US 2853071 A
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Description (OCR text may contain errors)
Sept. 23, 1958 2,853,071
J. A. SAFFIR MEDICAMENT VIAL Filed Dec. 27, 1954 IN VENTOR United States Patent MEDICAMENT VIAL Jacob A. Sattir, Los Angeles, Calif.
Application December 27, 1954, Serial No. 477,617
9 Claims. (Cl. 128-272) This invention relates to a medicament vial or medica ment container or bottle for hypodermic solution and more particularly to the type of vial, bottle, or container which is permanently sealed, withdrawal being possible by perforating the sealing means with a. hypodermic needle and syringe and then aspirating the contents.
When medicaments are to be injected anywhere into the body of man or animal, their sterility and freedom from contamination are an understandable requisite. It will however be apparent that for economic reasons 'it is not always expedient to package individually each single dose required. Thus we find sealed containers of hypodermic solutions holding'an amount adapted to provide several doses ofa particular medicament such as penicillin, vaccine, etc., wherefrom specified amounts are withdrawn at different times.
As an example-the sterile container for intramuscular injections of penicillin solutions may hold 6,000,000 units of the drug whereas the average single dose may be 500,000 units. It follows that the full use of the drug will necessitate entering and leaving the bottle at least ten times.
If the physicians instrumentsneedle and syringeare absolutely sterile and if no air is introduced during these entries and exits, the solution will remain sterile, but the least carelessness or inadvertence may lead to contamination with a very painful condition developing at the injection site as well as possible body harm.
It is an object of this invention to provide a multiple dose container wherefrom a specified dose can be conveniently removed without contamination to any remaining dose in the container.
Another object of this invention is to enable the physician to remove the exact dose required-from his multiple dose vialquickly and accurately and without the chance of error. Accurate dosing is of importance. In many cases amounts injected depend on body weight, age, or virulence of infection. Moreover a virulent infection may require a larger-dose, and a child may require a much smaller dose than an adult. Underdosing may delay recovery; overdosing can be disastrous.
In the present art, a dose of medicament is aspirated with a calibrated syringe'from a vial. This means is accurate'only as long as no air is introduced into the syringe and only so long as the physician or user can watch his markings while engaged in drawing up his solution and accurately gauge his action.
Should air be drawn up into the syringe, as it frequently is, it must be expelled, the container reentered and the shortage corrected. Withdrawal of too much solution into the syringe'often requires that the user return the surplus quantity to the original container whichmeans reentering thecontainer or vial. These solutions are generally expensive and cannot be wasted.
Another object'of this invention is to enablethe user to obtain more uniform solutions. Where solutions require shaking to keep particles in suspensions, removal of the contents too slowly or by stages may result in Patented Sept. 23, 1958 doses whose consistency is not uniform. It has been noted that watching the calibrations on the Luer syringe while withdrawing medicament from a container slows up the process sufficiently to settle particles and destroy the fine balance of-suspension obtained by the shaking.
Thus, a patient receiving a later dose from a present art hypodermic solution container may very well receive a more concentrated or less concentrated mixture, depending on whether he receives the first or last dose from the present art multiple dose vial.
Another object of this invention is to avoid reintroduction of the needle. It can be seen that to reinsert a needle into the sterile contents of a bottle may be deleterious to the contents by virtue of air introduced into the bottle,-quite apart from the possibility of a contaminated needle per se. Alcohol or other antiseptics ona needle can also be introduced.
Efiorts to'replace superfluous withdrawn fluid into the original container are often the cause of the introduction of air into a heretofore sterile medicament. Since air contains many types of bacillus, there are times when injurious organisms are carried on the needle.
With this invention, which comprises a container divided into a number of individual non-communicating chambers, the physician can insert his needle with assurmice that he can accurately and rapidly withdraw an exact sterile dose of medicament. Also, he can withdraw this single dose from the whole, assured of uniformity in every dose, particularly where suspended materials are involved or where concentrations of ingredients are important.
Uniformity of the remainder of a solution, sterility, concentration of suspended particles, and the like, are all adversely affected by the slow withdrawal of part of the whole body of a solution to permit careful scrutiny of calibration markings on, say, an aspirator device like a hypodermic syringe intended for dosage determination.
