US2878808A - Parenteral solution container closure - Google Patents

Description

March 24, was 0. R. BROMAN 2,878,808

PARENTERAL SOLUTION CONTAINER CLOSURE Filed March 26, 1957 PARENTERAL SOLUTION CONTAINER CLOSURE Cyrus R.'Broman, Evanston, Ill., assiguor to Baxter Laboratories, Inc.

Application March 26, 1957, Serial No. 648,623

6 Claims. (Cl. 128-272) This invention relates to a closure for a parenteral solution container.

Parenteral solutions are commonly provided in glass bottles, generally of a bell-shaped configuration and having an upwardly-extending neck. These bottles usually come in a number of sizes, such as 150 cc., 250 00., 500 cc., and 1,000 cc. Since the solutions are intended to'be introduced into the body of a human, it is imperative that they be maintained, between the time of manufacture and administration, under the most careful conditions of sterility. For this purpose, an effective seal for the bottle is required. The seal or closure should at the same time be readily removable so as to permit access to the liquid contents of the bottle. 7

For the last fifteen years or more, the generally employed closure has included a resilient plug which is mounted in the mouth of the parenteral solution bottle. The plug is equipped with a laterally-extending, annular flange which overlies the top lip of the bottle and which serves to maintain the plug in place against the tendency of the plug to be drawn into the bottle under the influence of the vacuum that generally is provided within the bottle. Overlying the top surface of the resilient stopper, which is generally constructed of a hard rubber, is a flexible sealing disc also made of a rubbery material, such as latex. The flexible disc serves to .protect the top surface of the resilient plug and especially to maintain it in a sterile condition. Where a resilient stopper is provided with passages extending through the plug, the flexible disc serves as a closure for these passages. The disc and plug are maintained in place in and over the mouth of the bottle by means of a clamping ring. The clamping ring is approximately C-shaped in cross section and engages with the lower inwardly-extending flange a portion of the bottle. The upper portion of the clamping ring, which includes the upper, inwardly-extending flange, overlies peripheral portions of the flexible disc and plug.

A closure might also include an additional disc as of metal, which overlies the flexible disc. The metal disc is maintained in place by a second clamping ring which also engages the bottle and which overlies the metal disc.

In use, the nurse or physician desiring to administer the parenteral solution provided in a bottle equipped with such a closure, removes the outer clamping ring or cap, which is generally provided with a tear-tab joint to the main body of the cap by means of a weakened portion. Manual pulling pressure on the tear-tab ruptures the outer cap and permits its complete removal. Thereafter the metal disc can be removed. There has been considerable difliculty, however, in removing the flexible disc which is maintained in place under the clamping ring. An expedient in the past has been to provide the clamping ring with a notched-out portion so that the edge of the thin flexible disc was exposed. This permitted the nurse or physician to grasp the edge of the disc and pull it out from its mounting under the clamping ring. Despite this cut-out expedient, those em- 2,878,808 Patented Mar. 24, 1959 ployed in administering such solutions have generally not availed themselves of the manual means of removing the flexible disc. It is to be appreciated that the disc is pressed very tightly against the top surface of the resilient plug so that it is difficult to obtain a good finger hold on the disc. Many administrators of parenteral solutions have instead resorted to employing a sharp instrument to lift out the flexible sealing disc. Often, however, employment of a sharp instrument such as one point of a scissors, ruptures the disc and does not completely remove it. At times also, the person wielding the scissors injures herself in an attempt to dislodge the flexible sealing disc. Others have chosen to ignore the disc and, instead of removing it, choose to thrust the pointed connector of an administration set through the flexible disc. 7 This is considered undesirable, since the top surface of the disc is not considered sterile, and may result in the introduction of contamination into the parenteral solution.

It is an object of my invention to provide a new closure for a parenteral solution container. Another object is to provide a closure that overcomes the drawbacks and disadvantages of the closures for parenteral solution bottles that have heretofore been used. Yet another object is to provide aclosure for a parenteral solution container that is readily removable. Another object is to provide a closure for a parenteral solution container having a flexible disc covering a resilient plug that is more readily removable than similar closures heretofore employed. A still further object is to provide a parenteral solution container closure that is readily removable by the provision of a convenient finger-insertable cut-out in the clamping ring maintaining the disc and plug in position so as to permit the person opening the closure to grasp a portion of the disc which overlies a recess in the plug. Yet another object is to provide a closure of the character set forth in the object recited immediately above, where the closure also provides a peripheral seal for the parenteral solution container. Other objects and advantages of my invention will be seen as this specification proceeds.

My invention will be explained in conjunction with the accompanying drawing, in which- Fig. 1 is a perspective view of a resilient plugcon structed according to the teaching of my invention; Fig; 2 is a view similar to Fig. 1 but with the plug equipped with additional closure portions; Fig. 3 is a fragmentary cross-sectional view of a parenteral solution bottle equipped with the closure of my invention, and Fig. 4 is a view similar to Fig. 3 but with the outer portions of the closure removed. I

Referring now to the drawing and particularly 'Fig. 3, the numeral 10 designates a parenteral solution bottle. Bottle 10 is ordinarily constructed of glass and is equipped with a neck portion 11 which provides a top lip 12 for the bottle. Top lip 12 defines a mouth 13 which usually is circular in top view.

As pointed out above, bottle 10 may assume any one of various sizes, depending upon the volume of fluid to be carried thereby. The fluid is generally discharged from the bottle when the bottle is positioned in a mouthdownward condition.

The mouth 13 of bottle 10 is closed by a resilient plug 14. Plug 14 is of a generally frusto-conical configuration and is equipped with an integral, annular, laterallyextending flange 15 that overlies and bears against lip 12.

