Note: Descriptions are shown in the official language in which they were submitted.
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PACKAGING FOR SAFETY NEEDLE
TECHNICAL FIELD
[0001] The present disclosure generally relates to
packaging for medical devices, and
more particularly to dual packaging for passive safety needles requiring
rotation of a tether or
housing for passive activation.
BACKGROUND
[0002] Clean or sterile articles particularly useful for
medical applications are packaged
to preserve their sterility. The packaging for these articles is intended to
provide a barrier to
prevent microorganisms from entering inside the packaging to contaminate its
contents. In
most instances, the packaging is opened immediately prior to using the
article, such as with a
blister pack housing a syringe or a needle, so as to minimize the time period
in which the
article is exposed to unsterile conditions.
[0003] Traditionally, practitioners that fill and inject
syringes can use a one or two-
needle technique. In the one-needle technique, the practitioner fills the
syringe from a
container (e.g. vial) having a liquid contained therein, and uses the same
needle for injection.
In the two-needle technique, the practitioner fills the syringe with a first
needle, but replaces
the needle with a new needle prior to injecting.
[0004] Both the one-needle technique and the two-needle
technique offer certain
advantages and disadvantages. For example, the one-needle technique is
convenient because
the practitioner does not have to change needles between filling and
injection, but the needle
can become contaminated between filling and injection. The two-needle
technique allows for
specialized needles that are optimized for filling and injection, but is more
cumbersome for the
practitioner.
[0005] Accordingly, there is a need for alternative packaging systems for
providing
needles to a user in a sterile condition. There is also a need to provide
packaging to prevent
unintended activation for passive safety needles that requiring rotation of a
tether or housing
for passive activation.
SUMMARY
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[0006] One aspect of the present disclosure pertains to a
packaging system comprising
a safety needle device having a tether and a retractable sleeve. The tether
includes a recess
disposed on a distal end of the tether, and the retractable sleeve advanceable
within the tether.
The packaging system further includes a hard package having a closed distal
end, an open
proximal end, and a compartment extending between the closed distal end and
the open
proximal end. A premature activation prevention element of the compartment
nests within the
recess of the safety needle device. A removable seal is disposed against the
open proximal end,
wherein the compartment and the removable seal define a sealed region, the
safety needle
device being disposed within the sealed region. In one or more embodiments,
the safety needle
device is a passive safety needle or an active safety needle.
[0007] In one or more embodiments, the premature activation
prevention element
comprises at least one rail, the at least one rail having a protruding ledge
extending from an
inner sidewall of the compartment, the protruding ledge extending toward the
center of the
compartment.
[0008] In one or more embodiments, the protruding ledge has a width that
is slightly
less than the width of the recess of the safety needle device. The protruding
ledge prevents
rotation of the safety needle device when the safety needle device is disposed
within the
compartment.
[0009] A second aspect of the present disclosure pertains
to a packaging system
comprising a safety needle device having a tether and a retractable sleeve.
The tether includes a
recess disposed on a distal end of the tether, and the retractable sleeve
advanceable within the
tether. The packaging system further includes a hard package comprising a
first compartment,
and a second hard package having a closed distal end, an open proximal end,
and a second
compartment extending between the closed distal end and the open proximal end.
A premature
activation prevention element disposed on an inner sidewall of the compartment
removably
nests within the recess of the tether of the safety needle device. The
premature activation
prevention element being at least one rail having a protruding ledge which
nests within the
recess of the safety needle device. A removable seal is disposed against the
open proximal end,
wherein the compartment and the removable seal define a sealed region, the
safety needle
device being disposed within the sealed region. A second removable seal is
sealed against the
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second compartment. The second removable seal defines a second sealed region
in which
the safety needle is disposed within. The first hard package is attached to
the second hard
package.
[0010] In one or more embodiments, the least one rail disposed on an
inner
sidewall of the compartment extends from a closed distal end of the
compartment at least
partially the length of the compartment.
[0011] In one or more embodiments, the least one rail is disposed on
an inner
sidewall of the compartment extends from a closed distal end of the
compartment to the
open proximal end.
[0012] In one or more embodiments, the least one rail has a width that is
less than
a width of the recess of the safety needle device.
[0013] In one or more embodiments, the first hard package is
connected to the
second hard package via press fitting, an adhesive bond, a solvent bond, a
ring connector,
a snap fit, a C-clip snap, heat staking or ultrasonic welding.
