Flexible intravenous container

BACKGROUND OF THE INVENTION

The present invention relates to new and improved intravenous containers, and it more particularly relates to an intravenous system for adding medications or other ingredients to the contents of a flexible-plastic intravenous container for packaging and feeding its contents to a patient.

When an intravenous fluid, such as a saline solution, is to be administered from an intravenous bottle to a patient, it frequently becomes necessary to add a medication, such as a vitamin supplement, to the intravenous solution. For example, in adding a vitamin supplement to a saline solution in an intravenous bottle, a small quantity of saline solution is injected with a suitable instrument, such as a hypodermic syringe, into a sterilized vial of the powdered vitamin supplement to dissolve it in the saline solution. The vitamin-saline solution can then be transferred from the vial to the intravenous bottle by means of the syringe. Therefore, it would be desirable to have a more simple and direct system for adding a medication to the contents of an intravenous container.

Therefore, it is the principle object of the present invention to provide a new and improved intravenous container.

Another object of the present invention is to provide a new and improved system for adding a medication to an intravenous fluid.

SUMMARY OF THE INVENTION

Briefly, the above and further objects of the present invention may be realized in accordance with the present invention by providing a flexible intravenous container having a flexible tubular container member which has each of its ends aseptically sealed together to provide a sealed package for an intravenous fluid and which has an outlet connector at a point midway between its ends to connect an intravenous tube in fluid communication with the container member. The ends of the container member are adapted to be attached to a support stand so that the container member can be folded over at its midpoint and its ends can be readily attached to the support stand whereby the outlet connector is disposed at the bottom of the container. At least one additive connector is provided near one of its ends so that a medication Container can be interconnected with the container member. Where the medication to be added is in powdered form, such as a vitamin supplement, and the intravenous fluid is a saline solution, a vial containing the vitamin supplement can be interconnected to the additive connector so that an attendant can squeeze the flexible container member to force a small quantity of the saline solution into the medication container to mix with the powdered vitamin. Upon releasing the container member, the vitamin-saline solution is drawn from the vial into the container member as a result of the suction which is created by the container member.

The intravenous container of the present invention is not bulky to use, and thus it can be easily handled and mounted on a support stand. Moreover, the inventive container can be readily hung on the stand before the medication is added to the contents of the container. Due to the unique construction of the container, it can be completely emptied, and it does not require an air vent since the container is composed of a flexible material. Furthermore, the container of the present invention is easily and inexpensively manufactured by in line techniques so that it can be made as a disposable item.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other objects and features of this invention and the manner of attaining them will become more apparent, and the invention itself will be best understood by reference to the following description of the invention taken in connection with the accompanying drawings, wherein:

FIG. 1 is a front elevational view of a flexible intravenous container mounted on a support stand and embodying the principles Of the present invention;

FIG. 2 is a reduced-scale, front elevational view of the container of FIG. 1, illustrating it in an unfolded position;

FIG. 3 is an enlarged, fragmentary, cross-sectional view of FIG. 2 taken substantially along the line 3-3 thereof; and

FIG. 4 is a cross-sectional view of another intravenous container in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

Referring now to the drawings, and more particularly to FIG. 1 thereof, there is shown a flexible intravenous container 10 which embodies the principles of the present invention and which is mounted on a support stand 12. The container 10 in15 eludes a sealed, flexible bag 14 which contains an intravenous fluid and which is hung by its apertured ends 16 and 18 from a hook 20 on the stand 12. In order to mount the container 10 on the stand 12, first the end 18 is slipped over the end of the hook 20, and then the bag 14 is folded over and its other end 20 16 is slipped over the end of the hook 20. As shown in FIG. 1, an outlet connector 22 at the bottom of the bag 14 is adapted to receive a tube connector 24 of an intravenous tube 26 to connect it in fluid communication with the inside of the bag. In order to add a medication to the intravenous fluid in the bag 25 14, a vial (not shown) containing a medication can be interconnected to one of a pair of additive connector assemblies 28 and 31 which are located near the respective ends 16 and 18 of the bag 14. The connector assembly 28 can accommodate a vial (not shown) which has a male connector and which is 30 commonly known as a Travenol package. The connector assembly 31 can be used with a vial (not shown) which has a female connector and is commonly known as a Squibb package.

In use, a medication vial is interconnected with one of the 35 connector assemblies, such as the connector assembly 28. If the medication in the vial is in powdered form, the bag 14 is compressed by the attendant to force a small quantity of the intravenous fluid into the vial to dissolve the powdered medication contained therein. After shaking the vial to dissolve the powder, as a result of the suction produced when the bag 14 is released, the medication solution is transferred from the vial to the bag 14 to mix with the remaining fluid contained therein. If the medication is in liquid form, the bag 14 is first ., squeezed, and then the vial is interconnected with one of the ³ additive connectors of the bag 14 so that when the bag 14 is released, the medication is drawn into the bag.

Referring now to FIGS. 2 and 3 of the drawings, the bag 14 is a seamless, extruded plastic tube which is composed of a jq thin plastic film, such as a three-ply film composed of polyethylene at the outer layers and mylar at the middle layer. However, it is to be understood that the bag 14 could also be formed in different manners, such as by forming the bag of two sheets of thin plastic film which are heat sealed together 55 along their side marginal edges. One of the ends 16 and 18 of the tubular bag 14 is heat welded together to form a container, and the other end is left open to fill the container with an intravenous fluid. The bag 14 is filled to a level which is slightly below the additive connector assemblies 28 and 31 when the 60 intravenous container 10 is mounted on the stand 12 as shown in FIG. 1. After filling, the open end may then be closed by heat welding to complete the package. Each of the ends 16 and 18 has a centrally disposed hole 33 for receiving the hook 20 on the stand 12.

