Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
1~464t~Z
...
A FLEXIBLE MEDIGAL FLUID CONTAINER HAVING A COMBINED
FILL AND ADMINISTRATION PORT AND REINFORCED HANGER
:~'
Background of the Invention
.j . ~
Medical solutions for irrigating purposes or
for in~ravenous administration are generally stored and
administered from glass bottles. The bottles are filled,
a special closure is attached, and the filled, sealed
; bottles are then sterilized. The closures generally
comprise a bung for sealing the mouth of~the bottle, the
bung including a puncturable diaphragm which can sub-
sequently be punctured for entry into the bottle. At the
- point of use, an administration set is attached to the
.. .. , :~
bottle by removing the protective portion of the closure --
and puncturing the diaphragm in the closure with a
i~ 15 piercing cannula. Communicstion to the fluid inside the
, bottle is thereby achieved and the fluid is subsequen~ly
administered to the patient through tubing attached to
the cannula. To permit the fluid to flow rom the bottle,
air must be permitted to enter therein which can be
achieved through an air filter incorporated in the ;
cannula or by an air entry port in the closure. Potentially,
, contamination of the fluid within~the bottle can result
i through the air filter or air entry port and consequently
`l it i8 desirable to administer such fluids from plastic
~ 25 con~ainers such as described and illustrated in patents
", .............. .
. ,! ~ .
' ' " ' '
, ~ ' .!
.~, ,. , .:
' .i . . .
.,,, '~ .
-`` 10~ 2
2,693,1a9 issued November 2, 1954 or 3,509,879 issued May 5,
1970. During administration of the fluid, such flexible con-
tainers will colla~se due to atmospheric pressure and hence it
is not necessary eO admit air wi~hin the container. Consequent-
ly, a po~ential source of contamination can be eliminated or
minimized. However9 such flexible containers are difficult to
fill and seal and when hung on a hospital hanger for adminis-
tration~ because of their flexible nature causing distor~ion,
it is difficult to read the meniscus which is necessary in order
to determine the amount of fluid being administered to the patient.
SUMMARY OF THE INVENTIO~ ~ -
The present invention comprises a flexible container
for medical fluids made of a chemically inert plastic material
and having a pair of opposed walls sealed along the entire per-
i~eter thereof to form the container. The container also in-
cludes a reinforced hanger portion at one end including a stiff
^ card encapsulated within an envelope formed by the sealed opposed
walls, the reinforced hanger portion minimizing distortion of ;-
the container so that the meniscus formed by the fluid therein
can be easily read and the amount of fluid being administered
can be accurately determined. A combined fill and administration
port i9 disposed on the end of the container opposite the hanger
portion and includes a fill port formed by a semirigid tubular
portion having open ends. The tubular portion is disposed be- ;
tween the opposed walls of the container and sealed therein to
~i provide communication into the interior of the container. An
;^ annular flange, perpendicular to the axis of the tubular por-
tion, extends from the end of the tubular portion spaced away
from the container. The administration port includes a close
fitting tubular section inserted into the tubular portion of
the fill port having a passageway therethrough with an open end
spaced away Erom the container. The other end of the passage-
:
- 2 -
: - .: . ........................... , . . : ,:
': ' , ' , ' ' , , ' ,':,: ' : :' . ' . . :,
1~)4~ .;Z
way is closed by a puncturable diaphraghm. The end of the
tubular section of the administration port spaced away from
the container has an annular flange also perpendicular to the
axis of the tubular portion and the tubular section and extend-
ing therefrom. The flange of the tubular section is coextensive
with the flange of the fill port. A cover for sealing the com-
bined fill and administration port is provided, the cover includ-
in8 a body having an annular flange extending therefrom coexten-
sive wlth the flanges of the fill and administration port. The
respective flanges of the fill port, administration port and
cover are sealed together to seal the container. The cover
includes a weakening ring formed in the inner surface of the
cover radially inwardly of the cover flange and adjacent the
~, :
administration port, and an integral handle extending perpen-
dicularly away from the outer surface of the cover, immedia~ely
~; . .
opposite the weakening ring9 which handle and weakening ring
facilitate removal of the cover.