[0014] In one or more embodiments, the first hard package has a perforated
attachment to the second hard package.
[0015] In one or more embodiments, the first removable portion
comprises a first
pull tab and the second removable portion comprises a second pull tab.
[0016] In one or more embodiments, the first removable seal includes
graphics,
symbols, diagrams, words or instructions to indicate that the first removable
seal is to be
opened first.
[0017] In one or more embodiments, the second removable seal includes
graphics, symbols, diagrams, words or instructions to indicate that the first
removable
seal is to be opened second.
[0018] In one or more embodiments, the first hard package has a first color
and
the second hard package has a second color.
[0019] A third aspect of the present disclosure pertains to a
packaging system
having a needle, a safety needle device, and a blister package having a first
cavity and a
second cavity. The second cavity has a premature activation prevention element
to nest
within the recess of the safety needle device. The first and second cavities
are sealed
against a backing, the first cavity and the backing defining a first sealed
region, and the
second cavity and the backing defining a second sealed region. A distal end of
the needle
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being disposed within the first sealed region and a distal end of a second
needle being
disposed within the second sealed region.
[0020] In one or more embodiments, the needle is a blunt fill needle.
[0021] In one or more embodiments, the safety needle device is a
passive safety
needle or an active safety needle.
[0022] In one or more embodiments, the recess has a width that is
slightly larger
than a width of the protruding activation element of the compartment, the
protruding
activation element preventing rotation of the safety needle device when the
protruding
activation element is nested within the recess.
[0023] In one or more embodiments, a cap is disposed about the distal end
of the
needle.
[0024] In one or more embodiments, the blister package includes a
peel tab.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Figure 1 illustrates a single packaging for a safety needle
device;
[0026] Figures 2A and 2B illustrate a safety needle device of Figure 1;
[0027] Figure 3A illustrates a compartment of the single packaging of
Figure 1;
[0028] Figure 3B illustrates a section view of the compartment of the
single
packaging of Figure 1;
[0029] Figure 3C illustrates a detailed section view of the
compartment of the
single packaging of Figure 1;
[0030] Figure 4A illustrates the safety needle device disposed within
the
compartment of the single packaging of Figure 1;
[0031] Figure 4B illustrates a detailed view the safety needle device
disposed
within the compartment of the single packaging of Figure 1;
[0032] Figure 4C illustrates a detailed side perspective view the safety
needle
device disposed within the compartment of the single packaging of Figure 1;
[0033] Figure 4D illustrates an exploded view of the safety needle
device and the
single compartment of Figure 1;
[0034] Figure 5 illustrates a dual packaging with two pull tabs;
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[0035] Figure 6 illustrates a hard package having two
removable portions with two pull
tab;
[0036] Figure 7 illustrates a blister pack containing a
blunt fill needle and a safety
needle.
DETAILED DESCRIPTION
[0037] Before describing several exemplary embodiments of
the present disclosure, it
is to be understood that the embodiments of the present disclosure are not
limited to the details
of construction or process steps set forth in the following description. The
embodiments of the
present disclosure are capable of other embodiments and of being practiced or
being carried
out in various ways.
[0038] With respect to terms used in this disclosure, the
following definitions are
provided.
[0039] As used herein, the use of "a," "an," and "the"
includes the singular and plural.
[0040] Reference to "needle" includes needles that are
suitable for filling and/or
injecting liquids into or out of a syringe_ In this disclosure, a convention
is followed wherein
the portion of a needle closest to the practitioner operating the needle is
termed "proximal" and
the portion of the needle toward the patient (for injection) or vial
containing liquid (for filling)
and farthest from the practitioner is termed "distal.- In various embodiments,
the needles
described herein can be blunt fill needles, safety needles and/or conventional
needles.
[0041] As used herein, a "fill needle" refers to a needle that is suitable
to fill a syringe
but may not be suitable for injection. For example, a fill needle may be a
blunt needle that is
not suitable to penetrate a patient's skin.
[0042] As used herein, a "safety needle" refers to a needle
suitable for injection that
includes one or more features to prevent needle stick injuries. In one or more
embodiments, a
safety needle includes a sheath that covers the distal end of the needle. As
used herein, an
"active safety needle" refers to a safety needle with a user-operated
activation mechanism to
cover the distal end of the needle after a patient has been injected. As used
herein, a "passive
safety needle" refers to a safety needle with a passive activation mechanism
that automatically
covers the distal end of the needle after a patient has been injected.
