U.S. patent application number 16/578498 was filed with the patent office on 2020-10-01 for medication delivery systems and methods.
The applicant listed for this patent is Eli Lilly and Company. Invention is credited to Jaime Ray ARNETT, Andrew Thomas SNOW.
Application Number | 20200306137 16/578498 |
Document ID | / |
Family ID | 1000005087232 |
Filed Date | 2020-10-01 |
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United States Patent
Application |
20200306137 |
Kind Code |
A1 |
ARNETT; Jaime Ray ; et
al. |
October 1, 2020 |
MEDICATION DELIVERY SYSTEMS AND METHODS
Abstract
The present disclosure relates to a medication delivery system
including a medication administration device, a medication within
the medication administration device, a container defining a cavity
receiving the medication administration device, and a cap attached
to the container and sealing the medication administration device
within the cavity. The medication administration device includes an
actuator extending from a body and operable to expel the medication
by depressing the actuator into the body. The cap includes hold
down members positioned to bear against the body of the medication
administration device to prevent movement of the medication
administration device toward the cap beyond a predetermined
distance. The medication administration device is thereby
prevented, inter alfa, from prematurely discharging the medication
during storage and transport.
Inventors: |
ARNETT; Jaime Ray; (Fishers,
IN) ; SNOW; Andrew Thomas; (Fishers, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eli Lilly and Company |
Indianapolis |
IN |
US |
|
|
Family ID: |
1000005087232 |
Appl. No.: |
16/578498 |
Filed: |
September 23, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62826093 |
Mar 29, 2019 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61J 1/1425 20150501;
A61K 38/28 20130101; A61K 9/14 20130101 |
International
Class: |
A61J 1/14 20060101
A61J001/14; A61K 9/14 20060101 A61K009/14 |
Claims
1. A medication delivery system comprising: a medication
administration device comprising a body having a discharge end
defining a medication discharge port and an opposed actuator end,
the medication administration device including a medication
reservoir, the medication administration device further including
an actuator for ejecting a medication from the reservoir through
the discharge port, the actuator extending out of the actuator end
of the body, the actuator being linearly moveable from an extended
position to a depressed position, the discharge port being sealed
when the actuator is in the extended position and the discharge
port being open when the actuator is in the depressed position, the
actuator being operable to discharge the medication from the
reservoir upon axial movement of the actuator from the extended
position to the depressed position; said medication received within
the reservoir of the medication administration device; a container
having an axially extending side wall and a closed bottom wall
defining a cavity having an access opening defined by an end wall
portion, the medication administration device being received within
the cavity with the discharge end adjacent the closed bottom wall
of the container, and a desiccant disposed within the cavity, the
desiccant having an annular shape to define an opening to receive
the medication discharge port of the medication administration
device, in which the container includes a continuous interior
shoulder disposed radially inward from an interior surface of the
axially extending side wall, the continuous interior shoulder
axially spaced from the closed bottom wall at a distance to
securely retain the desiccant between the continuous interior
shoulder and the closed bottom wall, in which the desiccant
includes an annular notch defined along a radially outer surface of
the desiccant, the annular notch configured to receive the
continuous interior shoulder when the desiccant is disposed within
the container; and a cap coupled to the container, and movable
relative to the container between an open position and a closed
position, the cap in the closed position is sealably engaged with
the container to enclose the medication administration device
within the cavity, the cap defining one or more hold down members,
wherein, when the cap is in the closed position, the one or more
hold down members extends axially from the cap in a direction
toward the closed bottom wall and is sized to allow at most a
predetermined amount of axial movement of the medication
administration device in the direction away from the closed bottom
wall, wherein the one or more hold down members is contactable with
a non-actuator portion of the medication administration device.
2. The medication delivery system of claim 1 in which the one or
more hold down members is a rigid structure.
3. The medication delivery system of claim 2 in which the body of
the medication administration device includes a radially extending
circumferential surface surrounding the actuator and facing away
from the closed bottom wall, wherein, when the cap is in the closed
position, the one or more hold down members is positioned radially
outside the actuator to be contactable against the circumferential
surface.
4. The medication delivery system of claim 3 in which the cap
having a cup shaped body comprising a cap side wall and defining a
recess configured to receive a portion of the actuator, wherein the
one or more hold down axial members extends out beyond the
recess.
5. The medication delivery system of claim 4 in which an interior
surface of the cap side wall and an interior surface of the one or
more hold down members define a continuous surface.
6. The medication delivery system of claim 4 wherein the one or
more hold down members comprises a pair of hold down axial
projections extending from the cup shaped body of the cap at
radially opposite sides of the cap.
7. The medication delivery system of claim 4 wherein the cap
includes an outer rim disposed around the cup shaped body, a
circumferential flange depending axially from a bottom wall facing
surface of the outer rim, the one or more hold down members
disposed spaced radially inward relative to the flange, and
extending axially beyond the flange.
8. The medication delivery system of claim 2 in which the cap is
coupled to the container by a hinged connection.
9. The medication delivery system of claim 8 in which the hinged
connection is a living hinge.
10. The medication delivery system of claim 8 in which the one or
more hold members includes two hold down members, the two hold down
members disposed circumferentially away from one another, the
hinged connection disposed circumferentially between the two hold
down members.
11. The medication delivery system of claim 8 in which the one or
more hold members includes a single hold down member.
12. The medication delivery system of claim 3 in which the cap
includes an outer rim extending radially from the cup shaped body,
and a circumferential flange depending axially from a bottom wall
facing surface of the outer rim, and the container and the cap
comprise a latch member to secure the cap to the container in the
closed position, the latch member including a latch extending
axially from the outer rim of the cap, wherein said flange extends
axially beyond the latch.
13. The medication delivery system of claim 12 in which the one or
more hold down members of the cap comprises two hold down members,
the two hold down members disposed circumferentially away from one
another, the hinged connection disposed circumferentially between
the two hold down members, and the latch disposed circumferentially
between the two hold down members radially opposite to the hinged
connection.
