Fabrication of multi-sensor arrays

• US 8,414,489 B2
• Filed: 01/12/2005
• Issued: 04/09/2013
• Est. Priority Date: 11/13/2003
• Status: Active Grant

• Current Assignee: DARE MB Incorporated, Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Pendo, Shaun M., Gottlieb, Rebecca K., Bruso, Gil, Soundararajan, Gopikrishnan, Wolfe, Katherine T.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US11/034,371
• Publication Number:
  US 20060076236A1
• Time in Patent Office: 3,009 Days
• Field of Search: 600/347, 600/345, 600/365, 204/403.01
• US Class Current: 600/365
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

The disclosure provides methods for fabricating a long-term analyte sensor for measuring at least one analyte in the body of a user. The analyte sensors made by these methods include a plurality of analyte contacting sensor elements and at least one structure for relaying information to and from the sensor. The analyte sensor so fabricated further includes at least one sensor protection membrane that is controllable in a manner such that sensor elements may be activated (e.g. exposed to the external environment) at different times so as to extend the useful life of the sensor. In illustrative analyte sensors, the analyte is glucose.

Claims

1. A method of making an analyte sensor apparatus for implantation within a mammal comprising the steps of:

providing a substrate layer;

forming a plurality of analyte sensor elements on the substrate layer including a first analyte sensor element and a second analyte sensor element, wherein each of the analyte sensor elements is adapted to contact and sense analyte and comprise;

at least three working electrodes disposed on the substrate layer;

a glucose oxidase layer disposed upon the at least three working electrodes;

an analyte modulating layer disposed on the glucose oxidase layer, wherein the analyte modulating layer comprises a hydrogel composition;

an adhesion promoting layer disposed between the glucose oxidase layer and the analyte modulating layer that functions to promote adhesion between the glucose oxidase layer and the analyte modulating layer, wherein the adhesion promoting layer comprises a compound having a siloxane moiety and;

forming a lid layer upon at least one of the plurality of analyte sensor elements;

forming a sealed aperture on the lid layer;

forming at least one analyte sensor membrane disposed upon at least one of the plurality of analyte sensor elements in a manner that can reversibly prevent an analyte from contacting the at least one of the plurality of analyte sensor elements, wherein the permeability of the analyte sensor membrane can be controlled to allow an analyte to contact at least one of the plurality of analyte sensor elements; and

forming at least one structure operatively coupled to the analyte sensing apparatus for relaying information to and away from the analyte sensing apparatus, wherein the analyte sensing device is made so that the first and second analyte sensor elements in the analyte sensing device sense different analytes, so that an analyte sensor apparatus is made.

2. The method of claim 1, wherein the analyte sensor membrane comprises a metal foil whose permeability is controlled by applying an electric current or an electric potential to the analyte sensor membrane.

3. The method of claim 1, further comprising hermetically coupling the analyte sensor membrane to the substrate layer, wherein the substrate layer comprises aluminum oxide.

4. The analyte sensing device of claim 1, wherein the analyte sensor membrane comprises a rupturable metallic membrane.

5. The method of claim 1, wherein the lid layer comprises one or more three dimensional features made by a process which includes chemical etching, reactive ion etching, ion milling, sputtering, evaporation, ion beam assisted deposition, chemical vapor deposition, welding, soldering or brazing.

6. The method of claim 1, wherein the analyte sensor apparatus is made so that the plurality of analyte sensor elements have a plurality of different analyte sensor membranes disposed thereon.

7. The method of claim 6, wherein each of plurality of analyte sensor membranes disposed on the analyte sensor elements is separately controlled.

8. The method of claim 1, wherein the analyte sensing device is made to be a prolonged analyte sensor or a permanent analyte sensor.

9. The method of claim 1, further comprising coupling the apparatus to a multi-lumen catheter in which a first lumen provides connectors for sensor power, data collection, and display, and a second lumen provides connectors which provide power used to change the permeability of the analyte sensor membrane.

10. The method of claim 1, wherein the first analyte sensor element senses glucose and the second analyte sensor element senses lactate.

11. The method of claim 1, wherein the second analyte sensor comprises lactate oxidase.