Osmotic delivery system flow modulator apparatus and method

• US 20050131389A1
• Filed: 11/22/2004
• Published: 06/16/2005
• Est. Priority Date: 07/25/1997
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: Intarcia Therapeutics, Inc.
• Inventors: Dehnad, Houdin, Peery, John R., Ly, Kevin S., Maruyama, Fred H., Hom, Lawton, Davis, Craig R., Peterson, Lewis L.
• Granted Patent: US 7,407,500 B2
• Time in Patent Office: Days
• US Class Current: 604/892.100
• 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 moderator assembly having a flow moderator 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 the venting means is a vent hole located through the body, the vent hole communicating the opposing ends;

a delivery path located separate from the venting means for delivering the beneficial agent from the osmotic delivery system, the delivery path being formed in at least one of the enclosure and the flow moderator assembly;

a stopper at least partially positioned in the vent hole to seal the vent hole the stopper including a shaft, a head, and tip located opposite from the head; and

a partition secured to the flow moderator body, the partition being secured between the flow moderator body and the head of the stopper.

2. The osmotic delivery system according to claim 1, wherein the partition is an elastomeric material.

3. 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 moderator assembly having a flow moderator 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;

a delivery path located separate from the venting means for delivering the beneficial agent from the osmotic delivery system, the delivery path being formed in at least one of the enclosure and the flow moderator assembly; and

a check valve located between the surrounding environment and the interior of the enclosure, the check valve including a surface of a partition which abuts against a surface of the enclosure.

4. The osmotic delivery system according to claim 3, wherein the surface of the enclosure is an interior surface of the enclosure.

5. The osmotic delivery system according to claim 3, wherein the surface of the enclosure is an exterior surface of the enclosure.

6. 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 moderator assembly having a flow moderator 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;

a delivery path located separate from the venting means for delivering the beneficial agent from the osmotic delivery system, the delivery path being formed in at least one of the enclosure and the flow moderator assembly; and

means for substantially preventing a liquid external of the osmotic delivery system from entering the interior of the osmotic delivery system, the preventing means allowing the beneficial agent to exit the osmotic delivery system to the surrounding environment, the preventing means including a partition attached to the body.

7. 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 moderator assembly having a flow moderator body at least partially positioned in the opening of the enclosure, the body having two opposing ends, and a hole located through the body communicating the opposing ends;

a delivery path located separate from the hole and formed in at least one of the flow moderator assembly and the enclosure for delivering the beneficial agent from the osmotic delivery system; and

means for substantially preventing a liquid external of the osmotic delivery system from entering the interior of the osmotic delivery system, the preventing means allowing the beneficial agent to exit the osmotic delivery system to the surrounding environment.

8. The osmotic delivery system according to claim 7, wherein the preventing means is a check valve formed between a surface of a partition and a surface of the enclosure.

9. The osmotic delivery system according to claim 8, wherein the surface is an interior surface of the enclosure of the osmotic delivery system.

10. The osmotic delivery system according to claim 8, wherein the partition is secured to the flow moderator body with a stopper positioned in the hole of the flow moderator, the stopper sealing the hole located through the body.

11. A method of assembling an osmotic delivery system having an enclosure, the enclosure having an opening, and the osmotic delivery system having a semipermeable portion, the method comprising the steps of:

positioning an osmotic agent in an interior of the enclosure;

inserting an osmotic delivery system flow moderator body at least partially in the opening of the enclosure to at least partially seal the opening; and

delivering a beneficial agent into the enclosure through a fill hole in the flow moderator body.

12. The method according to claim 11, further comprising the step of sealing the fill hole.

13. The method according to claim 11, further comprising the step of venting the interior of the enclosure through an additional hole in the flow moderator body to reduce the amount of gas within the enclosure.

14. The method according to claim 11, wherein the step of delivering of the beneficial agent into the enclosure through the fill hole is achieved with one of a pipette and a syringe.

15. The method according to claim 11, further comprising the step of inserting a semipermeable plug into a second opening of the enclosure.

16. The method according to claim 15, further comprising the step of sealing the additional hole.

17. The method according to claim 12, wherein the fill hole is sealed with a cap.

18. The method according to claim 11, further comprising the step of venting the interior of the enclosure through the fill hole in the flow moderator body while delivering the beneficial agent into the enclosure to reduce an amount of gas within the enclosure.

19. A method of delivering a beneficial agent into an osmotic delivery system, comprising the steps of:

inserting the beneficial agent through a hole in a flow moderator body inserted in an opening of the osmotic delivery system; and

venting gas from the osmotic delivery system through the hole while inserting the beneficial agent through the hole.

20. The method according to claim 19, further comprising the step of creating a vacuum adjacent to the flow moderator body to reduce an amount of gas within the osmotic delivery system.

21. The method according to claim 19, further comprising the step of sealing an interior of the hole from a surrounding environment.

22. A method of assembling an osmotic delivery system having an enclosure, the enclosure having an opening, and the osmotic delivery system having a semipermeable portion, comprising the steps of:

positioning an osmotic agent into an interior of the enclosure;

inserting an osmotic delivery system flow moderator body at least partially in the opening of the enclosure;

delivering a beneficial agent into the enclosure through the hole in the flow moderator body; and

creating a vacuum adjacent to the flow moderator body to reduce an amount of gas within the osmotic delivery system.

23. The method according to claim 22, further comprising the step of sealing the hole.

24. The method according to claim 23, wherein the hole is sealed with a stopper.

25. The method according to claim 23, further comprising the step of attaching to the inserted flow moderator body means for preventing a liquid external of the osmotic delivery system from entering the interior of the osmotic delivery system, the preventing means allowing the beneficial agent to exit the osmotic delivery system to a surrounding environment.