Drug handling apparatus and method

• US 4,722,733 A
• Filed: 02/26/1986
• Issued: 02/02/1988
• Est. Priority Date: 02/26/1986
• Status: Expired due to Fees

• Current Assignee: Intelligent Medicine, Inc. (Peninsula Holdings Group Ltd.)
• Original Assignee: Intelligent Medicine, Inc. (Peninsula Holdings Group Ltd.)
• Inventors: Howson, David C.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US06/833,067
• Time in Patent Office: 706 Days
• Field of Search: 604/411, 604/416, 604/406, 604/88, 604/89, 604/92, 604/201, 604/405, 141/19, 141/329, 141/330, 141/286
• US Class Current: 604/411
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

A drug handling apparatus and method are disclosed. A delivery receptacle, such as a syringe, is provided with a first substance, such as a liquid diluent, either stored in the delivery receptacle or provided from a separate storage receptacle, and the first substance in the delivery receptacle is transferred to a storage receptacle provided with a second substance, such as a drug in solid form, with the transfer being accomplished by moving an actuator, such as the piston within a syringe, in a first direction to create a positive flow of the first substance from the delivery receptacle through a vented transfer unit to the storage receptacle where the substances are mixed to thereby, for example, reconstitute the drug. By then moving the actuator in a second direction, such as by movment of the syringe piston in the opposite axial direction, the mixture is then withdrawn from the storage receptacle and transferred through the vented transfer unit to the delivery receptacle. After removal of the storage receptacle and transfer unit from the delivery receptacle, the mixture can then be discharged from the delivery receptacle to a patient connected therewith by again actuating the actuator in the first direction. Packaging for the delivery and storage receptacles is provided with the receptacles being stored in spaced and sealed relationship until needed.

Claims

1. A substance handling apparatus, comprising:

receptacle means having a storage chamber for receiving a first substance, said receptacle means having a first chamber opening at one portion thereof;

delivery means having a delivery chamber for receiving a second substance, said delivery means having a second chamber opening at one portion thereof;

transfer means sealingly engagable with said first chamber opening of said receptacle means and having a first conduit therein opening to first and second spaced ports, said transfer means permitting substance flow between said storage chamber and said delivery chamber through said first conduit when said transfer means is positioned with said first and second chamber openings in communication with said first and second ports, said transfer means also having a second conduit therein opening to third and fourth spaced ports with said third port being in communication with said storage chamber when said first spaced port is in communication with said storage chamber, with said fourth port opening externally of said storage chamber, and with said second conduit having filter means therein for permitting passage of air in either direction through said second conduit but substantially blocking passage of liquid and solid materials in either direction through said second conduit; and

actuating means at least partially within said delivery chamber to cause, when said first and second chamber openings are in communication with said first and second ports, positive movement of said second substance from said delivery chamber to said storage chamber through said conduit upon actuation of said actuating means in one predetermined direction so that said first and second substances can be mixed within said storage chamber, and to cause positive movement of said mixture of said first and second substances from said storage chamber to said delivery chamber through said conduit upon actuation of said actuating means in a second predetermined direction, said actuating means also causing positive delivery of said mixture of said first and second substances from said delivery means upon actuation of said actuating means when said mixture is within said delivery chamber.

2. The apparatus of claim 1 wherein said delivery means includes a syringe body, and wherein said actuating means includes a piston within said syringe body.

3. The apparatus of claim 1 wherein said actuating means includes means for actuating said piston in said one predetermined direction within said syringe body to cause flow of said second substance from said delivery chamber to said storage chamber, for actuating said piston in said second predetermined direction opposite to said one direction within said syringe body to cause flow of said mixture of said first and second substances from said storage chamber to said delivery chamber, and for actuating said piston within said syringe body in said one direction to cause flow of said mixture of said first and second substances from said delivery means.

4. The apparatus of claim 1 wherein said substance handling apparatus is for mixing substances at least one of which includes a drug, and wherein said apparatus includes means for maintaining sterile conditions during transfer and mixing of said substances.

5. The apparatus of claim 4 wherein at least one of said receptacle means and said delivery means has sufficient size to enable said apparatus to be utilized for multi-dose application.

6. The device of claim 1 wherein said apparatus includes second receptacle means for storing said second substance, and wherein said apparatus includes second transfer means connectable between said second receptacle means and said delivery means for allowing transfer of said second substance to said delivery means through said second transfer means.