14. A medication delivery system comprising: a medication
administration device comprising a body having a discharge end
defining a medication discharge port and an opposed actuator end, a
medication reservoir containing a medication, and an actuator for
ejecting the medication from the reservoir through the discharge
port, the actuator extending out of the actuator end of the body,
the actuator being linearly moveable from an extended position to a
depressed position, the discharge port being sealed when the
actuator is in the extended position and the discharge port being
open when the actuator is in the depressed position, the actuator
being operable to discharge said medication from the reservoir upon
axial movement of the actuator from the extended position to the
depressed position; and a container comprising an axially extending
side wall and a closed bottom wall defining a cavity having an
access opening defined by an end wall portion, the medication
administration device being received within the cavity with the
discharge end adjacent the bottom wall of the container, a cap
hingedly coupled to the container, the cap movable relative to the
container between an open position and a closed position, the cap
in the closed position is sealably engaged with the container to
enclose the medication administration device within the cavity, and
a desiccant disposed within the cavity, the desiccant having an
annular shape to define an opening to receive the medication
discharge port of the medication administration device, wherein the
body of the medication administration device includes a radially
extending circumferential surface surrounding the actuator and
facing away from the closed bottom wall, in which the container
includes a continuous interior shoulder disposed radially inward
from an interior surface of the axially extending side wall of the
container, the continuous interior shoulder axially spaced from the
closed bottom wall at a distance to securely retain the desiccant
between the continuous interior shoulder and the closed bottom
wall, in which the desiccant includes an annular notch defined
along a radially outer surface of the desiccant, the annular notch
configured to receive the continuous interior shoulder when the
desiccant is disposed within the container, wherein the cap defines
a pair of hold down members, wherein, when the cap is in the closed
position, the hold down members extend axially from the cap in a
direction toward the closed bottom wall and sized to allow at most
a predetermined amount of axial movement of the medication
administration device in the direction away from the closed bottom
wall, wherein each of the hold down members has a contact end
surface contactable with the circumferential surface of said
medication administration device, radially outside the actuator of
the medication administration device, wherein the hold down members
are configured to allow each of the contact end surfaces to
maintain its relative axial position and radial position relative
to the cap and the circumferential surface of said device.
15-16. (canceled)
17. The medication delivery system of claim 14 in which the
medication administration device is an air dispersion device.
18. The medication delivery system of claim 17 in which the
medication is an intranasal delivery powder.
19. The medication delivery system of claim 18 in which the powder
is glucagon.
20. A method for providing a medication delivery system containing
a glucagon composition, the method comprising: positioning a
medication administration device within a container, the medication
administration device comprising a body having a discharge end
defining a medication discharge port and an opposed actuator end,
the medication administration device including a medication
reservoir containing a glucagon medication, the medication
administration device further including an actuator for ejecting
said glucagon medication from the reservoir through the discharge
port, the actuator extending out of the actuator end of the body,
the actuator being linearly moveable from an extended position to a
depressed position, the discharge port being sealed when the
actuator is in the extended position and the discharge port being
open when the actuator is in the depressed position, the actuator
being operable to discharge the glucagon medication from the
reservoir upon axial movement of the actuator from the extended
position to the depressed position; the container having a side
wall and a closed bottom wall defining a cavity having an access
opening defined by an end wall portion, the cavity receiving the
medication administration device within the cavity with the
discharge end adjacent the closed bottom wall of the container, and
a desiccant disposed within the cavity, the desiccant having an
annular shape to define an opening to receive the medication
discharge port of the medication administration device, in which
the container includes a continuous interior shoulder disposed
radially inward from an interior surface of the side wall, the
continuous interior shoulder axially spaced from the closed bottom
wall at a distance to securely retain the desiccant between the
continuous interior shoulder and the closed bottom wall, in which
the desiccant includes an annular notch defined along a radially
outer surface of the desiccant, the annular notch configured to
receive the continuous interior shoulder when the desiccant is
disposed within the container; and sealing a cap to the container
to provide a hermetic seal enclosing the medication administration
device within the cavity, the cap defining one or more hold down
members positioned and configured to interfere with movement of the
medication administration device to allow at most a predetermined
amount of movement of the medication administration device in the
direction away from the closed bottom wall without the actuator
contacting an axial end surface of the cap.
21. A medication container and cap assembly for containing a
medication administration device, the medication administration
device comprising a body having a discharge end defining a
medication discharge port and an opposed actuator end, the
medication administration device including a medication reservoir
containing a medication, the medication administration device
further including an actuator for ejecting the medication from the
reservoir through the discharge port, the actuator extending out of
the actuator end of the body, the actuator being linearly moveable
from an extended position to a depressed position, the discharge
port being sealed when the actuator is in the extended position and
the discharge port being open when the actuator is in the depressed
position, the actuator being operable to discharge the medication
from the reservoir upon axial movement of the actuator from the
extended position to the depressed position, the assembly
comprising: a container having a side wall and a closed bottom wall
defining a cavity having an access opening defined by an end wall
portion, the cavity being sized and configured to receive the
medication administration device, the medication administration
device being receivable within the cavity with the discharge end
adjacent the closed bottom wall of the container, and a desiccant
disposed within the cavity, the desiccant having an annular shape
to define an opening to receive the medication discharge port of
the medication administration device, in which the container
includes a continuous interior shoulder disposed radially inward
from an interior surface of the side wall, the continuous interior
shoulder axially spaced from the closed bottom wall at a distance
to securely retain the desiccant between the continuous interior
shoulder and the closed bottom wall, in which the desiccant
includes an annular notch defined along a radially outer surface of
the desiccant, the annular notch configured to receive the
continuous interior shoulder when the desiccant is disposed within
the container; and a cap coupled to the container by a hinged
connection, and configured to mate with the container when in a
closed position and provide a hermetic seal to enclose the
medication administration device inserted within the cavity, the
cap defining a pair of hold down members positioned and configured
to interfere with movement of the medication administration device
to allow at most a predetermined amount of movement of the
medication administration device in the direction away from the
closed bottom wall, the hold down members disposed
circumferentially away from one another, the hinge connection
disposed circumferentially between the two hold down members.
22. The assembly of claim 21 in which the container side wall is
sized to allow an end portion of the actuator to extend out beyond
the container side wall, the cap having a cup shaped body defining
a recess configured to receive the end portion of the actuator,
each of the hold down members extending from the cup shaped body,
wherein an interior surface of the cup shaped body that faces the
recess and an interior surface of the hold down members define a
continuously smooth surface.
23-26. (canceled)
27. The medication delivery system of claim 1 in which the
medication administration device is an air dispersion device.
28. The medication delivery system of claim 27 in which the
medication is an intranasal delivery powder.
29. The medication delivery system of claim 28 in which the powder
is glucagon.
Description
TECHNICAL FIELD
[0001] This disclosure relates to medication delivery systems which
provide for maintaining a medication administration device and
contained medication in a viable condition. The disclosure further
pertains to medical delivery systems in which the medication
administration device may be quickly and easily removed from the
container assembly for use.
BACKGROUND
[0002] Medication systems including medication administration
devices with contained medications need to be maintained in proper
conditions from the time the medication administration device is
filled with the medication to eventual use by a patient. There is a
particular need for such delivery systems which enhance the
viability of pre-filled medication administration devices during
storage and transport. Medication administration devices of this
type are susceptible to a variety of quality issues. For example,
the US Food and Drug Administration (FDA) recently issued draft
guidance on quality considerations for aerosol drug delivery
systems. See,
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida-
nces/UCM070573.pdf (April 2018). The guidance provides
recommendations for the development and manufacture of aerosols.
