U.S. patent number 3,561,444 [Application Number 04/730,981] was granted by the patent office on 1971-02-09 for ultrasonic drug nebulizer.
This patent grant is currently assigned to Bio-Logics, Inc.. Invention is credited to Raymond Marcel Gut Boucher.
United States Patent |
3,561,444 |
Boucher |
February 9, 1971 |
ULTRASONIC DRUG NEBULIZER
Abstract
An ultrasonic drug nebulizer for forming droplets from a
medicated solution and emitting the same into the surrounding
atmosphere having a receptacle with a base and walls to form a
liquid containing chamber, a truncated conical cup for containing
the medicated solution removably mounted in the upper portion of
the receptacle so that its smaller base is below its larger base,
the smaller base being closed and the larger base being open, a
dome containing an inner, vertically disposed, column and an outer,
vertically disposed, column surrounding the inner, vertically
disposed, column removably mounted to the receptacle above the
truncated conical cup, the inner, vertically disposed, column and
the outer, vertically disposed, column both being open at the
bottoms thereof, the outer, vertically disposed, column having an
opening therein adjacent the top thereof, a transducer mounted in
the base of the receptacle, gas flow regulating means in the top of
the inner, vertically disposed, column, means for exciting the
transducer at an ultrasonic rate such that a geyser is formed from
the medicated solution in the truncated conical cup, and means for
introducing gas into the inner, vertically disposed, column through
the gas flow regulating means in the top thereof so that there is a
pressure difference between the gas in the column and the ambient
atmosphere to thereby sweep the mist of the geyser into the outer,
vertically disposed, column to be discharged through the opening
therein, the flow rate of the gas introduced into the inner column
controlling the size of the liquid droplets which are so discharged
from the column.
Inventors: |
Boucher; Raymond Marcel Gut
(Metuchen, NJ) |
Assignee: |
Bio-Logics, Inc. (Salt Lake
City, UT)
|
Family
ID: |
24937579 |
Appl.
No.: |
04/730,981 |
Filed: |
May 22, 1968 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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510537 |
Nov 30, 1965 |
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Current U.S.
Class: |
128/200.16;
261/DIG.65; 601/2; 261/DIG.48; 261/1 |
Current CPC
Class: |
B05B
17/0661 (20130101); A61M 11/001 (20140204); B05B
17/0615 (20130101); A61M 11/005 (20130101); A61M
15/0085 (20130101); Y10S 261/48 (20130101); Y10S
261/65 (20130101) |
Current International
Class: |
A61M
15/00 (20060101); B05B 17/06 (20060101); B05B
17/04 (20060101); A61M 11/00 (20060101); A61h
001/00 (); A61m 015/00 () |
Field of
Search: |
;128/194,24.05,172,173,186,193,419,421,424 ;310/(Inquired) ;324/51
;128/24 (A)/ ;128/(Ultrasonic Nob/ Digest)/ ;128/194 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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962,296 |
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Sep 1957 |
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DT |
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1,056,065 |
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Apr 1959 |
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DT |
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1,103,522 |
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Mar 1961 |
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DT |
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807,544 |
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Jan 1959 |
|
GB |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Mitchell; J. B.
Parent Case Text
This is a continuation-in-part of my application, Ser. No. 510,537,
filed Nov. 30, 1965, now abandoned.
Claims
I claim:
1. An ultrasonic drug nebulizer for forming a mist from a medicated
solution and emitting the same into the surrounding atmosphere
comprising:
a receptacle having a base with a sealed opening therein and walls
to form a liquid containing chamber;
a truncated conical cup for containing the medicated solution in
isolated relation to any source of solution, the cup being
removably mounted to the walls intermediate the length thereof
substantially in sealed relation so that the base of the receptacle
is below the base of the cup, the base of the cup being closed;
a dome containing an inner, vertically disposed, unobstructed
influent column and an outer, vertically disposed, effluent column
surrounding the inner column, the dome being removably mounted to
the receptacle above the truncated conical cup, the sealed opening,
the base of the cup and the inner column being in vertical
alignment;
the inner column and the outer column both being fully open at the
bottom thereof, the outer column having an effluent opening therein
adjacent the top thereof;
gas flow regulating means in the top of the inner column;
a transducer mounted at the base of the receptacle so as to cover
the opening in sealed relation;
means for exciting the transducer at an ultrasonic rate such at
that a geyser is formed from the medicated solution in the
truncated conical cup, said means for exciting being arranged such
that, the geyser extends upward in alignment with the inner
influent column; and
means for introducing gas at a pressure above ambient pressure into
the inner column through the gas flow regulating means in the top
thereof to impinge directly on the geyser and thereby force the
mist of the geyser into the outer column to be discharged through
the effluent opening therein.
2. The invention of claim 1 wherein the dome is formed of
transparent material such as a polycarbonate resin which is stable
at sterilization temperatures and through which the geyser formed
from the medicated solution may be observed.
3. The invention of claim 2 wherein the truncated conical cup is
formed of a material such as a polycarbonate resin which is stable
at sterilization temperatures.
4. The invention of claim 3 wherein the base of the truncated
conical cup is thinner than the walls thereof so that maximum
ultrasonic energy is transmitted from the transducer through the
liquid to the medicated solution.
