Note: Descriptions are shown in the official language in which they were submitted.
Packa~e_Havin~ Handle-Adapt~ble Fla~
Technical Field
The peesent invention relates to packaging, and in
particular to an easy opening medical container which must
be made in part of a material permeable by a sterilizing
gas such as ethylene oxide.
Background of the Invention
Packages for medical products such as parenteral fluid
and blood administration sets and catheters, needles and
the like preferably are of the type such that the contents
of the package may be sterilized after the package is
sealed~ Such a sterilizing process may be performed by
means of a sterilizing gas such as ethylene oxide, which
permeates the package. Postpackaging sterilization
reduces cost and eliminates the possibility of contamina-
tion during the packaging process as opposed to steriliz-
ing the medical prod~ct only prior to packaging.
Another requirement for medical product packaging is
that the package be easily and quickly opened and further,
that the package be opened without unnecessary manipula-
tion of the contents thereof which might increase the risk
of contamination. The easy and quick opening feature is
necessary for medical products because their use is often
required in an emergency where speed is highly desirable.
Even without the medical requirements for a quick opening
package, such an attribute is still desirable to save time
and increase efficiency in a hospital.
Increasingly, one-tlme use, disposable products are
being used in hospitals because the risk of contamination
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is drastically diminished and the increased cost o dis-
posable items is partially or totally offset by the
decreased labor previously necessary for handling and
resterilizing the products.
Because of the increased use of disposable products,
hospital supply rooms must necessarily stock a large
quantity of disposable medical product packages, both in
absolute numbers and in the number of different types of
products. Typicallyy such packages are fairly small.
ThusJ it is highly desirable that the medical product
packages be easily and neatly stackable and conten-t-iden
tifiable without rummaging through the inventory in the
supply room.
One type of package which meets the above requirements
is a semi-rigid paper or cardboard-like package such as
used by Travenol Laboratories, Inc~ of Deerfield, Illinois
to package their intravenous solution administration
se~s. These packages often have a type of score line
which makes the package easily and quickly openable~
Although an extremely high quality package, it has the
disadvantage of being high in cost relative to the package
of the present inventionO The packaging material is rela-
tively expensive. The package is expensive to manufacture
and it is often difEicult to insert the medical product to
be packaged into the package~
Another type of medical package widely used has a flat
or thermoformed blister plastic piece varying from
extremely flexible to extremely rigid and having a flex
ible cover~ The cover may be a plastic material such as
TYVEK , which is a high density polyethylene sold by
DuPont, or a paper material~ The plastic, paper or
paper-like material cover is usually permeable by a
sterilizing gas and after the package contents are
sterilized the cover maintains the chamber between the
plastic piece and cover in a sterile environment. Such
packages are generally more expensive than the card-
board-type packages described above. The plastic packages
vary ~ith respect to the ease of inserting the product
into the package. Many are difficult to open~ If able to
be opened quickly, many of the covers become fragmented
into several piecesO This can be frustrating, messy and
undesirable in a hospital,
Many such pac~ages are clumsy to open such that the
contents must be held during the opening procedure so that
the contents do not fall out. This is an extra handling
step which increases the risk of product contamination.
A plurality of such packages frequently are not a~le
to be neatly stack,ed and/or stored. This can lead to a
number of difficulties such as~ for example~ the necessity
of increased shelf space for a given number of packages,
the necessity of maintaining a plurality of the individual
packages in a larger carton, an extremely messy and incon-
venient supply room, and/or a supply room in which
products may not be quickly and readily identified.
The package of the present invention meets all of the
above-described, highly desirable and necessary require-
ments while avoiding the drawbacks of existing medical
packages.
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Summar~ the Invention
We have discovered a medical quality packaye which is
low in material cost, low in manufacturing cost and which
facilitates easy insertion of the package contents into
the package, lowering production costs. The package of
our invention is capable of being ~uickly and easily
opened. The construction permits the use of a lower cost
paper cover material which does not rip into numerous
pieces upon opening and which can be made to maintain a
sterile environment for the product. r~'he package permits
postpackagi~g stexilization.
