Long term analyte sensor array

• US 20060004272A1
• Filed: 11/15/2004
• Published: 01/05/2006
• 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, Van Antwerp, William P., Grovender, Eric A., Gottlieb, Rebecca K., Pendo, Shaun, Citron, Paul
• Granted Patent: US 7,577,470 B2
• Time in Patent Office: Days
• 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. An analyte sensing device for sensing at least one analyte, the analyte sensing device comprising:

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

at least one analyte sensor membrane disposed upon at least one of the plurality of analyte sensor elements in a manner that reversibly prevents 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

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

2. The analyte sensing device of claim 1, wherein the analyte sensor membrane is controlled 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 analyte sensing device of claim 1, wherein the analyte sensor membrane is controlled 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 analyte sensing device of claim 1, wherein the plurality of analyte sensor elements adapted to contact and sense the analyte are disposed in an array in the analyte sensing device.

5. The analyte sensing device of claim 1, wherein the analyte is glucose.

6. The analyte sensing device of claim 1, wherein the analyte is lactate.

7. The analyte sensing device of claim 1, wherein the analyte sensing device is implantable.

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

9. The analyte sensing device of claim 8, wherein the analyte sensor membrane hermetically seals the analyte sensor element.

10. The analyte sensing device of claim 1, wherein the analyte sensor membrane comprises a biodegradable polymer.

11. The analyte sensing device of claim 10, wherein the biodegradable polymer is comprised of materials selected for their ability to degrade at a defined rate within an in vivo environment.

12. The analyte sensing device of claim 1, wherein the plurality of analyte sensor elements has a plurality of different analyte sensor membranes disposed thereon.

13. The analyte sensing device of claim 12, wherein each of plurality of analyte sensor membranes disposed on the analyte sensor elements is separately controlled.

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

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

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

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

18. The analyte sensing device 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.

19. The analyte sensing device 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.

20. The analyte sensing device of claim 1, wherein the analyte sensing element comprises:

a base layer;

a conductive layer disposed upon the base layer wherein the conductive layer includes a working electrode, a reference electrode and a counter electrode;

an analyte sensing layer disposed on the conductive layer, wherein the analyte sensing layer detectably alters the electrical current at the working electrode in the conductive layer in the presence of an analyte;

an optional protein layer disposed on the analyte sensing layer;

an adhesion promoting layer disposed on the analyte sensing layer or the optional protein layer, wherein the adhesion promoting layer promotes the adhesion between the analyte sensing layer and an analyte modulating layer disposed on the analyte sensing layer; and

an analyte modulating layer disposed on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and

a cover layer disposed on at least a portion of the analyte modulating layer, wherein the cover layer further includes an aperture over at least a portion of the analyte modulating layer

21. The analyte sensing device of claim 1, wherein at least one of the at least one of the plurality of analyte sensor elements is not disposed in a reservoir or well.

26. A kit comprising a container and, within the container, an analyte sensor apparatus according to claim 1, and instructions for using the analyte sensor apparatus.

22. A long term sensor for measuring at least one analyte in the body of a user, the sensor comprising:

a housing;

a sensor coupled to the housing;

at least one structure operatively coupled to the sensor for relaying information away from the sensor,

wherein the sensor includes at least one sensor array having two or more elements that is controllable in a manner such that sensor elements may be activated at different times to extend the useful life of the sensor.

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

providing a plurality of analyte sensor elements adapted to contact and sense analyte;

providing at least one analyte sensor membrane disposed upon at least one of the plurality of analyte sensor elements in a manner that reversibly prevents 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

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

24. 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;

at least one analyte sensor membrane disposed upon at least one of the plurality of analyte sensor elements in a manner that reversibly prevents 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

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.

25. 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;

at least one analyte sensor membrane disposed upon at least one of the plurality of analyte sensor elements in a manner that reversibly prevents 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

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.