Note: Descriptions are shown in the official language in which they were submitted.
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TITLE
PACKAGING ASSEMBLY TO PREVENT PREMATURE ACTIVATION
BACKGROUND
[0001] The present disclosure relates generally to packaged
medical device
assemblies and more specifically to combinations of packages with medical
devices.
[0002] Certain drugs are supplied in lyophilized form. The
lyophilized drug
must be mixed with water to reconstitute the drug into a form suitable for
injection into a
patient. In particular, the components that form the injectable solution must
be sterile to
avoid infection. The reconstitution process presents difficulties to patients
or caregivers who
need to inject themselves or another, for example, in a home environment. The
patient or
caregiver has to follow a sequential manipulation of the drug container, the
diluent container
and the transfer syringes, which use needles to penetrate the stoppers
associated with the
respective containers. The patient or caregiver needs to follow established
aseptic practices to
avoid contamination.
[0003] As described in U.S. Patent Application No. 13/217,967
("the '967
Application"), the drug container, the diluent container and the transfer
syringes of the device
are mounted within a same housing at time of shipping from the manufacturer,
distributor or
assembler to the end user. Due to the specific arrangement of the transfer
syringes with
respect to each of the drug containers, extra care is taken to prevent
accidental premature
puncture or activation of the stoppers of the containers by the transfer
syringes during
shipment and handling. Shipment of reconstitution devices accordingly presents
challenges
in preventing premature activation of the product, ensuring sterility and
enabling ease of use
of the product by the end user. The lyophilized drugs are often very
expensive, making the
minimization of accidental activation or contamination suffered during
shipment even more
important.
SUMMARY
[0004] The present disclosure provides a packaged assembly
including a
package and a reconstitution assembly and associated medical products, which
prevent
premature activation of the reconstitution assembly. The package is shaped to
cradle the
reconstitution assembly. The package integrates with pertinent features of the
reconstitution
assembly, and maintains the isolation of various parts of the reconstitution
assembly from one
another in the package during shipment and handling.
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[0005] In one embodiment, the reconstitution assembly includes a
housing having
an upper sleeve and lower sleeve. The housing defines a generally tubular
passageway and
includes a plurality of radially spaced apertures in the upper sleeve, and a
plurality of radially
spaced windows in the lower sleeve. A transfer set assembly is disposed within
the housing
between the lower sleeve and the upper sleeve. The transfer set assembly
includes a pair of
opposing spikes including an upper spike and a lower spike. The upper and
lower spikes
form part of a flow path.
[0006] A first container is disposed at least partially inside the
upper sleeve of the
housing, within the passageway and near the upper spike. The first container
includes a first
vial and a first stopper providing a sterile barrier to the medicament
contents held within the
first vial. The first container is disposed in one embodiment so that the
first stopper faces
downward or towards a center of the housing. A second container is disposed
inside the
lower sleeve within the passageway near the lower spike. The second container
includes a
second vial and a second stopper providing a sterile barrier to the contents
of the second vial.
The second container is disposed in one embodiment so that the second stopper
faces upward
towards the first stopper. The flow path formed by the spike allows the
containers when
spiked to communicate fluidly with each other.
[0007] In an embodiment, the upper spike of the transfer set assembly
pierces the
first stopper upon application of a first force to the first container. The
force can be from the
patient or caregiver pressing down on the first container to push the first
container into the
housing and onto the upper spike. Subsequent to the upper spike piercing the
first stopper of
the first container, the second container is allowed to move axially relative
to the transfer set
assembly. The lower spike of the transfer set assembly then pierces the second
stopper upon
application of a second force and the engagement of a triggering mechanism by
the first
container, and specifically the first vial of the first container. When the
second stopper is
pierced, the vacuum of the second container is accessed. The first and second
forces may be
predetermined forces or at a desired level.
[0008] In an embodiment, the first container encloses a liquid and the
second
container encloses a lyophilized product. Piercing the first stopper of the
first container with
the upper spike, and piercing the second stopper of the second container with
the lower spike
places the first and second containers into fluid communication with each
other through the
flow path of the transfer set assembly. The vacuum of the second container
then causes the
liquid of the first container to aspirate through the fluid pathway into the
second container.
The liquid mixes with the lyophilized drug to formulate the drug for patient
use.
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[0009] The packaging assembly is constructed so that the
reconstitution
assembly fits within the package and the package physically inhibits axial
translation of either
the first container or the second container within the housing. By inhibiting
any significant
axial translation of the first or second containers within the housing,
accidental or premature
piercing of either the first stopper of the first container by the upper spike
or the second
stopper of the second container by the lower spike is prevented.
[0010] In an embodiment, the package includes an interior
chamber formed with
a plurality of recesses and protrusions that are shaped to compliment mating
features of the
reconstitution assembly. The interior chamber of the package is formed such
that the
reconstitution assembly properly engages with the complimentary recesses and
protrusions of
the package in a predetermined configuration. For example, there are first and
second
recesses at the ends of the package that cradle the first and second vials of
the first and second
containers extending from the housing of the reconstitution assembly. A
plurality of
protrusions extending into the interior chamber of the package match with and
extend through
a plurality of apertures in the upper sleeve and a plurality of apertures in
the lower sleeve of
the reconstitution assembly housing.
[0011] The apertures in the housing allow the protrusions of
the package body to
extend into the passageway formed by the housing, and engage the vials around
a portion of
the neck of the vials, which can be small glass bottles with necked openings.
