Valve for osmotic devices

• US 6,682,522 B2
• Filed: 12/04/2002
• Issued: 01/27/2004
• Est. Priority Date: 12/21/1999
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Eckenhoff, James B., Carr, John P.
• Primary Examiner(s): Yuen, Henry C.
• Assistant Examiner(s): Castro, Arnold
• Application Number:
  US10/310,742
• Publication Number:
  US 20030093063A1
• Time in Patent Office: 419 Days
• Field of Search: 604/892.1, 604/890.1, 424/422, 424/457
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic delivery system for controlled delivery of a beneficial agent includes an implant capsule having a beneficial agent reservoir, an osmotic agent which expands on contact with fluid imbibed through a permeable membrane retained by the implant capsule, a delivery port, and a valve for opening and closing the delivery port. When the osmotic agent expands, a pressure is exerted against a separating member positioned between the beneficial agent reservoir and the osmotic agent. The separating member moves within the capsule, thereby forcing the valve to move a distance such that the beneficial agent can exit the reservoir through the delivery port.

Claims

1. An osmotic delivery device for delivery of a beneficial agent, comprising:

an implantable capsule having a beneficial agent delivery orifice, the beneficial agent delivery orifice positioned between a first end and a second end of the implantable capsule;

a separating member positioned within the capsule between the first and second ends, the separating member dividing said capsule into a beneficial agent reservoir and a driving reservoir;

an osmotic agent positioned in the driving reservoir; and

a valve member positioned with an interior of the capsule between the first end and the beneficial agent reservoir such that the valve member opens and closes the beneficial agent delivery orifice.

2. The osmotic delivery device of claim 1, wherein the valve member is positioned within the capsule such that it separates the beneficial agent reservoir from a separate clearance area within the capsule.

3. The osmotic delivery device of claim 1, wherein the implantable capsule has an inner surface and an outer surface, and the valve member is positioned adjacent to the inner surface.

4. The osmotic delivery device of claim 1, further comprising a permeable membrane retained by the capsule and separating the osmotic agent from a surrounding fluid, wherein in operation, the osmotic agent imbibes the surrounding fluid through the permeable membrane, said osmotic agent forming an osmotic solute which exerts a pressure on the separating member and forces said separating member to move within the capsule, thereby moving the valve member to allow delivery of the beneficial agent through the beneficial agent delivery orifice.

5. The osmotic delivery device of claim 4, wherein the permeable membrane retained by the capsule controls a rate at which the surrounding fluid is imbibed into the osmotic agent, the rate at which said surrounding fluid is imbibed into the osmotic agent controlling a delivery rate of the beneficial agent.

6. The osmotic delivery device of claim 1, wherein the first end of the capsule includes a vent which allows fluid trapped between the valve member and the first end to escape from the capsule as the valve member moves.

7. The osmotic delivery device of claim 1, wherein the capsule provides a clearance between the valve member and the first end, wherein the clearance can receive at least a portion of said valve member in an open position.

8. The osmotic delivery device of claim 1, wherein at least a portion of the separating member forms a seal with an inner surface of the capsule.

9. The osmotic delivery device of claim 1, wherein at least a portion of the valve member has a length greater than a diameter of the beneficial agent delivery orifice.

10. The osmotic delivery device of claim 1, further comprising a cap forming the first end of the capsule, the cap capable of receiving at least a portion of said valve member.

11. The osmotic delivery device of claim 10, wherein the cap is attachable to a body of the capsule with a snap fitting mechanism.

12. The osmotic delivery device of claim 10, wherein the cap is hingedly attached to a body of the capsule.

13. The osmotic delivery device of claim 1, wherein the separating member is movable within the capsule.

14. An osmotic delivery device, comprising:

an implantable capsule having first and second ends, the capsule containing an osmotic agent and a beneficial agent; and

a beneficial agent delivery orifice located adjacent to a valve member, wherein the valve member is positioned within an interior of the capsule and movable from a closed position to an open position in response to fluid pressure created by the osmotic agent, in the closed position the valve member blocks fluid flow through the beneficial agent delivery orifice, and in the open position allows passage of fluid through the beneficial agent delivery orifice.

15. The osmotic delivery device of claim 14, further comprising a cap forming the first end of the capsule.

16. The osmotic delivery device of claim 15, wherein the beneficial agent delivery orifice is positioned adjacent the cap.

17. The osmotic delivery device of claim 14, further comprising:

a movable separating member between the osmotic agent and the beneficial agent; and

a permeable membrane retained by the capsule and separating the osmotic agent from a surrounding fluid, wherein in operation, the osmotic agent imbibes the surrounding fluid through the permeable membrane, said osmotic agent forming an osmotic solute which exerts a pressure on the separating member and forces said separating member to move within the capsule, thereby moving the valve member to allow delivery of the beneficial agent through the beneficial agent delivery orifice.