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[0043] Any suitable needle devices comprising a safety feature may be
used in
conjunction with the packaging disclosed herein. Exemplary safety needle
devices include, but
are not limited to, those described in commonly owned, U.S. Patent Application
Nos.
62/433,294, 62/433,350, 62/479,507, 62/533,786. Types of safety features vary
in structure
.. and mechanics but in general, safety needle devices have a fill state and
an inject state.
[0044] Reference to "syringe" includes syringes that are indicated for
use with needles,
nozzle, tubing, or for use in flush systems. As used herein, the term
"syringe" refers to a
simple pump-like device consisting of a plunger rod that fits tightly in a
barrel or tube. The
plunger rod can be pulled or pushed along inside the barrel, allowing the
syringe to take in and
expel a liquid or gas through an opening at the open end of the barrel. The
open end of the
syringe may be fitted with a needle, nozzle, or tubing to help direct the flow
of fluid into and
out of the barrel. The syringe may be sterile or unsterile, depending upon the
needs of the
technician.
[0045] As used herein, the teims "package" or "packaging" includes any
material used
to wrap or protect a good or product, such as a syringe or a needle. Packaging
can be rigid or
flexible. Packaging includes, but is not limited to, medical packaging,
pharmaceutical
packaging, and child-resistant packaging. Medical and pharmaceutical packaging
can include
blister packs or hard packages.
[0046] As used herein, the terms "blister package" or "blister pack"
includes several
types of pre-formed packaging used for consumer goods, foods, pharmaceuticals,
medical
devices, etc. The primary component of a blister pack is a cavity or pocket
made from a
formable web, usually a thermoformed plastic. The formable web can be rigid or
flexible. The
cavity or pocket is large enough to contain the good which is housed in the
blister package.
Depending on the application, a blister pack may have a backing of
thermoformable material
and a lidding seal of aluminum foil, paper, Tyvek0, plastic, or other medical
grade materials.
Blister packs can also be hinged, clamshell containers, that can include a
rigid backing, such as
paperboard_ Blister packages can provide barrier protection from
microorganisms and other
contaminants, and can provide a certain degree of tamper resistance. Within
the many options
that blister packaging provides, the blister pack must protect the product
contained inside while
still possessing the characteristic capable of making automated processing
possible.
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[0047] Blister packs are commonly used as unit-dose
packaging for pharmaceutical
tablets, capsules, or lozenges. The pharmaceutical product and its blister
pack act together to
serve as an integral unit. The blister pack protects the pharmaceutical
product from outside
influences that would otherwise render it useless while allowing the
manufacturer of the
pharmaceutical product to package it using form-fill-seal equipment. The form-
fill-seal
process involves creating the blister pack from rolls of flat sheet or film,
filling with the
pharmaceutical product, such as a drug tablet, and closing (sealing). This
type of blister pack
is sometimes referred to as push-through-packs because the consumer can push
the good (e.g.
drug tablet) through the backing. With pharmaceutical blister packs,
manufacturers must be
concerned with the moisture vapor transmission rate of the blister pack
because many
pharmaceutical products degrade and lose their efficacy through hydrolysis.
Additionally, the
blister pack must provide a barrier to oxygen in order to prevent degradation
of the
pharmaceutical product through oxidation. In one or more embodiments, the
blister pack is a
push-through-pack.
[0048] Blister packages that contain medical devices, such as a syringe,
differ from
pharmaceutical blister packs because medical blister packs are not push-
through packages.
Instead, the thermoformed base web is made of a thicker plastic and cannot be
collapsed, thus
forming a solid backing. The lidding film provides a peel-open feature that
can be peeled open
using two-hands, such as, e.g. the knuckle-roll-peel technique. The lidding
film of a medical
blister pack is generally porous to allow sterilization. Often, medical
blister packs are made of
Tyvek or a similar medical grade material that is breathable and permeable to
gases, but is
not permeable to microorganisms. The lidding film can also be made of medical
grade paper
or a completely non-permeable or non-breathable film. In instances where a non-
breathable
film is used, sterilization is through radiation (e.g. electron beams (E-
beam)). In one or more
embodiments, the blister pack is a medical blister pack.
[0049] Blister packs can be created via thermoforming or
cold forming. In the case of
thermoforming, a plastic film or sheet is unwound from a reel and guided
through a pre-heating
station on the blister line. The temperature of the pre-heating plates is such
that the plastic will
soften and become pliable. The warm plastic then arrives in a forming station
where a large
pressure forms the blister cavity into a negative mold. The mold is cooled
such that the plastic
becomes firm again and maintains its shape when removed from the mold.