5. The invention of claim 4 wherein:
the gas flow regulating means is a valve; and
the means for introducing gas into the inner column comprises:
a blower; and
a pipe connecting the blower to the top of the inner column such
that the valve is open when the pipe is connected thereto and is
closed when the pipe is disconnected therefrom.
6. The invention of claim 5 wherein the valve comprises an opening,
the size of which may be varied to thereby control the flow rate of
the gas entering the inner column to thereby control the size of
the liquid droplets which are emitted from the outer column.
7. The invention of claim 6 wherein the means for exciting the
transducer at an ultrasonic rate comprises:
an electronic signal generator having a transformer with a primary
and a secondary;
the primary being connected to a source of three wire, AC voltage
and the secondary being connected to a rectifier power supply;
a switch connected in series with the primary; and
a pilot light connected from one side of the primary to ground such
that if the connection to the source of AC voltage is improper, the
pilot light is lit with the switch open and is extinguished with
the switch closed.
8. The invention of claim 7 wherein the transducer comprises:
a polarized ceramic disc having an upper electrode and a lower
electrode on the opposite faces thereof;
a cylindrical brass cup having a closed bottom and a wall;
a threaded opening in the base of the liquid chamber larger than
the diameter of the brass cup and of the polarized ceramic
disc;
a lip in the base of the liquid chamber overlying the threaded
opening;
an insulating ring surrounding the brass cup and having external
threads engaging the threaded opening to electrically insulate the
brass cup from the liquid chamber;
the polarized ceramic disc being mounted above the brass cup so
that its lower electrode makes contact with the brass cup and its
upper electrode makes contact with the lip in the base of the
liquid chamber;
an insulated O-ring surrounding the polarized ceramic disc to
inhibit the flow of liquid out of the liquid chamber; and
means for making electrical connection to the brass cup and to the
liquid chamber.
9. The invention of claim 1 wherein the truncated conical cup is
formed of a material such as a polycarbonate resin which is stable
at sterilization temperatures.
10. The invention of claim 9 wherein the base of the truncated
conical cup is thinner than the walls thereof so that maximum
ultrasonic energy is transmitted from the transducer through the
liquid to the medicated solution.
11. The invention of claim 1 wherein:
the gas flow regulating means is a valve; and
the means and introducing gas into the inner, vertically disposed,
column comprises:
a blower;
a pipe connecting the blower to the top of the inner, vertically
disposed, column such that the valve is open when the pipe is
connected thereto and is closed when the pipe is disconnected
therefrom.
12. The invention of claim 11 wherein the opening in the valve may
be varied to thereby control the flow rate of the gas entering the
inner, vertically disposed, column.
13. The invention of claim 1 wherein the means for exciting the
transducer at an ultrasonic rate comprises:
an electronic signal generator having a transformer with a primary
and a secondary;
the primary being connected to a source of three wire, AC voltage
and the secondary being connected to a rectifier power supply;
a switch connected in series with the primary; and
a pilot light connected from one side of the primary to ground such
that if the connection to the source of AC voltage is improper, the
pilot light is lit with the switch open and is extinguished with
the switch closed.
14. The invention of claim 1 wherein the outer surfaces of the
walls of the receptacle are finned to facilitate the transfer of
heat therefrom.
15. In an ultrasonic drug nebulizer having a liquid chamber in
which a driving transducer is mounted adjacent an opening in the
base of the liquid chamber, the improvement comprising:
a polarized ceramic disc having an upper electrode and a lower
electrode on the opposite faces thereof;
a cylindrical brass cup having a closed bottom and a wall;
a threaded opening in the base of the liquid chamber larger in size
than the diameter of the brass cup and of the polarized ceramic
disc;
a lip in the base of the liquid chamber overlying the threaded
opening;
an insulating ring surrounding the brass cup and having external
threads engaging the threaded opening to electrically insulate the
brass cup from the liquid chamber;
the polarized ceramic disc being mounted above the brass cup, the
upper electrode making contact with the lip in the base of the
liquid chamber;
an insulated O-ring surrounding the polarized ceramic disc to
inhibit the flow of liquid out of the liquid chamber; and
means for making electrical connection to the brass cup and to the
liquid chamber.
Description
This invention relates to ultrasonic nebulizers and more
particularly to devices for producing fine liquid aerosols, as for
medicinal use, through the disintegration of the liquid geyser
produced by radiation pressure effect of ultrasonic vibrations of a
flat ceramic crystal transducer at a relatively high frequency. In
particular, the invention is directed to such devices heel holding
may be used to deliver either a steady supply of medicated solution
or a pulsed supply thereof.
The creation of ultrafine droplets by means of ultrasonic energy is
not new. Devices to accomplish this have been constructed but in
most instances the objective lay outside the area of medicinal
nebulization and have depended on surface wave disintegration at a
relatively low frequency. The problems associated with the
development of an ultrasonic nebulizer specifically for medicinal
nebulization include the production of uniformly small particles,
preferably with a high percentage less than 10 microns in diameter
and of the order of 80 to 90 percent, by weight, less than 10
microns. The nebulizer should have a reliable particle formation
rate (for example, 0.1 to 1.5 cc. per minute), and electrical
requirements at reasonable voltage and power levels.
