Microfabricated injectable drug delivery system

• US 20010044620A1
• Filed: 02/28/2001
• Published: 11/22/2001
• Est. Priority Date: 02/28/2000
• Status: Active Grant

• Current Assignee: Lawrence Livermore National Security LLC (Government of the United States of America)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Krulevitch, Peter A., Wang, Amy W.
• Granted Patent: US 6,454,759 B2
• Time in Patent Office: Days
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• 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: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02

Abstract

A microfabricated, fully integrated drug delivery system capable of secreting controlled dosages of multiple drugs over long periods of time (up to a year). The device includes a long and narrow shaped implant with a sharp leading edge for implantation under the skin of a human in a manner analogous to a sliver. The implant includes: 1) one or more micromachined, integrated, zero power, high and constant pressure generating osmotic engine; 2) low power addressable one-shot shape memory polymer (SMP) valves for switching on the osmotic engine, and for opening drug outlet ports; 3) microfabricated polymer pistons for isolating the pressure source from drug-filled microchannels; 4) multiple drug/multiple dosage capacity, and 5) anisotropically-etched, atomically-sharp silicon leading edge for penetrating the skin during implantation. The device includes an externally mounted controller for controlling on-board electronics which activates the SMP microvalves, etc. of the implant.

Claims

1. A system for injectable drug delivery, comprising:

an implantable device containing in at least one drug to be delivered by osmotic pressure,

valves in said device for at least controlling generation of said osmotic pressure, and

an externally located controller for activating said valves.

2. The system of

claim 1

, wherein said implantable device comprises a housing having at least one microchannel in said housing, said at least one drug to be delivered being located in a section of said at least one microchannel.

3. The system of

claim 2

, wherein said osmotic pressure is generated by an osmotic device located in said it least one microchannel.

4. The system of

claim 3

, additionally including a piston located in said at least one microchannel intermediate said osmotic device and said at least one drug to be delivered.

5. The system of

claim 2

, wherein said housing includes a sharp leading edge to assist in implantation thereof.

6. The system of

claim 5

, wherein said housing is composed of a silicon member and a glass member, said silicon member containing said at least one microchannel in a surface adjacent said glass member.

7. The system of

claim 6

, wherein said valves are mounted to control opening in said glass member, said openings being in fluid communication with said at least one microchannel.

8. The system of

claim 7

, additionally including at least electronics for activating said valves, said electronics be constructed to receive activation signals from said externally located controller.

9. The system of

claim 8

, wherein said electronics are mounted on said glass member.

10. The system of claims 1, wherein said externally located controller is constructed to be activated by detection of a chemical/biological material.

11. The system of

claim 1

, wherein said valves include shape memory polymer material, and wherein said implantable device includes a heater for said shape memory polymer material for activating said valves.

12. The system of

claim 1

, wherein said valves include a porous polymeric material, and wherein said implantable device includes a heater for said porous polymeric material for changing the porousity of the polymeric material.

13. The system of

claim 2

, wherein said housing includes a plurality of microchannels, each microchannel containing a drug and on osmotic device for dispensing the drug from said microchannel when said valves are activated.

14. In an implantable, osmotic driven drug delivery device, the improvement comprising:

a plurality of microchannels located in said device,

each microchannel having a drug-filled section,

each microchannel having an osmotic pressure generating section,

each microchannel having a piston located intermediate said osmotic pressure generating section and said drug-filled section,

said piston being constructed to prevent fluid leakage therepast,

valve means for controlling activation of said osmotic pressure generating section, and valve means for controlling discharge from said drug-filled section.

15. The improvement of

claim 14

, wherein said valve means comprises shape memory polymer valves.

16. The improvement of

claim 15

, additionally including means for controlling activation of said shape memory polymer valves.

17. The improvement of

claim 16

, wherein said microchannels are located in a silicon member, and wherein said silicon member includes a sharp leading edge for assisting in implanting said device.

18. The improvement of

claim 17

, additionally including a glass member having a plurality of openings are aligned with each of said microchannels.

19. The improvement of

claim 18

, wherein said valve means comprises a shape memory polymer valve for each of said openings.