Method for making device for controlled reservoir opening by electrothermal ablation

• US 7,910,151 B2
• Filed: 10/27/2005
• Issued: 03/22/2011
• Est. Priority Date: 08/16/2002
• Status: Active Grant

• Current Assignee: DARE MB Incorporated
• Original Assignee: MicroCHIPS Inc.
• Inventors: Sheppard, Norman F. Jr., Maloney, John M., Uhland, Scott A., Yomtov, Barry Y., Polito, Benjamin F., Herman, Stephen J.
• Primary Examiner(s): Barr; Michael
• Assistant Examiner(s): BOWMAN, ANDREW J
• Application Number:
  US11/260,526
• Publication Number:
  US 20080168921A1
• Time in Patent Office: 1,972 Days
• Field of Search: 427/2.1, 604/890, 119/650, 119/654
• US Class Current: 427/2.1
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

Devices and methods for the controlled release or exposure of reservoir contents, and methods of manufacture thereof, are provided. The device includes a reservoir cap formed of an electrically conductive material, which prevents the reservoir contents from passing out from the device and prevents exposure of the reservoir contents to molecules outside of the device; an electrical input lead connected to said reservoir cap; and an electrical output lead connected to said reservoir cap, such that upon application of an electrical current through the reservoir cap, via the input lead and output lead, the reservoir cap ruptures to release or expose the reservoir contents. The reservoir contents can comprise a release system containing drug molecules for release or can comprise a secondary device, such as a sensor. The controlled release system may be incorporated into an implantable drug delivery or biosensing device.

Claims

1. A method of fabricating a device for the controlled exposure or release of molecules or secondary devices, comprising:

forming a plurality of reservoirs in a substrate;

capping openings in said reservoirs with electrically conductive reservoir caps;

forming in operable connection with each reservoir cap an electrical input lead and an electrical output lead; and

connecting said electrical input and output leads to an electrical current supply and distribution means capable of selectively passing an electrical current through each reservoir cap.

2. The method of claim 1, wherein the electrical input and output leads and the reservoir cap are formed of the same material in the same step.

3. The method of claim 1, further comprising coating the reservoir cap, the leads, or both, with a dielectric material.

4. The method of claim 1, further comprising forming a layer of a dielectric material on the substrate, wherein the dielectric material is interposed between the reservoir cap and the substrate to isolate the reservoir cap from the substrate.

5. The method of claim 1, further comprising loading the reservoirs with reservoir contents.

6. The method of claim 5, wherein the reservoir contents comprises a release system comprising drug molecules.

7. The method of claim 5, wherein the reservoir contents comprises a sensor or sensor component.

8. The method of claim 5, wherein the reservoir contents comprises a sensor or sensor component for detection of glucose, urea, calcium, or a hormone in a patient in vivo.

9. The method of claim 1, wherein the reservoir caps comprise at least one metal film.

10. The method of claim 9, wherein the reservoir caps comprise titanium, platinum, gold, or a combination thereof.

11. The method of claim 1, wherein the substrate comprises silicon.

12. The method of claim 1, wherein the reservoirs are micro-reservoirs.

13. The method of claim 1, wherein the substrate part of an implantable catheter.

14. The method of claim 5, further comprising sealing the reservoirs closed with the reservoir contents contained therein.

15. A method of fabricating an implantable medical device for the controlled release of drug or for the controlled exposure of a biosensor, comprising:

forming a plurality of microreservoirs in a substrate, which comprises silicon;

capping openings in said microreservoirs with reservoir caps formed of at least one metal layer;

forming in operable connection with each reservoir cap an electrical input lead and an electrical output lead; and

connecting said electrical input and output leads to an electrical current supply and distribution means capable of selectively passing an electrical current through each reservoir cap.

16. The method of claim 15, further comprising placing a drug formulation or biosensor within the reservoirs and sealing said reservoirs, such that the drug formulation or biosensor is contained within an individual microreservoir.

17. The method of claim 16, further comprising hermetically sealing the substrate and the electrical current supply and distribution means within a packaging structure.

18. A method of fabricating a reservoir device, comprising:

providing a silicon substrate;

depositing at least one first metal layer on the silicon substrate in a pattern of an electrical input lead and an electrical output lead;

depositing at least one second metal layer on the silicon substrate to form a reservoir cap that is continuous with, or has intermetallic junction with, the electrical input lead and the electrical output lead;

etching a reservoir into the silicon substrate, forming an opening in the silicon which is covered by the reservoir cap,

wherein the electrical input and output leads are in electrical connection with the reservoir cap and suited for selectively conducting an electrical current through the reservoir cap.

19. The method of claim 18, further comprising loading the reservoir with a drug.

20. The method of claim 18, further comprising welding the silicon substrate to a packaging structure to hermetically seal the reservoir.

21. The method of claim 18, wherein the reservoir is a microreservoir.

22. The method of claim 21, wherein the reservoir cap comprises a multi-layer/laminate structure of platinum/titanium/platinum.