# US 7,407,500 B2 · Osmotic delivery system flow modulator apparatus and method

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- Number: US 7,407,500 B2
- Document ID: US7407500B2
- Status: Granted
- Kind: B2
- Application number: 10/994,615
- Filed: 2004-11-22
- Published: 2005-06-16
- Granted: 2008-08-05
- Earliest claimed: 1997-07-25
- Assignees: Alza Corporation
- Inventors: Lewis L. Peterson; Fred H. Maruyama; Houdin Dehnad; Lawton Hom; Kevin S. Ly; Craig R. Davis; John R. Peery
- Web page: https://patentgrep.com/patent/US7407500B2

## CPC

- A61M 5/14276: {specially adapted for implantation}
- A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas}
- A61M 5/141: {with capillaries for restricting fluid flow}
- A61M 5/14526: {the piston being actuated by fluid pressure}
- A61M 5/16813: {by controlling the degree of opening of the flow line}
- Y10T 29/494: Fluidic or fluid actuated device making
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 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, wherein an exterior surface portion of the flow modulator body contacts and cooperates with an interior surface of the enclosure to define the delivery path; 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.

### Claim 4 (depends on 3)

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

### Claim 5 (depends on 3)

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

### Claim 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, 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, wherein an exterior surface portion of the flow modulator body contacts and cooperates with an interior surface of the enclosure to define the delivery path; and
a check valve formed between a surface of a partition and a surface of the enclosure for substantially preventing a liquid external of the osmotic delivery system from entering the interior of the osmotic delivery system, the check valve allowing the beneficial agent to exit the osmotic delivery system to the surrounding environment.

### Claim 7 (depends on 6)

The osmotic delivery system according to claim 6, wherein the surface is an interior surface of the enclosure of the osmotic delivery system.

### Claim 8 (depends on 6)

The osmotic delivery system according to claim 6, 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.