BRIEF DFSCRIP~IO~-OF THE DRAWI~GS
,
The invention will be best understood by
reference to the following description of the invention together
with the acco~panying drawings, wherein;
~;Figure 1 is a front elevational view of a flaxible,
collapsible CQntainer of the present invention
Figure 2 is an elevational view o ~he reinforcement
-card which is encapsulated lnto the hanger partion of the con-
tainer;
`~Figure 3 is a side elevational view of the container
of Figure 1, filled with fluid;
Figure 4 is a sectional view of the additive port
. .
of the container of Figure 1 as viewed along the lines 4-4 of
Figure l; -
- ,
o~ z
Figure 5 is a sectional view of the combined fill
and administration port of the container of Figure l; and
Figure 6 ls an end elevational view of the container
as viewed along the lines 6-6 of F:Lgure 1.
,
~' ' ,,~ , .
,
', ''. '
. .
~! .
`~.
''Z~ .
Z:' ~;,,
,, .
~:i . .
' Z 'i''
,
~c ;,': '. ~
.. .
,
.
- 3a -
,i.~; ~ .
~: . . . ,. , .. :. . . . .
: ~ . : : . ,:: ,, : . ' . , . :., ,
-
~O~ Z
Detailed Description
- Referxing to the drawings, Figure 1 illustrates
a flexible, collapsible container 10 of the present
invention suitable for medical fluids. The container 10
includes a sealed flexible bag 11 made of a chemically
! inert, plastic materlal such as polyvinyl chloride.
The bag 11 includes a pair of opposed walls 12, 13 sealed
along the perimeter 14 thereof to form the container 10.
At one end 15 of the bag 11 a reinforced hanger portion
16 is fabricated. The xeinforced hanger portion 16
includes a stiff reinforcing card 17 encapsulated within
the envelope 18 formed by the two side walls 12, 13 when
they are sealed together. Extending from the envelope
~ 18 ls a flap 19 formed by sealing of the two shee~s or
; lS extruded tube of plastic together and having an opening
20 therein for hanging of the bag in use. Reinforcing
ribs 21, 22 are formed during the sealing process to
provide extra stiffness to the hanger portion -17. The
stiff card 17 encapsulated within the hanger portion 16
of the container 10 provldes reinforcement to the hanger
` portion 16 as well as containing label copy. Flexible
contaLners when suspended for use, tend to stretch and
; distort so that measurement of the fluid level within the
container is difficult. When the container 10 is sus-
pended from a hospital qtandard, the reinforced hanger
portion 16 acts to prevent distortion of the bag 11
.. '
_ 4 _
~; '
. -
' .
4~Z
:.' ..
" .
; and therefore provides a well defined meniscus for
. . .
improved readability of the calibrations and fluid level.
Of course, the opening 20 in the flap 19 can have a
variety of shapes.
^ 5 Depending on the end use intended for the
-' conta~ner 10, whether for irrigating 1uids or intra-
- venous fluidsJ one or more ports can be incorporated in
the bag 11. As illustrated, on the end 23 of the bag 11
: opposite the hanger portion 19 are positioned two ports,
.:
;~- 10 a fill and admlnistration port 24 and an additive port 45.
The fill and administration port 24 comprises a fill port
25 formed by a semi-rigid tubular portion 26 having open
~, ends 27 and 28, the tubular portion 26 extendlng within
!;'~ the bag 11 to provide communlcation into the interior
15 of the bag 11. An annular flange 29 extends from the end .
28 of the fill port 26. The fill port 25 is sealad in
.
place during fabrication of the bag 11. The tubular
. portion 26 of the fill port 25 is positioned in place
~; between two sheets of plastic forming the side walls 12,
13 of the bag 11. As the perimeter 14 of the opposed
~ walls 12, 13 is sealed together, the fill port 25 will
.~ be sealed in place, the port 25 providing-communication ~ :
- into the interior of the bag 11 for filling purposes. .~:
After the bag 11 is filled through the fill port 25,
an administration port 30 is inserted into the fill
port 25 and sealed thereto. The administration port 30
, ~ .
.- ~
., _ 5 _ .
, . .
. . .
:~.
.. , ,
', .
. ..................................................................... .
~464~;Z
! includes a tubular section 31 having a passageway 32
therethrough with an open end 33/ the other end 34 of
the passageway 32 being closed by a puncturable dlaphragm
35. Extending from the open end 33 of the administration
port 30 is an annular flange 36 adapted to mate with
the flange 29 of the fill port 25, The administration
port 30 is sealed by a cover 37 which comprises a body 38
having an annular flange 39 extending therefrom coextensive
with the flange 29 of the fill port and the flange 36 of
the administration port 30 and including a handle 40
extendlng therefrom~ A weakened portion 41 is formed in
; the cover 37 to facilitate removal. The fill port 25,
administration port 30 and cover 37 are sealed together
. along the flanges 29, 36, 39 thereof after assembly. If :: -
; 15 the container 10 is to be utilized for a fluid to which -~
no additional medicament is to be added, the fill and ;
administration port 24 is sufficient and no other ports
need be added,
The additive port 45 is positioned on one of
the side walls 12/ 13 and sealed thereto and comprises a
- tubular sec~ion 46 having an open end ~7 and a closed .