The protrusions
catch the housing apertures so as to prevent the first and second respective
containers from
rotating within the package. The engagement of the protrusions with the necks
of the vials
also prevents inadvertent axial translation of the containers relative to
either one another, the
transfer set assembly, or the housing. By keeping the first and second
containers generally
axially static relative to one another and relative to the transfer set
assembly, the protrusions
of the interior chamber of the package body maintain the upper spike and the
lower spike at a
separation distance from each of the first container and the second container
respectively.
Because the axial translation of the components of the reconstitution assembly
during
shipping or handling is minimized or prevented, the instances of premature
puncture of the
first or second containers by the respective spikes of the transfer set
assembly is also
minimized.
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[0011a] In another embodiment a medical package assembly
comprises a drug
reconstitution assembly including: (i) a housing forming at least one
aperture; (ii) a container
placed at least partially within an interior of the housing; and (iii) a spike
assembly arranged
within the housing so as to be able to spike the container; and a body shaped
to house the drug
reconstitution assembly, the body including at least one protrusion extending
through the at
least one aperture and into the interior of the housing, wherein the at least
one protrusion is
positioned and arranged to prevent movement of the container toward the spike
assembly
prior to the container reaching an undesirable displacement relative to the
spike assembly.
[0011b] In another embodiment a drug delivery product comprises
a drug
reconstitution assembly including a housing and a container placed within the
housing; and a
package including a body shaped to house the drug reconstitution assembly and
at least one
protrusion extending from the body, the at least one protrusion positioned and
arranged to
engage the housing and the container to inhibit axial translation of the
container relative to the
housing, wherein the container is a first container and which includes a
second container
placed within the housing, the at least one protrusion including a first
protrusion, the body
including a second protrusion positioned and arranged to engage with the
housing to inhibit
axial translation of the second container relative to the housing.
[0011c] In yet another embodiment a method of packaging a drug
reconstitution
assembly comprises providing a package with a removable lid and a body
configured to house
the drug reconstitution assembly, including at least one protrusion extending
from the body;
providing the drug reconstitution assembly with a housing having at least one
aperture, and a
container placed at least partially within the housing, wherein a neck portion
of the container
aligns with at least one of the apertures of the housing; assembling the drug
reconstitution
assembly within the body of the package, such that the at least one protrusion
of the body
extends through at least one of the apertures of the housing, wherein an
orientation of the drug
reconstitution assembly within the package is limited to a predetermined
number of
orientations; and sealing the drug reconstitution assembly within the body of
the package with
the removable lid.
[0012] Additional features and advantages are described
herein, and will be
apparent from the following Detailed Description and the figures
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BRIEF DESCRIPTION OF THE FIGURES
[0013] FIG. 1 is a perspective view of one embodiment of an assembled
package
of the present disclosure.
[0014] FIG. 2 is an exploded view of one embodiment of the package, a
reconstitution assembly contained in the package and a cover for the package
of the present
disclosure.
[0015] FIG. 3 is a body-side view of one embodiment of the assembled
package
and drug reconstitution assembly of the present disclosure.
[0016] FIG. 4 is a sectioned view of the assembled package of FIG. 3
taken along
line IV-IV of FIG. 3.
[0017] FIG. 5 is a bottom view of one embodiment of the package of the
present
disclosure.
[0018] FIG. 6 is a sectioned view of the package of FIG. 5 taken along
line VI-VI
of FIG. 5.
[0019] FIG. 7 is a side elevation view of one embodiment of the
assembled
package of the present disclosure.
[0020] FIG. 8 is an end elevation view of one embodiment of the
assembled
package of the present disclosure.
DETAILED DESCRIPTION
[0021] The present disclosure provides a packaged assembly including
an
assembled package and reconstitution assembly. The packaged assembly is
especially useful
for preventing premature activation of the reconstitution assembly during
shipping and
handling. Although the packaged assembly is described primarily herein as
including a
reconstitution assembly, it will be apparent that the an appropriately
configured package may
be used during shipment of other drug assemblies, or other products that have
components
separated prior to use.
[0022] Referring now to the drawings and in particular to FIGS. 1 and
2, an
assembled package 10 is generally indicated. Assembled package 10 in general
includes a
removable lid 12, a body 14, and a drug reconstitution assembly 100 (FIG. 2).
[0023] Removable lid 12 can be made of any one or more of a high-
density
polyethylene fibers, such as TYVEKO, a foil material or a paper material, and
is adhered to
the body 14 with heat activated adhesive in one embodiment. The adhesive and
application
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process enables removable lid 12 to remain securely adhered to the body 14 but
to also be
relatively easily removed by the patient.
[0024] Body 14 can be constructed from a thermoformable polyethylene
terephthalate ("PET") material. Body 14 can be formed into its desired shape
with
protrusions 16, 18, wells 20a to 20c, etc., formed via a thermoforming
process. In an
alternative embodiment, body 14 is made of a polymeric material and is formed
via an
injection molding process.
[0025] As illustrated in FIGS. 1 and 2, lid 12 attaches sealingly and
removably to
body 14 to enclose the drug reconstitution assembly 100 within package 10.
Removable lid
12 can provide a flat surface upon which manufacturer instructions and
identifying
information can be displayed. The information identifiers may include
barcodes, picture
codes, company information and internet addresses directing the user to more
detailed
information. The information may include medication information, patient
identification and
prescription information, manufacturer information, licensing and governmental
agency
information, creation and expiration date information, and directions for use.
[0026] As illustrated in FIGS. 1 and 2, body 14 is formed to define an
interior
chamber, which includes a plurality of protrusions 16 and 18 that protrude
into the chamber
and wells 20a to 20c that extend away from the interior of the chamber. These
features are
described in greater detail below. As used herein, protrusions in general
extend in towards a
center of the interior chamber of body 14, while wells in general extend out
away from the
center of the interior of the chamber.
