U.S. patent application number 12/851049 was filed with the patent office on 2010-11-25 for nebulizing drug delivery device with an increased flow rate.
This patent application is currently assigned to KONINKLIJKE PHILIPS ELECTRONICS N.V.. Invention is credited to ERIC A. LIEBERMAN, DIRK VON HOLLEN.
Application Number | 20100294269 12/851049 |
Document ID | / |
Family ID | 36953945 |
Filed Date | 2010-11-25 |
United States Patent
Application |
20100294269 |
Kind Code |
A1 |
LIEBERMAN; ERIC A. ; et
al. |
November 25, 2010 |
NEBULIZING DRUG DELIVERY DEVICE WITH AN INCREASED FLOW RATE
Abstract
The present invention provides a nebulizing drug delivery system
for delivering an aerosolized drug to a user having various
features to increase the capacity of the drug delivery device. The
drug delivery system includes a heater to increase the viscosity of
the drug, a double aerosolizing system to double the capacity of
the device, and a valve system to continuously replenish drug to
the aerosol generator thereby providing a high speed delivery.
Inventors: |
LIEBERMAN; ERIC A.; (Scotch
Plains, NJ) ; VON HOLLEN; DIRK; (Clark, NJ) |
Correspondence
Address: |
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
P.O. BOX 3001
BRIARCLIFF MANOR
NY
10510
US
|
Assignee: |
KONINKLIJKE PHILIPS ELECTRONICS
N.V.
EINDHOVEN
NL
|
Family ID: |
36953945 |
Appl. No.: |
12/851049 |
Filed: |
August 5, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11367649 |
Mar 3, 2006 |
|
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12851049 |
|
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60659919 |
Mar 9, 2005 |
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Current U.S.
Class: |
128/200.14 |
Current CPC
Class: |
A61M 2205/3653 20130101;
A61M 2205/8268 20130101; A61M 11/005 20130101; A61M 11/041
20130101; A61M 11/001 20140204 |
Class at
Publication: |
128/200.14 |
International
Class: |
A61M 11/00 20060101
A61M011/00 |
Claims
1. A nebulizing drug delivery device, comprising: a housing having
an inlet and an outlet; an aerosol generator in communication with
a fluid; a temperature sensor that senses a temperature of the drug
solution; and a heater in functional communication with the
temperature sensor, the heater being operable in response to the
temperature sensor to maintain the temperature of the drug solution
above a threshold temperature.
2. A nebulizing drug device according to claim 1, wherein the
threshold temperature can be adjusted.
3. A nebulizing device according to claim 1, wherein the heater is
positioned to heat the drug solution.
4. A nebulizing device according to claim 1, further comprising a
drug solution reservoir in the housing, and a valve that can be
opened to supply the drug solution from the reservoir, wherein the
heater is positioned to heat the drug solution in the
reservoir.
5. A nebulizing device according to claim 4, wherein the valve
comprises an electrically operated solenoid, the solenoid being in
communication with the temperature sensor, the solenoid being
operated to open the valve and enable the drug solution to flow
from the reservoir to the barrier in response to the temperature
sensor indicating that the temperature of the drug solution is
above the threshold level.
6. A nebulizing device according to claim 5, wherein the solenoid
remains open until the device is turned off.
7. A nebulizing device according to claim 1, wherein the
temperature sensor turns the heater on and off to maintain the drug
solution with a range.
8. A nebulizing device according to claim 1, wherein the heater is
turned off in response to the temperature sensor determining that
the drug solution is above an upper threshold level, and wherein
the heater is turned off and on to maintain the drug solution
within a temperature range.
9. A nebulizing device comprising: a housing having an inlet and an
outlet; an aerosol generator; a temperature sensor that senses a
temperature of the drug solution; and a heater in functional
communication with the temperature sensor, the heater being
operable in response to the temperature sensor to maintain the drug
above a threshold temperature; wherein the drug solution is a
surfactant.
10. The nebulizing device as recited in claim 9 wherein the
threshold temperature is approximately about 37 degrees Celsius.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C.
.sctn.119(e) from provisional U.S. Patent Application No.
60/659,919 filed Mar. 9, 2005; and U.S. application Ser. No.
11/367,649 filed Mar. 3, 2006, entitled "Nebulizing Drug Delivery
Device with an Increased Flow Rate" the contents of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to drug delivery devices, and,
in particular, to nebulizers used in an aerosolized drug
delivery.
[0004] 2. Description of the Related Art [0005] Nebulizing drug
delivery devices that use ultrasonic energy to nebulize a drug
solution are generally known. Such devices typically include an
acoustic wave generator to generate acoustic waves that are
transmitted to a drug solution. The ultrasonic energy transmitted
to the drug solution in the form of the acoustic waves energizes
the drug solution such that nebulized particles of the drug
solution are formed. The ultrasonic energy may be delivered with a
maximum density at a focal point of the acoustic waves, and
nebulization efficiency of the drug solution may be enhanced when
an upper surface of a pool of the drug solution is located at or
near the focal point of the acoustic waves. However, the ability to
take advantage of enhanced nebulization efficiency in this manner
has been limited by the fact that the upper surface of the drug
solution lowers during nebulization as the amount of drug solution
in the device is depleted.
[0006] It should be appreciated that several conventional
nebulizing drug delivery devices are configured to deliver drug
solutions to a user's lungs via inhalation. But these devices may
not be capable of effectively or efficiently nebulizing various
types of drug solutions for delivery that are typically delivered
directly into a patient's lungs, such as through injection. Thus,
typical nebulizing drug delivery devices may not be particularly
effective or efficient in delivering drug solutions of a higher
viscosity, and/or drug solutions that must be delivered at higher
flow rates.
SUMMARY OF THE INVENTION
[0007] In accordance with the broad teachings of the invention, one
aspect of the invention relates to a nebulizing device comprising a
housing including an outlet and a drug reservoir for receiving a
drug solution within the housing. An aerosol generator is disposed
in communication with a fluid, and a barrier separates the fluid
from a portion of the drug solution residing on the barrier. The
barrier is capable of transmitting acoustic waves in the fluid to
the portion of drug solution residing thereon. The acoustic waves
in the drug solution operate to form nebulized particles from the
portion of drug solution residing on the barrier to enable
nebulized particles of the drug solution to be communicated to a
user through the outlet. A valve permits drug solution within the
reservoir to replenish the portion of drug solution residing on the
barrier when the portion is less than a threshold amount.
[0008] In one embodiment, the valve comprises a float that floats
on the portion of drug solution residing on the barrier, the float
substantially sealing the reservoir from the barrier when the
amount of drug solution residing on the barrier is above the
threshold amount. The float permitting drug solution to flow from
the reservoir to the barrier when the amount of drug solution
residing on the barrier is less than the threshold amount.
[0009] In another aspect the invention relates to a nebulizing
device comprising a housing having an inlet and an outlet, and a
plurality of aerosol generators in communication with a fluid. A
barrier is disposed between the fluid and a drug solution provided
within the housing, the barrier being capable of transmitting
acoustic waves in the fluid to the drug solution. The plurality of
aerosol generators form a corresponding plurality of fountains that
generate nebulized particles of the drug solution. The plurality of
fountains are in communication with the outlet to enable a user to
inhale nebulized particles of the drug solution from the plurality
of aerosol regions through the outlet.
[0010] These and other objects, features, and characteristics of
the present invention, as well as the methods of operation and
functions of the related elements of structure and the combination
of parts and economies of manufacture, will become more apparent
upon consideration of the following description and the appended
claims with reference to the accompanying drawings, all of which
form a part of this specification, wherein like reference numerals
designate corresponding parts in the various figures. It is to be
expressly understood, however, that the drawings are for the
purpose of illustration and description only and are not intended
as a definition of the limits of the invention. As used in the
specification and in the claims, the singular form of "a", "an",
and "the" include plural referents unless the context clearly
dictates otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] A specific embodiment of the invention is now described with
reference to the accompanying drawings, wherein:
[0012] FIG. 1 illustrates a perspective view of the nebulizing
device in accordance with an embodiment of the invention.
[0013] FIG. 2A is a top plan view of an embodiment of the
nebulizing device with a fixed length cord.
[0014] FIG. 2B is a top plan view of an embodiment of the
nebulizing device with a cord in a retracted position.
[0015] FIG. 3 is a cross sectional view of the nebulizing device of
FIG. 2A, taken along section line 3-3 of FIG. 2A, according to an
embodiment of the invention.
[0016] FIG. 4 is a sectional view of the nebulizing device similar
to FIG. 3, but illustrating the device with the valves between the
barrier chambers and the drug reservoir open.
[0017] FIG. 5 is an exploded perspective view of the nebulizing
drug delivery device, in accordance with one embodiment of the
invention.
[0018] FIG. 6 is a cross-sectional view of the nebulizing device
similar to FIG. 3, but including an alternative valve arrangement
between the barrier chambers and the drug reservoir.
[0019] FIG. 7 is a cross-sectional view of the nebulizing device
similar to FIG. 4, but including a solenoid to operate a valve for
opening and closing the drug reservoir.
