Mass transport limited in vivo analyte sensor

Details Mass transport limited in vivo analyte sensor Mass transport limited in vivo analyte sensor

2000-06-16

2003-11-25

Nasser, Robert L. (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S345000, C600S365000

Reexamination Certificate

active

06654625

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to electrochemical analyte sensors, and more particularly to in vivo electrochemical analyte sensors.
BACKGROUND OF THE INVENTION
Subcutaneous glucose sensors based on hydrogen peroxide generation and its electrooxidation are known, for example, as described by David Gough in U.S. Pat. Nos. 4,484,987, 4,671,288, 4,890,620, 4,703,756, 4,650,547 and in Diabetes Care, vol. 5, No. 3, May-June 1982, Part 1, pp. 190-198. In these types of sensors, the production of peroxide or consumption of oxygen by enzymes (e.g., glucose oxidase) is detected on a platinum electrode. A core problem of these sensors is that the signal in such sensors is heavily dependent on a stoichiometrically adequate supply of oxygen to the sensing layer. Often, there is a relatively low concentration of oxygen in the sensing environment, as compared to glucose, which results in oxygen-dependence of the sensor.
SUMMARY OF THE INVENTION
Against this backdrop, the present invention has been developed.
In one embodiment, the invention is directed to an electrochemical sensor including a working electrode, and an analyte-responsive sensing layer proximate the working electrode. The sensing layer is exposed at or near an edge of the sensor, where the sensor signal is limited, at least in part, by mass transport of analyte to the sensing layer. The sensor is configured and arranged for implantation into the body of a mammal for contact with body fluids of the mammal.
In several embodiments of the sensor, the analyte diffuses to the sensing layer via the edge of the sensor, thereby restricting mass transport of the analyte to the sensing layer. This is because the solution-contacting surface area of the sensor edge is much smaller than an open face of the sensing layer.
In some embodiments, the edge is a peripheral edge of the sensor, for example a distal edge of the sensor. In other embodiments, the edge is a side edge of the sensor. In yet other embodiments, the sensor defines a channel having an inner peripheral surface extending into the sensor, and the edge is defined by at least a portion of the inner peripheral surface of the channel. The geometry of the sensor can be any of a broad variety of shapes, but in some embodiments the sensor is planar, and in other embodiments, the sensor is cylindrical.
In some preferred embodiments, the sensor includes a base layer and a top layer, and the sensing layer is at least partially disposed between the base layer and the top layer. Preferably, the base layer and the top layer are impervious to the analyte. In at least some embodiments, the top layer is oxygen permeable.
In another embodiment of the invention the sensor includes a sensor body having an edge, and the analyte-responsive sensing layer is disposed within the sensor body and is exposed at the edge of the sensor body. In at least some embodiments, the sensor body is impervious to analyte.
In some embodiments, sensors developed in accordance with the invention are intended for use in the subcutaneous glucose monitoring system described in U.S. Pat. No. 6,175,752, incorporated herein by reference, although they can be used with other devices and for monitoring other analytes in other parts of the body.
These and various other features as well as advantages which characterize the invention will be apparent from a reading of the following detailed description and a review of the associated drawings.


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