Plug 14 carries air tube 16 which extends inwardly of bottle 10 and which is mounted in passage 17 of plug 14. Passage 17 may extend completely through the thickness of plug 14, or it may be closed by a thin rupturable diaphragm. Plug 14 is equipped with a second passagfl.

designated 18 which, like passage 17, may or may not be equipped with an integral diaphragm extending thereacross. In the course of administration of the liquid contents of bottle 12, liquid flows out of passage 18 into a suitable tube and needle set (not shown), while air enters the bottle to replace withdrawn liquid through passage 17 and air tube 16.

The annular flange of plug 14 is seen to be provided with an L-shaped annular groove 15a adjacent the base of plug 14. Overlying the top surface or base of plug 14 is flexible sealing disc 19 (best seen in Fig. 4). Fexible sealing disc 19 is generally circular and has a diameter approximately the same as the diameter of flange 15. Flange 15 has a diameter approximatelythe same as the outer diameter of lip 12. The L-shaped recess or groove 15a in the flange 15 preferably extends inwardly a distance less than the thickness of lip 12. Satisfactory results have been obtained when the lateral dimension of groove 15a is about one-half the thickness of lip 12, such as indicated by the numeral 20 in Fig. 4.

Plug 14 and disc 19 are maintained in place by inner clamping ring 21. Clamping ring 21, as seen in Fig. 3, has a generally C-shaped cross-section. The bottom, inwardly-turned flange designated 22 engages a bead 23 on the neck 11 of bottle 10. The upper inwardly-extending flange 24 of clamping ring 21 overlies flexible disc 19 and peripheral portions of plug 14.

As seen in Fig. 3, the remaining portions of the closure include metal disc 25 and outer cap 26. Metal disc 25 overlies flexible disc 19 and the upper, inwardlyturned flange 24 of clamping ring 21. Outer clamping ring or cap 26 overlies metal clamping disc 25 and has a bottom, inwardly-turned portion that also abuts bead 23. Cap 26 is provided with tear-tab 27 which is integral with cap 26 but which can be readily pulled therefrom because of weakened portions in the side portion of cap 26.

When a parenteral solution bottle is closed by the closure of my invention, a strong peripheral seal is maintained between flexible disc 19 and the top surface of plug 14. This seal exists notwithstanding the fact that a cut-out portion 29 exists in upper inwardly-extending flange 24 and side wall 30 of clamping ring 21. A substantial clamping force is exerted around the entire periphery of inwardly-extending flange 24 by outer cap 26. Thus, during storage and up until the time of use, the top surface of plug 14 is maintained in a sterile condition.

Operation When it is desired to remove the portions of the closure of my invention so as to ready the bottle for administration, a nurse or other hospital attendant merely grips tear-tab 27 and pulls it outwardly to rupture the outer cap 26. The rupture automatically will occur in outer cap 26. Thereafter the nurse removes metal disc 25 and reaches into cut-out portion 29 to grasp an edge of flexible disc 19. A slight upward pull is all that is needed to remove flexible disc 19 and expose the top surface of plug 14.

The foregoing detailed description has been given for clearness of understanding only, and no unnecessary limitations are to be inferred therefrom.

I claim:

1. In combination with a parenteral solution bottle, a closure comprising a resilient plug closing the mouth of said bottle and having an integral, laterally-extending flange overlying the lip defining the mouth of said bottle, said flange being spaced below the top outer surface of said plug, a flexible disc overlying said top outer surface in overlapping relation thereto, and a clamping ring annular flange overlying the top of the neck of said container, said flange being spaced from the top of said plug, a flexible disc overlying the top of said plug having peripheral portions extending beyond the periphery of the top of said plug, a clamping ring engaging the neck of said container, said clamping ring having an inwardlyextending flange in pressing engagement with peripheral portions of the top of said plug, said inwardly-extending flange having an area cut away to expose a portion of the I peripheral portion of said flexible disc.

3. In combination with a container having a mouth, a closure for said container comprising a resilient plug seated in said mouth and having a laterally-extending annular flange seated on the mouth-defining lip of said container and substantially coextensive with said lip, said flange being adjacent the top outer surface of: said plug, an annular, generally L-shaped recess in said flange adjacent the outer top surface of said plug, a flexible disc overlying said top surface and being substantially coextensive with said flange, and a clamping ring engaging said container, said clamping ring having a bandportion extending around said container and a top flange portion in pressing relation with peripheral portions of the top outer surface of said container, a portion of said top flange portion being notched.

4. A combination of the characters set forth in claim 3, wherein the lateral dimension of said L-shaped recess is less than the thickness of said lip.

5. In combination with a container having a neck providing a top lip, said lip defining a mouth, a frustoconical resilient plug closing said mouth and having a laterally-extending annular flange portion overlying said lip, said flange being adjacent the base of said plug, a peripheral groove in said flange adjacent the base of said plug, said groove extending inwardly of said flange a distance about one-half the thickness of said lip, a flexible disc overlying said plug and having peripheral portions overlying said groove, and clamping means engaging said neck and the entire peripheral portion of the base of said plug except for a finger-insertable cut-out portion.

6. In combination with a parenteral solution bottle,

a closure comprising a resilient plug closing the mouth a metal disc overlying said clamping ring and said flexible disc, and a cap extending over said metal disc and engaging said container.

References Cited in the file of this patent I UNITED STATES PATENTS 2,236,491 Campbell Mar. 25, 1941 FOREIGN PATENTS 513,799 Great Britain Oct. 23, 1939 308,148 Switzerland Sept. 1, 1 955 Cutter et al. Feb. 13, 1940'

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