Note: Descriptions are shown in the official language in which they were submitted.
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SYSTEM AND METHOD FOR APPLICATION OF
MEDICAMENT INTO THE NASAL PASSAGE
This is a divisional of Application Serial
No. 2,394,559, filed December 11, 2000.
Field of the Invention
This invention relates generally to a system and
method for dispensing liquid droplets or spray-pattern
discharges, and relates more particularly to a system and a
method for dispensing droplets or spray-pattern discharges
of medicinal liquids into the nasal passage, which system
and method provide greater ease of application and privacy
for the user, as well as increased mechanical efficiency and
improved ability to prevent contamination of the stored
medicinal liquids.
Background of the Invention
Amongst various dispensers for applying
medicament, a typical medicament container includes a
flexible vial storage portion and a nozzle for dispensing
medicament by squeezing the vial between its side walls.
Another type of medicament dispenser is an accordion-like or
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piston-like pump dispenser which is actuated by squeezing
the vial between a bottom wall and the nozzle so as to
compress the vial in its longitudinal direction, rather than
from its sides. An example of the piston-like dispenser
which ejects precalibrated dosage of inedicarnent is described
in detail in U.S. Patent No. 5,613,957.
In recent years, pump-type dispensers have
received attention for their use in accurately dispensing
lo small doses of inedicaments, e.g., for nasal applications.
One persistent problem associated with pump-type dispensers
for dispensing medicaments is preventing contamination of
the medicament which can occur when the medicament that has
been exposed to ambient air returns and/or remains in the
outlet channel, e.g.., within the nozzle. One solution to
this problem is to simply add preservatives to the
medicament being dispensed, thereby preventing bacterial
growth. However, this solution has obvious disadvantages,
e.g., added costs and toxicity of the preservatives. In
order to prevent bacterial growth in medicament which does
not contain preservatives while allowing dispensation of
multiple doses of the medicament, the nozzle must prevent
any medicament that has been previously exposed to ambient
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air from being reintroduced, or "sucked back," into the
outlet channel of the nozzle, i.e., prevent any "dead
volume." "Dead volume" is defined herein as the volume of
space within the outlet channel of the pump where medicament
can come into contact with the open air and remain. If any
residual medicament remains within the dead volume, this
residue could serve as a host environment for germ growth.
Another consideration involved in designing pump-
type dispensers for medicaments is ensuring accurate
dispensation of a predetermined quantity of medicament,
e.g., ranging from 5 ul to greater volumes, upon each
actuation of the dispenser, irrespective of the orientation
of the dispenser or the force applied by the user to the
actuation mechanism of the dispenser. While many pump-type
dispensers provide an upper limit of the.quantity of
medicament dispensed upon each actuation of the dispenser,
these pumps often dispense varying quantities of medicament
as a function of the speed and/or force of actuation of the
actuation mechanism of the dispenser. In the case of a
pump-type dispenser which generates aerosol or spray-type
discharges, not only will the dispensed dose of medicament
vary with the speed and/or the force of actuation of the
actuation mechanism, but the spray pattern, or the plume, of
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the dispensed medicament will also vary with the speed
and/or the force of actuation.
It should also be noted that persons who suffer
from asthmatic or allergic condition routinely need to carry
a medicament dispenser with them for emergency situations,
but both the existing pressurized medicament dispensers and
non-pressurized dispensers have significant drawbacks. The
pressurized dispensers are not always ready for use unless
they incorporate a heavy glass bottle sustaining vacuum.
The non-pressurized devices generally require a particular
orientation for dispensing medicament, as well as suffering
from a measurable dead volume in the nozzle area.
Yet another problem in designing pump-type
dispensers for medicaments is ensuring the ease of applying
the medicament. Conventional pump-type dispensers for nasal
application, an example of which is shown in Fig. 2, are
generally actuated by compression along the length of the
dispenser. As shown in Fig. 2, the conventional nasal pump
200 is actuated by pushing down on the syringe arms 203
while supporting the bottom portion 202 with the thumb. The
combined actuation motion leads to difficulty in holding the
nasal pump in stationary position, and usually results in
removal of the nozzle tip 204 from the nostril area. For
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those users who may have greater than average difficulty
with the actuation motion, e.g., elderly patients with
arthritis or young children, accidental application of the
nasal medicament to the face or into the eye may occur.
Yet another problem associated with the pump-type
medicament dispensers is manufacturing complexity: pump-type
medicament dispensers are currently made of numerous parts
and are highly delicate to assemble. As the number of
components increases, the difficulty and cost of mass
production increases correspondingly. For example, many of
the pump-type dispensers incorporate springs, which pose
problems in the manufacturing process because of the
springs' tendency to get intermingled. In addition, very
small size of the gaskets and other components make relative
movement of the parts difficult. Furthermore, increased
number of components also increases the complexity of
achieving stability and compatibility of the component
materials with the medicament.
One attempt to solve the above-described problems
associated with applying medicament from a dispenser is
described in my U.S. Patent No. 5,267,986, which discloses a
system including a cartridge for actuating a piston-like or
accordion-like vial-dispenser for applying medicament to an
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eye. The cartridge disclosed in U.S. Patent No. 5,267,986
includes: a housing for holding the vial-dispenser; a
telescoping cylinder for compressing the vial-dispenser in
the longitudinal direction to load the vial with medicament;
a locking mechanism for locking the telescoping cylinder and
the vial-dispenser in the loaded position, against the
urging of a spring mechanism of the vial-dispenser; and a
trigger mechanism for releasing the telescoping cylinder and
the vial-dispenser from the locked position to release the
medicament loaded in the dispenser by means of the force of
the spring mechanism. In order to obviate the need for a
discrete spring element in the pump mechanism of the vial-
dispenser, a portion of the vial-dispenser body is made of
an elastic material which is compressible and provides
spring force. The two-step process in which the cartridge
disclosed in U.S. Patent No. 5,267,986 loads and
subsequently releases the medicament from a vial-dispenser
defines the basic operation a "reverse pump," an example of
which is described in U.S. Patent No.5,613,957.
The dispensing system disclosed in U.S. Patent No.
5,267,986 addresses some of the previously-mentioned
problems by enabling a user to apply a predetermined dose of
medicament independent of the physical force, or speed,
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applied to the dispensing system by the user: the releasing
force or speed of the dispensed medicament is dependent on
the integral spring element of the dispensing system.
Whereas conventional pump-type dispensers often utilize
compression along the longitudinal axis for release of
medicament, the actuation motion of the release mechanism
described in U.S. Patent No. 5,267,986 is preferably
achieved in a direction perpendicular to the longitudinal
axis of the vial-dispenser to ensure enhanced leverage for
the user.
While the dispensing system disclosed in U.S.
Patent No. 5,267,986 addresses some of the previously-
mentioned problems, at least one significant problem
remains: because elastic materials, particularly elastomeric
materials and springs, tend to exhibit hysteresis, spring
force decreases if the spring mechanism is kept in the
compressed position, i.e., in the loaded, locked position.
Although the deformation of spring is generally reversible
if the spring is returned to, and maintained in, the
unbiased state for some period, some of the deformation
becomes irreversible, or experiences "creep," if the spring
is kept in the compressed state beyond a certain threshold
period of time, which threshold period varies with the
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spring material. The amount of loss of spring force is
dependent on the tendency of a particular spring material to
"creep," and it is known that metal springs tend to exhibit
much less "creep" than plastic springs. The hysteresis of
elastic materials used to form the spring mechanism of the
pump described in U.S. Patent 5,613,957 is due to loss of
some of the spring property when the spring element remains
in the compressed state for an extended, and often
unexpected, period of time.
Two examples illustrate the practical implications
of the above-mentioned hysteresis problem in connection with
the dispensing system disclosed in U.S. Patent No.
5,267,986. As a first example, a user places the dispensing
system in the loaded state but does not actuate the release
mechanism for several hours due to an interruption. When
the release mechanism is finally actuated, hysteresis of the
spring mechanism causes the dosage of released medicament to
vary from the dosage calibrated to be released under normal
conditions. As a second example, a user places the
dispensing system in the loaded state but subsequently
forgets about the loaded system; the user does not actuate
the release mechanism for several weeks or months. In this
situation, not only will the initially-released dosage vary
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from the calibrated dosage, due to lower actuation speed or
force, but subsequently-dispensed dosages will also vary
from the calibrated dosage due to a type of permanent
deformation, or "creep," that has occurred, i.e., a
permanent change in the actuation stroke. In view of the
above-described problem of spring deformation, it would be
desirable to have a pump-type medicament-dispensing system
which allows the user, by means of a single actuation
motion, to load the vial with medicament and subsequently
dispense the medicament, without any intervening locking
step.
Pump-type dispensers for applying nasal
medicaments are faced with yet another problem in providing
the users with some level of discreetness: the sight of a
conventional pump-type nasal dispenser positioned inside of
a nostril is unseemly and often causes embarrassment for the
user. Accordingly, it would be desirable to achieve
dispensation of nasal medicament without presenting the
unsightly appearance of the dispenser positioned inside the
nostril.
Still another problem faced by pump-type
dispensers is achieving a tight seal of the dispenser after
filling it with liquid. The standard approach is to utilize
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plugs or lids which are formed to mechanically engage the
filling opening of a pouch or a container. The main
difficulty with this approach is that the allowable
mechanical tolerances of the interacting parts of the plug
or lid and the opening of the pouch or the container must be
extremely small in order to achieve a tight, substantially
hermetic seal. Furthermore, even if the interacting parts
initially form a tight seal, the portions of the interacting
parts which are under pressure tend to experience a "creep,"
i.e., deformation of the material, over time. Accordingly,
the "creep" phenomenon tends to reduce the tightness of the
seal. Thus, there is a need for a mechanical closure system
which achieves and maintains a hermetic seal of a pouch or a
container over the life of the container.
Accordingly, it is an object of the present
invention to provide a pump-type dispenser for dispensing
medicament in droplets or spray form, which dispenser
facilitates easy application of the medicament while
ensuring positional stability of the dispenser during the
actuation motion.
It is another object of the present invention to
provide a pump-type dispenser for applying medicaments into
the nasal passage, which dispenser provides the user with a
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nasal screen for discreetness.
It is yet another object of the present invention
to provide a pump-type dispenser for applying medicaments
into the nasal passage, which dispenser provides a guide for
aligning the dispenser nozzle with the nasal passage.
It is yet another object of the present invention
to provide a pump-type dispenser for applying medicament
into the nasal passage, which dispenser ensures a one-way
movement of inedicament through the nozzle of the dispenser.
It is yet another object of the present invention
to provide a pump-type dispenser which has a substantially
zero "dead volume" in the nozzle portion so'that no
medicament which has been exposed to ambient air can remain,
i.e., the medicament is completely released once it passes
through the outlet nozzle, or the combined effect of the
surface tensions of the medicament and the surrounding
outlet nozzle forces any remaining medicament out of, and
away from, the outlet portion.
It is yet another object of the present invention
to provide a pump-type dispenser for dispensing nasal
medicament, which dispenser minimizes the number of parts
for manufacturing.
It is yet another object of the present invention
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to provide a pump-type dispenser for nasal medicament, which
dispenser incorporates a nozzle adapted to generate an
aerosol-type discharge by means of elastic, radial
deformation along the circumference of the nozzle which
simultaneously functions as an integral spring and an
elastic valve, while substantially maintaining the physical
profile in the direction of the longitudinal axis of the
nozzle.
It is yet another object of the present invention
to provide a pump-type dispenser for nasal medicaments,
which dispenser does not require propellants such as CFCs,
the release of which is harmful to the ozone layer, or the
release pressure of which propellant is temperature
dependent, thereby creating variations in dispensed dosages.
It is yet another object of the present invention
to provide a pump-type dispenser for nasal medicaments,
which dispenser emits a predetermined dose of medicament
upon each actuation of the dispenser, irrespective of the
orientation of the dispenser and the force applied by the
user to actuation mechanism.
It is yet another object of the present invention
to provide a pump-type dispenser for nasal medicaments,
which dispenser emits a predetermined dose of medicament
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upon each actuation of the dispenser, irrespective of the
force applied by the user to the actuation mechanism of the
dispenser.
It is a further object of the invention to provide
a nasal-medicament dispensing system which can accurately
deliver a small, calibrated amount of medicament by means of
a single actuation motion which loads the system with
medicament and subsequently dispenses the loaded medicament
immediately thereafter without any intervening locking step.
It is a further object of the invention to provide
a nasal-medicament dispensing system having a single
actuation motion for loading and dispensing the medicament,
which system incorporates an elastomeric spring element as
an integral portion of the body of the dispensing system.
It is a further object of the invention to provide
a nasal-medicament dispensing system which includes an
actuation mechanism for actuating a vial-dispenser of the
type having a spring configuration, e.g., an accordion-like
or piston-like vial-dispenser, which actuation mechanism
2o requires minimal force for actuation.
It is a further object of the invention to provide
a nasal-medicament dispensing system which substantially
eliminates any possibility that spring elements of the
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dispensing system will exhibit hysteresis of spring
characteristics.
It is a further object of the invention to provide
a nasal-medicament system in which the actuation motion of
the actuation mechanism for dispensing the loaded medicament
is in the direction perpendicular to the longitudinal axis
of the vial dispenser to ensure enhanced leverage for the
user and to avoid the actuation motion being parallel to the
compression axis of the spring element.
It is a further object of the invention to provide
a method of accurately delivering a small, calibrated amount
of inedicament by means of a single actuation motion of a
medicament-dispensing system which loads the system with
medicament and immediately dispenses the loaded medicament
thereafter without any intervening locking step.
It is a further object of the invention to provide
a method of dispensing a small, calibrated amount of
medicament by means of an actuation mechanism for actuating
an accordion-like or piston-like vial-dispenser, which
actuation motion requires minimal force for actuation.
It is another object of the present invention to
provide a mechanical closure system for achieving a tight,
substantially hermetic seal of a pouch or a container having
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an opening.
It is another object of the present invention to
provide a method of mechanically sealing a pouch or a
container having an opening to achieve a tight,
substantially hermetic seal while simultaneously allowing
delivery of gels or suspensions via an outlet nozzle.
It is yet another object of the present invention
to provide a mechanical closure system for a pouch or a
container having an opening, which mechanical closure system
compensates for deformation of the interacting parts of the
mechanical closure system and the pouch or the container.
It is yet another object of the present invention
to provide a mechanical closure system for achieving a
tight, substantially hermetic seal of a pouch or a container
having an opening, which system does not require extremely
small tolerances for the interacting parts.
It is yet another object of the present invention
to provide a method of mechanically sealing an opening of a
pouch or a container after having introduced liquid into the
container through the opening, which method eliminates the
need to provide vacuum conditions for filling the container
and, thereby, substantially reduces the cost of the
mechanical system for filling the container.
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It is yet another object of the present invention
to provide a method of mechanically sealing an opening of a
pouch or a container, which method involves removably
sealing the opening of the pouch or the container in a first
configuration, and permanently sealing the opening of the
pouch or the container in a second configuration.
It is yet another object of the present invention
to provide a system of mechanically sealing an opening of a
pouch or a container, which system provides a single-piece
sealing element consisting of a mechanical plug detachably
coupled to a crimping element via a flange for removably
sealing the opening of the pouch or the container, and the
system further providing that the crimping element may be
detached from the mechanical plug to permanently seal the
opening of the pouch or the container.
It is yet another object of the present invention
to provide a spray-type dispensing system having a swirling
chamber in the region of the nozzle for generating a spray
pattern, which system substantially minimizes the head loss
in the swirling chamber and in the outflow channels
surrounding the swirling chamber.
It is yet another object of the present invention
to provide method of generating a spray-type emission from a
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medicament dispensing system having a swirling chamber in
the region of the nozzle for generating a spray pattern,
which method substantially minimizes the head loss in the
swirling chamber and in the outflow channels surrounding the
swirling chamber.
