Apparatus for parenteral infusion of fluid containing beneficial agent

• US 4,432,754 A
• Filed: 05/24/1982
• Issued: 02/21/1984
• Est. Priority Date: 05/24/1982
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Urquhart, John, Theeuwes, Felix
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/381,402
• Time in Patent Office: 638 Days
• Field of Search: 604/56, 604/80-85, 604/892
• US Class Current: 604/518
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances

Abstract

A parenteral delivery system is disclosed for administering a beneficial agent to a recipient. The system comprises (a) a primary container of a medical fluid; (b) a primary drip chamber in fluid communication with the primary container; (c) a primary formulation chamber in fluid communication with the primary drip chamber and housing an agent dispensing device or a beneficial agent; (d) a secondary container of a medical fluid; (e) a secondary drip chamber in fluid communication with the secondary container; (f) a secondary formulation chamber in fluid communication with the secondary drip chamber and housing an agent dispensing device or a beneficial agent; and (g) a common tubing in communication with the primary formulation chamber and the secondary formulation chamber for communicating the system with the recipient.

Claims

1. A parenteral delivery system for administering a beneficial agent formulation to an animal, the system comprising:

(a) a primary reservoir of a pharmaceutically acceptable fluid;

(b) a primary path in communication with the reservoir for the flow of a parenterally acceptable fluid therethrough;

(c) a formulation chamber in the primary path, the formulation chamber comprising;

(1) a wall surrounding a lumen;

(2) an inlet for letting fluid from the primary path into the formulation chamber;

(3) a beneficial agent in the formulation chamber that forms an agent formulation with fluid that enters the formulation chamber;

(4) an agent release means including a permeable film means within the formulation chamber that aids in controlling the rate of release of beneficial agent formulation from the formulation chamber; and

,

(5) an outlet for letting an agent formulation leave the formulation chamber;

(d) a secondary reservoir of a pharmaceutically fluid;

(e) a secondary path in communication with the reservoir for the flow of a parenterally acceptable fluid therethrough;

(f) a formulation chamber in the secondary path, the formulation chamber comprising;

(1) a wall surrounding a lumen;

(2) an inlet for letting fluid from the secondary path into the formulation chamber;

(3) a beneficial agent in the formulation chamber that forms an agent formulation with fluid that enters the formulation chamber;

(4) an agent release means including a permeable film means within the formulation chamber that aids in controlling the rate of release of beneficial agent formulation from the formulation chamber; and

,

(5) an outlet for letting an agent formulation leave the formulation chamber; and

,

(g) a common path in communication with the primary path and in communication with the secondary path for receiving agent formulation, which common path, when the parenteral system is in use, is in communication with the animal for administering beneficial agent formulation thereto.

2. The parenteral delivery system according to claim 1, wherein the system comprises a flow regulator on the primary path for governing flow therethrough.

3. The parenteral delivery system according to claim 1, wherein the system comprises a flow regulator on the secondary path for governing flow therethrough.

4. The parenteral delivery system according to claim 1, wherein the system comprises a valve in communication with the primary path, the secondary path, and the common path.

5. The parenteral delivery system according to claim 1, wherein the system comprises a drip chamber in the primary path.

6. The parenteral delivery system according to claim 1, wherein the system comprises a drip chamber in the secondary path.

7. The parenteral delivery system according to claim 1, wherein the system comprises a filter in the formulation chamber in the primary path.

8. The parenteral delivery system according to claim 1, wherein the system comprises a filter in the formulation chamber in the secondary path.

9. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in primary path is in powdered, particle, lypophilized, or tablet form.

10. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in the secondary path is in powdered, particle, lypohilized, or tablet form.

11. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in the primary path is in a delivery device that delivers the agent into the formulation chamber.

12. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in the secondary path is in a delivery device that delivers the agent into the formulation chamber.

13. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in the primary path is a drug.

14. The parenteral delivery system according to claim 1, wherein the beneficial agent in the formulation chamber in the secondary path is a drug.

15. A parenteral delivery system for the administration of a beneficial agent formulation to a patient, the system comprising:

(a) a primary container of a medically acceptable fluid;

(b) a primary tubing in fluid communication with the primary container;

(c) a primary formulation chamber in fluid communication with the primary tubing, the formulation chamber comprising;

(1) a wall that surrounds an internal space;

(2) an inlet for letting fluid into the chamber;

(3) separate agent release means in the formulation chamber for constituting an agent formulation with fluid that enters the formulation chamber, the means comprising an agent delivery device containing a beneficial agent that is released at a rate controlled by the device into fluid in the formulation chamber;

(4) an outlet for letting agent formulation leave the formulation chamber;

(d) a secondary container of a medically acceptable fluid;

(e) a secondary tubing in fluid communication with the secondary container;

(f) a secondary formulation chamber in fluid communication with the secondary tubing, the formulation chamber comprising;

(1) a wall that surrounds an internal space;

(2) an inlet for letting fluid into the chamber;

(3) separate agent release means in the formulation chamber for constituting an agent formulation with fluid that enters the formulation chamber, the means comprising an agent delivery device containing a beneficial agent that is released at a rate controlled by the device into fluid in the formulation chamber;

(4) an outlet for letting agent formulation leave the chamber; and

,

(g) a common tubing in communication with the primary formulation chamber and in communication with the secondary formulation chamber, for receiving agent formulation for administering to the patient through a delivery member attachable to the common tubing.

