Hermetically sealed microchip reservoir devices

• US 7,497,846 B2
• Filed: 12/06/2004
• Issued: 03/03/2009
• Est. Priority Date: 06/28/2001
• Status: Expired due to Fees

• Current Assignee: Microchips Biotech, Inc. (Keratin Biosciences, Inc.)
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. Jr., Maloney, John M., Uhland, Scott A., Herman, Stephen J., Polito, Benjamin F.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): MOULTON, ELIZABETH ROSE
• Application Number:
  US11/005,391
• Publication Number:
  US 20050077584A1
• Time in Patent Office: 1,548 Days
• Field of Search: 6048901-8921, 604/65, 604/66, 604/173
• US Class Current: 604/173
• 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

Devices are provided for the controlled exposure or release of contents stored in hermetically sealed reservoirs. The devices comprise a primary substrate having a front side and a back side, and including one or more hermetic sealing materials; a plurality of reservoirs in the primary substrate positioned between the front side and the back side; reservoir contents, which comprise chemical molecules (such as drugs) or a secondary device (such as a glucose sensor), located inside the reservoirs; a hermetic sealing substrate having a surface composed of one or more hermetic sealing materials; and a hermetic seal formed between and joining the primary substrate and the hermetic sealing substrate, wherein the hermetic seal independently seals the reservoirs.

Claims

1. An implantable medical device comprising:

a primary substrate having a front side and a back side, and including one or more hermetic sealing materials;

a plurality of reservoirs in the primary substrate positioned between the front side and the back side;

a plurality of biosensors disposed in the reservoirs;

a plurality of discrete reservoir caps sealing the reservoirs at the front side of the primary substrate;

a hermetic sealing substrate having a surface composed of one or more hermetic sealing materials;

a plurality of hermetic seals formed between and joining the primary substrate and the hermetic sealing substrate, wherein each of the hermetic seals individually seals one of the reservoirs at the back side of the primary substrate; and

means for selectively disintegrating the reservoir caps to expose the biosensors to the environment outside of the reservoirs.

2. The device of claim 1, wherein upon exposure to the environment the biosensor is capable of detecting an analyte in vivo.

3. The device of claim 2, wherein the biosensor comprises a glucose sensor.

4. The device of claim 1, wherein the reservoir caps comprise a metal film and the means for selectively disintegrating the reservoir caps comprises control circuitry and a power source.

5. The device of claim 1, wherein the plurality of hermetic seals is the product of a chemical reaction between the one or more hermetic sealing materials of the hermetic sealing substrate and the one or more hermetic sealing materials of the primary substrate.

6. The device of claim 1, wherein the plurality of hermetic seals is formed by localized heating effective to fuse together adjacent surfaces of the one or more hermetic sealing materials of the hermetic sealing substrate and the one or more hermetic sealing materials of the primary substrate.

7. The device of claim 6, wherein the plurality of hermetic seals is formed by a welding process to directly melt, mix, and bond the adjacent surfaces.

8. The device of claim 1, wherein the plurality of hermetic seals is formed by localized resistive heating using a resistor patterned on the primary substrate, the sealing substrate, or both.

9. The device of claim 1, wherein the plurality of hermetic seals comprises a metal gasket mechanically deformed around each reservoir opening.

10. The device of claim 9, wherein either the one or more hermetic sealing materials of the hermetic sealing substrate or the one or more hermetic sealing materials of the primary substrate comprises the gasket and the other hermetic sealing material comprises plurality of rigid, stress concentrating structures.

11. The device of claim 10, wherein the stress concentrating structures comprise a plurality of ridge members and valleys therebetween.

12. The device of claim 11, wherein the ridge members are tapered.

13. The device of claim 9, wherein the plurality of hermetic seals comprises a gold foil.

14. The device of claim 9, wherein the gasket is loaded in compression using mechanical fasteners or welding.

15. The device of claim 1, wherein the plurality of hermetic seals comprises a weld between the one or more hermetic sealing materials of the hermetic sealing substrate and the one or more hermetic sealing materials of the primary substrate.

16. The device of claim 1, wherein the plurality of hermetic seals comprises a metal or an alloy.

17. The device of claim 1, wherein the hermetic sealing materials of the primary substrate, of the sealing substrate, or of both, comprise a silicate glass.

