US 2957609 A
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Description (OCR text may contain errors)
Oct. 25, 1960 r R HOLMES '2,957,609
DEVICE Foa nrsPEnsmG L1vf u sr.1a RELAXANT DRUGS Filed Nov. 6. 1958 INVENTOR [llll Theodore R. Holmes BY M4. L
ATTORNEY DEVICE FOR DISPENSING `MUSCLE RELAXANT DRUGS Theodore R. Holmes, Tuckahoe, N.Y., assignor to Burronghs Wellcome & Co. (U.S.A.) 111C-, Tuckahoe, N.Y., a corporation of New York Filed Nov. 6, 1958, Ser. No. 772,325
3 Claims. (Cl. Z22-212) The present invention relates to a novel device for dispensing muscle relaxant drug concentrates and to a method for preparing injectable solutions of lsuch drugs by the transfer of the drug concentrate from the storage receptacle to the solution bottle under essentially aseptic conditions.
The method and device of the present invention is of particular value in connection with the dispensing of drug concentrates in granular or powder form from a sealed container in which it is stored in a'sterile condition. Its application is illustrated in the preparation of sterile solutions of muscle relaxant drugs such ,as succinyl choline for which the device and method are advantageously designed.
Succinyl choline is a muscle relaxant frequently administered by physicians in the course of surgical operations. lt is a short acting drug which `is considered a desirable safety factor and is ordinarily administered intravenously to the arm of the patient yfrom a suspended solution bottle in which it is stored. At the end of the operation the administration of the muscle relaxant drug is discontinued and the muscles of the patient rapidly resume their normal tone.
Since drugs of this character depreciate in potency while in solution, it is advantageous to preserve them in the form of concentrates or dry powders until shortly prior to administration when the drug concentrates are added to aqueous solution in the proper concentration for intravenous administration. The diluents commonly employed for muscle relaxant drugs are isotonic saline solutions and saline solutions containing small quantities of glucose. The maintenance and preservation of these solutions under sterile conditions during storage and use is of the utmost importance.
Prepared sterile solutions of diluent in convenient volume are supplied by a number of manufacturers, but the addition to such solutions of the muscle relaxant drug under absolutely aseptic conditions has presented a substantial problem. One proposed solution consisted of packing the diluent under diminished pressure and providing the concentrate container with a hypodermic needle by means of which the transfer is effected through puncture of a frangible diaphragm in the closure for the diluent bottle. By these means the drug is automatically sucked into the bottle of diluent and the solution thereby prepared for administration. This method has not proven entirely satisfactory since it is still necessary to store the muscle relaxant in concentrated solution form and the success of the mixing operation depends upon the preservation of an accurate vacuum in the diluent container.
In a copending application Serial No. 756,998, I have described and claimed a novel device for the storage of muscle relaxant drugs in essentially dry granular or powder form and a method whereby such drugs may be transferred with certainty and under absolutely sterile conditions from the storage container to the diluent States Patent if ice bottle. These means include a collapsible container for the granular or powder muscle relaxant drug and a novel valve arrangement which opens under the inuence of pressure applied to the collapsible container to allow the dry powder drug to flow through an elongated channel including a piercing device through the stopper of the diluent infusion bottle and into solution therein, while aseptically protected from the surrounding atmosphere.
The present invention constitutes an improvement over a preferred form of valve device shown in my aforementioned application which includes a plug type valve normally frictionally held in the valve opening formed in the upper portion of the Vvalve device.
Referring to the drawings wherein:
Figure 1 kis a vertical section through the vcollapsible container and associated mechanism for the aseptic transfer of the concentrated drug, showing the improved arrangement which is the subject of this invention.
.Figure 2 shows the use of the novel valve arrangement in the preparation of isotonic sterile solutions of the drug for intravenous administration.
Figure 3 is a sectional view showing the relationship of the displaced plug or disc valve to the outlet channel in operation.
Figure 4 is a detailed showing of the construction of the valve device with the plug valve removed.
Referring in detail to the drawings, it will be observed that numeral 10 designates a flexible plastic container 1 0 of polyethylene or similar material with the neck portion provided with conventional threads 11 of the type for application of the 4screw cap. The collapsible container 10 is provided with an external flange 12 having a series of knurls or lugs for the retention of a plastic sealing band 18, the -details of which are described in my copending application.