Summary of the Invention
In accordance with the above objects, the present
invention provides a pump-type dispenser for dispensing
predetermined doses of medicament in droplets or in spray
form to the nasal area, which pump-type dispenser
incorporates a nasal screen, a pump mechanism, a one-way
valve mechanism in the nozzle area, a one-way actuation
mechanism and an integral spring element. The nozzle area,
which includes the one-way valve mechanism, is adapted to
minimize the head loss experienced by the liquid in the
nozzle area, thereby achieving more efficient fluid
mechanics. The nasal screen not only guides and correctly
aligns the dispenser nozzle with the nasal passage, but the
screen also serves the important function of allowing the
user to discreetly apply the nasal medicament from the
dispenser without exposing the nasal area to the public.
Furthermore, the one-way valve mechanism in the nozzle area
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ensures a one-way movement of medicament from the dispenser,
thereby preserving substantially perfect sterility of the
medicament in the dispenser regardless of the environment
surrounding the dispenser, without requiring the use of
preservatives.
The one-way actuation mechanism enables the user
to sequentially load and dispense the medicament with a
single continuous motion of the actuation mechanism upon
application of a very small force on the actuation trigger
mechanism by the user. The use of the one-way actuation
mechanism also enables design simplification by allowing
replacement of the traditional metallic spring element with
a spring element formed as an integral part of the
dispensing system and made from the same elastomeric
material as the valve material. The actuation mechanism
operates transversely to the length of the dispenser,
thereby minimizing the risk that the user will accidentally
remove the dispenser nozzle from the nose during use. In
addition, the integral spring element formed as a portion of
the pump body minimizes the number of component parts for
the dispenser, thereby minimizing the manufacturing
complexity and the likelihood of mechanical failure during
use. Furthermore, the one-way actuation mechanism and the
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integral spring element provide the dispenser according to
the present invention with the unique characteristic of
delivering the same precise quantity of inedicament at the
same actuation force and speed, regardless of the actual
force applied to the actuation trigger by the user.
As can be seen from the above, the pump-type
dispenser according-to the present invention provides a
safe, stable and easily operable mechanism for applying
medicament to the nasal area. As an additional advantage,
the pump-type dispenser according to the present invention
for dispensing nasal medicament may be used with
substantially all types of liquid formulations, e.g.,
solutions, suspensions and gels. An exemplary pump
mechanism incorporated in the dispenser according to the
present invention has: a) a pump body having a front end or
tip on the fluid outlet side, the front end comprising an
outlet orifice sealed off by an elastic membrane, and
continuing backwards through a pump duct with a fluid inlet
orifice; and b) a movable piston fitted inside the pump
body, the relative displacement of the end of the piston in
relation to the pump body between the inlet orifice and a
stop position located towards the outlet orifice thus
determining the quantity of fluid expelled on displacement,
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the end of the piston fitting hermetically by slight
friction against the duct, the inlet orifice being of a
sufficient size for only the preset quantity of fluid or gel
to be trapped at the end of the pump duct for its expulsion
through the outlet orifice, the pump body and the piston
being totally enveloped by an elastic phial, with the
exception of the front end of the pump body.
The front end of the pump body, i.e., the tip or
"nose," incorporates an outlet orifice preferably in the
form of, for example, a cylindrical channel, opening into a
pump duct, the latter being, for example, a cylindrical
tube, the outlet orifice or channel and pump duct preferably
lying in the same general direction. The outlet orifice is
preferably a channel advantageously positioned essentially
axially along the length of the pump. However, as is clear
to those skilled in the field, the channel may be of any
shape, e.g., an elbow shape, so as to ensure a projection
perpendicular to the axis of the pump.
The elastic membrane may be made of any well-known
state-of-the-art elastic material, for example rubber, an
elastomer, and preferably thermo-elastic materials such as
polyurethane, Adrian0, or those available from AES under the
name of VISKAFLEXO, from DUPONT under the name of ALCRYN or
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HYTREL , from DSM under the name SARLINK , from SHELL under
the name KRATON , and from Monsanto under the name
Santoprene . The elastic membrane has, at the outlet
orifice, a sufficient thickness to form a one-way valve
towards the outlet. In other words by working the piston
towards the outlet orifice, the force exerted on the piston
enables the said valve to open thus enabling the fluid to be
expelled. By contrast, after expelling the liquid, if the
piston is then drawn back the valve becomes hermetically
sealed and, in the pump duct, a reduced pressure or vacuum
is created.
The pump duct has a fluid inlet orifice enabling
the fluid to fill through the latter. This inlet orifice
may be of any shape, rounded, elongated, and may be in the
shape of a channel, a slit, a groove, etc.
Similar to a syringe, the pump mechanism according
to the present invention incorporates a movable piston
fitted inside the pump body; the piston is preferably fitted
along the length of the device. "Movable" simply indicates
that the piston is movable in relation to the body in which
it is housed, without prejudicing which element, i.e., the
piston or body, moves. This piston can move between a stop
position located towards the fluid outlet orifice, and a
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position beyond the fluid inlet orifice. The stop may be,
as in a conventional syringe, the end of the pump duct on
the outlet side. However, another stop may be made, if
desired, before this end. In the first case, after the
fluid is expelled by the relative working of the piston and
pump body, the volume of fluid held between the outlet valve
and the piston end will be reduced merely to the volume of
the evacuation channel. In the second case, the volume of
fluid held between the outlet valve and the piston end will
include a certain portion of the pump duct in addition to
the evacuation channel.
As in a conventional syringe, the end of the
piston of the pump according to the present invention fits
hermetically by slight friction against the pump cylinder.
It will thus be understood that when the piston is drawn in
the opposite direction to the outlet orifice, a reduced
pressure is created in the pump duct, the said reduced
pressure being "broken" when the end of the piston reaches
the level of the fluid inlet orifice. At this point the
fluid is sucked into the pump duct which it fills. During
the relative displacement of the piston towards the outlet
orifice, when the piston goes beyond the inlet orifice, it
thus traps in the pump duct a certain volume of fluid. The
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set volume between this position and the most extreme, stop
position of the movable piston corresponds to the preset
quantity of fluid which will be expelled by the pump. The
compression of the fluid by the piston, the compression
being achieved, for example, and preferably with the aid of
an elastic, or by pressure with the aid of the thumb on the
piston, enables the elastic membrane forming a valve to open
and the fluid to be expelled.
The volume of formulation to be delivered by the
exemplary phial-pump incorporated in the present invention
is small, for example in the order of 5 ul.
As can be seen from the above, the rest position
of the pump according to the invention is the position where
the piston is at the stop. This is why preferably the pump
according to the invention has an elastic means of returning
the piston to the stop position. These elastic means are
well known to those skilled in the field and are such as a
spring, the said spring being fitted inside or outside the
pump, along the piston's axis of displacement; the spring
may be made of a metal or plastic material, the nature of
the spring being adapted to the fluid contained in the
bottle when the said spring is fitted inside the phial in
contact with the fluid.
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The above-mentioned elastic means may be formed as
a part of the envelope of the elastic phial itself, for
example, in the form of a concertina, or annular convex part
of sufficient thickness to form a mean of return. The
envelope is for example at this level integral on one side
with the pump body and on the other side with the piston by
means of rings with which these element may be fitted.
These rings can cooperate with corresponding slots which in
this case are made in the envelope. If desired, in order to
strengthen the means of return it is possible to use, for
example, two return element such as concertinas located more
particularly on either side of the retaining ring, integral
with the piston a illustrated below. The elastic membrane
may be alternatively a separate piece from the elastic
phial. However, in preferred conditions of embodiment of
the pump mechanism described above, the elastic membrane and
the elastic phial form a single piece. The number of pieces
of the pump mechanism according to the invention may
therefore be remarkably reduced. Indeed, according to the
invention, it is possible to have a pump mechanism
incorporating just three pieces: a phial made of an elastic
material; the pump body and the piston.
The exemplary pump mechanism according to the
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present invention has a pump body with a frontal ring,
fitted close to the fluid outlet. Such a frontal ring
enables the elastic phial to be hermetically fixed to the
pump body. Such a ring also enables the embodiment of
elastic means for returning the piston to the stop position.
The pump body may also include a rear ring, which can
perform several functions. The rear ring is preferably an
incomplete ring, i.e., portions of the ring are cut out.
The above-described piston has the general
conformation of an elongated element, corresponding to
conventional piston, the elongated element having a
plurality of elements, preferably three, in the shape of a
ship's anchor, each thus forming a radial element, at the
end of which is an arc-shaped element. The plurality of
arcs then forms the incomplete ring referred to above. In
such a case, for example, the pump body comprises a
cylindrical element, comprising at its front end a ring and
at its rear end another cylindrical ring, of larger diameter
than the diameter of the arcs described above, the front
base of the rear cylindrical ring being cut away so that the
above anchors can pass through the base of the cylinder thus
enabling, by means of slots corresponding to the above
radial elements, and made in the cylinder comprising the
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pump body, the longitudinal displacement of the piston.
The slots made in the pump body perform two
functions: a) on the one hand, they enable the displacement
of the piston, by the radial elements sliding along the axis
of the slots; and b) on the other hand, the end of the slots
on the front side constitutes the fluid inlet orifice
enabling the fluid to reach the final pump duct
corresponding to the preset volume of fluid to be expelled.
The above-described shape of the piston
facilitates the following: a) enable the nozzle portion to
be integral with the rear portion of the pump body; b)
eliminates the need for the nozzle portion to be snapped
into the housing when the piston is moved towards the rear;
and c) enables the pump mechanism to be interchangeable
within the same housing. The shape of the piston also
enables the piston to be actuated through the bellows
portion serving as the spring element, without causing or
resulting in any motion of the rear vial portion of the pump
mechanism. One advantage resulting from the lack of motion
involving the rear vial portion is that the pump mechanism
does not experience any momentum change as a function of the
fluid-content level of the vial, i.e., the pump mechanism
exhibits the same momentum characteristics whether the rear
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vial portion is full or nearly empty, thereby ensuring
substantially constant dosage.
In addition to the above-noted advantages, the
pump mechanism according to the present invention may also
incorporate two 0-shaped rings which are secured around the
circumference of the pump piston, such that the 0-shaped
rings provide'a fluid-tight seal between the piston and the
surrounding sleeve portion of the pump body. The 0-shaped
rings, which may be made of silicone, polyisoprene,
lo KratonT", AdrianTM, butyl or any rubber-like material,
maintain the bellows chamber free of fluid by providing a
fluid-tight seal between the pump piston and the surrounding
sleeve portion of the pump body. In turn, the absence of
fluid in the bellows chamber substantially eliminates the
possibility of fluid hindering the elastic deformation of
the rear bellows portion.
The dynamics of a pump according to the present
invention are summarized below. Let us assume that the
equilibrium position is the position in which the piston is
at the stop. As is clear for the man skilled in the art,
the displacements referred to in the present application are
in general relative displacements. Indeed preferably, the
piston may be kept stationary and the pump body moved as
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illustrated below, or the pump body kept stationary and the
piston moved to achieve the outlet of the fluid. When the
piston draws back, it creates a cavity whose state of
pressure is a partial vacuum, indeed the outlet orifice is
blocked off by the elastic membrane, preventing the entry of
air into the pump. On drawing back further, the piston ends
up by reaching the level of a fluid inlet orifice. At this
point the pump duct, also referred to as a "drop cavity" or
"dose chamber," quickly fills with fluid. The piston can
then be pushed back or left to move on to the stop position.
When the piston again reaches the level of the fluid inlet
orifice, on reaching the end of the latter, it traps a
preset volume of fluid. The volume between this extreme
position and the stop position of the piston then determines
the quantity of fluid expelled. From this moment, ejection
of the fluid occurs. As soon as the annular piston lip
contacts the compression chamber, the valve opens.
A pump mechanism according to the invention has
many advantages which it also confers to an elastic phial
fitted with such a pump. The preset volume proposed for the
pump may be adjusted by altering both the cross-sectional
area of the cavity or pump duct and the length of this
cavity by changing the depth of the inlet orifice. The dose
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is constant and depends neither on gravity nor the
activation speed of the pump. It can only depend on the
spring effect given to the relative pump body/piston
movement, and this for a given viscosity and orifice
diameter.
The use of an elastic wall for the envelope makes
it possible to achieve in one piece the following functions.
First, a one-way valve function is facilitated, enabling
operation without drawing in air or the actual substance
being delivered; the pump also makes it possible to dispense
formulations without preservative which may be used
repeatedly without the risk of contamination of the inside
of the phial. Second, a phial function is facilitated: the
elasticity of the wall in fact enables the wall to cave in
gradually as the liquid is evacuated by the pump. Third,
the elastic wall functions as an integral spring element.
The injection or filling of the above-described
pump mechanism may be associated with a suction which
precedes and/or accompanies and/or follows filling so as to
eliminate any residual gas in the phial after filling. The
dose delivered on each activation of the pump mechanism does
not vary, whatever the ambient pressure, because
substantially no gas exists inside the system, and the
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expulsion force applied to the liquid is not dependent on
the manual force applied by the user.
The pump-type dispenser mechanism according to the
present invention may further incorporate an inner pouch
made of an elastic material, e.g., KratonTM, and located
within the vial portion. The vial portion, in this case,
may be made of a rigid material which substantially
eliminates ingress of air into the vial portion. The
interior of the inner pouch contains varying volume of air,
depending on the amount of liquid contained in the vial
portion. The elastic inner pouch is collapsible such that
its bottom exterior surface conforms to the liquid level in
the vial portion. Accordingly, when the vial portion is
completely filled with fluid, the inner pouch is
substantially completely collapsed and the volume of the
interior is substantially zero. As the liquid in the vial
portion-is gradually depleted as the result of the pump
operation, the inner pouch expands correspondingly, drawn by
the suction pressure in the vial portion, thereby
substantially eliminating the residual air inside the vial
portion, which residual air may adversely affect the
operation of the pump. The volume of air in the inner pouch
is in turn regulated via air holes.
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One embodiment of the pump-type dispenser
mechanism according to the present invention may also
incorporate a nozzle mechanism for generating an aerosol-
type liquid discharge, which nozzle mechanism ensures one-
way movement of liquid and also has a substantially zero
"dead volume" at the tip of the nozzle. The nozzle
mechanism according to the present invention is not only
suitable for dispensing nasal medicaments, but may be also
adapted for use with a variety of types of liquid-dispensing
apparatuses, for example, medicament dispensers which
channel liquid from a liquid reservoir through the nozzle
mechanism by application of pressure via a pump mechanism.
One embodiment of the nozzle mechanism includes a
flexible nozzle portion with an outlet and fluid channels, a
rigid shaft received within the flexible nozzle portion, and
a rigid housing surrounding the flexible nozzle portion and
exposing the outlet. The rigid shaft interfaces the outlet
to form a second.normally-closed, circumferential valve as
well as to define a collecting chamber, or a "swirling
chamber," for temporarily collecting the liquid which has
been channeled from the liquid reservoir, prior to being
discharged via the outlet. The outlet has an elastic outer
wall, the thickness of which decreases along the elongated
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axis of symmetry of the outlet from a bottom portion of the
outlet toward the tip of the outlet, thereby facilitating
one-way movement of liquid through, and out of, the outlet.
In the above-described embodiment of the nozzle
mechanism, the fluid channels, which define a portion of a
fluid communication path between the liquid reservoir and
the collecting chamber, are positioned at various radial
edge or circumferential points within the flexible nozzle
portion. The radially positioned fluid channels provide
uniform pressure with a minimum of "head loss" which will be
explained later. As a result, the liquid pressure is
uniformly applied at the entry point of the swirling chamber
once the pressure within the radially positioned fluid
channels reach a threshold pressure sufficient to radially
deform a first normally-closed, annular or circumferential
valve forming a portion of the fluid communication path
between the liquid reservoir and the collecting chamber,
which first normally-closed valve is described in further
detail below. It should be noted that while the first
normally-closed valve is positioned annularly, i.e., applies
even pressure at all points of the circumference, the fluid
channels extend along the longitudinal axis of the flexible
nozzle portion and occupy only small sections of the
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circumference of the second normally-closed valve.