18. A method of preventing contamination from entering an osmotic delivery device before activation, comprising the steps of:

providing a delivery device capsule which encloses a first chamber containing a beneficial agent, the first chamber having a beneficial agent delivery orifice communicating with an external environment, and a valve member movable within the capsule; and

positioning the valve member in the delivery device capsule, such that the valve member occludes the beneficial agent delivery orifice.

19. The method of claim 18, further comprising the step of providing an osmotic agent which imbibes a surrounding fluid into the osmotic agent to form an osmotic solute which expands and exerts a pressure on the beneficial agent and the valve member, wherein the pressure moves the valve member to a position wherein the valve member does not occlude the beneficial agent delivery orifice.

20. The method of claim 19, further comprising the step of providing a movable separating member between the osmotic agent and the beneficial agent such that the valve member in the opened position allows the separating member to drive the beneficial agent from the first chamber, thereby insuring a flow of beneficial agent through the beneficial agent delivery orifice and preventing contamination from entering the delivery device.

21. A method of controlling an initial release of a beneficial agent from an osmotic delivery device, comprising the steps of:

providing a delivery device capsule which encloses a first chamber containing a beneficial agent, a valve member, and a second chamber containing an osmotic agent, wherein the first chamber has a beneficial agent delivery orifice;

positioning the valve member in the delivery device capsule, wherein before activation the valve member occludes the delivery orifice preventing passage of the beneficial agent contained in the first chamber through the beneficial agent delivery orifice; and

imbibing a surrounding fluid into the osmotic agent to form an osmotic solute which expands and exerts a pressure on the beneficial agent and the valve member, wherein the pressure moves the valve member to a position allowing the beneficial agent contained in the first chamber to pass through the beneficial agent delivery orifice.

22. An osmotic delivery device for delivery of a beneficial agent, comprising:

an implantable capsule having a hollow interior and substantially cylindrical side wall and a first end wall and a second end wall, the implantable capsule including;

a cap forming the first end wall of the implantable capsule; and

a capsule body forming the second end wall of the capsule;

a beneficial agent delivery orifice positioned in the cylindrical sidewall between the first and second ends;

a separating member positioned within the capsule between the first and second ends, the separating member dividing said capsule into a beneficial agent reservoir and a driving reservoir;

an osmotic agent positioned in the driving reservoir; and

a valve member positioned within the capsule between the first end and the beneficial agent reservoir such that the valve member occludes the beneficial agent delivery orifice in a first position and allows delivery of a beneficial agent in a second position.

23. The osmotic delivery device of claim 22, wherein the cap affixes to the body of the capsule by a snap fitting mechanism.

24. The osmotic delivery device of claim 23, wherein the snap fitting mechanism is a barbed stake.

25. The osmotic delivery device of claim 22, wherein the cap has a vent in the end wall which after assembly allows the valve to move in a direction towards the end wall.

26. The osmotic delivery device of claim 22, wherein the cap affixes to the capsule body by a hinge.

27. The osmotic delivery device of claim 22, wherein the capsule has at least one opening which communicates with the environment of use.

28. The osmotic delivery device of claim 27, wherein the opening is formed in the capsule body and is positioned adjacent a capsule contacting surface of the cap.

29. The osmotic delivery device of claim 27, wherein the opening is formed in the cap and positioned adjacent a cap contacting surface of the capsule body.

30. The osmotic delivery device of claim 22, wherein the semi-permeable membrane couples with the capsule at the opened second end.

31. The osmotic delivery device of claim 22, wherein the delivery orifice is positioned at an edge of the cap adjacent the capsule.

32. The osmotic delivery device of claim 22, wherein the delivery orifice is positioned at an edge of the capsule adjacent the cap.

33. The osmotic delivery device of claim 22, wherein said valve member is movable in a longitudinal direction within said capsule.

34. The osmotic delivery device of claim 22, further comprising a permeable membrane retained by the capsule and separating the osmotic agent from a surrounding fluid, wherein in operation, the osmotic agent imbibes the surrounding fluid through the permeable membrane, said osmotic agent forming an osmotic solute which exerts a pressure on the separating member and forces said separating member to move within the capsule, thereby moving the valve member to allow delivery of the beneficial agent through the beneficial agent delivery orifice.

35. The osmotic delivery device of claim 34, wherein the permeable membrane retained by the capsule controls a rate at which the surrounding fluid is imbibed into the osmotic agent, the rate at which said surrounding fluid is imbibed into the osmotic agent controlling a delivery rate of the beneficial agent.

36. The osmotic delivery device of claim 22, wherein a vent allows fluid trapped between the valve member and the cap to escape from the capsule as the valve member moves.

37. The osmotic delivery device of claim 22, wherein the capsule provides a clearance between the valve member and the first end, wherein the clearance can receive at least a portion of said valve member in an open position.

38. The osmotic delivery device of claim 22, wherein at least a portion of the separating member forms a seal with an inner surface of the capsule.

39. The osmotic delivery device of claim 22, wherein at least a portion of the valve member has a length greater than a diameter of the beneficial agent delivery orifice.