Most of the prior art drug nebulizers, which have been used to
dispense nebulized medicated solutions into the atmosphere
surrounding the patient or directly into the respiratory tract of
the patient through a face mask or device, have been of the
mechanical type wherein it was not possible to control the size of
the nebulized droplets without using screens or obstacles in the
aerosol path.
There is no universal agreement on the exact meaning the terms:
aerosol, fog and However, there has been a recommendation that
e.g., word "aerosol" be limited to airborne made up of particles
less than 1 micron in diameter (Conference on Aerosols, Nov. 1959,
Denver, Col.). For one could say that the word "fog" is used for
droplets the 5 to o50 microns range and the word "mist" is used for
droplets in the 50 to 500 microns range. The word "micromist" is
often used to describe liquid dispersoids in the 5 to 25 microns
range. The definitions set forth above may be used, in the
specification, to describe the various dispersoids of the medicated
solution.
The drug nebulizer of the the invention, utilizes high frequency
ultrasonic energy to disperse fine liquid particles of the
medicated solution into a It comprises a small plastic cup which
contains the medicated solution and a polarized, piezoelectric
ceramic (crystal) transducer which beams the ultrasonic energy to
the medicated solution through the bottom of the cup. A liquid such
as distilled or tap water, which is used to couple the ultrasonic
energy between the ceramic transducer and the cup which contains
the medicated solution, also serves as a cooling liquid to prevent
the transducer from overheating and becoming ineffective.
When the is energized at the proper frequency, say, between 500
kHz. and 2 mHz., mechanical vibrations are set up in the coupling
liquid. These mechanical vibrations occur at the frequency of the
excitation signal. The mechanical vibrations are coupled through
the coupling liquid to the bottom of the cup and thence to the
medicated solution contained in the cup. The internal turbulence in
the medicated solution is so great that the surface tension of the
liquid and the cohesive forces at the gas-liquid interface are
overcome and a geyser is produced due to the disintegration of the
liquid into a fine mist or aerosol.
The aerosol produced at the surface of the heel-holding solution is
carried out of the drug nebulizer to the atmosphere surrounding the
patient or directly into the patient's respiratory tract by the gas
flow produced by a small blower or by the pressure difference
caused by the patient's respiration.
Drug nebulizers are intended and used for the purpose of carrying
finely atomized therapeutic solutions through the lungs in order to
deposit the therapeutic agent at selective sites in the pulmonary
tree. This makes it possible to reach the blood circulatory system
without physical infraction. For a number of years, aerosol therapy
has been recognized as having many curative advantages. However,
its use has been limited by the disadvantages inherent in
mechanical nebulizers. There are drastic physical limitations on
the size of the droplets which may be produced by mechanical means
such as high-speed jets, centrifugation, impingement, etc. In order
to generate aerosol and fog particles of the size required for
maximum deposition of the drug in the lungs (0.4 to 10 microns), it
was necessary to develop sophisticated, complex, mechanical
nebulizing devices. Simple mechanical generators could not be used
satisfactorily because they always produced a certain amount of
drops which were too large or the drug reconcentrated through
filtration or the refluxing of the large particles.
Another object is to provide a richer, more abundant nebula without
the waste of the compressed-air-driven nebulizer which is noisy and
often entrains noxious oil vapors. The aerosol produced by the
generator is very uniform, providing optimum particle size for
deposition in the lung. The nebula can be generated continuously,
stored and made available to the patient only during
inspiration.
Still another object is to provide a system by which the crystal
transmits its sonic energy through a liquid medium to the
medicament which is held in a removable cup. Liquids placed in
direct contact with the crystal would penetrate into the crystal
and react chemically with it causing depolarization and resultant
crystal failure. Accordingly, the crystal is sealed with a suitable
covering, as an epoxy resin or a thin gold layer. The liquid
medium, medicament or transfer liquid aids in dissipating heat
generated in the crystal.
Yet another object is to provide compression mounting for the
piezoelectric crystal transducer. The mounting of the crystal
provides proper support to the electrodes, seals the crystal from
the coolant fluid, and eliminates damping of the sonic output.
A further object is to provide the apparatus with a replaceable cup
for the material to be nebulized so that various materials can be
used without great difficulty.
It is a further object of the invention to provide such a device
wherein the droplet size is controlled so that the large bulk of
the droplets of the drug delivered to the patient's respiratory
tract are of the proper size.
It is a still further object of the invention to provide such a
device wherein the output of the device is maintained at a steady
rate.
It is a still further object of the invention to provide such a
device wherein the output of the device is pulsed at a respiratory
or similar rate.
It is a still further object of the invention to provide a source
of aerosols which may be used for therapeutic or other
purposes.
One feature of this invention is the provision of a nebulizing
apparatus including a base, a ceramic crystal having conductive
electrodes, compression clamping means holding the crystal against
the base, and a seal, sealing the joint between the crystal and
base.
Another feature is the provision of a removable medication cup
mounted upon the base so that the ultrasonic energy is transmitted
to the medicament thereby producing fine liquid aerosols through
the disintegration of a liquid geyser due to the radiation pressure
force field.
