Long term analyte sensor array

• US 8,523,773 B2
• Filed: 07/15/2009
• Issued: 09/03/2013
• Est. Priority Date: 11/13/2003
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Gottlieb, Rebecca K., Grovender, Eric A., Pendo, Shaun M., Citron, Paul, Van Antwerp, William P.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US12/503,753
• Publication Number:
  US 20100331647A1
• Time in Patent Office: 1,511 Days
• Field of Search: 600/309, 600/347, 600/365
• US Class Current: 600/365
• 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: G01N 33/5438 Electrodes

Abstract

A long term analyte sensor for measuring at least one analyte in the body of a user and which includes a housing, a plurality of analyte contacting sensor elements and at least one structure for relaying information away from the sensor. This plurality of analyte contacting sensor elements are typically disposed in an array. The analyte sensor 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 sensing an analyte within the body of a mammal, the method comprising implanting an analyte sensor in to the mammal, the analyte sensor comprising:

a plurality of analyte sensor elements adapted to contact and sense analyte, the analyte sensor elements comprising;

a base layer;

at least three working electrodes disposed on the base layer;

a glucose oxidase layer disposed upon the at least three working electrodes, wherein the least three working electrodes are coated with the glucose oxidase layer so as to allow the analyte sensing device to sense glucose;

an analyte modulating layer disposed on the glucose oxidase layer, wherein the analyte modulating layer comprises a hydrogel composition that includes a compound selected for its ability to crosslink to a siloxane 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 siloxane composition crosslinked to the compound in the analyte modulating layer and;

at least one analyte sensor membrane disposed upon at least one sealable well in a manner that reversibly prevents an analyte from contacting the at least one of the plurality of analyte sensors, 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

at least one structure operatively coupled to the analyte sensing device for relaying information away from the analyte sensing device; and

sensing an analyte within the body of a mammal.

2. The method of claim 1, further comprising controlling the analyte sensor membrane so that a second analyte sensor element in the plurality of analyte sensor elements contacts analyte after a first analyte sensor element in the plurality of analyte sensor elements exhibits a decrease in the ability to sense analyte due to biofouling, so that the useful life of the analyte sensing device is extended.

3. The method of claim 1, further comprising controlling the analyte sensor membrane so that a second analyte sensor element in the plurality of analyte sensor elements is adapted to contact analyte after a first analyte sensor element in the plurality of analyte sensor elements exhibits a decrease in the ability to sense analyte due to loss of activity of an analyte sensing enzyme disposed in the first analyte sensor element, so that the useful life of the analyte sensing device is extended.

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

5. The method of claim 4, wherein the analyte sensor membrane hermetically seals the analyte sensor element.

6. The method of claim 1, wherein the analyte sensor membrane comprises a biodegradable polymer.

7. The method of claim 6, wherein the biodegradable polymer is comprised of materials selected for their ability to degrade at a defined rate within an in vivo environment.

8. The method of claim 1, wherein the plurality of analyte sensor elements has a plurality of different analyte sensor membranes disposed thereon.

9. The method of claim 1, further comprising controlling each of plurality of analyte sensor membranes disposed on the analyte sensor elements separately.

10. The method of claim 1, wherein the analyte sensing device is a prolonged analyte sensor.

11. The method of claim 1, wherein the analyte sensing device is a permanent analyte sensor.

12. The method of claim 1, wherein at least two of the analyte sensor elements in the analyte sensing device sense the same analyte.

13. The method of claim 1, wherein at least two of the analyte sensor elements in the analyte sensing device sense different analytes.

14. The method of claim 1, wherein a signal from an individual analyte sensor element within the plurality of analyte sensor elements adapted to contact and sense the analyte in the analyte sensing device is individually interrogated.

15. The method of claim 1, wherein at least one of the analyte sensor elements in the analyte sensing device comprises a hydrogel disposed thereon, wherein upon exposure to an aqueous solution, the hydrogel expands in a manner that increases the permeability of the analyte sensor membrane.

16. A method of extending the useful life of an analyte sensing device comprising analyte sensor elements that exhibit a decrease in the ability to sense analyte over time due to biofouling or a loss of activity of an analyte sensing enzyme disposed on an analyte sensor element;

the method comprising sensing an analyte with an analyte sensing device comprising;

a plurality of analyte sensor elements adapted to contact and sense analyte, the analyte sensor elements comprising;

a base layer;

at least three working electrodes disposed on the base layer;

a glucose oxidase layer disposed upon the at least three working electrodes, wherein the least three working electrodes are coated with the glucose oxidase layer so as to allow the analyte sensing device to sense glucose;

an analyte modulating layer disposed on the glucose oxidase layer, wherein the analyte modulating layer comprises a hydrogel composition that includes a compound selected for its ability to crosslink to a siloxane 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 siloxane composition crosslinked to the compound in the analyte modulating layer and;

at least one analyte sensor membrane disposed upon at least one sealable well in a manner that reversibly prevents an analyte from contacting the at least one of the plurality of analyte sensors, 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

at least one structure operatively coupled to the analyte sensing device for relaying information away from the analyte sensing device;

wherein the useful life of an analyte sensing device is extended by;

deactivating a first analyte sensor element in the plurality of analyte sensor elements that contact and sense analyte when the first analyte sensing element exhibits a decrease in the ability to sense analyte due to biofouling or a loss of activity of an analyte sensing enzyme disposed on the first analyte sensor element; and

activating a second analyte sensor element in the plurality of analyte sensor elements that contact and sense analyte by controlling the permeability of an analyte sensor membrane disposed upon the second analyte sensor element to allow an analyte to contact the second analyte sensor element, so that the useful life of the analyte sensing device is extended.