Note: Descriptions are shown in the official language in which they were submitted.
7~3
PORT FREE CONTAINER
Technical Field and Prior Art
This application relates to an improved container havina
flexible plastic walls, for sterile solutions or the like.
Flexible plastic solution containers are used in great quantities
in the medical field for holding sterile solution for intravenous
use, blood, sterile washing solutions, peritoneal dialysis
solutions and the like. Typical designs of flexible containers
include the ~iaflex~ containers for intravenous solutions and the
Dianeal~ peritoneal dialysis solution containers sold by Travenol
Laboratories, Inc.
Conventional flexible plastic containers carry tubular ports
at one end which are proportioned to receive a spike connector of
an administration set. The spike connector passes into a tubular
port passing through a diaphragm into flow communication with the
solution contents of the container.
The medical industry is currently under strong economic
pressure ko reduce costs. Thus, there is particularly important
value to be obtained from container designs which can be
manufactured with reduced cost.
One significant facet of the cost of a flexible container is
the cost of the access port. In Bieberdorf et al. U.S. Patent
~,~4~,71~, a design of flexible container is proposed which has
no tubular access port on the outside of the container, but
instead a puncture is made through the container wall itself.
Problems, however, result from the fact that the spike which
penetrates the container wall is not well supported for use. Thus
leakage can develop around the puncture site of the spike, and
the spike is susceptible to being accidentally dislodged from its
3n bag-penetrating position.
2 ~L2~7~)~3
The Entri-Pak~ container of Biosearch Medical
Products, Inc. of Somerville, New Jersey is an aluminum
foil-plastic laminatad bag of ent~ral feeding diet
material, with a projecting, ~lexible-walled protrusion~
The protrusion seals a tube which is closed with a
membrane. The tube, in turn, passes through the bag
wall for communication with the bag interior. The outer
end of the protrusion is torn away to expose thP outer
end of the tube, which may then be spiked with the spike
connector of an administration set.
In accordance with this invention, flexible plastic
containers are provided which are highly susceptible to
inexpensive, automated manufacture, and which may be
fres of outwardly protruding tubular access ports which
must be preformed and seal~d to the container during the
manufacturing operation. Thus, significant economies of
manufacturing can be achieved through the invention of
this application.
Summary of the Invention
Various aspects of the invention are as follows:
In a container comprising a flexible wall, and
means for sealingly receiving a puncture member through
said wall, which means comprises an insert member
positioned within said container, said insert member
defining an aperture with an end opening for sealingly
receiving said puncture member after penetration through
said wall, said aperture providing flow communication
between the container interior and a puncture member
received in said aperture, and means for securing said
insert member in position to cause said aperture to have
said end opening positioned adjacent a puncture
member-penetrable portion of said flexible wall, said
aperture having an axis that is generally parallel and
laterally offset from the longitudinal axis of said
wall portion in said secured position.
In a container defining a flexible wall, the
improvement comprising, in combination, a
flexible-walled protrusion defining a portion of the
2a ~24k76;~53
interior of said container and communicating with the
rest of the container interior through a relatively
narrow neck portion; an insert member positioned within
said flexible-walled protrusion, said insert member
de~ining a bore extending therethrough for sealingly
receiving at one end of said bore a p~ncture member
which can pass through the wall of said protrusion to
enter said bore, whereby said puncture member is
retained in said bore, and flow communication is
provided between the container interior and a puncture
member received in the bore, in which the wall material
of said container adjacent said insert member is
proportioned and of a type to permit the stretching of
said wall material as a puncture member passes into said
aperture to cause an annular portion of the container
wall to deform into a position between the puncture
member and the aperture wall, said annular portion being
sealingly locked and seated between the connected
puncture member and aperture wall to define a seal.
In a container defining a flexible wall, a
flexible-walled protrusion communicating with the rest
of the container wall through a relatively narrow neck
portion; an insert member positioned within said
protrusion, said insert member defining an aperture for
sealingly receiving a puncture membsr after penetration
through the flexible wall of said protrusion, said
aperture providing flow communication between the
container interior and a puncture member received in
said aperture, and tape means removably adhered to the
wall of said protrusion, whereby removal of said tape
means exposes a clean surface without further treatment
for puncturing by said puncture member.