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1100501 In the case of cold forming, an aluminum based-
laminate film is simply pressed
into a mold by means of a stamp. The aluminum elongates and maintains the
formed shape.
The use of aluminum offers a complete barrier for water and oxygen. However,
cold faun
blister packs take longer to produce compared to thermoforming. Cold form
blister packs are
also not transparent, which can lead to consumers not complying with
pharmaceutical
therapies.
[0051] The thermoformable backing of the medical blister
pack is generally comprised
of a flexible thermoformable plastic film. The film is often multi-layered.
The primary
component is regularly a layer of approximately 15-30% Nylon, while the
remaining layers can
comprise substances including, but not limited to, polyethylene. The sealant
layer can
comprise, among others, ethyl vinyl acetate (EVA).
[0052] The lidding film of a medical blister pack can be
made from plastic, aluminum,
or medical grade papers that are permeable to gases for sterilization but are
impermeable to
microorganisms. Most commonly, Tyvek is used as a lidding material for
medical blister
packs.
[0053] Blister packaging can also include the skin pack,
where a paperboard or other
backing material and product are covered with a thin sheet of transparent
plastic. The backing
generally has a heat-seal coating. The plastic film is softened by heat and
draped over the
product on the backing. Vacuum is sometimes used to assist in a snug fit.
Immediately after
forming the blister, the blister is transported to a vacuum sealing station
where a vacuum is
pulled and the blister is sealed shut, providing the snug fit. The plastic
film bonds to the heat-
seal coating on the paperboard or other backing. In one or more embodiments,
the blister pack
is a vacuum sealed thermoformed blister pack.
[0054] Blister packs can be sealed in a variety of ways
including, but not limited to,
heat-sealing and cold sealing. Lidding materials can have a heat-seal coating
applied to them;
the lidding is then sealed to the backing using heat, which activates the
coating. Blister packs
can also be sealed using a cold seal process, which uses a combination of a
pressure sensitive
fold-over blister card and a transparent blister; the blister is trapped
between two pieces of
hoard that are bonded together under pressure without using any heat.
Additionally, blister
packs can be sealed by orienting multiple layers of film properly in order to
make a seal.
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[0055] As used herein, the term "hard package" or the like
includes packaging having a
compartment with one or more openings that can be covered to create a seal. In
one or more
embodiments, the hard package includes one or more components made of a rigid
material
such as a rigid polymeric material. Examples of rigid polymeric materials
include, but are not
limited to, polyester, polycarbonate, polyethylene, polystyrene or
polypropylene, or
combinations or co-polymers thereof. In one or more embodiments, a hard
package can
thermoformed or molded, such as by injection molding. The techniques described
above for
blister packs can be applied to the rigid portions of hard packages and/or to
removable portions
of hard packages.
[0056] As used herein, the term "microorganism" refers to a microbe or
organism that
is unicellular or lives in a colony of cellular organisms. Microorganisms are
very diverse; they
include, but are not limited to bacteria, fungi, archaea, and protozoans.
[0057] Tyvek is a synthetic material consisting of
flashspun high-density
polyethylene fibers (i.e. a spunbound olefin fiber). The material is
lightweight and strong, and
is resistant to tearing but can be cut with scissors or a knife. Water vapor
and other gases can
pass through Tyvek as the material is highly breathable, but, at the same
time, the material is
impermeable to liquid water and microorganisms.
[0058] As used herein, the term "sterilization- refers to a
means of eliminating or
killing microorganisms present on a surface, contained in a fluid or in a
compound such as
biological culture media in order to achieve asepsis or a sterile microbial
environment.
Sterilization can be achieved by applying heat, chemicals,
irradiation/radiation, high pressure,
filtration, or combinations thereof. Chemical sterilization includes
sterilization with gases such
as ethylene oxide, hydrogen peroxide gas, and ozone, liquids such as chlorine
bleach, iodine,
glutaraldehyde and formaldehyde, ortho-phthaladehyde (OPA), hydrogen peroxide,
peracetic
acid, sodium hydroxide, silver, and cobalt. Radiation sterilization involves
the use of radiation
such as electron beams (E-bearrt), x-rays, gamma rays, or subatomic particles.