An additional object of this invention is to provide a closure device of this type embodying relatively few parts, each capable of simple manufacture and assemblage to furnish an inexpensive and readily usable device adapted to safely retain medicaments in a sterile manner for substantially predetermined intervals of time.
Other advantages and features of the invention will become apparent from the following description read in connection with the accompanying drawings.
Figure 1 is a longitudinal section of a container with the closure in position.
Figure 2 is a cross sectional view of the container shown in Figure 1, along the line A-A'.
Figure 3 is a cross sectional view of a container similar to FigureZ but showing an alternative form of structure.
Figure 4 is an enlarged view of a fragmentary section taken along the line B'B in the direction indicated by the arrows in Figure 3.
Figure 5 also comprises a fragmentary sectional view similar to Figure 4 showing another structural modification.
Figure 6 is an additional view in fragmentary cross section pertinent to a further modification of the structural details of the invention.
In Figure 1 there is shown a glass container or vial 2 having an opening at one end, which may desirably comprise the neck portion of the container, on which and into which fits a rubber closure or stopper 1, which is in fixed position relative to the said .open end, and if desired may be permanently sealed to the vial or container, in which event it is not removable. At"9 and 10 are flanges which'enable a tight seal and grip of the closure or stopper on the neck portion ofthe vial. There are other numerous well known means for keeping the closure or stopper in fixed position, or if de- T 3 sired immovably attached to the vial-such as by metal bands placed around the edges, 14 and 15, or clips or various adhesive bonding materials or glues.
The closure or stopper 1 is constructed to serve not only as a tight stopper but as a divider of the vial compartment into non-communicating chambers. The partition means or wall 3 is in leakproof coordination at its upper end with the undersurface of the closure and reaches down to the floor of the vial at 11 as well as extending completely across the vial chamber in a leakproof engagement with the bottom and lateral walls of the vial, dividing the latter into two separate non-communicating compartments 4 and 5. If deemed desirable, the stopper or closure wall extension 3 may be sealed to the sides and floor of the vial with any of the well known adhesives or paraffin. When using an adhesive, care must be employed to select one that will not be incompatible or in any way injurious to the solution in the various compartments.
On the upper surface of the stopper and directly above each compartment may be placed an indentation or guide, such as 6 and 7, indicating the area to penetrate with the hypodermic needle for reaching the contents of a respective compartment. Thus the cover or surface portion of the closure, in the event that it may not be penetrable in its entirety, is provided with at least predetermined areas that are penetrable by a hypodermic needle, each said area being in superimposed coordination with a compartment in the vial.
Although glass is a good material for making the container or vial, other materials such as metals or any of the suitable plastics, the styrenes, acrylics, melamines, and others may be used.
Similarly, although rubber is mentioned above in illustration of a suitable material for the closures or stoppers and their coordinated walls or partitions, other materials or combinations of materials can be used; for example, any pierceable substance such as neoprene, cork, or any of the synthetic rubbers.
Also, a combination of materials can be used in the closure, such as an upper portion, 16, of soft rubber to which can be attached a wall, 3, of any non-soluble stable material such as methyl methacrylate, styrene. Bakelite, waterproofed paper or cardboard, glass, metal, or any other material bondable to the under surface 17, 34 of the stopper.
Figure 2 illustrates a cross section of the vial at A-A' in Figure 1. At 2 is the outer container and at 3 the separating wall which divides the vial into two compartments 4 and 5. Although two compartments are here illustrated, it is, of course, quite apparent that one need but add more extensions or walls from the base or undersurface of the stopper to obtain any number of compartments.
Compartments 4 and 5 are shown as being of the same size. However, the size or volume of each compartment can be differentiated by altering the position of the wall or partition means. This feature can be a great advantage as, for example, adult doses are larger than childrens and doses vary in size and intensity with the virulence of an infection. Moreover differing drugs or drugs and their antidotes can be carried in the same container or vial. Thus, where a drug to be injected may cause an untoward reaction in a patient who is sensitive thereto, the counteractant is instantly available.
Surfaces 12 and 13 of the separating wall 3 are shown pressing tightly against the glass walls of the vial 2 and by pressure alone effecting a sealed coordination adapted to maintain the chambers moisture tight. But, as pointed out earlier, adhesives, cements, bonding agents, or parafiin can be used to seal this separating wall to the vial itself.