[0027] The interior chamber accepts drug reconstitution assembly 100
as
illustrated in FIG. 2. Drug reconstitution assembly 100 includes a housing 110
having an
upper portion 112 (when held for use) and a lower portion 114 (when held for
use). The
upper portion 112 and lower portion 114 form a generally cylindrical
passageway. The drug
reconstitution assembly 100 also includes an upper container 120 (when held
for use) housed
at least partially within the passageway formed by the upper portion 112 of
the housing, a
lower container 130 (when held for use) housed at least partially within the
passageway
formed by a lower portion 114 of the housing, and an access port plug 140
provided on the
outside of housing 110. Removable lid 12 of package 10 attaches sealingly to
body 14 to
enclose the drug reconstitution assembly 100 within the body 14.
[0028] Referring now to FIG. 3, a body side view of the assembled
package 10
from the outside looking in is illustrated. A first pair of protrusions 16 and
a second pair of
protrusions 18 extend from the surrounding surface of body 14 into the
interior chamber to
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contact mating features of drug reconstitution assembly 100. Wells 20a, 20b,
and 20c extend
outwardly from the interior chamber relative to surrounding surfaces of body
14. Wells 20a,
20b, and 20c are at least substantially flat and coplanar with each other (see
also FIGS. 1 and
2), such that package 10 can be rested on the body side by setting wells 20a,
20b, and 20c
onto a stable surface. Body 14 also forms wells 22 and 24 at the upper and
lower ends of
body 14 as illustrated in FIGS. 1 to 3.
[0029] Referring now to FIG. 4, a cross-sectional side view of FIG. 3
taken along
the line IV-IV is illustrated. Due to the radial spacing and geometry of
protrusions 16
compared to the radial spacing and geometry of protrusions 18, line IV-IV has
been staggered
in FIG. 3 to better show the cross-sections of both protrusions 16 and 18 in
the single view of
FIG. 4. The cross-section view of the reconstitution assembly 100 and its
housing 110
illustrate the contents of the reconstitution assembly. Specifically, the
reconstitution
assembly 100 includes first or upper container 120, second or lower container
130, and a
transfer set assembly 200.
[0030] As discussed in detail in the '967 Application incorporated
herein by
reference, transfer set assembly 200 includes an upper spike 202, a lower
spike 204, and a
flow path that travels through the upper spike 202 and the lower spike 204.
Upper spike 202
faces an opening 128 of the upper container 120, while lower spike 204 faces
an opening 138
of the lower container 130. In various embodiments, the plastic part of
transfer set assembly
200 is made of a suitable moldable and sterilizable plastic such as
acrylonitrile butadiene
styrene ("ABS"), polycarbonate ("PC") or acrylic.
[0031] Upper spike 202 can include an upper boot 206 configured to
cover and
maintain sterility of a lower portion of the upper spike and its flow path
portion. Similarly,
the lower spike 204 includes a lower boot 208 configured to cover and maintain
sterility of an
upper portion and the flow path in the lower spike. Upper 206 and lower 208
boots in one
embodiment are made with an elastomeric material that is relatively easily
punctured by the
upper spike 202 and lower spike 204 respectively, upon activation of the drug
reconstitution
assembly 100.
[0032] Transfer set assembly 200 can also include a syringe port
pathway
(beneath plug 140 illustrated in Fig. 2) that is generally perpendicular to
and maintains a
valved fluid communication with the flow path traveling through the upper
spike 202 and the
lower spike 204. The syringe port pathway can alternatively extend non-
perpendicularly
from the flow path of the transfer set assembly 200. The syringe port pathway
communicates
with a syringe port extending through housing 110 of reconstitution assembly
100. In FIG. 2,
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a syringe port plug 140 engages the syringe port to maintain the sterility of
the port and
connecting flow paths.
[0033] After full activation of the drug reconstitution assembly 100,
a user
removes the syringe port plug 140 to reveal the syringe port that the user can
access via a
separate syringe. Syringe port plug 140 is made of an elastomeric or a rubber
material, such
that it can be bent for grasping and removing. The syringe port pathway and
spike flow
paths allow fluid communication from the syringe port to the upper and lower
containers 120
and 130.
[0034] Upper 120 and lower 130 containers include upper 121 and lower
131
vials, which are made of a suitable medical grade, sterilizeable glass or
plastic, for example.
Upper vial 121 and lower vial 131 are each generally cylindrical and have
similar geometries,
including a neck portion 122a, 132a, a main portion 122c, 132c, and a rim
portion 126, 136.
The neck portion 122a, 132a has a smaller diameter than either the main
portion 122c, 132c
or the rim portion 126, 136. Upper stopper 124 sealingly plugs the upper
opening 128 of the
upper vial 121 to prevent contamination or leakage of the contents of the
upper container 120.
Similarly, lower stopper 134 sealingly plugs the lower opening 138 of the
lower vial 131 to
prevent contamination or leakage of the lower container 130. Upper stopper 124
and the
lower stopper 134 can be made of rubber or an elastomeric material. It should
be appreciated
that the assembly of the upper vial 121 and the upper stopper 124 is defined
herein as the
upper container 120. Similarly, the assembly of the lower vial 131 and the
lower stopper 134
is defined herein as the lower container 130.
[0035] Housing 110 of reconstitution assembly 100 includes an upper
housing
portion 112 and a lower housing portion 114, which again can be made of
acrylonitrile
butadiene styrene ("ABS"), polycarbonate ("PC") or acrylic. Upper housing
portion 112
includes or defines a plurality of apertures 116, while lower housing portion
114 includes or
defines a plurality of apertures 118 (illustrated best in FIG. 2). Apertures
or windows 116
and 118 are each spaced apart radially around the respective housings.
