U.S. patent number 3,809,084 [Application Number 05/224,497] was granted by the patent office on 1974-05-07 for pressurized portable dispenser.
This patent grant is currently assigned to American Cyanamid Company. Invention is credited to Lloyd Frank Hansen.
United States Patent |
3,809,084 |
Hansen |
May 7, 1974 |
PRESSURIZED PORTABLE DISPENSER
Abstract
A portable powder dispensing device has a medicament chamber in
which a dose of powdered medicament in an open capsule shell is
introduced and an outlet to cooperate with a human body cavity,
such as a mouthpiece or a nozzle for inserting in a nostril. A jet
of gas under pressure, from a propellant tank is introduced into
the chamber at a swirl angle. The shell containing the medicament
vibrates and spins thereby breaking up the particles or
aggregates.
Inventors: |
Hansen; Lloyd Frank (Campbell
Hall, NY) |
Assignee: |
American Cyanamid Company
(Stamford, CT)
|
Family
ID: |
26682523 |
Appl.
No.: |
05/224,497 |
Filed: |
February 8, 1972 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
11555 |
Feb 16, 1970 |
3653380 |
Apr 4, 1972 |
|
|
Current U.S.
Class: |
128/203.15;
222/190; 239/315 |
Current CPC
Class: |
A61M
15/00 (20130101); A61M 15/0028 (20130101); A61M
15/0031 (20140204); A61M 15/0008 (20140204); A61M
11/001 (20140204); A61M 2202/064 (20130101); A61M
2205/8225 (20130101) |
Current International
Class: |
A61M
15/00 (20060101); A61l 013/00 (); A61m
015/08 () |
Field of
Search: |
;128/172,173,185,186,194,203,206,209,260,265,266,187 ;222/190,193
;239/315,316 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Walker; Samuel Branch
Parent Case Text
CROSS REFERENCES
This application is a continuation-in-part of copending application
Ser. No. 11,555, filed Feb. 16, 1970, now U.S. Pat. No. 3,653,380,
dated Apr. 4, 1972. The references in the prosecution thereof are
hereby incorporated by this reference thereto.
Claims
1. A dispenser system for introducing a finely powdered medicament
into a body opening, comprising, in combination:
a dispenser housing having therein a medicament chamber, and
removably attached thereto,
a nozzle having one end shaped to cooperate with a body cavity, and
the other end attached to said dispenser housing and closing the
medicament chamber, and having a central discharge duct
therethrough from end to end,
said medicament chamber being adapted to hold a movable solid
medicament container having therein a single powdered medicament
dose which container vibrates and spins when gas under pressure is
introduced into said chamber thereby increasing the inherent swirl
and turbulence due to the introduction of gas under pressure,
in said medicament chamber a medicament container about the size
and shape of half of a hard shell capsule, adapted to move freely
in but not turn over in said medicament chamber, and a
predetermined single dose of a powdered medicament in said
container,
at least one gas duct passing through the wall of said dispenser
housing and entering nearly tangent to the medicament chamber for
introducing gas under pressure into the medicament chamber at a
swirl angle to the chamber, whereby turbulence results,
means to introduce gas under pressure through said gas duct,
whereby said powdered medicament in said container is efficiently
dispersed in the turbulent gas and essentially completely
administered at a single time of use, into the body cavity, said
means including
an outer dispenser holder attached to said dispenser housing
surrounding said gas duct and spaced from a portion of said
dispenser housing forming a damping chamber between said outer
dispenser holder and the dispenser housing, and a pressure chamber
adapter passing through said outer dispenser holder to receive the
stem of a dispensing compressed gas propellant tank, thereby
permitting pressurization of the damping chamber, and the damped
transfer of gas pressure through the gas duct into the medicament
chamber.
Description
BACKGROUND OF THE INVENTION
A number of medicaments are introduced either orally or nasally.
For instance, there are a number of nasal inhalators and there are
also some devices for introducing finely divided medicament into
the oral cavity and thence on into the respiratory system. In the
past there were two general types. The nasal inhalator had a
medicament chamber, openings to the atmosphere, and a nozzle which
was introduced into the nostril. On inhaling, air was sucked into
the chamber, picked up medicament, and was inhaled by the user. The
dispensers for the oral cavity not only had a different shaped
mouthpiece but often had a container feeding into a venturi tube
through which air or a gas flowed, picking up the medicament. Some
used a squeeze bulb or compressed air source to suspend the
powder.
Where there was no reason to measure the dose accurately, these
types of dispensers were quite satisfactory and are used on a large
scale, particularly the nasal inhalators. It was difficult or
impossible to introduce a definitely measured dose, with most of
these devices.