The above-mentioned swirling chamber is used to
create a spray pattern for the discharged liquid. The
greater pressure differential between the outside and the
inside of the pinhole opening of the swirling chamber, the
greater the homogeneity and the smaller the spray-particle
size. In order to minimize the source of resistance, also
referred to as "head loss" in fluid mechanics, the length of
the fluid channel incorporated in the present invention is
minimized, as well as the rate of reduction of the fluid-
channel width (if any) and the rate of change of the fluid-
channel angle relative to the swirling chamber.
The above-described embodiment of nozzle mechanism
according to the present invention may be coupled to a
flexible body portion which has a substantially tubular
shape and a wall thickness which decreases from the bottom
of the body portion toward the flexible nozzle portion,
along the elongated axis of symmetry of the body portion.
The rigid shaft received within the flexible nozzle portions
extends down into the flexible body portion so that a second
portion of the rigid shaft interfaces the flexible body
portion to form the first normally-closed, radially-
positioned valve in the fluid communication path between the
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liquid reservoir and the collecting chamber. As with the
second normally-closed, radially-positioned valve, the first
normally-closed, radially-positioned valve is opened when
the pressure on the liquid in the fluid communication path
reaches a threshold pressure sufficient to radially deform
the portion of the flexible body portion forming the first
normally-closed, radially-positioned valve.
One advantage of the nozzle mechanism according to
the present invention is that the configuration of the
outlet portion substantially eliminates the possibility that
liquid in the nozzle mechanism will come in contact with
ambient air and subsequently return and/or remain in the
interior portion of the nozzle mechanism. The nozzle
mechanism achieves this result by means of the second
normally-closed valve, which facilitates one-way movement of
liquid from the nozzle mechanism through the outlet portion
during discharge. Due to the second normally-closed valve,
the outlet portion has a substantially zero "dead volume",
i.e., a space in which liquid that may have been exposed to
ambient air can remain.
In addition to the second normally-closed valve,
the first normally-closed valve positioned along the fluid
communication path between the liquid reservoir and the
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nozzle mechanism adds further assurances that liquid in the
liquid reservoir will not be contaminated by the ambient air
and subsequently reintroduced into the nozzle mechanism.
Because the first and second normally-closed valves are
positioned along the fluid communication path to open
asynchronously during fluid communication leading to
discharge through the outlet, failure of either one of the
valves will not affect the integrity of the nozzle mechanism
to prevent contamination of the liquid in the liquid
reservoir.
Another advantage of the nozzle mechanism
according to the present invention is that the nozzle
mechanism experiences substantially no deformation along the
direction of the discharge path through the outlet, i.e.,
the elongated axis of symmetry for the outlet. As a result,
the physical profile of the fluid channel, which induces
swirling action of the liquid in the collecting chamber of
the nozzle mechanism, is maintained during liquid discharge.
Another advantage of the nozzle mechanism
according to the present invention is that the number of
parts which constitute the nozzle mechanism and, in turn,
the dispensing system which includes a pump mechanism in
combination with the nozzle mechanism, is significantly
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reduced in comparison to conventional nozzle mechanisms.
The reduced number of parts reduces costs and complexity of
assembly.
The pump-type nasal medicament dispenser according
to the present invention incorporates an exterior housing
and a cartridge positioned within the housing, which
cartridge is in turn particularly adapted for actuating an
accordion-like or piston-like vial-dispenser mechanism. The
vial-dispenser has an accordion-like front bellows portion
near the anterior end, a rear vial section or liquid storage
chamber at the posterior end, and a rear bellows portion
located between the front bellows portion and the rear vial
section. A drop cavity or a dosage cavity, which may be
located within either the front bellows portion or the rear
bellows portion, holds a precalibrated amount of inedicament
loaded from the liquid storage chamber. In addition, an
internal piston mechanism within the vial-dispenser acts in
concert with the front and rear bellows portions to expel
the medicament contained in the drop cavity.
The cartridge includes a generally elongated body
portion which is adapted to receive the vial-dispenser
between an anterior wall and a posterior wall of the
cartridge. The posterior wall of the cartridge may form a
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portion of a rear chamber of the cartridge, in which case
the rear chamber of the cartridge receives the rear vial
section of the vial-dispenser. The anterior wall of the
cartridge has an aperture for exposing the nozzle of the
vial.
Located on top portion of the cartridge is a
trigger mechanism which, when depressed, acts via, and in
concert with, a notched lever located in the interior
portion of the housing to extend the front bellows portion
and compress the rear bellows portion of the vial-dispenser
in the longitudinal direction, away from the anterior wall
of the cartridge and towards the rear chamber. In the case
of the exemplary embodiment of the vial-dispenser described
herein, extension of the front bellows portion and
compression of the rear bellows portion cause a
precalibrated dose of medicament to enter the dosage cavity
located in the front of the dispenser, thereby "loading" the
dosage cavity.
Continuing with the triggering motion, once the
notched lever located in the interior portion of the
cartridge has extended the front bellows portion of the
vial-dispenser a predetermined distance, the notched lever
is disengaged from the front bellows portion by a wedge-
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shaped arm extending from the rear wall of the cartridge.
Upon disengagement from the notched lever, the front bellows
portion contracts and the rear bellows portion extends
towards the anterior wall of the cartridge. In concert with
the movements of the front and rear bellows portions,
movement of the internal piston mechanism creates pressure
which forces the medicament from the dosage cavity via the
anterior nozzle of the vial-dispenser.
The present invention also provides an exemplary
embodiment of a mechanical lid or a plug which interacts
with an opening of the rear vial section of the vial-
dispenser mechanism, as well as with a rigid ring placed
inside the vial opening. The mechanical plug is snapped
into the vial opening such that the mechanical plug
compresses both the outside of the opening and the inner
face of the ring placed inside the vial opening, thereby
forming a tight seal of the opening.
The opening area of the vial has an annular recess
configured to accommodate the rigid ring, where the rigid
ring is snapped into the annular recess. After the rigid
ring has been snapped into the annular recess of the opening
region of the vial, the mechanical plug is snapped both into
the rigid ring and around the outside edge of the vial
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opening so that the vial opening is compressed between the
rigid ring and the mechanical plug. The radial edge of the
inner face of the mechanical plug is formed as an arch-
shaped region which extends around the plug such that the
radial edge of the plug is adapted to "hug" the perimeter of
the vial opening. In addition, attached to the inner face
of the mechanical plug are two or more legs which extend
perpendicular to the lower surface of the mechanical plug.
The ends of the legs are hook-shaped to engage the bottom of
the rigid ring/radial groove combination. The annular
recess and the legs of the mechanical plug facilitate both
vertical and radial compression of the opening region of the
vial and the rigid ring. In this manner, a tight seal of
the vial opening is ensured.
In addition, the outside surface of the opening
region of the vial and the interior surface of the annular
recess of the mechanical plug each has one or more
protrusions, or "interferences." Once the mechanical plug
has been snapped into the vial opening, the resulting
compression of the vial material tends to cause
displacement, or "creep," of the compressed material towards
areas of lesser compression. The protrusions limit the
range of displacement of the compressed vial material, i.e.,
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force the vial material displaced by compression to remain
within a defined area, thereby ensuring the tightness of the
seal for a prolonged period of time.
The central inner surface of the mechanical plug
may be equipped with an extension or a plunger which is
adapted to extend into the liquid content of the vial in
such a way that the mechanical plug snaps tightly into the
vial opening after, and only after, the plunger has
displaced the surface level of the liquid up to the upper
edge of the vial opening, thereby obviating the need for a
vacuum condition normally utilized for an airless filling
process. In this manner, the plunger substantially reduces
the residual air bubbles which may otherwise remain between
the surface of the liquid and the inner surface of the
mechanical plug.
As an alternative to the above-described
mechanical closure system, the present invention also
provides a rigid crimping element detachably coupled via a
breakaway flange to a rigid mechanical plug. These elements
may be molded as a single piece in order to simplify the
manufacturing and assembly process.
The mechanical plug is first inserted into an
opening of a neck of the rear vial section of the vial-
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dispenser mechanism. The mechanical plug and an interior
portion of the neck of the vial interact to maintain the
mechanical plug within the neck of the vial. However, a
predetermined amount of force may dislodge the mechanical
plug from the neck of the vial. This detachable engagement
between the mechanical plug and the neck of the vial allows
the vial to be temporarily sealed for some operations and
open for other operations.
In order to permanently and effectively seal the
vial, the crimping element is then repositioned relative to,
e.g., detached from, the mechanical plug and slipped over
the neck of the vial, which action results in compression of
the neck of the vial between an inner face of the crimping
element and an external face of the mechanical plug, thereby
providing a tight, hermetic seal of the vial.
The neck of the vial may be annular and has an
inner wall and configured to engage the mechanical plug. A
first semicircular protrusion extends substantially around
the entire circumference of the inner wall of the neck to
engage a first groove on the mechanical plug so that, when
the mechanical plug is inserted into the opening of the
neck, the first protrusion on the mechanical plug "snaps"
into the first groove on the mechanical plug. This first
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step of "snapping" the first protrusion into the first
groove is reversible so that sterilization of the vial using
R or y radiation can take place with the first protrusion
snapped into the first groove, and the plug can be detached
from the neck, i.e., by releasing the first protrusion from
the first groove, for subsequent filling of the vial.
A second protrusion extends around an outer wall
of the neck of the vial and is configured to engage the
crimping element. The second protrusion consists of a
semicircular portion extending substantially around the
entire circumference of the outer wall of the neck to engage
a second groove on the crimping element. When the crimping
element is slipped over the neck of the vial, the second
protrusion on the neck of the vial "snaps" into the second
groove on the crimping element to securely couple the
crimping element to the neck of the vial. Once the crimping
element is "snapped" into place, the neck of the vial is
then compressed between the crimping element and the
mechanical plug to provide a tight seal of the vial. This
second step of "snapping" the crimping element onto the vial
is irreversible, thereby forming a permanent seal.
The interacting surfaces of the crimping element
and the neck of the vial have complementary contours which
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ensure distribution of the compressive force over the entire
region of the interacting surfaces when the crimping element
is engaging the neck of the vial. In this manner, the
present invention substantially eliminates the "creep"
phenomenon exhibited by prior art closure mechanisms.
In order to further maintain the crimping element
on the neck of the vial, the mechanical plug may further
include an overhanging shoulder that extends around the
entire circumference of the outer face of the mechanical
wall. The crimping element may then have a conical-shaped
brim that extends underneath the shoulder of the mechanical
plug when the crimping element is slid over the neck of the
vial. Thus, any upward movement of the crimping element
would be further constricted since the brim of the crimping
element would then come into contact with the shoulder of
the mechanical plug.
A plunger or extension may also be provided on a
bottom surface of the mechanical plug so that, when the
mechanical plug is inserted into the neck of the vial, the
plunger may extend into a'liquid content of the vial in
order to raise the surface level of the liquid. Thus, the
plunger may substantially reduce the residual air bubbles
which may otherwise remain between the surface of the liquid
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and the inner surface of the mechanical plug.
Yet another exemplary embodiment of a mechanical
plug effectively seals the opening of the rear vial section
of a vial-dispenser mechanism which incorporates an inner
pouch within the rear vial section for minimizing the
presence of air inside the rear vial section. A rear
portion of the inner pouch has an inverted U shape, and the
rear portion radially clasps the opening area of the rear
vial section. A radial protrusion of the inner pouch is
seated in a complementary recess formed in the opening area
of rear vial section, and the rear plug, which also has an
inverted U shape, slides over, and radially clasps, the rear
portion of the inner pouch and the opening area of the rear
vial section to provide a tight seal along both the radial
and vertical directions.
Still another exemplary embodiment of a mechanical
plug has an annular protrusion which is snap-fitted into a
complementary annular recess formed in the opening area of
the rear vial section, thereby providing a radial seal along
the annular recess. The mechanical plug also has an annular
flange which rests against an annular flange of the opening
area of the rear vial section. The annular protrusion.of
the mechanical plug and the annular flange of the opening
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area act in concert to provide vertical compression of the
opening area of the rear vial section.
The pump-type dispenser system according to the
present invention for dispensing nasal medicament has
several distinct advantages. First, the dispenser system
according to the present invention substantially eliminates
ingress of air into the pump mechanism,.thereby providing
not only a sterile environment for the nasal medicament, but
also facilitating consistency of the dispensed dosage by
minimizing disruption of pump operation caused by air.
Second, because the pump-type dispenser according to the
present invention is substantially airless, the operation of
the pump, as well as the dispensed dosage, is completely
unaffected by the orientation of the pump-type dispenser
during use. Third, the present invention provides a one-way
valve in the nozzle area to further ensure a sterile
environment for the nasal medicament inside the dispenser.
The valve facilitates only one-way movement of medicament
from the interior of the nozzle to the exterior, thereby
substantially eliminating the possibility that medicament
which has been exposed to ambient air or the exterior of the
nozzle may be "sucked back" into the interior of the nozzle,
and, in turn, substantially eliminating the possibility of
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contamination of the medicament inside the dispenser.
In addition to the above-noted advantages, the
pump-type dispenser according to the present invention also
provides a mechanism by which aerosol-type discharges of
uniform dosage is achieved without any propellant gas such
as CFC. This is achieved by utilizing a combination of the
above-mentioned airless pump mechanism, a "one-way actuation
release mechanism", which facilitate loading and ejection of
a uniform dose of medicament with a single actuation motion,
and an aerosol-generating nozzle mechanism which achieves a
very low "head loss" for the fluid discharge.
According to one aspect of the present invention,
there is provided a pump mechanism for use in a medicament-
dispensing system having a vial for holding a volume of
medicament, a deformable body portion for providing spring
action to said pump mechanism, and a nozzle portion through
which said medicament is emitted, which comprises: a pump
sleeve positioned within said deformable body portion, said
sleeve having a dosage cavity of a predetermined volume for
collecting medicament from said vial, said dosage cavity
being connected to said nozzle portion, said sleeve also
having a fluid-inlet orifice for channeling said medicament
into said dosage cavity; and a piston at least partially and
slidably positioned within said pump sleeve for emitting
said medicament from said dosage cavity via said nozzle
portion, said piston being operationally coupled to said
deformable body portion; and at least one 0-shaped ring on
annular portion of said piston and slidably engaging said
pump sleeve, wherein said 0-shaped ring provides a fluid-
tight seal.
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Brief Description of the Drawings
Fig. 1 is a perspective view of an exemplary
embodiment of the pump-type dispenser for nasal medicaments
in accordance with the present invention.
Fig. 2 is a front-elevation view of a prior art
pump-type dispenser.
Fig. 3 is a perspective view of an embodiment of a
piston to be incorporated as a part of an embodiment of the
pump-type dispenser for nasal medicaments according to the
present invention.
Fig. 4 is a perspective view of an embodiment of a
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pump body to be incorporated as a part of an embodiment of
the pump-type dispenser for nasal medicaments according to
the present invention, which pump body is intended to cooperate
with the piston illustrated in Fig. 3.
Fig. 5 is a lateral cross-sectional view of the
piston shown in Fig. 3 fitted into the pump body shown in
Fig. 4.
Fig. 6 is a lateral cross-sectional view of an
embodiment of an envelope intended to cooperate with the
piston shown in Fig. 3 and the pump body shown in Fig. 4 to
form an embodiment of a phial-pump incorporated in the pump-
type dispenser for nasal medicaments according to the
present invention.
