US3050061A - Parenteral solution equipment - Google Patents

Description

1962 F. GOYKE 3,050,061

PARENTERAL SOLUTION EQUIPMENT Filed May 29, 1957 /N VE N TOR ATTORNEYS.

n ates trite This invention relates to parenteral solution equipment and the use thereof, and more particularly to equipment useful in supplementing bulk parenteral solutions.

The bulk parenteral solutions to which this invention is directed, are usually considered to be solutions in excess of 250 cc. Most usually, these solutions are provided in sizes of 250 cc., 500 cc., and 1000 cc. Depending upon the quantity of the solution and the requirements of the patient, the administration of these solutions may vary over a period from about one hour to as much as eight hours. The administration is usually achieved by a length of tubing communicated at one end with a parenteral solution bottle mounted mouth-downwardly and at the other end with a needle inserted under the skin of an intended recipient. Suitable flow-regulating means are associated with the administration set, usually a drip-meter and clamp for the tubing so as to permit dropwise administration of the parenteral solution.

Although parenteral solutions are often thought of in terms as a source of intravenous feeding, they are by no means limited to providing nutriment. They have been found useful in maintaining the recipient against shock, such as attends the loss of blood during surgery. They have been used to maintain the salt level of the blood in this connection. They have also been used as carriers for anesthetics and other associated medicines.

The wide use of parenteral solutions permits them to act as carriers for a wide variety of medicines. It is to be appreciated, however, that because of their bulk, a wide variety of parenteral solutions cannot be conveniently stored, even in hospitals of considerable size. Thus, it is not uncommon for parenteral solutions of a basic nature, such as glucose or saline, to be supplemented by a particular medicine just prior tothe administration of the bulk parenteral solution. I have noted reports that show that in as many as one in every four administrations, the basic solution has been supplemented by one type of medicine or another. This is particularly the case in the use of certain preparations such as vitamins that are unstable as water solutions.

Because of the increasing frequency with which basic parenteral solutions are being supplemented, a problem has arisen in the performance of this supplementation in a quick, efficient, and aseptic manner.

It is a general object of this invention to provide equip ment and the use thereof that solves the foregoing problem. Another object is to provide equipment to accomplish supplementation of a bulk parenteral solution with a minimum of manipulation, whereby aseptic transfer is substantially achieved. Still another object is to provide a novel method of supplementing a bulk parenteral solution. Yet another object is to provide a method for transferring a supplementing medicament from a separate source to a bulk parenteral solution container only under the influence of gravity. A still further object is to provide a method of supplementing a bulk parenteral solution in which the supplemental medication is introduced through the air tube of a bulk parenteral solution bottle. A still further object is to provide a novel closure structure for an additive vial which achieves the purposes and objects set forth above. Other objects and 3,050,061 Patented Aug. 21, 1962 advantages of my invention can be seen as this specification proceeds.

This invention will be explained in conjunction with the accompanying drawing, in -which FIGURE 1 is a cross-sectional view of a bulk parenteral solution container in communication with an additive vial; and FIG. 2 is an elevational view, partially in section, similar to FIG. 1 but showing the structure of FIG. 1 in a different operative condition.

In the illustration given, the numeral 10 (in both figures) denotes generally a parenteral solution container. Container 10 includes a glass bottle 11 provided with an annular groove or recess 12 adjacent the bottom thereof. Mounted on bottle 11 within recess 12 is band 13. Attached to lugs or ears 13a of band 13 is bail 14 (seen only in FIG. 2). Bail 14 and band 13 cooperate to provide a convenient means for suspending bottle 11 in a mouth-downward fashion, such as is shown in FIG. 1, and which is the position employed during dispensing of liquid from parenteral solution container 10.

Bottle 11 is provided with a mouth 15 into which is inserted stopper 16. Conventionally, stopper 16 is constructed of a resilient material such as rubber or rubber substitutes. Stopper 16 is provided with an annular flange portion 17 which overlies the top lip of bottle 11. Stopper 16 is maintained in place in the neck 15 of bottle 11 by a clamping ring 18 which is anchored to an annular bead 11a provided in the external wall of bottle 11. Overlying stopper 16 is a frangible diaphragm 19. Extending through stopper 16 are passages 20 and 21. Mounted within passage 20 and extending inwardly of bottle 11, is an air tube 22.