It is with improved dispensing devices which can dispense
accurately measured doses that the present invention deals.
SUMMARY OF THE INVENTION
The present invention departs from prior designs in several
important respects. First, there is a medicament chamber into which
gas or air under pressure is introduced at a swirl angle to create
turbulence so that the entire dose in the chamber is carried on
into the body cavity, e.g., nose or mouth, and thence into the
respiratory system, or vagina, ear or wound for local therapy. An
important feature is a loose element in the medicament chamber such
as half of the shell of a capsule carrying a dose of medicament.
This shell spins, vibrates and collides with the powdered
medicament thus preventing the formation of or breaking up any
coarser aggregates. Adhering of medicament to the walls of the
dispensing chamber is greatly reduced and for the most part
completely eliminated, and more importantly is consistent for any
given system.
The present invention permits discharging finely divided solid
particles from an accurately predetermined dosage either into the
nose or mouth or similar body cavity. No problem of over dosage is
presented, which was a problem with some dispensers used in the
past. With medicaments which in excessive amounts have undesirable
effects, complete safety is assured.
In one form, the dispenser of the present invention at first glance
appears somewhat similar to a nasal inhalator. However, the air
passages are sealed up and a gas duct carries gas under pressure
into a side of the mixing chamber. As the gas comes in at an angle,
called the swirl angle, there is high turbulence and a very
thorough distribution of the medicament results. A measured dose of
medicament is ordinarily introduced in a half of a capsule. The
capsule half vibrates violently, which results in complete emptying
of medicament dose and also breaks up aggregates, giving a fine
aerosol or smoke, defined as a suspension of solid particles in
gas.
Ordinarily the gas duct enters the medicament chamber at an angle
which is not a right angle. The particular angle is not critical so
long as it is a sufficient angle to produce a high degree of
turbulence. A liquid may be introduced in the capsule half shell,
if the medicament is more readily administered in liquid form. The
most important use for the present invention is to introduce a
medicament into the respiratory system, but it is possible to
introduce small doses of medicament into the nasal passages without
their being driven into the lungs. Also, while the nose and mouth
are the cavities in which the dispensers of the present invention
are primarily used, other bodily cavities can also receive
accurately predetermined dosages of finely divided medicament; and
therefore, in its broader aspects the present invention is not
strictly limited to dispensers to be used in oral or nasal use.
The source of the gas under pressure is not a critical part of the
present invention. It is convenient to form the gas introducing
tube for the mixing chamber so that it can be pressed on the
discharge valve of an ordinary aerosol container or pressure tank
which contains a volatile liquid or gas, such as Freon, of suitable
boiling point.
Chlorofluoroalkanes and mixtures of them give propellants with
preferred pressure characteristics. Dichlorodifluoromethane, sold
under trademarks such as Freon 12 or Genetron 12, is conveniently
commercially obtainable in small pressure tanks having a
depressable stem valve. Such pressure tanks are used as power units
for spray paints, noise devices, signaling systems, and many other
purposes.
In the quantities used for powder dispensing,
dichlorodifluoromethane is essentially non-toxic. In larger
quantities, it dilutes the oxygen in the air to such an extent that
it can become suffocating. Other propellants such as carbon dioxide
in cylinders, or compressed air or compressed oxygen from tanks or
a supply line may be used as a power source. Where fixed compressed
gases such as oxygen or air are used as a power source, the
complexity of pressure reducing devices to give a uniform pressure
for the dispensing of the medicament introduces a cost and weight
that is unacceptable for some usages. For use in a doctor's office
or under hospital conditions where a large number of doses are to
be dispensed and skilled maintenance is available and weight is not
critical, such compressed gas, particularly oxygen, is quite
advantageous as the oxygen can aid breathing performance and is
frequently used in respiratory therapy to reduce the load on the
heart and lungs, and is readily available.
The use of dichlorodifluoromethane or other of the haloalkanes
permits a very compact and readily portable package and may be
considered as the preferred form of use of the invention. It should
be understood that when the dispenser is pressed onto the discharge
valve of a pressure tank it should be pressed for a short but
sufficient time to assure that the full dosage of medicament in the
dispensing chamber is ejected into the desired body cavity. This
presents no problem as an exact time measurement is not needed.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-section through a nasal inhalator of the present
invention.
FIG. 2 is a cross-section through a nasal inhaler which fits
axially on the pressure tank and discharges powder at an angle.
FIG. 3 is a cross-section on line 3--3 of FIG. 2 showing a
cross-section of the dispenser, particularly the swirl angle of the
gas duct.
FIG. 4 is a modification of the dispenser showing radial
pressurization and axial discharge with threaded assembly.
