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

[57] 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.

Claims, 6 Drawing Figures

<img file="US3915212A_D0001.tif" />

U.S. Patent oct. 28,1975

3,915,212

<img file="US3915212A_D0002.tif" />

3,915,212

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 administration, because 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 that the 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 THE DRAWINGS

The invention will be best understood by reference to the following description of the invention together with the accompanying drawings, wherein;

FIG. 1 is a front elevational view of a flexible, collapsible container of the present invention;

FIG. 2 is an elevational view of the reinforcement 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. The container 10 includes a sealed flexible bag 11 made of a chemically inert, plastic material 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 Ila reinforced hanger portion 16 is fabricated. The reinforced 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 is a flap 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. 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 provides reinforcement to the hanger 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 the container 10 is suspended from a hospital standard, the reinforced hanger portion 16 acts to prevent distortion of the bag 11 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.

Depending on the end use intended for the container 10, whether for irrigating fluids or intravenous fluids, 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, a fill and administration 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 extending within the bag 11 to provide communication into the interior of the bag 11. An annular flange 29 extends from the end 28 of the fill port 26. The fill port 25 is sealed 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 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 diaphragm 35. Extending from the open end 33 of the administration port 30 is an annular flange 36 adapted to

3,915,212 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 extending perpendicularly away from the outer surface of said cover immediately opposite a weakening ring. A weakening ring 41 is formed in the cover 37 radially inwardly of the cover flange 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 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 section 46 having an open end 47 and a closed end 48 together with a passage 49 therethrough. The closed end 48 is spaced away from the open end 47 and forms a puncturable diaphragm 50 to facilitate entry of a needle or cannula into the bag 11. An integral cover 51 is positioned over the tubular section 46, the cover 51 comprising a tubular section 52 formed by the side walls 53 and an end wall 54, an annular flange 55 extending from the side wall. The end wall 54 includes a thin portion 56 to facilitate opening of the cover 51. A handle base 57 extends from the end wall 54 and includes a handle 58 extending therefrom. The flange 55 of the cover 51 is sealed directly to one of 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 maintain sterility so that upon use, there is no need to swab the puncturable diaphragm 50 with a bactericide.

The container 10 can be fabricated to form a bag 11 from two sheets of plastic sealed together preferably by heat sealing methods. Prior to sealing the perimeter 14 of the opposed walls 12, 13 to form the bag 11, the tubular portion 26 of the fill port 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 for use with intravenous fluid or other fluid which may require the addition of medicament thereto, an administration port 30 is 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 administration port 30 is thereafter inserted and sealed in place.

In use, the cover 37 of the administration 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 from the container 10 through the tubing of the administration set (not shown) to the patient. As the fluid is 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 con4 tainer 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 is to be used for the storage and administration of intravenous fluids to which it may be necessary to add additional medicament, an additive port 45 can be affixed to a side wall 12, 13 of the flexible bag 11. If the addition of a medicament to the fluid within the container 10 is necessary, the cover 51 of 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 diaphragm 50. As illustrated in FIG. 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.