Fig. 7 is a cross-sectional view of an assembled
phial-pump incorporating the piston, the pump body and the
envelope shown in Figs. 3,4 and 6, respectively.
Figs. 8A-BE show a sequence of cross-sectional
views of the phial pump shown in Fig. 7, the sequence
illustrating the operation of the phial-pump.
Fig. 9 is a cross-sectional view along the length
of aerosol dispenser including one embodiment of"a nozzle
mechanism according to the present invention.
Fig. 10 is a cross-sectional view illustrating the
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flow path of liquid through the fluid communication path
between the liquid reservoir and the nozzle mechanism of the
aerosol dispenser shown in Fig. 9.
Fig. 11 is a cross-sectional view along line A-A
shown in Fig. 9.
Fig. 12A is an enlarged cross-sectional view
showing one stage of deformation of a valve in the nozzle
mechanism according to the present invention shown in Fig.
9.
Fig. 12B is an enlarged cross-sectional view
showing another stage of deformation of the valve in the
nozzle mechanism according to the present invention shown in
Fig. 9.
Fig. 13A is an enlarged cross-sectional view
showing one stage of deformation of a valve in the body
portion of the aerosol dispenser shown in Fig. 9.
Fig. 13B is an enlarged cross-sectional view
showing another stage of deformation of the valve in the
body portion of the aerosol dispenser shown in Fig. 9.
Fig. 14A is a cross-sectional view showing a
second embodiment of the nozzle mechanism according to the
present invention.
Fig. 14B is a cross-sectional view along line B-B
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shown in Fig. 14A.
Fig. 15 is a detailed cross-sectional side view of
a the dispensing system including the cartridge and the
vial-dispenser in accordance with the present invention,
which dispensing system is shown in a rest position.
Fig. 16 is a detailed cross-sectional side view of
the dispensing system including the cartridge and the vial-
dispenser in accordance with the present invention, which
dispensing system is shown in an intermediate position
during actuation of the trigger mechanism.
Fig. 17 is a detailed cross-sectional side view of
the dispensing system including the cartridge and the vial-
dispenser in accordance with the present invention, which
dispensing system is shown in a release position during
actuation of the trigger mechanism.
Fig. 18 is an exploded view of components of one
preferred embodiment of the mechanical closure system
incorporated in the dispensing system according to the
present invention.
Fig. 19 is an exploded cross-sectional view of
components of the preferred embodiment of the mechanical
closure system according to the present invention shown in
Fig. 18.
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Fig. 20 is a cross-sectional view of assembled
components of the preferred embodiment of the mechanical
closure system according to the present invention shown in
Fig. 18.
Fig. 21 is an exploded cross-sectional view of
components of another preferred embodiment of the mechanical
closure system according to the present invention.
Fig. 22 is a cross-sectional view of assembled
components of the preferred embodiment of the mechanical
closure system according to the present invention shown in
Fig. 21.
Fig. 23a is a perspective view of a neck of a
container of an exemplary embodiment of the mechanical
closure system according to the present invention.
Fig. 23b is a cut-away view of the neck of the
container of Fig. 23a taken along line A-A.
Fig. 24a is a perspective view of a mechanical
plug and crimping element in accordance with the exemplary
embodiment of the mechanical closure system according to the
present invention.
Fig. 24b is a cut-away view of the mechanical plug
and crimping element of Fig. 24a taken along line B-B.
Fig. 25 is a cross-sectional view showing an
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interaction of the container of Fig. 23a with the mechanical
plug of Fig. 24a in accordance with the present invention.
Fig. 26 is a cross-sectional view showing an
interaction of the container of Fig. 23a with the mechanical
plug and crimping element of Fig. 24a in accordance with the
present invention.
Fig. 27a shows a first step in an exemplary
process for filling and sealing the container of Fig. 23a
with the exemplary embodiment of the mechanical closure
system according to the present invention shown in Fig. 25.
Fig. 27b shows a second step in the exemplary
process for filling and sealing the container of Fig. 23a
with the exemplary embodiment of the mechanical closure
system according to the present invention shown in Fig. 25.
Fig. 27c shows a third step in the exemplary
process for filling and sealing the container of Fig. 23a
with the exemplary embodiment of the mechanical closure
system according to the present invention shown in Fig. 25.
Fig. 27d shows a fourth step in the exemplary
process for filling and sealing the container of Fig. 23a
with the exemplary embodiment of the mechanical closure
system according to the present invention shown in Fig. 25.
Fig. 27e shows a fifth step in the exemplary
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process for filling and sealing the container of Fig. 23a
with the exemplary embodiment of the mechanical closure
system according to the present invention shown in Fig. 25.
Fig. 28 is a perspective view illustrating the
difference in height between a portion of the swirling
channel and a converging fluid channel in an exemplary
embodiment of the nozzle mechanism according to the present
invention shown in Figs. 9 and 11.
Fig. 29a is a cross-sectional view taken along the
longitudinal axis of another exemplary embodiment of a phial
pump in accordance with the present invention.
Fig. 29b is a cross-sectional view of the rear
plug mechanism for sealing the vial portion of the phial
pump shown in Fig. 29a.
Fig. 30a is a cross-sectional view taken along the
longitudinal axis of yet another exemplary embodiment of a
phial pump in accordance with the present invention.
Fig. 30b is a cross-sectional view of the rear
plug mechanism for sealing the vial portion of the phial
pump shown in Fig. 30a.
Detailed Description of the Invention
As shown in Fig. 1, an exemplary embodiment of the
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pump-type dispenser system100 for dispensing nasal
medicaments in accordance with the present invention has an
exterior housing 101, an actuation trigger mechanism or
button 103 on one side of the housing 101, a screen lid 102
hinged to the top portion of the housing 101 by means of an
articulation hinge 105, and a nozzle housing portion 104.
The screen lid 102 serves three primary functions. First,
the lid serves as a guide for aligning the axis of the
nozzle housing portion 104 with the axis of the nasal
passage: by simply placing the interior surface of the lid
102 against the nasal ridge, the user is able to easily
center the nozzle housing portion 104 within the nasal
passage. Second, the lid 102 serves as a screen for hiding
the nasal area from the public view, thereby enabling the
user to apply the nasal medicament in a discrete manner.
Third, when the lid 102 is folded down, it serves as a cover
which isolates the nozzle housing portion 104 from the germs
and other pollutants which may surround the nozzle housing
portion 104. Furthermore, because the lid is not detachable
from the exterior housing, this arrangement eliminates the
possibility of misplacing the lid and risking contamination
of the nozzle housing portion. In this manner, the lid 102
provides an excellent hygienic protection for the nozzle
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housing portion 104.
In the exemplary embodiment shown in Fig. 1, the
actuation trigger button 103 is connected to a one-way
actuation mechanism within the housing 101, and the one-way
actuation mechanism is in turn connected to a pump
mechanism. The one-way actuation mechanism and the pump
mechanism are explained in further detail below. By
depressing the actuation trigger button 103 transverse to
the axis of the nozzle housing portion 104, the pump
mechanism is operated in such a manner that the pump
mechanism sequentially loads and dispenses a precalibrated
amount of nasal medicament, all within a single continuous
motion of the trigger mechanism. Because the one-way
actuation mechanism accomplishes loading and dispensation of
medicament in a single continuous motion of the trigger
mechanism, there is no possibility of locking the pump
mechanism in a compressed state, which would lead to
~creeping," or permanent deformation, of the pump mechanism.
Because the actuation trigger button 103 is operated
transverse to the axis of the nozzle housing portion 104,
there is substantially no risk of accidentally removing the
nozzle housing portion 104 from the nasal area during
operation of the pump-type dispenser 100 according to the
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present invention.
An exemplary pump mechanism which may be
incorporated in the pump-type dispenser system according to
the present invention is a three-piece phial-pump. The
exemplary phial-pump, which will be explained further in
connection with Figs. 3-6E, is designed to eliminate the
presence of air or the need for preservatives in the
retained formulation and still prevent the contamination of
this formulation. In addition, this type of exemplary
phial-pump should be able to benefit from almost zero
exposure to the air whilst the phial is being filled with
the formulation, thus ensuring the sterility of the content
without requiring preservatives.
As shown in Fig. 3, the exemplary phial-pump has a
piston which features: a large longitudinal plunger 1, at
the front end of which is a flange 2 designed to ensure the
seal of the cavity of the pump body when the piston
increases the pressure therein; and ship's-anchor-shaped
fins 3, of which there are three in this configuration.
Each of the fins 3 has a spoke 4 at the end of which is an
arc 5.
As shown in Fig. 4, the exemplary phial-pump has a
pump body made up of three main parts: the front part, or
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"nose" 6; the middle part, or "sleeve" 7; and the rear part,
or "body" 8 of the pump. Nose 6 may have a purely
cylindrical or truncated-cone configuration; here, it
comprises a small cylinder 9 at the tip followed by a
truncated-cone area 10, itself perforate by the evacuation
orifice 11 of the pump. Behind the truncated-cone part is
another cylindrical part 12 and, behind this cylindrical
part 12, an annular groove 13 serving to seal an elastic
envelope which will be described'in further detail below;
this annular groove separates the nose proper from a disc or
"frontal disc" 13a.
As shown in Fig. 4, sleeve 7 is a cylindrical
sleeve, inside of which is the pump cavity. The cylindrical
wall of sleeve 7 is perforated by longitudinal slots 14, in
each of which slides a corresponding piston spoke 4. Each
slot has two portions: a wider rear portion 14 for the
piston spokes 14 to slide along; and a narrower front
portion constituting the communication orifice between the
external liquid and the pump cavity, and forming an inlet
orifice 15. The height of this pump cavity determines the
level at which the piston will effect compression upon the
fluid, and the height therefore determines the volume of the
dose to be ejected.
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On the inner wall of this sleeve, in its frontmost
part following the pump nose, is stop 16 comprising an
annular undercut, shown in Fig. 5, which houses the annular
flange of the piston when the pump is in the at-rest or
closed position. This undercut 16 enables the front annular
flange 2 of the piston to exert a very slight compression
after initial assembly, so as to keep the rest of the pump
in perfect occlusion without causing the front flange of the
piston to creep whilst storing the pump prior to its use.
It is thus impossible for the air or liquid contained in the
evacuation orifice 11 of the nose, here an ejection channel,
to come into contact with the liquid contained in the rest
of the pump or phial.
Continuing with Fig. 4, the pump body 8 comprises
a cylindrical cavity in continuity with the sleeve, and of a
decidedly larger diameter, and will itself be housed in the
rear ring of the envelope in order to activate the pump. In
the front part of this element there are cutaway sections 17
enabling fins 3 to pass through so as to fit the piston into
the pump body. In the example illustrated here, the pump
body is movable whereas the piston will be held in a
stationary position.
As shown in Fig. 5, the piston of Fig. 3 is fitted
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inside the pump body of Fig. 4. In addition to the elements
described previously, the front stop 16 of the piston with
its undercut is shown.= Also shown is the inlet orifice 15,
and the position of the piston inside the body is such that
if the piston moves forward, it will block off, in a cavity
(or "pump duct") 18, the preset volume of fluid admitted
through orifice 15. Also shown is the spoke 4, installed in
a longitudinal slot in which it is adapted to slide. In
addition, on the rear side of the pump body, a cutaway
section 17 enables a fin to pass through. It can be seen
from above that the pump mechanism according to the present
invention has three annular parts 12, 5 and 8.
As shown in Fig. 6, the exemplary elastic envelope
has three rings: a front ring 19, a middle ring 20 and a
rear ring 21, amongst which are confined a front concertina
22 and a rear concertina 23. The front ring 19 cooperates
with the ring 13a of the pump body, the middle ring 20
cooperates with the incomplete ring formed by the arcs 5 on
the piston, and the rear ring 21 cooperates with the rear
ring 8 of the pump body. These rings of the elastic
envelope securely retain the rings of the other two pieces,
i.e., the pump body and the piston; in particular, the
assembly at the level of rings 13a and 19 is perfectly
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hermetic. Moreover, at the frontmost level of the envelope
is an elastic membrane 24 forming a one-way valve towards
the outlet which is defined by at least the elastic membrane
and the complementary parts of the small cylinder 9 of the
truncated-cone area 10.
It will also be seen from Fig. 6 that, in this
exemplary configuration, the envelope comprises two parts
which have been designed to enable the passage of hollow
needles in an alternative method of filling the phial-pump
with a fluid, liquid or gel, i.e., areas 25 and 26. These
parts have a greater thickness than that of the surrounding
areas, and filling needles penetrate these areas if the rear
vial or phial section of the phial-pump doesn't have a
filling opening and doesn't employ a mechanical closure
element. Moreover, these areas each comprise a small
cylinder capable for example of being heat-sealed under
pressure between two heated jaws. Such a cylindrical device
may be replaced for example by an extra thickness raised
towards the outside of the envelope, thus protruding onto
the outer wall, and onto which a heated piece may be applied
so as to melt this raised part in order totally to seal the
orifice having enabled the penetration of a needle. Lastly,
it will be noted that in Fig. 6, the rear part of the
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envelope serving solely as a receptacle has not been shown
here.
The above-described components of the exemplary
phial-pump is assembled as follows. First, the piston is
fitted into the pump body until the front annular flange
reaches the stop, and the partially assembled "pump" is thus
in the at-rest closed position. The partially assembled
"pump" is then fitted into the elastic envelope whilst jets
of compressed gas dilate the elastic envelope during
assembly enabling the latter with a minimum of friction.
As shown in Fig. 7, an alternative embodiment of
the phial-pump incorporates three pieces similar to the
above pieces, but with a few minor differences. The
embodiment of Fig. 7 incorporates the rings 13a, 5 and 8
respectively in the rings of the envelope numbered 19, 20
and 21. Also shown are the front 22 and rear 23 concertina
springs. As can be seen from comparing Figs. 5 and 7,
length L corresponds to the backward travel of the piston
inside the body enabling on the one hand the introduction of
fluid into duct 18 of the pump and on the other determining,
on the basis of the inside diameter of duct 18, the volume
of fluid to be expelled. Furthermore, as shown in Fig. 7,
fluid from a vial portion 77 is in communication (as
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indicated by the bidirectional arrow "F") with a bellows
chamber contained within the bellows portion 23.
Fig. 7 also shows the phial-pump fitted inside a
rigid shell 27. Also more clearly distinguishable is the
annular undercut. In the cases illustrated above, for
projecting each individual dose of an ophthalmic liquid, the
dimensions may be, for example, as follows: a) diameter of
the channel constituting the outlet orifice, and its length
- approximately 1.0 mm and 2.0 mm, respectively; b)
thickness of the Kraton'" envelope at the level of valve 24
is approximately 0.8mm, decreasing towards the fluid outlet
end; and c) thickness of the Kraton envelope at the level of
concertina 23 is lmm, and at concertina 22, 0.75mm. Lastly,
we can see that the rear part of the envelope, at the top of
Fig. 7, has been enclosed for example by sealing, so that
the pump body and piston are totally enveloped with the
exception of the front end of the pump body.
It should be noted that two different types of
phial-pump systems may be implemented in accordance with the
present invention: a) a relative arrangement of the housing
and the phial-pump vial which allows the rear part of the
vial to be movable; or b) a relative arrangement in which
the rear part of the phial-pump vial is fixed relative to
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the housing, and only the piston is movable. It should be
noted that a given phial-pump may be incorporated as a part
of either one of the above-described relative arrangements.
Illustrated in connection with Figs. 8A-8E are various steps
involved in"the operation of the first type of phial-pump
system described above. In this series of Figs. 8A-8E, the
phial-pump has been assembled as shown in Fig. 7, inside a
rigid shell. In the phial-pump described here, by using
this rigid shell, the pump body is movable whilst the piston
is held in a stationary position.
