Many drugs are mixed with a diluent before being delivered intravenously to a patient. The diluent may be for example a dextrose solution, a saline solution or even water. Many such drugs are supplied in powder form and packaged in glass vials. Other drugs, such as some used in chemotherapy, are packaged in glass vials in a liquid state.
In order for powdered drugs to be given intravenously to a patient, the drugs must first be placed in liquid form. Other drugs, although in a liquid state, must be still be diluted before administration to a patient. In this specification, reconstitution also includes dilution.
One way of reconstituting a powdered drug is to first inject the liquid diluent into the drug vial. This may be performed by means of a combination syringe and syringe needle having diluent therein. After the rubber stopper of the drug vial is pierced by the needle, liquid in the syringe is injected into the vial. The vial is shaken to mix the powdered drug with the liquid. The liquid is then withdrawn back into the syringe. The steps may be repeated several times. The syringe is withdrawn. The drug may then be injected into a patient.
Another common means of drug administration is to inject the reconstituted drug in the syringe into a parenteral solution container, such as a Minibag.TM. flexible parenteral solution container or Viaflex.RTM. flexible parenteral solution container sold by Travenol Laboratories of Deerfield, Ill., a wholly owned subsidiary of the assignee of the present invention. These containers may already have therein dextrose or saline solution, for example. The drug, now mixed with the solution in the parenteral solution container, is delivered through an intravenous solution administration set to a vein access site of the patient.
Another means for reconstituting a powdered drug utilizes a reconstitution device sold by Travenol Laboratories, product code No. 2B8064. That device includes a double pointed needle and guide tubes mounted around both ends of the needle. This prior art reconstitution device is utilized to place the drug vial in flow communication with a flexible walled parenteral solution container for example. Once the connection is made, liquid in the solution container may be forced into the drug vial by squeezing the solution container. The vial is then shaken. The liquid in the vial is withdrawn by squeezing air from the solution container into the vial. When compression of the flexible-walled solution container is stopped, the pressurized air in the vial acts as a pump to force the liquid in the vial back into the solution container.
An improvement to this product is the subject of U.S. patent application Ser. No. 642,908, filed Aug. 21, 1984, entitled "Reconstitution Device", William R. Aalto et. al., inventors, now U.S. Pat. No. 4,607,671, assigned to the assignee of the present invention. The device of that invention includes a series of bumps on the inside of a sheath to grip a drug vial, making more difficult the inadvertent disconnection of the device and the vial.
Another form of reconstitution device is seen in U.S. Pat. No. 3,976,073 to Quick et al., assigned to the assignee of the present invention. Yet another type of reconstitution system is disclosed in U.S. Pat. No. 4,328,802 to Curley et al., entitled "Wet Dry Syringe Package" which includes a vial adapter having inwardly directed retaining projections to firmly grip the retaining cap lip of a drug vial to secure the vial to the vial adapter. The package disclosed in Curley is directed to reconstituting a drug by means of a syringe.
Other means for reconstituting a drug are shown for example in U.S. Pat. Nos. 4,410,321 to Pearson et al., entitled "Closed Drug Delivery System"; 4,411,662 to Pearson and 4,432,755 to Pearson, both entitled "Sterile Coupling;" and 4,458,733 to Lyons, entitled "Mixing Apparatus", all assigned to the assignee of the present invention.
With respect to those situations where it is desired to combine a drug in a drug vial with the liquid in a separate parenteral solution container, all without need for an intermediary syringe, there have been up until now several problems which are typically aggravated in a hospital environment, with many patients. First, many drugs are packaged in a powdered state in drug vials separate from a diluent because in the presence of moisture drug efficacy in some cases is maintained for less than twenty-four hours. Once the drug is reconstituted, the solution container with the drug therein must be used in a relatively short time period. Patient prescriptions are often changed after the drug is reconstituted by, for example, the hospital pharmacist. If a prescription is changed, the reconstituted drug and the diluent will most likely be wasted because they must be used in a short time period.
Another problem associated with drug reconstitution is that the parenteral solution container has no indication thereon as to what drug has been added to the container. In order to prevent confusion, the hospital pharmacist must create a label stating the drug contents and attach it to the solution container.
Yet another problem associated with drug reconstitution is that some drugs, e.g., some chemotherapy drugs, may be hazardous to hospital personnel who are repeatedly exposed to the drugs over long time periods. Use of any reconstitution means which uses separate drug and diluent containers will likely result in exposure of personnel to the drug. A common source of exposure is small volumes of the drug/diluent mixture which may drip from the needle utilized to reconstitute the drug.
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