US2957501A - Device for dispensing muscle relaxant drugs - Google Patents

Description

Oct. 25, 1960 1-. R.'HOLMES 2,957,501-

' DEVICE FOR DISPENSING MUSCLE RELAXANT DRUGS Filed Aug. 25, 1958 2 Sheets-Sheet 1 P WDERE D DRUG are CONCENTR Theodore H. Holmes ATTORNEY Oct. 25,. 1960 'r HOLMES 2,957,501

I A DEVICE FOR DISPENSING MUSCLE RELAXANT DRUGS Filed Aug. 25. 1958 2 Sheets-Sheet 2 v A $2 .7. IO

/ I 'u 2f!!! 24 INVENTOR ATTORNEY United States Patent Qifice DEVICE OR DISPENSING MUSCLE RELAXANT DRUGS Filed Aug. 25, 1958, Ser. No. 756,998 4 Claims. (Cl. 141-2) The present invention relates to a novel device for dispensing muscle relaxant drug concentrates and to a method for preparing injectable solutions of such 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. It is a short acting drug which is considered a desirablesafety factor and is ordinarily administered intravenously to the arm of the patient from 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. I

' 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 sterileconditions during storage and use is of the utmost importance.

7 Prepared sterile solutions of diluent in convenient volume are supplied byQa 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 meansof 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 suckedinto 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 concentratedsolution. form and the success ofthe mixing operation depends upon the preservation of an accurate vacuum in the diluent container.

I have discovered a novel device for the storage of muscle relaxant drugs in essentially dry granular or powder formand a method whereby such drugs may be transferred with certainty and under absolutely sterile conditions from the storage container to the diluent bottle. I thereby eliminate entirely the necessity for storing the drugs in solution form and ensure the preservation of full potency in the drug up to the time of actual use by the physician.

' invention I provide a collapsible container for the'dry granular or powder muscle relaxant drug and a novel valve arrangement which opens under the influence of pressure applied to the collapsible container to allow the dry powdered drug to flow from the storage container through an elongated channel in a piercing device attached to the container which is applied to the stopper of the diluent bottle, allowing the powdered drug to flow into solution while aseptically protected from the surrounding atmosphere.

The invention, accordingly, comprises the feature of construction, combination of elements and arrangement of parts which will be exemplified in the construction hereinafter set forth together with the described method and the scope of the invention will be indicated in the claims. Referring to the drawings, I have shown specific embodiments for purposes of illustration although the invention is not restricted to the specific details of the illustrated embodiments.

In the drawings:

Figure 1 is a vertical section of the aseptically sealed container for the powdered drug.

Figure 1A is an elevation of the plastic collapsible container.

Figure 2 shows schematically vertical section and plan views of the cylindrical valve device.

Figure 3 is a vertical section showing the valve device in open position.

Figure 4 shows schematically vertical section and plan views of a modified form of valve device.

Figure 5 shows schematically vertical section and plan views of a further modified form of valve device.

Figure 6 illustrates the application and use of the concentrate container in the preparation of isotonic sterile solutions of the drug suitable for intravenous administration. a

Figure 7 is a sectional view showing the use of the valve device of Figure 4 with a modified piercing device applied to the diluent bottle.

Referring in detail to the drawings, it will be observed that the numeral 10 designates a flexible plastic container 10 of polyethylene or similar material with the neck portions provided with conventional threads of the type for application of the screw cap. As shown in Figure -1A, the collapsible container is provided with a threaded neck section 11 and an integral flange 12 having a series of knurls or lugs for the retention of a plastic sealing band to be hereinafter described. V

The neck of the bottle is adapted for the reception of 1 an elastic or flexible valve device 13 of rubber, plastic or other similar material provided with 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 drawings. 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 supporting ledge for the valve device when positioned in the mouth of the bottle or container. In the embodiment illustrated in Figure 2, a crescent shaped flap valve 15 is formed in the upper disc portion of the valve device adapted to open and close in either direction under the influence of air' or fluid pres sure applied on the body portion of the collapsible container 10. Figure 3 shows the crescent shaped valve 15 in its open position.

As shown in Figure 1 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 17 of plastic or Patented Oct. ,25, 1960 other material is normally positioned over the piercing device 16.

The powdered or granular drug in the container 10 is aseptically maintained through means presently described. When the parts are assembled as shown in Figure 1, an annular flexible seal of plastic or other material 18 is shrunk or otherwise suitably applied over the neck portion of the assembly including the lower flange of the protective sheath 17, the lower collar on the piercing device 16 and below the knurled flange 12 on the neck of the collapsible container 10. The lower flanges on the piercing device 16 and the protective sheath 17 are formed with knurls 19 and 20 which cooperate with the knurls 12 on the neck portion of the collapsible container 10 to prevent relative movement of the parts when assembled.