The method of manufacturing flexible, collapsible
containers which comprises presenting to heat seal means
a double layer web of thermoplastic material having
opposed edges; sealing the double thickness web material
together by said heat seal means to form generally
diamond shaped containers in which a peripheral heat
2b ~247053
seal defines each diamond shaped container with at least
two opposed lengths of said peripheral heat seal
defining an acute angle to the opposed edges of said
web, including the step of depositing between the two
layers of the web an insert member defining a
spike-receiving aperture, and foxming a flexible-walled
protrusion about said insert member which holds the
insert member in a position whereby said spike-receiving
aperture has an end opening positioned adjacent a
puncture member-penetrable single thickness o~ said web
material, said aperture having an axis that is generally
parallel to and laterally offset from the longitudinal
axis of said container and generally perpendicular to
said puncture member-penetrable portion to Eacilitate
entry of a spike through said puncture member-penetrable
portion into said aperture.
A container defining a flexible wall, a puncture
member penetrating through said flexible wall, and an
insert member positioned within said container, said
insert member defining an aperture sealingly receiving
said puncture member aft~r penetration through said
wall, an annular portion of said flexible container wall
being deformed into position between said puncture
member and ths wall o~ said aperture to be sealingly
locked and seated between the connected puncture member
and aperture wall for prevention of leakage, said
aperture providing flow communication between the
container interior and said puncture member.
Description of the Invention
In this invention, a container is provided defining
a flexible wall. Means for sealingly receiving a
puncture member through the wall are present, comprisiny
an insert member positioned within the container. The
insert member defines an aperture for sealingly
receiving the puncture member after penetration through
the wall.
The aperture provides flow communication between
the container interior and a puncture member received in
5~
the aperture. Typically, the apertura is a bore
extending through the insert member.
As the puncture member passes into the aperture, it
typically causes an annular portion of the container
5 wall to deform or stretch into a position between the
puncture member and the
~7~
aperture wall, where the annular portion can be sealingly locked
and seated between the connected puncture member and aperture
wall. Thus, leakage can be prevented.
The container wall may define a flexible-walled protrusion
communicating with the rest of the container through a relatively
lo narrow neck portion, to permit flow communication between the
protrusion and the rest of the container. The insert member is
advantageously captured or retained in the protrusion, to provide
it with a fixed location without the need to seal it to the inner
wall ot the container.
lhe container may also carry removable tape means on the
outer surface of the flexible wall. The tape means may be
applied to the container prior to sterilization, so that the tape
means may be removed, when use of the container is desired, to
expose a clean, typically sterile surface for puncturing by the
puncture member. Thus, no alcohol swab or the like may be
required prior to the use of the device of this invention.
The container of this invention may be made from a pair of
plastic sheets, or a large, extruded, flattened tubular plastic
sheet, by appropriate peripheral heat sealing in a manner
analogous to present commercial container manufacture
techniques. Alternatively, a plastic sheet may be folded over
and then peripherally sealed together on all open sides to form
the container. The insert member may in this circumstance be
simply placed between facing plastic sheets within the
3n newly-formed container before the peripheral sealing operation,
to provide a very efficient, cost effective manufacturing
technique, since no separate application of port tubes is
required. Alternatively, blow molding or other techniques may be
used to manufacture the container.
~2~7~3
While a wide range of thermoplastic or other resilient
materials may be used to make the container wall, one preferred
material is DYPR0~ Z4650 polypropylene copolymer, sold by the
Arco Chemical Oompany. Ihe plastic material used may, if
desired, be about 0.01 inch thick and may optionally be a
coextrusion of the above recited DYPR0 plastic material as an
inner layer, and polypropylene as an outer layer of the container
wall. The insert member, in turn, may be made from a
polypropylene material, for example having about 3 weight percent
of copolymerized ethylene units in the formulation.
lf desired, the insert member may comprise a pair of tubes
in telescoping relation with each other and connected at one end,
with the aperture as defined above being defined by the bore of
the inner tube. This structure provides a certain desirable
resilience to the insert member, and facilitates the seal formed
between a puncture member and the aperture wall.