[0059] As used herein, the term "knuckle-roll-peel
technique" refers to the process
whereby a technician, such as a doctor or nurse, opens a package to release
the product
contained therein. With a knuckle-roll motion, the outer packaging material is
peeled apart
using two hands, and the inner product is released.
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[0060] Various embodiments of the present disclosure provide dual
packaging systems
containing two needles. In one or more embodiments, this dual packaging can
help to improve
work flow and efficiency for users of the two-needle technique by removing the
need to
remember to get two needles instead of one. In one or more embodiments, this
dual packaging
can also be helpful for clinicians who traditionally use a one-needle
technique to fill and inject,
as such practitioners may not be used to getting a separate packaged component
In one or more
embodiments, this dual packaging can also help to drive compliance in clinical
settings where
managers want clinicians to use a two-needle technique but the clinicians
would prefer to use the
more convenient one-needle technique. In one or more embodiments, dual
packaging can be
beneficial because it helps to prevent a user from injecting a patient with a
device in the fill state
either accidentally or purposefully. For passive safety, injection with a
device in a fill state could
prevent the safety from activating. In one or more embodiments, providing two
needles allows
a user to perform injection with a second needle that has not been dulled,
recapped, or undergone
risk of touch contamination. In one or more embodiments, the two needles
include a fill needle
(e.g. blunt fill needle) and a needle for injection (e.g. a safety needle). In
other embodiments,
one or both of the needles is a conventional needle.
[0061] One or more embodiments of the present disclosure relate to a
single
compartment or dual compartment packaging system having a hard package.
[0062] Figure 1 illustrates an exemplary embodiment of a single
compartment packaging
system 100. As illustrated, compartment 120 can house a safety needle device
130. A
removable seal 140 disposed against the open proximal end 122. As shown in
Figure 1, the
compartment 120 can be molded in a single piece, such as by injection molding.
[0063] Figures 2A and 2B illustrate a safety needle device 130
comprising a retractable
sleeve 134 having a protruding activation element 132 advanceable within a
tether 136, the
retractable sleeve and tether 136 being disposed within a housing 138. The
retractable sleeve at
least partially covers a needle 135 in an initial state. The tether 136
includes a recess 139
disposed on a distal end of the tether. As disclosed in further detail below,
the recess 139 of the
tether 136 interdigitates with a premature activation prevention element 125,
as shown in Figures
3A-3C of the compartment 120 to prevent inadvertent activation of the
retractable sleeve 134
.. during transportation, storage or packaging generally. For purposes of
illustration, in Figure 2B,
the housing 138 has been removed for purposes of clarity. In one or more
embodiments, the
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protruding activation element 132 is integral with the retractable sleeve 134.
In one or more
embodiments, the safety needle device 130 is a passive safety needle. In one
or more
embodiments, the safety needle device 130 is an active safety needle.
[0064] As shown in Figure 3A ¨ 3C, the single compartment
packaging system 100
may include a hard package having a closed distal end 121, an open proximal
end 122, and a
compartment 120 extending between the closed distal end 121 and the open
proximal end 122.
A removable seal 140 disposed against the open proximal end 122. Compartment
120 and
removable seal 140 define a sealed region in which the safety needle device
130 is disposed.
The removable seal 140 can be a pull tab.
[0065] As shown in Figure 3B ¨ 3C, the compartment 120 includes a premature
activation prevention element 125 which nests within the recess (not shown) of
the safety
needle device 130. In the preferred embodiment, the premature activation
prevention element
125 includes at least one rail 126 disposed on an inner sidewall 129 of the
compartment 120
extending from the closed distal end 121 at least partially the length of the
compartment. In
one or more embodiments, the at least one rail 126 extends to the open
proximal end. The at
least one rail 126 has a width that is less than a width of the recess 139 of
the safety needle
device 130. In one or more embodiments, the premature activation prevention
element 125
comprises two parallel rails, the two parallel rails having a distance between
them wherein the
two parallel rails are configured to nest within the width of the recess 139
of the safety needle
device 130. In one or more embodiments, premature activation prevention
element 125
comprises a single unitary rail.
[0066] As shown in figure 3C, the at least one rail 126
includes a protruding ledge 128.
The protruding ledge 128 protrudes towards the center of the compartment 120.
The protruding
ledge 128 is configured to nest within the recess 139.
