apparent and obvious to one skilled in the art, and
all equivalent relationships to those illustrated in the drawings
and described in the specification are intended to be encompassed
by the present invention.
[0136] Therefore, the foregoing is considered as illustrative only
of the principles of the invention. Further, since numerous
modifications and changes will readily occur to those skilled in
the art, it is not desired to limit the invention to the exact
construction and operation shown and described, and accordingly,
all suitable modifications and equivalents may be resorted to,
falling within the scope of the invention.
[0137] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *