Implantable sensor and integrity tests therefor

• US 20020042561A1
• Filed: 11/30/2001
• Published: 04/11/2002
• Est. Priority Date: 10/20/1997
• Status: Active Grant

• Current Assignee: Joseph H. Schulman, Rajiv Shah
• Original Assignee: Joseph H. Schulman, Rajiv Shah
• Inventors: Shah, Rajiv, Schulman, Joseph H.
• Granted Patent: US 7,778,679 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

An implantable sensor includes electronic circuitry for automatically performing on a periodic basis, e.g., every 1 to 24 hours, specified integrity tests which verify proper operation of the sensor.

Claims

1. In an electrochemical sensor having an hermetically sealed portion and a non-hermetically sealed portion, the hermetically sealed portion containing electronic circuitry, the non-hermetically sealed portion having at least one electrode associated therewith, the electronic circuitry comprising means for measuring a specified parameter within body fluids or tissue to which the at least one electrode is exposed, and means for performing at least one integrity test to verify proper operation of the sensor.

2. The electrochemical sensor of claim 1 wherein said means for performing at least one integrity test comprises means for automatically performing the at least one integrity test upon occurrence of a specified event.

3. The electrochemical sensor of claim 2 wherein the specified event comprises the passage of time in accordance with a predefined schedule, whereby the at least one integrity test is automatically performed in accordance with the predefined schedule.

4. The electrochemical sensor of claim 2-wherein the specified event comprises the measurement of a parameter that falls outside of predefined limits, whereby the at least one integrity test is automatically performed whenever a parameter measurement indicates the parameter is not within the predefined limits.

5. The electrochemical sensor of claim 2 wherein said at least one integrity test comprises performing an electrical measurement between the at least one electrode and another reference point within said sensor.

6. The electrochemcial sensor of claim 2 wherein the electrical measurement performed by the at least one integrity test comprises making an impedance measurement between the at least one electrode and reference point.

7. The electrochemical sensor of claim 1 wherein said sensor comprises an implantable glucose sensor having a plurality of electrodes associated with its non-hermetically sealed portion, wherein said plurality of electrodes comprise a first working electrode, a second working electrode, a reference electrode and a counter electrode.

8. The electrochemical sensor of claim 7 wherein the at least one integrity test comprises measuring the resistance between the first working electrode and second working electrode, and wherein said resistance measurement should be approximately 1000 ohms ±

50% when the sensor is functioning properly within its implantable environment.

9. The electrochemical sensor of claim 7 wherein the at least one integrity-test comprises measuring the voltage potential between the reference electrode and the counter electrode and determining if such voltage potential has changed more than about 40% since a previous measurement of the voltage potential.

10. The electrochemical sensor of claim-7 wherein said at least one integrity test comprises mesuring an electrical current that flows between one of the first or second working electrodes and the counter electrode while maintaining the reference electrode at first and second reference potentials, thereby obtaining two points on a voltage-current curve, and determining if the slope of the voltage-current curve is within a prescribed degree of flatness.

11. The electrochemical sensor of claim 10 wherein the first and second reference potentials at which the reference electrode is maintained are centered about 0.5 volts, wtih the first reference potential comprising 0.5 volts minus Vx, and the second reference potential comprising 0.5 volts plus Vx, where Vx is a voltage ranging from about 0.05 volts to 0.20 volts.

12. The electrochemical sensor of claim 1 wherein at least three of said electrochemical sensors are implanted within the same body fluids or tissue location in close proximity to each other, and wherein said at least one integrity test comprises independently measuring the specified parameter with each of said implantable sensors and comparing the results of said independent measurements to determine if all of the measurements are within about 20% of each other.

14. The implantable sensor of claim 13 wherein said implantable structure comprises an hermetically-sealed housing, an integrated circuit (IC) chip inside of said housing, at least one electrode external to said housing, and means for making an electrical connection between the IC chip and said at least one electrode.

15. The implantable sensor of claim 14 wherein said means for performing at least one specified integrity test comprises means for measuring voltage, current, or impedance between said at least one electrode and a specified reference point.

16. The implantable sensor of claim 15 wherein said specified reference point comprises a point external to said hermetically-sealed housing.

17. The implantable sensor of claim 15 wherein said specified reference point comprises a point internal to said hermetically-sealed housing.

19. The method of claim 18 further including implanting at least three senors in the same general tissue area, and wherein said step of periodically performing said at least one integrity test comprises periodically monitoring said output signal from each of said at least three sensors and checking to ensure that all three output signals remain within a specified tolerance of each other.

20. The method of claim 18 further including implanting at least three senors in the same general tissue area, and wherein said step of periodically performing said at least one integrity test comprises periodically monitoring a voltage, current or impedance measurement associated with each of said at least three sensors and checking to ensure that all three measurements remain within a specified tolerance of each other.

13. An implantable sensor comprising:

implantable structure;

means integral with said implantable structure for generating an electrical signal indicative of a monitored parameter; and

electronic circuitry integral with said implantable structure, said electronic circuitry including means for automatically performing on a periodic basis at least one specified integrity test which verifies proper operation of the sensor.

18. A method of testing an implantable sensor, said sensor including means for sensing a parameter and generating an output signal indicative thereof, said method comprising the steps of:

placing circuitry integral with said sensor that performs at least one integrity test designed to verify proper operation of said implantable sensor; and

periodically performing said at least one integrity test while said implantable sensor remains implanted