Aspiration, mixing, and injection syringe

A drug-mixing syringe comprising:

• a. a barrel and a main bore, the barrel having a distal end and an opening through said distal end in fluid communication with said bore;
• b. a drug vial having an open distal end and a proximal end;
• c. a stopper occluding said distal end of said drug vial;
• d. said drug vial being sized to be received within said barrel and to be advanced along said barrel to an advanced position adjacent said distal end of said barrel, said stopper being sized to engage said barrel and to be retained by said barrel adjacent said distal end of said barrel, said stopper in said advanced position being fixedly engaged with said barrel adjacent said distal end so that after said vial and said stopper have been advanced within said barrel to said advanced position, said vial is displaced away from said retained stopper when said vial is retracted along said barrel to open said vial within said barrel.

A medical mixing syringe for mixing a diluent with a beneficial agent, the syringe comprising:

• a. a barrel having a main bore and further having an open proximal end and a distal end;
• b. a lumen extending through said distal end in communication with said main bore;
• c. a handle having a distal end and a proximal end and a portion intermediate said handle ends;
• d. a reservoir adjacent said intermediate portion, said reservoir defining a chamber for containing a pharmaceutical, said reservoir having a distal open end and a proximal end, said reservoir being sized to be received into said barrel and being moveable to an advanced position along said barrel;
• e. a piston sized to be received within said barrel, said piston being connected to said handle;
• f. a stopper connected about said distal open end of said reservoir and occluding said distal reservoir end, said stopper including a member for engaging said barrel, said stopper being sized to be received within said barrel, said stopper being moveable with said reservoir to an advanced position along said barrel, said stopper member engaging said barrel to prevent retraction of said stopper from said advanced position and to retain said stopper in said advanced position within said barrel so that when said reservoir is retracted from said advanced position said reservoir is displaced away from said stopper to open said reservoir into said barrel so that [fluid may flow]said pharmaceutical may pass from out of said reservoir and into said barrel.

A syringe for mixing pharmaceutical agent with a diluent, the syringe comprising:

• a. a barrel and a main bore, the barrel having a distal end and an opening through said distal end in fluid connection with said bore;
• b. a drug vial defining an axis and having an open distal end and a outer wall adjacent said end, said vial being sized to be received within said barrel;
• c. a stopper having a distal face and a proximal face and being sized to be received within the distal end of said drug vial and to occlude said distal end, said stopper defining an axis and including a distal portion having a member for engaging said barrel, said member projecting beyond at least a portion of said outer wall of said drug vial when said stopper is sealingly received into said drug vial and when said drug vial and said stopper are inserted into said barrel bore;
• d. a handle connected to said drug vial for advancing and retracting said drug vial along said barrel;
• e. a sealing member mounted adjacent one said drug vial and said handle, the sealing member being sized to seal about said bore so that when said drug vial is advanced along said barrel, said sealing member seals circumferentially against said bore so that when said vial is so advanced, the pressure is increased within said bore distal to said vial and when said vial is retracted along said barrel, the pressure is decreased within said bore distal to said vial.

A system for storage and the enclosed sterile assembly of a syringe containing a pharmaceutical agent, the system comprising:

• a. a barrel and a main bore, the barrel having an open proximal end and a distal end and an opening through said distal end in fluid connection with said bore;
• b. a drug vial defining an axis and having an open distal end and a outer wall adjacent said end, said vial being sized to be received within said barrel;
• c. a stopper having a distal face and a proximal face and being sized to be received within the distal end of said drug vial and to occlude said distal end, said stopper defining an axis and including;
• a distal portion having a member for engaging said barrel, said member projecting beyond at least a portion of said outer wall of said drug vial when said stopper is sealingly received into said drug vial and when said drug vial and said stopper are inserted into said barrel bore;
• d. a handle connected to said drug vial for advancing and retracting said drug vial along said barrel;
• e. a flexible envelope enclosing said barrel, said handle, and said vial within a sealed sterile environment within said envelope, said envelope being sized so that said vial and said handle can be aligned with said open proximal end, and so that said vial can be sterilely inserted into said barrel within said envelope by contacting said handle and said vial through said envelope and manipulating said vial and said handle within said envelope.

A method for the enclosed and sterile mixing of a pharmaceutical agent from a closed and sealed pharmaceutical vial with a diluent and for subsequent injection of the mixture into a patient using a syringe having a barrel, the vial having an open distal end sealed by a stopper, and having a proximal end and a piston adjacent said proximal end, the method comprising steps of:

• a. inserting the closed pharmaceutical storage vial into the barrel;
• b. advancing the pharmaceutical storage vial along the barrel;
• c. disengaging the stopper from sealing contact with the open end of the pharmaceutical vial;
• d. aspirating diluent into the main bore into contact with said pharmaceutical agent to derive a mixture of said diluent and said pharmaceutical agent;
• e. advancing said proximal piston along said vial, said piston expelling the pharmaceutical agent from the vial;
• f. advancing said vial to inject said mixture into a patient. a portion of said outer wall.

A method for the enclosed and sterile mixing of a pharmaceutical agent from a closed pharmaceutical vial having an open end occluded by a stopper with a diluent, and for subsequent injection of the mixture into a patient using a syringe having a barrel, the method comprising steps of:

• a. inserting the occluded pharmaceutical storage vial into the barrel;
• b. advancing the pharmaceutical storage vial along the barrel;
• c. after the step of advancing, retracting said vial along said barrel;
• d. disengaging the stopper within said barrel from sealing contact with the open end of the pharmaceutical vial;
• e. aspirating said diluent into contact with said pharmaceutical agent;
• f. advancing said vial along said barrel to inject said mixture into a patient.