More particularly, our invention is directed to a
chamber-defining package employing a depending flap which
fractures from its connection to a base and is adaptable
as a handle to remove a cover from the baseO The base is
made of thermoEormed plastic, having a bottom wall and a
sidewall which together define a volume in which the
medical product may be placedO A flange extends outwardly
from the top of the sidewall. A fle~ible cover such as of
TYVEK plastic, paper or other similar material is used
and is sealed to the base by means of an adhesive and/or
heat seal. The flap is formed depending from a portion of
the flange, preferably along one of the shorter segments
of the sidewall.
The flap depends from the flange at a juncture-defin-
ing bend line which in one of the preferred embodiments is
fracturable upon rotation of the flap about the bend
line. The flap may be constructed so as to fracture from
the flange upon a single rotatiny movement of the flap
about the bend line of not greater than about 270
degrees. When the plastic material used is relatively
thin, the juncture-defining bend line is fracturable upon
rotating the flap abo~t the bend line several times.
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In the preferred embodiment the flap extends substan-
tially vertically downwardly at the bend line from the
portion of the flange and the cover is sealed by adhesive
and/or heat and pressure to the base in a continuous seal
about the flange and extending onto the flap to form a
sealed chamber. There is preferably no continuous seal on
that portion of the flange extending the length of the
bend line.
To open the package, the base may be grasped at the
flap. With the flap serving as a handle, the flap (with
cover attached thereto), is rotated upwardly about the
fracturable juncture-defining bend line. The flap breaks
away from the base and in a continuous motion the flap and
cover are pulled in a direction generally perpendicular to
the bend line and generally parallel with two segments of
the side wall, thereby enabling quick and easy removal of
the cover from the base in a firm motion while greatly
decreasing the possibility of tearing the cover and having
to tear a further piece of the cover away from the base.
The flap solves the problem of initially having to simul-
taneously rupture a substantial length of the seal not
parallel with the direction of cover removal.
We have found that the fracture may be easily made
when the base is formed of polystyrene sheet stock at
least 0.010 inch thick. Other plastics vary in their
ability to fracture easily. With thinner sheet stock the
flap will still fracture when more than one rotating move-
ment of the flap is made.
In the preferred embodiment formed gussets are dis-
posed in the portion oE the flange adjacent the bend linefor increased rigidity of the flange portion, thereby aid-
ing fracture. The sidewall and bottom wall have formed
ribs therein for increased strength permitting stacking of
a plurality of like packages~ When so stacked, the flaps
4 ~ ,.3
6 -t!
remain clearly visible. The contents of the package may
be clearly identified on the flap without rummagin~
through the packages.
The package is made by thermoforming the base from
polys~yrene sheet stock, sealing the cover to the base and
then forming the flap by simultaneously applying ultra-
sonic sound and pressure to the portion of the flange
where the flap is desired. This procedure heat sets the
flap at the juncture-defining bend line such that the flap
remains in a substantially set position depending from the
portion of the flange. Alternatively, the flap may be
formed by using a heated bar or wire which applies heat
along a narrow zone where the bend line is to be located.
The heated bar can be placed underneath the flange portion
and the flap bent dowrl over the heated bar.
In another embodiment of the invention, the junct~re~
defining bend line is not fracturable. Here, the base may
be made from a broad range of plastics such as, for
example, polypropylene, high density polyethylene, poly-
vinyl chloride, acrylonitrile, polyester, acrylic, orABS. The seal extends from the flange onto the flap so as
to form a V~shaped seal on the flap. In this embodiment
the cover may be easily separated from both the flap and
flange, without tearing. The base of this alternate
2S embodiment also facilitates stacking and easy product
identification in a relatively inexpensive container~
r~
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Thus, an aspect of this invention is as follows:
A chamber-de~ininy package comprising:
(a) a plastic base including
~i) a bottom wall,
lii) four sidewalls extending upwardly from said
bottom wall such t~at said sidewall and bottom wall define
a volume,
~iii) a flange extending outwardly from -the top
of said si~ewalls, and
(iv) a flap unltary with the said flange and
depending and extending s~stantially vertically downwardly
from a portion of said flange at a bend line defining the
juncture of said flange and said 1ap;
Ib) a cover closing the volume to form a chamber
and at least partially fastened to said base at said
flange along a r~pt~ra~le seal;
~ c) securing means fastening a part of said cover
to said flap;
~ d) content identification mar~ing on said part
O~ said cover to easily identify the contents of the
package, and
~ e) wherein said plastic base is heat-set at the
bend line during formation of said package such that said
flap remains in the substantially ver~ically downwaxd
position relative to said flange.
