Parenteral controlled therapy

• US 4,432,756 A
• Filed: 11/27/1981
• Issued: 02/21/1984
• Est. Priority Date: 11/27/1981
• 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): Pellegrino, Stephen C.
• Application Number:
  US06/325,206
• Time in Patent Office: 816 Days
• Field of Search: 128/214 G, 128/214 R, 128/214.2, 128/214.4, 128/272.1, 128/218 M, 128/260, 604/83, 604/84, 604/85, 604/92, 604/80, 604/56, 604/246
• US Class Current: 604/80
• 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 set is disclosed for administering a beneficial agent to a recipient. The set comprises (a) a primary container of a medical fluid; (b) a primary tubing in fluid communication with the primary container; (c) a secondary container of a medical fluid; (d) a secondary tubing in fluid communication with the secondary container; (e) a formulation chamber connected to the secondary tubing and housing an agent dispensing device or the beneficial agent; and (f) a common tubing in communication with the primary tubing and the secondary tubing for communicating the set to the recipient.

Claims

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

(a) a primary tube for the flow of a parenterally acceptable fluid therethrough;

(b) a secondary tube for the flow of a parenterally acceptable fluid therethrough;

(c) a formulation chamber in communication with the secondary tube, the formulation chamber comprising;

(1) a wall surrounding a lumen;

(2) an inlet for letting fluid from the secondary tube 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) a release rate controlling membrane in the formulation chamber, said membrane formed of a polymeric material that governs the rate of release of agent formulation from the formulation chamber;

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

,

(d) a common tube in communication with the primary tube for receiving fluid from the primary tube, and in communication with the secondary tube for receiving agent formulation from the secondary tube, which common tube, when the set is in use is in communication with the animal, administers the beneficial fluid and the beneficial agent formulation thereto.

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

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

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

5. The parenteral delivery set according to claim 1, wherein the set comprises a valve in communication with the primary tube, the secondary tube and the common tube, and which valve is adjustable for establishing fluid communication between the primary tube and the common tube.

6. The parenteral delivery set according to claim 1, wherein the set comprises a valve in communication with the primary tube, the secondary tube and the common tube, and which valve is adjustable for permitting agent formulation to flow from the secondary tube into the common tube.

7. The parenteral delivery set according to claim 1, wherein the set comprises a drip chamber in fluid communication with the primary tube.

8. The parenteral delivery set according to claim 1, wherein the set comprises a drip chamber in fluid communication with the secondary tube.

9. The parenteral delivery set according to claim 1, wherein the set comprises a filter in the formulation chamber.

10. The parenteral delivery set according to claim 1, wherein the beneficial agent in the formulation chamber is in tablet form.

11. The parenteral delivery set according to claim 1, wherein the beneficial agent in the formulation chamber is in lypohilized form.

12. The parenteral delivery set according to claim 1, wherein a skin piercing member is in communication with the common tube.

13. The parenteral delivery set according to claim 1, wherein the beneficial agent is a drug.

14. A parenteral delivery system for the administration of a beneficial fluid and 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 secondary container of a medically acceptable fluid;

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

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

(1) a wall that surrounds a lumen;

(2) an inlet that communicates with the secondary tubing for letting fluid 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) a beneficial agent release rate controlling membrane in the formulation chamber, said membrane formed of a polymeric material that governs the rate of agent formulation release from the formulation chamber;

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

,

(f) a common tubing in communication with the primary tubing for receiving fluid from the primary tubing, and in communication with the secondary tubing for receiving agent formulation from the secondary tubing, which common tubing is attachable to a skin piercing member for communicating with the patient.

15. The parenteral delivery system according to claim 14, wherein the system comprises a drip chamber connected to the primary tube.

16. The parenteral delivery system according to claim 14, wherein the system comprises a drip chamber connected to the secondary tubing.

17. The parenteral delivery system according to claim 14, wherein the system comprises a flow control regulator on the primary tubing.

18. The parenteral delivery system according to claim 14, wherein the system comprises a flow control regulator on the secondary tubing.

19. The parenteral delivery system according to claim 14, wherein the system comprises a valve that is in communication with the primary tubing, the secondary tubing and the common tubing.

20. The parenteral delivery set according to claim 14, wherein the set comprises a valve in communication with the primary tubing, the secondary tubing and the common tubing, and which valve is adjustable for permitting fluid flow between the primary tubing and the common tubing.

21. The parenteral delivery set according to claim 14, wherein the set comprises a valve in communication with the primary tubing, the secondary tubing and the common tubing, and which valve is adjustable for permitting agent formulation to flow from the secondary tube into the common tube.