[0020] FIG. 8 is a cross-sectional view of the nebulizing device
similar to FIG. 7, but illustrating the valve for opening and
closing the drug reservoir as being open.
[0021] FIG. 9 is an exemplary illustration of the circuitry of the
nebulizing device according to one embodiment of the invention.
[0022] FIG. 10 is an exemplary illustration of a method of
controlling the nebulizing device in accordance with an embodiment
of the invention.
[0023] FIGS. 11A-11C illustrate a front perspective view, a side
plan view, and a rear plan view of the nebulizing drug delivery
device, according to one embodiment of the invention.
[0024] FIG. 12 is a sectional view of the nebulizing device of FIG.
11B, taken along section line 12-12 of FIG. 11B, in accordance with
an embodiment of the invention.
[0025] FIG. 13 is a cross sectional view of the nebulizing device
of FIG. 11B, take along section line 13-13 FIG. 11B, according to
one embodiment of the invention.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS OF THE
INVENTION
[0026] FIG. 1 is a front perspective view, and FIG. 2A is a top
view of a nebulizing device 110, according to an embodiment of the
invention. Nebulizing device 110 is adapted to nebulize and deliver
a drug solution to a user. Nebulizing device 110 provides various
advantages in nebulizing and/or delivering the drug solution to the
user. For example, nebulizing device 110 is capable of nebulizing
viscous drug solutions such as drug solutions containing a
surfactant, or other viscous drug solutions, delivers the drug
solution at an enhanced flow rate, and provides other advantages as
described herein. As shown, nebulizing device 110 includes a
housing 112, a gas inlet 114, a nebulized drug delivery outlet 116,
and a user control interface 118.
[0027] In one embodiment of the invention, housing 112 includes a
plurality of housing members. Housing 112 includes an upper housing
portion 120, a middle housing portion 121, and a lower housing
portion 122. The front surface of upper housing portion 120 has a
step region 124 formed thereon. Specifically, upper housing portion
120 has a top surface 126, an angled surface 128 extending
downwardly from top surface 126, and a longitudinal horizontal
ledge surface 130 extending outwardly from the bottom of angled
surface 128. Thus, top surface 126 and ledge surface 130 are formed
as offset parallel planar surfaces with angled surface 128
structurally joining top surface 126 and ledge surface 130 to form
step region 124.
[0028] According to one embodiment of the invention, gas inlet 114
includes one or more inlet ports 132 formed in housing 112. Inlet
ports 132 are located at middle housing portion 121 of housing
112.
[0029] The nebulized drug delivery outlet 116 includes a first
outlet port 134 and a second outlet port 136. First outlet port 134
and second outlet port 136 are formed in housing 112 at angled
surface 128. In an alternate embodiment, first outlet port 134 and
second outlet port 136 may be formed as a single outlet port.
[0030] User control interface 118 includes a control knob 138.
Control knob 138 is located on housing 112. In a non-limiting
example, control knob 138 is located at lower housing portion 122
of housing 112. Of course, various other user interfaces could be
used without departing from the scope of the present invention such
as keypads, touch screens, wirelessly via a memory storage device,
sent over a radio frequency, or Infrared communication link.
[0031] FIGS. 3 and 4 are cross sectional views, taken along cross
section line 3-3, as illustrated in FIG. 2A, of nebulizing device
110. Referring to FIG. 3, nebulizing device 110 includes a drug
solution reservoir 310, a first nebulization section 312, a second
nebulization section 314, control electronics 316, and a power
source/connection 318.
[0032] Drug solution reservoir 310 is contained in a reservoir
housing member 319, included within housing 112. Drug solution
reservoir 310 includes an upper drug solution receiving opening
320, a drug dispensing opening 322, a reservoir wall 324, and a
reservoir floor 326. Drug solution reservoir wall 324 is generally
cylindrical in shape, or may be otherwise shaped. Drug solution
receiving opening 322 is defined by the upper periphery of
reservoir wall 324, and is circular, or otherwise shaped. Reservoir
floor 326 angles from reservoir wall 324 in a downward slope to
drug dispensing opening 322 formed within reservoir floor 326.
[0033] In one embodiment of the invention, the nebulizing device
110 also includes a heating/sensor unit 327 for heating the drug
solution. This may be useful with higher viscosity drug solutions,
or for increased comfort of a user. For example, to warm the drug
solution prior to inhalation in instances when the device and/or
drug solution contained therein have been exposed to cold
temperatures. As shown in the embodiments of FIGS. 3-8 and as can
be particularly appreciated from the exploded view of the
embodiment of FIG. 5, heating/sensor unit 327 may be annularly
disposed about the outer wall 324 that contains drug reservoir 310.
As illustrated in FIG. 5, heating/sensor unit 327 may include an
annular band member 1022, with a resistive heating element (or
heater) 1024 and a temperature sensor 1026 disposed thereon. The
temperature sensor 1026 within heating/sensor unit 327 is in
functional communication with the heater 1024, to sense a
temperature of the drug solution or the heater 1024 itself.
Heating/sensor unit 327 is operatively coupled to one or both of
control electronics 316 and power source/connection 318.
Heating/sensor unit 327 is controlled via control electronics 316,
and is powered via power source/connection 318.
[0034] The heater is operable in response to the temperature sensor
1026. In some instances, heating/sensor unit 327 maintains the
temperature of the heater 1024 in a temperature range between an
upper threshold temperature and a lower threshold temperature. Or,
heating/sensor unit 327 maintains the temperature of the heater
1024 above a threshold temperature. It is contemplated that
heating/sensor unit 327 is configured and/or arranged to heat the
drug solution in at least one of drug reservoir 310, first barrier
chamber 332, second barrier chamber 432, first reservoir channel
328, second reservoir channel 330, first aerosol region 340, and/or
second aerosol region 440.
[0035] In another embodiment, the heater/sensing unit 327 can be
separated so that either the heater or the sensor is disposed
within the drug solution reservoir 310, in contact with the drug
solution, and the other element (heater or sensor) is in contact
with the outer wall 324 that contains drug reservoir 310. The
sensor 1026 may be a thermocouple or other temperature sensing
element such as a thermistor, resistance thermal detector,
bimetallic, or Infrared.
[0036] It is further contemplated that the heater element 1024 need
not be a resistive heater, but can be any suitable heater that can
be used to raise the temperature of the drug solution.
[0037] According to various embodiments of the invention, first
nebulization section 312 includes a first reservoir channel 328, a
first valve 330, a first barrier chamber 332, a first barrier 334,
a first fluid chamber 336, transmitting fluid 337, a first aerosol
generator 338, and a first aerosol region 340. First reservoir
channel 328 is formed within housing 112 and runs from drug
dispensing opening 322 to first valve 330. First valve 330 is
positioned outwardly from drug dispensing opening 322 within
housing 112, between first reservoir channel 328 and first barrier
chamber 332.
[0038] In one embodiment, seen best in FIG. 4, first valve 330
includes a first valve opening 342, and a valve seal 344. First
valve opening 342 is formed within housing 112 as an outer opening
of first reservoir channel 328. First valve structure 344 is
disposed at first valve opening 342 to selectively seal first valve
opening 342. In one embodiment, first valve structure 344 includes
a first float 346, disposed within first valve 330 at a first float
reception cavity 348. First float 346 is composed of a material
that enables first float 346 to float in the drug solution, such
as, for example, a closed cell foam. First float reception cavity
348 is formed in housing 112 between first reservoir channel 328
and first barrier chamber 332. First valve 344 includes a first
float/cavity interface 350 that includes corresponding surfaces of
first float 346 and first float reception cavity 348. First float
346 seals first valve opening 342 as first float 346 rises to seal
first valve opening 342. For example, as is illustrated in FIGS. 3,
and 4, first float/cavity interface 350 includes corresponding
angled surfaces of first float 346 and first float reception cavity
348.
[0039] Referring to FIG. 6, an exemplary illustration of nebulizing
device 110 provides an alternate configuration for valves 330 and
430. According to the embodiment illustrated in FIG. 6, floats 346
and 446 include a body 510 and an annular protrusion 512. Annular
protrusion 512 surrounds body 510, and extends outward from body
510 in a direction normal to the surface of body 510 that annular
protrusion 512 protrudes from. As floats 346 and 446 rise up to
contact float/cavity interfaces 350 and 450, bodies 510 of floats
346 and 446 contact an upper surfaces 514 of float cavities 348 and
448, annular protrusions 512 effectively seal valve openings 342
and 442, closing valves 330 and 430.
[0040] In other embodiments, valves 330 and 430 may take the form
of one or more electrically operated solenoid valves. Such valves
can each be open in response to an associated liquid level detector
that detects the amount of drug solution on one of the barriers.
When the detector detects that the amount of drug solution is at or
below a threshold level, it sends a signal that is used to open the
associated valve and permit the drug solution to flow from the
associated reservoir to the associated barrier. In such an
embodiment, the liquid level detector can optionally be an
adjustable detector to enable the threshold level at which the drug
solution will be released from the reservoir to the barrier to be
adjusted.