Apertures 116, 118
allow for gas sterilization to flow to the internal parts and components of
reconstitution
assembly 100. In addition to easing the sterilization process, apertures 116,
118 provide at
least partial access to the upper 120 and lower 130 containers when housed
within
reconstitution housing 110.
[0036] As is discussed in more detail in the '967 Application, upon
activation of
the drug reconstitution assembly 110, the upper spike 202 penetrates the upper
boot 206 and
upper stopper 124 to access the contents of the upper container 120, after
which the lower
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spike 204 penetrates the lower boot 208 and lower stopper 134 to access the
contents of the
lower container 130. A flow path is created between the upper container 120
and the lower
container 130 when the upper 202 and lower spikes 204 have accessed the
contents of the
upper 120 and lower containers 130 respectively. The '967 Application
discusses other
internal mechanisms of assembly 110 that ensure that upper container 120
travels towards the
upper spike 202, and that the upper stopper 124 is fully penetrated by the
upper spike 202
before lower spike 204 can contact the lower stopper 134 of the lower
container 130.
[0037] FIG. 4 illustrates how containers 120 and 130 fit within
housing 110 of the
drug reconstitution assembly 100 and how the drug reconstitution assembly 100
fits within
the interior chamber of package body 14 during shipment (unactivated state).
As illustrated,
upper container 120 fits at least partially within the upper housing portion
112. The upper
rim 126 of upper vial 121 and upper stopper 124 are each oriented toward the
transfer set
assembly 200 and upper spike 202. In the illustrated unactivated state, upper
stopper 124 of
upper container 120 is disposed near the upper spike 202, but not in contact
with the upper
spike 202.
[0038] Upper housing portion 112 in one embodiment includes three
apertures
116 substantially evenly radially disposed about the upper housing portion
112, as partially
illustrated in FIG. 2. It should be appreciated that any number of apertures
may be
incorporated into the upper housing portion 112, and the spacing need not be
equal or radial.
Upper housing portion 112 is formed such that when upper container 120 is
secured in its
shipping configuration, various features of upper vial 121, such as the upper
shoulder 122b,
upper neck 122a, and upper rim 126, are aligned longitudinally with the
apertures 116.
[0039] Similar to the upper container 120, the lower container 130
fits at least
partially within the lower housing portion 114. Lower rim 138 of lower vial
131 and lower
stopper 134 are each oriented towards lower spike 204 of the transfer set
assembly 200. In
the unactivated state (as illustrated), lower stopper 134 of the lower
container 130 is disposed
near the lower spike 204, but not in contact with the lower spike 204 of the
transfer set
assembly 200.
[0040] The lower housing portion 114 in one embodiment includes six
apertures
118 evenly, radially disposed about the lower housing portion 114, as
partially illustrated in
FIG. 2. Any suitable number of apertures may be incorporated into the lower
housing portion
114 and need not be the spaced evenly or radially. In FIG. 4 two of apertures
118 of lower
housing portion 114 are visible. Lower housing portion 114 is formed such that
when lower
container 130 is secured in its shipping configuration, various features of
lower vial 131, such
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as lower shoulder 132b, lower neck 132a, and the lower rim 136, are aligned
longitudinally
with apertures 118.
[0041] It is important that upper container 120 and the lower
container 130 do not
shift out of their shipping configuration before the user intentionally
activates drug
reconstitution assembly 100. Such an undesirable displacement of either the
upper container
120 or the lower container 130, caused by shipment, handling, or mishandling,
could result in
premature contact between the upper 202 or lower 204 spikes and the respective
upper 124 or
lower 134 stoppers. Even rupture or disturbance of the relatively thin boots
206 and 208 by
the respective spikes 202 and 204 can destroy the sterile environment of the
flow path
traveling through the spikes 202 and 204 of the transfer set assembly 200.
Package 10
prevents these undesirable displacements as discussed in detail below.
[0042] It should be appreciated that, for the present disclosure, an
undesirable
displacement defines any one of a plurality of different resulting positions
of the upper 120
and lower 130 containers, the upper 202 and lower 204 spikes, the upper 124
and lower 134
stoppers, the upper 206 and lower 208 boots, the transfer set assembly 200,
and the housing
110. Each of the undesirable displacement positions that could occur
unintentionally during
shipping is prevented by the body 14's interaction with the drug
reconstitution assembly 100.
Described below are several undesirable displacement positions. It should be
appreciated
that, although discussed with respect to both the upper and lower containers,
it is
contemplated that each of the undesirable displacement positions applies
either individually
or collectively to each of the upper 120 and lower 130 containers.
[0043] In a first undesirable displacement position, the upper
container 120 or
lower container 130 axially shifts relative to the transfer set assembly 200
such that the upper
stopper 124 or lower stopper 134 makes contact with upper boot 206 or lower
boot 208,
which in turn makes contact with and is at least partially pierced by upper
spike 202 or lower
spike 204, respectively. It should be appreciated that in the first
undesirable displacement
position, the respective spike 202, 204 does not fully penetrate the upper 124
or lower 134
stopper. In the first undesirable displacement position, the puncture of the
upper 206 and
lower 208 boots by the respective upper 202 and lower 204 spikes makes the
transfer set
assembly 200 and its flowpath susceptible to contamination.
[0044] In a second undesirable displacement position, the upper
container 120 or
lower container 130 axially shifts relative to the transfer set assembly 200
such that the upper
stopper 124 or lower stopper 134 makes contact with upper boot 206 or lower
boot 208,
respectively. The upper boot 206 or lower boot 208, in turn, is forced against
the upper spike
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202 or lower spike 204 by the axial translation of the respective container.
