CA1046462A - Flexible medical fluid container having a combined fill and administration port and reinforced hanger - Google Patents

Flexible medical fluid container having a combined fill and administration port and reinforced hanger

Info

Publication number
CA1046462A
CA1046462A CA215,246A CA215246A CA1046462A CA 1046462 A CA1046462 A CA 1046462A CA 215246 A CA215246 A CA 215246A CA 1046462 A CA1046462 A CA 1046462A
Authority
CA
Canada
Prior art keywords
container
port
cover
tubular
fill
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA215,246A
Other languages
French (fr)
Inventor
Eugene A. Parker
Harold A. Betka
Albert F. Bujan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Application granted granted Critical
Publication of CA1046462A publication Critical patent/CA1046462A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1462Containers with provisions for hanging, e.g. integral adaptations of the container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S383/00Flexible bags
    • Y10S383/904Filling tube
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S383/00Flexible bags
    • Y10S383/906Dispensing feature

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A B S T R A C T

A flexible container for medical fluids having a combined fill and administration port of at least two parts so that the container can be filled through the first part of the port, the second part thereafter being inserted into the first part to seal the container, and a reinforced hanger portion to prevent uneven collapse of the top of the container and thereby permit a well defined meniscus for improved readability of the fluid level within the container.

Description

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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 ", .............. .

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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-:

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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.
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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 _ ~; ' . -' .

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; 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 , ~ .
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! 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 . . .

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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~

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, 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 ., , , ;
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"',', `'' ' ' ' ' ' . ' , ,. . . ' , ' , , . ' ' ', ' "'" ' ~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.
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Claims (4)

The embodiments of the invention in which an exclusive property or privilege is claimed, are defined as follows:"
1. A flexible, collapsible container for medical fluids made of a chemically inert plastic material, said con-tainer comprising:
a pair of opposed walls sealed along the entire perimeter thereof to form said container, a reinforced hanger portion at one end of said container including a stiff card encapsulated within an envelope formed by said sealed opposed walls, said rein-forced hanger portion minimizing distortion of said con-tainer so that the meniscus formed by said fluid therein can be easily read and the amount of fluid being adminis-tered can be accurately determined, a combined fill and administration port disposed on the end of said container opposite said hanger portion and including a fill port formed by a semirigid tubular portion having open ends, said tubular portion being dis-posed between said opposed walls of said container and sealed therein to provide communication into the interior of said container, and an annular flange perpendicular to the axis of said tubular portion and extending from the end of said tubular portion spaced away from said container, said administration port including a close fitting tubular section inserted into said tubular portion of said fill port and having a passageway therethrough with an open end spaced away from said container, the other end of said passageway being closed by a puncturable diaphraghm, the end of said tubular section of said administration port spaced away from said container having an annular flange also perpendicular to the axis of said tubular portion and said tubular section and extending therefrom, said flange of said tubular section being coextensive with said flange of said fill port, and a cover for sealing said combined fill and ad-ministration port, said cover including a body having an annular flange extending therefrom coextensive with said flanges of said fill and administration port, the respec-tive flanges of said fill port, administration port and cover being sealed together to seal said container, said cover including a weakening ring formed in the inner sur-face of said cover radially inwardly of said cover flange and adjacent said administration port, and an integral handle extending perpendicularly away from the outer sur-face of said cover, immediately opposite said weakening ring, which handle and weakening ring facilitate removal of said cover.
2. The flexible, collapsible container of Claim 1 including reinforcing ribs formed in said reinforced hanger portion and arranged transverse to the longitudinal axis of said container.
3. The flexible, collapsible container of Claim 1 including an additive port for adding medicament to said container, said additive port positioned on and sealed to one of the walls of said container and comprising a tubular section having an open end and a closed end, said open end sealed to said container and said closed end spaced away from said container to provide a puncturable diaphragm adapted to facilitate sterile entry into said container.
4. The flexible, collapsible container of Claim 3 wherein said additive port further comprises a tubular cover positioned over said additive port tubular section and formed by a side wall, one closed end wall, and an annular flange extending from said side wall at the end opposite said closed end wall and sealed to said container wall, said end wall including a thin portion that can be fractured to facilitate opening said tubular cover and a handle extending there-from adapted for fracturing said thin portion of said tubular cover.
CA215,246A 1973-12-10 1974-12-04 Flexible medical fluid container having a combined fill and administration port and reinforced hanger Expired CA1046462A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US423324A US3915212A (en) 1973-12-10 1973-12-10 Flexible medical fluid container having a combined fill and administration port and reinforced hanger

Publications (1)

Publication Number Publication Date
CA1046462A true CA1046462A (en) 1979-01-16

Family

ID=23678473

Family Applications (1)

Application Number Title Priority Date Filing Date
CA215,246A Expired CA1046462A (en) 1973-12-10 1974-12-04 Flexible medical fluid container having a combined fill and administration port and reinforced hanger

Country Status (8)

Country Link
US (1) US3915212A (en)
JP (1) JPS6219868B2 (en)
CA (1) CA1046462A (en)
FR (1) FR2253496B1 (en)
GB (1) GB1479045A (en)
IT (1) IT1026875B (en)
PH (1) PH12068A (en)
ZA (1) ZA747751B (en)

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Also Published As

Publication number Publication date
IT1026875B (en) 1978-10-20
AU7623274A (en) 1976-06-10
US3915212A (en) 1975-10-28
FR2253496B1 (en) 1980-04-18
DE2458220A1 (en) 1975-06-12
JPS6219868B2 (en) 1987-05-01
FR2253496A1 (en) 1975-07-04
PH12068A (en) 1978-10-30
ZA747751B (en) 1975-12-31
GB1479045A (en) 1977-07-06
JPS50113090A (en) 1975-09-04
DE2458220B2 (en) 1977-07-14

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