The guidance addresses quality profiles that include elements such
as stability, dosage form, aerodynamic performance, and the
delivery system. All of these aspects impact the utility of the
dispensed medication.
[0003] In a particular aspect, the disclosed medication delivery
system is used in connection with the delivery of glucagon.
Normally, glucagon is produced in the pancreas and works with
insulin to regulate blood glucose levels in the body. Glucagon is
released in the body when blood glucose levels are low, signaling
the liver to release glucose into the blood. People with diabetes
either no longer produce insulin (Type 1) or their bodies are less
able to respond to insulin (Type 2).
[0004] Both the medication administration device and the medication
need to be provided in a manner that materially enhances the safety
and efficacy of the dispensed medication. The medication may be
provided with a stable environment to maintain proper moisture
content, aerodynamic particle size distribution, and/or activity.
The medication administration device may be maintained under proper
conditions. Medication administration devices can be retained in a
hermetically sealed enclosure prior to use. This can inhibit
contact with moisture, foreign particulate matter, impurities,
degradants, and other deleterious materials which might impair the
proper functioning of the medication administration device. The
medication administration devices should also be protected from
physical damage and premature actuation.
[0005] While insulin and insulin pumps have evolved into highly
technical and effective tools for treating diabetes, the methods
for delivering emergency glucagon to save the lives of people with
diabetes experiencing hypoglycemia have not progressed as far as
desirable. Reconstituting powdered glucagon and injecting it can be
difficult, and often the person with diabetes needs assistance. A
simple nasal spray allows glucagon to be administered quickly and
easily in a rescue situation.
[0006] For those with Type 1 diabetes (T1D), too much insulin can
limit the body's ability to release glucagon as blood glucose
levels fall; thus, if the person with T1D is unable to eat or drink
sugar, treatment with glucagon is needed to bring blood glucose
levels back into balance. Severe hypoglycemia can lead to
hospitalization or even death in extreme cases. Maintaining the
integrity of both the glucagon and its delivery device is therefore
understood to be of great importance.
SUMMARY
[0007] In accordance with an aspect of the present disclosure, a
medication delivery system is provided which comprises a medication
administration device, medication received within the medication
administration device, a container defining a cavity to receive the
medication administration device, and a cap to seal the medication
administration device within the container. The medication
administration device is of a type in which an actuator extends
from a body and is movable from the extended position to a
depressed position to expel the medication. The container defines
an access opening to a cavity into which the medication
administration device is placed. A cap is secured to the container
in the closed position to form a hermetic sealing of the medication
administration device within the cavity. The cap includes one or
more hold down members which are position to prevent the medication
administration device from moving against the cap.
[0008] In another aspect, a training system includes a training
module that is configured to simulate the medication delivery
device, but does not contain a medication product, and/or a
training container configured to simulate operation of the product
container.
[0009] It is an object to provide a cap and container assembly
which provides a secure and sealed enclosure for the medication
administration device, while also including components which
prevent premature discharge of the medication.
[0010] Another object is to provide a medication delivery system
which contains a medication administration device in a manner that
the medication administration device can be readily and quickly
removed from a container for use.
[0011] Methods for the containment of medication administration
devices in a manner to maintain the operability of the medication
administration device and the viability of the contained medication
are also disclosed.
[0012] Other objects and advantages of the disclosed medication
delivery system will be apparent to those of ordinary skill in the
art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The features and advantages of the present disclosure will
become more apparent to those skilled in the art upon consideration
of the following detailed description taken in conjunction with the
accompanying figures.
[0014] FIG. 1 is a perspective view of components useful in
conjunction with a medication delivery system, depicting a
medication administration device and a container in a side-by-side
relationship.
[0015] FIG. 2 is a perspective view of an embodiment of the
medication delivery system, depicting the device inserted within
the container with the cap in an open position.
[0016] FIG. 3 is a side, cross-sectional view of the container of
the medication delivery system of FIG. 2 with the device
inserted.
[0017] FIG. 4 is a side, elevational view of the medication
delivery system of FIG. 2, showing the hinged connection of the cap
with the container.
[0018] FIG. 5 is a side, elevational view of the container with the
cap in a closed position, showing additional details of a living
hinge.
[0019] FIG. 6 is a partial perspective view of the medication
delivery system shown in FIG. 2, showing details of a latch
mechanism of the container and the cap.
[0020] FIG. 7 is a side, partial cross-sectional view of the
container of the medication delivery system, showing the cap in the
closed position sealed with the container with the device inserted
therein.
[0021] FIG. 8 is a partial, cross-sectional view of the container,
showing the interior of the container with a desiccant plug.
[0022] FIG. 8a is a detailed view of the desiccant plug retention
mechanism from FIG. 8.
[0023] FIG. 9 is a perspective view of a training container with
its cap in the open position.
[0024] FIG. 10 is a side, cross-sectional view of the training
container shown in FIG. 9 with its cap in the closed position.
DETAILED DESCRIPTION
[0025] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of the invention is
thereby intended.
[0026] In one aspect there are disclosed intranasal delivery
systems comprising a medication administration device for
dispensing a medication. Such medication administration devices
typically include a body containing a medication reservoir
communicating through a discharge port, and an actuator mechanism
for expelling the medication through the discharge port. The
discharge port is sealed prior to use. The actuator is operable to
unseal the discharge port and cause delivery of the medication. A
common configuration for such a medication administration device
includes an actuator that extends from the body prior to delivery
of the medication. Moving the actuator from the extended position
to a depressed position unseals the discharge port and releases the
medication.
[0027] In an embodiment, there is disclosed a medication delivery
system comprising a medication administration device, medication
received within the medication administration device, a container
receiving the medication delivery system, and a cap sealing the
medication delivery system within the container. In another
embodiment, there is provided a method for containing a medication
administration device in a sealed condition protecting a contained
medication. In yet another embodiment, there is provided a
container assembly for a medication administration device including
a container having an internal cavity for receiving the medication
administration device, and a cap attached to the container and
sealing the internal cavity in a closed position.
[0028] Referring to FIG. 1, there is shown an exemplary medication
delivery system 10 comprising a medication administration device 12
containing a medication (not shown), a container 14 for receiving
medication administration device 12, and a cap 16 for sealing
container 14. Medication administration device 12 comprises a body
18 disposed generally longitudinally along a device axis DA, having
a discharge end 20 and an opposed actuator end 22. The medication
administration device includes a medication reservoir defined by
body 18 and containing a medication to be dispensed from the
medication administration device. The medication is dispensed
through a medication discharge port 24 which comprises an opening
communicating with the medication reservoir.
[0029] Medication administration device 12 further includes an
actuator 26 for ejecting the medication from the reservoir through
discharge port 24. Actuator 26 extends out of the actuator end of
body 18. Actuator 26 further is linearly movable from an extended
position shown in FIG. 1 to a depressed position (not shown).
