Two-Piece, Internal-Channel Osmotic Delivery System Flow Modulator

• US 20070281024A1
• Filed: 05/30/2007
• Published: 12/06/2007
• Est. Priority Date: 02/03/2005
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Zamora, Pauline C., Lautenbach, Scott D., DesJardin, Michael A., de la Serna, Pedro E.
• Granted Patent: US 8,052,996 B2
• Time in Patent Office: Days
• US Class Current: 424/473
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: Y10T 137/0402 Cleaning, repairing, or assembling
• CPC Class Codes: Y10T 29/49236 Fluid pump or compressor making
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Claims

1. An osmotic delivery system flow modulator, comprising:

an outer shell constructed and arranged for positioning in an opening of a reservoir of an osmotic delivery system;

an inner core inserted in the outer shell; and

a fluid channel having a spiral shape defined between the outer shell and the inner core, the fluid channel being adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

2. The flow modulator of claim 1, wherein the fluid channel is formed on an outer surface of the inner core which mates with an inner surface of the outer shell.

3. The flow modulator of claim 1, wherein the fluid channel is formed on an inner surface of the outer shell which mates with an outer surface of the inner core.

4. The flow modulator of claim 1, further comprising a flow insert disposed between the outer shell and inner core, wherein the fluid channel is formed in the flow insert.

5. The flow modulator of claim 4, wherein the outer shell, inner core, and flow insert are made of an inert material.

6. The flow modulator of claim 5, wherein the inert material is a non-metallic material.

7. The flow modulator of claim 1, wherein the outer shell and inner core are made of an inert material.

8. The flow modulator of claim 7, wherein the inert material is a non-metallic material.

9. The flow modulator of claim 1, wherein the outer shell sealingly engages the inner core.

10. The flow modulator of claim 1, wherein the inner core includes an outer shoulder and the outer shell includes an inner shoulder, wherein the outer shoulder and inner shoulder engage to prevent expulsion of the inner core from the outer shell in use.

11. The flow modulator of claim 1, wherein a length of the fluid channel ranges from 10 to 50 mm.

12. The flow modulator of claim 1, wherein an effective cross-sectional diameter of the fluid channel ranges from 0.1 to 0.5 mm.

13. An osmotic delivery system, comprising:

a reservoir;

a semipermeable plug disposed at a first end of the reservoir to selectively permit fluid flow into the reservoir; and

a flow modulator disposed at a second end of the reservoir, the flow modulator comprising an internal spiral channel adapted for delivery of an active agent formulation contained in the reservoir to a fluid environment in which the osmotic delivery system operates.

14. The osmotic delivery system of claim 13, wherein the flow modulator comprises an outer shell and an inner core inserted in the outer shell, wherein the spiral channel is defined between the outer shell and the inner core.

15. The osmotic delivery system of claim 14, wherein the flow modulator is press-fitted into the second end of the reservoir.

16. The osmotic delivery system of claim 14, further comprising a partition disposed and movable within the reservoir, the partition defining a first chamber containing an osmotic engine and a second chamber containing the active agent formulation, wherein the first chamber is adjacent the semipermeable plug and the second chamber is adjacent the flow modulator.

17. The osmotic delivery system of claim 13, wherein the active agent formulation comprises interferon-omega.

18. An implantable delivery system for an active agent formulation, comprising:

a reservoir made of an impermeable material;

a first chamber in the reservoir containing an osmotic engine;

a second chamber in the reservoir containing an active agent formulation;

a semipermeable plug disposed at a first end of the reservoir adjacent the first chamber; and

a flow modulator disposed at a second end of the reservoir adjacent the second chamber, the flow modulator comprising an outer shell constructed and arranged for positioning in an opening at the second end of the reservoir, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core, the fluid channel being adapted for delivery of the active agent formulation from the second chamber.

19. The implantable delivery system of claim 18, wherein the active agent formulation comprises interferon-omega.

20. The implantable delivery system of claim 18, further comprising a partition between the osmotic engine and the active agent formulation.