[0041] In the embodiment illustrated in FIGS. 3, and 4, first
barrier chamber 332, which communicates with first reservoir
channel 328 via first valve 330 is formed within housing 112
between first barrier 334 and first aerosol region 340. First
barrier 334 is mounted within housing 112 to a first mounting
surface 352 that is formed on an upper surface of first fluid
chamber 336, between first barrier chamber 332 and first fluid
chamber 336. First barrier forms a physical separation (i.e., a
seal) between first barrier chamber 332 and first fluid chamber
336. First barrier 334 is composed of one or more materials
designed to enable first barrier 334 to be capable of transmitting
ultrasonic energy therethrough, even under high temperature
conditions. For example, polyetheretherketone (PEEK), or other
materials may be used.
[0042] According to one embodiment of the invention, first fluid
chamber 336 is formed within housing 112 between first barrier 334
and first aerosol generator 338. In one embodiment, the first
aerosol generator 338 is an acoustic wave generator, such as a
piezoelectric transducer, and first fluid chamber 336 holds a fluid
337 in communication with first barrier 334 and first aerosol
generator 338. Fluid 337 can be selected to be capable of
transmitting acoustic waves, such as, for example, water, or other
fluids. Fluid 337 may include one or more sterilants, such as,
alcohol, or other sterilants.
[0043] In one embodiment of the invention, first aerosol generator
338 is disposed at a first seating portion 354 formed within
housing 112. In embodiments where first aerosol generator 338
comprises a piezoelectric transducer, it may be formed to have a
concave configuration with a silver electrode. First aerosol
generator 338 generates acoustic waves at a generator frequency,
such as, for example, 2.5 MHz, or another frequency. The acoustic
waves are focused at a focal point, or focal band, that is a focal
length from first aerosol generator 338. First seating portion 354
is formed within housing 112 such that the focal point will be
within first barrier chamber 332. First aerosol generator 338 is
operatively linked to control electronics 316 so that control
electronics 316 can control various aspects of acoustic wave
generation by first aerosol generator 338, such as, for instance,
activation and deactivation. First aerosol generator 338 is
operatively linked to power source/connection 318 so that power can
be provided to first aerosol generator 338 via this operative
link.
[0044] Power source/connection 318 may include a power cord 140.
Power cord 140 can be connected to a contemporary household socket
to deliver power to the nebulizing device 110. Cord 140 could have
a fixed length or could have a mechanism to retract a majority of
cord 140 into housing 112. This feature of the present invention
could be used regardless of the aerosol generator being used. The
present invention contemplates that cord 140 could also be used
with a variety of nebulizers including jet nebulizers, traditional
planar ultrasonic nebulizers, vibrating mesh nebulizers, vibrating
plate nebulizers, or electro spray nebulizers. The unique advantage
this feature of the present invention provides is that it prevents
cord 140 from becoming tangled with objects present in the user's
environment when not in use.
[0045] According to an embodiment of the invention, first aerosol
region 340 includes a first fountain region 356, one or more first
aerosol region inlets 358, a first chimney 360, a first drug
delivery region 361, and a first drug return region 362. First
fountain region 356 is formed within housing 112 between first
barrier chamber 332 and first chimney 360. First fountain region
356 includes a lower first fountain region 364 and an upper first
fountain region 366. Lower first fountain region 364 is open at a
first end to first barrier chamber 332 and at a second end to upper
first fountain region 366. Lower first fountain region 364 is
cylindrical, or may be otherwise shaped. Upper first fountain
region 366 is open at a first end to lower first fountain region
364 and at a second end to first chimney 360. Upper first fountain
region 364 is formed as a funnel with a smaller opening at the
first end and a larger opening at the second end, or may be
otherwise shaped.
[0046] As is illustrated in FIGS. 3, and 4, first aerosol region
inlets 358 are formed in housing 112 at first fountain region 356.
First aerosol region inlets 358 provide an opening for one or more
corresponding inlet channels 368. Inlet channels 368 are formed in
housing 112, and run between first aerosol region inlets 358 and
inlet ports 132.
[0047] In one embodiment, first chimney 360 is formed in housing
112, and opens at a first end to first fountain region 356. A first
chimney ceiling 370 is formed within housing 112 at a second end of
first chimney 360. At a side of first chimney 360, proximate to
first chimney ceiling 370, first chimney 360 opens to first drug
delivery region 361.
[0048] According to an embodiment of the invention, first drug
delivery region 361 is formed within housing 112 to communicate
with first chimney 360, first outlet port 134, and first drug
return region 361. First drug delivery region 361 is open to first
drug return region 361 at a first end, and is bounded at a second
end by first drug delivery region ceiling 372. First drug delivery
region ceiling 372 and first chimney ceiling 370 form a first
aerosol region ceiling 374.
[0049] In one embodiment of the invention, first drug return region
362 is formed in housing 112 to be open at a first end to drug
reservoir 310. First drug return region 362 also communicates with
first drug delivery region 361.
[0050] According to the embodiment of the invention shown in FIGS.
3, 4, second nebulization section 312 includes a second reservoir
channel 428, a second valve 430, a second barrier chamber 432, a
second barrier 434, a second fluid chamber 436, a second fluid 437
within second fluid chamber 436, a second aerosol generator 438,
and a second aerosol region 440. Second reservoir channel 428 is
formed within housing 112 and runs from drug dispensing opening 422
to second valve 430. Second valve 430 is positioned outwardly from
drug dispensing opening 422 within housing 112, between second
reservoir channel 428 and second barrier chamber 432.
[0051] The invention contemplates that first aerosol generator 338
and second aerosol generator 438 may be any device capable of
forming aerosol. For instance, the unique aspects of the present
invention can also be used with compressor driven jet nebulizers,
traditional planar ultrasonic nebulizers, vibratory mesh
nebulizers, vibrating plate nebulizers, or electrospray nebulizers
without departing from the teachings of the present invention.
[0052] The second valve 430 includes a second valve opening 442,
and a valve seal 444. Second valve opening 442 is formed within
housing 112 as an outer opening of second reservoir channel 428.
Second valve seal 444 is disposed at second valve opening 442 to
selectively seal second valve opening 442. In some instances,
second valve seal 444 includes a second float 446, disposed within
second valve 430 at a second float reception cavity 448. Second
float 446 is composed of materials that enable second float 446 to
float in the drug solution. Second float reception cavity 448 is
formed in housing 112 between second reservoir channel 428 and
second barrier chamber 432. Second valve 444 includes a second
float/cavity interface 450 that includes corresponding surfaces of
second float 446 and second float reception cavity 448, and is
arranged to bias second float 446 against second valve opening 442
as second float 446 rises to seal second valve opening 442. For
example, as is illustrated in FIGS. 3, and 4, second float/cavity
interface 450 includes corresponding angled surfaces of second
float 146 and second float reception cavity 448.
[0053] According to an embodiment of the invention, second barrier
chamber 432, which communicates with second reservoir channel 428
via second valve 430 is formed within housing 112 between second
barrier 434 and second aerosol region 440. Second barrier 434 is
mounted within housing 112 to a second mounting surface 452 that is
formed on an upper surface of second fluid chamber 436, between
second barrier chamber 432 and second fluid chamber 436. Second
barrier forms a physical separation (i.e., a seal) between second
barrier chamber 432 and second fluid chamber 436. Second barrier
434 is composed of one or more materials designed to enable second
barrier 434 to be capable of transmitting ultrasonic energy
therethrough, even under high temperature conditions. For example,
polyetheretherketone (PEEK), or other materials may be used.
[0054] In accordance with the embodiment of the invention
illustrated in FIGS. 3, and 4, second fluid chamber 436 is formed
within housing 112 between second barrier 434 and second aerosol
generator 438. The aerosol generator 438, in one embodiment, is a
concave shaped piezoelectric transducer with a silver electrode.
The piezoelectric aerosol generator 438 achieves its functionality
by generating acoustic waves in the drug solution as described with
respect to the first aerosol generator 338. Second fluid chamber
436 holds a fluid in communication with second barrier 434 and
second aerosol generator 438. Fluid 337 includes one or more fluids
capable of transmitting acoustic waves, such as, for example,
water, or other fluids. Fluid 337 may include one or more
sterilants, such as, alcohol, or other sterilants.
[0055] In one embodiment of the invention, second aerosol generator
438 is disposed at a second seating portion 454 formed within
housing 112. In some instances, second aerosol generator 438
includes a concave piezoelectric transducer with a silver
electrode. Second aerosol generator 438 generates acoustic waves at
a generator frequency, such as, for example, 2.5 MHz, or another
frequency. The acoustic waves are focused at a focal point, or
focal band, that is a focal length from second aerosol generator
438. Second seating portion 454 is formed within housing 112 such
that the focal point will be within second barrier chamber 432.
Other embodiments of second aerosol generator 438 exist. Second
aerosol generator 438 is operatively linked to control electronics
316 so that control electronics 316 can control various aspects of
acoustic wave generation by second aerosol generator 438, such as,
for instance, activation and deactivation, or other aspects. Second
aerosol generator 438 is operatively linked to power
source/connection 318 so that power can be provided to second
aerosol generator 438 via this operative link.