Medication discharge port 24 is sealed from communication with the
medication reservoir when actuator 26 is in the extended position
to retain the contained medication in a sealed condition. Actuator
26 is operable to discharge medication from the reservoir upon
axial movement from the extended position to the depressed
position. During such movement, communication between the discharge
port and the reservoir is provided to allow for dispensing of the
medication.
[0030] Also shown in FIG. 1 are the container 14 and cap 16.
Container 14 has a tubular side wall 28 disposed longitudinally
along a container axis CA. Side wall 28 is closed by bottom wall 30
at one end to define a cavity 32 within container 14. The opposed
end provides an access opening 34 defined by end wall portion 36.
Cavity 32 is sized and configured to receive medication
administration device 12 with discharge end 20 adjacent bottom wall
30. Side wall 28 may generally define a cylindrical shape.
[0031] Cap 16 is sized and configured to mate with container 14 in
the closed position to provide a hermetic seal enclosing cavity 32
for medication administration device 12 when received therein. Cap
16 includes one or more hold down members (described later with
reference to FIG. 2) positioned and configured to bear against a
non-actuator portion of body 18 of medication administration device
12. The one or more hold down members retain the medication
administration device in the cavity 32 without pressure being
applied to actuator 26 while cap 16 is in the closed position. In
particular, each of the hold down members comprises a projection
extending from cap 16 toward bottom wall 30. In one example, each
of the hold down members is formed integrally from the same
material with the cap using a molding process. In other examples,
the hold down members may be formed separately and bonded or
otherwise securely fixed to the cap. The hold down members may be
made from a material that provides a rigid structure. In one
example, rigid hold members are configured to maintain their
relative orientation and positioning relative to the cap (and each
other if more than one) and the non-actuator portion of body 18 of
medication administration device 12 to avoid movement of the ends
of the hold down members to an undesirable position that could
cause premature actuation of the device. A rigid hold member can
maintain its relative axial position and radial position of the
members ends relative to the cap and the device.
[0032] Medication administration device 12 is shown received within
container 14 in FIGS. 2-3. Actuator 26 is shown extending axially
out of body 18 of medication administration device 12. At least an
end portion 38 of actuator 26 extends beyond the plane of end wall
portion 36. Cap 16 may include a cup shaped body 39 having a cap
side wall 41 that defines a recess 40 receiving end portion 38 of
actuator 26. The cup shaped body 39 of cap 16 may include a
radially outward rim portion 66.
[0033] In FIG. 2, body 18 of medication administration device 12
includes a circumferential surface 42 surrounding, and coaxial
with, actuator 26 about device axis DA and facing in the direction
away from bottom wall 30. The hold down members 44 are shown in
FIGS. 2-3 to be axially extending along the container axis CA when
the cap is in the closed position. In one embodiment, there are two
hold down members 44 extending from cap 16. The hold down members
are configured to have end contact surfaces 46 positioned to bear
against circumferential surface 42, representing the non-actuator
portion, that is radially outside and clear of the actuator, in the
event that medication administration device 12 is urged to move
axially in a direction away from bottom wall 30. With a rigid hold
member, the end contact surface 46 maintains its relative axial
position and radial position relative to the cap and the
circumferential surface 42 of the device. Movement of the end
contact surface 46 from a structure having a spring configuration
may permit the end contact surfaces to inadvertently cause
premature actuation of the device. In one embodiment, shown in FIG.
7, an interior surface 41a of the cap side wall 41 and an interior
surface 44a of the hold down members 44 define a continuous
surface, and in some instances, a continuously smooth surface. The
hold down members 44 may include a support rib along the radially
outer surface of the hold down member. Other portions of the device
may be used as the non-actuator portion that is contacted by the
hold down members.
[0034] The relative positioning of the components is evident in
FIG. 3. The one or more hold down members are provided to prevent
the medication administration device from moving away from bottom
wall 30 a distance that would cause end portion 38 of actuator 26
to bear against the interior axial surface 48 of cap 16. If such
contact was allowed, it would be possible for the medication
administration device to be damaged or to prematurely discharge the
medication.
[0035] The one or more hold down members are positioned and
configured to interfere with movement of the medication
administration device to allow at most a predetermined amount of
movement of the medication administration device in the direction
away from bottom wall 30 and toward cap 16. It is not required that
end contact surfaces 46 be engaged with circumferential surface 42
at all times. Rather, a slight gap can be provided between end
contact surfaces 46 and circumferential surface 42 when the
components of the medication delivery system are in an at rest
position. If an external force is applied that would cause
medication administration device 12 to move away from bottom wall
30, then the contact surfaces 46 of hold down members 44 serve as
an end stop to such movement.
[0036] In this respect, as shown in FIG. 3, a small gap is provided
between the contact surfaces 46 and the surface 42 of body 18.
There is also a larger gap between the end surface 47 of end
portion 38 and the interior surface 48 of cap 16. This relative
sizing of the two gaps prevents the interior surface 48 from
contacting the actuator 26. The smaller gap may, for example, be
between 0.1 mm and 1.865 mm.
[0037] With reference FIGS. 4-5, cap 16 may be joined to container
14 with a hinged connection 50. Connection 50 may be in the form of
a "living hinge" comprising a continuous material bridge 52
integrally connecting cap 16 and container 14. FIG. 5 shows an
external view regarding the hinged connection. An enlarged,
axially-extending portion 54 of side wall 28 extends to end wall
portion 36 to provide a living hinge 52. Portion 54 is flat,
instead of matching the radius of wall 28. If the hinge is not
straight, it will result in high stress on the ends of the hinge.
This hinge design is intended to minimally vary the shape of the
outside of the container for improved appearance. Other common
hinges would result in a portion of the hinge protruding from wall
28. In this embodiment the cap and container are formed as one
integral piece such as by injection molding.
[0038] Various embodiments of suitable hinges are known. For
example, in an alternative embodiment the hinge comprises an
axle-like member extending horizontally along the outside of the
container. The axle is held at a position spaced from the exterior
of the container wall, such as by a pair of outwardly extending
flanges. In this embodiment, the cap includes a
partially-cylindrical member that is received over and pivots
around the axle. Alternatively, these structures may be reversed
with the cap including the pivot axle and the container including
the cylindrical component. In these alternate embodiments the cap
and container would be formed separately and assembled
together.
[0039] The two hold down members are disposed circumferentially
away from one another, and the hinged connection 50 is disposed
circumferentially between the two hold down projections. In an
exemplary embodiment, cap 16 includes two hold down members 44
positioned in opposed orthogonal positions, that is, about ninety
degrees, relative to hinged connection 50. This provides two points
of contact between hold down members 44 and body 18. The hold down
members may extend from the cup shape body of the cap at radially
opposite sides of the cap. In some examples, this can be
diametrically opposite. In other examples, need not be directly
radially opposite, but can be offset by, for example, 150 degrees.