More particularly, the mounting for the crystal which has upper and
lower conductive electrodes comprises compression clamping means
holding the crystal against a base and holding a circular seal so
as to close off the joint between the base and crystal, the
clamping means also holding a lead between a circular washer and
the lower metallized electrode. The epoxy or thin gold layer may be
used to protect the upper crystal surface.
These and other objects, advantages, features and uses will be
apparent during the course of the following description, when taken
in conjunction with the accompanying drawings, wherein:
FIG. 1 is a plot showing the percentage of particles deposited in
the respiratory tracts;
FIG. 2 is a vertical sectional view of an embodiment of ultrasonic
drug nebulizer embodying the invention;
FIG. 3 is an enlarged is section of the transducer mounting used in
the ultrasonic drug nebulizer of FIG. 2;
FIG. 4 is an enlarged detail of the transducer mounting of FIG.
3;
FIG. 5 is an illustration of the ultrasonic nebulizer system of the
invention utilizing the embodiment of FIGS. 2--4;
FIG. 6 is a view, in perspective, of another form of ultrasonic
drug nebulizer of the invention;
FIG. 7 is a front elevational view of the ultrasonic drug nebulizer
of FIG. 6;
FIG. 8 is a horizontal, plan view of the ultrasonic drug nebulizer
of FIG. 6;
FIG. 9 is an enlarged, sectional view, taken along the lines 9-9 of
FIG. 8, viewed in the direction of the arrows;
FIG. 10 is an enlarged view similar to and of a portion of FIG. 9
showing the transducer and its mounting;
FIG. 11 is a top, horizontal, plan view, viewed in the direction of
the arrows 11-11 of FIG. 9;
FIG. 12 is a bottom, horizontal, plan view, viewed in the direction
of the arrows 12-12 of FIG. 9;
FIG. 13 is a sectional view, taken along the lines 13-13 of FIG.
11, viewed in the direction of the arrows;
FIG. 14 is an enlarged, top, plan view of the check valve used in
the ultrasonic drug nebulizer of FIG. 6;
FIG. 15 is a sectional view, taken along the lines 15-15 of FIG.
14, viewed in the direction of the arrows;
FIG. 16 is a top, plan view of the liquid containing chamber,
viewed in the direction of the arrows 16-16 of FIG. 9;
FIG. 17 is a bottom, plan view of the liquid containing chamber,
viewed in the direction of the arrows 17-17 of FIG. 9;
FIG. 18 is an elevational view of the liquid containing chamber,
viewed in the direction of the arrow 18 of FIG. 16;
FIG. 19 is a bottom, plan view of the truncated, conical cup,
viewed in the direction of the arrows 19-19 of FIG. 9;
FIG. 20 is an enlarged, sectional view, taken on the lines 20-20 of
FIG. 19, viewed in the direction of the arrows;
FIG. 21 is an enlarged, vertical sectional view, similar to that of
FIG. 13, of a further embodiment of the invention;
FIG. 22 is a view, similar to that of FIG. 21 of a modification
thereof; and
FIG. 23 is a schematic diagram of the circuit of the generator used
with the ultrasonic drug nebulizers of FIGS. 2 and 6.
FIG. 1 is a plot showing the percent of retention of droplets in
the respiratory tract against droplet size. Curve 100 illustrates
the overall droplet retention in the respiratory tract against
droplet size. The outline of area 102 designates the plot of
percent of retention of droplets in the alveolar portion of the
pulmonary tree against droplet size. The outline of area 104
designates the plot of percent of retention of droplets in the
tracheobronchial portion of the pulmonary tree against droplet size
and the outline of area 106 is the plot of percent of retention of
droplets in the nasopharyngeal portion of the pulmonary tree
against droplet size.
From FIG. 1, it can be seen that the predominant mechanism for
collecting droplets larger than 1 micron in diameter through the
pulmonary tree is by inertial impingement in the tracheobronchial
portion. Droplets in the submicron range reach the pulmonary tree
in the alveolar region mainly by diffusion under the influence of
Brownian motion.
In addition to the droplet size, one must also consider the mass of
the droplets when attempting to deposit a drug is inside the
pulmonary tree. This is quite obvious when one considers that,
since the volume varies as the cube of the diameter, one drop 10
microns in diameter will contain as much of the therapeutic agent
as 1000 droplets, each of which is 1 micron in diameter. Since one
wishes to arrive at a size range which will deliver the maximum
therapeutic benefit with the mt most readily usable droplet size,
it is desirable to be able to tailor the droplet size delivered to
the patient in the ideal range. This range appears to be from about
0.4 to about 10 microns in diameter.
The following table, based on 1 milliliter of liquid, taken in
conjunction with FIG. 1, will serve to illustrate the advantage of
ultrasonic nebulizers over mechanical nebulizers for the production
of therapeutic aerosols. ##SPC1##
The average droplet size of a therapeutic aerosol and fog is given
as the mass median diameter (MMD) which is defined as the droplet
size such that one-half the mass of the aerosol is in droplets
smaller in size than said droplet size. The mass median diameter is
related to the mean particle diameter as shown by the following
formula: log D = log MMD - 6.9 log.sup.2 .sigma.; where D = mean
particle diameter; MMD = mass median diameter; .sigma. = standard
deviation
FIG. 1 shows that a droplet size of 10 microns is collected in the
tracheobronchial and nasopharyngeal regions and the overall
retention in the respiratory tract (from the table) is 89 percent.