[0067] As shown in figures 4A ¨ 4D, the safety needle device 130 is
disposed within
the compartment 120. For purposes of clarity, a spring of the safety needle
device 130 has been
obscured from view in order to better illustrate the protruding ledge 128 of
the premature
activation element 125 being nested within the recess 139 of the safety needle
device 130.
When the safety needle device 130 is disposed within the compartment 120, the
protruding
ledge 128 of the premature activation prevention element 125 of the
compartment 120 is nested
within the recess 139 of the housing 138 of the safety needle device 130. The
premature
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activation element 125 of the compartment 120 prevents premature or
inadvertent activation of
the safety needle device 130 by preventing rotation of the safety needle
device 130. Due to the
at least one rail 126 of the premature activation element 125 having a width
that is less than
the width of the recess 139 of the tether 136, the protruding ledge 128 sits
within the recess
139. In one or more embodiments, the width of the at least one rail 126 is
slightly less than the
width of the recess 139, thereby allowing only minimal rotation, but not free
rotation of the
safety needle device 130 within the compartment 10.
[0068] Figure 5 illustrates an exemplary embodiment of a
dual packaging system 200.
The packing system has a first compartment 220 that can house a first needle
and a second
compartment 250 that can house a safety needle device 230. As shown in Figure
3, the first
compartment 220 and second compartment 250 can be molded in a single piece,
such as by
injection molding.
[0069] The first compartment 220 has an opening that is
covered by a first removable
seal 225. The first removable seal 225 is sealed against the first compartment
220, with the
first compartment 220 and the first removable seal 225 defining a first sealed
region. The first
removable seal 225 can include a pull tab for a user to grab in order to
remove the first
removable seal 225 to access the first compartment 220.
[0070] In one or more embodiments, the first removable seal
225 can include graphics,
symbols, diagrams, words or other instructions to indicate that it is to be
opened first. For
example, the first removable seal 225 can include the number "1". The first
removable portion
may also include graphics, symbols, diagrams, words or other instructions to
indicate the
intended use of the needle stored in the first compartment 220. In one or more
embodiments,
the first removable seal 225 can include graphics, symbols, diagram, words or
other
instructions to indicate that it is to be opened first.
[0071] The second compartment 250 has an opening that is covered by a
second
removable seal 255. Second compartment 250 includes a premature activation
prevention
element 235 disposed within the compartment that can nest a recess 239
disposed on a distal
end of a tether 236 of the safety needle device 230. In one or more
embodiments, the
premature activation prevention element 235 is in the form of at least one
rail 226 disposed on
an inner sidewall of the compartment 250. In one or more embodiments, the
premature
activation prevention element 225 interdigitates with the recess 239 of the
protruding
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activation element 232. The at least one rail 226 includes a protruding ledge
228. The
protruding ledge 228 protrudes towards the center of the compartment 250. The
protruding
ledge 228 is configured to nest within the recess 239,
[0072] The second removable seal 255 is sealed against the
second compartment 250,
with the second compartment 250 and the second removable seal 255 defining a
second sealed
region. The second removable seal 255 can include a second pull tab 260 for a
user to grab in
order to remove the second removable seal 255 and access second compartment
250.
[0073] The second removable seal 255 can include graphics,
symbols, diagrams, words
or other instructions to indicate that it is to be opened second. For example,
the second
removable seal 255 can include the number "2". The second removable portion
may also
include graphics, symbols, diagrams, words or other instructions to indicate
the intended use of
the needle stored in the second compartment 250. For example, if the needle
stored in the
second compartment 250 is to he used for injecting a patient, the second
removable seal 255
can include a graphic showing a person with a syringe. Furthermore, if the
needle stored in the
second compartment 250 is a single-use needle device that locks after use, the
second
removable seal 255 can also include a lock symbol.
[0074] Figure 6 illustrates an exemplary embodiment of a
dual packaging system 300.
The packing system has a first compartment 320 that can house a first needle
and a second
compartment 350 that can house a safety needle device 330. As shown in in
Figure 4, the first
compartment 320 and second compartment 350 can be molded separately and joined
by an
attachment 375. In one or more embodiments, the first compartment 320 can be
attached to the
second compartment 350 via press fitting, an adhesive bond, a solvent bond, a
ring connector,
a snap fit, a C-clip snap, heat staking or ultrasonic welding. In one or more
embodiments, the
first compartment 320 can be attached to the second compartment 350 by a
perforated or
temporary attachment.
[0075] In one or more embodiments, the first compartment
320 and the second
compartment 350 are composed of different materials or have different colors.