In the second
undesirable displacement position, the upper spike 202 or lower spike 204 each
fully
penetrate the respective boots 206, 208, and at least partially penetrate the
stoppers 124, 134
of respective containers 120, 130. In the second undesirable displacement
position of various
embodiments, the spikes 202, 204 fully penetrate the respective stoppers 124,
134. In the
second undesirable position, the partial or full penetration of the upper 124
or lower 134
stoppers by the upper 202 or lower 204 spikes leads to an increased chance of
contamination
of the transfer set assembly 200, as well as contamination of the contents of
either container
120 or 130.
[0045] In a third undesirable displacement position, the upper
container 120 or
lower container 130 radially or axially shifts relative to the housing 110,
causing a failure of
the seals between vials 121, 131 and the interior of housing 110. In the third
undesirable
displacement position, failed seals could reduce the secure positioning of the
upper container
120 and lower container 130 within the housing 110, thereby increasing the
likelihood of
premature axial translation, and lead to an additional undesirable
displacement position.
[0046] Prior to attachment of removable lid 12 to body 14, drug
reconstitution
assembly 100 is inserted into the interior chamber of the body 14. In doing
so, protrusions 16
and 18 and wells 20a to 20c, 22 and 24 mate with different features of the
drug reconstitution
assembly 100 including and the upper 120 and lower 130 containers held within
the drug
reconstitution assembly 100.
[0047] Referring now to FIGS. 5 and 6, the protrusions and wells are
further
illustrated. Wells 20a, 20b and 20c extend outwardly from the body 14 and form
a
substantially coplanar surface on which the assembly 10 can be supported. Well
20c is
shaped to substantially match the outline shape of syringe port plug 140 of
the drug
reconstitution assembly 100. In the shipping position, syringe port plug 140
faces downward
towards the bottom of assembly to mate with well 20c. The syringe port plug
140's
engagement with well 20c inhibits rotational movement of the port within body
14. The
syringe port plug 140 also mates with well 20c to provide an additional axial
constraint on the
housing 100 with respect to the body 14. Orienting the syringe port plug 140
downwardly
towards the lower end of assembly 100 prevents the user, upon peeling back
removable lid
12, from removing drug reconstitution assembly 100 by the syringe port plug
140, which can
increase the likelihood that the plug 140 accidentally detaches from the
syringe port
increases. Syringe port plug 140 should instead be removed just before the
connection of
assembly 100 by an external syringe.
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[0048] Fig. 5 illustrates that two protrusions 16 extend from package
body 14
inwardly into the interior chamber of the body. As illustrated in FIG. 6,
protrusions 16
include several geometrical features that are formed to cooperate with mating
features of drug
reconstitution assembly 100. Specifically, each protrusion 16 includes
multiple faces
including a tapered face 16a, a lid side face 16b, a body side face 16c, an
upper face 16d, and
a lower face 16e. FIGS. 1 to 6 make it clear that the two protrusions 16
extend in from the
outside of body 14 spaced equally on either side of the longitudinal center of
body 14.
[0049] FIG. 2 shows the exploded view of how the drug reconstitution
assembly
100 fits within the body 14. When the drug reconstitution assembly 100 is
inserted into the
body 14, the two protrusions 16, extend through two corresponding apertures
116 of the
upper housing portion 112. As illustrated in FIG. 4, protrusion 16 extends
through aperture
116 toward the upper container 120. Specifically, body side face 16c of
protrusion 16 is
configured and arranged to engage with side 116a of the upper housing portion
112 forming
aperture 116, the lid side face 16b of protrusion 16 is configured and
arranged to engage with
side 116b of the upper housing portion 112 forming aperture 116, the upper
face 16d is
configured and arranged to engage with side 116c of the upper housing portion
112 forming
aperture 116, and the lower face 16e is configured and arranged to engage with
side 116d of
the upper housing portion 112 forming aperture 116.
[0050] The engagement between protrusions 16 and apertures 116
prevents drug
reconstitution assembly 100 from translating axially or rotating within body
14. In particular,
the lid side face 16b contacts side 116b of the upper housing portion 112
forming aperture
116, and body side face 16c contacts side 116a of the upper housing portion
112 forming
aperture 116 to prevent the drug reconstitution assembly 100 from rotating
within body 14.
Similarly, lower face 16e contacts side 116d of the upper housing portion 112
forming
aperture 116, and the upper face 16d contacts side 116c of the upper housing
portion 112
forming aperture 116 to prevent the drug reconstitution assembly 100 from
translating axially
within body 14.
[0051] In various embodiments, the protrusions 16 need not make
constant or any
contact with the sides 116c, 116d of the aperture 116 while making physical
contact with the
upper vial 121 of upper container 120. It should be appreciated that the
protrusions 16 help
to hold upper container 120 secure within the upper housing portion 112
because any axial
shift of the upper container 120 is inhibited by the protrusions 16, and any
axial shift of the
apertures 116 (i.e., the upper housing portion 112) is inhibited by the same
protrusions 16.
Because the protrusions 16 extend between the apertures 116 and between the
neck 122a and
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rim 126 of the upper vial 121 of upper container 120, the protrusions 16, and
therefore the
body 14, prevent axial shift of the upper container 120 with respect to the
upper housing
portion 112.