A droplet, which is 0.4 micron in diameter, would be collected in
the alveolar and tracheoabronchial regions and the overall
retention in the respiratory tract is about 30 percent.
Thus, it can be seen that the ideal droplet size for therapeutic
use is in the aerosol and fog range from 0.4 micron to 10 microns
in diameter. Since these size droplets cannot be produced readily
by mechanical means, other means must be found.
While illustrative embodiments of the invention are shown in the
drawings and will be described in detail herein, the invention is
susceptible of embodiment in many different forms and it should be
understood that the present disclosure is to be considered as an
exemplification of the principles of the invention and is not
intended to limit the invention to the embodiment illustrated. The
scope of the invention will be pointed out in the appended
claims.
Referring not to FIG. 2, the nebulizing unit 10 consists of a
flat-surfaced piezoelectric crystal 11 housed in an aluminum
transducer base 12 and an aerosol chamber 13 mounted upon the base.
The crystal 11 transmits its acoustic energy through a cooling
(coupling) liquid 14 to the medicament 15 which is held in a
removable cup 16 thereby creating a turbulent fountain 17.
Nebulization occurs around the outer surface of the fountain
producing a mist which is held in the aerosol chamber 13. This mist
can be withdrawn from the chamber through an outlet 18 as needed.
The radiation pressure fountain or geyser occurs only at relatively
high sonic frequencies as of the order of at least 500 kilocycles
and may be generated with presently available transducers operating
at frequencies up to the order of 2 megacycles. The details of the
crystal and mounting will be described below.
The transducer base 12 is cylindrical with cooling fins 20 on its
lower portion and a shoulder 21 along its top. A fluid cavity 22 is
formed within the base 12 and has a transverse lower wall 22a with
an opening 22b therethrough. A plastic medication cup 16 fits into
the open top of the fluid cavity 22 with its outer portion resting
on the shoulder 21. The cup is tapered, having a truncated conical
form with the bottom portion 23 approximately the same diameter as
the face of crystal 11. The cup may be of a suitable material as a
plastic, a metal foil or the like.
A cooling (coupling) liquid 14 such as water or oil is contained
within a fluid cavity 22 between the cup and the base 12. This
liquid transmits the acoustic energy from the crystal 11 to the
medicament 15 which is held in the cup thereby causing a radiation
pressure fountain 17 and nebulization as will be described in
detail later.
Referring now to FIGS. 3 and 4, the transducer mounting is shown in
detail. The piezoelectric ceramic crystal body 30 may be made of
materials such as lead zirconate, lead titanate zirconate, or
calcium titanate with or without traces of salts of yttrium,
lanthanum, strontium, or cobalt. The flat ceramic crystal can have
various configurations, as circular, rectangular, square, etc. In
one specific embodiment of the invention, the crystal is a circular
flat disc with a diameter of 0.75 inch, a thickness of 0.1 inch,
and a nominal resonant frequency of approximately 750 kilocycles,
To establish good electrical contact with the crystal body, the
upper 31 and lower 32 faces are coated with electrically conductive
layers, 33 and 34, respectively, of metal such as gold, platinum,
irridium or silver.
The crystal 11 closes opening 22b at the bottom of cavity 22 and is
mounted under compression in the transducer base 12 by means of a
series of clamp screws 35 which squeeze a circular shaped metal
clamp ring 36 against a neoprene or synthetic rubber O-ring seal
37. Clamp ring 36 has an L-spaed cross section defining a generally
rectangular space with the undersurface of wall 22a and the
periphery of the crystal. Sealing ring 37 engages four
surfaces.
The electrical connection to the upper face 31 of the crystal is
achieved by direct contact of the base 12 with the upper metallized
surface 33. A tin or copper ground lug 38 is provided on one of the
clamp screws 35 to permit the base to be grounded.
The electrical connection to the lower face 32 of the crystal is
achieved by direct contact of a copper foil lead 39 compressed
between a circular neoprene washer 40 and the metal-coated bottom
face 34 by an extending leg 36a of the metal clamp 36.
The upper face 31 of the crystal is in contact either with a liquid
14 (water, oil, etc.) or with the solution to be dispersed. Where
liquid 14 is used, it serves the dual function of cooling the
crystal and coupling sonic energy to the material to be dispersed.
To protect the metallized surface 33 from corrosion, chemical
reaction with the liquid or mechanical projections in the liquid
phase during irradiation, it is covered with a sealing coating as a
layer of epoxy resin 41. This design permits a satisfactory
electrical contact along the circular edge 33a of the upper crystal
surface and at the same time gives maximum protection to the upper
vibrating face.
The sealing coating for the upper surface of the crystal must
accommodate deflection of the crystal and the high accelerations
which occur. For the crystal described above, driven with a voltage
of the order of 150 volts (RMS), there will be a deflection of the
order of 0.25 micron and accelerations as high as 500,000 G.