FIG. 5 is a drawing on a smaller scale showing the use of a
dilution chamber for the dispersed aerosol.
FIG. 6 is a cross-section of a simplified two-piece assembly in
which the propellant tank feeds directly into the medicament
chamber.
FIG. 7 is a cross-section along lines 7--7 of FIG. 6.
DESCRIPTION OF PREFERRED EMBODIMENTS
FIG. 1 shows a powder dispenser in which a gas duct 13, which at
its other end attaches to the valve of the aerosol can or
propellant tank 14 enters at a swirl angle into the medicament
chamber 12 in the dispenser housing 11. In use, the nasal nozzle 15
is removed by unscrewing at the threaded nozzle coupling 16 and
half of a hard shell capsule 17 containing a powdered medicament 18
is introduced into the medicament chamber 12. The nasal nozzle 15
is then fastened on by screwing or by friction fit and the gas duct
13 is brought into contact with the valve stem 19 of an aerosol can
or propellant tank 14. The blast of Freon enters at a swirl angle,
causes high turbulence in the medicament chamber 12 which is
further enhanced by the vibration and spinning of the half capsule
17, resulting in complete emptying thereof and in further
turbulence, so that the whole dose of powdered medicament 18 is
introduced through the nasal nozzle 15 into the nostril of the
user.
The medicament to be dispensed may be any of the therapeutic agents
which are desirably administered in finely divided powdered form.
While not restricted to such powder size, materials having a
particle size of 90 percent smaller than 5 microns are conveniently
administered by the present type of portable powder dispenser.
Larger powders may be administered, but usually less elegant
techniques are satisfactory with the larger powders. Among the
finely powdered medicaments are penicillin or salts or derivatives
thereof, steroids or a therapeutically effective salt or derivative
thereof, and isoproternol as well as live virus materials. Some
such live viruses materials are disclosed in U.S. Pat. No.
2,798,835, Markham and Cox, NEWCASTLE DISEASE AND INFECTIOUS
BRONCHITIS VACCINES AND PRODUCTION THEREOF, and U.S. Pat. No.
2,798,836, Bird and Markham, INHALABLE LIVE VIRUS VETERINARY
VACCINE. For some uses, such as with poultry, live virus vaccines
can be dispensed as a finely divided material to be inhaled by
poultry. With other materials depending on the patient, live virus
products may be administered to humans or other mammals. The
present type of dispenser is particularly advantageous with
medicaments which are sensitive to moisture or storage conditions.
The medicament may be stored under conditions most advantageous for
storage, and yet readily transferred to the present dispenser for
the most advantageous methods of dispersion on administration.
An axial-feed, angular-dispensing modification of the invention is
shown in FIG. 2. Here the dispenser housing 21 is a massive plastic
block in which is formed the medicament chamber 22. A gas duct 23
is formed in the dispenser housing, conveniently by drilling, so
that one wall is nearly tangent to the medicament chamber, as shown
in FIG. 3. This gives a highly effective swirl angle so that as the
dispersing propellant is introduced into the medicament chamber a
high degree of spin and turbulence is attained. The nasal nozzle 25
is a press fit into the medicament chamber and has a discharge duct
26 leading axially from the medicament chamber, with a bend of
approximately 45.degree., so that the finely divided powder being
dispersed is dispensed at a convenient angle for oral or nasal
administration. Half of a hard shell capsule 27 containing a
powdered medicament 28 fits into the medicament chamber 22 to be
dispersed at time of use.
One configuration which gives excellent results for powdered
steroids is for the inner chamber to be about 0.28 inches in
diameter and about 0.5 inch depth with a radius at the bottom of
the chamber. The larger portion of a number 5 hard shell capsule
which is approximately 0.38 inches long and approximately 0.19
inches in diameter fits loosely into the medicament chamber. With
this size, the half of a hard shell capsule cannot turn over but is
maintained in a somewhat upright position where it can rotate and
vibrate but not turn over. If the chamber diameter is too small,
the half capsule shell forming the medicament container will not
rotate and vibrate and if it is too large, the capsule shell can
become tilted and jammed and hence prevent rotation. The gas
pressure through the gas duct should be such that the half capsule
shell has a high rotational velocity, but not so high as to
fracture. If too much pressure is fed in, the half capsule shell
itself may be disintegrated. Stroboscopic observation shows that a
rotational and vibrational rate of about 1,200 to 2,000 cycles per
minute gives excellent results. For such rotational speeds the
rotation and vibration dislodges the finely divided powder from the
capsule shell, causing the powder to be picked up by the moving
gas, and the entire suspension, now known as an aerosol or smoke,
is discharged through the discharge duct for administration, such
as inhalation by the subject.