[0056] The second aerosol region 440 includes a second fountain
region 456, one or more second aerosol region inlets 458, a second
chimney 460, a second drug delivery region 461, and a second drug
return region 462. Second fountain region 456 is formed within
housing 112 between second barrier chamber 432 and second chimney
460. Second fountain region 456 includes a lower second fountain
region 464 and an upper second fountain region 466. Lower second
fountain region 464 is open at a first end to second barrier
chamber 432 and at a second end to upper second fountain region
466. Lower second fountain region 464 is cylindrical, or may be
otherwise shaped. Upper second fountain region 466 is open at a
first end to lower second fountain region 464 and at a second end
to second chimney 460. Upper second fountain region 464 is formed
as a funnel with a smaller opening at the first end and a larger
opening at the second end, or may be otherwise shaped.
[0057] In one embodiment of the invention, second aerosol region
inlets 458 are formed in housing 112 at second fountain region 456.
Second aerosol region inlets 458 provide an opening for one or more
corresponding inlet channels 468. Inlet channels 468 are formed in
housing 112, and run between second aerosol region inlets 458 and
inlet ports 132.
[0058] In one embodiment, second chimney 460 is formed in housing
112, and opens at a first end to second fountain region 456. A
second chimney ceiling 470 is formed within housing 112 at a first
end of second chimney 460. At a side of second chimney 460,
proximate to second chimney ceiling 470, second chimney 460 opens
to second drug delivery region 461.
[0059] According to the embodiment of the invention shown in FIGS.
3, and 4, second drug delivery region 461 is formed within housing
112 to communicate with second chimney 460, second outlet port 134,
and second drug return region 461. Second drug delivery region 461
is open to second drug return region 461 at a first end, and is
bounded at a second end by second drug delivery region ceiling 472.
Second drug delivery region ceiling 472 and second chimney ceiling
470 form a second aerosol region ceiling 474.
[0060] The second drug return region 462 is formed in housing 112
to be open at a first end to drug reservoir 310. Second drug return
region 462 also communicates with second drug delivery region
461.
[0061] According to an embodiment of the invention, barrier
chambers 332 and 432 hold an amount of the drug solution at each of
barriers 334 and 434. Fountains are formed at barrier chambers 332
and 432. The fountains create nebulized particles of the drug
solution that are delivered to aerosol regions 340 and 440. The
nebulized particles of the drug solution are formed by acoustic
waves within the drug solution held in barrier chambers 332 and 432
at barriers 334 and 434. The acoustic waves are generated by
aerosol generators 338 and 438. The acoustic waves transmitted from
aerosol generators 338 and 438 to barrier chambers 332 and 432 via
the fluid held in fluid chambers 336 and 436. The transmitted
acoustic waves pass from fluid chambers 336 and 436 to barrier
chambers 332 and 432 via barriers 334 and 434.
[0062] In accordance with the embodiment of the invention
illustrated in FIGS. 3, and 4, the acoustic waves transmitted to
barrier chambers 332 and 432 are focused at the focal point. The
drug solution in barrier chambers 332 and 432 absorbs the
ultrasonic energy provided by the focused acoustic waves to create
a fountain within each of barrier chambers 332 and 432. The
ultrasonic energy delivered by the acoustic waves has a maximum
density at or near the focal point of the acoustic waves. The
fountains shed a portion of the drug solution as particles. Some of
these particles are so large they immediately fall out. Some are
small enough to pass into drug return regions 362,462 before
falling out. The remaining particles which are appropriately sized,
pass out through first and second outer ports 134,136. In this
manner, substantially consistent particle size is achieved.
[0063] In one embodiment of the invention, the nebulized particles
are communicated from barrier chambers 332 and 432, through aerosol
regions 340 and 440, and to the user via outlet ports 134 and 136
included in outlet 116. More particularly, the nebulized particles
and the larger droplets of the drug solution formed at the
fountains are received by aerosol regions 340 and 440 at fluid
chambers 364 and 464, and pass into chimneys 360 and 460. From
chimneys 360 and 460, the nebulized particles are communicated to
the user via drug delivery regions 361 and 461 and outlet ports 134
and 136. In contrast, due to size and/or weight, the larger
droplets may not be communicated to the user, but instead may
contact a surface of aerosol regions 340 and 440, such as aerosol
ceilings 372 and 472, or other surfaces. The larger droplets then
condense on the contacted surface(s), thereby separating the larger
droplets from the nebulized particles prior to delivery to the
user. The condensed larger droplets are passed back to drug
solution reservoir 310 via drug return regions 362 and 462.
[0064] The nebulization of the drug solution at the fountains is
enhanced when the focal point of the acoustic waves coincides
(exactly or substantially) with an upper surface of the drug
solution in first barrier chamber 332. This requires a level of the
upper surface to be controlled with some particularity to enhance
the operation of the fountains. To control the level of the upper
surface, a flow of the drug solution from drug reservoir 310 to
barrier chambers 332 and 432 via reservoir channels 328 and 428 are
controlled via valves 330 and 430 by independently sealing and
unsealing valve openings 342 and 442 with valve seals 344 and 444.
For example, when the level of the upper surface of the drug
solution on either of barriers 334 and/or 434 reaches a threshold
level at or near the focal point of the acoustic waves,
corresponding ones of floats 346 and/or 446 are positioned to seal
valve openings 342 and/or 442 by virtue of the buoyancy of floats
346 and 446 with respect to the drug solution. However, as
particles are formed at the fountains, the level of the upper
surface in one or both of barrier chambers 332 and 432 may drop
below the threshold level, which in turn lowers one or both of
floats 346 and 446 from valve openings 342 and 442, thereby opening
valves 330 and/or 430, as is illustrated in FIG. 4.
[0065] Referring to FIG. 3, in some embodiments of the invention,
activation of aerosol generators 338 and 438 enable generation of
particles of the drug solution to be propelled by the fountains
into aerosol regions 340 and 440. As particles are propelled by the
fountain into aerosol regions 340 and 440, the atmosphere within
aerosol regions 340 and 440 is disturbed such that intake gas
present within inlet channels 368 and 468 is pulled into particle
receiving regions 366 and 466 via aerosol region inlets 358 and
458. Pulling air into particle receiving regions 366 and 466 may
initiate the flow of intake gas through aerosol regions 340 and 440
to outlet ports 134 and 136, which may in turn motivate the
nebulized particles formed at the fountains toward outlet ports 134
and 136. Thus, the atmospheric disturbances that may be caused by
the nebulized particles from the fountains, and the resulting flow
of intake gas through aerosol regions 340 and 440 may function in a
cooperative manner to "drive" the delivery of nebulized particles
from the fountains to the user without requiring additional active
moving parts such as a pump or compressor.
[0066] FIG. 5 is an exploded view of nebulizing device 110
according to an embodiment of the invention. Housing 112 includes
an outlet housing member 1010, a drug return housing member 1012, a
reservoir housing member 319, a drug reservoir seating member 1016,
a barrier chamber housing member 1018, and a base housing member
1020.
[0067] The outlet housing member 1010 is disposed at the upper
housing portion 120 of housing 112. Outlet 116 is formed in outlet
housing member 1010. As may be seen in FIGS. 3, 4, 7, and 8
illustrating cross sections taken along cross section line 3, show
various components of aerosol regions 340 and 440 are formed within
outlet housing member 1010. For example, aerosol region ceilings
374 and 474, and drug delivery regions 361 and 461 are formed
within outlet housing member 1010.
[0068] According to one embodiment of the invention, drug return
housing member 1012 may be disposed adjacent outlet housing member
1010. As may be seen in the FIGS. 3, 4, 7, and 8 illustrating cross
sections taken along cross section line 3-3, show various
components of aerosol regions 340 and 440 are formed within drug
return housing member 1012. For example, chimneys 360 and 460, and
drug return regions 362 and 462 are formed within drug return
housing member 1012. Inlet ports 132 of gas inlet 114, and
corresponding inlet channels 368, are partially formed in drug
return housing member 1012.
[0069] In the embodiment illustrated in FIG. 5, heating/sensor unit
327 is disposed around an outer surface of reservoir housing member
319. Drug return housing member 1012 may be adapted to receive
heating/sensor unit 327 and reservoir housing member 319. Reservoir
housing member 319 is disposed primarily within drug return housing
member 1012, and forms drug reservoir 310.
[0070] According to various embodiments of the invention, drug
reservoir seating member 1016 is disposed adjacent to drug return
housing member 1012. A drug reservoir seating portion 1028 is
formed on drug reservoir seating member 1016. Drug reservoir
seating portion 1028 is configured to receive a seating portion
1030 of reservoir housing member 319 therein. Upper fluid chambers
366 and 466 are formed in drug reservoir seating member 1016. Inlet
ports 132 of gas inlet 114, and corresponding inlet channels 368,
are partially formed in drug reservoir seating member 1016. As may
be seen in FIGS. 3, 4, 7, and 8 illustrating cross sections taken
along cross section line 3-3, when drug reservoir seating member
1016 is disposed adjacent to drug return housing member 1012, inlet
ports 132 of gas inlet 114, and the corresponding inlet channels
368 are formed in housing 112 at an inlet interface 1032 between
drug return housing member 1012 and drug reservoir seating member
1016.