Description of the Drawin~s
Fig. 1 is a perspective view of the package of
the invention.
Fig. 2 is a perspective view as in Fig. 1, after
the flap has been fractured and with the flap adaptable
for use as a handle.
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Fig. 3 is a side elevational view of the base before
the f lap is formed~
Fig. 4 is a top plan view of the base and cover before
the flap is formed.
Fig. 5 is a perspective view of the base.
Fig. 6 is a bottom plan view of the base.
- Fig. 7 is a top plan view of the base.
Fig. 8 is a side elevational view of the package,
indicating movement of the flap to fracture at the bend
line.
- FigO 9 is a rear elevational view of the package~
Fig. lO is a p~rspective view of a plurality of
packages stacked in a bottom-on-cover manner.
Fig~ ll is a perspective view of the package standing
on the flap.
Fig. 12 is a fragmentary perspective view of another
embodiment of the invention, wherein the cover is
chevron-shaped~
Fig~ 13A is a fragmentary perspective view of the base
of a third embodiment of the invention, including a stress
concentrating ridge in the flap.
Fig. 13B is a fragmentary side elevational view of the
base shown in Fig. 13A~
Fig. 14 is a side elevational view of a fourth embodi~
ment of the invention wherein the flap depends directly
from the sidewall of the base.
~l6'3~q~p~
Detailed ~escrl~tion of_the ~
Wi~h reference to the draw.ings, ~ig5. 1 through ll
illustrate the package in accordance with one embodiment
of the inventionO
S Referring to Figs. l, 8 and 9, the package 20 includes
a base 22 and a cover 24~ The base 22 îs shown separately
in Figs. 5, 6 and 7. ~Ihe base 22 includes a bottom wall
26. A sidewall 28 extends upwardly from the bottom wall
26 to form a defined volume 30. In the preferred embodi-
ment the sidewall 28 includes opposed first and second
segments 32, 34 each adjacent to opposed third and fourth
segments 36~ 38 such that the bottom wall 26 and the top
40 of the sidewall 28 are substantially rectangular in
shape. ~ flange 42 extends o-ltwardly from the side wall
at top 40. The flange 42 is also preferably rectang~lar
in shapeO
Depending from a portion 44 of flange 42 i5 a flap
46. The flange portion 44 from which the flap 46 depends
is preferably along a shorter segment of the sidewall 28,
such as first segment 32~ The flap is unitary with the
flange 42 and depends from said flange portion 44 at a
fracturable, juncture-defining bend line 48. The flap 46
may ~xtend upwardly from the flange 42 but the package
will be more compact if the flap 4~ extends substantially
vertically do~mwardly from said flange portion 44.
The base 22 includes formed ribs 50 in the side~all 28
and bottom wall 26 ~or increased rigidity oE base 22.
There are many possible configurations for the formed ribs
on the base 22. As seen in Figs. 5, 6, 7 and 8, the
flange portion 44 includes one or more gussets 52 which
may be formed in a manner identical to formed ribs 50.
Gussets 52 increase the rigidity of the flange portion
4~.
Referring to Figs. 1, 2, 8 and 9~ it is seen that the
cover 24 lies adjacent the base 22 along flange 42 and
flap 46. The construc~ion of the base and the securing of
the cover 24 thereto may be best seen in Figs. 3 and 4.
The base 22 lS made of plastic and in the preferred
embodiment of polystyrene. 'rhe base is ~hermoformed from
plastic sheet stock preferably at least 0.008 inch thick.
Upon thermoforming, the flange 42 is made without the
depending formed flap 46. Instead, the pre-flap flange
portion 44' extending from first segment 32 is wider than
the remainder of the flange 42 and includes to-be-formed
flap 46'.