The relative positioning of the hold down members also makes it
easier for the hold down members to "clear" side wall 28 and
actuator 26 as cap 16 is moved between an open position and a
closed position. However, it will be appreciated that any number
and positioning of hold down members 44 may be used. It will also
be appreciated that cap 16 need not be hingedly connected to
container 14, and that in itself may require or allow different
configurations of one or more hold down members.
[0040] In another exemplary embodiment, the cap includes a hinge
joining the cap to the container. In one aspect, the cap only
includes a single hold down member which can be disposed along any
position from the interior of the cap. In one embodiment, the
single hold down member is positioned interior of and radially
aligned with the hinge, providing a good containment of the
medication delivery device within the container. In another
embodiment, the single hold down member may be positioned in either
location of any one of the hold down members shown in, for example,
FIG. 2, or, for example, positioned in the location of the one
shown in FIG. 9.
[0041] Alternatively, cap 16 may be fully detachable from container
14. However, an advantage of the hinged connection is that it
facilitates attachment and removal of cap 16. It also orients the
hold down members in a desirable position relative to container
14.
[0042] Regardless of the manner of attachment of cap 16 with
container 14 in the closed position, the provision of the hold down
members as a part of the cap provides distinct advantages. Hold
down members 44 are made available to retain the medication
administration device while attached to the cap that is removed
when the medication administration device is needed. Therefore, the
removal of cap 16 also results in a removal of the hold down
members, without requiring a separate action to unlock the
medication administration device from the container. This allows
for quick and easy removal of the medication administration device
from the container. Although not required, the hold down members
may also be provided as an integral component of cap 16, which
facilitates production of the hold down members and avoids
additional production steps and costs if provided as a separate
component.
[0043] Referring to FIG. 6, it is shown that the medication
delivery system may include a locking mechanism 56 to hold cap 16
in the closed position with container 14 in the absence of an
intended separation of the two components. Any such locking
mechanism may be used that provides sufficient security to hold the
components in a locked condition, while also permitting a
reasonable release of the locking mechanism when desired. In one
embodiment, locking mechanism 56 comprises mating latch members or
latching mechanism. Latch 58 is attached to cap 16 and extends
axially along the container axis when cap 16 is in the closed
position. In this position, latch 58 is positioned to be received
adjacent an exterior surface 60 of side wall 28. Latch 58 includes
a pair of apertures 62. A pair of complementary nubs 64 is formed
in exterior surface 60 and are positioned to be received within
apertures 62 when cap 16 is placed in its closed position. The
latch components and supporting members are sufficiently flexible
and resilient for the latch to be opened and closed as
required.
[0044] Alternative locking and sealing mechanism may also be used.
For example, in one embodiment the cap is snap fit with the
container. In another embodiment, the cap is secured to the
container by a press fit.
[0045] Latch 58 may be attached to and depending from an underneath
surface of the rim portion 66 of cap 16, as shown in FIG. 2. This
allows for the placement of latch 58 to be received adjacent the
exterior surface 60 of side wall 28. The radial extent of the rim
portion 66 away from the outer surface of the cup shaped body of
the cap may be constant. In one example, the radial extent of the
rim portion 66 may vary, such as, for example, where the portion 67
of the rim portion 66 that is adjacent the latch 58, may be is
radially extended farther than the portion of the rim portion 66
outside of the latch. Extended portion 67 may also serve as a thumb
tab to facilitate removal of cap 16 from access opening 34 of
container 14. The underneath surface of extended portion 67 may
define a thumb contact tab to provide an outwardly-extending
surface which may be pressed up and away from container 14 to
facilitate removal of the cap from the container. User applies an
axial force to the portion 67 to cause portion 67 to pivot due to
flexible of material, thereby moving the latch 58 in a manner such
that the latch apertures 62 are removed from nubs 64 and the latch
58 clears the nubs 64 to permit the cap to move to its open
position.
[0046] The medication delivery system is configured to maintain the
integrity of the medication administration device and medication
from the time they are sealed within the cap and container assembly
until the medication administration device is removed and used to
dispense the medication. The cap and container are provided with
complementary sealing components to ensure a hermetic seal between
them. Referring to FIGS. 6 and 7, container 14 includes end wall
portion 36 defining access opening 34. Cap 16 includes a
circumferential sealing member comprising peripheral axially
extending flange 68 which is sized and configured to extend along
and closely mate with the interior surface of end wall portion 36
to provide a hermetic seal enclosing the medication administration
device in the cap 16 and container 14 assembly. Cap sealing flange
68 extends axially along the container axis CA and is disposed
spaced radially inward from the latch 58 to define a gap for
receiving the radial thickness of end wall portion 36. The
circumferential sealing flange 68 may depend axially from an
underneath surface of the rim portion 66. The hold down members 44
are disposed spaced radially inward relative to the flange 68, as
shown in FIG. 7. The hold down members 44 are sized to extend
axially beyond the bottom wall facing end surface of the flange 68.
Flange 68 is shown extending axially beyond the latch 58 of the
latching mechanism. A shorter latch relative to the flange wall may
reduce the cap opening forces. Latch 58 is shown disposed
circumferentially between the two hold down members 44, but across
the recess and radially opposite to the hinged connection 50. Hold
down members 44 may be about 180 degrees apart, and latch 58 and
hinged connection 50 may be about 180 degrees apart.
[0047] The materials used in the cap and container are of a type
well known in the art. The materials must provide the desired
sealing function. If a living hinge, latch or other features are
included, the materials must have sufficient strength, elasticity
and resilience to fulfill the functional requirements. A wide
variety of materials suitable for use in container 14 and cap 16
are known in the art, and typically include plastics, particularly
thermoplastics such as polypropylene and polyethylene
[0048] Many medications are adversely affected by contact with
deleterious levels of moisture. In one embodiment, the medication
delivery system contains a moisture sensitive medication and
container 14 and/or cap 16 includes a desiccant. Referring to FIG.
8, there is shown a desiccant plug 70 received within container 14.
The desiccant plug is configured to fit within container 14
adjacent bottom wall 30, and has an annular shaped body provided
with a central cavity 71 to receive medication discharge port 24 of
medication administration device 12.
[0049] The desiccant plug may be formed, for example, as an
injection molded plug of a molecular sieve type, using known
materials to absorb moisture that may otherwise degrade the
medication. The desiccant plug is sized to comprise enough material
to provide sufficient absorption of moisture. For this purpose the
desiccant plug may be configured to substantially fill cavity 32
between medication administration device 12 and the interior of
side wall 28 of container 14.