In the specific instance of DYPR0~ Z4650 copolymer, it is be
desirable for the insert member to be made of a generally rigid
material such as polypropylene as mentioned above. However, in
other instances, for use with other resilient sheet materials, it
may be desirable to use a softer, semiflexible insert member.
The aperture of the insert member may be proportioned to be of a
diameter which is dependent upon the wall thickness of the facing
plastic sheets, so that on penetration of the containèr wall by a
puncture member, the annular portion of the container wall is
3n formed by deformation and stretching into the desired sealing
position between the puncture member and the aperture wall.
The various dimensions and proportions of the system may vary
in accordance with frictional characteristics of the puncture
member and insert member with the plastic of the container wall
to optimi~e the formation of the desired deformed or stretched
annular portion used for sealing between the connected puncture
~Zfl~ 3
member and aperture wall. Additionally, one may adjust the
sharpness of the puncture member to provide the desired results.
For example, it may be desired to provide a sharp spike with a
highly resilient material, coupled with materials that provide a
rather high coefficient of friction. On the other hand, when
using a bag wall material that is not very resilient, a duller
spike may be desired in some instances, and one may wish to use
materials that have a relatively lower coefficient of friction.
~n the other hand, a sharp spike may be used in this instance as
well for facilitating access to the container.
Accordingly, it is believed to be basically a routine matter
to select materials for the container wall and insert member, and
to proportion them into proper dimensions, to achieve good
results with a large number of different materials in accordance
with this invention.
Description of the ~rawings
In the drawings, Figure 1 is a plan view of a flexible,
collapsible container, with a portion broken away, utilizing the
invention ot this application.
Figure ~ is a side elevational view of the container of
Figure 1, taken along line 2-~ of Figure 1.
Figure ~ is a fragmentary, longitudinal sectional view of a
portion of the container of Figures 1 and 2, showing how a spike
may penetrate the bag wall and the insert member to provide
access to the contents of the container.
3~ Figure 4 is a plan view of another embodiment of container
using the invention of this application.
Figures 5 through 7 are fragmentary, plan views of alternate
designs of the flexible-walled protrusion of the container of
this invention, containing alternate designs for the insert
member.
~L2~7~?~i3
Figure 8 is a plan view of an alternate design of insert
member.
Figures ~ and 10 are elevational views, rotated 90 about
their longitudinal axis from each other, of the insert member of
Figure ~.
Figure 11 is a plan view of another design of flexible
collapsible container in accordance with this invention.
Figure 12 is a fragmentary elevational view of the container
of Figure 11, rotated gO about its longitudinal axis.
~escription of Specific Embodiments
.
Reterring to Figures 1 through 3, one embodiment of the
invention of this application is disclosed. Container or bag 10
is maae of a pair of overlying thermoplastic sheets 12, 14, which
are heat sealed together. A peripheral heat seal 16 is used.
The seal may be made by conventional radio frequency sealing
processes if polyvinylchloride sheeting is used, or by a hot bar
seal if polyolefin sheeting or the like is used.
The top of container 10 may carry other peripheral seals 18,
ana a corner hanger hole 20 for suspension of the container. At
the other end of container 10 from hanger hole 20, and at the
oppose~ corner thereof, flexible-walled protrusion 22 is defined,
being surrounded by the extension 2~ of heat seal 16.
As shown in Figure 2, for example, sheet 12 defines a portion
of protrusion 22 which may be thermoformed in conventional manner
to form a pocket 26. Pocket 26, in turn, receives and holds
insert member 28, which may be a molded plastic piece of a design
shown in longitudinal section in Figure 3.
As another desired feature, tape member 30 may be provided,
adhering to an outer end of pocket 26 as shown in Figure 2. Tape
member 30 may be a known plastic foil tab which is sealed to bag
q53
--7--
1~, defining a handle portion 32, so it can be manually removed
to expose the surface of pocket 26 underneath foil tab 30. If
foil tab 30 is applied and then bag lU is radiation or steam
sterilized, for example, removal of tab 30 can present a sterile
surface to the user for application of a spike connector 34 to
bag 10 to obtain access thereto.