In Figs. 8A-8E, "F" represents the fluid with
which the elastic envelope has been filled. In the at-rest
position shown in Fig. 8A, the piston is held in a
stationary position by receptacle 27 of the pump, i.e., by a
different structure to the three elements of the actual
phial-pump. In the phial-pump system described here, the
piston rings are held secure by the compression of rear
concertina spring 23. In Fig. 8B, on activating the pump,
the pump body is thrust forwards by its rear part 8 and
transmits this thrust to the nose which is made integral
with it by means of the sleeve. The effect of this is to
create a cavity of drops in pump duct 18 in this space,
which remained virtual during the pump's at-rest period and
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which is then of a volume determined by the height of the
bottom lip of front groove 14 from sleeve 7, which places
this cavity of drops 18 in communication with the cavity
limited by the front concertina. This cavity of drops 18 is
limited at the front by pump stop 16, at the sides by the
front cylindrical par 18 of the sleeve not opened by the
lateral slots 14 and, a the rear, by the front part 2 of the
piston limited by front annular flange 2 of this piston.
Continuing with Fig. 8C, when the nose is pushed
sufficiently far forward so that front flange 2 of the
piston is then behind the front lips 15 of the front grooves
of sleeve 7, the depression in the cavity of drops 18 is
then made up for by the arrival of fluid F. The pump is then
said to be in the filled or open position. This filled
position may be locked by a ratchet system on receptacle 27
which itself will be unlocked if the user applies pressure
to a pawl. The pawl may form a part of the receptacle case
27 in which this pump is housed. The locking/unlocking
mechanism and operation will be explained in detail in a
separate section below. During activation, rear spring
concertina 23 is under compression and front concertina 22
is extended. Subsequently, as shown in Fig. 8D, during the
stage of ejecting the drops of fluid F, i.e. when the nose
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and body return to their initial at rest position, rear
spring concertina 23, initially compressed, extends and the
assembly resumes the at-rest position shown in Fig. 8E.
Illustrated in Fig. 29a is another exemplary
embodiment of a type of phial pump in which the piston
portion is movable and the rear part of the vial is fixed
relative to the housing. The operation of the pump 7000
shown in Fig. 29a is similar to that of the phial pump
illustrated in Figs. 3-7 and 8a-8e, but several mechanical
features distinguish the pump 7000. The pump 700 includes a
main piston 7001 which is slidably engaged within a sleeve
formed by a collet 7026 and longitudinally-extending
portions 7014 and 7016. The piston 7001 is coupled via a
radially-extending flange 7005 to an elastic envelope 7300
having a front concertina portion 7022, a rear bellows
portion 7023, a rear portion 7028, a front ring 7029, an
exterior nozzle portion 7006 and a front cone 7025. The
front concertina portion 7022 and the rear bellows portion
7023 provide spring action to the coupled piston 7001. The
rear portion 7028 of the elastic envelope 7300 securely
retains the collet 7026 and the rear segment 7016a of the
longitudinally-extending portion 7016, and in turn, rear
portion 7028 is securely retained within the front segment
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of a vial portion 7027, inside of which defines a fluid
reservoir 7077. The vial portion is made of a rigid
material which substantially eliminates ingress of air into
the fluid reservoir 7077.
Continuing with the exemplary embodiment of the
pump shown in Fig. 29a, a fluid-outlet valve 7024 is defined
by the interface of the exterior nozzle portion 7006 and a
rigid interior nozzle portion 7004 which is secured via a
radial protrusion 7030 to a complementary ring portion 7029
of the elastic envelope 7300. The exterior nozzle portion
7006 has a radial thickness that decreases along the
longitudinal axis from the base of the nozzle portion to the
tip. When the pump 7000 is at its ambient position, the
piston 7001 rests against a base segment 7007 of the rigid
interior nozzle portion 7004. During operation of the pump
7000, a cavity (or "pump duct") 7018 is defined between the
base segment 7007 and a front end of the piston 7001 when
the piston is initially withdrawn relative to the base
segment 7007. Furthermore, an outlet orifice 7011 provides
a fluid communication channel between the cavity 7018 and
the fluid-outlet valve 7024.
The longitudinally-extending sleeve portion 7014
shown in Fig. 29a has an elongated slot 7015 which serves as
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the inlet orifice to the cavity 7018 and which is
substantially similar to the slot 15 shown in Fig. 5.
Furthermore, two 0-shaped rings 7003a and 7003b are secured,
or molded, around the circumference of the piston 7001 as
shown in Fig. 29a, such that the 0-shaped rings provide a
fluid-tight seal between the piston 7001 and the surrounding
sleeve formed by the collet 7026 and longitudinally-
extending portions 7014 and 7016. The 0-shaped rings 7003a
and 7003b may be made of silicone, polyisoprene, KratonTM or
any rubber-like material. In addition, the base segment
7007 delimits the forward compressive movement of the piston
7001 and its front flange 7002 which ensures the seal of the
cavity 7018 during the compressive movement.
Operation of the pump 7000 may be substantially
similar to the operation illustrated in Figs. 8a-8e. From
the ambient position of the piston 7001 depicted in Fig.
29a, the relative movement of the piston away from the base
segment 7007 of the rigid interior nozzle portion 7004
creates a suction, or depression, within the cavity 7018
defined by the space between the base segment 7007 and the
front end of the piston 7001. The maximum relative movement
of the piston 7001 away from the base segment 7007 is
predefined. When the flange 7002 of the piston 7001 is
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positioned behind the slot 7015, a fluid communication
channel is established through the slot 7015, and the
depression in the cavity 7018 draws in the fluid to the
cavity from a surrounding cavity 7008 defined between the
front concertina portion 7022 and the front sleeve portion
7014. During this "filling" stage in which the pump piston
7001 is moved rearward relative to the base segment 7007,
the front concertina 7022 is extended and the rear bellows
portion 7023 is compressed.
During the fluid-ejection stage, the piston 7001
urged forward by the spring action of the front concertina
7022 and the rear bellows portion 7023. When the front
flange 7002 has moved forward of the elongated slot 70015,
the fluid in the cavity 7018 is compressed by the forward
movement of the piston 7001, and the compressed fluid is
channeled through the outlet orifice 7011 to the fluid-
outlet valve 7024. When sufficient fluid pressure exists at
the fluid-outlet valve 7024, the exterior nozzle portion
7006 is radially deformed and separated from the rigid
interior nozzle portion 7004 to pass the fluid. Because the
exterior nozzle portion 7006 has a radial thickness that
decreases along the longitudinal axis from the rear or the
base of the nozzle portion to the front or the tip, the
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front segment of the fluid-outlet valve 7024 is closed when
the base segment of the valve is initially opened, and as
the fluid passes through the valve 7024, the base segment of
the valve is closed by the time the front segment of the
valve 7024 is opened to emit the fluid. At the completion
of the fluid-ejection stage, the piston 7001, the front
concertina 7022 and the rear bellows 7023 return to the
ambient position shown in Fig. 29a.
In the above-described pump 7000, the two 0-shaped
rings 7003a and 7003b provide a fluid-tight seal between the
piston 7001 and the surrounding sleeve formed by the collet
7026 and longitudinally-extending portions 7014 and 7016,
thereby maintaining the bellows chamber 7023a free of fluid.
The absence of fluid in the bellows chamber substantially
eliminates the possibility of fluid hindering the elastic
deformation of the rear bellows portion 7023.
As previously noted above, the interior of the
vial portion 7027 defines the fluid reservoir 7077. The
interior of the vial portion 7027 also contains, however, an
inner pouch 7100 made.of an elastic material, e.g.,
KratonT". As shown in Fig. 29a, the inner pouch 7100 is
secured to the vial portion 7027 by means of a rear plug
7200, which will be described in further detail below. The
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interior 7078 of the inner pouch 7100 contains varying
volume of air, depending on the amount of liquid contained
in the fluid reservoir 7077. Fig. 29a depicts the fluid
reservoir 7077 containing an amount of fluid which is about
a third of the reservoir's maximum capacity. The elastic
inner pouch 7100 is collapsible, or expandable, such that
the exterior surface 7100a of the inner pouch conforms to
the liquid level in the fluid reservoir 7077, i.e., when the
vial portion 7027 is completely filled with fluid, the inner
pouch is substantially completely collapsed and the volume
of the interior 7078 is substantially zero.
As the liquid in the reservoir 7077 is gradually
depleted as the result of the pump operation, the pouch 7100
expands correspondingly, drawn by the suction pressure in
the reservoir 7077, thereby substantially eliminating the
residual air inside the reservoir 7077, which residual air
may adversely affect the operation of the pump. The volume
of air in the interior 7078 is in turn regulated via air
holes 7201 formed in the rear plug. In the above manner,
the inner pouch functions as an effective air-regulation
mechanism for the fluid reservoir 7077.*
As shown in detail in Fig. 29b, the rear of the
vial portion 7027 of the phial pump 7000 shown in Fig. 29a
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is sealed by means of the rear plug 7200. Furthermore, the
inner pouch 7100 is secured to the vial portion 7027 by the
rear plug 7200. As previously noted, the rear plug 7200 has
a plurality of air holes 7201 which regulate the volume of
air in the interior 7078 of the inner pouch 7100. A rear
portion 7103 of the inner pouch 7100 has an inverted U
shape, and the rear portion 7103 radially clasps the rear of
the vial portion 7207. A radial protrusion 7101 of the
inner pouch 7100 is seated in a complementary recess 70271
formed in the rear of the vial portion 7207. In addition,
the rear plug 7200, which also has an inverted U shape,
radially clasps the rear portion 7103 of the inner pouch
7100.
The rear plug 7200 has two notch portions 7201 and
7202 which protrude radially inward, and the notch portions
7201 and 7202 interact with a notch portion 7102 of the rear
portion 7103 of the inner pouch and a notch portion 70272 of
the rear of the vial portion 7207, respectively. When the
rear plug is being placed into the sealing position, one
interior surface of the rear plug compressively engages the
radial protrusion 7101 of the rear portion 7103 of the inner
pouch 7100, and the notch portions 7201 and 7202 of the rear
plug slide over the notch portions 7102 and 70272,
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respectively, to firmly engage the underside of the notch
portions 7102 and 70272. For this reason, the rear plug is
also referred to as a "sliding plug." In this manner, the
rear plug 7200 provides compression along both the radial
and vertical directions to the rear portion 7103 of the
inner pouch 7100 and the rear of the vial portion 7207 to
provide a tight seal of the rear of the vial portion 7207
along both the radial and vertical directions.
Illustrated in Fig. 30a is yet another exemplary
embodiment of a type of phial pump in which the piston
portion is movable and the rear part of the vial is fixed
relative to the housing. The pump 8000 illustrated in Fig.
30a is substantially similar to the pump illustrated in Fig.
29a, except for a couple of differences. First, the pump
8000 does not have an inner pouch 7100. Instead, the
elastic envelope portion 7300, which include the front
concertina portion 7022 and the rear bellows portion 7023,
extends into the rear to form a vial portion 7301. The vial
portion 7301 is substantially enclosed within a rigid
exterior housing 8027. Second, the rear plug 8200
incorporated in the exemplary embodiment of Fig. 30a is
simpler than the rear plug 7200 incorporated in the pump
7000 shown in Fig. 29a.
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As shown in further detail in Fig. 30b, the rear
plug 8200 cooperates with the rear segment 7301a of the vial
portion 7301 to provide a tight seal. The rear plug 8200
has an annular protrusion 8201 which is snap-fitted into a
complementary annular recess 7302 formed in the rear segment
7301a of the vial portion 7301, thereby providing a radial
seal along the annular recess 7302. The rear plug 8200 also
has an annular flange 8202 which rests against an annular
flange 7302 of the rear segment 7301a of the vial portion
7301. The annular protrusion 8201 and the annular flange
8202 act in concert to provide vertical compression of the
rear segment 7301a. In this manner, the rear plug 8200
provides a tight seal of the rear segment 7301a of the vial
portion 7301 along both the radial and vertical directions.
Turning to Figs. 9 and 11, shown in these figures
is a first exemplary embodiment of an aerosol tip or nozzle
mechanism 32 which may be incorporated in the nasal
dispenser system according to the present invention
indicated generally by numeral 31. The first exemplary
embodiment of the aerosol tip mechanism 32 includes a
flexible nozzle portion 310 having an outlet portion 3108
and fluid channels (or feed channels) 3104, a rigid shaft
3102 received within the flexible nozzle portion 310, and a
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rigid external housing 3101 surrounding the flexible nozzle
portion 310 and exposing the outlet portion 3108. The rigid
shaft 3102 interfaces the interior of the outlet portion
3108 to form a first normally-closed valve 3105, as well as
to define a swirling chamber or collecting chamber 3103 for
liquid which has been channeled from a liquid reservoir,
e.g., a vial container, prior to being discharged via a
pinhole formed at the end of the outlet portion 3108 of the
aerosol tip mechanism 32.
As shown in Figs. 9 and 11, for the first
exemplary embodiment of the aerosol tip mechanism, the fluid
channels (also referred to as "feed channels") 3104
initially extend longitudinally (vertically) along the walls
31021a, 31021b and 3102c, which walls circumferentially
surround the rigid shaft 3102, then the fluid channels
continue horizontally (radially) to deliver fluid into the
swirling chamber 3103. It should be noted that wall 31021c
is only shown in Fig. 11, and not shown in Fig. 9, for the
sake of clarity of illustration. The vertical portion of
the feed channels is designated as 3104a, and the horizontal
portion is designated as 3104b. The fluid channels 3104 are
described in further detail in later sections.
A brief description of the fluid mechanics
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involved in the fluid channels 3104 and the swirling chamber
3103 is helpful here. The swirling chamber 3103 is used to
create a spray pattern for the discharged medicament, and
several factors affect the physical characteristics of
discharged spray pattern. First, the length of the pinhole
formed at the end of the outlet portion 3108 is the main
parameter controlling the cone angle of the spray pattern,
i.e., the shorter the length of the pinhole at the end of
the outlet portion 3108, the wider the spray pattern.
Second, the.greater the pressure differential between the
outside and the inside of the pinhole opening at the end of
the outlet portion 3108, the greater the homogeneity of the
particles and the smaller the particle size. Third, the
smaller the diameter of the pinhole at the end of the outlet
portion 3108, the smaller the particle size in the spray.
In order to increase the homogeneity of the spray-
particle size and generally reduce the particle size, the
dispensing system according to the present invention
maximizes the relative pressure differential between the
outside and the inside of the pinhole opening at the end of
the outlet portion 3108 by means of minimizing the
resistance sources in the fluid path, also referred to as
"head loss" in fluid mechanics. In this regard, the length
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of the fluid channel 3104 incorporated in the present
invention is minimized, as well as the rate of reduction of
the fluid-channel width as the fluid channel approaches the
swirling chamber 3103, and the rate of change of the fluid-
channel angle relative to the swirling chamber, i.e., the
transition from the vertical portion 3104a to the horizontal
portion 3104b is made as gradually as possible without
unduly extending the overall length of the fluid channel
3104. Using the embodiment of the dispensing system
incorporating the fluid channels and the swirling chamber
shown in Figs. 9 and 11, the average particle size of the
discharged spray pattern was 40 pm.
As shown in Figs. 9 and 11, three separate
horizontal channel portions 3104b merge into the swirling
chamber 3103. In this configuration, additional reduction
in head loss can be achieved by creating a relative
difference in ramp slope a between the swirling chamber 3103
and the converging channel portions 3104b, as shown in Fig.
28, such that the liquid 2801 already swirling in the
swirling chamber 3103 is already halfway to the top of the
swirling chamber when this liquid merges with the liquid
2802 entering the swirling chamber 3103 from an adjacent
horizontal channel portion 3104b.
