U.S. patent application number 11/272447 was filed with the patent office on 2006-11-23 for metered dose delivery device for liquid and powder agents.
This patent application is currently assigned to New England Pharmaceuticals, Inc.. Invention is credited to John C. Armstrong, Richard C.J. Palson.
Application Number | 20060260608 11/272447 |
Document ID | / |
Family ID | 23099475 |
Filed Date | 2006-11-23 |
United States Patent
Application |
20060260608 |
Kind Code |
A1 |
Armstrong; John C. ; et
al. |
November 23, 2006 |
Metered dose delivery device for liquid and powder agents
Abstract
A delivery device for the delivery of an agent to the mouth,
nose or other bodily site of a user. The delivery device includes
an aerosol canister that is actuated to expel propellant, which
captures and disperses the agent. In a preferred embodiment, the
propellant captures and disperses the agent into the mouth or nose
of a user, and inhalation by the user directs the agent to the
lungs of the user. The delivery device is particularly suitable for
the treatment of bronchial asthma, respiratory conditions and for
the delivery of systemically absorbed agents.
Inventors: |
Armstrong; John C.; (South
Dartmouth, MA) ; Palson; Richard C.J.; (Medfield,
MA) |
Correspondence
Address: |
EDWARDS & ANGELL, LLP
P.O. BOX 55874
BOSTON
MA
02205
US
|
Assignee: |
New England Pharmaceuticals,
Inc.
Medfield
MA
|
Family ID: |
23099475 |
Appl. No.: |
11/272447 |
Filed: |
November 9, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10134041 |
Apr 26, 2002 |
7025058 |
|
|
11272447 |
Nov 9, 2005 |
|
|
|
60286634 |
Apr 26, 2001 |
|
|
|
Current U.S.
Class: |
128/200.23 |
Current CPC
Class: |
A61M 15/009 20130101;
A61M 15/0036 20140204; A61M 15/0003 20140204; A61M 15/0028
20130101; A61M 2202/064 20130101; A61M 15/0081 20140204 |
Class at
Publication: |
128/200.23 |
International
Class: |
A61M 11/00 20060101
A61M011/00 |
Claims
1-71. (canceled)
72. A device for delivery of two or more agents comprising: a body
member having at a first end a canister housing a propellant and a
second end adapted for insertion into the mouth or nose of a user;
a container within the body member positioned between the canister
and the second end; the container housing two or more agents,
wherein the two or more agents are separated from each other with
piercable material; a mechanism for exposing the agents in the
container to the propellant, the mechanism positioned between the
canister and the container; whereby as the canister is moved
towards the container, the mechanism exposes the two or more agents
in the container to the propellant and the canister is actuated to
expel the propellant and agents into the mouth or nose of the
user.
73. The device of claim 72 wherein the container comprises one or
more compartments, each compartment being sealed at a bottom and
top end with a piercable material, each compartment housing the two
or more agents.
74. The device of claim 73 wherein the compartments house two or
more agents in layers, the layers being separated from each other
with piercable material.
75. The device of claim 72 wherein the canister further houses a
dose of agent in suspension or solution.
76. The device of claim 75 wherein the dose of agent is selected
from flavoring agents, surfactants, water, alcohol or other
solvents, and medicinal agents.
77. The device of claim 72 wherein the mechanism passes through the
container thereby carrying the agents towards the second end.
78. The device of claim 77 wherein the mechanism is sized to carry
precise doses of agents to the second end.
79. The device of claim 77 wherein the size of the mechanism
controls the doses of agents delivered by the device.
80. The device of claim 72 wherein the mechanism is a piercing
member.
81. The device of claim 80 whereby as the canister is moved towards
the container, the piercing member passes through the container,
thereby carrying the agents towards the second end.
82. The device of claim 80 wherein at least the tip portion of the
piercing member is hollow and the agents are picked up within the
hollow portion of the piercing member.
83. The device of claim 82 wherein the inner diameter of the
piercing member is sized to pick up precise doses of the
agents.
84. The device of claim 82 wherein the size of the inner diameter
of the piercing member controls the doses of agents delivered by
the device.
85. The device of claim 80 wherein the piercing member is a blade
or blade-like member.
86. The device of claim 72 wherein the propellant is a
chlorofluorocarbon or hydrofluoroalkane propellant.
87. The device of claim 72 wherein the propellant is selected from
hydrofluoroalkane 134a and hydrofluoroalkane 227.
88. The device of claim 72 wherein the canister includes a valve
stem through which propellant is expelled, and wherein the valve
stem comprises the mechanism.
89. The device of claim 74 wherein the mechanism comprises a
piercing member and wherein the piercing member passes through the
piercable material at the top end of the container, passes through
the layers of agents and piercable material separating the layers
of agents, and passes through the piercable material at the bottom
end thereby carrying the agents towards the second end.
90. A device for delivery of an agent for treating diabetes
comprising: a body member having at a first end a canister housing
a propellant and a second end adapted for insertion into the mouth
or nose of a user; and a container within the body member, for
holding an agent effective in treating diabetes, wherein the
container is positioned between the canister and second end;
whereby as the canister is moved towards the container, the
canister is actuated to expel the propellant and agent into the
mouth of a user, whereby device delivers a respirable fraction of
agent that is effective in treating diabetes.
91. A device for delivery of an agent comprising: a body member
having at a first end a canister housing a propellant and a second
end adapted for insertion into the mouth or nose of a user; and a
container within the body member, for holding the agent, wherein
the container is positioned between the canister and second end;
whereby as the canister is moved towards the container, the
canister is actuated to expel the propellant and agent into the
mouth or nose of the user, and wherein the device delivers a
respirable fraction of agent of at least about 60%.
92. The device of claim 91 wherein the respirable fraction is at
least about 65%.
93. The device of claim 91 wherein the respirable fraction is at
least about 70%.
94. The device of claim 91 wherein the respirable fraction is at
least about 75%.
95. The device of claim 91 wherein the respirable fraction is at
least about 80%.
96. The device of claim 91 wherein the respirable fraction is at
least about 85%.
Description
[0001] The present application claims the benefit of U.S.
provisional application No. 60/286,634, filed on Apr. 26, 2001, the
teachings of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to improved devices for the
oral, nasal or topical delivery of finely divided materials, such
as medicinal agents and drugs. More particularly, the present
invention relates to a device that delivers medicament to the mouth
or nose of a user by use of an aerosol canister housing a
propellant.
BACKGROUND OF THE INVENTION
[0003] Certain disease of the respiratory tract are known to
respond to treatment by the direct application of medicinal agents.
As many such agents are most readily available as a finely divided
material, e.g., in dry powdered form, their delivery is most
conveniently accomplished by inhaling the finely divided material
through the nose or mouth. This results in better utilization of
the medicinal agent in that it is deposited exactly at the site
desired and where its action may be required; hence, very minute
doses of the therapeutic agent are often equally as efficacious as
larger doses administered by other means, with a consequent marked
reduction in the incidence of undesired side effects. Alternately,
the therapeutic agent in this form may be used for treatment of
diseases other than those of the respiratory system, for example,
for the delivery of systemically absorbed medicaments such as
insulin. When the drug is deposited on the very large surface areas
of the respiratory tract, it may be very rapidly absorbed into the
blood stream; hence, this method of application may take the place
of administration by injection, tablet, or other conventional
means.
[0004] A variety of inhalation devices for the delivery of finely
divided materials are known in the art. For example, U.S. Pat. No.
4,240,418 discloses inhalation devices wherein a container of
finely divided material is positioned so that the material from the
container can pass by gravity to a delivery area of the device from
which it is dispensed. Accordingly, these devices suffer the
disadvantage that the use must maintain the device in a particular
position so that the finely divided material can pass by gravity to
the collecting plate and is not dislodged therefrom prior to
dispensing. It appears that such devices also require a large
dispensing passage to prevent interference with the free fall of a
relatively large load of the finely divided material.
[0005] Other known inhalation devices incorporate a deflector (U.S.
Pat. No. 4,098,273) or a hollow tube (U.S. Pat. No. 3,938,516) to
divert air flow into a chamber to dislodge the finely divided
material, thereby requiring a substantial flow of air to disperse
the finely divided material. Inhalation sufficient to create such a
substantial flow of air is difficult for some users, e.g.,
asthmatics. Furthermore, it is believed that such devices deliver
somewhat imprecise doses due to the inevitable variations in
residue of finely divided material left behind in the container
after dispensing.
[0006] Some known inhalation devices use members which vibrate to
dispense the finely divided material, thus increasing the
complexity and bulk of the device. For example, the devices of U.S.
Pat. No. 3,948,264, utilize batteries to activate vibrators. Other
devices incorporate breath activated vibratable members to disperse
the finely divided materials. See, e.g., U.S. Pat. Nos. 3,888,253
and 4,995,385 which include a member which vibrates in the airflow
to dispense the finely divided material. Still other known devices
use a breath activated propeller device to spin the container of
finely divided material, thereby casting the material out by
centrifugal force, e.g., U.S. Pat. No. 3,507,277. A relatively high
velocity of air flow is required to activate such devices, again a
problem for breath impaired users.
[0007] Moisture in most powders tends to cause agglomeration and
clumping thereby inhibiting the breakup and dispersion of the
finely divided medication, an essential step in effective
dispensing of the material. However, the manner in which many known
devices operate renders hermetic sealing of the container of finely
divided material impossible. In still other known devices, the
containers for finely divided materials are gelatin capsules which
are susceptible to atmospheric moisture.