[0071] As is illustrated in FIG. 5, barrier chamber housing member
1018 is disposed in housing 112 adjacent to drug reservoir seating
member 1016. Barrier chambers 332 and 432, and an upper portion of
a plunger channel 618 are formed in barrier chamber housing member
1018. When barrier chamber housing member 1018 is disposed in
housing 112 adjacent to drug reservoir seating member 1016 a valve
interface 1034 is formed. As may be seen in FIGS. 3, 4, 7, and 8
illustrating cross sections taken along cross section line 3,
reservoir channels 328 and 428, and valves 342 and 442 are formed
at valve interface 1034. Also illustrated in FIGS. 3, 4, 7, and 8,
barrier chamber housing member 1018 includes mounting surfaces 352
and 452.
[0072] Returning to FIG. 5, base housing member 1020 is disposed
adjacent to barrier chamber housing member 1018, at lower housing
portion 122 of housing 112, forming a base for housing 112. Base
housing member 1020 may form fluid chambers 336 and 436, solenoid
cavity 610, and a lower portion of plunger channel 618. A solenoid
612 is mounted within solenoid cavity 610 via solenoid bracket
1036. Aerosol generator 338 is seated within base mounting member
1020 at seating portion 354, formed therein. Base mounting member
1020 is adapted to receive user control interface 118.
[0073] It will be appreciated that the configurations of housing
112 shown, including housing members 1010, 1012, 319, 1016, 1018,
and 1020 are illustrated for exemplary purposes only, and that
other embodiments of housing 112 and its various members exist.
[0074] FIGS. 7 and 8 illustrate another embodiment of the invention
that enables the drug solution held within housing 112 to be heated
prior to, during, and/or after nebulization. The drug solution may
be heated to enhance a comfort of the user, to lower a viscosity of
the drug solution to augment nebulization of the drug solution,
increase drug delivery flow rate, or for other purposes.
[0075] As illustrated in FIGS. 7 and 8, nebulizing device 110
includes a solenoid cavity 610 formed in housing 112. A solenoid
612 is mounted in solenoid cavity 610. Solenoid 612 has a solenoid
body 613 and a solenoid shaft 616, which is joined to a movable
plunger 614. In FIG. 7, the solenoid is shown energized, while in
FIG. 8 it is de-energized. When the solenoid 612 is actuated, shaft
616 extends from the solenoid body 613. Of course one of ordinary
skill in the art can best appreciate that the solenoid could be
reconfigured so that when it is energized it retracts into the
solenoid body.
[0076] Plunger 614 is joined to the solenoid body 613 at a first
end and includes a plunger head 620 at a second end. Plunger head
620 interacts with drug dispensing opening 322 to comprise a
reservoir valve 622. Plunger 614 is actuated between the engaged
position (illustrated in FIG. 7) and the disengaged position
(illustrated in FIG. 8) to open and close reservoir valve 622. In
the engaged position, plunger head 620 engages drug dispensing
opening 322 of drug solution reservoir 310 such that plunger head
620 seals drug dispensing opening 322. Sealing drug dispensing
opening 322 keeps the drug solution in drug solution reservoir 310
from flowing to barrier chambers 332 and 432 along reservoir
chambers 328 and 428 respectively. In the disengaged position,
plunger head 620 is withdrawn from drug dispensing opening 322 to
enable the drug solution held in drug solution reservoir 310 to
flow to barrier chambers 332 and 432. Solenoid 612 is operatively
coupled to control electronics 316 and power source/connection 318.
Solenoid 612 is controlled via control electronics 316. Solenoid
612 is powered via power source/connection 318. It can be
appreciated that while at rest, the solenoid 612 is positioned to
seal the opening 322 and activated to unseal it, the opposite
arrangement can alternatively be provided so that the solenoid 612
is activated to seal the opening and deactivated to unseal the
opening 322
[0077] FIG. 9 is an exemplary illustration of circuitry 626 that
may be used in nebulizing device 110 according to an embodiment of
the invention. As shown, control electronics 316 are operatively
linked with various components of nebulizing device 110, such as,
for example, user control interface 118, power source/connection
318, aerosol generators 338 and 438, reservoir valve 622,
heating/sensor unit 327, and/or other components.
[0078] FIG. 10 is an exemplary illustration of a method 910 of
controlling a nebulizing device according to one embodiment of the
invention. Method 910 is commenced from a state in which the device
is deactivated. In this state, a drug solution is held in drug
reservoir 310 with closed valve 622, the heater/sensing unit 327
associated with the device is at room temperature, and aerosol
generators 338 and 438 associated with the device are
deactivated.
[0079] An activation command is conveyed from the user to the
device at an operation 912. For example, the activation commend is
input via user control interface 138, or otherwise conveyed from
the user to the device.
[0080] Method 910 includes an operation 914, at which a first
threshold temperature and a second threshold temperature is
determined. The first threshold temperature and/or the second
threshold temperature is determined, in non-limiting examples,
according to an input from the user, determined based on a default
setting, determined automatically based on one or more measured
variables, and/or otherwise determined. The inventors presently
contemplate that the preferred operating temperature is 37 degrees
Celsius or between 33 degrees to 41 degrees Celsius. Of course,
delivery temperatures outside this range could also be used without
departing from the scope of the present invention as dictated by
the requirements of the particular drug being delivered and/or user
preferences.
[0081] Method 910 includes an operation 916, at which the heater in
heater/sensing unit 327 associated with the nebulizing device 110
is activated. Activating the heater includes transmitting power to
the heater. Activation causes the temperature of the heater to
rise.
[0082] As is shown in FIG. 10, method 910 includes an operation
918, at which the temperature of the heater associated with
heater/sensing unit 327 is sensed to determine if the temperature
is above the first temperature threshold. If the temperature of the
heater is below the first threshold temperature, method 910 returns
to operation 916.
[0083] If the temperature of the heater is above the first
threshold temperature, method 910 proceeds to an operation 920. At
operation 920, the drug solution is released from the drug
reservoir 310 for nebulization. For example, the drug solution is
released to barriers 334 and 434 by opening valve 622.
[0084] Method 910 includes an operation 922, at which aerosol
generators 338 and 438 are activated. The acoustic waves generated
by the activated aerosol generators 338 and 438 are delivered to
the drug solution to form nebulized particles from the drug
solution at corresponding ones of barriers 334 and 434.
[0085] Method 910 includes an operation 924, at which the
temperature of the heater is sensed by the temperature sensor to
determine if the temperature is between the first temperature and
the second temperature. If the temperature of the heater is
determined to be below the first temperature, method 910 proceeds
to an operation 926. At operation 926, the flow of the drug
solution from the drug reservoir 310 to the barriers 334 and 434
are sealed (or substantially sealed), effectively stopping the
delivery of the drug solution from the drug reservoir 310 to the
barriers 334 and 434. For example, the flow of the drug solution is
sealed by closing valve 622. At operation 926, the aerosol
generators 338 and 438 are deactivated. From operation 926, method
910 may return to operation 916.
[0086] As is illustrated in FIG. 10, at operation 924, if the
temperature of the heater is above the first threshold and the
second threshold, method 910 proceeds to an operation 928, at which
the heater is deactivated. This causes the heater to stop producing
heat. In some instances, the flow of the drug solution from the
drug reservoir 310 to the barriers 338 and 438 is sealed (or
substantially sealed), effectively stopping the delivery of the
drug solution from the drug reservoir 310 to the barriers 334 and
434, and the aerosol generators 338 and 438 are deactivated.
However, in other instances, the delivery of the drug solution from
the drug reservoir 310 to the barriers 334 and 434 is continued and
the aerosol generators 338 and 438 are deactivated. From operation
928, method 910 returns to operation 924.
[0087] At operation 924, if the temperature of the heater is
between the first temperature threshold and the second temperature
threshold, method 910 proceeds to an operation 930. At operation
930, it is determined if a treatment session with the nebulizing
device 110 has been completed. The completion of a treatment
session includes, among other things, receiving a deactivation
command from the user, completing nebulization of a predetermined
or threshold amount of the drug solution, nebulizing the drug
solution for a predetermined or threshold amount of time, or
otherwise completing the treatment session. If the treatment
session is not completed, method 910 returns to operation 924. If
the treatment session is completed, method 910 proceeds to an
operation 932.
[0088] At operation 932, the nebulizing device 110 is deactivated.
Deactivating the nebulizing device 110 includes, among other
things, deactivating the aerosol generators 338 and 438, closing
the valve 622, and/or otherwise deactivating the nebulizing device
110.
[0089] FIGS. 11A-11C and 12 are exemplary illustrations of a
handheld nebulizing device 1110 in accordance with another
embodiment. In this embodiment, device 1110 includes a housing
1112, an inlet 1114, an outlet 1116, and a user control interface
1118.