While shown as a nasal nozzle, the orifice can be adapted to suit
the site of application, for instance the mouth, the ear, the
vagina, or a surface to which the powder is to be applied.
The dispenser housing is shown as fitting tightly into an outer
dispenser holder 29. The space between the outer dispenser holder
29 and the dispenser housing 21 acts as a damping chamber 30 which
smooths out any vibrations or variations in the propellant flow,
aids in preventing liquid portions of the propellant being fed into
the medicament chamber, and enhances smooth operation. A pressure
chamber adapter 31 has a size and shape to fit over the stem 32 of
a discharge valve on a propellant tank 24. Conveniently the
pressure chamber adapter has a size such that from about 10 to
about 15 cubic feet per minute of propellant gas flow into the
damping chamber. The size of the pressure chamber adapter is
critical to the extent that it must fit smoothly over the stem of
the dispensing valve on the propellant tank without excess gas
leakage but other than mating to each other, there are no critical
limitations on such dimensions. Preferably the pressure chamber
adapter fits current commercial valve stem standards.
In FIG. 4 is shown a modification in which the dispenser housing 34
has female threads 35 to receive male threads 36 on the end of an
axial nasal nozzle 37. In this configuration, there is less chance
of the nasal nozzle being blown out of the medicament chamber 38.
The dispenser housing 34 is also adapted to be retained by screw
threads 39 in the outer dispenser holder 40. A pressure adapter 41
fits over the stem 42 of the valve on a propellant tank 43. Here
the propellant tank and stem are radial, and hence adapted to be
held vertically while the nasal nozzle 37 is held horizontal to
dispense a medicament into the mouth, ear or nose of a user.
Because of the nature of the device, the complete assembly may be
held in any angle which is convenient for administration. Some
valves on the propellant tank operate more effectively if held
above the surface of any propellant in the tank which may be in
liquid form, but other valves work satisfactorily when held in any
position.
A modification of the axial flow device in FIG. 4 is shown in FIG.
5 in which a shoulder 45 is formed on the dispenser housing 34 to
cooperate with a dilution chamber 46. The dilution chamber is a
hollow cylinder, conveniently with a housing coupling 47 which fits
over and against the shoulder 45 to hold the dilution chamber in
position. Vents 48 permit the flow of air into the dilution
chamber. The discharge end of the dilution chamber has a mouthpiece
49 which can fit into the mouth of the user. A dust cap 50 may be
removably placed over the mouthpiece to keep it clean when not in
use.
In use, the dilution chamber permits the aerosol or smoke as it is
emitted from the nozzle to be diluted with air, and aggregates or
unground particles to settle out or fall against the wall of the
dilution chamber, so that a more uniform, more dilute aerosol is
served to the user whereby a deeper therapy is readily obtained by
inhaling the smoke or aerosol deeper into the lungs. Such a
dilution chamber also aids in maintaining a uniform dosage. Part of
the dose in the capsule shell is lost in the dilution chamber but
as the portion lost is consistent, a more consistent dosage may be
administered to the user. A small but consistent loss to give a
more uniform dosage is advantageous with those medicaments for
which the dosage level is critical.
A simplified modification is shown in FIGS. 6 and 7 in which the
dispenser housing 52 is a single rectangular block having a
medicament chamber 53 formed therein with screw threads to hold the
nasal nozzle 54. The nasal nozzle is axial with the medicament
chamber and conveniently formed on automatic screw machines. At
right angles an offset is the pressure chamber adapter 55 which
fits over the stem of a propellant tank, not shown, and which feeds
the pressurizing gas directly into the medicament chamber where the
gas spins the half hard shell capsule 56 containing the medicament
57. This configuration may be smaller and lighter than those above
shown and is thus adapted to be carried in the pocket of a
user.
The assembly of a small pressure tank, the dispenser housing, the
nasal nozzle and a supply of capsules containing medicaments may be
put in a small case which fits into the pocket of and is carried by
the user. For such uses, it is convenient to have the other half of
the hard shell capsule emplaced over the half containing the
medicament so that a complete hard shell capsule is carried by the
user and opened just prior to administration. The top can be
removed from the hard shell capsule, the half containing the
medicament dropped into the medicament chamber, and the nasal
nozzle screwed into retaining location, the stem of the pressure
tank placed in the pressure chamber adapter, and a dose dispensed
to the user with a minimum of time if the patient is subject to
distress symptoms such that rapidity of administration becomes
critical.
Other modifications of the present powder dispenser are within the
scope of the invention which is defined by the following
claims:
* * * * *