[0008] Recently, inhalation devices have been developed which
include an aerosol container housing a mixture of a propellant and
a drug. See, e.g., U.S. Pat. Nos. 6,126,919, 6,120,752 and
6,054,488. Certain drugs cannot be successfully mixed with
propellants. Further, such mixtures often result in agglomeration
of the drug, degradation of the components, chemical instability,
and limited shelf lives. In an attempt to solve these problems,
certain additives such as, for example, cosolvents, surfactants and
dispersants are often added. As a result, pure medicinal agent is
not delivered. Further, with such devices, prior to each use, it is
required to shake the device vigorously to ensure that the mixture
of drug, cosolvents, surfactants, dispersants and other components
are suspended in the propellant and to try to provide a uniform
mixture of the components. Further, with such devices, it is
important to keep track of how much medicine has been used so that
the user replaces the device before running out of the medicine.
One way this is done is for the user to write a refill date on the
device. To figure out the refill date, a user must divide the
number of puffs in the device (often, this number is printed the
device) by the number of puffs the user takes each day. The
resulting number is the number of days the device should last. The
user than counts forward that many days to estimate the refill
date. However, this process is inconvenient and is often inaccurate
because it does not take into account days in which more or fewer
puffs are taken.
[0009] New and more potent drugs which can be used in increasingly
small quantities are being developed on an ongoing basis. In most
instances, known inhalation devices for finely divided materials
are not capable of delivering such small quantities without the
addition of a significant amount of filler. It is highly desirable
to minimize the use of such fillers, e.g., in order to reduce the
likelihood of side effects.
[0010] It can be seen that presently known devices for the delivery
of finely divided materials suffer disadvantages which include,
among others, imprecise delivery, inability to deliver directly
from a hermetically sealed container, agglomeration and clumping of
the medicinal agents, reduced shelf life of the medicinal agents,
chemical instability, inability to deliver small doses of pure
medicinal agent, requirement of good coordination for use and high
breath demands upon the user, requirement to shake the device to
prevent settling of the medicinal agent, limited portability due to
bulk, difficulty to keep track of how much medicinal agent has been
used and how much remains and complexity of design. Thus,
alternative inhalation devices are being sought.
SUMMARY OF THE INVENTION
[0011] The present invention provides a novel device for the oral
or nasal delivery of agents, such as medicinal agents and drugs,
which reduces or overcomes many deficiencies of prior art devices.
More particularly, the present invention relates to a device that
delivers an agent to the mouth or nose of a user by means of an
aerosol canister housing a propellant. In particular, the present
invention provides a device in which the agent and the propellant
are kept separated, e.g. in separate containers or compartments,
and combined at the instant of actuation. The delivery device may
also provide beneficial effects for the delivery of agents to other
bodily sites including, for example, the eye and ear.
[0012] As used herein, a propellant includes both compressed and
liquefied gases. In some embodiments, however, liquefied gases,
which require lower pressures than compressed gasses to be
liquefied, are preferable to compressed gases.
[0013] In an exemplary embodiment, the delivery device includes a
body member having an aerosol canister at a first end and a second
end for insertion into a user's mouth or nose. A container, housed
within the body member between the aerosol canister and the second
end, contains an agent. A mechanism for exposing the agent in the
container to the propellant is further included. In a preferred
embodiment, the mechanism is a piercing member, such as a needle or
a blade, housed within the body member between the aerosol canister
and the container. Preferably, the mechanism is movable within the
body member and, during use, the mechanism, e.g. piercing member or
blade, is lined up with the agent in the container and is moved
towards and through the container. The agent is then delivered to
the mouth or nose of a user by the propellant, which is expelled by
actuation of the aerosol canister. The propellant captures and
disperses the agent through the second end and into the mouth or
nose of the user. Preferably, the propellant is expelled with a
force adequate to cause substantially complete dispersion of the
agent, and inhalation by the user directs the agent to the lungs of
the user.
[0014] In a particularly preferred embodiment, the aerosol canister
is movable within the body member and the mechanism is a piercing
member in connection with the aerosol canister such that, as the
aerosol canister is moved within the body member towards the
container, the piercing member, likewise, moves towards and through
the container. As the aerosol canister moves towards and through
the container, it preferably encounters a stop or similar mechanism
that actuates the aerosol canister to expel propellant.
[0015] In yet another preferred embodiment, the mechanism is a
piercing member in the form of a needle having at least a hollow
tip portion that pierces and passes through the container. As the
hollow tip portion pierces and passes through the container, the
agent is picked up within the hollow portion of the piercing member
and is carried towards the second end of the body member.
Propellant, expelled from the aerosol canister then forces the
agent from the needle, through the second end and into the mouth or
nose of a user.
[0016] Preferably, the piercing member is designed such that it is
substantially hollow along its length. As such, when the piercing
member is in line with the aerosol canister, propellant expelled
from the aerosol canister passes through the hollow of the piercing
member. As the propellant travels through the piercing member, it
encounters the agent picked up within the piercing member and
disperses the agent out of the piercing member into the mouth or
nose of the user.
[0017] The hollow needle is not limited in its cross sectional
shape and, for example, it may have a circular, oval, square,
triangular, or other cross sectional shape. In one preferred
embodiment, the needle is designed such that the hollow portion is
sized to accommodate and pick up a precise dose of agent. For
example, the cross section of the hollow portion may be made larger
or smaller to accommodate more or less agent.
[0018] Preferably, the hollow needle is sized such that the cross
section of the needle is substantially the same as the cross
section of the portion of the container housing the agent, so as to
minimize any residue of agent in the container.
[0019] In another preferred embodiment, the mechanism is a piercing
member in the form of a solid needle. In this embodiment, as the
needle is moved through the container, it picks up the agent in the
container and pushes the agent through the container toward the
second end of the body member. The agent is then delivered to the
mouth or nose of a user by the propellant, which is expelled by
actuation of the aerosol canister. The propellant picks up and
disperses the agent out of the second end and into the mouth or
nose of the user. Preferably, the propellant is expelled with
adequate force to substantially completely disperse the agent, and
inhalation by the user directs the agent to the lungs of the
user.
[0020] The solid needle is not limited in its cross sectional shape
and it may have, for example, a circular, oval, square, triangular,
or other cross sectional shape. Preferably, the solid needle is
sized such that the cross section of the needle is substantially
the same as the cross section of the portion of the container
housing the agent, so as to minimize any residue of agent in the
container.
[0021] In embodiments where the solid needle is sized with a cross
section substantially the same as the cross section of the portion
of the container housing the agent, bypass pathways are preferably
included in the device. For example, one or more bypass pathway may
be formed around the portion of the container housing the agent
such that propellant expelled from the aerosol canister passes
through the one or more bypass pathway to the second end of the
body member where the propellant captures and disperses the agent
into the mouth or nose of the user. The bypass pathways may also be
included in other embodiments, for example, where the mechanism is
a hollow needle.
[0022] In some embodiments of the present invention, the solid or
hollow needle may be sized with a cross section smaller than the
cross section of the portion of the container housing the agent
such that at least a portion of the propellant may be expelled
through the portion of the container housing the agent around the
needle. In this embodiment, the bypass pathways may also be
included to allow for additional pathways through which additional
propellant can be expelled. Thus, the propellant may be expelled
both through the portion of the container housing the agent (e.g.
around the needle and through the hollow needle) and through the
bypass pathways.
[0023] In another embodiment, the piercing member is in the form of
a blade having a cross section less than the cross section of the
portion of the container housing the agent. As the blade pierces
the container, an opening through the container housing the agent
is formed. Propellant is then expelled around the blade and through
the opening formed by the blade, thereby forcing the agent out of
the container, through the second end and into the mouth or nose of
a user. In one embodiment, the agent within the container is sealed
at the top and/or bottom of the container by a conventional
piercable material such as, for example, a plastic or metal film,
to ease piercing of the container and to enable further opening up
of the container. Thus, as the propellant is forced around the
blade through the opening formed by the blade, the force of the
propellant against the piercable material surrounding the opening
formed by the blade further opens up the piercable material and
assists in driving the agent out of the container. In this case,
most if not all of the agent in the container will be expelled.
[0024] In this blade embodiment, bypass pathways may also be
included to allow for additional pathways through which additional
propellant can be expelled. Thus, the propellant may be expelled
both through the portion of the container housing the agent around
the blade and through the bypass pathways.
[0025] Preferably, the delivery device is designed to deliver
precise doses of agent. This may be accomplished by, for example,
sizing the portion of the container housing the agent so as to
accommodate a precise dose of agent. For example, the thickness
and/or cross-section of the container or portion of the container
holding the agent may be increased or decreased to hold more or
less agent. This may also be accomplished by, for example, sizing
the hollow portion of the piercing member so as to accommodate a
particular dose of agent.
[0026] The present invention provides delivery devices and methods
of use that greatly reduce and, in some instances, eliminate the
problems associated with currently available delivery devices. For
example, the present delivery devices and methods of use
effectively deliver precise doses of agents, prevent agglomeration
and clumping of the medicinal agents, are easy to use, require
minimal inhalation by the user and are capable of delivering small
amounts of medicaments without the use of fillers.
[0027] Still further, contrary to devices that mix the medicinal
agent with a propellant in an aerosol canister, the present device
does not require the agent to come into contact with the propellant
until the point in time that the agent is administered. Thus, the
agent may be provided in substantially pure form. As a result, the
chemical stability of the agent is not diminished by contact with a
propellant and the shelf life of the agents is not diminished in
this manner. Further, the device need not be shaken well prior to
use to prevent settling of the agent.
[0028] In preferred embodiments of the present invention, the agent
is provided in containers housing individually sealed doses rather
than providing a bulk amount of agent mixed in a propellant. Thus,
a user need not keep track of uses of the device to estimate how
many doses of the medicinal agent remain in the device as with
conventional aerosol delivery devices. A user of the present device
merely uses the device and replaces the container housing the agent
between each use with single dose containers. Alternatively, with
multiple dose containers having a plurality of compartments each
housing a single dose, a user merely needs to look at the container
to see how many compartments have been pierced to see how many
doses have been used and how many doses remain. Thus, the potential
for erroneously estimating the number of doses remaining is
eliminated and a user can eliminate the danger of carrying a
delivery device with no remaining doses or fewer doses than
believed.