[0052] Similar to the protrusions 16 discussed above, body 14 also
includes two
protrusions 18 at its lower end, which extend from body 14 inwardly into the
interior
chamber of the body. In FIG. 6, one of protrusions 18 is illustrated in
greater detail. Like
protrusions 16, protrusion 18 includes several geometrical features that are
sized and
arranged with respect to body 14 to cooperate with mating features of the drug
reconstitution
assembly 100 when inserted into package 10. Specifically, protrusion 18
includes a tapered
face 18a, a lid side face 18b, a body side face 18c, a lower face 18d, and an
upper face 18e.
FIGS. 1 to 6 make it clear that the two protrusions 18 extend inwardly from
body 14 spaced
equally on either side of the longitudinal center of body 14.
[0053] FIG. 2 shows that when the drug reconstitution assembly 100 is
inserted
into the body 14, the two protrusions 18, extend through two corresponding
apertures 118 of
the lower housing portion 114. As illustrated in FIG. 4, protrusion 18 extends
through
aperture 118 towards lower container 130. Specifically, the body side face 18c
of protrusion
18 is configured to engage with side 118a of the lower housing portion 114
forming aperture
118, the lid side face 18b of protrusion 18 is configured to engage with side
118b of the lower
housing portion 114 forming aperture 118, the lower face 18d is configured to
engage with
side 118c of the lower housing portion 114 forming aperture 118, and the upper
face 18e is
configured to engage with side 118d the lower housing portion 114 forming
aperture 118.
[0054] The engagement between protrusions 18 and apertures 118
prevents drug
reconstitution assembly 100 from translating axially or rotating within body
14. In particular,
the lid side face 18b contacts side 118b of the lower housing portion 114
forming aperture
118, and body side face 18c contacts side 118a of the lower housing portion
114 forming
aperture 118 to prevent the drug reconstitution assembly 100 from rotating
within body 14.
Similarly, lower face 18d contacts side 118c of the lower housing portion 114
forming
aperture 118, and the upper face 18e contacts side 118d of the lower housing
portion 114
forming aperture 118 to prevent the drug reconstitution assembly 100 from
translating axially
within body 14.
[0055] In various embodiments, the protrusions 18 need not make
constant or any
contact with the sides 118c, 118d of the aperture 118 while making physical
contact with the
lower vial 131 of lower container 130. It should be appreciated that the
protrusions 18 help
to hold lower container 130 secure within the lower housing portion 114
because any axial
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shift of the lower container 130 is inhibited by the protrusions 18, and any
axial shift of the
apertures 118 (i.e., the lower housing portion 114) is inhibited by the same
protrusions 18.
Because the protrusions 18 extend between the apertures 118 and between the
neck 132a and
rim 136 of the lower vial 131 of lower container 130, the protrusions 18, and
therefore the
body 14, prevent axial shift of the lower container 130 with respect to the
lower housing
portion 114.
[0056] Protrusions 16 and 18 accordingly work in cooperation to
prevent both
axial and rotational movement of the housing 110 of the drug reconstitution
assembly 100
within the package 10. While two of each protrusion 16 and 18 are illustrated
mating
respectively with two of each of the apertures 116 and 118, other embodiments
include one of
each protrusion 16 and 18 mating with one corresponding aperture 116 and 118,
or more than
two of each protrusion 16, 18 mating with more than two corresponding
apertures 116, 118.
It should also be appreciated that, for reasons discussed in more detail in
the '967
Application, internal mechanisms and frictions within the drug reconstitution
assembly 100
serve to secure the upper 120 and lower 130 containers with respect to the
housing 110.
[0057] In various embodiments, if the upper 120 or lower 130
containers radially
shift about the longitudinal axis of the drug reconstitution assembly 100,
various internal
seals or components described in more detail in the '967 Application could be
compromised.
It should be appreciated that, the protrusions 20c, 16, and 18 cooperate to
prevent accidental
rotational shift of the upper 120 or lower 130 containers within the housing
110, or any other
features of the drug reconstitution assembly 100 within the package 10.
[0058] Referring again to FIGS. 3 to 6, the mating relationship
between the body
14 with each of the upper vial 121 of container 120 and the lower vial 131 of
lower container
130 is further discussed and illustrated. In addition to the interaction
between protrusions 16
with housing 110 apertures 116 and protrusions 18 with housing 110 apertures
118 to prevent
movement of housing 110 as described above, protrusions 16 also mate with
different
features of upper vial 121, while protrusions 18 also mate with different
features of lower vial
131 to prevent significant movement of the upper 120 and lower 130 containers.
To this
end, protrusions 16 and 18 each extend through the respective apertures 116
and 118 to make
contact with upper vial 121 and lower vial 131. In various embodiments, axial
translation of
the upper 120 and 130 containers with respect to the housing 110, and more
specifically the
upper housing portion 112 and lower housing portion 114 respectively, is
inhibited by the
protrusions 16 simultaneously engaging with upper vial 121 and apertures 116
and
protrusions 18 simultaneously engaging with lower vial 131 and apertures 118.
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[0059] As described above, the upper 120 and lower 130 containers are
arranged
so that the respective shoulders 122b, 132b, necks 122a, 132a, and rims 126,
136 of upper
vial 121 and lower vial 131 are aligned with each of the apertures 116, 118
respectively. In
the illustrated embodiment, protrusions 16 are configured to contact three
different portions
of upper vial 121, namely, the shoulder 122b, the neck 122a, and the rim 126.
Similarly, the
protrusions 18 contact three different portions of lower vial 131, namely,
shoulder 132b, the
neck 132a, and rim 136. FIG. 2 shows that port plug 140 ensures that apertures
116 and 118
are rotated properly to receive protrusions 16 and 18, respectively.
[0060] Tapered portion 16c of protrusion 16 of body 14 is configured
to follow
along the contour of and consequently hold the shoulder 122b of the upper vial
121.