[0050] Desiccant plug 70 may be secured within cavity 32 by various
means, such as an interference fit. Container 14 may also include a
snap fit retention feature in which a radially inward projecting
continuous ring or continuous interior shoulder 72 extending from
an interior surface of the side wall of the container engages with
the axial end surface of desiccant plug 70 once it has been moved a
sufficient distance into cavity 32. The desiccant plug 70 may
include an annular notch 73 defined along a radially outer surface
75 of the desiccant body, which is shown formed at the intersection
of the cap facing axial planar surface 77 of the desiccant body and
the radially outer surface of the desiccant body. The annular notch
73 is sized and configured to receive the shoulder 72 when the
desiccant is disposed within the container, such as shown in FIG.
8a. Alternatively, the shoulder 72 may be operable to retain an
annular shaped desiccant by engaging the cap facing axial planar
surface 77 of the desiccant body without the desiccant having the
notch 73.
[0051] The disclosed medication delivery systems have application,
inter alfa, with medication administration devices that are
pre-filled and provide a medication in dosage form. In particular,
the medication administration devices may comprise dispersion
devices which, as used herein, are considered to be devices which
deliver a medication in a dispersed form, such as in metered
aerosol or spray devices. These medication administration devices
are pre-filled with the medications in a finished dosage form.
Embodiments include devices such as referenced in 68 Fed. Reg.
36,675, 36,676 and 36,680 (Jun. 18, 2003). Exemplary embodiments
include intranasal aerosol and spray devices.
[0052] The medication delivery systems may comprise a wide range of
medication administration devices and medications. The medication
delivery system is particularly well suited for use with medication
administration devices which are used for administration of powder
medications, such as intranasal delivery powders. The medications
may be any that can be delivered by the dispersion devices. The
medications may be associated with one or more other ingredients,
as referenced, for example, at 21 CFR .sctn. 314.3.
[0053] In an exemplary embodiment, the medication is glucagon. A
medication administration device has been developed that provides
for the delivery of glucagon in a simple, one-use nasal powder.
This provides significant advantages over complicated systems that
involve mixing liquid and powder together and then injecting the
solution. The use of this medication administration device has been
determined to bring blood sugar levels close to normal within 30
minutes of taking the powdered glucagon.
[0054] In an embodiment, the medication is intranasal AMG504-1
product (Locemia Solutions) containing 2 mg glucagon in 20 mg dry
powder or 3 mg glucagon in 30 mg dry powder, depending on the dose.
The nasal powder is administered with a single-use, one-step
dispensing device. The tip of the device is inserted in one
nostril, and the dose is delivered by simply depressing an actuator
connected to a piston that discharges the powder into the nostril.
No cooperative measure is required from the patient, as absorption
takes place through the nasal mucosa. The glucagon formulation is
provided in the medication delivery system as disclosed herein,
resulting in a highly effective protection for the viability of
both the glucagon and its delivery device.
[0055] It is sometimes desirable to provide a training device that
allows potential users the opportunity to become familiar with the
manner of using a commercial form of a medication delivery system.
In one aspect, a modified version of the described medication
delivery system is provided which has the same basic structures and
functions as the commercial device. However, it is also important
that it is not possible to confuse the training device with the
commercial device as the training device need not be provided with
the same level of refinement. For example, the commercial device is
designed to provide a tight seal when the lid is closed upon the
container, which is not required for a training device.
[0056] Accordingly, the training device is designed in a manner to
preclude interchange of parts with the commercial device. For
example, the training medication delivery device is configured to
prevent its placement inside the commercial container and/or cap.
Conversely, the training container and/or cap are configured to
preclude reception of the commercial medication delivery
device.
[0057] In one example, the training device may be sized such that
its container and/or cap define a cavity that is too short and/or
too narrow to receive the commercial medication device. Similarly,
the training medication delivery device may be designed to have a
dimension that is not able to be received within the cavity defined
by the commercial container and/or cap. It will be appreciated that
the container, cap and/or medication delivery device for the
training device and the commercial device may be made incompatible
in various other ways.
[0058] Referring to FIGS. 9 and 10, there is shown an exemplary
training container and cap assembly. Container 74 comprises a
cylindrical body including a grid 76 simulating the space occupied
by desiccant plug 70 of the prior embodiment. A pair of arms 78
extend outwardly from the top of container 74 and support a hinge
pin 80. Cap 82 includes a cup shaped portion 84 defining a channel
in which hinge pin 80 is received. Cup shaped portion 84 is formed
from a material that is sufficiently flexible as to allow it to be
pressed onto hinge pin 80. The combination of the cup shaped
portion 84 received over hinge pin 80 provides a hinge 86
connecting cap 82 and container 74.
[0059] Container 74 further includes a ridge 88 along the top edge
of container 74 in a position opposed to hinge 86. Ridge 88 extends
transverse of container 74 and has a slightly convex shape as
viewed in cross section. See FIG. 10. Cap 82 incudes a flange 90
positioned to be engaged by ridge 88 when cap 82 is in the closed
position.
[0060] Cap 82 further includes a single hold down member 92 aligned
with hinge 86. Hold down member 92 includes a T-shaped end surface
94 positioned to prevent upward displacement of a simulated
administration device received in container 74.
[0061] Container 74 and cap 82 thereby form a receptacle having
variations from the design of the earlier described embodiment. Cap
82, for example, demonstrates a design having a single hold down
member, rather than the pair of hold down members 44. Hinge 86 and
flange 90 represent alternative designs to the living hinge and
latch of the earlier embodiment.
[0062] In one aspect, there is provided a medication delivery
system comprising two different container and cap assemblies
constituting a product system and a training system. The product
system is used to contain a medication administration device
containing a medication to be delivered to a patient. The training
system is used to allow the patient to become familiar with the
structures and function of the product system. Instead, it only
serves the purpose of allowing a patient to manipulate the training
module relative to the container and cap assembly of the training
system to learn how the product assembly operates.
[0063] The embodiments of FIGS. 2 and 9 are representative of this
overall medication delivery system. By way of example, the
embodiment of FIG. 2 may serve as the product system and the
embodiment of FIG. 9 may serve as the training system.
[0064] To obtain maximum effect, the training system includes a
training module that simulates the medication delivery device, but
does not contain a medication product. However, the training module
is configured to operate with the container and cap assembly of the
training system in substantially the same as a medication
administration device is configured to operate with the contain and
cap assembly of the product system.
[0065] Thus, the training module may comprise a body having a
discharge end defining a simulated medication discharge port and an
opposed actuator end including a simulated actuator. The actuator
extends out of the actuator end of the body, and the actuator being
linearly moveable from an extended position to a depressed
position. The training module is configured to be similar to the
medication delivery device, although it need not be fully
functional, e.g., it need not include an operating actuator. The
training container and cap assembly similarly is configured to
simulate the container and cap assembly of the product system, but
it need not be fully functional, e.g., containing a desiccant.
