Osmotic delivery system with membrane plug retention mechanism

• US 6,899,887 B2
• Filed: 05/17/2001
• Issued: 05/31/2005
• Est. Priority Date: 12/29/1997
• Status: Expired due to Term

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: Micron Technology, Inc.
• Inventors: Ayer, Rupal
• Primary Examiner(s): Sharareh, Shahnam
• Application Number:
  US09/858,632
• Publication Number:
  US 20010022974A1
• Time in Patent Office: 1,475 Days
• Field of Search: 424/423, 424/422, 424/425, 604/890.1, 604/892.1, 604/891.1
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

An osmotic delivery system has a membrane plug retention mechanism which can also be used to control the delivery rate of a beneficial agent from the osmotic delivery system. The osmotic delivery device includes an implant capsule containing a beneficial agent and an osmotic agent. Holes are formed along a side wall of the implant capsule at an open end of the capsule. When the membrane plug is inserted into the open end of the capsule, the membrane material swells into the holes in the capsule side wall creating a large frictional force which prevents expulsion of the membrane plug. A beneficial agent delivery rate of the osmotic delivery system is controllable by varying the size and number of the holes to change the amount of exposed surface area of the membrane plug. An increase in the surface area of the membrane plug exposed to the exterior environment causes a corresponding increase in the liquid permeation rate of the membrane and thus, increases the beneficial agent delivery rate.

Claims

1. An osmotic beneficial agent delivery device with a controllable beneficial agent delivery rate comprising:

a substantially cylindrical body having an open end and a beneficial agent delivery port at a closed end;

a plurality of openings formed in a side wall of the substantially cylindrical body at the open end, the plurality of openings of a size and number determined to achieve a predetermined beneficial agent delivery rate; and

an expandable, semipermeable membrane plug received in the open end of the body and covering the plurality of openings.

4. The osmotic beneficial agent delivery device according to claim 1, further comprising a separating member positioned within the substantially cylindrical body and movable in a longitudinal direction within the substantially cylindrical body to dispense a beneficial agent.

5. The osmotic beneficial agent delivery device according to claim 4, further comprising an osmotic engine positioned adjacent one side of the separating member.

7. The osmotic beneficial agent delivery device according to claim 5, wherein the plurality of openings in the side wall are through holes allowing fluid to pass through the plurality of openings into the membrane plug and into the osmotic engine within the substantially cylindrical body.

8. The osmotic beneficial agent delivery device according to claim 1, wherein the plurality of openings are cylindrical bores spaced in an annular manner around the side wall.

9. The osmotic beneficial agent delivery device according to claim 1, wherein the substantially cylindrical body includes an inwardly directed annular lip at the open end of the substantially cylindrical body which provides additional retention of the membrane plug in the open end of the substantially cylindrical body.

10. The osmotic beneficial agent delivery device according to claim 1, further comprising a beneficial agent to be delivered through the delivery port of the substantially cylindrical body and an osmotic agent for drawing external liquids into the substantially cylindrical body to cause the beneficial agent to be delivered.

11. The osmotic beneficial agent delivery device according to claim 1, wherein the substantially cylindrical body further comprises a movable piston separating a first chamber containing a beneficial agent from a second chamber containing an osmotic agent and causing the beneficial agent to be delivered through the delivery port when the osmotic agent draws external liquids through the membrane plug.

12. The osmotic beneficial agent delivery device according to claim 1, wherein external liquid is drawn into the substantially cylindrical body through the membrane plug by way of the open end of the substantially cylindrical body and the plurality of openings.

14. The osmotic beneficial agent delivery device according to claim 1, wherein the substantially cylindrical body has a substantially cylindrical side wall and the plurality of openings is formed in the substantially cylindrical side wall.

15. The osmotic beneficial agent delivery device according to claim 14, wherein the substantially cylindrical side wall includes an inwardly directed annular lip at the open end of the delivery device body which provides additional retention of the membrane plus in the delivery device body.

16. The osmotic beneficial agent delivery device according to claim 1, wherein the device is an implantable osmotic beneficial agent delivery device.

17. The osmotic beneficial agent delivery device according to claim 1, wherein the membrane plug is formed of a semipermeable composition.

2. An osmotic beneficial agent delivery device with a controllable beneficial agent delivery rate comprising:

a substantially cylindrical body having an open end and a beneficial agent delivery port at a closed end;

a plurality of openings formed in a side wall of the substantially cylindrical body at the open end, the plurality of openings of a size and number determined to achieve a predetermined beneficial agent delivery rate; and

an expandable, semipermeable membrane plug received in the open end of the body and covering the plurality of openings, wherein the membrane plug swells into the plurality of openings preventing expulsion of the membrane plug.

3. The osmotic beneficial agent delivery device according to claim 2, wherein the plurality of openings allow fluid to pass through the side wall and through the membrane plug into an interior of the body.

6. An osmotic beneficial agent delivery device with a controllable beneficial agent delivery rate comprising:

a substantially cylindrical body having an open end and a beneficial agent delivery port at a closed end;

a plurality of openings formed in a side wall of the substantially cylindrical body at the open end, the plurality of openings of a size and number determined to achieve a predetermined beneficial agent delivery rate; and

an expandable, semipermeable membrane plug received in the open end of the body and covering the plurality of openings, wherein the membrane plug is formed of a material which swells causing a portion of the membrane plug to extend into the plurality of openings in the side wall increasing friction between the membrane plug and the substantially cylindrical body and preventing expulsion of the membrane plug from the substantially cylindrical body.

13. An osmotic beneficial agent delivery device with a controllable beneficial agent delivery rate comprising:

a substantially cylindrical body having an open end and a beneficial agent delivery port at a closed end;

a plurality of openings formed in a side wall of the substantially cylindrical body at the open end, the plurality of openings of a size and number determined to achieve a predetermined beneficial agent delivery rate; and

an expandable, semipermeable membrane plug received in the open end of the body and covering the plurality of openings, wherein each of the plurality of openings is a cylindrical bore spaced in an annular manner around the side wall of the substantially cylindrical body adjacent the open end of the substantially cylindrical body.