Furthermore, the material must have good adhesive qualities, permit
the dissipation of heat from the crystal and transfer the sonic
energy with little attenuation. A suitable material is an epoxy
resin sold under the trademark E. POX. E. by The Woodhill Chemical
Corp., Cleveland, Ohio. A layer with a thickness on the order of
0.015 inch on the crystal discussed provides adequate protection
without excessive heating or attenuation of the sonic energy.
In the present mounting the lower face of the ceramic crystal
vibrates freely into air space 42 thus allowing near perfect
reflection of the acoustic energy in the upward direction. More
than 80 percent of the acoustic energy is contained inside the
solid cone angle 45 on the axis 46 of the transducer. The solid
cone angle 45 is equal to 2 sin.sup.- 1 .61 x/R where x is the wave
length of the emission and R the radius of the vibrating disc. From
experimental results the maximum value of angle 45 is
12.degree..
As shown in FIG. 2, the acoustic energy is transmitted through the
cooling liquid 14 to the medicament 15 held in the cup 16 thereby
creating a turbulent fountain 17. The high degree of internal
turbulence achieved inside the fountain produced by the upward
radiation pressure of the crystal causes nebulization to occur
around the outer surface of the fountain 17.
A wide variation in the liquid level does not affect the fog
production since the ceramic crystal has an excellent
electroacoustic output sufficient to disintegrate the liquid geyser
regardless of liquid level. A focusing (curved) transducer is not
used since it would not produce a geyser as stable as the one
erected by the flat transducer.
Aerosol chamber 13 is fitted on transducer base 12, above the
medication cup. Chamber 13 is a clear plastic canopy to contain the
nebula generated by the device. The chamber 13 has an outlet 18
that permits the aerosol to be directly inhaled or to which
accessory devices such as mouth pieces and face masks can be
attached.
The air inlet 50 to the chamber is through the top 51 by means of a
plastic tube 52 that extends downward to the fountain 17 produced
in the medicament 15. This tube not only provides a means of
allowing air to be drawn into the chamber but also contains the
fountain 17 so that it does not splash up into the upper surfaces
of the aerosol chamber. The larger particles impinge on the tube
wall and drain back into the body of medicament 15, leaving only
the smaller particles suspended. The tube also brings the inlet air
into the bottom of the chamber at a velocity sufficient to push the
nebula upward allowing complete utilization of the generated
aerosol. The velocity of the air in the outer chamber is much lower
and the larger, more dense particles fall back into the cup. A
one-way valve 53 in the top of the tube allows air to enter during
inhalation but then closes so that it is impossible to exhale
through the chamber. In the absence of air flow, the nebula remains
in the chamber and provides for an "on demand" delivery to the
user. All of the nebula formed is drawn out by the user or falls
back into the cup, resulting in complete utilization of the
medicament.
FIG. 5 shows the nebulizer system which consists of a generator 60,
nebulizer 10, and mask 61. The generator 60 contains an oscillator
circuit which provides power which is transmitted to the transducer
by a coaxial cable 62. The cable 62 is connected between an output
terminal 63 at one end and copper foil lead 39 and ground lug 38 at
the other end. The generator may have an on-off switch 64 and
indicator light 65. Furthermore, a vernier tuning control 66 is
provided for balancing the system to various medicaments. A timer
67 is provided to control the amount of time the system operates
for different dosages.
To operate the nebulizer, the transducer base is filled with cold
tap water to the proper level. The medication cup is then placed
into the transducer base and medication is added to the cup. The
plastic aerosol chamber is placed on the shoulders of the base.
After throwing the On-off switch to the "on" position and allowing
a short period for the generator to warm up, the "timer" is set to
the prescribed interval. Using the vernier tuning control, the
system is tuned for the desired amount of nebulization
activity.
A mask 51 or other means may be placed on the nebulizer outlet 18
of the mist chamber, and the patient may breathe the aerosol
medicament.
In FIGS. 6 through 21, there are shown a further embodiment of
ultrasonic drug nebulizer of the invention and some modifications
thereof.
Nebulizer 110 is seen to cm comprise (FIGS. 6--8), cabinet 112,
receptacle housing 114, transparent dome 116 and air pipe 118. The
electronic signal generator is contained in cabinet 112, is
actuated by timer switch 120 and is tuned by means of tuning
control 122. Pilot light 124 is used to indicate that power has
been applied to the signal generator and to indicate safe
connection to the power mains as will appear further on in this
description.
FIG. 9 is an enlarged sectional view of the receptacle and
transparent done used in the ultrasonic drug nebulizer 110.
Receptacle 114 is preferably formed of a metal such as aluminum and
is finned as shown in FIGS. 16 and 17 to facilitate the transfer to
heat from the receptacle to the surrounding atmosphere. Receptacle
126 is provided on cabinet 112 to receive receptacle 114.
When receptacle 114 is placed on receptacle 126, connector 128 on
the receptacle 114 mates with connector 130 which is mounted in
cabinet 112 and thereby makes electrical connection between the
output of the signal generator and transducer 134 which is mounted
in the base of receptacle 114. In a preferred form of the
invention, the insertion of receptacle 114 on receptacle 126 also
closes limit switch 136, as shown in FIG. 9. This serves as a
safety feature and prevents the user from turning the generator on
with its output unloaded.