[0029] Other aspects and embodiments of the invention are discussed
below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] FIG. 1 is a side cross-sectional view of one embodiment of
the delivery device in accordance with the present invention.
[0031] FIG. 2 is an enlarged side cross-sectional view of the
piercing member and container portions of the delivery device shown
in FIG. 1.
[0032] FIG. 3 is a view of the aerosol container within the
delivery device of FIG. 1.
[0033] FIG. 4 is a cross-sectional view of the components inside
the body member in accordance with another embodiment of the
delivery device wherein the delivery device includes a plurality of
bypass channels.
[0034] FIG. 5 is an enlarged cross-sectional view of FIG. 4
excluding the aerosol canister.
[0035] FIG. 6 shows a view of the device shown in FIG. 5 taken
along line A-A.
[0036] FIG. 7 is a side cross-sectional view of the components
inside the body member in accordance with another embodiment of the
delivery device wherein the delivery device includes a plurality of
bypass channels and wherein the device is shown with the top
portion separated from the bottom portion.
[0037] FIG. 8a is an enlarged view of the top and bottom portions
of the device shown in FIG. 7.
[0038] FIG. 8b is an enlarged view of a holding member for holding
the container of agent in accordance with one embodiment of the
present invention.
[0039] FIG. 8c is an enlarged view of a holding member having
grooves and a container having protrusions in accordance with one
embodiment of the present invention, wherein the grooves in the
holding member and protrusions in the container correspond to each
other when the container is properly inserted in the holding
member.
[0040] FIG. 8d is an enlarged view of a holding member having
protrusions and a container having grooves in accordance with one
embodiment of the present invention, wherein the grooves in the
holding member and protrusions in the container correspond to each
other when the container is properly inserted in the holding
member.
[0041] FIG. 9 is a cross-sectional view of the components inside
the body member in accordance with another embodiment of the
delivery device wherein the delivery device includes an expansion
chamber.
[0042] FIG. 10 is an enlarged view of the device shown in FIG.
9.
[0043] FIG. 11a shows an enlarged view of the container having a
single center compartment housing the agent.
[0044] FIG. 11b shows an enlarged view of the container having a
plurality of compartments housing the agent.
[0045] FIG. 12a shows views of another embodiment of the present
invention, wherein the container is elongate and can be slid into
and out of a slot in the device, like a drawer.
[0046] FIG. 12b shows an upper enlarged view of an elongate
container in accordance with one embodiment of the present
invention.
[0047] FIG. 12c shows a side enlarged view of an elongate container
in accordance with one embodiment of the present invention.
[0048] FIG. 13a shows a view of another embodiment of the present
invention, wherein a drawer-like holding member holds the container
of agent and wherein the drawer-like holding member can be slid
into and out of a slot in the device.
[0049] FIG. 13b shows an upper enlarged view of a drawer-like
holding member in accordance with one embodiment of the present
invention.
[0050] FIG. 13c shows a side enlarged view of a drawer-like holding
member in accordance with one embodiment of the present
invention.
[0051] FIG. 14a shows a view of another embodiment of the present
invention, wherein an elongate container that can be slid into and
out of a slot in the device, like a drawer, is stabilized by a
vertical stabilizing member.
[0052] FIG. 14b shows a view of another embodiment of the present
invention, wherein an elongate container that can be slid into and
out of a slot in the device, like a drawer, is stabilized by one or
more horizontal stabilizing members.
[0053] FIG. 15a shows an enlarged view of another embodiment of the
present invention wherein the mechanism for exposing the agent in
the container to the propellant is the valve stem and wherein a
stop member or cover is used to form a channel through which the
propellant is directed through the container.
[0054] FIG. 15b shows FIG. 15a without the container or valve stem
in place.
[0055] FIG. 16a-b show embodiments of the piercing member passing
through the compartment in the container while providing clearance
between the piercing member and one or both sides of the
compartment.
[0056] FIG. 17a shows another embodiment of the delivery device of
the present invention wherein the device includes a guiding
mechanism that guides the piercing member through a precise
location in the container, wherein the guiding mechanism is in the
form of one or more pins and corresponding grooves that line up
when the piercing member is precisely aligned with the desired
location in the container.
[0057] FIG. 17b shows an enlarged view of the guiding mechanism of
FIG. 17a.
[0058] FIG. 18a shows another embodiment of the delivery device of
the present invention wherein the second end of the device is
enlarged or flared.
[0059] FIGS. 18b-e show the steps of using the delivery device in
accordance with another embodiment of the present invention.
[0060] FIG. 19 shows the "black box" used in the Examples.
[0061] FIG. 20a shows a cross-section side view of another
embodiment of the delivery device of the present invention wherein
the device includes a guide mechanism that guides the piercing
member through a precise location in a drawer-like holding member
including the container for the agent, wherein the guiding
mechanism is in the form of one or more pins and corresponding
holes and grooves that line up when the piercing member is
precisely aligned with the desired location in relation to the
container.
[0062] FIG. 20b shows a top view of the drawer-like holding member
of FIG. 20a.
[0063] FIG. 20c is an enlarged cross-section view of the device of
FIG. 20a in the discharge position wherein the needle has passed
through the container in the drawer-like member and is stopped at
the top of a curved section adjacent to the nozzle.
[0064] FIG. 21a is an exploded cross-section front view of the
device shown in FIG. 20, showing guide pins and apertures for
accepting the pins.
[0065] FIG. 21b is a cross-section front view of the device shown
in FIG. 20 in the discharge position, wherein the needle has passed
through the container and stopped.
DETAILED DESCRIPTION OF THE INVENTION
[0066] Although the delivery devices of the present invention are
primarily illustrated and described herein by means of devices
which have been adapted for oral delivery, it will be appreciated
by those skilled in the art that such devices may also be adapted
for nasal and other bodily site delivery. Further, although the
devices of the present invention are primarily illustrated and
described herein by means of devices having a mechanism in the form
of a piercing member, particularly a hollow needle, it will be
appreciated by those skilled in the art that such devices may also
be adapted having other forms of mechanisms such as solid needles
and blades.
[0067] Referring now to the various figures of the drawing, wherein
like reference characters refer to like parts, there is shown in
FIGS. 1-18e various views of a delivery device 1, in accordance
with the invention.
[0068] As shown in FIG. 1, the delivery device 1 includes a body
member 2 having a first end 4 and a second end 6. An aerosol
canister 8, housing a propellant, is located at the first end 4 of
the body member 2. The second end 6 is designed for insertion into
a user's mouth or nose. A container 10, which contains an agent, is
further housed within the body member 2 between the aerosol
canister 8 and the second end 6. The delivery device further
includes a mechanism for exposing the agent in the container 10 to
the propellant. In a preferred embodiment, the mechanism is a
piercing member 12, such as a needle or blade, preferably
positioned within the body member 2, between the container 10 and
the aerosol canister 8. The piercing member 12 is movable within
the body member 2 and may be moved so as to pierce and pass through
the container 10. The agent within the container 10 is delivered to
the mouth or nose of a user by actuation of the aerosol canister 8.
Actuation of the aerosol canister 10 expels the propellant from the
aerosol canister 10 towards the agent and disperses the agent out
of a nozzle 27 into the second end 6 and into the mouth or nose of
the user.
[0069] The body member 2 may be any convenient shape. As shown in
FIG. 1, the body member 2 may be formed of an upper portion 14 and
a lower portion 16 extending at an angle from the bottom of the
upper portion 14 as is conventional in the art. For example,
conventional devices have been formed with an angle between the
upper and lower portions ranging from about 110.degree. to about
115.degree.. Such an angled arrangement has been found to assist in
directing the propellant and agent to the desired treatment
location and makes it easier to comfortably use of the device. Of
course, the shape of the body member 2 is not limited to such an
arrangement, and other body member 2 shapes may be used.
[0070] In a preferred embodiment, the lower portion 16 extends at
an angle from the upper portion 14 and is connected to the upper
portion 14 via hinges or other fastening means 18 such as, for
example, corresponding threaded portions on the upper portion 14
and lower portion 16, that allow the lower portion 16 to be
separated from the upper portion 14. Any other type of mechanism
that is useful in providing access to the interior of the body
member 2 and/or to allow for easy insertion and removal of the
container 10 housed within the body member 2 may be used.
[0071] In the embodiment shown in FIGS. 1 and 2, a holding member
20 is mounted within the body member 2 for holding the container 10
in place within the device. For example, the holding member 20 may
be mounted in the lower portion 16, as shown in FIG. 1, such that
as the lower portion 16 of the body member 2 is separated from the
upper portion 14, for example, by swinging the lower portion 16
open along hinges or other fastening means 18, the holding member
20, likewise, swings along with the lower portion 16 and easy
access is provided to remove and replace the container 10.
[0072] The container 10 may be any convenient shape. In the
embodiments shown in FIGS. 6 and 11a-b, the container 10 is
cylindrical. In the embodiment shown in FIGS. 12a-c, the container
10 is elongate. Furthermore, the container 10 may be single or
multicompartmental.
[0073] In the embodiment shown in FIG. 1, the holding member 20 is
designed to securely hold the container 10 and prevent vertical,
horizontal and rotational movement of the container 10 during use.
Thus, for example, the holding member 20 may be designed to have an
opening 34, as shown in FIG. 8b, that is sized and shaped to snugly
fit the container 10. In some embodiments, the container 10 has a
snap fit within the opening 34 of the holding member 20. In some
embodiments, the holding member 20 has an opening 34 that includes
one or more protrusions 35 or grooves 37 that correspond to one or
more grooves 36 or protrusions 38 in the container 10, so that the
container 10 is placed into the opening 34 with the grooves 36 or
protrusions 38 of the container 10 engaging the protrusions 35 or
grooves 37 in the opening 34 of the holding member 20, as shown,
for example, in FIGS. 8c-d.