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A second exemplary embodiment of the aerosol tip
or nozzle mechanism 32 according to the present invention is
shown in Figs. 14A and 14B. The second exemplary embodiment
is substantially similar to the first exemplary embodiment,
with one exception. In contrast to the first exemplary
embodiment shown in Figs. 9 and 11, the second exemplary
embodiment of the aerosol tip or nozzle mechanism does not
include walls 31021a, 31021b and 31021c circumferentially
surrounding the rigid shaft 3102, and the feed channel 3104
solely consists of obliquely vertically oriented channel
extending along the interface of the exterior of the second
portion 3102a of the rigid shaft and the interior surface of
the flexible body portion 3107. Accordingly, in the second
embodiment, the obliquely vertically oriented feed channel
3104 is connected directly to the swirling chamber 3103.
As shown in Fig. 9, the first exemplary embodiment
of the aerosol tip or nozzle mechanism 32 according to the
present invention is coupled to a flexible body portion 3107
which has a substantially tubular shape and a wall thickness
which decreases from the bottom of the body portion toward
the flexible nozzle portion 310, along the elongated axis of
symmetry of the body portion. The rigid shaft 3102 received
within the flexible nozzle portion 310 extends down into the
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flexible body portion 3107 so that a second portion 3102a of
the rigid shaft interfaces the flexible body portion 3107 to
form a second normally-closed valve 3106.
Referring generally to Figs. 9 and 10, the fluid
communication path 3201 of liquid from the liquid reservoir
to the outlet portion 3108 successively traverses the first
normally-closed valve 3106 and the second normally-closed
valve 3105. A pump mechanism 3110 of the nasal dispenser
system generally indicated by reference numeral 31, acting
in concert with a pump-body portion 3111 of the dispenser
system, channels the liquid from the liquid reservoir along
the fluid communication path 3201 by application of
pressure. A segment of the pump-body portion 3111 defines a
portion of the first normally-closed valve 3106, which
prevents the outfiowing liquid from reversing direction and
flowing back towards the liquid reservoir. It should be
noted that the nozzle mechanism according to the present
invention is intended to be used in conjunction with a wide
variety of liquid dispensing systems, one example of which
was illustrated previously in connection with Figs. 3-8E.
It should be understood that the pump mechanism 3110 and the
pump-body portion 3111 of the dispenser system shown in
~
Figs. 9 and 10 are merely exemplary and generic
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representation of a wide variety of dispensing systems.
As shown in Figs. 9 and 10, the liquid from the
liquid reservoir is initially channeled along the fluid
communication path 3201 to the entrance point of the first
normally-closed valve 3106 which regulates the liquid flow
to the vertical portion 3104a of the feeding channel 3104
formed along the interface of the exterior of the second
portion 3102a of the rigid shaft and the interior surface of
the flexible body portion 3107. Once the pressure on the
liquid in the fluid communication path reaches a threshold
pressure sufficient to radially deform the flexible body
portion 3107, a portion 3501 of the flexible body portion
3107 forming a lower segment of the first normally-closed
valve 3106 is radially deformed by the liquid, thereby
opening the first normally-closed valve 3106, as shown in
Fig. 13A. As the liquid passes through the first normally-
closed valve 3106 toward the vertical portion 3104a of the
feeding channel 3104, sequential segments of the flexible
body portion 3107 forming the first normally-closed valve
3106 are radially deformed, as shown in Figs. 13A and 13B,
until the liquid finally traverses the upper-most segment
3502 of the flexible body portion 3107 forming the first
normally-closed valve 3106 and passes into the vertical
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portion 3104a of the feeding channel 3104.
As shown in Figs. 13A and 13B, because the wall
thickness of the flexible body portion 3107 decreases from
the lower segment 3501 to the upper segment 3502 of the
first normally-closed valve 3106, i.e., along the elongated
axis of symmetry S of the nozzle mechanism, the lower
segment 3501 of the valve 3106 is substantially closed by
the time the liquid has reached the upper segment 3502.
Fig. 13A illustrates the initial opening action of the
segment 3501, and Fig. 13B illustrates the subsequent
opening of the upper segment 3502. Because the energy
required to open the lower segment 3501 of the valve 3106 is
greater than the energy required to open the upper segment
3502, the liquid is naturally biased to maintain its forward
movement through the first valve 3106 in the flexible body
portion 3107 once the lower segment 3501 has been opened.
In this manner, the first normally-closed valve 3106 ensures
liquid movement only in the direction towards the vertical
portion 3104a of the feeding channel 3104.
Once the liquid in the fluid communication path
3201 has traversed the first normally-closed valve 3106, the
liquid then enters the vertical portion 3104a of the feed
channel 3104 extending along the interface of the exterior
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of the second portion 3102a of the rigid shaft and the
interior surface of the flexible body portion 3107 of the
first embodiment of the aerosol tip mechanism 32, as shown
in Figs. 9, 10 and 11. The feed channel 3104 defines the
portion of the fluid communication path 3201 between the
first normally-closed valve 3106 and the swirling chamber
3103, and the vertical portion 3104a of the feed channel is
connected to a horizontal, i.e., radial, portion 3104b of
the feed channel which in turn is connected tangentially to
the cylindrical swirling chamber 3103 within the flexible
nozzle portion 310, as shown in Figs. 11, 13A and 13B. The
tangential connection of the horizontal portion 3104b of the
feed channel 3104 to the cylindrical swirling chamber 3103
creates a swirling action of the liquid in the swirling
chamber 4ts indicated in Fig. 11 by the directional arrow
3301.
In the second embodiment of the aerosol tip
mechanism shown in Figs. 14A and 14B, the feed channel 3104
consists of only the obliquely vertical portion, designated
3104c, extending along the interface of the exterior of the
second portion 3102a of the rigid shaft and the interior
surface of the flexible body portion 3107. Accordingly, in
the second embodiment.of the aerosol tip mechanism, the
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liquid directly enters the swirling chamber 3103 via the
obliquely vertically oriented feed channel 3104c once the
liquid in the fluid communication path 3201 has traversed
the first normally-closed valve 3106. The swirling action
of the liquid, which is indicated by the directional arrow
3301 and is induced by the tangential (oblique) orientation
of the feed channel 3104c relative to the swirling chamber
3103, is maintained in the swirling chamber until the liquid
is discharged via the outlet portion 3108, the mechanics of
which discharging action is described in detail below.
Referring generally to Figs. 9, 12A and 12B, the
liquid in the swirling chamber is discharged via the outlet
portion 3108 when the liquid pressure reaches a threshold
pressure sufficient to radially deform the outlet portion
3108 forming the second normally-closed valve 3105. As with
the first normally-closed valve 3106 described above, the
liquid movement through the second normally-closed valve
3105 involves sequential deformation of segments of the
outlet portion 3108. As shown in Fig. 12A, a portion 3401
of the outlet portion 3108 forming a lower segment of the
second normally-closed valve 3105 is radially deformed by
the liquid, thereby opening the second normally-closed valve
3105. As the liquid passes through the second normally-
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closed valve 3105 toward the tip of the outlet portion 3108,
sequential segments of the outlet portion 3108 forming the
second normally-closed valve 3105 are radially deformed, as
shown in Figs. 12A and 12B, until the liquid finally passes
through the upper-most segment 3402 of the outlet portion
3108 forming the second normally-closed valve 3105.
As shown in Figs. 9, 12A and 12B, the wall
thickness of the outlet portion 3108 decreases from the
lower segment 3401 towards the upper segment 3402 of the
second normally-closed valve 3105, i.e., along the elongated
axis of symmetry S of the aerosol tip or-nozzle mechanism.
Due to this steady decrease in wall thickness, the lower
segment 3401 of the valve 3105 is substantially closed by
the time the liquid has reached the upper segment 3402, as
shown in Figs. 12A and 12B. Because the energy required to
open the lower segment 3401 of the valve 3105 is greater
than the energy required to open the upper segment 3402, the
liquid is naturally biased to maintain its forward movement
through the second valve 3105 in the outlet portion 3108
once the lower segment 3401 has been opened. Accordingly,
the valve 3105 ensures liquid movement only in the direction
towards the exterior tip of the nozzle portion 310.
During the discharge of liquid through the outlet
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portion 3108, the only segnient of the flexible nozzle
portion 310 which experiences deformation along the
elongated axis of symmetry S of the aerosol tip or nozzle
mechanism is the outlet portion 3108. The remaining
segments of the flexible nozzle portion are prevented by the
rigid housing 3101 from deformation along the elongated axis
of symmetry S. Even the outlet portion 3108 experiences
only minimal deformation along the axis S; the significant
deformation is along the radial direction. Furthermore, the
outlet portion 3108 does not exert a force along the axis S
on the rigid shaft 3102, i.e., the outlet portion 3108 does
not rub the rigid shaft during opening or closing of the
second valve 3105. Accordingly, because of the absence of
any rubbing contact between the outlet portion 3108 and the
rigid shaft 3102, the chances of contaminants entering the
swirling chamber 3103 are minimized.
One advantage of the aerosol tip or nozzle
mechanism according to the present invention is the above-
described prevention of axial deformation of the flexible
nozzle portion 310 by the rigid housing 3101. Because the
flexible nozzle portion 310, with the exception of the
outlet portion 3108, experiences substantially no
deformation along the elongated axis of symmetry S shown in
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Fig. 12A, the physical profile of the fluid channel 3104,
which induces swirling action of the liquid channeled into
the swirling chamber 3103, is maintained during liquid
discharge. An axial deformation of the flexible nozzle
portion 310 along the direction of liquid discharge would
deform the fluid channel 3104, which in turn would prevent
the swirling action from occurring.
In the above-described embodiment of the aerosol
tip or nozzle mechanism according to the present invention,
the flexible nozzle portion 310, the flexible body portion
3107 and the pump-body portion 3111 may be made of any one
of several materials well known in the art, including
butadiene polyethylene styrene (KRATONT"), polyethylene,
polyurethane or other plastic materials, thermoplastic
elastomers or other elastic materials. KRATONTM is
particularly well suited for this purpose because of its
characteristic resistance to permanent deformation, or
"creep," which typically occurs with passage of time.
Another advantage of the aerosol tip or nozzle
mechanism according to the present invention is that the
number of parts which constitute the nozzle mechanism and,
in turn, the nasal dispenser system which includes a pump
mechanism in combination with the nozzle mechanism, is
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significantly reduced in comparison to conventional nozzle
mechanisms. As can be seen from Fig. 9, a nasal dispenser
system incorporating the nozzle mechanism according to the
present invention can be made using only three discrete
parts: the rigid housing 3101; an integral, flexible piece
encompassing the flexible nozzle portion 310, the flexible
body portion 3107 and the pump-body portion 3111; and the
rigid shaft 3102 formed integrally with the pump mechanism
3110. Because only three discrete parts are required, the
cost and complexity of manufacturing the nasal dispenser
system is significantly reduced.
Yet another advantage of the aerosol tip or nozzle
mechanism according to the present invention is that the
second normally-closed, one-way valve 3105 with its
decreasing wall thickness of the outlet portion 3108
substantially eliminates the possibility that liquid in the
nozzle mechanism will come in contact with ambient air and
subsequently return to the interior portion of the nozzle
mechanism, i.e., that the liquid will be "sucked back." Due
to the decreasing wall thickness of the outlet portion 3108,
the liquid is naturally biased to maintain its forward
movement through the second valve 3105 in the outlet portion
3108 once the thicker base portion of the valve has been
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opened. Accordingly, the outlet portion 3108 has a
substantially zero "dead volume," i.e., a space in which
liquid that has been previously exposed to ambient air can
remain.
Still another advantage of the aerosol tip or
nozzle mechanism according to the present invention is that
the outlet portion 3108 does not rub the rigid shaft 3102
during opening or closing of the second valve 3105.
Accordingly, because of the absence of any rubbing contact
1o between the outlet portion 3108 and the rigid shaft 3102,
the chances of contaminants entering the swirling chamber
3103 are minimized.
Still another advantage of the aerosol tip or
nozzle mechanism according to the present invention is the
presence of multiple valves along the fluid communication
path leading to the outlet portion 3108. In addition to the
second normally-closed valve, the first normally-closed
valve positioned along the fluid communication path between
the liquid reservoir and the outlet adds further assurances
that liquid in the liquid reservoir will not be contaminated
by liquid that may have been accidentally exposed to ambient
air and subsequently reintroduced into the nozzle mechanism.
Because the first and second normally-closed valves are
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positioned along the fluid communication path to open
sequentially, and hence asynchronously, during fluid
communication leading to discharge through the outlet,
failure of either one of the valves will not affect the
integrity of the nozzle mechanism to prevent contamination
of the liquid in the liquid reservoir.
The medicament-dispensing system according to the
present invention also incorporates a one-way actuation
release mechanism, shown in Figs. 15-17, in connection with
the housing 101, shown in Fig. 1, which is adapted to house
and work in conjunction with the accordion-like or piston-
like vial-dispenser 4200, also shown in Figs. 15-17. It
should be understood that the vial-dispenser 4200 depicted
in Figs. 15-17 is a generalized representation of a system
combining the pump system shown in Figs. 3-8 and the nozzle
mechanism shown in Figs. 9-14, and the description of the
components shown in Figs. 15-17 will also be a generalized
description of the corresponding components shown in Figs.
3-14. Although the present invention is described in
conjunction with the vial-dispenser generally depicted in
Figs. 15-17 and specifically depicted in Figs. 3-14, the
present invention is not limited to this particular type of
dispenser, i.e., the pump system and the nozzle mechanism
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may be different from the ones described herein.
As shown in Fig. 15, the vial-dispenser generally
depicted at 4200 includes a nozzle 42, a front ring 43, a
front bellows portion 44, a rear ring 46, a rear bellows
portion 47 and a rear vial section or liquid storage chamber
48 containing a storage supply of liquid medicament. The
vial-dispenser 4200 is compressible in the longitudinal
direction along the bellows. For this purpose, the front
and rear bellows portions 44 and 47, respectively, are
constructed of a soft flexible plastic material such as
Kraton . Resiliency of the dispenser is provided by the
spring action of the front and rear bellows made of Kraton ,
which has an excellent memory and serves as an excellent
spring. It should be noted that the rear bellows portion 47
shown in Fig. 15 has a dome shape, and this dome shape may
be incorporated into the front bellows portion 44.
Similarly, the shape of the front bellows portion 44 shown
in Fig. 15 may be incorporated into the rear bellows portion
47.
As shown in Fig. 16, the vial-dispenser 4200
further includes a drop cavity, or dosage cavity, 431
therein which holds, when the dispensing system is
activated, a predetermined volume of fluid to be emitted
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through the nozzle 42. In addition, a pump piston 49 within
the vial-dispenser is anchored to the rear ring 46 such that
the piston 49 moves in unison with the rear ring 46.
Furthermore, as shown in Figs. 15 and 16, conduit channels
410, which connect the rear vial section 48 to the front
bellows portion 44, and circumferential channels 411 within
the front bellows portion 44, are provided to serve as
conduits for supplying medicament to the drop cavity 431
upon actuation of the dispensing system. As will be
described in further detail below, a single actuation motion
of the trigger mechanism of the dispensing system
sequentially accomplishes filling, or loading, of the drop
cavity with medicament from the rear vial section 48, and
subsequent discharge of the medicament from the drop cavity
via the nozzle 42.
As illustrated in Fig. 15, which represents a
cross sectional view taken along the longitudinal axis of
the dispensing system shown in Fig. 1, contained within the
housing exterior housing 101 (not shown) is a cartridge 4101
of the dispensing system that includes an anterior wall 4104
which has an aperture 4106 for the discharge of medicament
from the nozzle 42, a posterior wall 4105, wedge-shaped arms
4103 which extend internally from the posterior wall 4105, a
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trigger 1103 and an internal notched lever 4102 which acts
in concert with the trigger 1103. It should be noted that
although this particular embodiment is illustrated as having
a separate external housing 101 and an internal cartridge
4101, some or all components of the external.housing and the
internal cartridge may be combined, e.g., the trigger button
103 of the external housing 101 shown in Fig. 1 may be the
same component as the internal trigger 1103 shown in Fig.
