US3915212A - Flexible medical fluid container having a combined fill and administration port and reinforced hanger - Google Patents

Abstract

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

United States Patent Bujan et al.

[4 1 Oct. 28, 1975 FLEXIBLE MEDICAL FLUID CONTAINER HAVING A COMBINED FILL AND ADMINISTRATION PORT AND REINFORCED HANGER Inventors: Albert Frank Bujan; Harold Anthony Betka, both of Waukegan; Eugene Anthony Parker, Lindenhurst, all of I11.

Abbott Laboratories, North Chicago, Ill.

Filed: Dec. 10, 1973 Appl. N0.: 423,324

Assignee:

US. Cl. 150/8; 215/258; 128/214 D Int. Cl.B65D 33/016; B65D 41/058 Field of Search 150/8, DIG. 1, 9; 206/804, 206/69; 128/272, 274, 214 D, DIG. 24, DIG. 26; 215/232, 258, 298, 349

References Cited UNITED STATES PATENTS 11/1954 Ryan 128/272 3,171,412 3/1965 Braun 128/214 D 3,215,299 11/1965 Coanda 150/12 3,330,281 7/1967 Visser 128/272 3,331,421 7/1967 Lambert 150/9 3,394,831 7/1968 Bathish 128/272 3,415,299 12/1968 l-linman 150/1 3,661,153 5/1972 Polk 150/8 3,810,503 5/1974 Lewis 150/8 Primary ExaminerWilliam 1. Price Attorney, Agent, or Firm-Aaron L. I-lardt; Robert L. Niblack [5 7 ABSTRACT 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.

2 Claims, 6 Drawing Figures U.S. Patent Oct. 28, 1975 FIG.6

FLEXIBLE MEDICAL FLUID CONTAINER HAVING A COMBINED FILL AND ADMINISTRATION PORT AND REINFORCED HANGER BACKGROUND OF THE INVENTION Medical solutions for irrigating purposes or for intravenous 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'subsequently 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 piercing cannula. Communication to the fluid inside the bottle is thereby achieved and the fluid is subsequently administered to the patient through tubing attached to the cannula. To permit the fluid to flow from 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 through the air filter or air entry port and consequently it is desirable to administer such fluids from plastic containers such as described and illustrated in U.S. Pat. Nos. 2,693,189 issued Nov. 2, 1954 or 3,509,879 issued May 5, 1970. During administration of the fluid, such flexible containers will collapse due to atmospheric pressure and hence it is not necessary to admit air within the container. Consequently, a potential source of contamination can be eliminated or minimized. However, such flexible containers are difficult to fill and seal and when hung on a hospital hanger for administratiombecause of their flexible nature causing distortion, 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 INVENTION The present invention comprises a flexible container having a fill and administration port of at least two separate parts so thatthe container can be filled through the first part of the port which is attached to the container, the second part thereafter inserted therein and sealed thereto to thereby seal the container. The container also includes a reinforced hanger portion so that when the filled container is suspended from the hospital standard, a well defined meniscus will result for improved readability of the fluid level within the container. The reinforcement preferably comprises a card encapsulated within the hanger portion of the container as well as a stiffening rib positioned along the hanger portion of the container transverse to the axis thereof.

BRIEF DESCRIPTION OF DRAWINGS card which is encapsulated into the hanger portion of the container;

FIG. 3 is a side elevational view of the container of FIG. 1, filled with fluid;

FIG. 4 is a sectional view of the additive port of the container of FIG. 1 as viewed along the lines 4-4 of FIG. 1;

FIG. 5 is a sectional view of the combined fill and administration port of the container of FIG. 1; and

FIG. 6 is an end elevational view of the container as viewed along the lines 6-6 of FIG. 1.

DETAILED DESCRIPTION Referring to the drawings, FIG. 1 illustrates a flexible,collapsible container 10 of the present invention suitable for medical fluids. Thecontainer 10 includes a sealed flexible bag 11 made of a chemically inert, plastic material such as polyvinyl chloride. The bag 11 includes a pair ofopposed walls 12, 13 sealed along theperimeter 14 thereof to form thecontainer 10. At oneend 15 of the bag 11 a reinforcedhanger portion 16 is fabricated. The reinforcedhanger portion 16 includes astiff reinforcing card 17 encapsulated within theenvelope 18 formed by the twoside walls 12, 13 when they are sealed together. Extending from theenvelope 18 is aflap 19 formed by sealing of the two sheets or extruded tube of plastic together and having an opening 20 therein for hanging of the bag in use. Reinforcingribs 21, 22 are formed during the sealing process to provide extra stiffness to thehanger portion 17. Thestiff card 17 encapsulated within thehanger portion 16 of thecontainer 10 provides reinforcement to thehanger portion 16 as well as containing label copy. Flexible containers when suspended for use, tend to stretch and distort so that measurement of the fluid level within the container is difficult. When thecontainer 10 is suspended from a hospital standard, the reinforcedhanger portion 16 acts to prevent distortion of the bag 1 1 and therefore provides a well defined meniscus for improvedreadability of the calibrations and fluid level. Of course, the opening 20 in theflap 19 can have a variety of shapes.

Depending on the end use intended for thecontainer 10, whetherfor irrigating fluids or intravenous fluids, one or more ports can be incorporated in the bag 11. As illustrated, on theend 23 of the bag 11 opposite thehanger portion 19 are positioned two ports, a fill andadministration port 24 and anadditive port 45. The fill andadministration port 24 comprises afill port 25 formed by a semi-rigidtubular portion 26 havingopen ends 27 and 28, thetubular portion 26 extending within the bag 11 to provide communication into the interior of the bag 11. Anannular flange 29 extends from theend 28 of thefill port 26. Thefill port 25 is sealed in place during fabrication of the bag 11. Thetubular portion 26 of thefill port 25 is positioned in place between two sheets of plastic forming theside walls 12, 13 of the bag 11. As theperimeter 14 of theopposed walls 12, 13 is sealed together, thefill port 25 will be sealed in place, theport 25 providing communication into the interior of the bag 11 for filling purposes.