[0074] The container 10 and holding member 20 are preferably sized
and shaped such that when the container 10 is inserted into the
opening 34 of the holding member 20, the container 10 is
automatically positioned in line with the aerosol canister 8 and
the piercing member 12 or other mechanism. In preferred
embodiments, the container 10 is designed such that it is
symmetrical left to right and top to bottom, for example, as shown
in FIGS. 11a-b, so that the container 10 can be quickly and easily
inserted into the opening 34 left end first, right end first,
facing up or facing down. Alternatively, the container 10 may be
designed so that it is, for example, properly inserted facing up,
for example, as shown in FIGS. 8c-d. To ensure proper insertion,
the top end could, for example, be enlarged to a size larger than
the opening 10 so that the container 10 could not be inserted
facing down because it would not fit. Another way to ensure proper
insertion could be to include some type of indicia on the container
10, such as an arrow, indicating the proper direction of
insertion.
[0075] In another embodiment, a drawer-like or similar mechanism 40
may be included in the body member 2 such that the drawer-like or
similar mechanism may be, for example, pulled out or swung open,
thereby providing access to the interior of the body member for
insertion and replacement of the container 10. In one preferred
embodiment, for example, as shown in FIG. 13, the drawer 40 may be
pulled in and out of the body member 2 such that when the drawer 40
is pulled out, the drawer 40 has a bottom surface that is designed
as a holding mechanism on which the container 10 is placed and when
the drawer 40 is pushed back inside the body member, the container
10 is positioned for use. Preferably, as with the holding member
20, the drawer-like or similar mechanism 40 is designed to securely
hold the container 10 and prevent vertical, horizontal and
rotational movement of the container 10 during use. Thus, the
drawer-like or similar mechanism 40 may, like the holding member,
20 include an opening 42 like that described above for the holding
member 20. The container 10 and drawer-like or similar mechanism 40
are preferably sized and shaped such that when the container 10 is
inserted into the drawer-like or similar mechanism 40, the
container 10 is automatically positioned in line with the aerosol
canister 8 and the piercing member 12 or other mechanism. In
preferred embodiments, the container 10 is designed such that it is
symmetrical left to right and top to bottom so that the container
10 can be quickly and easily inserted into the drawer-like or
similar mechanism 40 left end first, right end first, facing up or
facing down. Alternatively, the container 10 may be designed so
that it is, for example, properly inserted facing up. To ensure
proper insertion, the top end could, for example, be enlarged to a
size larger than the opening 42 in the drawer-like or similar
mechanism 40 so that the container 10 could not be inserted facing
down because it would not fit. Another way to ensure proper
insertion could be to include some type of indicia on the container
10, such as an arrow, indicating the proper direction of insertion.
In some embodiments, one or more stabilizing members 46 are
positioned within the body ember 2, for example, as shown in FIG.
13a and 14b, on and/or between which the drawer-like or similar
mechanism 40 can rest when inserted in the device to prevent the
drawer-like or similar mechanism 40 from vertical movement during
use. For example, as shown in FIG. 13a, a vertically extending
stabilizing member 46 is positioned such that the drawer 40, when
inserted, rests on the stabilizing member 46 and prevents vertical
movement. In another embodiment, as shown in FIG. 14b, one or more
horizontally extending stabilizing members 46 can be located about
the slot 44 such that the drawer 40 or elongate container 10, when
inserted rests on or between the one or more horizontally extending
stabilizing members 46. These stabilizing members 46 can extend
along a portion of the drawer 40 length, for example, as shown in
FIG. 14b or along the entire drawer 40 length, for example, as
shown in FIG. 14c. When the stabilizing member(s) 46 extend along
the compartment 22 of the container 10 that houses the agent, a
lumen 48 is located in the stabilizing member(s) 46 through which
the piercing member 12, propellant and agent may pass, for example,
as shown in FIG. 14a. The horizontally extending stabilizing
members 46 prevent the drawer-like or similar mechanism 40 from
horizontal movement during use.
[0076] In yet another preferred embodiment, rather than provide a
drawer-like or similar mechanism 40 for holding the container 10, a
slot 44 is located in the body member 2 and the container 10 is
designed to slide in and out of the slot 44 much like a drawer. For
example, as shown in FIGS. 12a-c, the container 10 can be elongate
in shape, like a drawer, and the slot 44 is sized and shaped in
accordance with the size and shape of the container 10 so that the
container 10, when inserted into the slot 44, is held securely and
is prevented from vertical, horizontal and rotational movement
within the slot 44. The container 10 is preferably sized and shaped
such that when it is inserted into the slot 44, it is automatically
positioned in line with the aerosol canister 8 and the piercing
member 12 or other mechanism. For example, as shown in FIGS. 14a-b,
the container 10 may be elongate in shape, and inserted into the
slot 44 such that at least a portion of one end of the container 10
remains external to the slot or opening for easy removal and
replacement. In preferred embodiments, the container 10 is designed
such that it is symmetrical left to right and top to bottom so that
the container 10 can be quickly and easily inserted left end first,
right end first, facing up or facing down. Alternatively, the
container 10 may be designed so that it is properly inserted left
end first. To ensure proper insertion, the right end could be
enlarged to a size larger than the slot or opening so that the
container 10 could not be inserted right end first because it would
not fit. Another way to ensure proper insertion could be to include
some type of indicia on the container 10, such as an arrow,
indicating the proper direction of insertion. Further, the
container 10 could also be designed such that it is properly
inserted facing up. Likewise, the container may be sized to prevent
insertion with the container 10 facing down or could include some
type of indicia on the container that indicates proper direction of
insertion. As with the drawer-like or similar mechanism 40, when
the container 10 is in the form of a drawer that is slid into and
out of a slot 44, one or more stabilizing members 46 are preferably
positioned within the body member 2, for example, as shown in FIG.
14a-b, on and/or between which the container 10 can rest when
inserted in the device to prevent the container 10 from vertical
movement during use. For example, as shown in FIG. 14a, a
vertically extending stabilizing member 46 is positioned such that
the container 10, when inserted, rests on the stabilizing member 46
and prevents vertical movement. In another embodiment, as shown in
FIG. 14b, one or more horizontally extending stabilizing members 46
can be located about the slot 44 such that the container 10, when
inserted rests on or between the one or more horizontally extending
stabilizing members 46, which prevent the drawer-like or similar
mechanism 40 from horizontal movement during use. These stabilizing
members 46 can extend along a portion of the container 10 length,
for example, as shown in FIG. 14b or along the entire drawer 40
length, for example, as shown in FIGS. 2, 7, 8a-d, 13a, 14b and
15a-b. When the stabilizing member(s) 46 extend along the
compartment 22 of the container 10 that houses the agent, a lumen
48 is located in the stabilizing member(s) 46 through which the
piercing member 12, propellant and agent may pass, for example, as
shown in FIG. 14a.
[0077] The container 10, which houses an agent, is located within
the body member 2 between the aerosol canister 8 and the second end
6. The container 10 has a top end 11 and bottom end 13, and the
container 10 is housed within the body member 2 such that the
piercing member 12 passes through the top end 11 then the bottom
end 13 as it pierces and passes through the container 10.
[0078] In one embodiment, as best shown in FIG. 8, 11a and 11b, the
container 10 has one or more compartments 22, 22a that house the
agent. The one or more compartments 22, 22a are depicted as
cylindrical in shape. However, the shape of the one or more
compartments 22, 22a is not particularly limited in shape.
[0079] For example, in one embodiment, as shown in FIGS. 8 and 11a,
the container 10 may be cylindrical in shape and have a singe
center compartment 22a housing the agent. In this embodiment, the
container 10 is positioned within the body member 2 such that the
center compartment 22a is directly in line with the path of travel
of the piercing member 12. However, the portion of the container 10
housing the agent need not be in the center of the container 10 as
long as the compartment 22, 22a containing the agent is in line
with the path of travel of the piercing member 12.
[0080] In another embodiment, as shown in FIG. 11b, rather than
having a single center compartment 22a of the container 10 housing
the agent, a plurality of compartments 22 within the medicament
container 10 may contain the agent such that a single container 10
may contain a plurality of doses of agent. Thus, containers 10 of a
given size can contain different numbers of single doses depending
upon the requirements of the particular agent in use. Thus, one
inhalation device in accordance with the present invention can have
many different applications.
[0081] The container 10 having a plurality of compartments 22 is
preferably mounted within the body member 2 so that the container
10 may be rotated or positioned to line up each of the compartments
22 with the piercing member 12. For example, in one embodiment, the
container 10 is disk-like in shape with the plurality of
compartments 22 positioned in a circle, see FIG. 11b. In this
embodiment, the container 10 is preferably rotatably mounted in the
body member 2 to allow for a user to line up each compartment 22
with the piercing member 12 by simple rotation of the compartment
10. As such, for example, the container 10 may be rotatably,
centrally disposed on a pin or similar mechanism (not shown). The
container 10 may further be provided with a conventional locking
means (not shown) so that during rotation, the container 10 is
locked in position each time a compartment 22 is disposed in line
with the path of travel of the piercing member 12, thereby locating
each single dose for dispensation. The container 10 can be rotated
mechanically or, alternatively, may be rotated by hand. Alternative
designs for the medicament container 10 may also be used, such as,
for example, multiple compartment strips, either rigid or in
flexible rolls, e.g., as in a cartridge belt for an automatic
weapon, and so forth. For embodiments wherein the container 10 is
in the form of an elongate drawer that is slid into and out of a
slot 44 into position, a plurality of compartments 22 can be
arranged in a line and the container 10 slid into the slot at
varying depths for delivery of agent from each compartment 22. In
this embodiment, the container 10 is preferably provided with a
conventional locking means (not shown) so that as the container 10
is slid into the slot 44, the container 10 is locked in position
each time a compartment 22 is disposed in line with the path of
travel of the piercing member 12, thereby locating each single dose
for dispensation.