It will be appreciated that the arrangement described enables a dry granular concentrate of muscle relaxant or other drug to be stored for prolonged periods of time entirely out of contact with any liquid or moisture which tends to depreciate the potency of the drug. At the same time, the sealed container for the dry drug concen trate is easily and readily adapted for the transfer of the dry powdered drug under thoroughly aseptic conditions from the collapsible container and the pressure responsive valve into the diluent container for solution adapted for parenteral administration. When the physician or surgeon desires to prepare a sterile solution of muscle relaxant or other active drug for intravenous use, the flexible seal 18 and protective sheath 17 are removed thereby exposing the channel piercing device 15. The collapsible container 10 for the concentrated drug is then inverted and the frangible diaphragm 25 of an infusion bottle 26 punctured by the piercing device 15 which then projects into the passage 27 of the infusion container 26. The application of pressure to the walls of the collapsible container 10 forces open the pressure responsive valve 15 and causes the dry granular drug to flow through the open valve, the channeled piercing device 16 and into the solution contained in the infusion container 2 6 as shown in Figures 6 and 7 of the drawings.

Figure 4 illustrates another form of valve device 21 also provided with a skirt portion 22 and a plug type valve 22a normally frictionally held in the valve opening formed in the upper portion of the valve device.

Figure shows a still further modified form of valve device 23 having a skirt portion 24 and formed with a plurality of radial slits 24A which come together at a central point of the disc. Both the modified forms of valves shown in Figures 4 and 5 operate in response to pressure applied to the walls of the collapsible container to allow the dry granular drug to pass from the collapsible container through the valve and piercing device into the container of diluent for parenteral administration. Figure 7 illustrates the operation of the type of valve shown in Figure 4 wherein the central disc 22a has been blown out of its seat by pressure applied to the collapsible container 10 in the manner indicated. In this case, the dome of the piercing device is provided with a number of fins 28 to prevent the loose plug valve 22a from clogging the outlet channel in the piercing device 15. The term granular used in the appended claims is intended to include dry comminuted material of any size including fine powders.

What I claim is:

1. A method of transferring under aseptic conditions a drug concentrate to a container of diluent adapted for parenteral administration, which comprises packaging the drug in granular form to partially fill a collapsible container thereby providing an air space therein above the granular drug concentrate, said collapsible container having an outlet passage and a pressure responsive valve normally closing the outlet passage, opening a channel of communication between the outlet passage of the collapsible container and the diluent container and applying pressure to the collapsible container while inverted to open the pressure responsive valve and allow the granular drug concentrate to flow from the collapsible container into the diluent container.

2. A method of transferring under aseptic conditions a drug concentrate to a container of diluent adapted for parenteral administration, which comprises packaging the drug in granular form to partially fill a collapsible container thereby providing an air space therein above the granular drug concentrate, said collapsible container having an outlet passage and a channeled piercing device communicating with the outlet passage of the container and having a pressure responsive valve normally closing the passage between the container and the piercing device, opening a channel of communication between the collapsible container and the diluent container by means of the piercing device and establishing a pneumatic pressure differential across the valve while the container is inverted to open the valve and allow the granular drug to flow from the collapsible container into the diluent container,

3. A method of transferring under aseptic conditions a drug concentrate to a container of diluent adapted for parenteral administration, which comprises pack-aging the drug in granular form to partially fill a collapsible container thereby providing an air space therein above the granular drug concentrate, said collapsible container having a channeled piercing device communicating with the outlet passage of he container and having a flexible pressure responsive valve normally closing the passage between the container and the piercing device, opening a channel of communication between the collapsible container and the diluent container by means of the piercing device and applying pressure to the collapsible container to open the valve and allow the granular drug to flow from the collapsible container into the diluent container.

4. A method of transferring under aseptic conditions a drug concentrate to a container of diluent adapted for parenteral administration, which comprises packing the drug in granular form to partially fill a collapsible container thereby providing an air space therein above the granular drug concentrate, said collapsible container having an outlet passage and a flexible flap valve normally closing the outlet passage, opening a channel of communication between the collapsible container and the diluent container and applying pressure to the collapsible container while inverted to allow the powdered drug to flow through the channel of communication into the diluent container.

References Cited in the file of this patent UNITED STATES PATENTS

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