[0090] Housing 1112 includes mouthpiece module 1120, an
intermediate module 1122, and a base module 1124. Modules 1120,
1122, and 1124 are selectively coupled to each other, and may be
coupled and uncoupled to each other by the user.
[0091] As is illustrated in the rear plan view of FIG. 11C, inlet
1114 includes an inlet port 1121 formed in housing 1112, and
particularly in mouthpiece module 1120.
[0092] As shown in the front plan view of FIG. 11A, outlet 1116
includes an outlet port 1126 formed in housing 1112 at mouthpiece
module 1120. Outlet port 1126 is configured for engagement by the
user's mouth.
[0093] In some embodiments, user control interface 1118 includes a
control knob 1128. Control knob 1128 is located on the front of
housing 1112 at base module 1124.
[0094] Intake gas, such as air from the atmosphere, is received
into inlet 1114. At outlet 1116, nebulized particles of the drug
solution are communicated from device 1110 to the user. The user
may control various aspects of operation of device 1110 via control
interface 1118.
[0095] As is illustrated in FIG. 11C, device 1110 includes a power
receiving connector 1130. Power connector 1130 is provided in
housing 1112 at base module 1124. Power is provided to device 1110
via power connection 1130. Alternatively, power may be provided to
device 1110 via an internal power source, such as a battery, a fuel
cell, or other power source.
[0096] FIG. 12 is a cross sectional view, taken along cross section
line 12-12 in FIG. 11B. In some instances, device 1110 includes a
drug solution reservoir 1310, a first nebulization section 1312, a
second nebulization section 1314, and control electronics 1316.
[0097] Drug solution reservoir 1310 includes a drug solution
receiving opening 1320, a drug dispensing opening 1322, a reservoir
wall 1324, and a reservoir floor 1326. Drug solution reservoir 1310
is generally cylindrical in shape, or may be otherwise shaped. Drug
solution receiving opening 1322 is formed by reservoir wall 1324,
and is circular, or otherwise shaped. Reservoir floor 1326 angles
from reservoir wall 1324 in a downward slope to drug dispensing
opening 1322, which is formed by reservoir floor 1322.
[0098] First nebulization section 1312 includes a first reservoir
channel 1328, a first valve 1330, a first barrier chamber 1332, a
first barrier 1334, a first fluid chamber 1336, a first aerosol
generator 1338, and a first aerosol region 1340. First reservoir
channel 1328 is formed within housing 112 and runs from drug
dispensing opening 1322 to first valve 1330. First valve 1330 is
positioned outwardly from drug dispensing opening 1322 within
housing 112, between first reservoir channel 1328 and first barrier
channel 1332.
[0099] In some embodiments of the invention, first valve 1330
includes a first valve opening 1342, and a valve seal 1344. First
valve opening 1342 is formed within housing 1112 as an outer
opening of first reservoir channel 1328. First valve seal 1344 is
disposed at first valve opening 1342 to selectively seal first
valve opening 1342. First valve seal 1344, in one embodiment, may
include a first float 1346 disposed within first valve 1330 at a
first float reception cavity 1348. First float 1346 is composed of
a material that enables first float 1346 to float in the drug
solution, such as a closed cell foam. First float reception cavity
1348 is formed in housing 1112 between first reservoir channel 1328
and first barrier chamber 1332. First valve 1344 includes a first
float/cavity interface 1350 that includes corresponding surfaces of
first float 1346 and first float reception cavity 1348. First float
1346 is forced against first valve opening 1342 as first float 1346
rises to seal first valve opening 1342.
[0100] In the embodiment illustrated in FIG. 12, first float 1346
includes a first protruding center portion 1345 and first sloping
lateral portions 1347. First protruding center portion 1345
protrudes from first sloping lateral portions 1347, which slope
away from first protruding center portion 1345. First float
reception cavity 1348 includes a first vertical channel 1349 and
first lateral sloping surfaces 1351, arranged such that first
protruding center portion 1345 is constantly positioned in first
vertical channel 1349 even when first float 1346 is not sealing
first valve opening 1342 to maintain the orientation of first float
1346. Maintaining the orientation of first float 1346 ensures that
first sloping lateral portions 1347 will contact sloping lateral
surfaces 1351 to seal first valve 1330 when first float rises due
to its buoyancy.
[0101] According to an embodiment of the invention, first barrier
chamber 1332, which communicates with first reservoir channel 1328
via first valve 1330, is formed within housing 1112 between first
barrier 1334 and first aerosol region 1340. First barrier 1334 is
mounted within housing 112 to a first mounting surface 1352 that is
formed on an upper surface of first fluid chamber 1336, between
first barrier channel 1332 and first fluid chamber 1336. First
barrier forms a physical separation (i.e., a seal) between first
barrier channel 1332 and first fluid chamber 1336. First barrier
1334 is composed of one or more materials designed to enable first
barrier 1334 to be capable of transmitting ultrasonic energy
therethrough, even under high temperature conditions. For example,
polyetheretherketone (PEEK), or other materials may be used.
[0102] According to one embodiment of the invention, first fluid
chamber 1336 is formed within housing 1112 between first barrier
1334 and first aerosol generator 1338. First fluid chamber 1336
holds a fluid 1339 in communication with first barrier 1334 and
first acoustic wave aerosol generator 1338. Fluid 1339 includes one
or more fluids capable of transmitting acoustic waves, such as, for
example, water, or other fluids. Fluid 1339 may include one or more
sterilant, such as, alcohol, or other sterilants.
[0103] In the embodiment of the invention illustrated in FIG. 12,
first aerosol generator 1338 is disposed at a first aerosol
generator seating portion 1354 formed within housing 112. In some
instances, first aerosol generator 1338 includes a concave
piezoelectric transducer with a silver electrode. First aerosol
generator 1338 generates acoustic waves at a generator frequency,
such as, for example, 2.5 MHz, or another frequency. The acoustic
waves are focused at a focal point, or focal band, that is a focal
length from first aerosol generator 1338. First aerosol generator
seating portion 1354 is formed within housing 112 such that the
focal point will be within first barrier chamber 1332. Other
embodiments of first aerosol generator 1338 exist. First aerosol
generator 1338 is operatively linked to control electronics 1316 so
that control electronics 1316 can control various aspects of
acoustic wave generation by first aerosol generator 1338, such as,
for instance, activation and deactivation, or other aspects. First
aerosol generator 1338 is operatively linked to power receiving
connection 1130 so that power can be provided to first aerosol
generator 1338 via this operative link.
[0104] According to an embodiment of the invention, first aerosol
region 1340 includes a first fountain region 1356, one or more
first aerosol region inlets 1358, a first chimney 1360, and a first
drug return region 1362. First fountain region 1356 is formed
within housing 1112 between first barrier chamber 1332 and first
chimney 1360. First fountain region 1356 is open at a first end to
first barrier chamber 1332 and at a second end to first chimney
1360. First fountain region 1356 is formed as a funnel with a
smaller opening at the first end and a larger opening at the second
end, or may be otherwise shaped.
[0105] The first aerosol region inlet 1358 is formed in housing
1112 at first fountain region 1356. First aerosol region inlet 1358
is in communication with inlet port 1132.
[0106] In one embodiment, first chimney 1360 is formed in housing
1112, and opens at a first end to first fountain region 1356. A
first aerosol region ceiling 1374 is formed at a second end of
first chimney 1360. First chimney 1360 provides operable
communication between first fountain region 1356 and outlet
1116.
[0107] In some embodiments of the invention, first drug return
region 1362 is formed in housing 1112. First drug return region
1362 is open at a first end to drug reservoir 1310. First drug
return region 1362 communicates with first chimney 1360.
[0108] In accordance with an embodiment of the invention shown in
FIG. 12, second nebulization section 1314 includes a second
reservoir channel 1428, a second valve 1430, a second barrier
chamber 1432, a second barrier 1434, a second fluid chamber 1436, a
second aerosol generator 1438, and a second aerosol region 1440.
Second reservoir channel 1428 is formed within housing 1112 and
runs from drug dispensing opening 1422 to second valve 1430. Second
valve 1430 is positioned outwardly from drug dispensing opening
1422 within housing 1112, between second reservoir channel 1428 and
second barrier chamber 1432.
[0109] In the embodiment shown, second valve 1430 includes a second
valve opening 1442, and a valve seal 1444. Second valve opening
1442 is formed within housing 1112 as an outer opening of second
reservoir channel 1428. Second valve seal 1444 is disposed at
second valve opening 1442 to selectively seal second valve opening
1442. In some instances, second valve seal 1444 includes a second
float 1446, disposed within second valve 1430 at a second float
reception cavity 1448. Second float 1446 is composed of materials
that enable second float 1446 to float in the drug solution. Second
float reception cavity 1448 is formed in housing 1112 between
second reservoir channel 1428 and second barrier chamber 1432.
Second valve 1444 includes a second float/cavity interface 1450
that includes corresponding surfaces of second float 1446 and
second float reception cavity 1448, and is arranged to bias second
float 1446 against second valve opening 1442 as second float 1446
rises to seal second valve opening 1442. For example, second
float/cavity interface 1450 is structured similarly to first
float/cavity interface 1350.
