IMPLANTABLE MEDICAL DEVICE INCLUDING ISOLATION TEST CIRCUIT

• US 20110160808A1
• Filed: 12/23/2010
• Published: 06/30/2011
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bocek, Joseph M., Stahmann, Jeffrey E., Lyden, Michael J.
• Granted Patent: US 8,750,997 B2
• Time in Patent Office: Days
• US Class Current: 607/63
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

An implantable medical device can include a hermetically-sealed implantable housing, an exposed first conductor located on or near the housing, and at least one insulated second conductor located near the exposed first conductor. In an example, the implantable medical device can include an isolation test circuit to provide a test stimulus to the exposed first conductor and configured to measure a portion of the test stimulus coupled to the second conductor.

Claims

1. An implantable medical device, comprising:

a hermetically-sealed implantable housing;

an exposed first conductor located on or near the housing;

at least one insulated second conductor located near the exposed first conductor; and

an isolation test circuit configured to provide a test stimulus to the exposed first conductor and configured to measure a portion of the test stimulus coupled to the second conductor, the isolation test circuit including;

a comparator configured to compare the portion of the test stimulus coupled to the second conductor to a specified threshold value; and

a controller circuit configured to trigger an alert to a user in response to the comparison when the portion of the stimulus coupled to the second conductor exceeds the specified threshold value.

2. The implantable medical device of claim 1, wherein the isolation test circuit includes a test stimulus generator comprising a current source, and wherein the test stimulus signal includes at least one current pulse generated by the current source, the current source configured to selectively inject the current at least between the first and second conductors.

3. The implantable medical device of claim 2, wherein the isolation test circuit includes a measurement circuit configured to measure a voltage developed between the first and second conductors.

4. The implantable medical device of claim 3, wherein the controller circuit is configured to determine an impedance between the first and second conductors using information about the injected current and the measured voltage.

5. The implantable medical device of claim 4, wherein the controller circuit is configured to determine a baseline impedance between the first and second conductors using at least two impedance determinations;

and

wherein the controller circuit is configured to determine a relative indication of impedance information using a present impedance determination and one or more previous impedance determinations, or the baseline.

6. The implantable medical device of claim 5, wherein the controller circuit is configured to trigger the alert to the user when the relative indication of impedance information is outside a relative indication range;

and wherein the relative indication range is selected from a list including a standard deviation range, a ratio range, a percentage range, or a variance range.

7. The implantable medical device of claim 1, wherein the isolation test circuit comprises a magnetic detector;

and

wherein the controller circuit is coupled to the magnetic detector and configured to automatically trigger an isolation test between the first and second conductors in response to a signal from the magnetic detector when the magnetic detector is or has been exposed to a magnetic field having an intensity above a specified threshold.

8. The implantable medical device of claim 1, comprising a header block configured to receive one or more implantable lead assemblies;

and wherein the header block includes the insulated second conductor, the insulation including a cavity for a seal plug.

9. The implantable medical device of claim 8, wherein the isolation test circuit is configured to detect at least one of a missing seal plug or an insulation failure near the second conductor when the specified threshold is exceeded, using the coupled portion of the test stimulus signal as measured by the isolation test circuit, when the implantable medical device is implanted.

10. The implantable medical device of claim 8, wherein the isolation test circuit is configured to measure a baseline voltage developed across the first and second conductors using the measurement circuit without requiring use of the stimulus circuit;

wherein the comparator is configured to compare the baseline voltage with a specified baseline threshold voltage value; and

wherein the controller circuit is configured to trigger an alert to a user in response to the comparison when the baseline voltage exceeds the specified baseline threshold voltage value.

11. An implantable medical device, comprising:

a hermetically-sealed implantable housing;

an exposed first conductor located on or near the housing;

at least one insulated second conductor located near the exposed first conductor; and

an isolation test circuit configured to provide a test stimulus to the exposed first conductor and configured to measure a portion of the test stimulus coupled to the second conductor, the isolation test circuit including;

a comparator configured to compare the portion of the test stimulus coupled to the second conductor to a specified threshold value;

a controller circuit configured to trigger an alert to a user in response to the comparison when the portion of the stimulus coupled to the second conductor exceeds the specified threshold value;

a magnetic detector coupled to the controller circuit and wherein the controller circuit is configured to provide a trigger to the isolation test circuit, the trigger causing the isolation test circuit to measure the coupled portion between the first and second conductors when the magnetic detector is exposed to a magnetic field having an intensity above a specified threshold.

12. A method, comprising:

providing an isolation test between a first conductor located on or near a hermetically-sealed implantable medical device housing and at least one insulated second conductor located near the exposed first conductor, the isolation test including;

providing a test stimulus to the exposed first conductor using an isolation test circuit included in the implantable medical device housing;

measuring a portion of the test stimulus coupled to the insulated second conductor; and

comparing the measured portion of the test stimulus to a specified threshold value; and

in response triggering an alert to a user using a control circuit included within the implantable medical device housing when the comparing the measured portion indicates that the measured portion exceeds the specified threshold value.

13. The method of claim 12, wherein the providing the test stimulus includes providing at least one current pulse generated by a current source included in the isolation test circuit, the at least one current pulse injected at least between the first and second conductors.

14. The method of claim 13, wherein the measuring a portion of the test stimulus includes measuring a voltage developed between the first and second conductors in response to the at least one current pulse injected between the first and second conductors.

15. The method of claim 14, comprising determining an impedance between first and second conductors using information about the injected current and the measured voltage.

16. The method of claim 15, comprising determining a baseline impedance between the first and second conductors using at least two impedance determinations;

and

determining a relative indication of impedance information using a present impedance determination and one or more previous impedance determinations, or the baseline.

17. The method of claim 16, wherein the triggering the alert using the controller circuit includes triggering an alert to the user when the relative indication of impedance information is outside a relative indication range, the relative indication range selected from a list including a standard deviation range, a ratio range, a percentage range, or a variance range.

18. The method of claim 12, comprising detecting a magnetic field using a magnetic detector included in the implantable medical device housing;

and

triggering the isolation test between at least the first and second conductors using the controller circuit using information from the magnetic detector when the magnetic detector is or has been exposed to a magnetic field having an intensity above a specified threshold.

19. The method of claim 12, wherein the measuring the portion of the stimulus coupled to the second conductor includes measuring the portion of the stimulus coupled to the second conductor when the second conductor is included as a portion of a header block attached to the housing of the implantable medical device, the header block configured to receive one or more implantable lead assemblies, and including a cavity for a seal plug.

20. The method of claim 19, wherein the providing the isolation test includes detecting at least one of a missing seal plug or an insulation failure near the second conductor when the specified threshold value is exceeded as indicated by the comparing of the measured portion of the stimulus coupled to the second conductor;

and

wherein the method comprises storing information about one or more of a patient activity level, or a patient posture, corresponding to at least a portion of an interval of time where the isolation test stimulus is provided.