[0082] Alternatively, rather than using one or more compartments
22, 22a of the container 10 housing the agent, the entire container
10 may be hollow and may house the agent if desired.
[0083] The container 10 is typically made of conventional molded
plastics, such as acrylic, polypropylene, polyethylene, acetal, ABS
and so forth. However, other conventional materials known to those
skilled in the art may also be used.
[0084] In one embodiment, the portion of the container 10 housing
the agent may be sized so as to provide a precise dose of agent to
a user. For example, in one embodiment, the agent is housed within
one or more compartments 22, 22a having a particular diameter
and/or height. As the diameter and/or height of the compartment(s)
22, 22a increase, more agent may be contained within the
compartment(s) 22, 22a.
[0085] Compartment(s) 22, 22a for use in the present invention may
be sealed at the top end 11 and bottom end 13 with a conventional
piercable material using methods known to those skilled in the art.
In such embodiments, the thickness of the piercable material is
preferably no greater than about 0.004 inch, more preferably,
between about 0.001 and about 0.003 inch, and more preferably,
between about 0.001 and about 0.0015 inch. The desired
characteristics for such piercable materials are high tensile
strength to avoid tearing during perforation and resistance to the
passage of moisture. In one preferred embodiment, a polyester film
having heat activating adhesive on one side is used to seal the
container 10. Although polyester is preferred, other films known in
the art, such as aluminum foil, polyolefin and polypropylene may
also be employed. In a particularly preferred embodiment, a
lamination of aluminum foil and a high tensile strength material,
such as a plastic film, is used. For example, the seal may be a
multilayered seal fabricated of one or more layers of aluminum foil
and one or more layers of polyester, polyolefin and/or
polypropylene film. In such embodiments, the aluminum foil layer(s)
provide a barrier that protects the agent within the container from
moisture and other external elements and the plastic layer(s)
provide additional strength to prevent inadvertent piercing of the
easily piercable aluminum layer and also assists in preventing the
seal from becoming completely detached from the container as the
piercing member 12 passes through the seal. For example, in one
embodiment, the outermost layer is an aluminum foil layer, followed
by an inner polyester layer laminated on the aluminum foil layer. A
heat activating adhesive on the polyester layer secures the seal to
the container 10. Alternatively, the entire container 10 or the
entire top end 11 and bottom end 13 of the container 10 may be
fabricated of a piercable material.
[0086] In the manufacture of such embodiments, the container 10 is
typically first sealed on one side 11 or 13 with the piercable
sealing material. The agent is then added to the container 10 and
the container 10 is then hermetically sealed by sealing the other
side 11 or 13 of the container 10 with the piercable sealing
material.
[0087] The agent may comprise a single type of component or a blend
of components. Preferably, the agent is selected from one or more
medicinal agents and drugs. If desired, the agent may further
comprise flavoring agents, surfactants, water, alcohol or other
solvents provided that such additives are compatible with the
agents and do not adversely impact stability.
[0088] The agent may be in the form of a liquid or in the form of
finely divided particles. In one embodiment, the agent is in the
form of finely divided particles having diameters ranging from
about 1 micron to about 50 microns, more preferably, from about 2
microns to about 50 microns. In some embodiments, the agent can,
for example, be dissolved in water or another solvent in which the
agent is stable to dilute the dose of agent if, for example, the
agent is a medicament that must be administered at very low doses.
Alternatively, the agent could be dispersed in a material (e.g. a
powder or particulate material) in which the agent is stable to
dilute the dose of agent.
[0089] Preferably, the agent is provided in a pharmaceutically
effective amount for the particular condition that the device is
utilized for. For example, in one embodiment, the device is
utilized to treat respiratory conditions such as bronchial asthma,
and the agent is provided in a dose that ranges from about 5 .mu.g
to about 30 mg, more preferably, from about 10 .mu.g to about 20
mg.
[0090] The device of the present invention can be used to deliver a
variety of agents that can be used to systemically treat a variety
of conditions. By way of example, some conditions that the device
can be used to treat include, but are not limited to bronchial
asthma, diabetes and cystic fibrosis. As such, the agent can
include a variety of agents utilized to treat these conditions. For
example, some conventional agents used to treat bronchial asthma
include Albuterol, Serevent, Flovent, Ventolin, Singulair, Missing,
Azmacort, Pulmicort, Accolate, Proventil and Atrovent. Any agents
used to treat these and other conditions systemically can be used
with the present invention.
[0091] In one embodiment, the agent may comprise two or more
components housed within the container 10 as a blend. However, by
blending certain components together, the shelf-life of the blend
may, in some cases, be reduced. Thus, in another embodiment, where
it is desirable to deliver the blend of components in one
application or blast of propellant, it is preferred to provide a
container 10 wherein the two or more agents are separated from each
other until use. For example, this may be accomplished by providing
a container 10 with layers of the agents separated by, for example,
piercable material. Thus, in one embodiment, the container 10 has
at its bottom end 13 a layer of piercable material, then a layer of
an agent, then another layer of piercable material, then a layer of
another agent, and so on, finally sealed at the top end 11 with a
layer of piercable material. In such an embodiment, as the piercing
member 12 passes through the container 10, it pierces the piercable
material at the top end 11, passes through a first agent, pierces
another layer of piercable material, passes through a second agent,
and so on until the piercing member 12 exits the container 10
through the piercable material at the bottom end 13. The propellant
then is expelled to capture the plurality of agents and deliver the
blend of agents to the user.
[0092] In the manufacture of such embodiments, the container 10 is
typically first sealed on one side 11 or 13 with a piercable
sealing material. The first agent is then added to the container
10. A layer of piercable material then seals off the first agent. A
second agent is then added to the container followed by another
layer of piercable material. When each of the desired agents is
added to the container 10, the container 10 is then hermetically
sealed by sealing the other side 11 or 13 of the container 10 with
a piercable sealing material.
[0093] The mechanism for exposing the agent in the container 10 to
the propellant is shown in the various Figures in the form of a
piercing member 12, particularly a needle or a blade. However, the
mechanism is not particularly limited to such forms provided it is
capable of allowing for the agent in the container 10, which is
sealed, to be exposed to the propellant, released from the
container 10 and carried out of the second end 6 of the body member
2 by the propellant into the mouth or nose of a user.
[0094] In one embodiment, mechanism is a piercing member 12 in the
form of a needle having at least a hollow tip portion. As the
needle pierces and passes through the container 10, the agent in
the container 10 is picked up within the hollow portion of the
needle and is carried towards the second end 6 of the body member
2. Propellant expelled from the aerosol canister then forces the
agent from the needle, through the second end and into the mouth or
nose of a user or to other bodily sites.
[0095] Preferably, the needle is substantially hollow along its
length and is in line with the aerosol canister 8 such that
propellant expelled from the aerosol canister 8 travels through the
inside of the needle. As the propellant travels through the needle,
it contacts and carries the agent within the needle out of the
needle, through the second end and into the mouth or nose of the
user.
[0096] The needle may be designed such that the hollow portion is
sized and/or shaped so as to provide a precise dose of agent to a
user. For example, the hollow portion may be sized and/or shaped to
accommodate and pick up a precise dose of agent. Thus, for example,
the diameter of the hollow portion of the needle may be made larger
or smaller to accommodate more or less agent as the needle pierces
and passes through the container 10.
[0097] The needle is not limited in its cross sectional shape and,
for example, it may have a circular, oval, square, triangular, or
other cross sectional shape. Preferably, the needle has a cross
section substantially the same as the cross section of the portion
of the container housing the agent, so as to minimize any residue
of agent in the container 10.
[0098] In one preferred embodiment, the inner diameter of the
hollow needle ranges from about 0.005''to about 0.1'', more
preferably, from about 0.01'' to about 0.08''. Of course, if the
needle is not circular, the largest dimension of the cross section
can be used to approximate the mean diameter for this purpose.
[0099] In another embodiment, the mechanism is a piercing member 12
in the form of a solid needle. In this embodiment, as the needle is
moved through the container, it pierces the container 10 so as to
provide a passageway through which propellant from the aerosol
canister 8 may be expelled. Preferably, the solid needle is
designed push the agent through and out of the container 10 as it
passes through the container 10. The agent is then delivered to the
mouth or nose of a user by the propellant, which is expelled from
the aerosol canister 8 by actuation of the aerosol canister 8. The
propellant passes around the solid needle, captures the agent, and
carries the agent out of the second end and into the mouth or nose
of a user. Preferably, the propellant is expelled with adequate
force to cause substantially complete dispersion of the agent, and
inhalation by the user directs the agent to the lungs of the
user.
[0100] The solid needle is not limited in its cross sectional shape
and, for example, it may have a circular, oval, square, triangular,
or other cross sectional shape. In one embodiment, the needle has a
cross section substantially the same as the cross section of the
portion of the container 10 housing the agent, so as to minimize
any residue of agent in the container 10. As such, the propellant
expelled from the aerosol canister 8 may pass through the container
10 around the needle to capture and disperse the agent to the mouth
or nose of a user. To provide greater passageway through which the
propellant may pass to capture and disperse the agent, one or more
bypass pathways 15 may further be formed through which propellant
from the aerosol canister 8 may travel. For example, one or more
bypass pathways 15 may be situated so as to direct propellant from
the aerosol canister 8 towards the second end 6 of the body member
2 where the needle pushes the agent from the container 10. The
propellant, thus, travels through the one or more bypass pathways
15 to the second end where it meets up with the agent from the
container and disperses the agent into the mouth or nose of a
user.
[0101] Alternatively, the needle may be sized with a cross section
smaller than the cross section of the portion of the container 10
housing the agent such that the propellant may be expelled through
the portion of the container housing the agent around the outer
surface of the needle. In this embodiment, the one or more bypass
pathways 15 may also be used provide additional space through which
propellant may travel. Thus, the propellant may be expelled both
around the outer surface of the needle and through the one or more
bypass pathways 15.
