US 3375858 A
Description (OCR text may contain errors)
A ril 2, 1968 D. A. JELLIES VARIABLE DOSE MEDICAME NT VIAL Filed Oct. 22, 1965 A TTORNE Y United States Patent 3,375,858 VARIABLE DOSE MEDICAMENT VIAL David A. Jellies, Glendale, Calif., assignor to Don Baxter, Inc., Glendale, Calif., a corporation of Nevada Filed Oct. 22, 1965, Ser. No. 501,427 Claims. (Cl. 141-363) ABSTRACT OF THE DISCLOSURE A sterile additive vial for use with a parenteral liquid container or the like in which a closed flexible chamber communicates with an outlet spout and includes a onepiece valve operable through the walls of the chamber by manipulating the walls and in which the valve comprises an elongated flexible rod which is normally axially deformed, and the normal axial deformation urges one end of the valve head of the rod into seated relation on a valve seat controlling fluid flow through the spout.
This invention relatesto a vial for adding supplemental medicament to a parenteral liquid container.
Parenteral liquids such as normal saline, 5% dextrose, etc. are administered intravenously to patients to replace body fluids lost during surgery and to correct electrolyte imbalances in the human body. These parenteral liquids are administered by means of the familiar one liter bottle hanging above the patient with a flexible tube leading from the bottle to a needle inserted into the patients vein.
Often sterile additive drugs are aseptically added to the parenteral liquid container prior to administering the liquid to the patient to tailor the particular liquid to the patient. These additive drugs are supplied to the doctors ofiices and hospitals in vials which are generally referred to as additive vialsiIt is to such vials that this invention is related.
After connecting previous additive vials to a parenteral liquid container to transfer medicament to the container, the entire contents had to be transferred. To get less than the full vial dose into the parenteral liquid bottle, the physician had to take a separate calibrated syringe, withdraw part of the additive medicament from the vial, and then inject this desired amount into the parenteral liquid bottle. This was very time consuming and the double transfer procedure increased chances of contamination.
An object of this invention is to provide an additive vial for metering out a precise portion of its medicament contents and aseptically transferring this portion to a parenteral liquid container.
Another object of this invention is to provide an additive vial with an on-off valve within the vial which is manipulatable from without the vial.
Another object of this invention is to provide an additive vial which will administer a precise portion of its medicament contents to a parenteral liquid container whether or not the contents of the parenteral liquid container are under vacuum.
Other objects of this invention will become more clear upon further description with reference to the following drawings, in which:
FIGURE 1 is a front elevational view of the additive container showing it transferring medicament to a parenteral liquid container;
FIGURE 2 is an enlarged sectional front elevational view of the additive vial showing its outlet passage closed off;
FIGURE 3 is a view similar to FIGURE 2 but showing the additive vial with its outlet passage open;
FIGURE 4 is an enlarged fragmentary view of a valve and valve seat inside the additive container showing the valve closing off the vials outlet passage; and
FIGURE 5 is an enlarged fragmentary view similar to FIGURE 4 but showing the valve lifted from its seat to open the vials outlet passage.
'Just how my novel additive vial operates can best be understood with reference to the drawings. FIGURE 1 shows the additive vial 30 connected to a parenteral liquid container 1 through a resilient closure 2. Calibrations '80 on vial 30 show exactly how much medicament has been transferred to the parenteral liquid container.
At a lower end of the vial 30 is a pointed spout 17 with an outlet passage 20 therein communicating with an interior of vial 30. A removable protector 19 keeps the spout sterile and is removed just prior to inserting the spout through the resilient closure 2 of container 1.
The outlet passage 20 is opened and closed by a valve head 12. FIGURE 4 best shows valve head 12 which has a spherical nose 13 firmly seating in spherical seat in partially closed end 50 of vial 30 closing off outlet passage 20. Valve nose 13 is pressed against spherical seat '85 by axial compressive force applied to actuating member 11. I have found this compressive force will sometimes slightly bow actuating member 11 shown in FIG- URE 2. Flange 14 surrounding nose 1.3 on valve head 12 :is spaced a slight distance from partially closed end 59, and so does not unseat valve nose 13 when actuating member 11 is only slightly bowed. Instead, valve head 12 remains substantially axially aligned with outlet passage '20, closing it off as shown in FIGURE 4.
When valve head 12 is materially cocked or canted, such as shown in FIGURES 3 and 5, flange 14 dips down and contacts partially closed end 50, thus lifting valve nose 13 out of spherical seat 85 and opening outlet passage 20.
