Osmotic delivery system flow modulator apparatus and method

• US 6,524,305 B1
• Filed: 07/24/1998
• Issued: 02/25/2003
• 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, Ly, Kevin S., Maruyama, Fred H., Hom, Lawton, Davis, Craig R., Peterson, Lewis L., Peery, John R.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/122,073
• Time in Patent Office: 1,677 Days
• Field of Search: 604/892.1, 604/247, 604/890.1, 604/891.1, 604/131, 604/151, 604/27, 604/93.01, 604/43, 604/45, 604/500, 604/502, 424/422-426, 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 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, a delivery path formed in the body, located separate from the hole, and for controllably delivering a beneficial agent from the osmotic delivery system;

a stopper at least partially positioned in the vent hole; and

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.

2. 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.

3. 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, the flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system and including;

two opposing ends,

a hole located through the body, the hole communicating the opposing ends,

a delivery path for controllably 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, and

a partition, the shaft being positioned through the partition so that at least a portion of the partition is located between the head and the tip of the shaft; and

delivering a beneficial agent into the enclosure through the hole through the flow modulator body.

4. The method according to claim 3, further comprising the step of sealing the hole.

5. The method according to claim 3, 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.

6. The method according to claim 3, wherein the step of delivering of the beneficial agent into the enclosure through the hole is achieved with one of a pipette and a syringe.

7. The method according to claim 3, further comprising the step of inserting a semipermeable plug into a second opening of the enclosure.

8. The method according to claim 5, further comprising the step of sealing the additional hole.

9. The method according to claim 4, wherein the hole is sealed with a cap.

10. The method according to claim 3, further comprising the step of venting the interior of the enclosure through the hole in the flow modulator body while delivering the beneficial agent into the enclosure to reduce an amount of gas within the enclosure.

11. 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,

the flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system and including;

two opposing ends,

a hole located through the body, the hole communicating the opposing ends,

a delivery path for controllably 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, and

a partition, the shaft being positioned through the partition so that at least a portion of the partition is located between the head and the tip of the shaft; and

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

12. The method according to claim 11, 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.

13. The method according to claim 11, further comprising the step of sealing an interior of the hole from a surrounding environment.

14. 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, the flow modulator body constructed and arranged for at least partial positioning in an opening of an enclosure of an osmotic delivery system and including;

two opposing ends,

a hole located through the body, the hole communicating the opposing ends,

a delivery path for controllably 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, and

a partition, the shaft being positioned through the partition so that at least a portion of the partition is located between the head and the tip of the shaft;

delivering a beneficial agent into the enclosure through the hole through 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.

15. The method according to claim 14, further comprising the step of sealing the hole.

16. The method according to claim 15, wherein the hole is sealed with a stopper.

17. The method according to claim 14, 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.