When the solution 23 contained within bottle 11 is intended to be dispensed without supplementation, the connector portion of an administration set is inserted into passage 21, the act of insertion causing rupture of diaphragm 19 if it has not already been removed. Suitable puncture of diaphragm 19 is also required in the portion overlying passage 20. When bottle 11 is disposed in the condition shown in FIG. 1, parenteral solution 23 flows out of passage 21 and the space vacated by solution 23 is replaced by air entering through passage 20 and air tube 22.

The foregoing parenteral solution container structure and operation is considered conventional, and is set forth in detail only for the sake of clearness of understanding of this invention. In this connection, it is to be noted that in some instances integral diaphragms are provided in stopper 19 to close passages 20 and 21.

In both FIGURES, the numeral 24 designates generally an additive vial structure which embodies teachings of this invention. Vial 24, like bottle 11, can be conveniently constructed of glass. Vial 24 is equipped with a top closure 25 which, in the illustration given, is shown secured to vial 24 in a manner similar to the securement of stopper '16 to bottle 11. In the illustration given, vial stopper 25 is provided with an annular flange 25a which overlies the top lip of vial 24. Stopper 25 is maintained in place by a clamping ring 26 which is anchored to vial 24 under an annular bead 24a.

Extending through stopper 25 are a pair of passages 27 and 28. Passages 27 and 28 are spaced apart a distance approximately the same as the separation of passages 20 and 21 in stopper 16.

Mounted in passageway 27 is connector fitting 27a. Fitting 27a extends outwardly of vial 24 and is shown inserted into passage 21 of stopper 16 of parenteral solution container 10.

Mounted in passageway 28 is puncture fitting 29, which is shown inserted into passage 20 of stopper 16. Preferably, fitting 29 is of a length sufficient to extend into air tube 22 when fitting 27a is inserted into passage 21 and in communication with parenteral solution 23.

Fitting 29 is provided with a tight fitting annular sleeve 30 which terminates a distance spaced from the end of puncture fitting 29. Optimum operation is achieved when sleeve 30 is constructed of a resilient material such as rubber, in which case it can act as a seal in cooperation with stopper 16 or diaphragm 19, as the case may be.

It is believed that a brief description of the use of vial 24 in the environment set forth will be helpful in understanding this invention.

Operation When it is desired to supplement a parenteral solution 23 such as is contained within parenteral solution container with a liquid medicine, it is only necessary to communicate the suplemental medicine-containing vial with the parenteral solution container as shown in FIG. 2. In FIG. 2, the mouth of bulk parenteral solution container 10 is positioned upwardly. Not shown associated with additive vial 24 is a suitable protector or cap structure for fittings 27a and v29 to protect them from contamination. When additive vial 24 is coupled or communicated to container 10 as shown in FIG. 2, the liquid 31 in vial 24 flows downwardly through fitting 29 into air tube 22 and eventually into the body of solution 23. Meanwhile, air moves from container 10 upward through fitting 27a into Vial 24 to replace the liquid which is dispensed therefrom under the influence of gravity. During the transfer of liquid medicine 31 from vial 24 into container 10, vial 24 and container 10 provide a closed system, i.e., a system in which no contact with unsterile outside air is permitted. As seen in FIG. 2, fitting 27a is pressed-fitted into passage 21 of stopper 16 so as to effectively seal air from entering container 10 through passage 21. The abutment of sleeve 30 against the top surface of stopper 16 likewise prevents entry of unsterile air into parenteral solution container 10.

When it is desired to supplement parenteral solution 23 with a solid medicament, the arrangement shown in FIG. 1 is first employed. In FIG. 1, as in the arrangement just described with respect to FIG. 2, vial 24 and container 10 are communicated by virtue of having fittings 27a and 29 inserted into passageways 21 and 20, respectively. The coupled or communicated vial 24 and container 10 are disposed in the position shown in FIG. 1, wherein container 10 is uppermost and positioned in a mouth-downward condition. When such is the case, solution 23 flows out of container 10 through passage 21 and through fitting 27a into vial 24 to come in contact with the solid medica ment container in vial 24. In FIG. 1, particles 32 of solid medicament contained within vial 24 are shown in a state prior to solution or dispersion within solution 23. Meanwhile, air from vial 24 is forced upwardly through fitting 29 into air tube 22 and therefrom as shown by the arrows in FIG. 1 to replace the liquid solution withdrawn from container 10. After a short period, all air is forced from vial 24 and any solid medicament therein is dispersed or dissolved in solution 23 entering vial 24. Thereafter, inversion of the coupled vial and bottle to the condition shown in FIG. 2 results in flow of liquid 31 from vial 24 as described above, the air entering vial 24- through fitting 27a and being shown in the form of bubbles 33.