22. The parenteral delivery system according to claim 14, wherein the beneficial agent is in tablet form.

23. The parenteral delivery system according to claim 14, wherein the beneficial agent is in a lypholizied form.

24. The parenteral delivery system according to claim 16, wherein the beneficial agent is a drug.

25. A method for administering a beneficial agent and a parenteral fluid 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 primary container of a parenterally acceptable fluid;

(2) a primary tube in fluid communication with the primary container for the flow of fluid therethrough;

(3) a secondary container of a parenterally acceptable fluid;

(4) a secondary tube in fluid communication with the secondary container for the flow of fluid therethrough;

(5) a formulation chamber connected to the secondary tube, the formulation chamber comprising;

(i) a wall that surrounds a lumen;

(ii) an inlet that communicates with the secondary tube for letting fluid into the formulation chamber;

(iii) a beneficial agent in the formulation chamber, which agent forms an agent solution with fluid that enters the formulation chamber;

(iv) a release rate controlling membrane in the formulation chamber, said membrane formed of a polymeric material that governs the rate of agent formulation release from the formulation chamber;

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

(6) a valve in communication with the primary tube and in communication with the secondary tube;

(7) a common tube in communication with the valve and in communication with the delivery member; and

wherein,

(b) agent is administered to the animal by positioning the valve to let agent solution flow from the secondary tube into the common tube, and

(c) fluid is administered to the animal by positioning the valve to let fluid flow from the primary tube into the common tube.

26. The method for administering the beneficial agent and the parenteral fluid according to claim 25, wherein the agent is administered continuously to the animal by regulating the valve to let agent solution continuously leave the secondary tube.

27. The method for administering the beneficial agent and the parenteral fluid periodically to the animal according to claim 25 wherein the valve is alternatively regulated to let fluid flow through the primary tube and then regulated to let agent solution flow through the secondary tube.

28. A parenteral delivery set for administering a beneficial fluid and a beneficial agent formulation to an animal, the set comprising:

(a) a primary tube for the flow of a parenterally acceptable fluid therethrough;

(b) a secondary tube for the flow of a parenterally acceptable fluid therethrough;

(c) a formulation chamber in the secondary tube, the formulation chamber comprising;

(1) a wall surrounding a lumen;

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

(3) means for automatically constituting a beneficial agent formulation in the formulation chamber, said means a beneficial agent delivery device for releasing at a rate controlled by the device a therapeutically effective amount of a beneficial agent that forms a beneficial agent formulation with parenteral fluid that enters the formulation chamber;

(4) a beneficial agent in the means;

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

,

(d) a common tube in communication with the primary tube for receiving fluid from the primary tube, and in communication with the secondary tube for receiving agent formulation from the secondary tube, which common tube, when the set is in use in communication with the animal, administers the beneficial agent and the beneficial agent formulation thereto.

29. The parenteral delivery set according to claim 28, wherein the set comprises a drip chamber in fluid communication with the formulation chamber.

30. The parenteral delivery set according to claim 28, wherein the set comprises a drip chamber in fluid communication with the primary tube.

31. The parenteral delivery set according to claim 28, wherein the set comprises a drip chamber in fluid communication with the secondary tube.

32. The parenteral delivery set according to claim 28, wherein the beneficial agent is a drug.

33. The parenteral delivery set according to claim 28, wherein the set comprises a valve in communication with the primary tube, the secondary tube, and the common tube, and which valve is adjustable for establishing fluid communication between the primary tube and the common path, and is adjustable for permitting agent formulation to flow from the secondary path into the common path.

34. The parenteral delivery set according to claim 28, wherein the set comprises a flow regulator on the primary tube for governing flow therethrough.

35. The parenteral delivery set according to claim 28, wherein the set comprises a flow regulator on the secondary path for governing flow therethrough.

36. The parenteral delivery set according to claim 28, wherein the set comprises a skin piercing member in communication with the commom path.

37. A parenteral delivery system for the administration of a beneficial fluid and 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 secondary container of a medically acceptable fluid;

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

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

(1) a wall that surrounds a lumen;

(2) an inlet that communicates with the secondary tubing for letting fluid into the formulation chamber;

(3) means for automatically constituting a beneficial agent formulation in the formulation chamber, said means a rate controlled dosage delivery form that delivers at a rate controlled by the form, a therapeutically effective amount of a beneficial agent that constitutes a beneficial agent formulation with fluid that enters the formulation chamber;

(4) a dosage amount of a beneficial agent in the dosage delivery form;

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

,

(f) a common tubing in communication with the primary tubing for receiving fluid from the primary tubing, and in communication with the secondary tubing for receiving agent fromulation from the secondary tubing, which common tubing is attachable to a skin piercing member for communicating with the patient.

38. The parenteral delivery system according to claim 37, wherein the system comprises a drip chamber in fluid communication with the primary tube.

39. The parenteral delivery system according to claim 37, wherein the system comprises a drip chamber in fluid communication with the secondary tube.

40. The parenteral delivery system according to claim 37, wherein the system comprises a flow control on the primary tubing.

41. The parenteral delivery system according to claim 37, wherein the system comprises a flow control on the secondary tubing.

42. The parenteral delivery system according to claim 37, wherein the system comprises a valve that is in communication with the primary tubing, the secondary tubing and the common tubing.