The cover 2~ is flexible and in the preferred embodi-
ment is made of plastic or paper material. The package of
the invention has been made using Eorty pound paper
stock. Thinner paper stock will probably also work satis-
factorily, depending on the size of the cover. Frequent-
ly, paper material has oriented fibersD For easy removal
of the cover from the base it is preferred that the cover
is secured to the base such that the cover fiber orienta~
tion is similar to the direction of removal of the cover
from the base. In the package shown, this would be along
the length of segments 36, 38 of sidewall 28.
As seen by phantom markings in Figs. 2 and 4, the
cover 24 is secured to the base 22 along a rupturable seal
54. The rupturable seal may be, for example, an adhesive
seal or a heat seal. Commonly, an adhesive-like heat seal
coating is placed on the cover 24 and the cover is secured
to base 22 by the application of heat and pressureO The
rupturable seal 54 circumscribes the sidewall 28 to form a
sealed chamber from the defined volume 30O At pre-flap
flange portion 44' the rupturable seal is curved into a
- V-shaped or chevron-shaped pattern. The chevr~n-shape
portion of the rupturable seal extends primarily onto the
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to-be-formed flap 46'. A tack seal 58 may be made at
pre-flap flange portion 44' along to-be-formed fract~rable
juncture-defin~ng ben~ line 48, whose position is shown in
Fig. 4 by phantom line 60. Additional seals such as spot
seals 62 are used as securing means for attaching the
cover 24 to the to-be-formed flap 46'. As seen in Fig. 4
the portion of the rupturable seal 54 extending onto the
to-be-formed flap 46l also serves as a securing means.
Spot seals 62 are not necessary but help to keep the cover
24 from curling away from the base 22, which looks
undesirable. Similarlyt tack seal 58 is not necessary but
may be preferable.
The flap 46 is formed by the simultaneous application
of pressure and heat, the heat being generated by ultra-
sonic sound. The flap 46 may be formed in a well knownmanner such as by the placement of an ultrasonic horn and
anvil combination above and below the pre-flap flange por
tion 44'. The horn emits ultrasonic sound to heat the the
pre-flap flange portion 44' and is brought down into
engagement with the pre-flap flange portion 44'~ applying
pressure, forrning the flap 46 and the fracturable junc-
ture~defining bend line 48 as seen for example in Figs. l
and 5. Fracturable juncture-defining bend line 48 is a
formed heat set line~ The plastic is heat-s~
at the bend line 48 such that flap 46 remains in the
substantially vertically downward position relative to
flange portion 44.
When the base 22 is formed of polystyrene sheet stock
at least about 0.010 inch thic~, the juncture-defining
bend line ~8 fractures upon a single rotating movement of
the flap 46 about the bend line 48 of not more than 270
degrees. When at least about 0.008 inch thick, fracture
usually occurs upon a single rotation. A slight tug may
be given to the flap in addition to the rotating
~3~
movement. The direction of movement of the flap to the
point of fracture is shown by a phantom arrow 56 in Fig.
8.
To open the packagel the fla~ 46 is grasped as a
handle and rotated as in Fig. 8 until the bend line 48
fractures. Fig. 2 illustrates the flap 46 after it has
been broken away from the flange portion 44. As seen in
Fig. 2, the cover 24 remains attached to the handle adapt-
able flap 46. In a continous motion, the cover 24 and
attached flap 46 may be pulled in the direction of arrow
64 shown in Figs. 2 and ~.
Because there is no seal or only a tack seal 58
extending adjacent the bend line 48 r upon fracture the
force of removal applied to the cover 24 through the flap
46 is esssentially directed to points 54a and b, allowin~
for easy rupture of rupturable seal 54O
The seal is ruptured cleanly and without tearing the
cover 24 because of a number of factors in addition to the
absence of a continuous cross wise seal at the point where
cover/base separation begins. Rupturable seal 54 runs
substantially perpendicular to the bend line 48 an~ sub-
stantially parallel to the direction of cover removal 64
along substantially the entire length of the package, so
that the rupturable seal is substantially parallel to the
direction of movement of the handle-adaptable flap 46~
Preferably, the Elange 42 is coplanar with bend line 48 so
that the cover 24 sits flat on the flange 42u Further,
when paper is used the fiber orientation of the cover 24
is in the same general direction as the direction of
cover~base separation. Combined, these different factors
allow for the use of a thinner cover material which ade-
quately protects the contents until the time of use, act-
ing as a barrier which in some circumstances may be made
to maintain a sterile environment in the chamber and which
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may in addition be permeable by ethylene oxide gas or the
like f3r sterilization. O~her means of product sterili-
zation may of course be used.