15.
As shown in Fig. 15, the vial-dispenser 4200 is
positioned within the cartridge 4101 such that in resting
position the front ring 43 rests against the anterior wall
4104, the rear vial section 48 rests against the posterior
wall 4105, and the notched lever 4102 engages the rear ring
46. Preferably, the cartridge 4101 is dimensioned such that
the dispenser 4200 can fit snugly within the cartridge, with
the nozzle 42 completely receded within the aperture 4106 of
the anterior wall 4104, thereby preventing accidental
contact of the nozzle 42 with the eye, as well as preventing
contamination of the outside of the nozzle. In addition,
the posterior wall 4105 may form, in conjunction with the
wedge-shaped arms 4103, a rear chamber for accommodating the
rear vial section 48.
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From the rest position illustrated in Fig. 15, the
dispensing system according to the present invention is
actuated by depressing the trigger 1103. In concert with
the depression of trigger 1103, the notched lever 4102 moves
laterally towards the posterior wall 4105 while engaged to
the rear ring 46, thereby extending the front bellows
portion 44 and compressing the rear bellows portion 47 along
the longitudinal axis of the vial-dispenser 4200, as shown
in Fig. 16. As can be seen from Figs. 15 and 16, when the
front bellows portion is extended by the notched lever 4102
which is engaged to the rear ring 46, the internal pump
piston 49 is also moved laterally towards the posterior wall
4105. The combined movement of the front bellows 44, the
pump piston 49 and the rear bellows 47 causes drop in
pressure in the drop cavity 431, and the drop cavity is
filled, or "loaded," with medicament channeled from the rear
vial section 48 via the conduit channels 410 and
circumferential channels 411.
Continuing with the actuation sequence, further
depression of the trigger 1103 causes the notched lever 4102
to eventually reach a position where the notched lever comes
in contact with the wedge-shaped arm 4103. At this point,
the wedge-shaped arm engages the notched lever 4102 and
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lifts the notched lever clear of the rear ring 46, as shown
in Fig. 17. Upon release from the notched lever 4102, the
spring action of the front bellows portion 44 and the rear
bellows portion 47 causes the rear ring 46 and the pump
piston 49 to move towards the anterior wall 4104, as shown
in Fig. 17. The movement of the pump piston 49 creates
pressure which forces the medicament to be discharged from
the drop cavity 431 via the nozzle 42. Subsequently, when
the trigger 1103 is released, the notched lever 4102 is
disengaged from the wedge-shaped arm 4103, and the spring
action of the notched lever 4102 allows the notched lever to
snap back into the resting position shown in Fig. 15.
As can be seen from the above description, one
advantage of the dispensing system according to the present
invention is that there is virtually no possibility of the
front and rear bellows portions exhibiting hysteresis of
spring characteristics since the front and rear bellows
portions are never "locked" in a deformed state for an
extended period of time. Accordingly, the dispensing system
according to the present invention ensures that the
discharged dosages do not substantially deviate from the
calibrated dosage. The consistency of the dispensed dosages
is also ensured by the fact that the actuation spring force
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is independent of the force applied to the actuation
mechanism by the user.
Another advantage of the dispensing system
according to the present invention is that the actuation
motion of the trigger 1103 is perpendicular to the
longitudinal axis of the dispensing system. Accordingly,
there is little danger of accidental poking of the nasal
passage with the nozzle 42 since the motion to depress the
trigger is not in the direction of the nasal passage.
Yet another advantage of the dispensing system
according to the present invention is that a single
actuation motion of the trigger 1103 perpendicular to the
longitudinal axis of the dispensing system enables the user
to both load the drop cavity and subsequently discharge the
Is precalibrated amount of inedicament. The dispensing system
according to the present invention is particularly useful
for arthritic patients and young children because the
trigger mechanism is a lever which allows for very easy
actuation and release of a medicament drop, thereby enabling
more accurate delivery of the medicament drop to the nasal
passage.
In order to facilitate fast, efficient and aseptic
filling, the nasal dispenser system according to the present
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invention may incorporate a mechanical closure system for
the liquid container portion of the system, e.g., the rear
vial section generally indicated by reference numeral 48 in
Fig. 15. As shown in Fig. 18, which is an exploded view of
a first exemplary embodiment of a mechanical closure system
according to the present invention, the first embodiment
includes a mechanical lid or plug 5101 and a rigid annular
ring 5102, both of which interact with a neck region 5103d
near an opening 5103b of a pouch or container 5103 to
tightly seal the opening 5103b. The pouch or container 5103
may be made of any one of several materials well known in
the art, including butadiene polyethylene styrene
(KRATONT"), polyethylene, polyurethane or other plastic
materials, thermoplastic elastomers or other elastic
materials. As shown in Fig. 18, the container 5103, which
has a nozzle 5103a, is a generalized representation of a
medicament dispensing system with a nozzle, for example, the
vial dispenser 4200 shown in Fig. 15. However, it should be
noted that the neck region 5103d near the opening 5103b of
the nozzle 5103 is a more detailed, exemplary depiction of
the corresponding portion of the rear vial section 48 shown
in Fig. 15, i.e., the end portion facing the wall 4105,
which end portion is shown without a mechanical closure
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element.
As shown in Fig. 18, which is an exploded cross-
sectional view of the first embodiment of the mechanical
closure system according to the present invention, the
contour of the rigid ring 5102 is complementary to the
inside contour 5103c of the neck region 5103d of the
container 5103 near the opening 5103b, thereby allowing the
rigid ring 5102 to be snapped into the inside contour 5103c
of the neck region 5103d. Similarly, as shown in Figs. 18
and 19, radial edge 5101a of the mechanical plug 5101 is
formed as a U-shaped region which extends around the plug
and complements the exterior contour of the combination of
the rigid ring 5102 and the neck region 5103d. After the
rigid ring 5102 has been snapped into the inside contour
5103c of the neck region 5103d, the mechanical plug 5101 is
subsequently snapped into place around the container opening
5103b such that the U-shaped region 5101a tightly engages
the neck region 5103d of the pouch 5103 and the interior
surface of the rigid ring 5102.
As shown in Fig. 19, the U-shaped region 5101a of
the mechanical plug 5101 has protrusions 51013, 51014 and
51015, and at least one recess 51016. Similarly, the
exterior surface of the neck region 5103d of the mechanical
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plug has protrusions 51031 and 51033, and the interior
surface of the neck region has a protrusion 51035. In
addition, the rigid ring 5102 has recesses 51021 and 51022
at the vertical interior surface 5102a and the bottom
surface, respectively. The recess 51022 of the rigid ring
5102 accommodates the protrusion 51035 of the neck region
5103d, thereby securely engaging the rigid ring to the neck
region of the container 5103 once the rigid ring has been
snapped into place. The protrusions 51013, 51014 and 51015,
as well as a portion 51018, of the U-shaped region 5101a of
the mechanical plug engage the recess 51021 of the rigid
ring and portions 51034, 51036 and 51037 of the exterior
surface of the neck region 5103d, respectively. In
addition, the protrusions 51031 and 51033 of the exterior
surface of the neck region 5103d engage a portion 51017 and
the recess 51016 of the U-shaped region 5101a of the
mechanical plug.
In addition to the above-described combinations of
interlocking protrusions and recesses, attached to the lower
surface of the mechanical plug 5101 are at least two legs
51011 which extend perpendicularly to the lower surface of
the mechanical plug, as shown in Fig. 19. Each of the legs
51011 has a hook-shaped end portion 51012 adapted to engage
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a recess region 51032 at the bottom interior of the
assembled combination of the rigid ring 5102 and the neck
region 5103d of the mechanical plug. The legs 51011 are
flexible enough such that, during assembly of the mechanical
closure system according to the present invention, the legs
51011 slide down the vertical interior surface 5102a of the
rigid ring and snap into place at the recess region 51032,
against a portion 51038 of the neck region 5103d of the
container.
The combination of the U-shaped region 5101a and
the legs 51011 of the mechanical plug 5101 facilitates both
vertical and radial compression of the neck region 5103d of
the container and the rigid ring against the mechanical
plug. For example, as shown in Fig. 19, the portion 51=12
of the legs 1011 interact with the portion 51023 of the
rigid ring and the portion 51038 of the neck region 5103d of
the container, and portions 51014 and 51018 of the
mechanical plug interact with portions 51034 and 51037 of
the neck region 5103d of the container, respectively, to
vertically compress the neck region between the mechanical
plug 5101 and the rigid ring 5102. Similarly, the portions
51013, 51015 and 51017 of the U-shaped region 5101a of the
mechanical plug 5101 interact with the portions 51021, 51036
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and 51031, respectively, to radially compress the neck
region 5103d between the mechanical plug and the rigid ring
5102. In this manner, a substantially hermetic seal of the
container opening 5103b is achieved, as shown in Fig. 20.
As can be understood from the above description
and Figs. 19 and 20, the first embodiment of the mechanical
closure system according to the present invention achieves
two types of mechanical seals. First, a seal extending
along the horizontal direction of the neck region, e.g., the
area extending between the portions 51034 and 51037, as well
as the interface of the regions 51022 and 51035, is achieved
by the vertical compression of the neck region 5103d by the
mechanical plug against the rigid ring 5102. Second, a seal
extending along the vertical direction, e.g., the area
extending between the portions 51036 and 51034, as well as
the interface of the regions 51021 and 51013, is achieved by =
the horizontal compression of the neck region 5103d by the
mechanical plug against the rigid ring 5102.
Once the mechanical plug has been snapped into the
container opening, the resulting compression of the
container material tends to cause displacement, or "creep,"
of the compressed material towards areas of lesser
compression. The protrusions force the container material
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displaced by compression to be confined within a restricted
area, thereby ensuring the tightness of the seal for a
prolonged period of time. For example, the protrusions
51014 and 51015 of the mechanical plug 5101 delimits the
protrusion 51031 on the exterior surface of the neck region
5103d of the container. Accordingly, when the material of
the protrusion 51031 is initially compressed by the portions
51015 and 51017, the displaced material of the protrusion
51031 is forced towards the protrusion 51014, which limits
any further movement of the displaced material, thereby
maintaining a tight seal. In effect, the relative
arrangement of protrusions 51014, 51015 and 51031
constructively guides the creeping phenomenon for sealing
enhancement.
As shown in Figs. 19 and 20, the central portion
of a lower surface 51019 of the mechanical plug 5101 is
preferably equipped with an extension or a plunger 51017
which is adapted to extend into the liquid content of the
container before the mechanical plug 5101 has been snapped
into place around the container opening 5103b. The inserted
plunger 51017 forces the liquid level to rise, hence
allowing air or gas bubbles to rise along with the liquid
level and escape through the container opening 5103b which
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is not yet sealed by the mechanical plug 5101. In this
manner, the plunger 51017 substantially reduces the residual
air bubbles which may otherwise remain between the surface
of the liquid and the lower surface of the mechanical plug.
The configuration and dimensions of the mechanical plug
5101, the neck region 5103d and the rigid ring 5102 are such
that the U-shaped region 5101a and the legs 51011 of the
mechanical plug interact with the neck region 5103d and the
rigid ring 5102 to form a tight seal only after the plunger
51017 has forced the liquid level to rise to approximately
the upper edge of the neck region 5103d, thereby obviating
the need for a vacuum condition normally utilized for an
air-less filling process.
The lower surface 51019 of the mechanical plug
5101 is sloped in order to ensure that the air or gas
bubbles which have been forced up to the surface level of
the liquid by the insertion of the plunger 51017 are not
trapped between the liquid level and the lower surface of
the mechanical plug. The sloped surface 51019 facilitates
radially upward movement of the air bubbles which eventually
escape through the opening 5103b of the container, via the
area between the two legs 51011.
As shown in Fig. 21, which is an exploded cross-
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sectional view of a second exemplary embodiment of a
mechanical closure system according to the present
invention, the second embodiment of the present invention is
substantially similar to the first embodiment and includes a
mechanical plug or plug 5401 and a rigid annular ring 5402,
both of which interact with a neck region 5403d of a pouch
or container 5403. As in the first embodiment described in
conjunction with Figs. 18-20, the contour of the rigid ring
5402 is complementary to the inside contour of the neck
region 5403d of the container 5403, thereby allowing the
rigid ring 5402 to be snapped into the inside contour of the
neck region 5403d. In addition, radial edge 5401a of the
mechanical plug 5401 is formed as an arch-shaped region
which extends around the plug and complements the exterior
contour of the combination of the rigid ring 5402 and the
neck region 5403d. After the rigid ring 5402 has been
snapped into the inside contour of the neck region 5403d,
the mechanical plug 5401 is subsequently snapped into place
around the container opening 5403b defined by the neck
region 5403d such that the arch-shaped region 5401a tightly
engages the neck region 5403d of the pouch 5403 and the
rigid ring 5402, as shown in Fig. 22.
As with the first embodiment of the mechanical
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closure system, the lower surface 54019 of the mechanical
plug 5401 of the second embodiment is sloped, or tapered, in
order to ensure that the air or gas bubbles which have been
forced up to the surface level of the liquid by the
insertion of the plunger 54017 are directed radially upward
and eventually escape through the opening 5403b of the
container, via the area between the two legs 54011.
In addition, similar to the first embodiment of
the mechanical closure system, the second embodiment shown
in Figs. 21 and 22 preferably have at least two legs 54011
attached to the lower surface of the mechanical plug 5401,
each of the legs having a hook-shaped region 54012 at the
end. The hook-shaped region 54012 is adapted to engage a
region 54023 at the bottom surface of the rigid annular ring
5402. In addition, attached to the central lower surface of
the mechanical plug 55401 is an extension or a plunger 54017
which is adapted to extend into the liquid content of the
container before the mechanical plug 5401 is snapped into
place around the container opening 5403b, thereby
substantially reducing the residual air bubbles which may
otherwise remain between the surface of the liquid and the
lower surface of the mechanical plug.
The second embodiment of the mechanical closure
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system according to the present invention utilizes fewer
protrusions on the surfaces of the mechanical plug 5401 and
the neck region 5403d than the number of protrusions found
on the corresponding parts of the first embodiment.
However, the unique arrangement of the interacting
components, i.e., the mechanical plug 5401, the rigid ring
5402 and the neck region 5403d, ensures a substantially
hermetic seal of the pouch 5403. As shown in Figs. 21 and
22, a protrusion 54015 and a region 54017 of the mechanical
plug interact with a region 54031 of the neck region 5403d,
which region 54031 includes a protrusion from the regular
contour of the exterior surface of the neck region 5403d,
and a portion 54016 of the mechanical plug interacts with
the region 54022 of the rigid ring 5402, thereby achieving
radial compression of the rigid ring 5402 and the neck
region 5403d. In addition, portions 54016 and 54012 of the
mechanical plug interact with regions 54022 and 54023 of the
rigid ring 5402 to vertically compress the neck region 5403d
and the rigid ring 5402.
- In order to ensure that the displacement or creep
of the container material around the points of compression
does not result in reduced tightness of the seal, the second
embodiment of the mechanical closure system provides the
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protrusion 54015 at the radial edge of the mechanical plug
5401. As shown in Figs. 21 and 22, the protrusion 54015
forces the container material of region 54031 displaced by
compression to be channeled upwards, towards a space 54018
delimited by the annular rigid ring 5402. Accordingly, the
protrusion 54015 and the rigid ring 5402 confine the
displaced material of the region 54031 of the container
5403, thereby maintaining a tight seal for a prolonged
period of time.
As an alternative means of facilitating an
efficient and aseptic filling and closure of the phial-type
pump mechanism incorporated in the nasal dispenser system
according to the present invention, a"self -crimping"
mechanical closure system may be utilized. Fig. 23a shows a
perspective view of a neck 6102 of a container or pouch 6100
adapted for use in connection with an exemplary embodiment
of the self-crimping mechanical closure system. The
container 6100 is another generalized depiction of the rear
vial section 48 shown in Fig. 15, and the neck 6102 is a
more detailed, exemplary depiction of the corresponding
portion of the rear vial section 48, i.e., the end portion
facing the wall 4105, which end portion is shown without a
mechanical closure element.