- end 48 together with a passage 49 therethrough. The
closed end 48 is spaced away from the open end 47 and
i forms a puncturable diaphragm 50 to ~acilitate entry
of a needle or cannula into the bag 11. An intergral
cover 51 is positioned over the tubular section 46, the
- 6 -
. . .
:~ . . . ..
~ . .
... . ;:
4~;2
cover 51 comprising a tubular section 52 formed by the
; side walls 53 and an end wall 54, an ~nnular flange 55extending ~rom the side wall. The end wall 54 includes
` a thin portion 56 to facilitate opening of the cover 51.
' 5 A handle base 57 extend~ from the end wall 54 and includes
a handle 58 extending therefrom. The flange 55 of the
cover 51 is sealed directly to one o~ the bag 11 walls
12, 13 so that the wall 12, 13 closes off the passage
:. ...
;~ and further, forms a puncturable membrane. As is apparent,
since the puncturable diaphragm 50 of the additive port
45 is spaced away from the open end 47, the port 45 allows
.. . . .
piercing with a long hypodermic needle and minimizes the
.
possibility of piercing the opposite wall of the container
10. Additionally, once sterilized, the~ cover 51 will
,~ 15 maintain sterility so that upon use, there isno need to
swab the puncturable diaphragm 50 with~a bactericide.
The container 10 can be fabricated to form a
bag ll from two sheets of plastic sealed together pre-
ferably by heat sealing methods. Prior to sealing ~he
perimeter 14 of the opposed walls 12, 13 to ~orm the
bag 11, the tubular portion 26 of the fill por~ 25 is
`' positioned between the two sheets of plastic and sealed
; in place as previously described. Any excess plastic is
~ trimmed from the sides of the container 11 and, if the
'
container 11 is intended fox use with intravenous fluid
or other fluid which may require the addition o~ medicamen~
.
I _ 7 _
.. .: ':
~, :
.. :
,:',;
. .
: -
,
.
,
t
4 ~ ~ 2
thereto, an administration port 30 i8 sealed to the side
~ wall 12, 13 of the container 10. The appropriate fluid
-~ is then added to the container 10 through the fill port
25 and the admini~trstion port 30 is thereafter inserted
` 5 and sealed in place.
In use, the cover 37 of the ad~inistration port
30 is removed and the piercing cannula of an administration
set is inserted therein, piercing the diaphragm 35 and -
thereby providing communication with the inside of the
bag 11 so that fluid can flow rom the container 10
- through the tubing of the administratiQn set (not shown)
to the patient~ As the fluid i8 administered, the container
10 will collapse due to atmospheric pressure. Accordingly~
no air vent is required, thereby minimizing the
. . . . .
possibility of contamination. Likewise, the reinforced
hanger portion 16 and particularly the card 17 which is
encapsulated therein will prevent the container 10 from -~
distorting so that the meniscus formed by the fluid can
be easily read and the amount of fluid being administered
,, , :
to the patient can be easily and accurately determined.
As previously described, if the container 10 iB
., .
; to be used for the storage and administration o~ lntra-
venous fluids to which it may be necessary to add
additional medicament, an additive port 45 can be affixed
to a side wall 12, 13 o~ the flexible bag 11. If the
., , , ;
,''
.
., ,
,~ ;.,' '
.'~ . '`.
. , : , .... . . . ~ . , - . . . . .
"',', `'' ' ' ' ' ' . ' , ,. . . ' , ' , , . ' ' ', ' "'" '
~o~ z
addition of a medicament to the fluid within the container
10 i8 necessary, the cover 51 o the additive port 55
can be opened by grasping the handle 58 and applying ::
pressure thereby causing the thin portion 56 of the cover
51 to fracture to expose the d:Laphragm 50. As illustrated
in Figure 4, the needle of a syringe or additive vial can
then be inserted through the puncturable diaphragm 50
and the medicament within the syringe or vial emptied
into the bag 11.
.''' " ',
'
',: .
g_ ~
~ ~ '
~, .
~ .
