Osmotic delivery system flow modulator apparatus and method

• US 20030114837A1
• Filed: 10/25/2002
• Published: 06/19/2003
• Est. Priority Date: 07/25/1997
• Status: Active Grant

• 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.
• Granted Patent: US 6,840,931 B2
• Time in Patent Office: Days
• 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, the delivery path being formed in at least one of the enclosure and the flow modulator assembly.

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 hole 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 6, further comprising a partition secured to the flow modulator body, the stopper including a shaft, a head, and a tip located opposite from the head, the partition being secured between the flow modulator body and the head of the stopper.

8. The osmotic delivery system according to claim 7, wherein the partition is an elastomeric material.

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

10. The osmotic delivery system according to claim 1, further comprising 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.

11. The osmotic delivery system according to claim 10, wherein the surface of the enclosure is an interior surface of the enclosure.

12. The osmotic delivery system according to claim 10, wherein the surface of the enclosure is an exterior surface of the enclosure.

13. The osmotic delivery system according to claim 1, further comprising 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.

14. The osmotic delivery system according to claim 1, wherein the flow modulator body includes threads, at least a portion of the threads mating an interior surface of the enclosure of the osmotic delivery system.

15. T he osmotic delivery system according to claim 14, 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.

16. 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.

17. An osmotic delivery system flow modulator assembly comprising:

an osmotic delivery system flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system, the body having two opposing ends, a vent hole located through the body, the vent hole communicating the opposing ends, and a delivery path formed in the body, located separate from the vent hole, and for delivering a beneficial agent from the osmotic delivery system.

18. The osmotic delivery system flow modulator assembly according to claim 17, further comprising an additional hole located through the body and communicating the opposing ends of the body.

19. The osmotic delivery system flow modulator assembly according to claim 17, further comprising a stopper at least partially positioned in the vent hole.

20. The osmotic delivery system flow modulator assembly according to claim 19, further comprising a partition secured to the flow modulator body with the stopper, wherein the stopper includes a shaft, a head, and a tip located opposite from the head, the partition being secured between the flow modulator body and the head of the stopper.

21. The osmotic delivery system flow modulator assembly according to claim 17, wherein the delivery path is formed by a thread in an exterior surface of the body.

22. An osmotic delivery system flow modulator assembly comprising:

a flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system, the body including two opposing ends, a first hole located through the body, a second hole located through the body, the first hole and the second hole each communicating the opposing ends, and a delivery path for delivering a beneficial agent from the osmotic delivery system, the flow modulator assembly including means for sealing at least one of the first and second holes.

23. The osmotic delivery system flow modulator assembly according to claim 22, wherein the flow modulator body includes threads formed in an exterior surface of the body.

24. The osmotic delivery system flow modulator assembly according to claim 23, wherein the delivery path is a space formed between the threads in the exterior surface of the body.

25. The osmotic delivery system flow modulator assembly according to claim 22, wherein the first hole and the second hole are cylindrical and elongated.

26. The osmotic delivery system flow modulator assembly according to claim 25, wherein the first hole and the second hole are substantially parallel to each other.

27. The osmotic delivery system flow modulator assembly according to claim 22, wherein the sealing means includes a first cap positioned in the first hole and a second cap positioned in the second hole.

28. 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, at least one of the flow modulator assembly and the enclosure including a delivery path for delivering a beneficial agent from the osmotic agent delivery system.

29. The osmotic delivery system according to claim 28, wherein the flow modulator body includes threads, at least a portion of the threads mating an interior surface of the enclosure of the osmotic delivery system.

30. The osmotic delivery system according to claim 29, 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.

31. The osmotic delivery system according to claim 28, wherein the semipermeable portion is a semipermeable plug at least partially inserted in a second opening of the enclosure.

32. The osmotic delivery system according to claim 28, further comprising a dividing member located within the enclosure and between the beneficial agent and the osmotic agent.

33. The osmotic delivery system according to claim 32, wherein the dividing member is a movable piston.

34. The osmotic delivery system according to claim 28, 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.

35. The osmotic delivery system according to claim 34, 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.

36. An osmotic delivery system flow modulator assembly comprising:

a flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system, the body including two opposing ends, a hole located through the body, communicating the opposing ends, and a delivery path for delivering a beneficial agent from an osmotic delivery system;

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

a partition secured to the body with the stopper so that the partition is secured between the body and the head of the stopper.

37. 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 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 modulator 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.

38. The osmotic delivery system according to claim 37, wherein the preventing means is a check valve formed between a surface of a partition and a surface of the enclosure.

39. The osmotic delivery system according to claim 38, wherein the surface is an interior surface of the enclosure of the osmotic delivery system.

40. The osmotic delivery system according to claim 38, wherein the partition is secured to the flow modulator body with a stopper positioned in the hole of the flow modulator, the stopper sealing the hole located through the body.

41. 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 modulator 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 modulator body.

42. The method according to claim 41, further comprising the step of sealing the fill hole.

43. The method according to claim 41, further comprising the step of venting the interior of the enclosure through an additional hole in the flow modulator body to reduce the amount of gas within the enclosure.

44. The method according to claim 41, 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.

45. The method according to claim 41, further comprising the step of inserting a semipermeable plug into a second opening of the enclosure.

46. The method according to claim 43, further comprising the step of sealing the additional hole.

47. The method according to claim 42, wherein the fill hole is sealed with a cap.

48. The method according to claim 41, further comprising the step of venting the interior of the enclosure through the fill hole in the flow modulator body while delivering the beneficial agent into the enclosure to reduce an amount of gas within the enclosure.

49. 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 modulator 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.

50. The method according to claim 49, further comprising the step of creating a vacuum adjacent to the flow modulator body to reduce an amount of gas within the osmotic delivery system.

51. The method according to claim 49, further comprising the step of sealing an interior of the hole from a surrounding environment.

52. 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 modulator body at least partially in the opening of the enclosure;

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

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

53. The method according to claim 52, further comprising the step of sealing the hole.

54. The method according to claim 53, wherein the hole is sealed with a stopper.

55. The method according to claim 52, further comprising the step of attaching to the inserted flow modulator 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.