As shown in FIGS. 2 and 3, the outlet connector· 22. is heat welded to the bag 14 midway between the ends 16 and 18 in line with the holes 33 therein. The connector 22 is tubular in shape and is heat welded over a hole 35 in the bag 14. An axial hole 37 in the connector 22 is aligned with the hole 35, and an 70 annular flange 39 surrounding the hole 37 is heat welded to the outer surface of bag 14. A protective cap 41 is disposed over and conforms to the shape of the outer end of the connector 22 and has an annular flange 43 which abuts the flange 39 and surrounds the open end of the cap 41 for removing it 75 from the connector 22. The cap 41 includes a centrally

3,554,256 disposed depending portion 45 which extends into the hole 37 to seal the connector 22. An internal annular groove 47 receives a complementary-shaped annular bead or ridge 49 surrounding the end of the depending member 45 to lock the cap 41 on the connector 22. The depending member 45 abuts a membrane portion 52 which is integrally formed in the connector 22 and extends across and blocks the hole 37. The membrane 52 permits the cap 41 to be removed while the bag 14 is mounted on the support 12 since the membrane 52 provides a second aseptic seal which prevents the fluid from leaving the bag 14. When the cap 41 is removed from the connector 22, the complementary-shaped connector 24 of the intravenous tube 26 may be inserted into the connector 22. The tube connector 24 on the vial includes a cutting edge (not shown) to pierce the membrane 52. The ruptured membrane serves the purpose of sealing the tube connector 24 in the outlet connector 22. The tube connector 24 includes a complementary-shaped annular ridge (not shown) which slips into the internal annular groove 47 of the connector 22 to interlock it with the tube connector 24, whereby when the bag 14 is compressed, the tube connector 24 is not forced out of engagement with the connector 22.

The connector 22 is composed of a plastic material, such as linear polyethene. The protective cap 41 may be formed of vinyl or a vinyl compound such as ethylvinylacetate acid by E. I. duPont de Nemours & Co., under the name, E. V. A. The connector member 22 is injection molded directly into the cap 41 so that the cap 41 is aseptically seals the connector 22. A process for such an injection molding process is disclosed in detail in my copending U.S. application, Ser. No. 763,097, filed on Sept. 27, 1968, entitled “Aseptic Connector and Closure Assembly”.

The connector assembly 28 includes a connector 54, which is substantially identical to the connector 22, and a protective cap 56 which fits over the connector member 54 and is substantially identical to the protective cap 41. The connector member 54 has an axial hole 58 which is aligned with a hole 60 located near and in line with the hole 33 in the end 16 of the bag 14. The connector 54 is thus adapted to interconnect with a connector (not shown) of a medication vial in the same manner as the connector 22 interconnects with the tube connector 24.

The connector assembly 31 comprises a connector 62 which has a protective cap 64 disposed over and conforming to the surface of the outer end of the connector 62. The connector 62 is tubular in shape and has an axial hole 66 extending therethrough in alignment with a hole 68 which is located near and in alignment with the hole 33 in the end 18 of the bag 14. The connector 62 includes an annular flange 71 which is heat welded to the bag 14. The outer end 73 of the connector 62 is cut on a bias to provide a cutting edge to pierce a diaphragm or membrane (not shown) on a medication vial when the two containers are interconnected.

The cap 64 includes a centrally disposed depending portion 75 which extends into the open end 73 to seal the connector 62. The connector 62 further includes an annular flange 77 which is disposed adjacent the annular flange 62 to permit the cap 64 to be removed from the connector 62. On the inside of the connector 62 opposite the outer annular flange 77 is an annular ridge or bead 79 which fits into a complementaryshaped annular groove 81 in the outer edge of the connector 62 adjacent the annular flange 71 to lock the cap 64 on the connector 62 and to receive a complementary-shaped annular bead (not shown) on the connector of the medication vial. An enlarged portion 83 of the cap 64 adjacent the bead 79 receives an annular boss or collar 83 which provides a stop member for the connector of the medication bottle.

The connector assembly 31 may be formed of the same material and in the same manner as the outlet connector 22 and its cap 41 so that an aseptic and hermetic seal is formed between the cap 64 and the connector 62.

Referring now to FIG. 4, there is shown a cross-sectional view of another intravenous container 90 in accordance with the present invention. The container 90 is similar to the container 10, but the container 90 is formed of a single sheet 92 of flexible plastic material which is folded over longitudinally and heat welded together at a seam 94 and which has the connector assemblies, such as a connector assembly 96, heat welded to its outer surface opposite to the seam 94. In order to permit the empty container 90 to occupy a minimum amount of space, a pair of V-shaped bellow-type gussets 98 in the form of pleats or folds extend along each side of the container 90. When the container 90 is filled, the gussets 98 unfold to increase the capacity of the container 90 accordingly.

While the present invention has been described in connection with particular embodiments thereof, it will be understood that those skilled in the art may make many changes and modifications without departing from the true spirit and scope of this invention, and accordingly all such changes and modifications which fall within the true spirit and scope of this invention are intended to be covered in the appended claims.