After the bag 11 is filled through thefill port 25, anadministration port 30 is inserted into thefill port 25 and sealed thereto. Theadministration port 30 includes atubular section 31 having apassageway 32 therethrough with anopen end 33, theother end 34 of thepassageway 32 being closed by apuncturable diaphragm 35. Extending from theopen end 33 of theadministration'port 30 is anannular flange 36 adapted to mate with theflange 29 of thefill port 25. Theadministration port 30 is sealed by acover 37 which comprises abody 38 having anannular flange 39 extending therefrom coextensive with theflange 29 of the fill port and theflange 36 of theadministration port 30 and including ahandle 40 extending perpendicularly away from the outer surface of said cover immediately opposite a weakening ring. A weakeningring 41 is formed in thecover 37 radially inwardly of the cover flange to facilitate removal. Thefill port 25,administration port 30 andcover 37 are sealed together along theflanges 29, 36, 39 thereof after assembly. If the container is to be utilized for a fluid to which no additional medicament is to beadded, the fill andadministration port 24 is sufficient and no other ports need be added.

Theadditive port 45 is positioned on one of the side walls l2, l3 and sealed thereto and comprises atubular section 46 having anopen end 47 and aclosedend 48 together with apassage 49 therethrough. The closedend 48 is spaced away from theopen end 47 and forms apuncturable diaphragm 50 to facilitate entry of a needle or cannula into the bag 11. Anintegral cover 51 is positioned over thetubular section 46, thecover 51 comprising atubular section 52 formed by theside walls 53 and anend wall 54, anannular flange 55 extending from the side wall. Theend wall 54 includes athin portion 56 to facilitate opening of thecover 51. Ahandle base 57 extends from theend wall 54 and includes ahandle 58 extending therefrom. Theflange 55 of the coverSl is sealed directly to one of the bag 11 walls l2, 13 so that thewall 12, 13 closes off the passage and further, forms a puncturable membrane. As is apparent, since thepuncturable diaphragm 50 of theadditive port 45 is spaced away from theopen end 47, theport 45 allows piercing with a long hypodermic needle and minimizes the possibility of piercing the opposite wall of thecontainer 10. Additionally, once sterilized, thecover 51 will maintain sterility so that upon use, there is no need. to swab thepuncturable diaphragm 50 with a bactericide.

.Thecontainer 10 can be fabricated to form a bag 11 from two sheets of plastic sealed together preferably by heat sealing methods. Prior to sealing theperimeter 14 oftheopposed walls 12, 13 to form the bag 11, thetubular portion 26 of the fill port 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 for use with intravenous fluid or other fluid which may require the addition of medicament thereto, an administration port is sealed to the side wall l2, 13 of thecontainer 10. The appropriate fluid is then added to thecontainer 10 through thefill port 25 and theadministration port 30 is thereafter inserted and sealed in place.

In use, thecover 37 of theadministration port 30 is removed and the piercing cannula of an administration set is inserted therein, piercing the diaphragm and thereby providing communication with the inside of the bag 11 so that fluid can flow from thecontainer 10 through the tubing of the administration set (not shown) tothe patient. As the fluid is administered, thecontainer 10 will collapse due to atmospheric pressure. Accordingly, no air vent is required, thereby minimizing the possibility of contamination. Likewise, the reinforcedhanger portion 16 and particularly thecard 17 which is encapsulated therein will prevent thecontainer 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 thecontainer 10 is to be used for the storage and administration of intravenous fluids to which it may be necessary to add additional medicament, anadditive port 45 can be affixed to a side wall l2, 13 of the flexible bag 11. If the addition of a medicament to the fluid within thecontainer 10 is necessary, thecover 51 of theadditive port 55 can be opened by grasping thehandle 58 and applying pressure thereby causing thethin portion 56 of thecover 51 to fracture to expose thediaphragm 50. As illustrated in FIG. 4, the needle of a syringe or additive vial can then be inserted through thepuncturable diaphragm 50 and the medicament within the syringe or vial emptied into the bag 11.

What is claimed is:

l. A flexible, collapsible container for medical fluids made of a chemically inert plastic material, said container 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 reinforced hanger portion minimizing distortion of said container so that the meniscus formed by said fluid therein can be easily read and the amount of fluid being administered can be accurately determined, combined fill and administration port disposed on the end of said container opposite said hanger portion and including a fill port formed by a semi-rigid tubular portion having open ends, said tubular portion being disposed 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 diaphragm, 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 administration port, said cover including a body having an annular flange extending therefrom coextensive with said flanges of said fill and administration ports, the respective 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 surface of said cover radially inwardly of said cover flange and adjacent said administration port, and an integral handle extending perpendicularly away from the outer surface 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 the reinforced hanger portion and arranged transverse to the longitu- 'dinal axis of the container.

Claims (2)

1. A flexible, collapsible container for medical fluids made of a chemically inert plastic material, said container 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 reinforced hanger portion minimizing distortion of said container so that the meniscus formed by said fluid therein can be easily read and the amount of fluid being administered 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 semi-rigid tubular portion having open ends, said tubular portion being disposed 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 diaphragm, 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 administration port, said cover including a body having an annular flange extending therefrom coextensive with said flanges of said fill and administration ports, the respective 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 surface of said cover radially inwardly of said cover flange and adjacent said administration port, and an integral handle extending perpendicularly away from the outer surface 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 the reinforced hanger portion and arranged transverse to the longitudinal axis of the container.

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