[0110] In other embodiments, valves 1330 and 1430 include, for
example, one or more electrically operated solenoid valves that are
actuated to open and/or close second valve 1430.
[0111] According to one embodiment of the invention, second barrier
chamber 1432, which communicates with second reservoir channel
1428, via second valve 1430 is formed within housing 1112 between
second barrier 1434 and second aerosol region 1440. Second barrier
1434 is mounted within housing 1112 to a second mounting surface
1452 that is formed on an upper surface of second fluid chamber
1436, between second barrier chamber 1432 and second fluid chamber
1436. Second barrier forms a physical separation (i.e., a seal)
between second barrier chamber 1432 and second fluid chamber 1436.
Second barrier 1434 is composed of one or more materials designed
to enable second barrier 1434 to be capable of transmitting
ultrasonic energy therethrough, even under high temperature
conditions. For example, polyetheretherketone (PEEK), or other
materials may be used.
[0112] The second fluid 1436 is formed within housing 1112 between
second barrier 1434 and second aerosol generator 1438. Second fluid
1436 holds an fluid 1439 in communication with second barrier 1434
and second aerosol generator 1438. Fluid 1439 includes one or more
fluids capable of transmitting acoustic waves, such as, for
example, water, or other fluids. Fluid 1439 may include one or more
sterilant, such as, alcohol, or other sterilants.
[0113] Second aerosol generator 1438 is disposed at a second
aerosol generator seating portion 1454 formed within housing 1112.
In one embodiment, second aerosol generator 1438 includes a concave
piezoelectric transducer with a silver electrode. Second aerosol
generator 1438 generates acoustic waves at a generator frequency,
such as, for example, 2.5 MHz, or another frequency. The acoustic
waves are focused at a focal point, or focal band, that is a focal
length from second aerosol generator 1338. Second aerosol generator
seating portion 1454 is formed within housing 1112 such that the
focal point will be within second barrier chamber 1432. Second
aerosol generator 1438 is operatively linked to control electronics
1316 so that control electronics 1316 can control various aspects
of acoustic wave generation by second aerosol generator 1438, such
as, for instance, activation and deactivation, or other aspects.
Second aerosol generator 1438 is operatively linked to power
connection 1130 so that power can be provided to second aerosol
generator 1438 via this operative link.
[0114] Second aerosol region 1440 includes a second fountain region
1456, one or more second aerosol region inlets 1458, a second
chimney 1460, and a second drug return region 1462. Second fountain
region 1456 is formed within housing 1112 between second barrier
chamber 1432 and second chimney 1460. Second fountain region 1456
is open at a first end to second barrier chamber 1432 and at a
second end to second chimney 1460. Second fountain region 1456 is
formed as a funnel with a smaller opening at the first end and a
larger opening at the second end, or may be otherwise shaped.
[0115] In some embodiments of the invention, second aerosol region
inlet 1458 is formed in housing 1112 at second fountain region
1456. Second aerosol region inlet 1458 is in communication with
inlet port 1132.
[0116] In the embodiment of FIG. 12, second chimney 1460 is formed
in housing 1112, and opens at a first end to second fountain region
1456. A second aerosol region ceiling 1474 is formed at a second
end of second chimney 1460. Second chimney 1460 provides operable
communication between second fountain region 1456 and outlet
1116.
[0117] In one embodiment of the invention, second drug return
region 1462 is formed in housing 1112. Second drug return region
1462 is open at a first end to drug reservoir 1310. Second drug
return region 1462 communicates with second chimney 1460.
[0118] The barrier chambers 1332 and 1432 hold an amount of the
drug solution at each of barriers 1334 and 1434. Nebulized
particles of the drug solution are formed by the fountains and are
delivered to aerosol regions 1340 and 1440. The fountains are
formed by acoustic waves within the drug solution held in barrier
chambers 1332 and 1432 at barriers 1334 and 1434. The acoustic
waves are generated by aerosol generators 1338 and 1438. The
acoustic waves transmitted from aerosol generators 1338 and 1438 to
barrier chambers 1332 and 1432 via the fluid held in fluid chambers
1336 and 1436. The transmitted acoustic waves pass from fluid
chambers 1336 and 1436 to barrier chambers 1332 and 1432 via
barriers 1334 and 1434.
[0119] According to various embodiments of the invention, the
acoustic waves transmitted to barrier chambers 1332 and 1432 are
focused at the focal point. The drug solution in barrier chambers
1332 and 1432 absorbs the ultrasonic energy provided by the focused
acoustic waves to create a fountain within each of barrier chambers
1332 and 1432. The ultrasonic energy delivered by the acoustic
waves has a maximum density at or near the focal point of the
acoustic waves. The fountains shed a portion of the drug solution
as particles. Some of these particles are so large they immediately
fall out. Some are small enough to pass into drug return regions
1362, 1462 before falling out. The remaining particles which are
appropriately sized, pass out through first to second outlet 1116.
In this manner, substantially consistent particle size is
achieved.
[0120] In one embodiment of the invention, the nebulized particles
are communicated from barrier chambers 1332 and 1432, through
aerosol regions 1340 and 1440, and to the user via outlet 1116.
More particularly, the nebulized particles and the larger droplets
of the drug solution formed at the fountains are received by
aerosol regions 1340 and 1440 at fluid chambers 1364 and 1464, and
pass into chimneys 1360 and 1460. From chimneys 1360 and 1460, the
nebulized particles are communicated to the user via outlet 1116.
In contrast, due to size and/or weight, the larger droplets may not
be communicated to the user, but instead may contact a surface of
aerosol regions 1340 and 1440, such as aerosol region ceilings 1374
and 1474, or other surfaces. The larger droplets then condense on
the contacted surface(s), thereby separating the larger droplets
from the nebulized particles prior to delivery to the user. The
drug solution contained in the condensed larger droplets are passed
back to drug solution reservoir 1310 via drug return regions 1362
and 1462.
[0121] The nebulization of the drug solution by the fountains is
enhanced when the focal point of the acoustic waves coincides
(exactly or substantially) with an upper surface of the drug
solution in first barrier chamber 1332. This requires a level of
the upper surface to be controlled with some particularity to
enhance the operation of the fountains. To maintain the level of
the upper surface, an amount of the drug solution at barriers 334
and 434 is controlled by manipulating a flow of the drug solution
from drug reservoir 1310 to barrier chambers 1332 and 1432 via
reservoir channels 1328 and 1428 are controlled via valves 1330 and
1430 by independently sealing and unsealing valve openings 1342 and
1442 with valve seals 1344 and 1444. For example, when the level of
the upper surface of the drug solution on either of barriers 1334
and/or 1434 reaches a threshold level at or near the focal point of
the acoustic waves that corresponds to a threshold amount of the
drug solution being present on one of barriers 1334 and 1434,
corresponding one of floats 1346 and/or 1446 are positioned to seal
valve openings 1342 and/or 1442 by virtue of the buoyancy of floats
1346 and 1446 with respect to the drug solution. However, as
particles are formed by the fountains, the level of the upper
surface in one or both of barrier chambers 1332 and 1432 may drop
below the threshold level, which in turn lowers one or both of
floats 1346 and 1446 from valve openings 1342 and 1442, thereby
opening valves 1330 and/or 1430. This functionality is illustrated
with respect to valves 330, and 430 in FIGS. 3, and 4.
[0122] Referring to FIG. 12, activation of aerosol generators 1338
and 1438 enable generation of particles of the drug solution to be
propelled by the fountains into aerosol regions 1340 and 1440. As
particles are propelled by the fountain into aerosol regions 1340
and 1440, the atmosphere within aerosol regions 1340 and 1440 is
disturbed such that intake gas is pulled into particle receiving
regions 1366 and 1466 via aerosol region inlets 1358 and 1458.
Pulling air into particle receiving regions 1366 and 1466 may
initiate the flow of intake gas through aerosol regions 1340 and
1440 to outlet 1116, which may in turn motivate the nebulized
particles formed at the fountains toward outlet 1116. Thus, the
atmospheric disturbances that may be caused by the nebulized
particles from the fountains, and the resulting flow of intake gas
through aerosol regions 1340 and 1440 may function in a cooperative
manner to "drive" the delivery of nebulized particles from the
fountains to the user without requiring additional active moving
parts.
[0123] FIG. 13 is an exemplary cross sectional view of the handheld
nebulizing device 1110, taken along cross section line 13-13, in
accordance with another embodiment of the invention. In the
embodiment illustrated in FIG. 13, device 1610 includes a first
nebulization section 1612, a second nebulization section 1614, and
control electronics 1616.
[0124] In the embodiment of FIG. 13, first nebulization section
1612 includes a first aerosol generator 1618, a first fluid 1620, a
first barrier 1622, a first barrier chamber 1624, a first guide
tube 1626, and a first separator structure 1628. First aerosol
generator 1618 may include a concave piezoelectric transducer with
a silver electrode. First aerosol generator 1618 generates acoustic
waves at a generator frequency, such as, for example, 2.5 MHz, or
another frequency. The acoustic waves are focused at a focal point
that is a focal length from first aerosol generator 1618. Device
1110 is arranged such that the focal point is within first barrier
chamber 1624. Other embodiments of aerosol generator 1618 exist.