[0102] In another embodiment, the mechanism is a piercing member 12
in the form of a blade having a cross section less than the cross
section of the portion of the container 10 housing the agent. As
the blade pierces the container 10, an opening is formed. Aerosol
is then expelled around the outer surface of the blade and through
the opening formed by the blade, thereby carrying the agent out of
the container 10, through the second end and into the mouth or nose
of a user.
[0103] In one embodiment, the agent within the container 10 is
sealed at the top and/or bottom of the container 10 by a
conventional piercable material such as, for example, a plastic or
metal film or combinations of plastic and metal films as described
above, to ease piercing of the container 10 and to enable further
opening up of the opening formed by the blade in the container 10.
Thus, as the propellant is forced around the blade through the
opening formed by the blade, the force of the propellant against
the piercable material surrounding the opening further opens up the
piercable material and assists in carrying the agent out of the
container 10. This embodiment is not limited to use with the blade
and, for example, in any embodiment wherein the piercing member 12
is smaller in cross section than the cross section of the portion
of the container 10 housing the agent, the container may be sealed
with a piercable material or the like that promotes further opening
up of the opening formed by the piercing member 12 in the container
10.
[0104] The blade is not limited in cross sectional shape and it
may, for example, have an "X"-shaped, "T"-shaped, "U"-shaped or
linear shaped cross section to provide openings in the form of an
"X", a "T", a "U" or a slit, respectively. It is believed that any
of these blade shapes will provide an opening wherein pressure of
the propellant expelled from the aerosol canister 8 will have a
tendency to further open up the opening formed by the blade to
facilitate escape of the agent out of the container 10.
[0105] The piercing member 12 is preferably designed to avoid
cutting a piece of the container 10 or piercable material free as
it pierces and passes through the container 10, thereby preventing
ingestion of the container 10 or piercable material. This may be
accomplished by, for example, providing a piercing member 12 that
is sharpened at the piercing end to about a 30.degree. to
60.degree. angle and blunted at the rim of the piercing member 12
opposite the apex of the point. With such an arrangement, the
piercing member 12 leaves the pierced portion of the container 10
or piercable material "hinged" to the container 10. This can
further be accomplished by fabricating the piercable material of
one or more layers of aluminum foil and one or more layers of
polyester, polyolefin and/or polypropylene film as set out above.
In such embodiments, the plastic layer(s) assists in preventing the
seal from becoming completely detached from the container as the
piercing member 12 passes through the seal. Rather, with such an
arrangement, the piercing member 12 leaves the piercable material
"hinged" to the container 10. Further, in some embodiments, by
forming the piercing member 12 smaller than the cross section of
the portion of the container housing the agent and smaller than the
piercable material sealing the portion of the container 10 housing
the agent, the piercable material is further prevented from
becoming cut free as the piercing member 12 pierces and passes
through the container 10.
[0106] In each of the embodiments of the piercing member 12, it may
be desirable to include one or more bypass pathways 15 situated so
as to divert a portion of the propellant around the piercing member
12 and around the portion of the container 10 housing the agent.
Thus, for example, a portion of the propellant expelled from the
aerosol canister may pass through the piercing member 12 and/or
around the outer surface of the piercing member 12 through the
portion of the container housing the agent, and a portion of the
propellant may pass through the one or more bypass pathways 15. The
bypass pathways 15 in conjunction with the propellant passing
through and/or around the piercing member 12, then expel the
propellant towards the second end 6 where the propellant can
capture the agent from the container 10 and assist in dispersing
the agent into the mouth or nose of a user. Such bypass pathways 15
are shown, for example, in FIGS. 4-8.
[0107] In a preferred embodiment, the bypass pathways 15 are
included in delivery devices wherein the piercing member 12 is in
the form of a hollow needle. Preferably, in embodiments wherein the
inner diameter of the hollow needle is smaller than the size of the
portion of the aerosol canister 8 through which the propellant is
expelled (e.g. the valve stem 13), the propellant expelled from the
aerosol canister 8 may be in excess of the amount that can pass
through the hollow needle at a given time. This may cause backup of
the propellant and a reduction in the force of the propellant as it
passes from the aerosol canister through the device. In this
embodiment, inclusion of the one or more bypass pathways 15
provides additional areas through which the propellant from the
aerosol canister 8 may pass, thereby eliminating backup of the
propellant at the needle and eliminating reduction in the force of
the propellant as it passes from the aerosol canister 8 through the
device and out of the second end 6. Inclusion of the bypass
pathways 15 may be advantageous in certain embodiments where it is
desirable to utilize hollow needles with small diameters, for
example, where it is desirable to deliver a small does of agent and
the size of the hollow needle determines the size of the dose
delivered.
[0108] In an alternative embodiment, the mechanism for exposing the
agent in the container to the propellant is the force of the
propellant against the sealed container 10. In some embodiments,
the device is designed such that the force of the propellant
against the sealed container removes or opens the seal on the
container 10, thereby releasing the agent from the container 10 and
carrying the agent out of the second end 6. In one embodiment, for
example, the propellant would be expelled to hit the container 10,
thereby causing the seal to open. The propellant would then force
the agent through the container 10 and through the seal at the
bottom of the container 10. Preferably, a channel 50 or similar
sealing mechanism, such as that shown in FIG. 15, would be included
that extends from the aerosol canister 8 directly to the surface of
the sealed container 10. This channel 50 would preferably be formed
so that the propellant is directed solely through the container 10
to prevent the propellant from opening the sealed container 10 and
allowing the agent to flow upwards out of the container 10 towards
the aerosol canister rather than through the container 10 towards
the second end 6 to the user. One such embodiment is shown, for
example, in FIG. 15, wherein the channel 50 is formed between the
holding member 20 and a stop block or cover 52 that is placed over
the container 10 and holding member 20. The formation of the
channel 50 is not limited to this embodiment and other means of
forming channels 50 could be used. The channel 50 is sized to
precisely surround the portion of the container 10 housing the
agent and is positioned directly against the surface of the
container 10 to provide a sealed pathway from the aerosol canister
to the container 10. This channel 50, in some embodiments, could
comprise the valve stem 13 of the aerosol canister 8. When the
valve stem comprises the channel, the valve stem 13 is the same
size or larger than the portion of the container 10 housing the
agent and the valve stem forms a seal over the portion of the
container 10 housing the agent, such that the propellant is
directed solely through the portion of the container 10 housing the
agent and propellant is prevented from flowing upwards and allowing
the agent to flow upwards out of the container 10 towards the
aerosol canister.
[0109] In one embodiment, as shown in FIGS. 4 and 5, a swirl
chamber 17 or similar compartment is located within the body member
2 between the container 10 and the second end 6. The piercing
member 12 pierces and passes through the container 10 and
propellant expelled from the aerosol canister 8 passes through the
container 10 and/or through the bypass pathway(s) 15. Propellant
and agent travel through the container 10 into the swirl chamber 17
and propellant from the bypass pathway(s) 15 is deposited into the
swirl chamber 17 where it assists in breaking up the agent and
distributing the agent within the propellant. Increased
passageways, through which additional propellant may flow through,
may be beneficial in some applications because it can provide
enhanced dispersement of the agent into the mouth or nose of a
user. Preferably, the propellant captures and disperses the agent
into the mouth or nose of a user and inhalation by the user directs
the agent to the lungs of the user.
[0110] As shown in FIGS. 9-10, the device may further include an
expansion chamber 25 positioned between the aerosol canister 8 and
the container 10. The propellant housed within the aerosol canister
8 is typically in a liquid state and, as it is expelled from the
aerosol canister 8, it expands to a gaseous state. The expansion
chamber 25 may further be included in the device to provide a space
wherein the propellant may expand to a gaseous state before it
passes through the container 10 and captures the agent.
[0111] A nozzle 27 or similar mechanism is located in between the
second end 6 of the body member 2 and the container 10. The nozzle
27 assists in regulating and directing the flow of the propellant
and agent through the second end 6 of the body member 2 and into
the mouth or nose of the user. Nozzle 27 includes an orifice 27a.
Orifice 27a typically will have a diameter of from about 0.010 to
0.060 inches, preferably 0.012 to 0.020 inches. However, dimensions
outside these ranges may be useful in delivering particular
agents.
[0112] The device may further include a sealing mechanism 19
positioned between the aerosol canister 8 and the container 10 for
sealing off the passageway of the propellant expelled from the
aerosol canister 8 through the container 10 so as to prevent escape
of propellant and to direct the propellant through the container 10
and/or bypass pathway(s) 15. For example, as shown in FIG. 2, the
sealing mechanism 19 may form a tunnel-like pathway between the
portion of the canister through which the propellant is expelled
and the container 10. Thus, as the propellant exits the aerosol
canister 8, it travels solely through the tunnel-like pathway and
through the container 10 thereby eliminating what is commonly
referred to as "blow-by."
[0113] Aerosol canisters are well known and, thus, although
described and shown with reference to a preferred embodiment, the
general features (e.g. size, shape, materials) of the aerosol
canister 8 may be in accordance with conventional aerosol
canisters.
[0114] One embodiment of the aerosol canister 8 is shown in FIG. 3.
As shown, the aerosol canister 8 has a valve stem 13 extending from
its bottom end. The valve stem 13 may be connected to the aerosol
canister 8 via a collar 16 or similar connection mechanism. The
valve stem 13 is movable within the aerosol canister 8 such that as
pressure is applied to the valve stem 13 in a direction towards the
aerosol canister 8, the valve stem 13 is depressed within the
aerosol canister 8. This may be accomplished by, for example, a
stop member 9 positioned between the aerosol canister 8 and
container 10, such that the aerosol canister 8 contacts the stop
member 9 as the aerosol canister 8 is moved downwards towards the
container 10. Located through a side wall of the valve stem 13 is
an aperture 31. When the valve stem 13 is in its normal state
extending out of the aerosol canister 8, as shown in FIG. 8, the
aperture 31 is located outside the aerosol canister 8. As pressure
is applied to the valve stem 13 and the valve stem 13 is depressed
into the aerosol canister 8, the aperture 31 enters the aerosol
canister 8, thereby actuating the aerosol canister 8. Upon
actuation, the propellant within the aerosol canister 8 is driven
out of the aerosol canister through the aperture 31 and through the
valve stem 13.
