US3343541A - Parenteral container - Google Patents

Description

Sept. 26, 1967 D. BELLAMY, JR 3,343,541

PARENTERAL CONTAINER Filed Jan. 8, 1964 INVENTOR. DAVID BELLAMY JR.

MP by ATTORNEY United States Patent 3,343,541 PARENTERAL CONTAINER David Bellamy, Jr., Glenview, 11]., assignor to Baxter Laboratories, 1120., Morton Grove, 111., a corporation of Delaware Filed Jan. 8, 1964, Ser. No. 336,569 1 Claim. (Cl. 128-272) The present invention relates to a parenteral solution container provided with a tamper proof closure. More particularly, it relates to a plastic parenteral solution container with a closure structure which provides for a sterile port means and a sterile zone about the port means.

Various attempts have been made to prepare a plastic parenteral solution bag with a tamper proof closure. For the most part these attempts have comprised placing a rubber stopper in the opening of the outlet port and attaching a tamper proof metal collar to the port or embedding the entire port structure and stopper in plastic. Such closure systems, although they are tamper proof, possess several disadvantages. First, they are diflicult and uneconomic-a1 to assemble; second, they are difficult to disassemble without violating the sterility of the port; and third, even though the port itself is sterile often the area immediately surrounding the port becomes highly contaminated and presents a hazard which can lead to contamination of the port structure and the contents of the solution container.

It is an object of the present invention to provide a closure structure for a plastic solution bag which is tamper proof, easy to assemble and disassemble, and furthermore, provides a sterile zone about the port.

This and still other objects and advantages will be apparent from the description which follows.

It has now been discovered that a plastic solution container with a superior tamper proof closure may be prepared by sealing a section of relatively thin tearable plastic film to the container about and surrounding the port area. The tearable film is preferably provided with tab means for rupturing said film to expose the port area. The tab means may be a relatively thicker plastic film which is sealed to the tearable film within the periphery of the seal which attaches the tearable film to the bag.

In further describing the invention reference will be had to the drawings in which:

FIGURE 1 is an elevational view showing one embodiment of the novel tamper proof closure of the present invention.

FIGURE 2 is a sectional view taken along lines 2-2 of FIGURE 1 showing the details of the port and closure structure.

FIGURE 3 is an elevational view of the embodiment of FIGURE 1 showing the method of exposing the sterile port area.

In FIGURE 1 is seen aplastic solution container 10 provided with hanger means 11,port 12, and a tamper proof protective closure for said port generally referred to as 13. As seen in FIGURES 1 and 2, theprotective closure 13 comprises a section of relativelythin film 14 which is attached to thesolution container 10 by aseal 15 about its periphery. Within the periphery of the seal lies theport structure 12. Attached to thetearable film 14 is a section of relativelythick film 16 which is united to the tearable film by aseal 17 which lies within the area bounded by theseal 15. As seen in FIGURE 2, theseal 17 is spaced in from the boundaries of theseal 15 thus creating the tab means 18. The tab means 18 are adapted to be grasped as shown in FIGURE 3 and manipulated to expose the port and the adjacent sterile area. To fur ther facilitate the removal or the tearing of thetearable film 14 theseal 17 may be shaped as shown in FIGURES 3,343,541 Patented Sept. 26, 1967 l and 3. If desired, additional ports may be included within the sterile zone. For example, a second port which is provided with a resealable stopper might be included to provide for the administration of supplemental medication.

In the preferred embodiment of the present invention, thebag 10 is formed of polyvinylchloride resin or a laminate thereof; the section oftearable film 14 is formed of a relatively thin polyvinylchloride resin film about 0.006 inch thick, and the section of relativelythick film 16 is formed of polyvinylchloride resin film about 0.015 inch thick. If desired the tab means 18 may be ribbed or otherwise modified to provide a secure gripping surface (as seen in FIGURE 3). The use of the polyvinylchloride resin for all three components is preferred because of the ease with which components formed of that resin may be sealed to each other.

If desired, the novel tamper proof closure may be sealed to the container immediately after the container has been filled with solution. However, in a completely automated operation in which the solution bag is simultaneously formed, filled and sterilized, it may be desirable to have the tamper proof closure already attached to one of the sheets of plastic which will eventually form a wall of the container. If such is the case the tamper proof closure and the zone it protects might be sterilized separately as by gas sterilization or sterilized with the bag and its contents by any conventional sterilization technique.

In the embodiment illustrated in the drawings a sterile zone is provided only in the area immediately adjacent the port structure, however, it may in some circumstances be desirable to more or less completely enclose the side of the solution bag within the tamper proof protective closure. For example, if desired, a parenteral solution administration set may be integrally connected to the bag and completely enclosed within the novel tamper proof closure system of the present invention. This method of construction would provide substantial advantages for military use where a single sterile compact unit for parenteral administration is desired. In such a case the sterile zone provided would have to be much larger than that required when a separate unconnected administration set is to "be employed. The integral parenteral solution administration set referred to is a modified outlet port and is intended to be covered by the term port as used herein.

It may also be desirable for thetearable film 14 to be provided with printed directions as to method of use, description of the contents, etc., thereby eliminating the necessity of printing such data directly upon the wall of the parenteral solution container. This has the advantage of effectively protecting against the migration of any of the ingredients of the printing materials through the wall of the container and into the parenteral solution.

While in the preferred practice, the films to be employed have been described as being of polyvinylchloride resin it will be understood that other plastics which are equivalent to the polyvinylchloride resin for this particular use such as polyolefin resins, polyhalocarbon resins and the like may be used and are intended to be covered by the term polyvinylchloride resin as used herein.

It will be further understood that the tamper proof clo sure of the present invention may be sealed to the parenteral solution bag by heat sealing, dielectric sealing, ultrasonic sealing, gluing or any other suitable means.

It will be readily apparent to those skilled in the art that the present invention provides many substantial advantages over the practice of the prior art. Some of these advantages have been described, still others will be apparent to those skilled in the art.

What I claim is:

In a plastic solution bag for containing a sterile par- M enteral solution and provided with port means including a tubular extension through the wall of said bag, a tamper proof closure for said port means comprising a relatively thin tearable plastic film permanently sealed to said hag around its edges and encompassing a sterile zone, said port means being located within said sterile zone, tab means for rupturing said tearable plastic film to expose the sterile zone and port means, said tab means including a relatively thick tear tab being located within the periphery of the seal which joins the thin plastic film to the bag.

References Cited UNITED STATES PATENTS Cherkin 128-272 Spees 229-51 Flynn 128-214 Spees.

Cocoran et a1 128-272 Barton et al. 128-272X 10 RICHARD A. GAUDET, Primary Examiner.

DALTON L. TRULUCK, Examiner.

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