The inventors contemplate that various other aerosol generators
could be employed with the teachings of the present invention. For
instance, the aerosol generator may be a jet type nebulizer, a
vibrating mesh nebulizer, a vibratory plate nebulizer, a
traditional planar ultrasonic nebulizer, or an electrospray
nebulizer.
[0125] According to one embodiment of the invention, first aerosol
generator 1618 is seated in a first aerosol generator seating
portion 1630 within intermediate module 1122. First aerosol
generator seating portion 1630 is defined by an upper surface of a
first seating portion wall 1632 that extends upward from a bottom
plane of intermediate module 1122.
[0126] In this embodiment of the invention, first fluid 1620 is
formed adjacent to aerosol generator seating portion 1630 such that
first aerosol generator 1618 forms a portion of a lower surface of
first fluid 1620.
[0127] A first barrier mounting surface 1634 is located at an upper
surface of first fluid 1620. First barrier mounting surface 1634
defines a first barrier opening 1636. First barrier opening 1636
enable communication between first fluid 1620 and first barrier
chamber 1624. First barrier 1622 is mounted to first barrier
mounting surface 1634, effectively sealing first fluid 1620 from
first barrier chamber 1624.
[0128] According to the embodiment illustrated in FIG. 13, first
barrier chamber 1624 is formed by a first barrier chamber wall 1638
and a first barrier chamber floor 1640. First barrier chamber floor
1640 is sloped such that first barrier opening 1636 is a lowest
point within first barrier chamber 1624.
[0129] In one embodiment of the invention, first guide tube 1626 is
provided over first barrier 1622 such that a first end of first
guide tube 1626 extends down into first barrier chamber 1624 and a
second end of first guide tube 1626 extends out of first barrier
chamber 1624. First guide tube 1626 is held in position over first
barrier 1622 by a first guide tube collar 1638 associated with
first separator structure 1628. First guide tube collar 1638 holds
first guide tube 1626 in position such that the second end of first
guide tube 1626 extends up into first separator structure 1628.
First separator structure 1628 provides communication between the
second end of first guide tube 1626 and outlet 1116.
[0130] According to an embodiment of the invention, first aerosol
generator 1618 may be activated by control electronics 1616 to
generate acoustic waves that are introduced into first fluid 1620.
First fluid 1620 contains a fluid 1629 that is capable of
transmitting the received acoustic waves. For example, the
transmitting fluid 1629 may include water, or other fluids. In some
instances, a sterilant, such as alcohol, or another sterilant, may
be added to the transmitting fluid.
[0131] The second nebulization section 1614 includes a second
aerosol generator 1718, a second fluid 1720, a second barrier 1722,
a second barrier chamber 1724, a second guide tube 1726, and a
second separator structure 1728. Second aerosol generator 1718 may
include a concave piezoelectric transducer with a silver electrode.
Second aerosol generator 1718 generates acoustic waves at a
generator frequency, such as, for example, 2.5 MHz, or another
frequency. The acoustic waves are focused at a focal point that is
a focal length from second aerosol generator 1718. Device 1110 is
arranged such that the focal point is within second barrier chamber
1724. Other embodiments of aerosol generator 1718 exist.
[0132] According to one embodiment of the invention, second aerosol
generator 1718 is seated in a second aerosol generator seating
portion 1630 within intermediate module 1122. Second aerosol
generator seating portion 1630 is defined by an upper surface of a
second seating portion wall 1632 that extends upward from a bottom
plane of intermediate module 1122.
[0133] In the embodiment of the invention shown in FIG. 13, second
fluid 1720 is formed adjacent to aerosol generator seating portion
1630 such that second aerosol generator 1718 forms a portion of a
lower surface of second fluid 1720.
[0134] In this embodiment, a second barrier mounting surface 1634
is located at an upper surface of second fluid 1720. Second barrier
mounting surface 1634 defines a second barrier opening 1636. Second
barrier opening 1636 enable communication between second fluid 1720
and second barrier chamber 1724. Second barrier 1722 is mounted to
second barrier mounting surface 1634, effectively sealing second
fluid 1720 from second barrier chamber 1724.
[0135] The second barrier chamber 1724 is formed by a second
barrier chamber wall 1638 and a second barrier chamber floor 1740.
Second barrier chamber floor 1740 is sloped such that second
barrier opening 1636 is a lowest point within second barrier
chamber 1724.
[0136] In accordance with one embodiment of the invention, second
guide tube 1726 is provided over second barrier 1722 such that a
first end of second guide tube 1726 extends down into second
barrier chamber 1724 and a second end of second guide tube 1726
extends out of second barrier chamber 1724. Second guide tube 1726
is held in position over second barrier 1722 by a second guide tube
collar 1738 associated with second separator structure 1728. Second
guide tube collar 1728 holds second guide tube 1726 in position
such that the second end of second guide tube 1726 extends up into
second separator structure 1728. Second separator structure 1728
provides communication between the second end of second guide tube
1726 and outlet 1116.
[0137] According to an embodiment of the invention, second acoustic
wave aerosol generator 1718 may be activated by control electronics
1716 to generate acoustic waves that are introduced into second
fluid 1720. Second fluid 1720 contains a fluid 1729 that is capable
of transmitting the received acoustic waves. For example, the fluid
1729 may include water, or other fluids. In some instances, a
sterilant, such as alcohol, or another sterilant, may be added to
the transmitting fluid.
[0138] In one embodiment, the acoustic waves introduced to fluids
1620 and 1720 are transmitted from fluids 1620 and 1720 to barrier
chambers 1624 and 1724 via barriers 1622 and 1722. The acoustic
waves transmitted to barrier chambers 1624 and 1724 are focused at
the focal points of aerosol generators 1618 and 1718. Pools of drug
solution held within barrier chambers 1624 and 1724 absorb the
ultrasonic energy provided by the focused acoustic waves, thereby
energizing the drug solution to create a fountain at the top of
guide tubes 1626, 1726. The fountains shed a portion of the drug
solution as particles. Some of these particles are so large they
immediately fall out. The remaining particles, which are
appropriately sized, pass out of barrier chambers 1624, 1724. In
this manner, a substantially consistent particle size is
achieved.
[0139] In the embodiment of FIG. 13, the nebulization of the drug
solution by the fountains is enhanced when the focal point of the
acoustic waves coincides (exactly or substantially) with a surface
of the drug solution in barrier chambers 1624 and 1724. This may
require a level of the surface to be controlled with some
particularity to enhance the operation of the fountain.
[0140] In the illustrated embodiment, the fountains are formed at
the top of guide tubes 1626 and 1726. The drug solution within
guide tubes 1626 and 1726 is propelled toward the second ends of
guide tubes 1626 and 1726 by the ultrasonic energy from the
acoustic waves. At the second ends of guide tubes 1626 and 1726,
ultrasonic energy received by guide tubes 1626 and 1726 from the
acoustic waves are transmitted to the drug solution propelled up
from first ends of guide tubes 1626 and 1726, and is delivered to
the drug solution at the second ends of guide tubes 1626 and 1726
to form the nebulized particles of the drug solution. Thus, guide
tubes 1626 and 1726 enhance the formation of the nebulized
particles of the drug solution within the fountains by energizing
the drug solution within guide tubes 1626 and 1726 to nebulize drug
solution that is not located at the respective focal points of the
acoustic waves. Preferably the guide tubes are 2 mm-3 mm in
diameter. One of ordinary skill in the art can best appreciate that
the particles discharged from guide tubes 1626, 1726 can be
adjusted by adjusting the size of the guide tubes 1626, 1726.
[0141] The above described systems are particularly well suited for
delivering drugs to patients that have previously been difficult to
administer. For instance, one such drug that has been difficult to
deliver in an aerosolized form is pulmonary surfactants.
Surfactants mainly consist of phosphelipids and surfactants
proteins that are used to replace deficient endogenous surfactants
in patient's lungs. There are a variety of surfactant medications
available such as natural human surfactants (obtained from amniotic
fluid or a bio-synthetic material), natural animal surfactants
(obtained from bovine lung extracts, porcine lung extracts, or a
bio-synthetic material), or synthetic preparations. What makes
pulmonary surfactants particularly difficult to delivery in aerosol
form is that they are highly viscous. Accordingly using one or more
of the above described features of the present invention permits
high speed delivery of viscous drugs such as pulmonary surfactants.
Of course, the novel aspects of the present invention can also be
used with a variety of other drug formulations.
[0142] Although the invention has been described in detail for the
purpose of illustration based on what is currently considered to be
the most practical and preferred embodiments, it is to be
understood that such detail is solely for that purpose and that the
invention is not limited to the disclosed embodiments, but, on the
contrary, is intended to cover modifications and equivalent
arrangements that are within the spirit and scope of the appended
claims.
* * * * *