The surfaces 18 and 19 of wall 3 may, if necessary, be coated with an inert material such as parafiin, varnish, or cellophane wherever the medicament to be used should prove incompatible with the material from which the separating wall is made.
Figure 3 illustrates, in cross section, a container or vial 2 divided by walls 20, 21, 22 into three compartments 23, 24, 25. In this case, three separating walls descend from the lower surface portion of the stopper to divide the vial chamber. In this container, the glass was so cast as to form three pockets or recesses 26, 27, 28, which receive and hold the ends of the walls in socket like grips especially where the walls are of a resilient material or derivation, and facilitate the formation of an extremely tight seal. These seals can also be further strengthened by the additional use of parafiin or cement.
Figure 4 is a fragmentary sectional view of the portion of the container below the line BB' in Figure 3, showing the pocket or recess 26, having a curvilinear wall surface configuration, filled by the wall 21.
In Figures 5 and 6 different types of recesses receive the walls. In Figure 5, an oblong recess 30 is used to receive wall or partition means 26. In the modification of Figure 6 there are undercuts 31 and 32 to tightly engage small flanges of the wall or partition means 26. In these structural embodiments of Figs. 5 and 6, the use of adhesives is optional.
It will be understood that the term integral or any equivalent thereof, as utilized in the foregoing disclosure and in the appended claims with reference to the coordination of one or more walls or partition means to the undersurface of the closure, is intended to embrace a unitary structure, illustratively such as that afforded by the molding or casting of the closure and walls or partition means in the form of a single member. Likewise within the scope of the said quoted term is any correlated attachment of the wall or partition means with the undersurface of the closure to provide a combined structural device, notwithstanding the separate fabrication of each of these parts.
While I have described my invention in accordance with desirable embodiments, it is obvious that many changes may be made in the details of construction, and in the combination of parts and materials, without departing from the spirit of the invention as defined in the following claims.
1. A container having an opening at one end thereof, a unitary closure coordinated in sealed relationship with the open end of the container and in fixed position relative thereto, and at least one wall means in leakproof coordination at its upper end with the undersurface of the closure and extending from the said undersurface to the bottom of the container for subdividing the container into a plurality of leakproof compartments permanently sealed relative to each other, the said closure being adapted for penetration by a hypodermic needle at least at one predetermined area in superimposed coordination with each compartment in the container.
2. A medicament container having an opening at an end thereof, a closure coordinated with said opening in sealed relationship therewith, and at least one wall means integral with and extending from the undersurface of the closure to the bottom of the container for subdividing the container into a plurality of leakproof compartments, the said closure being adapted for penetration by a hypodermic needle at least at one predetermined area in superimposed coordination with each compartment in the container.
3. A medicament container as in claim 2, wherein the closure comprises flanged end portions adapted for interlocking association with indentations on the container surface at the open end thereof.
4. A medicament container having an opening at an end thereof, a closure coordinated with said opening in sealed relationship therewith, a wall means integral with and extending from the undersurface of the closure to the bottom of the container, said wall means being in fitted sealed correlation with the lateral inner wall surface of the container and thereby subdividing the container into leakproof compartments, the said closure being adapted for penetration by a hypodermic needle at least at one predetermined area in superimposed coordination with each compartment in the container.
5. A medicament container having an opening at an end thereof, a closure coordinated with said opening in sealed relationship therewith, a plurality of wall means integral with and extending from the undersurface of the closure to the bottom of the container, said wall means being in fitted sealed correlation with the laterallinner wall surface of the container and thereby subdividing the container into a plurality of leakproof compartments, the said closure being adapted for penetration by a hypodermic needle at least at one predetermined area in superimposed coordination with each compartment in the container.
6. A medicament vial as in claim 4, wherein the vertically-extending edges of the wall means are in fitted References Cited in the file of this patent UNITED STATES PATENTS 1,862,057 Lewis June 7, 1932 2,168,686 Safiir Aug. 8, 1939 2,318,778 Hines May 11, 1943 2,433,242 Shaw Dec. 23, 1947 2,615,448 Fields Oct. 28, 1952 2,661,870 Huenergardt Dec. 8, 1953 2,731,013 Holmes Jan. 17, 1956