Device and method for accurate delivery of an active agent

• US 7,648,496 B2
• Filed: 05/31/2006
• Issued: 01/19/2010
• Est. Priority Date: 09/17/2001
• Status: Expired due to Fees

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Wickman, Peter, Culwell, John, Poutiatine, Andrew L., Filice, James A., Dinka, John S., Gillis, Edward M.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/444,934
• Publication Number:
  US 20060224145A1
• Time in Patent Office: 1,329 Days
• Field of Search: 604/890.1, 604/891.1, 604/93.01, 604/131, 604/288, 604/422, 604/423, 604/424, 604/425
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

Implantable delivery devices (1) for accurately controlling release of an agent therefrom and for preventing release of the agent during storage, prior to use. The devices include a reservoir (3) for storing the agent, a driving means for driving the agent from the reservoir (3) and a valving and control mechanism (10) which is positively actuatable between a closed configuration and an open configuration.

Claims

1. An implantable device for accurate delivery of an active agent, said device comprising:

the active agent;

a housing (2) including a reservoir (3) that contains the active agent;

a valving and control mechanism (10) fitted at least partially within said housing (2) and fitted at least partially between the reservoir and an opening to an environment of use, wherein the valving and control mechanism comprises a valve seat member (12) peripherally sealed with respect to said reservoir and a plunger (18) adapted to slide with respect to said valve seat member (12) and said valving and control mechanism (10) is able to withstand pressure buildup in the reservoir during temperature and atmospheric pressure cycling during storage and capable of assuming an open configuration and a closed configuration, said valving and control mechanism (10) closes off said reservoir (3) when in said closed configuration, thereby preventing leakage of the active agent during storage in said device; and

further wherein said valving and control mechanism (10) opens said reservoir (3) to a flow path when in said open configuration, thereby permitting controlled delivery of the active agent.

2. The device of claim 1, wherein said flow path has sufficient capacitance to accommodate thermal expansion of the agent due to a change in temperature from room temperature to a patient body temperature and upon changing said valving and control mechanism (1) from said closed configuration to said open configuration.

3. The device of claim 1, wherein said valving and control mechanism (10) is positively actuatable between said closed configuration and said open configuration.

4. The device of claim 3, therein said valving and control mechanism (10) is manually actuatable.

5. The device of claim 3, wherein said valving and control mechanism (10) is actuated from said closed configuration to said open configuration by pushing an actuation portion thereof.

6. The device of claim 3, wherein said valving and control mechanism (10) is actuated from said closed configuration to said open configuration by pulling an actuation portion thereof.

7. The device of claim 3, wherein said valving and control mechanism (10) is actuated from said closed configuration to said open configuration by rotating an actuation portion thereof.

8. The device of claim 3, wherein said valving and control mechanism (10) is further positively actuatable from said open configuration back to said closed configuration.

9. The device of claim 1, further comprising means for applying a driving force to the agent in said reservoir to drive the agent through the flow path and out of the device when said valving and control mechanism are in said open configuration.

10. The device of claim 9, wherein said means for applying a driving force is selected from the group consisting of osmotic pumps, diffusion pumps, electrodiffusion pumps, electroosmotic pumps, and electrochemical pumps.

11. The device of claim 9, wherein said means for applying a driving force comprises an actively driven device.

12. The device of claim 9, further comprising a driver separating said means for applying a driving force from the agent.

13. The device of claim 12, wherein said driver comprises a piston.

14. The device of claim 1, wherein said valve seat member has an opening therethrough including a valve neck (12c) adapted to seat with a portion (18c) of said plunger (18) when said valving and control mechanism is positioned in said closed configuration, and wherein upon sliding said plunger to push said portion (18c) out of said valve neck, said valving and control mechanism (10) is in said open configuration and said reservoir is opened to the flow path via said valve neck (12c).

15. The device of claim 14, wherein said valve seat member (12) is contained within a lower ring (16) abutting said housing (2), said device further comprising an upper ring (20) abutting said lower ring (16), said plunger (18) being slidably positioned within said upper ring (20) and said flow path extending between said housing (2) and said upper ring (20).

16. The device of claim 15, wherein said flow path spirals around said upper ring (20).

17. The device of claim 1, wherein said valving and control mechanism (10) comprises a valve seat member (12) peripherally sealed with respect to said reservoir (3) and having a passageway extending therethrough for connecting said reservoir (3) with the flow pathway;

a septum (24) overlaying said passageway and sealing off the reservoir (3) when said device is in said closed configuration; and

a plunger (18) adapted to slide with respect to said valve seat member (12) and to puncture said septum (24) upon pushing said plunger to pierce said septum (24) wherein said valving and control mechanism (10) assumes the open configuration and the reservoir (3) is thereby opened to the flow pathway.

18. The device of claim 17, further comprising an upper ring (20) fitted within said housing (2), said plunger (18) being slidably positioned within said upper ring (20) and said flow path extending between said housing (2) and said upper ring (20).

19. The device of claim 18, wherein said flow path spirals around said upper ring (20).

20. The device of claim 1, wherein said valving and control mechanism (10) comprises a valve seat member (12) peripherally sealed with respect to said reservoir (3) and having a passageway extending therethrough for connecting said reservoir (3) with the flow pathway;

a valve seal (26) overlaying said passageway and sealing off the reservoir (3) when said device is in said closed configuration; and

a plunger (18) adapted to slide with respect to said valve seat member (12) and to compress said valve seal (26) against said valve seat member (12) to seal off the reservoir (3) when said valving and control mechanism (10) is in said closed configuration; and

wherein, upon pulling said plunger (18) away from said valve seal (26), said valve seal (26) opens said flow path to said reservoir (3) wherein said valving and control mechanism (10) assumes the open configuration.

21. The device of claim 20, further comprising an upper ring (20) fitted within said housing (2), said plunger (18) being slidably positioned within said upper ring (20) and said flow path extending between said housing (2) and said upper ring (20).

22. The device of claim 21, wherein said flow path spirals around said upper ring (20).

23. The device of claim 20, wherein said plunger (18) is pulled away by translating said plunger (18).

24. The device of claim 20, wherein said plunger (18) is pulled away by rotating said plunger (18).

25. The device of claim 1, wherein said valve seat member (12) is peripherally sealed with respect to said reservoir (3) and has a passageway connecting said reservoir (3) with a peripheral opening in said valve seat member (12), said valving and control mechanism (1) comprises a top ring (20) surrounding a top portion of said valve seat member (12) and fitted within said housing (2), and said valve seat member (12) is rotatable with respect to said top ring (20), said top ring (20) further having an opening extending through a wall thereof and connecting with said flow path extending between said top ring (20) and said housing (2);

and further wherein, upon rotation of said valve seat member (12) so that said valving and control mechanism assumes said open configuration, said peripheral opening aligns with said opening extending through the wall of said top ring (20), thereby connecting said reservoir (3) with said flow path.

26. The device of claim 1, wherein said valving and control mechanism (10) comprises a cap (34) arranged for rotation with respect to said valve seat member (12), said valve seat member (12) having a bore (12f) fluidly connecting said reservoir (3) with said cap (34) and a peripheral opening (12j) fluidly connecting said cap with said flow path;

said cap (34) having a passageway (34a, 34b) fluidly connecting with said bore (12f) and extending peripherally out of said cap (34), wherein, upon rotation of said cap (34) so that said valving and control mechanism (10) assumes said open configuration, said passageway (34b) aligns with said peripheral opening (12j), thereby connecting said reservoir (3) with said flow path.