From the foregoing, it is seen that the structure and method of this invention permits the supplementation of bulk parenteral solutions with a minimum of manipulation. All that is required is coupling of a medicamentcontaining vial to a parenteral solution bottle. This is achieved by thrusting fittings 27a and 29 into passageways 21 and 20, respectively, when container 10 is positioned mouth-downwardly, as seen in FIG. 1. Flow of liquid out of container 10 is prevented by virtue of diaphragm 19 closing passages and 21. Alternatively, it is possible to couple vial 24 to container 10 when the latter is positioned as shown in FIG. 2, i.e., mouth-up- Ward. This has been found particularly convenient when vial 24 contains a solid medicament, since a solid medicament does not have a tendency to flow out of vial 24.

After insertion of fittings 21 and 20, liquid solution 23 from container 10 flows into vial 24, diluting or dissolving the medicament contained in vial 24 and effectively making it possible to transfer all of the medicament into container 10. Thereafter, inversion of the coupled container and vial to the condition shown in FIG. 2 efiectuates transfer of the supplemental medication.

While, in the foregoing specification, my invention has been set forth in considerable detail to facilitate understanding thereof, it is to be understood that variations therein will be apparent to those skilled in the art and that no unnecessary limitations are to be inferred from the foregoing detailed description, given, as it is, for purposes of illustration.

I claim:

1. In combination, a parenteral solution container equipped with a resilient stopper, said stopper having a pair of passages therein adapted to communicate the interior of said container with the exterior of said stopper, an air tube mounted in one of said passages and extending only inwardly of said container and to a point adjacent the bottom of said container, a vial containing a supplemental medicament for the container solution, a closure secured to said vial, said closure being equipped with a pair of spaced apart spouts of equal length extending only outwardly of the portion of said closure connected to said vial, said spouts having passages extending there through, both of said spouts being of generally circular cross-section and one spout being of smaller outer diameter than the other, the smaller outer diameter spout being received in the air tube-equipped passage of said stopper, the larger outer diameter spout being received in the other passage of said stopper, the smaller diameter spout being equipped with resilient means in sealing en gagement with said stopper.

2. In combination, a parenteral solution container equipped with a resilient stopper, said stopper having a pair of passages therein adapted to communicate the interior of said container with the exterior of saidstopper, an air tube mounted in one of said passages and extending only inwardly of said container and to a point adjacent the bottom of said container, a vial containing a supplemental medicament for the container solution, a closure secured to said vial, said closure being equipped with a pair of spaced apart, outwardly extending tubular spouts disposed in generally parallel relation, one of said spouts being of larger outer diameter than the other, the larger outer diameter spout being in sealing engagement with the Walls of the passage of said stopper other than the passage equipped with said air tube, the smaller diameter spout being mounted in the air tube-equipped passage of said stopper, and sealing means about said smaller diameter spout interposed between said spout and said stopper.

3. In combination with a parenteral solution container closed with a resilient stopper having a liquid outlet passage and an air inlet passage equipped with an air tube, a device for coupling engagement with said container comprising a medicament-containing vial and a closure for said vial, said closure having a pair of parallel, spacedapart, outwardly extending, tubular, puncturing spouts having passages extending therethrough, said spouts being of unequal outside diameter, the outside diameter of the larger of said spouts being about equal in size to the inside diameter of said outlet passage and the outside diameter of the smaller of said spouts being less than the inside diameter of said air tube, said smaller spout being equipped with an annular resilient sleeve extending along the length therefo but, terminating a spaced distance from the tip of said spout so that when said device is in coupling engagement with said parenteral solution container, the spout of smaller outside diameter extends into said air tube and the resilient annular sleeve cooperates with 2,612,163 Norman Sept. 30, 1952 said stopper to provide a contamination preventing seal. 2,689,564 Adams et a1 Sept. 21, 1954 2,704,544 Ryan Mar. 22, 1955 References Cited in the file of this patent 2,863,451 Ban- Dec. 9, 1958 UNITED STATES PATENTS 5 2,884,924 Shaw y 1959 1,526,595 Gillrnan Feb. 17, 1925 FOREIGN PATENTS 2, Mlllford e a1 May 28, 1940 1,122,616 France May 28, 1956 2,580,836 Rausch Jan. 1, 1952 971,839 France Apr. 16, 1950

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