Likewise, tapered portion 18c of protrusion 18 of body 14 is configured to
follow along the
contour of and consequently hold shoulder 132b of the lower vial 131. Tapered
portions 16a,
18a accordingly also serve to support each of the upper 121 and lower 131
vials so as to
prevent significant translational shifting of the respective upper 120 and
lower 130 containers
within the package 10. To prevent movement of the vials to the undesirable
displacement
position it should be appreciated that, in various embodiments the tapered
portions 16a, 18a
need not make constant contact with the contoured shoulders 122b, 132b. Due to
the
contoured nature of the shoulders 122b, 132b and the corresponding tapered
shape of the
tapered portions 16a, 16b, the upper 120 and lower 130 containers are urged
against shifting
relative to the body 14 and the housing 110. The contoured shape of the body
also provides a
cradling effect that enables a snug fit between the upper 121 and lower 131
vials and the
body 14.
[0061] In various embodiments, the lid side face 16b of protrusion 16
of body 14
is arranged to extend towards the neck 122a of the upper vial 121, between rim
126 and
shoulder 122b of upper vial 121. Lid side face 16b wedged between rim 126 and
shoulder
122b further serves to prevent translational shifting of the upper container
120 within
package 10. Similarly, lid side face 18b of protrusion 18 is configured to
extend towards
neck 132b of lower vial 131 and between the rim 136 and the shoulder 132b of
the lower vial
131. Lid side face 18b wedged between rim 136 and the shoulder 132b further
serves to
prevent translational shifting of the lower container 130 within package 10.
To prevent
movement of the vials to the undesirable displacement position it should be
appreciated that,
in various embodiments the lid side faces 16b, 18b need not make constant
contact with the
rims 126, 136 and shoulders 122b, 132b.
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[0062] It should be appreciated that, although the transfer set
assembly 200 is not
necessarily part of either the upper 112 or lower 114 housings, the transfer
set assembly 200
does remain static with respect to the housing due in part to its connection
at the syringe port.
Therefore, it should be appreciated that for similar principles described
above regarding the
containers 120, 130 and the housing 100, the body 14 and its protrusions 16,
18 also function
to prevent axial translation of the upper 120 and lower 130 containers with
respect to the
transfer set assembly 200.
[0063] Additionally, due to the orientation of the tapers 116a, 118a
formed into
the body 14, the upper 120 and lower 130 containers are, if anything, urged
away from the
transfer set assembly 200. As illustrated in FIGS. 4 and 6, the shoulders
122b, 132b of the
respective upper 121 and lower 131 vials rest upon the contours 116a, 118a
respectively,
which are angled such that, absent all other axial obstructions, the upper 120
and lower 130
containers would be unable to shift inward, or toward the transfer set
assembly 200, and
specifically the upper spike 202 and boot 206 and the lower spike 204 and boot
208 and into
the undesirable displacement position. It should be appreciated that the upper
120 and lower
130 containers are inhibited from axial translation with respect to one
another for at least the
same reasons as why they are inhibited from axial translation with respect to
the transfer set
assembly 200.
[0064] End portion 22 of body 14 is formed to support and constrain
different
features of drug reconstitution assembly 100 when assembled in the package 10.
FIG. 4
shows that end portion 22 of the body 14 is configured to constrain the upper
container 120
by limiting upward axial movement of upper vial 121. End portion 22 also
supports the base
portion 122c of upper vial 121. Similarly, end portion 24 of the body 14 is
configured to
constrain the lower container 130 by limiting downward axial movement of lower
vial 131.
End portion 24 also supports the base portion 132c of lower vial 131. It
should be
appreciated that some embodiments include a body 14 that is toleranced such
that the end
portions 22, 24 make contact or near contact with the respective bottoms of
the upper 121 and
lower 131vials, respectively. In various embodiments, the end portions 22, 24
do not make
contact with the bottoms of the upper 121 and lower 131 vials respectively.
[0065] It should be appreciated from the above discussion that the
geometry and
features of formed body 14 interact at multiple contact locations with (i)
drug reconstitution
assembly 100 to prevent its rotational and translational movement, and (ii)
upper 120 and
lower 130 containers to prevent their rotational and translational movement
into the
undesirable displacement position.
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[0066] Aspects of the subject matter described herein may be useful
alone or in
combination with one or more other aspects described herein. Without limiting
the foregoing
description, in a first aspect of the present disclosure, a medical package
assembly includes: a
drug reconstitution assembly including: (i) a housing forming at least one
aperture, (ii) a
container placed at least partially within an interior of the housing, and
(iii) a spike assembly
arranged within the housing so as to be able to spike the container; and a
body shaped to
house the drug reconstitution assembly, the body including at least one
protrusion extending
through the aperture and into the interior of the housing, wherein the at
least one protrusion is
positioned and arranged to prevent movement of the container toward the spike
assembly
prior to the container reaching an undesirable displacement relative to the
spike assembly.
[0067] In accordance with a second aspect of the present disclosure,
which may
be used in combination with the first aspect, which includes a lid attached to
the body and
configured to sealingly enclose the drug reconstitution assembly within the
body.
[0068] In accordance with a third aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
lid is
attached to the body with heat-activated adhesive.
[0069] In accordance with a fourth aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
at least one
protrusion is configured to prevent axial translation of the container
relative to the housing.
[0070] In accordance with a fifth aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
at least one
protrusion further prevents rotation of the drug reconstitution assembly
within the body.
[0071] In accordance with a sixth aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
body is
structured with at least one flat surface so as to prevent rolling of the
body.