As shown in Figure 3, insert member 28 may be a single,
moldea plastic piece comprising a pair of tubular portions 36,
38, joined together at one end 40 in telescoping relation. The
outer telescoping portion 36 serves as a good manual gripping
member, so that one may hold protrusion 26 with the fingers, thus
also gripping insert member 2&. One then may then manually
advance spike 34, penetrating the wall of protrusion 26 to gain
access to container 10. Portions of the container wall 42 may be
stretched to fold inwardly into bore 44 of insert member 28 as
2() spike 34 penetrates bore 44, so that wall portions 42 provide an
added sealing lip or ring to the connection system between spike
~4 and insert member 2~. Accordingly, liquid 46 in container 10
may pass through the lumen of spike 34 into an administration set
or the like, for flow communication between the bag interior and
the set to which spike 34 is attached.
The telescoping tube structure of insert member 28 provides a
certain resilience to the tube 38 defining bore 44 which can
improve the sealing characteristics of the insert member with
spike 34. Also, less plastic is used, when compared with a solid
piece insert member which does not detine annular space 48.
The illustration of Figure 3 is somewhat schematic. The
inner wall of tube 38 defining bore 44 will be commonly expected
to contact the outer wall of spike 34, to provide improved
sealing along most of its length. The cut and folded-in portions
42 of the bag wall provide extra sealing, typically stre~ching
insert member 2~ outwardly a small amount to accommodate for
their presence.
7~53
`~hile the container of this invention may be made by blow
molding or the like, the specific design of Figure 1 is
contemplated to be made on a mass production basis by heat
sealing together two overlapping continuous webs 50, 51 of
plastic material to form the container walls 12, 149 respectively
lo after inserting insert member 2~ between webs 50, 51 in its
desired position. The two overlapping, continuous plastic webs
50, 51 shown in phantom lines represent the portion of continuous
plastic web material (for example, a roll of material) that
typically may be allocated to the manufacture of a single
container. It can be seen that high efficiency of use can be
obtaine~, with excess portions of the plastic web material being
typically trimmed away by an automatic trimmer as part of the
manufacturing process. lf desired, an adjacent bag on the
production line may be defined in continuous webs 50, 51 with its
flexible-walled protrusion 22 facing bag 10 and occupying the
area indicated by reference numeral 52, for further economy of
manufacturing~
lt can be seen that the heat seals 16 at the respective ends
of container 10 are formed to be in angular relationship other
than ~O~to the lateral heat seals 16 of the edges of webs 50,
51. When container 10 hangs on a pin projecting through hole 20,
protrusion 22 is the lowest point of container 10, so that all
liquid will pass into protrusion 22 and thus out of spike 34.
Even if container 10 is held perpendicular to the ground for
draining, the slight downward slope of the lower end seal line 16
will assure that all liquid passes into protrusion 22.
Alternatively, protrusion 22 may be placed at a centered
location of container I0 at the lower end thereof, and hanger
hole 20 may also be centered.
Referring to Figure 4, another design of container of this
invention is disclosed. Container lOa once again is made by
7(~3
peripheral heat sealing along seal lines 16a, 16b to form a
generally diamond-shaped container. Flexible walled protrusion
22a may be of substantially similar design to protrusion 22, and
may contain an insert member 28a which may be of similar design
to insert member 28. Inner heat seal 54 is provided at the top
ot the container to separate its contents from hangar hole S6.