[0115] The propellant may be selected from those used in the art
such as, for example, liquid chlorofluorocarbons (CFCs), which
include fluorotrichloromethane, dichlorodifluoromethane and
dichlorotetrafluoroethane. However, because CFC's are believed to
be destructive of the ozone layer, hydrofluorocarbons (HFCs) such
as, for example, 1,1,1,2-tetrafluoroethane (also commonly referred
to as propellant 134a, HFC-134a, and HFA-134a) and
1,1,1,2,3,3,3-heptafluoropropane (also commonly referred to as
propellant 227, HFC-227, and HFA-227), are preferred because they
are believed to be more ozone friendly than CFC's.
[0116] In addition to propellants, the aerosol canister 8, if
desired, may also contain a variety of agents. For example, the
aerosol canister 8 may further house an agent in suspension or
solution. The agent in suspension or solution may be, for example,
selected from flavoring agents, surfactants, water, alcohol or
other solvents, and medicinal agents.
[0117] The aerosol canister 8 may be prepared by conventional
methods such as, for example, pressure filling or cold filling the
propellant into the canister. Such methods are well known to those
skilled in the art. Conventional valves, preferably metering
valves, are used to deliver the propellant of the present
invention. Such metering valves deliver a particular amount of
propellant per actuation. Thus, the use of metering valves may be
desirable to automatically provide the desirable amount of
propellant required for a particular application. Preferably, the
aerosol canister 8 having a metering valve contains an amount of
propellant for multiple uses.
[0118] It is also possible to use other types of valves such as,
for example, open flow type valves. Such valves allow for expulsion
of the contents of the can for as long as the valve is depressed.
Preferably, because it is possible with such valves to deliver an
excessive amount of propellant, such aerosol canisters 8 of this
form are single-use pressurized containers holding an amount of
propellant suitable for a single use. Thus, after a single use, the
aerosol canister 8 is either replaced or the device thrown out.
[0119] In a preferred embodiment, the aerosol canister 8 is movable
within the body member 2 towards the container 10 and the piercing
member 12 is situated such that, as the aerosol canister 8 is moved
towards the container 10, the piercing member 12 likewise moves
towards the container 10. For example, the piercing member 12 may
be directly mounted to the aerosol canister 8 via the valve stem
13. In another embodiment, as shown in FIGS. 1, 2, 7 and 8, a
spring 29 and pin 30 mechanism connects the piercing member 12 to
the valve stem 13. In such an embodiment, as the aerosol canister 8
is depressed downwards within the body member 2 towards the
container 10, the spring 29 is compressed and the piercing member
12 pierces and passes through the container 10. The aerosol
canister 8 is actuated and propellant is expelled. Then, when the
user releases the aerosol canister 8, the spring 29 and pin 30
mechanism acts to bring the aerosol canister 8 back upwards in the
body member 2 to its start position.
[0120] In another embodiment, as shown in FIGS. 18b-e, a stop
member 9 is positioned between the aerosol canister 8 and the
container 10 housing the agent. A spring 60 or similar mechanism is
further situated between the stop member 9 and the container 10.
The container 10 can be held within the body member 2 by a holding
mechanism comprising a lower portion 20a and an upper portion 20b
which fit together and which hold the container 10 as shown in
FIGS. 18b-c. The nozzle 27 is preferably located in the lower
portion 20a of the holding mechanism, through which the agent and
propellant are expelled from the device. Prior to use, the delivery
device 1 is configured as shown in FIG. 18c, with the valve stem 14
positioned in the stop member 9 and the spring expanded to separate
the piercing member 12 from the container 10. The device can then
be actuated by pushing the aerosol canister 8 downwards towards the
container, as shown in FIG. 18d. As the aerosol canister 8 is moved
downwards, the stop member 9 is also pushed downwards, thereby
compressing the spring 60. The piercing member 12 passes through
the container 10 and picks up the agent. As the aerosol canister 8
is moved further downwards, the valve stem 14 is pushed upwards
into the aerosol canister 8, as shown in FIG. 18e, thereby
actuating the aerosol canister 8 to expel propellant. The
propellant passes through the piercing member 12 (also around the
piercing member and/or through bypass pathways 15 in some
embodiments), captures and disperses the agent out of the second
end 6 of the device. As shown in FIG. 18e, the lower portion 20a of
the holding mechanism may include a lumen 48 through which the
propellant and agent pass and exit through nozzle 27, which directs
the propellant and agent through the second end 6.
[0121] In one embodiment, the valve stem 13 of the aerosol canister
8 is the piercing member. Thus, in this embodiment, as the aerosol
canister 8 is moved downwards, the valve stem 13 pierces and passes
through the container 10. The valve stem 13 may be hollow such that
as the valve stem 13 pierces and passes through the container 10,
agent is picked up within the valve stem 13. The aerosol canister 8
is then actuated and propellant is expelled through the hollow
valve stem 13, thereby capturing and dispersing the agent out of
the valve stem 13 and into the mouth or nose of a user. Preferably,
in this embodiment, the valve stem 13 is designed with a cross
section substantially the same as the cross section of the portion
of the container housing the agent, so as to minimize any residue
of agent in the container 10. The valve stem 13 and/or portion of
the container 10 housing the agent may further be designed so as to
accommodate a precise dose of agent.
[0122] Alternatively, it is possible to provide as a piercing
member a valve stem 13 with a cross section substantially the same
as the cross section of the portion of the container 10 housing the
agent and a narrow hollow portion such that as the valve stem 13
pierces and passes through the container 10, the agent is pushed
through the container 10 rather than or in addition to being picked
up within the valve stem 13. Then, upon actuation of the aerosol
canister 8, propellant expelled through the valve stem 13 contacts
and disperses the agent picked up in the valve stem and/or pushed
through the container 10 into the mouth or nose of a user.
[0123] In some embodiments, wherein the valve stem 13 is the
piercing member 12, the valve stem 13 can be sharpened at the
piercing end to facilitate piercing of the container 10 and to
avoid cutting a piece of the piercable material free as it pierces
and passes through the container 10. As set out above, for example,
the piercing member, in this embodiment, the valve stem 13, can be
sharpened to about a 30.degree. to 60.degree. angle and blunted at
the rim of the piercing member 12 opposite the apex of the
point.
[0124] The device of the present invention is particularly superior
to other devices in that it delivers a very high emitted dose of
the agent from the container 10. As used herein, "emitted dose" is
defined as the percentage of the agent housed in a single dose
compartment 22 of the container 10 that is emitted from the device
during use.
[0125] The exceptionally high emitted dose using the device of the
present invention is achieved by the present invention by reducing
the amount of residue that collects and remains in the device. This
can be accomplished in a number of ways.
[0126] In some embodiments wherein the mechanism comprises a
piercing member 12 in the form of a hollow needle, the hollow
piercing member 12 has an outer diameter that is approximately the
same size as the diameter of the compartment 22 housing the agent.
This minimizes the amount of agent that collects between the outer
diameter of the piercing member 12 and the walls of the compartment
22 as the piercing member passes through and picks up the agent.
Further, the thickness of the piercing member 12 wall (i.e. the
distance between the outer diameter of the hollow piercing member
and the inner diameter of the hollow piercing member) is preferably
minimized so that as the piercing member 12 passes through the
container 10, most if not all of the agent is picked up inside the
hollow of the piercing member 12. Further, any agent not picked up
inside the hollow of the piercing member 12 is pushed through the
container by the walls of the piercing member. In this embodiment,
because the piercing member 12 has an outer diameter that is
approximately the same size as the diameter of the compartment 22
housing the agent, approximately all of the agent from the
compartment 22 is either picked up within the hollow of the
piercing member 12 or pushed out of the compartment 22 by the walls
of the piercing member. Agent collected between the outer diameter
of the piercing member 12 and the compartment 22 walls is
minimized.
[0127] Likewise, in some embodiments wherein the mechanism is a
solid piercing member 12, the piercing member 12 has an outer
diameter that is approximately the same size as the diameter of the
compartment 22 housing the agent. This minimizes the amount of
agent that collects between the outer diameter of the piercing
member 12 and the compartment 22 walls as the piercing member
passes through the compartment 22. As the solid piercing member 12
passes through the compartment 22, approximately all of the agent
is pushed through the compartment towards the second end of the
device by the piercing member 12. Agent collected between the outer
diameter of the piercing member 12 and the compartment 22 walls is
minimized.
[0128] During use, as the piercing member 12 passes through the
container 10, it first pierces and passes through the piercable
material that seals the agent in the container 10. Preferably, the
piercable material is pierced but remains connected to the
container 10 to prevent the piercable material from being pushed
out of the second end 6 of the device into the mouth or nose of the
user. The piercable material is described above and, preferably, is
formed of one or more thin layers of material (e.g. polyester,
aluminum foil, polyolefin and polypropylene. The thickness of the
piercable material is preferably no greater than about 0.004 inch,
more preferably, between about 0.001 and about 0.003 inch, and more
preferably, between about 0.001 and about 0.0015 inch. In some
embodiments, to prevent the piercable material from becoming
separated from the container as the piercing member 12 passes
through, some clearance space is preferably provided between the
piercing member 12 and the walls of the compartment 22 housing the
agent. This clearance space allows the piercable material to be
pushed up against the wall of the compartment 22 by the piercing
member 12. If insufficient clearance is provided, then the
piercable material may become separated from the container 10.