For example, in
one or more embodiments the first compartment 320 can be colored to indicate a
specific use
(e.g. red to indicate a blunt fill needle) and the second compartment 350 can
he clear, semi-
transparent or have a different color indicating a specific use. In other
embodiments, both the
13
CA 03170267 2022- 8- 31
first compartment 320 and the second compartment 350 are clear or semi-
transparent, or are
the same color.
[0076] The first compartment 320 has an opening that is covered by a
removable
portion 325. The first removable seal 325 is sealed against the first
compartment 320, with
the first compartment 320 and the first removable seal 325 defining a first
sealed region. The
first removable seal 325 can include a first pull tab for a user to grab in
order to remove the
first removable seal 325 to access the first compartment 320.
[0077] The second compat ttnent 350 has an opening that is covered
by a second
removable seal 355. The second removable seal 355 is sealed against the second
compartment 350, with the second compartment 350 and the second removable seal
355
defining a second sealed region. The second removable seal 355 can include a
second pull tab
360 for a user to grab in order to remove the second removable seal 355 and
access the second
compartment 350.
[0078] Second compartment 350 includes a premature activation
prevention element
335 in the compartment which nests within a recess 339 of a tether 336 of the
safety needle
device 330. In one or more embodiments, the premature activation prevention
element 335
interdigitates with the recess 339 of the tether 336 of the safety needle
device 330. The second
removable seal 355 is sealed against the second compartment 350, with the
second
compartment 350 and the second removable seal 355 defining a second sealed
region. The
second removable seal 355 can include a second pull tab 360 for a user to grab
in order to
remove the second removable seal 355 and access second compartment 350.
[0079] The first removable seal 325 and second removable seal 355 can
include any of
the features described above for the first removable seal 325 and second
removable seal 355,
such as graphics, symbols, diagrams, words or other instructions to indicate
the order of
opening compartments or the intended use of the needles stored in the
compartments.
[0080] One or more embodiments of the present disclosure relate to a
dual packaging
system having a blister package. An exemplary embodiment of a dual packaging
system 400
is shown in Figure 7. A first cavity 420 houses at least a portion of a needle
405, and a
second cavity 450 houses at least a portion of a safety needle device 435. In
one or more
embodiments, first cavity 420 houses a syringe and pre-attached blunt fill
needle. Safety
needle device 435 having a protruding activation element 436. In one or more
embodiments,
14
Date Recue/Date Received 2022-12-22
WO 2021/178173
PCT/US2021/019381
needle 405 and safety needle device 435 can be packed side by side in dual
blister packaging
system 400.
[0081] In one or more embodiments, second cavity 450 having
a recess 460 to nest the
protruding activation element of the safety needle device. The distal portion
410 of the needle
405 can be covered with a more rigid material than the proximal portion 415 of
the first needle.
The distal portion 410 of the needle 405 can be covered by a cap 490.
Similarly, the distal
portion 440 of the safety needle device 435 can be covered with a rigid
material. The distal
portion 445 of the safety needle device 435 can be covered by a cap 490. A
backing 485 can
provide a seal against the first cavity 420 and the second cavity 450. The
blister package can
also include a peel tab 495 to open the blister package. In one or more
embodiments, direction
of peel is on the right hand side of the packaging to reduce the chance of
contamination. In
another embodiment, direction of peel is on the left hand side of the
packaging.
[0082] Reference throughout this specification to "one
embodiment," "certain
embodiments," "various embodiments," "one or more embodiments" or "an
embodiment"
means that a particular feature, structure, material, or characteristic
described in connection
with the embodiment is included in at least one embodiment of the disclosure.
Thus, the
appearances of the phrases such as "in one or more embodiments," "in certain
embodiments,"
"in various embodiments," "in one embodiment" or "in an embodiment" in various
places
throughout this specification are not necessarily referring to the same
embodiment of the
disclosure. Furthermore, the particular features, structures, materials, or
characteristics may be
combined in any suitable manner in one or more embodiments.
[0083] Although the disclosure herein provided a
description with reference to
particular embodiments, it is to be understood that these embodiments are
merely illustrative of
the principles and applications of the disclosure. It will be apparent to
those skilled in the art
that various modifications and variations can be made to the present
disclosure without
departing from the spirit and scope thereof. Thus, it is intended that the
present disclosure
include modifications and variations that are within the scope of the appended
claims and their
equivalents.
CA 03170267 2022- 8- 31