Alternatively, switch 136 can be omitted or locked closed so that
receptacle 114 may be removed from the cabinet and connection made
between connectors 128 and 130 by means of a suitable jumper cable
(not shown). shown). In such circumstances, the receptacle and dome
assembly may be held by the patient at a distance (depending upon
the jumper length) from the cabinet. However, since it is necessary
that the dome 116 be held in a vertical attitude, it is not
advisable to have weak patients use the nebulizer in this
manner.
Receptacle 114 is filled with water 138 or a similar liquid to a
suitable level such that the vibrations of transducer 134 are
coupled to medicated solution 140. Medicated solution 140 is
contained in truncated conical cup 142 which is preferably formed
of a transparent polycarbonate resin such as is marketed under the
trademark LEXAN by the General Electric Co. Truncated conical cup
142 is provided with a circumferential lip 144 surrounding its
open, larger base to facilitate its installation in receptacle 114.
Lip 144 rests on the top of receptacle 114 and the truncated
conical cup 142 is held in place by dome 116 which is threaded to
receptacle 114 as shown at 146.
Dome 116 is formed of a transparent material, preferably a
polycarbonate resin such as LEXAN, and comprises inner, vertically
disposed, column 148 and outer, vertically disposed, column 150
surrounding column 148. The aerosol is emitted to the surrounding
atmosphere through exit 152 which is connected to column 150.
Transducer 134 is formed of flat circular disc 154 to which
suitable electrodes 156 have been applied in a manner well known in
the transducer art (FIG. 10). Disc 154 is preferably formed of a
polarized, piezoelectric ceramic such as barium titanate, lead
titanate, barium-lead titanate or any other suitable material with
or additives. Transducer 134, upon excitation at a frequency in the
range from about 450 kHz. to about 2 mHz., vibrates in its
thickness mode and transmits mechanical vibrations to coupling
liquid 138. The vibrations are transmitted, in turn, to medicated
solution 140 and are of sufficient intensity to form geyser 158
therefrom.
Receptacle 114 is provided with opening 160 in the bottom thereof
which is threaded as shown at 161 and with lip 162 overlying the
threaded opening. O-ring 164 surrounds transducer 134 to keep it in
position against lip 162 and to prevent any liquid leak around the
transducer and its mounting. The upper electrode 154 is in intimate
contact with lip 162 and thereby makes electrical contact with
receptacle 114 (equipment ground).
Cup 166 is formed of a metal such as brass with its open base
facing the lower electrode 156 and is held in position against the
electrode by means of insulating ring 168 which threads into
threads 161. Ring 168 serves to insulate cup 166 from receptacle
114. The circumference of the open base of cup 166 is in intimate,
electrical contact with the lower electrode 156 of transducer 134.
Spring 170 makes the electrical connection between cup 166 and the
hot lead of connector 128.
A gas, such as air, is introduced at a pressure above ambient
pressure into column 148 through pipe 118 which is connected to an
air blower in cabinet 112. The air blower is of a type well known
in the art and the structural details are not shown. The gas enters
column 148 and impinges against geyser 158 and causes the mist
droplets to enter column 150 and to be emitted through exit 152 as
the gas sweeps past geyser 158 and up into column 150.
Since different ailments require different droplet sizes for ideal
therapeutic benefit, the gas flow past geyser 158 can be modulated
to select the desired droplet size to be emitted through exit 152.
The blower is run at constant velocity and the airflow is
controlled by means of valve assembly 174. Valve assembly 174
comprises rotating control 176 and flap-type, check valve 178.
Check valve 178 (FIGS. 14 and 15) is normally a part of dome 116
and is in the gas stream input to column 148. It comprises an outer
support 180 to which spider 182 is attached. Membrane 184 of
material such as neoprene is fixed to the center of spider 182 with
its periphery free. It is biased upward so that it is normally
closed. When the membrane is pushed down by gas pressure or
otherwise, the valve opens and the gas enters the column. This
membrane is principally useful when the nebulizer is used without
the blower. However, for the sake of simplicity of manufacture, the
same valve assembly is used when the nebulizer is operated both
with and without the blower.
Rotating control 176 is a part of pipe 118 and is provided with
openings 186 which cooperate with openings 188 in fixed element 177
to control the gas flow. When the openings are aligned as shown in
FIG. 13, the maximum flow of gas is delivered to the column 148. To
ensure that check valve 178 is open when used with the blower,
control 176 is provided with a pair of stiff wires 190. These wires
190 open the valve mechanically when pipe 118 is connected to dome
116.
The embodiment illustrated is provided with three control
positions, as shown by indicia 192 of FIG. 9. By way of example, in
the maximum position, the gas flow from a blower running at 3,250
r.p.m. is 12 1i./min. which will produce an aerosol with the
droplets having a mass median diameter between 11/2 to 3 microns.