It is seen that the handle adaptable flap 46 permits
fast, efficient, selective and neat separation of the
cover and the base to open the sealed chamber to permit
ready access to the contents thereof, such as administra
tion set 65.
The flap 46 serves an important additional purpose.
Content identification marking may be placed on that part
of the cover 24 which overlaps flap 46. As seen in Fig.
lO, when a plurality of such packages are stacked in a
bottom 26-on-cover-24 manner the flaps 46 are prominent
and any marking thereon, such as seen in Figs. l and lO,
is easil~ readable. The extent of such stacking is
limited by the strength of the sidewall 28 which may be
reinforced to varying degrees by the formed ribs 50.
The above-described package may be made of thinner
sheet stock, for example 0.008 inch thick. When made of
polystyrene, the flap 46 will fracture from flange portion
44 at juncture~defining bend line 48 but more than one
rotation of the flap 46 about the bend line 48 or a slight
pulling force applied to the flap may be required. The
time period for cover removal is therefore somewhat
lengthened but it is still relatively short and still pro-
vides an assured means of opening the package cleanly.
The use of still thinner sheet stock is possible, although
additional flap rotation will probably be necessary. The
base may be made of other plastic materials but the
ability of the flap to fracture must then be tested~
The above-described package 20, when the base is made
of sufficiently thick sheet stock, may be stored or dis-
played on end as seen in Fig. ll, wherein the flap 46
serves as a stand. This feature may be most advantageous
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when the package is used for nonmedical products such as
would be displayed and sold in public retail outlets~
Figs. 13A, 13B illustrate an alternative ~mbodiment of
the package of the invention. An additional ridge such as
depressed ridge 66 may be formed in the to-be-formed flap
46' previously described with reference to FigO 4, such
that after the flap 46 is formed ~he depressed ridge 66
serves as a stress concentration line. Upon rotation of
the handle adaptable flap 46, the depressed ridge faci]i-
tates an early fracture of bend line 480 ~ike gussets 52,
~he depressed ridge insures fracture at the bend line and
enables the use of thinner sheet stock for the base 22.
Referring now to the third embodiment of theinvention, illustrated in Fig. 12, there is shown a
package 68 similar to the package 200 Here the cover 70
is itself chevron-shaped over the flap 72. The rupturable
seal 71 may ex~end near the edge of the chevron-shaped
cover 70. Here, the flap 72 may be manufactured without
the requirement that the juncture~defining bend line must
fracture. This enables a broader range of plastic
materials for the base 74 and allows the use of less
material. When the package 68 is to be opened, the cover
70 is separated from the flap 72 at the chevron-shaped
portion 71a of the rupturable seal 71 and then along the
remainder of the rupturable seal 71. Such a cover shape
could of course stlll be used with the fracturable flap 46
seen in package 20.
Although the flap may not be adaptable as a handle in
the embodiment shown in Fig. 12, the cover is still rela-
tively easy to separate from the base. As in the packase20 shown in Figs. 1 through 11, a tack seal (not shown)
may be used adjacent the length of the bend line. In the
embodiment seen in Fig. 12, the flap 72 remains suitable
t;~ S j~
for easy content identification. The cover 70 may of
cou~se overlap the entire flap 72. Also shown in Fig~ 12
is a flap seal 73 to temporarily o~ permanently seal the
flap 72 to the rest of the base 74,
Fig. 14 illus~rates still another embodiment of the
invention. Here, the flap 76 depends directly from the
top 78 of sidewall 80. The base 82 may be formed such
that the 1ap 76 is or is not fracturable. In this
embodiment it is somewhat more difficult to form the flap
76 such that it extends substantially vertically down-
wardly and thus, although suitable for content identifica-
tion, it is perhaps not as desirable as the above-
described embodiments.
While several embodiments of the present invention
have been described in detail herein and shown in accom-
panying drawings, it will be evident that various further
modifications are possible without departing from the
scope of the invention.