It shouldube realized that the valve head 12 and flexible laterally .displaceable actuating member 11 are completely enclosed within the vial 30. The actuating member 11, however, is manipulatable from without the vial 30. Any contamination tothe outside surface of the vial, such as by touching it, cannot reach the medicament inside vial 30 or contaminate actuating member 11 or valve head 12. The actuating member 11 is laterally displaced or bowed by laterally pushing ones thumb against an external protrusion 32 on a closure 15 sealed to elongated chamber wall 10 of vial 30. One end of actuating member 11 connects to valve head 12 and an opposite end fits within a socket 16 inside protrusion 32. Lateral external manipulation of protrusion 32 opens and closes passage 20.
In FIGURES 2 and 3, I have shown a closure 15 of a thermoplastic material bonded to a transparent thermoplastic elongated cylindrical chamber ll). Such bonding can be accomplished by sonic or spin welding the two thermoplastic parts together. Chamber 10 and closure 15 are made of such thermoplastics as polyethylene, polypropylene, ethylenepropylene copolyrner, etc. I have found that a thermoplastic closure 15 has sufiicient give without breaking to laterally displace or bend actuating member 11, particularly if an annular thinned portion or hinge 82 is provided about protrusion 32. A closure 15 of rubber hermetically sealed in a bacteria-type manner to transparent chamber 10 could also be used.
In use, the additive vial of my invention is connected to a parenteral liquid container as shown in FIGURE 1, and the protrusion 32 pressed to one side with a thumb to open passage 20. When the desired portion of medicament has been transferred, the protrusion 32 is released and outlet 20 is closed off by valve head 12.
The additive vial of my invention will aseptically transfer medicaments to a parenteral liquid container whether or not the parenteral liquid container contains a vacuum. A parenteral solution container under vacuum simply parenteral liquid sucks the medicament from the vial 30 into the parenteral liquid container 1. If container 1 is at atmospheric pressure, the medicament from vial 30 can be manually pumped into container 1. The elongated chamber walls 10 are sufliciently thin so as to partially collapse and spring back upon alternately laterally squeezing and releasing them. This changes the volume of vial 30 and pumps the medicament into container 1. The partially collapsed elongated chamber walls 10 are shown in dotted lines in FIGURE 3.
In the above description of my invention I have used specific examples to illustrate my invention. It is understood that persons skilled in the art may make certain modifications to these examples without departing from the spirit and scope of this invention.
1. In combination, a parenteral solution container partially filled with parenteral solution and a variable dose additive vial containing a medicament, said additive vial connected to the parenteral solution container for aseptic transfer of the medicament to the parenteral solution container through an outlet passage of said vial, a valve means Within said vial closing off the outlet passage, and a laterally displaceable actuating member enclosed within the vial but laterally manipulatable from without the vial to move said valve means to open the passage for fluid flow, said additive vial having a thin tubular body, the internal volume of which can be varied by alternatively laterally squeezing and releasing the tubular body to thereby pump the medicament into the parenteral solution 2 container when the outlet passage is open, said outlet passage closable by said valve means through lateral manipulation of the actuating member after a portion of the medicament has been transferred to the parenteral solution container.
2. A sterile additive vial for adding medicament to a parenteral container or the like comprising:
an, elongated, flexible chamber including a spout communicating with and extending from one end theref, said chamber including a valve seat at said spout and opening toward the longitudinal axis of said chamber; and one-piece valve means mounted within said chamber for manipulation through and exteriorally of said chamber while maintaining the sterile integrity of the medicament in said chamber,
said valve means comprising an elongated, laterally flexible actuator rod, said rod extending along the longitudinal axis of said chamber and including an integral valve head at one end and normally in seated controlling engagement on said valve seat, said rod including another end abuttingly engaged at the opposite end of said chamber, said rod being normally axially deformed between the opposite ends of said chamber and normally applying an axial force on said valve head at said valve seat.
3. The structure as claimed in claim 2 in which said chamber includes a flexible, tubular protrusion communicating with said opposite end of said chamber and into which the adjacent end of said rod is telescopically and abuttingly received.
4. The structure as claimed in claim 3 in which said tubular protrusion includes a weakened hinge portion at its connection to said chamber for facilitating deformable manipulation of said rod from outside said chamber and through said protrusion.
5. The structure as claimed in claim 2 in which said chamber includes a tapered bottom concentric to the longitudinal axis of said chamber and surrounding converging toward said valve seat, said actuator rod including a flange integral therewith and spaced axially from but adjacent said valve head and engageable on said tapered bottom when said actuator rod is deformed to pivot said valve head olf said valve seat about the edge portion of said flange.
References Cited UNITED STATES PATENTS 588,045 8/1897 Anderson 222--5l0 1,681,966 8/1928 Zeidler 251-303 X 2,345,470 3/11944 Edwards 141-21 2,689,564 9/1954 Adams 251342 X FOREIGN PATENTS 621,130 1/1927 France.
LAVERNE D. GEIGER, Primary Examiner.