Valve for osmotic devices

• US 6,508,808 B1
• Filed: 12/21/2000
• Issued: 01/21/2003
• 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): Mancene, Gene
• Assistant Examiner(s): Castro, Arnold
• Application Number:
  US09/748,099
• Time in Patent Office: 761 Days
• Field of Search: 604/892.1, 604/890.1, 424/457, 424/422
• 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 including a first end having a beneficial agent delivery orifice and a second end;

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, said separating member is movable in a longitudinal direction within the capsule;

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 opens and closes the beneficial agent delivery orifice, wherein said valve member is movable in a longitudinal direction within said capsule.

2. 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.

3. The osmotic delivery device of claim 2, 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.

4. 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 membrane.

5. The osmotic delivery device of claim 4, wherein the cap is attachable to a body at the capsule with a snap fitting mechanism.

6. The osmotic delivery device of claim 4, wherein the cap is hingedly attached to a body of the capsule.

8. 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.

9. 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.

10. 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.

11. 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.

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

13. The osmotic delivery device of claim 11, wherein the cap is hingedly attached to a body of the capsule.

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

an implantable capsule including a first end having a beneficial agent delivery orifice and a second end, 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;

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, said separating member is movable in a longitudinal direction within the capsule;

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 opens and closes the beneficial agent delivery orifice.

14. The osmotic delivery device of claim 7, 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.

15. The osmotic delivery device of claim 14, 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.

16. An osmotic delivery device, comprising:

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

a beneficial agent delivery orifice; and

a valve member positioned within an interior of the capsule and movable longitudinally 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.

17. The osmotic delivery device of claim 16, further comprising:

a cap forming the first end of the capsule.

18. The osmotic delivery device of claim 17, wherein the beneficial agent delivery orifice is positioned adjacent the cap.

19. The osmotic delivery device of claim 16, 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.

20. 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 longitudinally within the capsule to open and close the delivery orifice; and

positioning the valve member in the delivery device capsule at a closed position such that the valve member occludes the beneficial agent delivery orifice.

21. The method of claim 20, 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 from the closed position to an open position.

22. The method of claim 21, 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.

23. 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 at a closed position 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 longitudinally from the closed position to an open position whereby the beneficial agent contained in the first chamber can pass through the beneficial agent delivery orifice.