Method and apparatus to manage lead-related conditions for fault tolerance enhancements

• US 8,798,751 B2
• Filed: 06/09/2011
• Issued: 08/05/2014
• Est. Priority Date: 06/09/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Spear, Thomas H., Germanson, Nancy M., Miller, Patrick D.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US13/156,660
• Publication Number:
  US 20120316621A1
• Time in Patent Office: 1,153 Days
• Field of Search: 607/27, 607/28, 607116-128
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

The disclosure describes methods and devices for providing early indicators of a lead-related condition in a medical electrical lead. Among other things, the methods and devices will detect, obtain, or provide indicators of static or intermittent disruptions in a conductive pathway of the lead based on changes in conductive continuity properties of a medical electrical lead. The conductive behaviors and properties will be managed to facilitate signal stability and fidelity. In some embodiments, the methods and devices may include functions to enable one or more of monitoring a lead'"'"'s conductive pathway, detecting static and transient behaviors of the conductive pathway, stabilizing the monitored pathway, reconfiguring the pathway, and providing lead-related condition data to an associated implantable medical device. The early indicators may be generated in a real-time, continuous manner to provide early detection and notification of lead degradation.

Claims

1. An implantable medical device, comprising:

a housing including circuitry configured to control a medical function;

a medical electrical lead operative to perform the medical function, the lead having;

a distal end,

a proximal end configured for coupling to the housing;

a first conductor extending from the distal end to the proximal end of the lead;

a sensing element electrically coupled to the first conductor at the distal end; and

a signal stability module coupled along a length of the first conductor operative to process a physiologic signal sensed by the sensing element and to generate a lead condition signal based on the sensed physiologic signal, wherein the lead condition signal is a function of an electrical property of the first conductor and is indicative of a lead-related condition associated with the lead.

2. The implantable medical device of claim 1, wherein the signal stability module comprises means for generating a default state signal for transmission to the circuitry within the housing in response to the lead condition signal being indicative of the presence of a lead-related condition of the first conductor.

3. The implantable medical device of claim 1, wherein the signal stability module comprises:

means for detecting a discontinuity in the first conductor in response to the monitored electrical property; and

means for generating the lead condition signal in response to the detected discontinuity.

4. The implantable medical device of claim 3, wherein the means for detecting the discontinuity classifies the discontinuity as being indicative of a discontinuity selected from the group consisting of a static and an intermittent discontinuity.

5. The implantable medical device of claim 4, wherein the means for detecting the discontinuity further categorizes the intermittent discontinuity as being indicative of an indicator selected from the group consisting of a leading indicator and a system critical indicator.

6. The implantable medical device of claim 1, wherein the signal stability module includes a lead monitoring module, comprising:

means for receiving a representation of the monitored electrical property of the first conductor;

means for evaluating the representation to determine whether the representation is indicative of a state transition, wherein the lead condition signal is generated in response to the evaluation.

7. The implantable medical device of claim 6, wherein the evaluation is performed based on a comparison of the received representation to a threshold parameter.

8. The implantable medical device of claim 6, wherein the lead condition signal comprises a first output generated in response to the monitored electrical property satisfying a first criteria and a second output generated in response to the monitored electrical property satisfying a second criteria.

9. The implantable medical device of claim 8, wherein the first criteria is satisfied in response to the level of the representation being less than the threshold parameter and the second criteria is satisfied in response to the level of the representation exceeding the threshold parameter.

10. The implantable medical device of claim 9, wherein a notification is generated in response to the second criteria being satisfied.

11. The implantable medical device of claim 9, further comprising a transient processing module operative to compute the number of times the second criteria is satisfied.

12. The implantable medical device of claim 1, further comprising

means for decoupling the sensing element from the medical electrical lead in response to a detection of a lead-related condition of the first conductor that is detected based on the processing of the physiologic signal sensed by the sensing element.

13. The implantable medical device of claim 1, further comprising

wherein the sensing element is an electrode and the sensed signal is representative of a cardiac depolarization of a heart.

14. The implantable medical device of claim 1, wherein the sensing element is a sensor selected from the group consisting of a blood pressure sensor and an oxygen sensor.

15. The implantable medical device of claim 1, wherein the signal stability module is disposed within the medical electrical lead.

16. The implantable medical device of claim 1, wherein the signal stability module includes a comparator circuit, comprising:

a reference signal generator configured to generate a reference signal; and

a monitoring module configured to compare the electrical property of the first conductor that is derived from the lead condition signal with the generated reference signal to detect a deviation of the monitored electrical property from the reference signal.

17. The implantable medical device of claim 16, wherein the reference signal generator comprises a bias voltage source and at least a resistor for dividing the voltage generated by the bias voltage source.

18. The implantable medical device of claim 16, wherein the monitoring module comprises a comparator having an op-amp configured to receive the electrical property of the first conductor and the predetermined reference signal.

19. The implantable medical device of claim 16, further comprising means for stabilizing the first conductor, wherein the stabilizing means triggers a default electrical state in response to the detected deviation.

20. The implantable medical device of claim 19, wherein the stabilizing means comprises a pull-up resistor coupled to a voltage generator operable to generate a voltage signal greater than a reference voltage signal generated by the reference signal generator.

21. The implantable medical device of claim 1, wherein controlling the medical function comprises performing reconfiguration of a therapy delivery function associated with the first conductor.

22. The implantable medical device of claim 1, wherein the signal stability module generates the lead condition signal including lead condition attributes that provide an indication of a detected state transition of the sensed signal.

23. The implantable medical device of claim 22, wherein the detected state transition is indicative of the lead-related condition.

24. The implantable medical device of claim 22, wherein the state transition is represented by a deviation of an electrical parameter of the sensed signal from a pre-selected level.

25. The implantable medical device of claim 1, further comprising a processing module configured to control the medical function through the medical electrical lead, wherein controlling the medical function comprises performing containment of a therapy delivery function associated with the first conductor.

26. The implantable medical device of claim 1, further comprising a notification module configured to generate a notification signal as a function of the lead condition signal.

27. The implantable medical device of claim 26, wherein the notification signal is generated in response to detection of a state transition of the signal sensed by the sensing element.

28. The implantable medical device of claim 26, wherein in response to the monitored electrical property of the signal sensed by the sensing element, the signal stability module performs one of:

a. propagates the sensed signal, and

b. propagates the notification signal.

29. The implantable medical device of claim 6, wherein the lead monitoring module includes a comparator for evaluating the signal sensed by the sensing element to detect the lead-related condition.

30. The implantable medical device of claim 29, wherein the evaluation is performed by comparing the signal sensed by the sensing element to a predetermined level.

31. The implantable medical device of claim 1, further comprising a processing module configured to control the medical function through the medical electrical lead based on the lead condition signal.

32. The implantable medical device of claim 1, further comprising a behavior remodeling module configured to generate a remodeled signal responsive to an indication of a lead-related condition associated with the lead, wherein the remodeled signal is transmitted to the circuitry within the housing to control the medical function through the medical electrical lead.