Thus, a clearance at least as thick as the piercable material is
preferably provided between the piercing member 12 and the inner
walls of the compartment 22. In other words, the piercing member 12
is preferably slightly smaller than the diameter of the compartment
22 housing the agent by at least the thickness of the piercable
material. The clearance space can be provided on one side of the
piercing member 12 as it passes through the compartment 22 or it
can be provided on both sides of the piercing member 12. For
example, if the piercable material is 0.001 inch thick, then the
piercing member 12 could be about 0.001 smaller in diameter than
the diameter of the compartment 22 and the piercing member 22 would
be aligned to pass through the compartment 22 with at least about
0.001 inch clearance on one side of the compartment and
approximately no clearance on the other side of the compartment 22,
for example, as shown in FIG. 16a. Alternatively, for example, if
the piercable material is 0.001 thick, then the piercing member 12
could be at least about 0.002 smaller in diameter than the diameter
of the compartment 22 and the piercing member 12 would be aligned
to pass through the center of the compartment 22 with at least
about 0.001 inch clearance on each side of the compartment 22, for
example, as shown in FIG. 16b.
[0129] In some of the embodiments, it is desirable to include a
guiding mechanism that ensures that the piercing member 12 passes
through the container 10 precisely where intended. The guiding
mechanism could, for example, ensure that the piercing member 12
passes precisely through the center of the compartment 22 or in any
other place within the compartment. For example, in the embodiment
above where the piercable material is 0.001 inch thick and the
piercing member 12 is at least about 0.002 inch smaller in diameter
than the diameter of the compartment 22, the guiding mechanism
could ensure that the piercing member 12 is aligned to pass through
the center of the compartment 22 with at least 0.001 inch clearance
space on each side of the compartment 22. In the embodiment above
where the piercable material is 0.001 inch thick and piercing
member 12 is at least about 0.001 inch smaller in diameter than the
diameter of the compartment 22, the guiding mechanism could ensure
that the piercing member 22 is aligned to pass through the
compartment 22 with at least about 0.001 inch clearance space on
one side of the compartment 22 and approximately no clearance on
the other side of the compartment 22.
[0130] In one embodiment, the guiding mechanism is in the form of
one or more pins 53 and corresponding apertures 54 located within
the device, for example, as shown in FIG. 17. Thus, for example,
one or more pins 53 (or apertures) could be located on a portion of
the device that moves downwards as the source of negative pressure
and piercing member 12 are moved downwards and one or more
apertures 54 (or pins) could be located near the container 10. As
the source of negative pressure and piercing member 12 are moved
downwards, the pins 53 will slide into the apertures 54 when
properly lined up. If the alignment is off, the pins 53 and
apertures 54 will prevent further downward movement and will assist
in realigning the device so that the pins 53 and openings 54 line
up. In a particularly preferred embodiment, two pins 53 and two
corresponding apertures 54 are located in the device, for example,
as shown in FIG. 17, for aligning the piercing member 12 to pass
through the proper portion of the container 10.
[0131] The amount of residue that is collected and remains within
the compartment 22 after use, e.g. along the side walls of the
compartment 22, can be further eliminated by providing an aerosol
canister that expels propellant not only through the hollow
piercing member 12 but also through the compartment 22 around the
piercing member 12.
[0132] In some embodiments, the amount of residue that is collected
and remains in the device is further reduced by designing the
second end 6 ("mouthpiece") accordingly. In general, the second end
6 is designed to inhibit collection of residue along the surfaces.
For example, in some embodiments, the second end 6 through which
the agent and propellant exit the device and enter the user's mouth
is enlarged. When the propellant and agent exit the second end 6,
the stream of the propellant and agent is believed to expand into a
generally conical-like shape. Thus, by forming the second end 6 to
prevent impingement of the propellant and agent against the inner
walls of the second end 6, collection and residue can be minimized.
This can be done, for example, by forming the sides of the second
end 6 to flared outwards, for example, as shown in FIG. 18
[0133] The collection of residue in the device is further minimized
by eliminating potential surfaces and crevices within the device
where the agent can collect. In one preferred embodiment shown in
FIG. 20, accumulation is reduced by having piercing member 12 stop
just above a curved surface 58 that sweeps down towards nozzle 27
as shown in FIG. 20c. This is also shown in FIG. 18.
[0134] Further, when the piercing member 12 is passed through the
container 10 and the propellant expelled to drive the agent through
the second end 6, the piercing member 12 is preferably positioned
at the top of the radius of curved surface 58, as shown in FIG. 20.
This further minimizes the collection of agent within the inner
surfaces of the device.
[0135] In the device shown in FIG. 20, the drawer-like member is
provided with a guiding mechanism in the form of one or more pins
53 and corresponding structure, e.g., apertures 54 shown in FIG. 2
la to accept pins 53. Similar to the embodiment shown in FIG. 17,
pins 53 pass through notches 53a in the drawer on either side of
the container in order to perfectly align the passage of piercing
member 12 through the aperture and thereby capture the maximum
amount of agent. Guide pins 53 are longer than the needle, so that
pins 53 pass through notches 53a to sufficiently secure drawer 40
before piercing member 12 passes through container 10 in
drawer-like member 40. Piercing member 12 thus stops at radius 58
as shown in FIG. 20c, thereby centralizing piercing member 12 with
great accuracy and thereby maximizing capture of the agent.
[0136] The collection of residue in the device can further be
reduced by providing piercing member 12 or other mechanism with a
beveled tip, as shown in FIG. 1, wherein the beveled tip is
positioned to face the exit through which the propellant and agent
exit the second end 6. This will direct the propellant and agent
through the exit of the second end 6 so that the agent and
propellant does not impinge on the inner surfaces of the second end
6.
[0137] Still further, collection of residue in the device is
further minimized by providing highly polished inner surfaces of
molded parts forming the device as opposed to machined
surfaces.
[0138] The present device is capable of delivering particularly a
high respirable fraction of agent. As used herein, the respirable
fraction is the percentage of the dose that is delivered to the
lungs. With prior delivery devices, a respirable fraction of less
than 30% was possible. However, with the present invention,
respirable fractions of greater than 30%, more preferably, greater
than 35%, more preferably, greater than 40%, more preferably,
greater than 45%, more preferably, greater than 50%, more
preferably, greater than 60%, more preferably, greater than 65%,
more preferably, greater than 70%, more preferably, greater than
75%, more preferably, greater than 80%, and even greater than 85%
can be achieved.
[0139] The use of the delivery device 1 of the present invention
can be further understood from the following discussion relating to
a method for treating bronchial asthma and with reference to FIGS.
1-10.
[0140] To operate the device, a user places the second end 6 of the
device near the bodily site. For example, when used to deliver the
agent to the mouth or nose, the user inserts the second end 6 of
the device into the mouth or nose. The user then presses the
aerosol canister 8 downwards towards the container 10 within the
body member 2 until the piercing member 12 pierces and passes
through the container 10, thereby picking up and carrying the agent
towards the second end 6 of the device. The aerosol canister 8 is
actuated to expel propellant through the body member 2 towards the
second end 6. The expelled propellant captures and disperses the
agent into the mouth or nose of the user. During use, the
propellant captures and disperses the agent into the mouth or nose
of the user and inhalation by the user directs the agent to the
lungs. When used to deliver the agent to other bodily sites, for
example, to the ear of a user, the device is used as described
above, without the user's inhalation to direct the agent.
[0141] The present invention also includes kits that comprise one
or more delivery device 1 of the invention. Kits of the invention
also may be include one or more containers 10 and aerosol canister
8 for use with the delivery device 1, and/or written instructions
for use of the delivery device 1 and other components of the
kit.
[0142] The delivery device 1 and methods of use of the present
invention will be further illustrated with reference to the
following Examples which are intended to aid in the understanding
of the present invention, but which are not to be construed as a
limitation thereof.
[0143] All documents mentioned herein are incorporated by reference
herein in their entirety.
EXAMPLES
[0144] A number of tests were performed to analyze the dispersement
of the propellant and agent out of the second end of the device. In
these tests, the delivery device of the present invention was used
to deliver the propellant with dispersed agent into a "black box"
shown in FIG. 19. The black box comprises an elongate box
approximately 2 feet long, 1.0 foot high and 1.0 foot wide. The
black box has, at one end of its length, an opening through which
the second end 6 of the device is inserted. Along the front of the
black box is a short wall shielding a series of eight to ten lights
from the camera lens and highlighting the powder stream discharged
into the box. A camera on a tripod operating at, for example,
approximately 300 frames/second, in some cases 3000 frames/second
takes snapshots of the interior of the black box. The device of the
present invention is actuated to dispel propellant and agent
through the opening in the black box as the camera takes snapshots
of the interior of the black box.
[0145] In each of the tests, the propellant with dispersed agent
exits the second end 6 of the present device in the form of a soft,
low velocity cloud. Further, when the device is used to deliver the
propellant with dispersed agent into a large open space, e.g. a
room, that is well lit, the propellant with dispersed agent exits
the second end 6 of the present device in the form of a soft, low
velocity cloud that remains suspended and remains visible for
greater than about 3 seconds post actuation.
[0146] Without being bound by theory, it is believed that the
suspension of the mixture by the present device provides a higher
respirable fraction of agent. With prior devices, for example, the
propellant and agent mixture is expelled from the devices in a high
velocity, liner stream. This high velocity, linear stream impinges
on the back of the mouth and throat of the user. With the present
device, on the other hand, the mixture is delivered to the mouth in
a soft, low velocity, cloud-like formation that remains suspended
as the user inhales and directs the mixture down the throat to the
treatment area (e.g. lungs).
[0147] The foregoing description of the invention is merely
illustrative thereof, and it is understood that variations and
modifications can be effected without departing from the scope or
spirit of the invention as set forth in the following claims.
* * * * *