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As shown in the cut-away view of the container
6100 illustrated in Fig. 23b, the neck 6102 includes an
inner face 6106 and an outer face 6108. A substantially
semicircular first recess or groove 6110 is provided on the
inner face 6106 of the neck 6102 near an opening 6104 of the
container 6100. The first groove 6110 may extend
substantially around the entire circumference of the inner
face 6106 of the neck 6102.
A first protrusion 6112 is provided on the outer
face 6108 of the neck 6102, and extends substantially around
the entire circumference of the outer face 6108. The first
protrusion 6112 includes a substantially semicircular upper
portion 6112a and a substantially angular lower portion
6112b. The upper portion 6112a of the first protrusion 6112
may be substantially vertically aligned__.with the
substantially semicircular first groove 6110 located on the
inner face 6106 of the neck 6102 so that, in a cross-
sectional view as shown in Fig. 23b, a substantially
semicircular shell is formed by the first groove 6110 and
the upper portion 6112a of the first protrusion 6112.
An annular rim 6114 may be provided on top of the
substantially semicircular shell formed by the first groove
6110 and the first protrusion 6112. The annular rim 6114 is
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outwardly offset in relation to the neck 6102 of the
container 6100, and the annular rim 6114 defines the opening
of the container 6100.
Fig. 24a shows a further perspective view of the
exemplary embodiment of the self-crimping mechanical closure
system according to the present invention, which includes a
rigid mechanical plug 6200 and a rigid crimping element
6300. As shown in the cut-away view of Fig. 24b, the
mechanical plug 6200 is coupled to the crimping element 300
via a breakaway flange 6400. The mechanical plug 6200
includes a floor 6202, and a plug wall 6204 that extends
normal to and surrounds the entire circumference of the
floor 6202.
Since the mechanical plug 6200 is detachably
coupled to the crimping element 6300 via the breakaway
flange 6400, the mechanical plug 6200 and crimping element
6300 may be manufactured as a single-piece element. This
simplifies the handling process, and the sealing process
since the mechanical plug 6200 and the crimping element 6300
may be handled together. The breakaway flange 6400 may be
designed or constructed of a certain material to allow for
the removal and reinsertion of the mechanical plug
6200/crimping element 6300 combination from the neck 6102 of
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the container, and only breaking upon an application of a
predetermined amount of force. Although this exemplary
embodiment includes the mechanical plug 6200 and the
crimping element detachably coupled together via the
breakaway flange 6400, those skilled in the art will
understand that other coupling mechanisms, e.g., a hinged
flange, may also be implemented without departing from the
scope of the present invention.
The floor 6202 of the mechanical plug 6200 has a
substantially flat top surface 6202a and a bottom surface
6202b that is tapered from a radial outer edge 6202c towards
a center portion 6202d of the floor 6202, so that the
vertical thickness of the floor 6202 increases from the
radial outer edge 6202c to the center portion 6202d. As the
mechanical plug 6200 is inserted in the container 6100, the
tapered shape of the bottom surface 6202b allows for any
liquid content in the container to be directed towards the
radial outer edge 6202c of the floor 6202. A plunger 6500
may also be provided at the center portion 6202d of the
bottom surface 6202b of the floor 6202, extending
substantially perpendicular to the floor 6202. This plunger
6500 would allow for further displacement of the liquid
content towards the radial outer edge 6202c of the floor
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6202.
As discussed above, the plug wall 6204 surrounds
the circumference of the floor 6202. A substantially
semicircular second protrusion 6212 is formed in an exterior
surface 6210a of a lower portion 6210 of the plug wall 6204.
The second protrusion 6212 may extend substantially
completely around the entire circumference of the exterior
surface 6210a.
As shown in Fig. 24b, an interior surface 6210b of
the lower portion 6210 of the plug wall 6204 may be
initially perpendicular to the top surface 6202a of the
floor 6202, and then curve away from a radial center 6250 of
the floor 6202 to adjoin an interior surface 6220b of an
upper portion 6220 of the plug wall 6204. The upper portion
6220 of the plug wall 6204 is substantially parallel to but
offset radially outward from the interior surface 6210b of
the lower portion 6210 of the plug wall.
Continuing with Fig. 24b, a cross-sectionally
substantially triangular overhanging shoulder 6230 may
extend from the top of the exterior surface 6220a of the
plug wall 6204. A breakaway flange 6400 may be provided on
the overhanging shoulder 6230 to detachably couple the
mechanical plug 6200 to the crimping element 6300.
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The crimping element 6300 includes a compressing
ring 6302 and a conical-shaped brim 6304. An exterior
surface 6302a of the compressing ring 6302 may be
substantially parallel to the upper portion 6220 of the plug
wall 6204. A bottom portion 6302d of the interior surface
6302b of the compressing ring 6302 may be tapered and adjoin
a substantially semicircular second groove 6310 formed in
the interior surface 6302b of the compressing ring 6302.
The second groove 6310 may extend substantially around the
entire circumference of the interior surface 6302b of the
compressing ring 6302.
As shown in Fig. 24b, the brim 6304 extends from
the compressing ring 6302 of the crimping element 6300 and
angles into the interior of the crimping element 6300. The
brim 6304 may have an inner diameter Li that is slightly
smaller than an outer diameter L2 of the overhanging
shoulder 6230 on the mechanical plug 6200. Li and L2 should
be dimensioned so that the brim 6304 may be slid over the
overhanging shoulder 6230 of the mechanical plug 6200 with a
sufficient downward force, but then the brim 6304 will then
be positioned underneath the shoulder 6230 to prevent
substantial upward movement of the crimping element 6300.
As shown in Fig. 25, which is a cross-sectional
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view of the mechanical plug 6200 inserted into the opening
6104 of the neck 6102 of the container 6100, the mechanical
plug 6200 is inserted into the opening 6104 until the
semicircular first groove 6110 on the interior surface 6106
of the neck 6102 is mated with the second protrusion 6212 on
the exterior surface 6210a of the mechanical plug 6200. As
discussed above, the interior surface 6106 of the neck 6102,
including an interior portion 6114a of the rim 6114, and the
exterior surface 6210a of the mechanical plug 6200 have been
1o designed and proportioned so that these elements interlock
as shown in Fig. 25.
The exterior surface portions 6210a, 6220a and the
second protrusion 6212 of the mechanical plug 6200 may
preferably be dimensioned so that, when the mechanical plug
6200 is inserted within the neck 6102 of the container, they
directly abut the interior portions 6114, 6106 of the neck
6102 of the container 6100 and the first groove 6110 on the
neck 6102 of the container is mated with the second
protrusion 6212 of the mechanical plug. Thus, as shown in
the configuration illustrated in Fig. 25, the rigidity of
the mechanical plug 6200 provides substantial resistance to
any inward compression of the neck 6102 of the container
6100. In addition, the interaction between the first groove
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6110 on the neck 6102 and the second protrusion 6212 of the
mechanical plug 6200 provides resistance to any vertical
movement of the mechanical plug 6200 within the neck 6102 of
the container 6100.
Of course, since the crimping element 6300 has not
yet been locked into place in the configuration shown in
Fig. 25, a predetermined amount of force in an upwards
direction may dislodge the mechanical plug 6200 from within
the neck 6102 of the container 6100. This allows the
container 6100 to be transferred through potentially
contaminated areas and then opened for operations such as,
for example, filling the container 6100. Upon completion of
the operation necessitating the removal of the mechanical
plug 6200, the mechanical plug 6200 may then be re-inserted
into the neck 6102 of the container 6100 and "snapped" into
place as shown in Fig. 25.
In the process of inserting the mechanical plug
6200 into the neck 6102 of the container 6100, the plunger
500 on the bottom surface 6202b of the floor 6202 will also
be inserted into any material, e.g., liquid, disposed within
the container 6100. The insertion of the plunger 6500 into
the material within the container 6200 will cause a
displacement within the material which may be taken
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advantage of in an exemplary process according to the
present invention by setting the amount of material in the
container 6100 to a predetermined level so that the
displacement caused by the insertion of the plunger 6500
causes the top level of the material to rise to a point
directly adjacent to the bottom portion 6202 of the
mechanical plug 6200. Thus, the insertion of the mechanical
plug 6200 with the plunger 6500 attached thereto may cause
any air bubbles or excess gas to be displaced from within
the container 6100, thereby achieving a substantially
airless condition within the container 6100.. -
Fig. 26 shows a cross-sectional view of a sealed
configuration of the mechanical closure system according to
the present invention. Starting with the configuration as
shown in Fig: 25, a sufficient downward force is applied to
the crimping element 6300 to break the flange 6400 that
couples the crimping element 6300 to the mechanical plug
6200. The downward force applied to the crimping element
6300 should also be sufficient to slide the crimping element
6300 over the neck 6102 of the container 6100 and
simultaneously "snap" the upper portion 6112a of the first
protrusion 6112 on the neck 6102 of the container 6100 into
the second groove 6310 on the interior surface 6302b of the
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crimping element 6300. The tapered shape of the bottom
portion 6302d of the crimping element 6300 facilitates
sliding the crimping element 6300 over the upper portion
6112a of the first protrusion 6112. Once the crimping
element 6300 is slid over the neck 6102, the bottom portion
6302d of the crimping element 6300 rests against the angular
bottom portion 6112b of the first protrusion 6112 on the
neck 6102.
The crimping element 6300 may preferably be
composed of a substantially rigid material and dimensioned
to snugly encircle the neck 6102 of the container 6100.
Thus, as shown in Fig. 26, the neck 6102 of the container
6100 will then be compressed between the crimping element
6300 and the plug wall 6204 of the mechanical plug 6200,
thereby creating a tight, hermetic seal for the container
6100.
In the configuration shown in Fig. 26, the
substantially conical shape of the brim 6304 of the crimping
element 6300 and the dimensions of the brim 6304 and the
overhanging shoulder 6230 on the mechanical plug 6200 allow
a top section 6304a of the brim 6304 to extend underneath
the overhanging shoulder 6230. This substantially prevents
the crimping element 6300 from sliding up and off the neck
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6102 of the container 6100, thereby further maintaining the
crimping element 6300 on the neck 6102 of the container
6100.
Figs. 27a-27e illustrate, via a sequence of cross-
sectional views, an exemplary process for filling and
sealing the container 6100 in accordance with the present
invention. Fig. 27a shows a first step in the exemplary
process in which a predetermined downward force Fo is
applied to the mechanical plug 6200 so that the mechanical
plug 6200 (with the crimping element 6300 attached via the
breakaway flange 6400) is inserted into the neck 6102 of the
container 6100. Although Fig. 27a shows the force Fo being
applied to the center of the mechanical plug 6200, those
skilled in the art will understand that the force may be
applied to any portion(s) of the mechanical plug 6200. This
also applies to any forces illustrated in any of the
drawings. Those skilled in the art will also understand
that any "downward" and "upward" direction for applying the
forces is relative to the orientation of the container 6100.
Once the mechanical plug 6200 has been fully
inserted, the container 6100 may then be irradiated to
sterilize the container. The container 6100 with the
mechanical plug 6200 inserted therein may then be conveyed
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to, for example, a filling machine, which is not shown.
Since the mechanical plug 6200 is still inserted within the
neck 6102 of the container 6100, the interior of the
container 6100 is protected from outside contaminants during
the transfer.
In the next step, shown in Fig. 27b, a
predetermined upwards force F1 is applied to the mechanical
plug 6200 in order to remove the mechanical plug 6200 from
the container 6100. The removal of the mechanical plug 6200
is possible because the crimping element 6300 has not been
slid over the neck 6102 of the container at this stage.
Then, in the next step, shown in Fig. 27c, a conventional
needle 6600 of the filling machine, which is not shown, may
be used to fill the container 6100 with whatever desired
material.
In conventional filling machines, a diameter DN of
the needle 6600 needs to be minimized to reduce the size of
the puncture point through the mechanical plug 6200 because
the puncture point needs to be then sealed with an external
sealing agent. However, since the mechanical plug 6200 is
removable in the mechanical closure system according to the
present invention and there is no puncture point, the
diameter DN of the needle 6600 can be almost as wide as the
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opening 6104 of the container 6100. This enables faster
filling times than in conventional systems, which allows for
faster cycle times for filling multiple containers 6100.
In the next step, shown in Fig. 27d, a
predetermined downward force F2 is applied to the mechanical
plug 6200 to re-insert the mechanical plug 6200 into the
neck 6102 of the container 6100. In the process of re-
inserting the mechanical plug 6200, the plunger 6500 that is
provided on the bottom surface 6202b of the mechanical plug
6200 is also inserted into the material 6700 that has been
received within the container 6100. As a result, a surface
level 6700a of the material 6700 is raised, which may be
advantageously exploited to substantially eliminate the
amount of air or excess gas in the container 6100.
Subsequently, a predetermined force F3 may be
applied to the crimping element 6300 as shown in Fig. 27e,
which results in a separation of the crimping element 6300
from the mechanical plug 6200 at the flange 6400. The force
F3 may also be sufficient to cause the crimping element 6300
to slide over the neck 6102 of the container 6100. The
interaction of the crimping element 6300, the neck 6102 of
the container, and the mechanical plug 6200, as described
above with respect to Fig. 26, may then provide the
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container 6100 with a tight, hermetic seal.
In this exemplary process, the detachable
arrangement of the mechanical plug 6200 relative to the
crimping element 6300 allows the container to be temporarily
closed when only the mechanical plug 6200 is operatively
engaging the neck 6102 of the container 6100. This prevents
contamination during transportation or transfers, and allows
certain operations requiring access to the interior of the
container 6100 to be performed before finally sealing the
container 6100 with the crimping element 6300. For example,
the container 6100 may be exposed to heat or radiation to
decontaminate the container 6100, or the container 6100 may
be filled with a liquid content.
As an alternative to the above-described exemplary
process, the forces F2 and F3 may be replaced with a single
force applied to both the mechanical plug 6200 and the
crimping element 6300, which would result in the
simultaneous insertion of the mechanical plug 6200 into the
neck 6102 of the container 6100 and sliding the crimping
element 6300 over the neck 6102 of the container 6100.
In the foregoing specification, the invention has
been described with reference to specific exemplary
embodiments thereof. It will, however, be evident that
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various modifications and changes may be made thereto
without departing from the broader spirit and scope of the
invention as set forth in the appended claims. For example,
the cartridge or housing may be adapted for use in
conjunction with various types of vial-dispensers not
specifically described herein, for example the vial-
dispenser which is described in my U.S. patent 5,613,957
which has been expressly incorporated herein by reference.
Furthermore, the spring action provided by flexible plastic
material forming the front and rear bellows, shown in Fig.
15, may be alternatively provided by a longitudinally
disposed spring which urges the vial-dispenser to return to
original position upon being released from the compressed
state. In addition, although the vial-dispenser has been
described in this specification as having an accordion-like
front bellows portion and a rear bellows portion, the
dispenser may alternatively incorporate any other spring
configuration, e.g., a single spring element which is either
integral with the dispenser body or separately formed.
Furthermore, the specific arrangement of the trigger 1103,
the notched lever 4102 and the wedge-shaped arm 4103 may be
modified, e.g., the trigger 1103 and the notched lever 4102
may be formed separately from one another and/or from the
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cartridge 4101. Still yet, while the mechanical closure
system according to the present invention have been
described as being adapted for a container or vial having a
circular opening, the mechanical closure system according to
the present invention may be adapted for openings of other
shapes, e.g., square or rectangle. The specification and
drawings are accordingly to be regarded in an illustrative
rather than a restrictive sense.
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