Method and apparatus for dynamically monitoring, detecting and diagnosing lead conditions

• US 20060247706A1
• Filed: 04/29/2005
• Published: 11/02/2006
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: McVenes, Rick D., Germanson, Nancy M., Braly, Alan R., Spear, Thomas H.
• Granted Patent: US 7,515,961 B2
• Time in Patent Office: Days
• US Class Current: 607/27
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

The present invention provides diverse methods and apparatus for in vivo monitoring, detecting and/or predicting potential failure modes or deleterious trends of chronically implanted medical electrical leads prior to actual failure of said leads. Certain embodiments of the invention involve applying a relatively increased data sampling rate at various time intervals (e.g., periodically, randomly, and/or manually-triggered and the like) prior to actual detection of a deleterious trend, to thereby increase the probability of detecting one or more parameters indicative of a potential lead performance issue. At least some of the parameters are utilized because they are not typically reliably detected at relatively lower data sampling rates. In addition to an initial relatively increased data sampling rate, certain embodiments provide for adjusting the sampling rate and storing and/or adjusting data pattern template-based data to execute pattern related triggers so that additional information regarding a medical electrical lead can be obtained.

Claims

1. A method for detecting a lead-related condition, comprising:

collecting at a first relatively high data sampling rate a plurality of medical electrical lead surveillance parameters from an active implantable medical device (IMD) implanted in a subject; and

comparing the collected parameters to a baseline template, wherein said baseline template includes a similar plurality of medical electrical lead surveillance parameters from the active IMD implanted in the subject.

2. A method according to claim 1, wherein if the comparison of the plurality of surveillance parameters measured with the baseline template is outside an acceptable range of deviation then:

comparing template adjustment criteria to the plurality of surveillance parameters measured, and if the criteria are met,

replacing the baseline template with an adjusted baseline template.

3. A method according to claim 2, wherein if the adjustment criteria are not met, comparing the plurality of surveillance parameters measured with the lead surveillance criteria.

4. A method according to claim 2, wherein the adjustment criteria include additional surveillance parameter data.

5. A method according to claim 4, wherein the additional surveillance parameter data include at least one of:

a wave morphology metric, a slew metric, a sense/pace counter metric, a short-circuit pace event metric, an open circuit pace metric, a non-physiologic sense metric, a premature ventricular contraction (PVC) metric, a loss of capture metric, a capture interval metric, a capture duration metric, a heart wall acceleration metric, an activity sensor data metric, a heart rate metric, a blood pressure metric, a stress metric, a strain metric, an oxygen saturation metric, an enzyme activity metric.

6. A method according to claim 5, wherein, as applicable, said metric values represent one of:

a number of occurrences, a time-rate-of-change, an amount of change, an integral, a maximum magnitude, a minimum magnitude, a threshold.

7. A method according to claim 6, wherein the additional surveillance parameter data is cross-referenced to an activity signal of the subject taken during the collecting step and said activity signal is generated by the IMD.

8. A method according to claim 1, wherein the IMD comprises:

a pacemaker, an implantable cardioverter-defibrillator, a neurological stimulation device, a deep brain stimulation device, a muscle stimulation device, an implantable pulse generator, an active medical device coupled to at least one elongated medical electrical lead.

9. A method according to claim 1, further comprising:

storing one of the collected parameters and the results of the compared parameters in a memory structure.

10. A method according to claim 9, further comprising telemetering a signal related to the results of the comparison to a remote device.

11. An apparatus for detecting a lead-related condition, comprising:

means for collecting at a first relatively high data sampling rate a plurality of medical electrical lead surveillance parameters from an active implantable medical device (IMD) implanted in a subject; and

means for comparing the collected parameters to a baseline template, wherein said baseline template includes a similar plurality of medical electrical lead surveillance parameters from the active IMD implanted in the subject.

12. An apparatus according to claim 11, wherein if the means for comparing of the plurality of surveillance parameters measured with the baseline template lies outside an acceptable range of deviation then further comprising:

means for comparing template adjustment criteria to the plurality of surveillance parameters measured; and

means for replacing the baseline template with an adjusted baseline template.

13. An apparatus according to claim 12, further comprising wherein if the adjustment criteria are not met means comparing the plurality of surveillance parameters measured with the lead surveillance criteria.

14. An apparatus according to claim 12, wherein the adjustment criteria include additional surveillance parameter data.

15. An apparatus according to claim 14, wherein the additional surveillance parameter data include at least one of:

a wave morphology metric, a slew metric, a sense/pace counter metric, a short-circuit pace event metric, an open circuit pace metric, a non-physiologic sense metric, a premature ventricular contraction (PVC) metric, a loss of capture metric, a capture interval metric, a capture duration metric, a heart wall acceleration metric, an activity sensor data metric, a heart rate metric, a blood pressure metric, a stress metric, a strain metric, an oxygen saturation metric, an enzyme activity metric.

16. An apparatus according to claim 15, wherein, as applicable, said metric values represent one of:

a number of occurrences, a time-rate-of-change, an amount of change, an integral, a maximum magnitude, a minimum magnitude, a threshold.

17. A method to detect a lead-related condition that can indicate possible future lead degradation or failure, the method comprising of:

measuring a plurality of surveillance parameters that can include impedance and threshold from an active lead implanted in a body at a first sampling rate;

comparing the plurality of surveillance parameters measured with a baseline template; and

generating an output dependent on the comparison.

18. A method according to claim 17, wherein the baseline template is created by:

selecting default programmable surveillance parameters;

inputting values for the default programmable surveillance parameters; and

creating the baseline template from the values for the default programmable surveillance parameters for a particular measurement interval.

19. A method according to claim 17, wherein the output generated is used to create an adjusted template.

20. A method according to claim 17, wherein the output generated is used to send a notification signal to a remote station.