At the same blower velocity in the middle position a gas flow of 6
1i./min. is obtained and produces a light fog with the droplets
having a mass median diameter between 3 and 6 microns. At the same
blower velocity, the minimum position delivers a gas flow of 3
1i./min. and a fog in which the mass median diameter of the
droplets is between 7 and 10 microns. The foregoing is by way of
example and is not intended to limit the scope of the
invention.
FIGS. 16 through 18 are enlarged views of receptacle 114. It is
preferably formed of aluminum or some other electrically and
thermally conductive material. The outer periphery is provided with
fins 194 to accelerate the transmission of heat away from the
receptacle. Threads 196 at the top are used to connect dome 116 to
receptacle 114. Screws 197 are utilized to hold the transducer
assembly in place at the bottom of receptacle 114.
FIGS. 19 and 20 are views of the truncated conical cup 142 which is
preferably formed of polycarbonate resin such as LEXAN. This
material is transparent so that the action in the interior may be
observed and is stable at sterilization temperatures so that it may
be treated in an autoclave without harm or damage. Its large base
198 is open and its small base 200 is closed so that, in use, its
small base is down. To facilitate the maximum transfer of
acoustical energy from the transducer through the coupling liquid
to the medicated solution in the cup, it is desirable to make base
200 as thin as possible. Generally, the thickness of base 200
should be about one-quarter of that of the wall 202. By way of
example but not by way of limitation of the scope of the invention,
a wall thickness of 0.02 inch and a base thickness of 0.005 inch
have produced excellent results.
In FIG. 23, there is shown the schematic diagram of signal
generator 132. It delivers a power output of approximately 30 watts
at a nominal frequency of 800 kHz. It comprises tuned grid electron
coupled oscillator 204 which feeds power amplifier 206. The output
of power amplifier 206 is delivered to connector 130. Tuning
control 122 is adjustable by the operator and is used to adjust the
geyser to maximum height.
Since ultrasonic drug nebulizers of the invention are intended to
be used by persons who are not technically trained in the
electronic and electroacoustical arts, it has been found advisable
to utilize pilot light 124 as a warning light to indicate correct
or incorrect connection to the AC mains.
The generator is provided with a standard, three-prong, 115 volt AC
connector. When it is properly connected to the AC mains, pilot
light 124 remains out when either interlock switch 136, or timer
switch 120, or both are open. It goes on when both switches are
closed.
However, if the ground connection is not made to the AC mains or if
the hot terminal 208 is connected to the grounded terminal of the
AC mains, pilot light 124 will light when either or both switches
120 and 136 are open. The light will go out when both switches are
closed. This gives an immediate indication to the patient or
technician that the connection should be corrected and will prevent
possible electric shocks.
Operation of the ultrasonic drug nebulizer 110 proceeds as follows:
the receptacle 114 is filled with water to the marked level and the
cup 142 is placed on top of the receptacle 114. Medicated solution
is now added to the cup to the desired level. Dome 116 is screwed
in place on receptacle 114 thereby locking cup 142 in position. The
assembly is now placed in position in receptacle 126 so that
connection is made between connectors 128 and 130 and limit switch
136 is closed. Next, pipe 118 is connected to dome 116 and the
nebulizer is ready for operation. The timer is turned to the
desired time, which turns on the generator and blower, and the
geyser after 15 seconds forms in the medicated solution. The tuning
control is adjusted to produce maximum geyser height and is left
there. The valve control is set for the desired droplet size and
therapeutic treatment commences and continues until the set time
expires and the generator and blower turn off.
FIG. 21 is an enlarged sectional view of an alternative form of
valve which may be used with the ultrasonic nebulizer of FIG. 6.
Pipe 118 is disconnected from dome 116 and flap-type, check valve
210, which is similar to check valve 178, is inserted at the top of
column 148. A respiratory mask such as mask 61 of FIG. 5 is
suitably connected to exit 152. Then, air is drawn into column 148
when the patient inhales and valve 210 is closed when the patient
stops inhaling or exhales.
FIG. 22 is a view similar to FIG. 13 showing another form of valve
used with the ultrasonic nebulizer of FIG. 6. Valve assembly 212 is
similar to valve assembly 174 and is in the forced gas stream
between pipe 118 and column 148. It is provided with rotating
control 214 and fixed element 216. Element 216 is provided with
openings 220 and rotating control 214 is provided with openings
218. The construction of flap valve 210 is the same as that of
valve 178 and the amount of gas (air) received by column 148 is
controlled by the position of rotating control 214 and the
relationship of the positions of openings 218 with the positions of
openings 220. Check valve 210 is constructed so that it opens under
the pressure of the gas delivered by blower 172 and closes when
there is insufficient pressure. This prevents the gas from escaping
from column 148 back into pipe 118.
Ultrasonic drug nebulizers of the invention may be used for all
types of treatment as well as for aerosol studies in flame
spectroscopy and similar scientific investigations. In addition, a
pulsed valve may be substituted for the valve illustrated and
described to produce a pulsed output emission instead of the
constant output delivered by the device described heretofore. The
output of the device may be emitted in a room, in a tent or through
the typical respirator mask directly to the respiratory tract of
the patient.
The invention is not limited to the particular arrangements of the
apparatus described, but may be variously modified without
departing from the spirit and scope of the invention.
* * * * *