7. The substance handling apparatus of claim 1 wherein said filter means is a one-piece micropore, hydrophobic filter.

8. The substance handling apparatus of claim 7 wherein said filter means has a pore size of about 0.22 microns.

9. A drug handling apparatus, comprising:

a receptacle forming a reservoir for receiving one of a drug and a diluent therein, said receptacle having a reservoir access opening at one portion thereof;

a syringe having a body portion forming a compartment for receiving the other of said drug and diluent, a piston within said body portion, and a compartment access opening at one end; and

a transfer element having a body portion with a first conduit therein opening to first and second spaced ports, said body portion being sealingly engageable with said reservoir access opening to enable communication of said first port with said receptacle reservoir when so positioned, said body portion also being adapted for sealing engagement with said syringe body to establish communication of said second port with said syringe compartment access opening so that, when so positioned, said one of said drug and diluent in said syringe compartment is caused to be moved from said compartment to said storage reservoir by actuation of said syringe piston in one direction so that said drug and diluent are mixed in said storage receptacle, and so that said mixture of said drug and diluent is caused to be moved from said receptacle reservoir to said delivery compartment by actuation of said syringe piston in the direction opposite to that of said one direction, and so that, after removal of said transfer means and receptacle from said syringe, said mixture is discharged from said syringe through said compartment access opening upon actuation of said syringe piston in said one direction, and said transfer element also including a second conduit having third and fourth spaced ports and a filter, said third port being in communication with said receptacle reservoir when said transfer element is in said sealing engagement with said receptacle, with said fourth port opening externally of said transfer element, and with said filter being within said second conduit for permitting passage of air in either direction through said second conduit but substantially blocking passage of liquid and solid material in either direction through said second conduit.

10. The apparatus of claim 9 wherein said apparatus includes a second receptacle like that of said first receptacle for receiving a diluent, and wherein said apparatus also includes a second transfer element like that of said first transfer element whereby said diluent may be transferred to said syringe by positioning the outer port of said second transfer element in sealing engagement with said second receptacle and said syringe to establish communication of said second receptacle reservoir with said syringe compartment through the conduit in said second transfer element.

15. The method of claim 10 wherein said method includes providing a second reservoir having said first substance therein, and introducing said first substance into said delivery chamber by establishing a flow path therebetween prior to establishing said flow path for said first substance from said delivery chamber to said first reservoir.

11. A method for handling of substances, said method comprising:

providing a delivery chamber having an access opening and an actuator at least partially within the delivery chamber;

introducing a first substance into said delivery chamber;

providing a storage reservoir having an access opening and a second substance within the storage reservoir;

providing a transfer element sealingly engagable with said access opening of said storage reservoir;

providing an air passage through said transfer element permitting air flow to and from said storage receptacle but substantially blocking passage of liquid and solid material to end from said storage receptacle;

establishing a flow path through said transfer element extending between the access openings of said storage reservoir and said delivery chamber;

moving said actuator to thereby cause positive flow of said first substance from said delivery chamber to said storage reservoir through said established flow path;

mixing said first and second substances at said storage reservoir;

moving said actuator to thereby cause positive flow of the mixture of said first and second substances from said storage reservoir to said delivery chamber through said established flow path;

terminating said established flow path between the access openings of said storage reservoir and said delivery chamber; and

moving said actuator to thereby cause positive flow of the mixture of said first and second substances through said access opening of said delivery chamber to a patient when connected with said delivery chamber.

12. The method of claim 11 wherein providing the delivery chamber and actuator includes providing a syringe having a piston therein.

13. The method of claim 11 wherein at least one of said substances to be mixed is a drug, and wherein said flow path is established in a closed pathway to maintain sterile conditions.

14. The method of claim 11 wherein said method includes repeatedly establishing said flow path between said storage reservoir and said delivery chamber whereby said mixture of said substance can be repeatedly withdrawn from said storage reservoir to said delivery chamber to a patient connected therewith.

16. A method for handling drugs requiring mixing prior to delivery of the resulting mixture from a syringe to a patient, said method comprising:

providing a liquid diluent storage receptacle;

transferring liquid diluent in said storage receptacle into the reservoir of a syringe having a syringe piston therein, which reservoir opens from the syringe through a tapered opening at one end thereof;

providing a storage chamber having a drug stored therein and an outlet opening;

establishing a flow path from said outlet opening of said storage chamber to said tapered opening of said syringe;

actuating said syringe piston in one direction to cause diluent to flow from said syringe reservoir to said storage reservoir with said discharged diluent flowing through said syringe opening, established flow path, and chamber outlet opening to the storage chamber;

mixing said drug with said diluent at said storage chamber;

actuating the syringe piston in a direction opposite to said one direction to cause withdrawal of the mixture of said drug and diluent from said storage chamber with said withdrawn mixture flowing through said chamber output opening, established flow path, and syringe opening to said syringe reservoir;

terminating said flow path between said storage chamber and said syringe reservoir; and

actuating said syringe piston in said one direction to cause delivery of said mixture from said syringe reservoir to a patient when connected therewith.