Medical device with array of electrode-containing reservoirs

• US 20040248320A1
• Filed: 07/07/2004
• Published: 12/09/2004
• Est. Priority Date: 12/10/1999
• Status: Active Grant

• Current Assignee: John T. Santini Jr, Michael J. Cima, Robert S. Langer
• Original Assignee: John T. Santini Jr, Michael J. Cima, Robert S. Langer
• Inventors: Cima, Michael J., Santini, John T. Jr., Langer, Robert S.
• Granted Patent: US 7,070,592 B2
• Time in Patent Office: Days
• US Class Current: 436/174
• 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
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

Devices are provided for medical diagnostics comprising a substrate; an array of reservoirs; one or more electrodes located at least partially inside the reservoirs; a plurality of discrete reservoir caps covering openings in the plurality reservoirs; control circuitry for selectively disintegrating or permeabilizing the reservoir cap over a reservoir opening; and, optionally, a diagnostic reagent in the reservoirs. Devices also are provided for the controlled delivery of molecules comprising a substrate; an array of reservoirs; a release system in the reservoirs comprising molecules for release; one or more electrodes attached to the substrate inside the reservoirs or to a surface outside of the reservoirs, wherein the electrodes are not reservoir caps; and means for applying an electric current or potential across the electrodes effective to activate release of the molecules from the reservoirs. The devices can be adapted for implantation for in vivo diagnostics or drug delivery.

Claims

1. A device for use in medical diagnostics comprising:

a substrate;

an array of reservoirs in the substrate, the interior of the reservoirs having sidewalls;

a plurality of electrodes located at least partially inside the reservoirs;

a plurality of discrete reservoir caps covering openings in the array of reservoirs; and

control circuitry for selectively disintegrating or permeabilizing the reservoir cap over the opening of at least one of the reservoirs.

2. The device of claim 1, further comprising a diagnostic reagent in the interior of the reservoirs.

3. The device of claim 1, wherein the electrodes are located on sidewalls of the reservoirs.

4. The device of claim 1, wherein the electrodes comprise a thin film of a conducting metal or doped semiconductor.

5. The device of claim 1, wherein the reservoir caps comprise a metal.

6. The device of claim 1, wherein the substrate comprises silicon.

7. The device of claim 1, wherein the control circuitry is adapted to deliver an electric current or potential to the reservoir cap effective to cause the reservoir cap to disintegrate.

8. The device of claim 1, further comprising an inner cap beneath the reservoir cap and in the opening, for passively controlling transport of molecules through the reservoir opening via diffusion of molecules through the inner cap.

9. The device of claim 8, wherein the inner cap comprises a polymeric material.

10. The device of claim 1, wherein the device is formed or coated with a biocompatible material, the device being suitable for implantation into a human or animal.

11. An implantable medical device for in vivo medical diagnostics/comprising:

a substrate;

an array of reservoirs in the substrate, the interior of the reservoirs having sidewalls;

a diagnostic reagent in the interior of the reservoirs; and

a plurality of electrodes located at least partially inside the reservoirs,

wherein the device is formed or coated with a biocompatible material and is suitable for implantation into a human or animal.

12. The device of claim 11, further comprising:

a plurality of discrete reservoir caps covering openings in the array of reservoirs; and

control circuitry for selectively disintegrating or permeabilizing the reservoir cap over the opening of at least one of the reservoirs.

13. The device of claim 11, wherein the electrodes are located on sidewalls of the reservoirs.

14. The device of claim 11, wherein the electrodes comprise a thin film of a conducting metal or doped semiconductor.

15. The device of claim 11, wherein the reservoir caps comprise a metal.

16. The device of claim 11, wherein the substrate comprises silicon.

17. The device of claim 12, wherein the control circuitry is adapted to deliver an electric current or potential to the reservoir cap effective to cause the reservoir cap to disintegrate.

18. The device of claim 12, further comprising an inner cap beneath the reservoir cap and in the opening, for passively controlling transport of molecules through the reservoir opening diffusion of molecules through the inner cap.

19. The device of claim 18, wherein the inner cap comprises a polymeric material.

20. A device for the controlled delivery of molecules comprising:

a substrate;

an array of reservoirs in the substrate;

a release system in the reservoirs comprising molecules for release;

one or more electrodes attached to the substrate inside the reservoirs or to a surface outside of the reservoirs, wherein the one or more electrodes are not reservoir caps; and

means for applying an electric current or potential across the one or more electrodes effective to activate release of the molecules from the reservoirs.

21. The device of claim 20, wherein the device is formed of or coated with a biocompatible material suitable for implantation into a human or animal.

22. The device of claim 20, wherein the release system comprises a matrix material and the molecules for release comprise drug molecules, which are dispersed in the matrix material.

23. The device of claim 22, wherein the matrix material comprises a biodegradable polymer.

24. The device of claim 22, wherein the matrix material disintegrates due to local pH changes induced by application of the electric potential or current.

25. The device of claim 22, wherein, upon application of the electric potential or current, the matrix material exchanges ions in solution with an ionically bound active substance in the release system.

26. The device of claim 20, further comprising reservoir caps positioned over the release system, wherein release of the molecules is controlled by diffision through or disintegration of the reservoir caps.

27. The device of claim 26, wherein application of the electric current or potential across the one or more electrodes swells the release system to rupture the reservoir cap and release the molecules.

28. The device of claim 26, wherein the reservoir caps are outer reservoir caps, and the device further comprises inner reservoir caps positioned in the reservoirs beneath the outer reservoir caps, wherein the inner reservoir caps are permeabilized or disintegrated to release the molecules after the outer reservoir caps are permeabilized or disintegrated.

29. The device of claim 26, wherein the reservoir caps are outer reservoir caps and the release system is a first release system layer, and the device further comprises at least one additional release system layer and at least one additional reservoir cap layer beneath the outer reservoir caps and first release system layer.