In-line drug delivery device for use with a standard IV administration set and a method for delivery

• US 5,484,406 A
• Filed: 12/16/1993
• Issued: 01/16/1996
• Est. Priority Date: 11/19/1992
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Wong, Joseph, Levine, Irwin B.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): ELGART, VANITHA M
• Application Number:
  US08/168,594
• Time in Patent Office: 761 Days
• Field of Search: 604/28, 604/49, 604/403, 604/404, 604/408-416, 604/201, 604/204, 604/205, 604/56, 604/82-84, 604/86-88, 604/90, 128/DIG. 24, 141/21, 141/23-25, 141/27, 141/114, 141/313, 141/329, 141/330, 222/206, 222/213
• US Class Current: 604/87
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing

Abstract

A drug delivery device (250) is provided for coupling a container (260) including a beneficial agent (262) to the device (250). The device (250) includes a substantially hollow member for housing a solution (256) wherein the hollow member includes an upper section (254) having flexible walls and a lower section (252) having substantially rigid walls. A spike (258) extends from the lower section (252) to provide fluid communication between an interior of the device (250) and the container (260). To this end, the beneficial agent (262) mixes with the solution (256) forming a mixture for administration to a patient. A cannula (266) and a plunger (264) are further provided for administration of the mixture (270) to the patient.

Claims

1. A device for mixing a solution with a beneficial agent in a container thereby forming a mixture for further administration, the device comprising:

a substantially hollow member having a length and an interior containing a solution and further having walls that at least partially define an exterior of the hollow member and are capable of, at least in part, being biased inwardly thereby exerting a pressure on the solution contained within the hollow member, the length of the hollow member being greater than the width;

means for piercing constructed and arranged substantially perpendicularly to the length of the hollow member and integrally connected to and extending from a wall of the hollow member wherein the means for piercing provides fluid communication between the interior of the substantially hollow member at a lower section of the hollow member and the container; and

a port constructed and arranged at an end of the hollow member opposite the lower section, the port providing access to the interior of the hollow member.

2. The device of claim 1 wherein portions of the walls are flexible.

3. The device of claim 1 wherein the lower section is defined by substantially rigid exterior walls.

4. The device of claim 1 wherein the solution is a diluent required for mixing with the beneficial agent.

5. The device of claim 1 wherein the means for piercing provides two way fluid communication with the container.

6. The device of claim 1 further comprising:

a plunger operatively attached to the hollow member and capable of being received within the interior of the hollow member and movable into and out of the interior of the hollow member.

7. A method for mixing a beneficial agent housed in a first container with a solution housed in an interior of a second container forming a mixture for administration thereof, the method comprising the steps of:

providing the second container having an upper section with flexible walls and a lower section with rigid walls wherein the upper section is integrally formed with the lower section to form the interior of the second container and further wherein a length of the second container is defined by the integrally formed sections, the length being greater than the width;

providing a means for piercing constructed and arranged to provide selective fluid communication between the first container and the second container wherein the means for piercing is integrally connected to and extends peripherally from the length of the second container;

coupling the second container to the first container with the means for piercing;

compressing the upper section from an exterior of the second container forcing the solution from the second container into the first container; and

releasing compression on the upper section of the exterior of the second container allowing the mixture to return to the second container from the first container.

8. The method of claim 7 further comprising the step of:

administering the mixture to a patient.

9. The method of claim 7 wherein the means for piercing extends substantially perpendicularly from a length of the second container.

10. The method of claim 7 further comprising the step of:

mixing the solution and the beneficial agent in the first container.

11. The method of claim 7 wherein only a portion of the solution is compressed from the second container into the first container.

12. A method for drug delivery comprising the steps of:

providing a syringe having an interior for housing a solution, the syringe further having an upper section with flexible walls and a lower section;

coupling a container having an interior containing a beneficial agent to the lower section of the syringe;

establishing fluid communication between the interior of the container and the lower section of the syringe;

compressing a portion of the flexible walls defining the upper section to cause the solution to flow into the container;

releasing compression on the portion of the wall allowing a mixture of the solution and the beneficial agent to return to the interior of the syringe; and

coupling a means for administering the mixture in the syringe to a patient.

13. The method of claim 12 wherein the mixture is an individual unit dosage for administering to the patient.

14. The method of claim 12 wherein the lower section of the syringe is substantially rigid.

15. The method of claim 12 wherein the means for administering is a cannula.

16. The method of claim 12 wherein the container is a vial having a re-sealable injection site.

17. The method of claim 12 further comprising the step of:

coupling the syringe to a fluid line for administering the mixture.