Implantable device for monitoring changes in analyte concentration

• US 6,466,810 B1
• Filed: 11/28/2000
• Issued: 10/15/2002
• Est. Priority Date: 11/22/1995
• Status: Expired due to Fees

• Current Assignee: Legacy Good Samaritan Hospital And Medical Center
• Original Assignee: Legacy Good Samaritan Hospital And Medical Center
• Inventors: Wilgus, Eric S., Ward, W. Kenneth
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/724,918
• Time in Patent Office: 686 Days
• Field of Search: 600/345-350, 600/353, 600/355, 600/357, 600/364, 600/365, 600/363, 600/377, 204/415
• US Class Current: 600/345
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode

Abstract

The invention provides an electrochemical sensor system for measuring analyte concentrations in a fluid sample. The invention is particularly useful for measuring analytes such as glucose in a patient. An implantable glucose sensor includes a disc-shaped sensor body containing multiple anodes on opposing sides of the sensor body. Electrodes including an anode and a cathode are connected to a transmitter which transmits radio signals to an external receiver and computer where data is processed to yield glucose concentration figures. An enzyme layer coating the anodes specifically reacts with glucose to increase signals generated by the anodes in response to the presence of glucose. In an alternate embodiment, some of the anodes are coated with the enzyme to generate a first signal, and other anodes that are not coated generate a second signal for comparison with the first signal to eliminate effects of interfering substances on the accuracy of the glucose measurement.

Claims

1. An implantable device for electrochemically sensing changes in the concentration of an analyte of interest, and transmitting signals indicative of the concentration changes, comprising

a transmitter including a power source

a sensor electrically coupled to the transmitter, the sensor including a disc-shaped body having two opposing sides, each side of the sensor body having a cathode and a plurality of anodes, whereby the combined transmitter and sensor can be implanted in a mammal for wireless transmission to an external receiver of data indicative of analyte concentration.

2. The device of claim 1 wherein the analyte of interest is glucose.

3. The device of claim 2 further comprising

an enzyme layer comprising glucose oxidase covering the anodes, and

a membrane semi-permeable to glucose covering the enzyme layer.

4. The device of claim 1 further comprising an amplifier and an electrometer, the cathodes and anodes from the sensor being connected to the amplifier and the electrometer converting current signals into voltage signals before transmitting corresponding data signals to an external processing device.

5. The device of claim 1 further comprising an analog-to-digital converter connected to the sensor for converting analog signals indicative of current changes into digital signals prior to transmitting corresponding data to an external receiver.

6. An analyte concentration monitoring system comprising

a sensor including a sensor body having two opposing sides, each side of the sensor body having at least one cathode, plural anodes and a semi-permeable membrane covering the anodes, the sensor being capable of generating analog data signals indicative of analyte concentration in a fluid surrounding the sensor,

a transmitter including a power source, the transmitter being electrically coupled to the sensor and capable of converting the data signals into corresponding radio transmission signals

a receiver for receiving the radio transmission signals at a remote location.

7. The system of claim 6 further comprising a processor connected to the receiver for interpreting and converting the radio transmission signals into analyte concentration information.

8. A method of making an implantable analyte sensor comprising

providing a sensor body having two opposing sides,

creating at least one cathode and plural anodes on both sides of the sensor body, and

depositing a semi-permeable membrane on the cathodes and anodes.

9. The method of claim 8 wherein the analyte is glucose, further comprising depositing an enzyme layer including glucose oxidase on the anodes before the step of depositing the semi-permeable membrane.

10. The method of claim 8 wherein the depositing of a semi-permeable membrane includes depositing a layer of polyparaxylxylene or a carbonate-based polyurethane.

11. The method of claim 8 wherein the sensor body is substantially disc-shaped.

12. The method of claim 9 further comprising electrically coupling the sensor to a radio transmitter.

13. The method of claim 12 further comprising

implanting the sensor and transmitter into a mammal,

sensing glucose concentration changes,

transmitting corresponding radio signals to a remote receiver, and

processing and interpreting the radio signals into glucose concentration data.