16. The parenteral delivery system according to claim 15 wherein the system comprises a drip chamber in fluid communication with the primary container.

17. The parenteral delivery system according to claim 15, wherein the system comprises a drip chamber in fluid communication with the secondary container.

18. The parenteral delivery system according to claim 15, wherein the system comprises a flow regulator on the primary tubing.

19. The parenteral delivery system according to claim 15, wherein the system comprises a flow regulator on the secondary tubing.

20. The parenteral delivery system according to claim 15, wherein the system comprises a valve in communication with the primary tubing, the secondary tubing, and the common tubing.

21. The parenteral delivery system according to claim 15, wherein the agent in the delivery device in the primary formulation chamber is a drug.

22. The parenteral delivery system according to claim 15, wherein the agent in the delivery device in the secondary formulation chamber is a drug.

23. A method for administering a beneficial agent to a warm-blooded animal, the method comprising:

(a) admitting parenterally into an animal in need of a beneficial agent a delivery member in communication with a parenteral delivery system, the system comprising;

(1) a large volume container of a parenterally acceptable fluid;

(2) a primary drip chamber in fluid communication with the large volume container;

(3) a primary formulation chamber in fluid communication with the primary drip chamber, the formulation chamber containing a beneficial agent that forms an agent solution with fluid that enters the formulation chamber, and an agent release means including a film aiding in controlling the rate of release of beneficial agent formulation from the formulation chamber;

(4) a small volume container of a parenterally acceptable fluid;

(5) a secondary drip chamber in fluid communication with the small volume container;

(6) a secondary formulation chamber in fluid communication with the secondary drip chamber, the formulatin chamber containing a beneficial agent that forms an agent solution with fluid that enters the formulation chamber, and an agent release means including a film aiding in controlling the rate of beneficial agent formulation from the formulation chamber;

(7) a common tubing in fluid communication with the primary formulation chamber and in fluid communication with the secondary formulation chamber, and in communication with the delivery member; and

,

(b) administering agent to the animal by letting agent solution flow from the primary formulation chamber and the secondary formulation chamber through the delivery member to the animal.

24. The method for administering the beneficial agent according to claim 23, wherein the primary formulation chamber, the secondary formulation chamber, and the common tubing are in fluid communication through a coupling member.

25. The method for administering the beneficial agent according to claim 23, wherein the system comprises a valve in communication with the primary formulation chamber, the secondary formulation chamber, and the common tubing, and which valve is adjustable for permitting fluid flow between the primary formulation chamber and the common tubing, and for permitting fluid flow between the secondary formulation chamber and the common tubing.

26. A method for administering beneficial agent to a warm-blooded animal, the method comprising:

(a) admitting parenterally into an animal in need of a beneficial agent a delivery member in communication with a parenteral delivery system, the system comprising;

(1) a large volume container of a parenterally acceptable fluid;

(2) a primary drip chamber in fluid communication with the large volume container;

(3) a primary formulation chamber in fluid communication with the primary drip chamber, the formulation chamber containing an agent delivery device containing a beneficial agent that is released at a rate controlled by the device into fluid that enters the formulation chamber;

(4) a small volume container of a parenterally acceptable fluid;

(5) a secondary drip chamber in fluid communication with the small volume container;

(6) a secondary formulation chamber in fluid communication with the secondary drip chamber, the formulation chamber containing an agent delivery device containing a beneficial agent that is released at a rate controlled by the device into fluid that enters the formulation chamber;

(7) a common tubing in fluid communication with the primary formulation chamber and in fluid communication with formulation chamber, and in communication with the delivery member; and

,

(b) administering agent to the animal by letting agent solution flow from the primary formulation chamber and the secondary formulation chamber through the delivery member to the animal.

27. The method for administering the beneficial agent according to claim 26, wherein the primary formulation chamber, the secondary formulation chamber, and the common tubing are in fluid communication through a coupling member.

28. The method for administering the beneficial agent according to claim 26, wherein the system comprises a valve in communication with the primary formulation chamber, the secondary formulation chamber, and the common tubing, and which valve is adjustable for permitting fluid flow between the primary formulation chamber and the common tubing, and for permitting fluid flow between the secondary formulation chamber and the common tubing.