[0072] In accordance with a seventh aspect of the present disclosure,
which may
be used in combination with any one or more of the preceding aspects, wherein
the drug
reconstitution assembly includes a syringe port plug and the body includes a
cavity shaped to
mate with the syringe port plug of the drug reconstitution assembly.
[0073] In accordance with an eighth aspect of the present disclosure,
which may
be used in combination with any one or more of the preceding aspects, wherein
the container
is a first container, and which includes a second container placed at least
partially within the
housing of the drug reconstitution assembly, the housing forming at least one
second aperture
wherein the at least one protrusion is a first protrusion and which includes a
second
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protrusion, the second protrusion positioned and arranged to extend through
the second
aperture and into the interior of the housing and prevent movement of the
second container
toward the spike assembly prior to the second container reaching an
undesirable displacement
relative to the spike assembly.
[0074] In accordance with a ninth aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
container is a
first vial including a neck and a shoulder, the first container arranged
relative to the housing
to align at least a portion of the neck of the first vial with the first at
least one aperture, the
first at least one protrusion configured to extend toward the neck and engage
the shoulder
prior to the first vial reaching an undesirable displacement relative to the
spike assembly.
[0075] In accordance with a tenth aspect of the present disclosure,
which may be
used in combination with any one or more of the preceding aspects, wherein the
container is a
first container, and including a second container placed at least partially
within the housing of
the drug reconstitution assembly and the second container is a vial including
a neck and a
shoulder, the housing forming at least one second aperture, the second
container arranged
relative to the housing to align at least a portion of the neck of the second
container with the
at least one second aperture wherein the at least one protrusion is a first
protrusion and the
body forming a second protrusion, the second protrusion positioned and
arranged to extend
through the second aperture and into the interior of the housing toward the
neck of the second
container and engage the shoulder of the second container prior to the second
container
reaching an undesirable displacement relative to the spike assembly.
[0076] In accordance with an eleventh aspect of the present
disclosure, which may
be used in combination with any one or more of the preceding aspects, a drug
delivery
product includes: a drug reconstitution assembly including a housing and a
container placed
within the housing; and a package including a body shaped to house the drug
reconstitution
assembly and at least one protrusion extending from the body, the at least one
protrusion
positioned and arranged to engage the housing and the container to inhibit
axial translation of
the container relative to the housing.
[0077] In accordance with a twelfth aspect of the present disclosure,
which may
be used in combination with any one or more of the preceding aspects in
combination with
the eleventh aspect, wherein the container is a first container and which
includes a second
container placed within the housing, the protrusion a first protrusion, the
body including a
second protrusion positioned and arranged to engage with the housing to
inhibit axial
translation of the second container relative to the housing.
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[0078] In accordance with a thirteenth aspect of the present
disclosure, which may
be used with any one or more of the preceding aspects in combination with the
eleventh
aspect, wherein the first protrusion engages the housing at a first location
adjacent the first
container and the second protrusion engages the housing at a second location
adjacent the
second container.
[0079] In accordance with a fourteenth aspect of the present
disclosure, which
may be used with any one or more of the preceding aspects in combination with
the eleventh
aspect, wherein the first and second engagements include the first and second
protrusions
extending through first and second apertures, respectively, of the housing.
[0080] In accordance with a fifteenth aspect of the present
disclosure, which may
be used with any one or more of the preceding aspects in combination with the
eleventh
aspect, wherein at least one of: (i) the first aperture is one of a plurality
of first apertures
spaced radially about the housing or (ii) the second aperture is one of a
plurality of second
apertures spaced radially about the housing.
[0081] In accordance with a sixteenth aspect of the present
disclosure, which may
be used with any one or more of the preceding aspects in combination with the
eleventh
aspect, wherein the first and second protrusions extending through the first
and second
apertures further inhibit rotational movement of the housing relative to the
body.
[0082] In accordance with a seventeenth aspect of the present
disclosure, which
may be used with any one or more of the preceding aspects in combination with
the eleventh
aspect, wherein the first and second containers are accessed by a transfer set
assembly, the
transfer set assembly including a port accessible by a user, the body
including a well
positioned and arranged to engage the port, or a plug plugging the port, to
inhibit axial
movement of the housing.
[0083] In accordance with an eighteenth aspect of the present
disclosure, which
may be used with any one or more of the preceding aspects in combination with
the eleventh
aspect, wherein the engagement of the drug reconstitution assembly by the at
least one
protrusion also inhibits rotational movement of the hosing relative to the
body.
[0084] In accordance with a nineteenth aspect of the present
disclosure, which
may be used with any one or more of the preceding aspects in combination with
the eleventh
aspect, wherein the engagement of the drug reconstitution assembly by the at
least one
protrusion also inhibits axial movement of the housing relative to the body.
[0085] In accordance with a twentieth aspect of the present
disclosure, which may
be used with any one or more of the preceding aspects, a method of packaging a
drug
18
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reconstitution assembly, comprising: providing a package with a removable lid
and a body
configured to house the drug reconstitution assembly, including at least one
protrusion
extending from the body; providing the drug reconstitution assembly with a
housing having at
least one aperture, and a container placed at least partially within the
housing, wherein a neck
portion of the container aligns with at least one of the apertures of the
housing; assembling the
drug reconstitution assembly within the body of the package, such that the at
least one
protrusion of the body extends through at least one of the apertures of the
housing, wherein an
orientation of the drug reconstitution assembly within the package is limited
to a
predetermined number of orientations; and sealing the drug reconstitution
assembly within the
body of the package with the removable lid.
[0086] The
scope of the claims should not be limited by the preferred
embodiments set forth above, but should be given the broadest interpretation
consistent with
the description as a whole.
19