18. The device of claim 1, wherein the plurality of hermetic seals comprises a eutectic bond.

19. The device of claim 18, wherein the eutectic bond comprises a eutectic composition comprising indium or tin.

20. The device of claim 18, wherein the eutectic bond comprises a eutectic composition selected from the group consisting of gold/silicon, gold/germanium, gold/tin, gold/indium, lead/tin, lead/indium, and platinum/silicon.

21. The device of claim 1, wherein the hermetic sealing materials of the primary substrate, of the sealing substrate, or of both, comprise a metal selected from the group consisting of gold, tin, indium, platinum, titanium, palladium, tantalum, aluminum, stainless steel, and combinations thereof.

22. The device of claim 1, wherein the hermetic material of the primary substrate comprises aluminum oxide, aluminum nitride, silicon dioxide, or silicon nitride.

23. The device of claim 1, wherein the plurality of hermetic seals comprises a metal seal and a layer of a biocompatible polymeric material.

24. The device of claim 23, wherein the polymeric material comprises a poly(hydroxy acid) or poly(lactic acid), an epoxy, a polyurethane, a latex, a silicone, or a parylene.

25. The device of claim 24, wherein the primary substrate and the sealing substrate each comprise a gold layer, the two gold layers being bonded together to form the hermetic seal.

26. The device of claim 1, wherein the front side of the substrate comprises metal traces and the hermetic sealing substrate is welded onto the metal traces.

27. The device of claim 1, wherein the hermetic sealing substrate comprises a multi-layered structure including a glass layer anodically bonded to the primary substrate, the glass layer having apertures in communication with the reservoirs.

28. The device of claim 27, wherein the multi-layered structure further comprises a patterned metal layer anodically or eutectically bonded to the glass layer on the side distal the primary substrate.

29. The device of claim 28, wherein the patterned metal layer has apertures in communication with the reservoirs and with the apertures in the glass layer.

30. The device of claim 29, wherein the multi-layered structure further comprises a metal foil laser welded to the patterned metal layer on the side distal the glass layer, the metal sheet sealing the space defined by the reservoirs and apertures.

31. The device of claim 1, wherein the primary substrate or sealing substrate or both substrates comprise a glass or ceramic substrate having a metal layer deposited or bonded thereon.

32. An implantable medical device comprising:

a primary substrate having a front side and a back side, and including one or more hermetic sealing materials;

a plurality of reservoirs in the primary substrate positioned between the front side and the back side;

a plurality of biosensors disposed in the reservoirs;

a plurality of discrete reservoir caps sealing the reservoirs at the front side of the primary substrate;

a hermetic sealing substrate having a surface composed of one or more hermetic sealing materials;

a plurality of hermetic seals formed between and joining the primary substrate and the hermetic sealing substrate, wherein each of the hermetic seals, at the back side of the primary substrate, isolates a first at least one of the discrete reservoirs from a second at least one of the discrete reservoirs; and

control circuitry and a power source for selectively disintegrating the reservoir caps to expose the biosensors to the environment outside of the reservoirs.

33. The device of claim 32, wherein upon exposure to the environment the biosensor is capable of detecting an analyte in vivo.

34. The device of claim 33, wherein the biosensor comprises a glucose sensor.

35. The device of claim 32, wherein the plurality of hermetic seals comprises a metal or an alloy.

36. The device of claim 32, wherein the plurality of hermetic seals comprises a eutectic bond.

37. The device of claim 32, wherein the hermetic sealing materials of the primary substrate, of the sealing substrate, or of both, comprise a metal selected from the group consisting of gold, tin, indium, platinum, titanium, palladium, tantalum, aluminum, stainless steel, and combinations thereof.

38. The device of claim 32, wherein the hermetic material of the primary substrate comprises aluminum oxide, aluminum nitride, silicon dioxide, or silicon nitride.

39. The device of claim 32, wherein the plurality of hermetic seals comprises a metal gasket mechanically deformed around each reservoir opening.

40. The device of claim 32, wherein the primary substrate and the sealing substrate each comprise a gold layer, the two gold layers being bonded together to form the hermetic seal.