Osmotic delivery system flow modulator apparatus and method

• US 6,840,931 B2
• Filed: 10/25/2002
• Issued: 01/11/2005
• Est. Priority Date: 07/25/1997
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Dehnad, Houdin, Peery, John R., Ly, Kevin S., Maruyama, Fred H., Hom, Lawton, Davis, Craig R., Peterson, Lewis L.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maynard, Jennifer J
• Application Number:
  US10/279,957
• Publication Number:
  US 20030114837A1
• Time in Patent Office: 809 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/27, 604/43, 604/45, 604/500, 604/502, 604/93.01, 604/131, 604/151, 604/247, 424422-426, 424/473
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14526 the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

An osmotic delivery system flow modulator assembly, an osmotic delivery system with a flow modulator assembly, and a method of assembling an osmotic delivery system. The osmotic delivery system flow modular assembly includes a body having a hole located through the body and communicating two opposing ends of the body. The use of the osmotic delivery system flow modulator assembly lessens the chance that air or gas pockets will form in the enclosure of the osmotic delivery system during assembly of the system. Because less air is within the osmotic delivery system, performance of the system is enhanced. Use of the flow modulator assembly also lessens the chance that beneficial agent will be wasted during assembly of the osmotic delivery system.

Claims

1. An osmotic delivery system comprising:

an enclosure having an opening and an interior for holding a liquid swellable osmotic agent and a beneficial agent, the enclosure provided with a semipermeable portion, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment through the semipermeable portion and causing a delivery rate of the beneficial agent from the enclosure;

an osmotic delivery system flow modulator assembly having a flow modulator body at least partially positioned in the opening of the enclosure, the body having two opposing ends and means for venting the osmotic delivery system when the beneficial agent is inserted into the osmotic delivery system; and

a delivery path located separate from the venting means for delivering the beneficial agent from the osmotic delivery system, wherein an exterior surface portion of the flow modulator body contacts and cooperates with an interior surface portion of the enclosure to define the delivery path.

2. The osmotic delivery system according to claim 1, wherein the venting means is a vent hole located through the body, the vent hole communicating the opposing ends.

3. The osmotic delivery system according to claim 2, further comprising an additional hole located through the body and communicating the opposing ends of the body.

4. The osmotic delivery system according to claim 3, wherein the vent hole and the additional bole are cylindrical and straight.

5. The osmotic delivery system according to claim 3, further comprising a cap positioned in one of the vent hole and the additional hole to seal one of the holes.

6. The osmotic delivery system according to claim 2, further comprising a stopper at least partially positioned in the vent hole to seal the hole.

7. The osmotic delivery system according to claim 2, further comprising means for sealing an interior of the vent hole from the surrounding environment.

8. The osmotic delivery system according to claim 1, wherein the exterior surface portion of the flow modulator body includes threads and at least a portion of the threads mate with the interior surface portion of the enclosure of the osmotic delivery system.

9. The osmotic delivery system according to claim 1, wherein the delivery path includes a length, interior cross-sectional shape and area, the length, interior cross-sectional shape and area adapted to control an average linear velocity of beneficial agent delivered through the delivery path.

10. An osmotic delivery system comprising:

an enclosure having an opening and an interior for holding a liquid swellable osmotic agent and a beneficial agent, the enclosure provided with a semipermeable portion, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment through the semipermeable portion and causing a delivery rate of the beneficial agent from the enclosure;

an osmotic delivery system flow modulator assembly having a flow modulator body at least partially positioned in the opening of the enclosure, the body having two opposing ends and means for venting the osmotic delivery system when the beneficial agent is inserted into the osmotic delivery system, wherein an exterior surface of the flow modulator body includes threads and at least a portion of the threads mate with an interior surface of the enclosure of the osmotic delivery system; and

a delivery path located separate from the venting means and defined between the exterior surface of the flow modulator body and the interior surface of the enclosure, the delivery path for delivering the beneficial agent from the osmotic delivery system, wherein the delivery path is a space formed between the threads and the interior surface of the enclosure, the liquid swellable osmotic agent for imbibing liquid from the surrounding environment through the semipermeable portion to cause delivery of the beneficial agent through the delivery path.

11. An osmotic delivery system comprising:

an enclosure having an opening and an interior for holding a liquid swellable osmotic agent and a beneficial agent, the enclosure provided with a semipermeable portion, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment through the semipermeable portion and causing a delivery rate of the beneficial agent from the enclosure;

an osmotic delivery system flow modulator assembly having a flow modulator body at least partially positioned in the opening of the enclosure, the body having two opposing ends, a first hole located through the body, and a second hole located through the body, the first and second holes each communicating the opposing ends, the flow modulator assembly including at least one cap positioned in one of the first and second holes; and

a delivery path located separate from the first and second holes for delivering the beneficial agent from the osmotic delivery system, wherein an exterior surface portion of the flow modulator body contacts and cooperates with an interior surface portion of the enclosure to define the delivery path.

12. The osmotic delivery system according to claim 11, wherein the exterior surface portion of the flow modulator body includes threads and at least a portion of the threads mate with the interior surface portion of the enclosure of the osmotic delivery system.

13. The osmotic delivery system according to claim 11, wherein the semipermeable portion is a semipermeable plug at least partially inserted in a second opening of the enclosure.

14. The osmotic delivery system according to claim 11, further comprising a dividing member located within the enclosure and between the beneficial agent and the osmotic agent.

15. The osmotic delivery system according to claim 14, wherein the dividing member is a movable piston.

16. The osmotic delivery system according to claim 11, wherein the delivery path includes a length, interior cross-sectional shape and area, the length, interior cross-sectional shape and area adapted to control an average linear velocity of beneficial agent delivered through the delivery path.

17. The osmotic delivery system according to claim 16, wherein the length, interior cross-sectional shape and area of the delivery path have a predetermined size such that the average linear velocity of beneficial agent delivered through the delivery path is greater than a linear inward flux of a liquid into the delivery path from an environment of use.

18. An osmotic delivery system comprising:

an enclosure having an opening and an interior for holding a liquid swellable osmotic agent and a beneficial agent, the enclosure provided with a semipermeable portion, the liquid swellable osmotic agent for imbibing liquid from a surrounding environment through the semipermeable portion and causing a delivery rate of the beneficial agent from the enclosure;

an osmotic delivery system flow modulator assembly having a flow modulator body at least partially positioned in the opening of the enclosure, the body having two opposing ends, a first hole located through the body, and a second hole located through the body, the first and second holes each communicating the opposing ends, the flow modulator assembly including at least one cap positioned in one of the first and second holes, wherein the flow modulator body includes threads and at least a portion of the threads mate with an interior surface of the enclosure of the osmotic delivery system; and

a delivery path located separate from the first and second holes and defined between an exterior surface of the flow modulator body and the interior surface of the enclosure, the delivery path for delivering the beneficial agent from the osmotic delivery system, wherein the delivery path is a space formed between the threads and the interior surface of the enclosure, the liquid swellable osmotic agent for imbibing fluid from the surrounding environment through the semipermeable portion to cause delivery of the beneficial agent through the delivery path.