[0066] As previously noted, the components of the product and
training systems are configured such that the medication
administration device is incompatible with the training container
and cap assembly, and the training module is incompatible with the
product container and cap assembly. This may be accomplished in a
variety of ways. For example, the training module may be provided
with an outer diameter that does not fit within the container of
the product system. Alternatively, the container of the training
system may be made to be too short for the medication
administration device such that the cap cannot be closed over the
medication administration device. In general, it is sufficient if
there is any dimension of the medication administration device that
is incompatible with the device being received in the training
container with the cap closed.
[0067] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes, equivalents, and modifications
that come within the spirit of the inventions defined by following
claims are desired to be protected. All publications, patents, and
patent applications cited in this specification are herein
incorporated by reference as if each individual publication,
patent, or patent application were specifically and individually
indicated to be incorporated by reference and set forth in its
entirety herein.
[0068] Various aspects are described in this disclosure, which
include, but are not limited to, the following aspects:
[0069] 1. A medication delivery system including: a medication
administration device comprising a body having a discharge end
defining a medication discharge port and an opposed actuator end,
the medication administration device including a medication
reservoir, the medication administration device further including
an actuator for ejecting a medication from the reservoir through
the discharge port, the actuator extending out of the actuator end
of the body, the actuator being linearly moveable from an extended
position to a depressed position, the discharge port being sealed
when the actuator is in the extended position and the discharge
port being open when the actuator is in the depressed position, the
actuator being operable to discharge medication from the reservoir
upon axial movement of the actuator from the extended position to
the depressed position; a medication received within the reservoir
of the medication administration device; a container having an
axially extending side wall and a closed bottom wall defining a
cavity having an access opening defined by an end wall portion, the
medication administration device being received within the cavity
with the discharge end adjacent the bottom wall of the container;
and a cap coupled to the container, and movable relative to the
container between an open position and a closed position, the cap
in the closed position sealably engaged with the container to
enclose the medication administration device within the cavity, the
cap defining one or more hold down axial projections, wherein, when
the cap is in the closed position, the one or more hold down axial
projections extend axially from the cap in a direction toward the
bottom wall and sized to allow at most a predetermined amount of
axial movement of the medication administration device in the
direction away from the bottom wall, wherein the one or more hold
down axial projections are contactable with a non-actuator portion
of the medication administration device.
[0070] 2. The medication delivery system of aspect 1 in which the
one or more hold down axial projections is a rigid structure.
[0071] 3. The medication delivery system of any one of aspects 1-2
in which the body of the medication administration device includes
a radially extending circumferential surface surrounding the
actuator and facing away from the bottom wall, wherein, when the
cap is in the closed position, the one or more hold down axial
projections are positioned radially outside the actuator to be
contactable against the circumferential surface.
[0072] 4. The medication delivery system of any one of aspects 1-3
in which the cap having a cup shaped body comprising a cap side
wall and defining a recess configured to receive a portion of the
actuator, wherein the one or more hold down axial projections
extend out beyond the recess.
[0073] 5. The medication delivery system of aspect 4 in which an
interior surface of the cap side wall and an interior surface of
the one or more hold down axial projections define a continuous
surface.
[0074] 6. The medication delivery system of any one of aspects 1-5
wherein the one or more hold down axial projections comprises a
pair of hold down axial projections extending from the cup shaped
body of the cap at radially opposite sides of the cap.
[0075] 7. The medication delivery system of any one of aspects 1-6
wherein the cap includes an outer rim disposed around the cup
shaped body, a circumferential flange depending axially from a
bottom wall facing surface of the outer rim, the one or more hold
down axial projections disposed spaced radially inward relative to
the flange, and extending axially beyond the flange.
[0076] 8. The medication delivery system of any one of aspects 1-7
in which the cap is coupled to the container by a hinged
connection.
[0077] 9. The medication delivery system of aspect 8 in which the
hinged connection is a living hinge.
[0078] 10. The medication delivery system of aspect 8 in which the
cap includes two hold down axial projections, the two hold down
projections disposed circumferentially away from one another, the
hinged connection disposed circumferentially between the two hold
down projections.
[0079] 11. The medication delivery system of aspect 8 in which the
cap includes a single hold down axial projection.
[0080] 12. The medication delivery system of any one of aspects
1-11 in which the cap includes an outer rim extending radially from
the cup shaped body, and a circumferential flange depending axially
from a bottom wall facing surface of the outer rim, and the
container and the cap comprise a latch member to secure the cap to
the container in the closed position, the latch member including a
latch extending axially from the outer rim of the cap, wherein said
flange extends axially beyond the latch.
[0081] 13. The medication delivery system of aspect 12 in which the
one or more hold down axial projections of the cap comprises two
hold down axial projections, the two hold down projections disposed
circumferentially away from one another, the hinged connection
disposed circumferentially between the two hold down projections,
and the latch disposed circumferentially between the two hold down
projections radially opposite to the hinged connection.
[0082] 14. A medication delivery system including: a medication
administration device comprising a body having a discharge end
defining a medication discharge port and an opposed actuator end, a
medication reservoir containing a medication, and an actuator for
ejecting the medication from the reservoir through the discharge
port, the actuator extending out of the actuator end of the body,
the actuator being linearly moveable from an extended position to a
depressed position, the discharge port being sealed when the
actuator is in the extended position and the discharge port being
open when the actuator is in the depressed position, the actuator
being operable to discharge medication from the reservoir upon
axial movement of the actuator from the extended position to the
depressed position, wherein the body of the medication
administration device includes a radially extending circumferential
surface surrounding the actuator and facing away from the bottom
wall; and a container comprising an axially extending side wall and
a closed bottom wall defining a cavity having an access opening
defined by an end wall portion, the medication administration
device being received within the cavity with the discharge end
adjacent the bottom wall of the container, a cap hingedly coupled
to the container, the cap movable relative to the container between
an open position and a closed position, the cap in the closed
position sealably engaged with the container to enclose the
medication administration device within the cavity, and a desiccant
disposed within the cavity, wherein the cap defines a pair of hold
down axial projections, wherein, when the cap is in the closed
position, the hold down axial projections extend axially from the
cap in a direction toward the bottom wall and sized to allow at
most a predetermined amount of axial movement of the medication
administration device in the direction away from the bottom wall,
wherein each of the hold down axial projections have a contact end
surface contactable with the circumferential surface of said
device, radially outside the actuator of the medication
administration device, wherein the hold down axial projections are
configured to allow each of the contact end surfaces to maintain
its relative axial position and radial position relative to the cap
and the circumferential surface of said device
[0083] 15. The medication delivery system of aspect 14 in which the
container includes a continuous inner ring disposed radially inward
from an interior surface of the side wall of the container, the
inner ring axially spaced from the bottom wall at a distance to
securely retain the desiccant between the inner ring and the bottom
wall.
[0084] 16. The medication delivery system of aspect 15 in which the
desiccant includes an annular notch defined along a radially outer
surface of the desiccant, the annular notch configured to receive
the inner ring when the desiccant is disposed within the
container.