It should be noted that this design provides particular
efficiency, in providing a very low scrap rate frorn a continuou
web of overlapping plastic sheets 58 from which container lOa may
be maae. lhis may be accomplished by providing that peripheral
seal lines 16b, which are nonparallel to the edges 60 of plastic
webs 58, are not perpendicular to such edges 60, but define an
angle with them of typically 35 to 70, i.e. an acute angle. It
can be seen that a very low scrap rate of web material to be
trimmed away from the container is provided by this
configuration, since other containers l~a can be formed in
portions 61 of overlapping web material 58.
keferring to Figure 5, another design of flexible protrusion
62 for a container is disclosed. In this case, the two side
walls ot container 64 may be formed by folding a web along fold
line 66 at the end of protrusion 62, and forming peripheral heat
seals 68 with insert member 70 inside. Insert member 70 is shown
to define bore 72 extending from end to end thereof3 and also to
~efine a pair of opposed, lateral projections 74 to facilitate
manual gripping of the insert member by the user within
3n flexible-walled protrusion 62.
~ eferring to Figure 6, another design of container is shown
having flexible-walled protrusion 76, with the container being
otherwise of similar and generally conventional design.
Protrusion 76 may be defined by a peripheral heat seal line 78
which passes across its end, but such heat seal line does not
interfere with a spike connection because oF the novel shape of
~%~53
-10-
insert member 80 carried in pro~rusion 76. Insert member 80, as
shown, may be a block of plastic which may be smaller or flatter
in its depth than its width or length, and defines a bore 82
passing generally diagonally through it as shown, so that the
connecting spike will penetrate the bag wall at a position spaced
from seal line 7~.
Referring to Figure 7, another flexible-walled protrusion 84
for a flexible, collapsible bag is disclosed. In this case, in a
manner similar to Figure 5, the two sides of the bag are folded
along fold line 86 at the end of protrusion 84, and then sealed
together by peripheral seal lines 88. Insert member 90, trapped
within protrusion 84, may be roughly triangular in shape as
shown, and defines a bore 92 extending therethrough. As shown,
the area of insert member 90 adjacent one end 94 of the aperture
is transversely enlarged relative to the area g6 of insert member
~' 90 adjacent the other end. This triangular configuration
facilitates ~he use of a more tightly fitting, generally
triangular, flexible-walled protrusion.
Reterring to Figures 8 to lO, another design of molded insert
member 98 is disclosed, being capable of fitting in a
flexible-walled collapsible bag of any desired design, either
captured in a protrusion, or loosely in the bag, or adhered to
the inner bag wall. Aperture or bore lO0 is provided to receive
a connecting spike penetrating through the bag wall, while
various ribs 102, 104 are provided for ease of manually gripping
the device through the bag wall.
Referring to Figures ll and 12, another design of container
105 is disclosed, comprising a pair of thermoplastic sheets lying
one on top of the other and sealed together with a peripheral
heat seal 106. Relatively narrow neck portion 108 is defined by
part of heat seal 106 in a centered position on the container.
Insert member 98, which may be of the design of Figures 8 to lO,
~ L7~53
is carried within neck portion 108 in a manner ~nalogous to the
previous embodiments, so that bore 1~0 extending through insert
member 98 faces the end wall 109 of neck portion 108 to receive a
puncture member in a manner similar to that previously
described. ~eck portion 108 may carry an offset portion 111 made
1~ by a thermotorming step or the like, so that a spike 34 can pass
through end wal'l 109 without interference by peripheral heat seal
106.
Wall 10~ may carry removable tape portion 113, if desired,
similar in structure and function to tape member ~0.
As delivered from the sealing machine, flexible container 105
may have an open end 114 to serve as a temporary filling port
when bag 1~5 is delivered to a filling machine. Thereafter, a
subsequent heat seal line 116 may be applied as shown to seal off
the bag, and an appropriate hanger hole may be punched into the
plastic material 11~ ou~side of the seal lines 106, 116 for
hanging of the container.
The flexible containers of this invention may be made by mass
production techniques as described above, with significant cost
savings over the puncturable, collapsible containers of the prior
art~ At the same time, they provide great convenience,
reliability, and facility of use, particularly as containers for
enteral feeding, blood or its components, or dialysis,
parenteral, or washing solutions. l'hey may be manufactured in a
continuous form, fill and seal manufacturing process if desired.
l'he above has been offered for illustrative purposes only,
and is not intended to limit the scope of the invention of this
application, which is as defined in the claims below.
