Device for monitoring changes in analyte concentration

Details Device for monitoring changes in analyte concentration Device for monitoring changes in analyte concentration

1998-05-22

2001-04-03

O'Connor, Cary (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S347000, C600S365000, C600S373000, C204S403060, C435S287100, C435S817000

Reexamination Certificate

active

06212416

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to electrochemical systems for measuring analyte concentration. In particular, the invention involves a sensor including electrodes under a semi-permeable membrane for monitoring analyte concentrations in fluids surrounding the sensor.
BACKGROUND OF THE INVENTION
There are many instances when it is necessary to monitor the concentration of molecules (“analytes”) in a fluid. For example, glucose levels must be frequently monitored in persons with diabetes so that appropriate doses of insulin can be administered in a timely manner. Many other analytes are measured commonly in human blood and in other fluids.
A variety of methods and devices for measuring analytes in fluids have been devised. One such device, referred to as an electrochemical sensor, typically includes oppositely charged electrodes under a semi-permeable membrane. Depending on what analyte is being monitored, membranes, enzymes and/or other appropriate materials are provided around the electrodes so that analyte reaction and transport from the fluid surrounding the sensor is controlled. Oxidative and reductive reactions take place at or near the electrodes, thus causing electrical potentials measured as changes in current which may be correlated to the concentration of analyte in the fluid.
Electrochemical sensors have been used to measure glucose in human blood. Most of these sensors are designed to measure glucose in a blood sample which has been drawn or extracted from the patient. For patients such as people with diabetes who must test blood glucose levels as often as several times per day, the regular blood drawing process (typically by finger tip puncture) becomes quite cumbersome, messy and even painful. The person with diabetes must carry special equipment for extracting blood. Some patients fail to test as frequently as they should because of problems associated with the blood extracting process.
Therefore, it has been recognized for a long time that an implanted glucose sensor would offer the important advantage of avoiding the need for repeated blood extraction. However, there are other problems which must be addressed with an implantable sensor. First, there must be a mechanism for accessing raw electrical data generated by the sensor under the patient's skin. Protruding wires are undesirable because they are cumbersome, prone to causing infection and sometimes painful. Accordingly, it is preferable to include a wireless data transmission (telemetry) device coupled to the sensor in a single implantable unit so that no trans-dermal wires are required.
Second, an implanted sensing unit may cause internal trauma, i.e., bruising or bleeding from the patient's routine movement or contact with his or her environment, especially if the sensing unit is large or thick or if it is geometrically shaped with any sharp points or edges.
Another problem associated with implantable sensors is that over time (days and weeks) a cellular coat tends to develop around the sensor which may eventually block the analyte of interest from contacting the electrodes, thus causing the sensor to fail.
For these reasons, and perhaps other reasons, researchers in the field have been unsuccessful in their attempts to produce an implantable sensor unit which is capable of functioning satisfactorily for a sufficient period of time to justify the expense and inconvenience of producing and surgically implanting the sensing hardware.
A viable implantable glucose sensor should provide reliable performance for at least 1-2 months, preferably three months or more. During its useful life, the device should generate a predictable dose response over a concentration range of approximately 40 to 400 milligrams per deciliter (mg/dl). The device should exhibit a lag time between a concentration change and the resulting signal output of less than 20 minutes, preferably less than 10 minutes. The sensor should be relatively insensitive to potential interfering substances such as ascorbic acid and acetaminophen. The device should be relatively accurate for at least several days after calibration (stability). Glucose measurement with the sensor should be precise to at least within approximately 10 mg/dl. The sensor should be incorporated in an implantable unit which is capable of wireless data transmission, and which is dimensioned so as to minimize surgical complication and risk of pain, bruising or other internal trauma.
SUMMARY OF THE INVENTION
The objectives stated above are achievable with the device and system of the present invention which includes a device for electrochemically sensing changes in the concentration of an analyte of interest.
In one embodiment of the invention, the device includes a sensor body having two opposing sides. Each side of the body includes at least one, preferably several, anode(s) and at least one cathode spaced apart from each other and covered by a membrane which is semi-permeable to the analyte of interest. In a preferred sensor design for measuring glucose, plural anodes are disposed on two opposing sides of a disc-shaped sensor body. The anodes are covered by an enzyme layer including glucose oxidase and an outer semi-porous membrane layer made of material such a Parylene™ (“PPX”) or Chronoflex™ AR (“CAR”).
In another embodiment of the invention, the sensor body contains a plurality of electrode pairs, each pair including an anode and a cathode. The electrode may take the form of points or lines. In one design, linear electrodes are arranged in a “spoke-like” configuration. The electrode pairs preferably are disposed on both sides of the body.
An implantable glucose sensor, according to the present invention, may be electrically coupled to a transmitter which includes a power source, for example a battery. The transmitter is capable of converting data signals from the sensor into corresponding radio signals. A receiver is provided remotely from the sensor for receiving the radio signals. A processor is connected to the receiver and used to interpret the radio signals, to yield analyte concentration figures.
The present invention also provides a method of making an analyte sensor. A substantially disc-shaped body is provided with two opposing sides. At least one cathode and plural anodes are created on each side of the body. A semi-permeable membrane is deposited on the electrodes. When the method is employed to make a glucose sensor, the enzyme layer including glucose oxidase is created between the anodes and the semi-permeable membrane. An interferent retarding layer may be created between the anodes and the enzyme layer.


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