[0085] 17. The medication delivery system of any one of aspects
1-16 in which the medication administration device is an air
dispersion device.
[0086] 18. The medication delivery system of any one of aspects
1-17 in which the medication is an intranasal delivery powder.
[0087] 19. The medication delivery system of aspect 18 in which the
powder is glucagon.
[0088] 20. A method for providing a medication delivery system
containing a glucagon composition, the method including:
positioning a medication administration device within a container,
the medication administration device including a body having a
discharge end defining a medication discharge port and an opposed
actuator end, the medication administration device including a
medication reservoir containing a glucagon medication, the
medication administration device further including an actuator for
ejecting a medication from the reservoir through the discharge
port, the actuator extending out of the actuator end of the body,
the actuator being linearly moveable from an extended position to a
depressed position, the discharge port being sealed when the
actuator is in the extended position and the discharge port being
open when the actuator is in the depressed position, the actuator
being operable to discharge the glucagon medication from the
reservoir upon axial movement of the actuator from the extended
position to the depressed position; the container having a side
wall and a closed bottom wall defining a cavity having an access
opening defined by an end wall portion, the cavity receiving the
medication administration device within the cavity with the
discharge end adjacent the bottom wall of the container; and
sealing a cap to the container to provide a hermetic seal enclosing
the medication administration device within the cavity, the cap
defining one or more hold down axial projections positioned and
configured to interfere with movement of the medication
administration device to allow at most a predetermined amount of
movement of the medication administration device in the direction
away from the bottom wall without the actuator contacting an axial
end surface of the cap.
[0089] 21. A medication container and cap assembly for containing a
medication administration device, the medication administration
device including a body having a discharge end defining a
medication discharge port and an opposed actuator end, the
medication administration device including a medication reservoir
containing a glucagon medication, the medication administration
device further including an actuator for ejecting the glucagon
medication from the reservoir through the discharge port, the
actuator extending out of the actuator end of the body, the
actuator being linearly moveable from an extended position to a
depressed position, the discharge port being sealed when the
actuator is in the extended position and the discharge port being
open when the actuator is in the depressed position, the actuator
being operable to discharge the glucagon medication from the
reservoir upon axial movement of the actuator from the extended
position to the depressed position, the assembly including: a
container having a side wall and a closed bottom wall defining a
cavity having an access opening defined by an end wall portion, the
cavity being sized and configured to receive the medication
administration device, the medication administration device being
receivable within the cavity with the discharge end adjacent the
bottom wall of the container; and a cap coupled to the container by
a hinged connection, and configured to mate with the container when
in a closed position and provide a hermetic seal to enclose the
medication administration device inserted within the cavity, the
cap defining a pair of hold down members positioned and configured
to interfere with movement of the medication administration device
to allow at most a predetermined amount of movement of the
medication administration device in the direction away from the
bottom wall, the hold down members disposed circumferentially away
from one another, the hinge connection disposed circumferentially
between the two hold down members.
[0090] 22. The assembly of aspect 21 in which the container side
wall is sized to allow an end portion of the actuator to extend out
beyond the container side wall through the open end of the
container, the cap having a cup-shaped body defining a recess
configured to receive the end portion of the actuator, wherein an
interior surface of the cup-shaped body that faces the recess and
an interior surface of each of the hold down members where the hold
down members extend from the cup-shaped body define a continuous
surface.
[0091] 23. The assembly of aspect 22 in which the desiccant is
configured to fit within the container adjacent the bottom wall,
the desiccant including an annular shaped body with a central
cavity configured to receive the medication discharge port of the
medication administration device therein, the container including
an inner ring disposed radially from an interior surface of the
side wall of the container, and the desiccant includes an annular
notch defined along a radially outer end of the annular shaped body
that faces away from the bottom wall, the annular notch configured
to receive the inner ring when the desiccant is disposed within the
container.
[0092] 24. A training module for use in a medication delivery
system including: a training module including a body having a
discharge end defining a simulated medication discharge port and an
opposed actuator end including a simulated actuator, the actuator
extending out of the actuator end of the body, a training container
having a side wall and a closed bottom wall defining a cavity
having an access opening defined by an end wall portion, the cavity
being sized and configured to receive the training module, the
training module being received within the cavity with the discharge
end adjacent the bottom wall of the container; and a training cap
hingedly attached to the training container, the training cap
mating with the training container and enclosing the training
module within the cavity, the training cap defining one or more
hold down members positioned and configured to interfere with
movement of the training module to allow at most a predetermined
amount of movement of the training module in the direction away
from the bottom wall, each of the one or more hold down members
including a projection extending from the training cap in a
direction toward the bottom wall.
[0093] 25. A medication delivery system including: a medication
administration device including a body having a discharge end
defining a medication discharge port and an opposed actuator end,
the medication administration device including a medication
reservoir, the medication administration device further including
an actuator for ejecting a medication from the reservoir through
the discharge port, the actuator extending out of the actuator end
of the body, the actuator being linearly moveable from an extended
position to a depressed position, the discharge port being sealed
when the actuator is in the extended position and the discharge
port being open when the actuator is in the depressed position, the
actuator being operable to discharge medication from the reservoir
upon axial movement of the actuator from the extended position to
the depressed position; medication received within the reservoir of
the medication administration device; a product container having a
side wall and a closed bottom wall defining a cavity having an
access opening defined by an end wall portion, the cavity being
sized and configured to receive the medication administration
device, the medication administration device being received within
the cavity with the discharge end adjacent the bottom wall of the
container; a product cap attached to the container, the product cap
mating with the container and providing a hermetic seal enclosing
the medication administration device within the cavity, the product
cap defining one or more hold down members positioned and
configured to interfere with movement of the medication
administration device to allow at most a predetermined amount of
movement of the medication administration device in the direction
away from the bottom wall, each of the one or more hold down
members including a projection extending from the cap in a
direction toward the bottom wall, a training module including a
body having a discharge end defining a simulated medication
discharge port and an opposed actuator end including a simulated
actuator, the simulated actuator extending out of the actuator end
of the body of the training module, a training container having a
side wall and a closed bottom wall defining a cavity having an
access opening defined by an end wall portion, the cavity being
sized and configured to receive the training module, the training
module being received within the cavity with the discharge end
adjacent the bottom wall of the container; and a training cap
attached to the training container, the training cap mating with
the training container and enclosing the training module within the
cavity, the training cap defining one or more hold down members
positioned and configured to interfere with movement of the
training module to allow at most a predetermined amount of movement
of the training module in the direction away from the bottom wall,
each of the one or more hold down members including a projection
extending from the training cap in a direction toward the bottom
wall, the medication delivery device including a dimension that is
incompatible with it being received within the training container
with the training cap closed.
[0094] 26. The medication delivery system of aspect 25 in which the
training module includes a dimension that is incompatible with it
being received within the product container with the product cap
closed.
* * * * *
References