The neck of the bottle is adapted for the reception of an elastic valve device 13 of rubber, plastic or other similar material having a depending annular skirt portion 14 which is received in the neck portion of the collapsible container as clearly shown in Figure 1 of the drawing. The upper portion of the valve device 13 is in the form of a disc of greater diameter than the skirt portion to provide a supported ledge for the valve device when positioned in the mouth of the collapsible container. As shown in the drawings, an internally threaded piercing device 16 is adapted to be threaded onto the mouth portion of the collapsible container 10 in such a manner that the outer flanged edge of the valve device 13 is clamped between an annular shoulder formed internally above the threaded section of the piercing device and the lip of the container mouth. A protective sheath of plastic or other material 17 is positioned over the piercing device 16 and aseptically seals the upper part of the assembly from contamination.
In the present construction the valve device 13 is provided with a plug type valve 15 which may be in the form of a disc or any other appropriate configuration. In the illustrated embodiment, the sides of the valve opening are sloped inwardly as illustrated in order to preclude accidental displacement of the valve from the central valve opening in the valve device 13. As shown in Figure 1, the `dome of the piercing device 16 is formed with an integral inwardly directed n 19 as shown particularly in Figures 1, 2 and 3. v
When the physician or surgeon desires to prepare a sterile solution of muscle relaxant or other active drug for parenteraluse, the flexible seal 18 and protective sheath 17 are removed thereby exposing the channel piercing device 16. The collapsible container 10 for the drug concentrate lis then inverted `and the frangible diaphragm 20 of an infusion bottle 21 punctured by the piercing device 16 which then projects into the passage 22 of the infusion container 21.
The intentional application of pressure to the Walls of the collapsible container forces the pressure responsive valve plug to blow out of its seat lin the valve device 13 coming to rest eventually at a slanted position on the internal iin 19 in the dome of the piercing device 16 as shown 'in Figure 2 of the drawings. The powder or granular muscle relaxant drug then flows freely from the collapsible container 10 through the open valve, the channeled piercing device 16 past the displaced plug valve 15 :and into the solution contained in the infusion container 21 as clearly Shown in Figure 2 of the drawings. It will be observed that the improved form of fin 19 tilts the displaced plug valve 15 and prevents it from becoming centered and clogging the outlet channel in the piercing device.
In certain cases, infusion containers for the diluent infusible liquid are packaged under vacuum so that a subatmospheric pressure is present in the dome of the bottle above the liquid. The purpose of this procedure is to accelerate the transfer of the drug concentrate from its container into the infusion bottle 21. In such cases, it is only necessary to insert the channel piercing device 16 of the container 10 into the inlet passage 22 of the infusion container. The vacuum in the container then automatically snaps the valve plug 15 out of its seat, rapidly transferring the contents of the container through the channeled piercing device 16 and into the infusion container 21 without manual application of pressure to the collapsible container 10.
Changes and modifications may be made within the specifically claimed embodiment without departing from the spirit and scope of the invention dened in the claims.
Whatl claim is:
1. As an article of manufacture an internally sterile collapsible container having a dry comminuted drug concentrate partially filling the container, and having an outlet `and a pressure-responsive removable stopper normally closing the outlet, said stopper being adapted to be pneumatically displaced outwardly to open the container outlet on the application of pressure to the collapsible container while inverted, a dispensing channel for the container disposed exteriorly of the container outlet through which the dry` drug concentrate is adapted to ow after passing through the container outlet, a tilting device in the dispensing channel downstream of the container outlet `for tilting the stopper relative to the dispensing channel, after displacement from the container outlet, to permit unrestricted Iflow of the dry comrninuted drug concentrate through said dispensing channel.
2. As an article of manufacture an internally sterile container for transfer of a drug concentrate to a parenteral diluent bottle, said container having a dry comminuted drug concentrate partially lling the container and having an outlet and a pressure-responsive removable stopper normally closing the outlet, said stopper being adapted to be displaced outwardly to open the container outlet on the establishment of a pneumatic pressure differential across the said stopper on inversion of the container, a dispensing channel for the container disposed exteriorly of the container outlet adapted for connection with a parenteral diluent bottle through which the dry drug concentrate is adapted to tow after passing through the container outlet, a tilting device in the dispensing channel downstream of the container outlet for tilting the stopper relative to the dispensing channel, after displacement from the container outlet, to permit unrestricted flow of the dry comminuted drug concentrate through said dispensing channel into the parenteral bottle, and means for sealing the dispensing channel from the atmosphere during storage.
3. An article of manufacture as set forth in claim 2 wherein the tilting device is an integral projection on the inside of the dispensing channel.
References Cited in the le of this patent UNITED STATES PATENTS 489,620 Widness Ian. 10, 1893 1,154,269 Penna Sept. 21, 1915 2,594,161 Harrison Apr. 22, 1952 2,724,383 Lockhart Nov. 22, 1955