ICD with continuous regular testing of defibrillation lead status

• US 5,944,746 A
• Filed: 10/30/1998
• Issued: 08/31/1999
• Est. Priority Date: 10/30/1998
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kroll, Mark W.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/183,263
• Time in Patent Office: 305 Days
• Field of Search: 607/8, 607/27, 607/28
• US Class Current: 607/27
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable cardiac stimulating device which incorporates the functionality of both a pacemaker and an implantable cardioverter-defibrillator (ICD). The implantable cardiac stimulating device is adapted to periodically obtain an impedance measurement by applying a pacing pulse to the pacing tip and measuring the resulting current on a lead connected to one of the high voltage shocking coils implanted within the heart. The measured impedance between the pacing lead and the shocking lead is compared to previously obtained impedance measurements to determine if an increase in the impedance has occurred. The system is further adapted to compare the impedance measurement to the impedance measured between the pacing lead and the casing of the implantable cardiac stimulating device to determine whether any increase in the measured impedance is due to a problem with the pacing lead or a problem with the high voltage coil or high voltage lead.

Claims

1. An implantable cardiac stimulating device comprising:

means for delivering pacing pulses to the heart of a patient;

means for delivering high voltage therapeutic waveforms to the heart of a patient;

impedance measuring means for selectively obtaining a first impedance measurement between the means for delivering pacing pulses to the heart of a patient and the means for delivering high voltage therapeutic waveforms to the heart of the patient;

control means for controlling the delivery of pacing pulses and high voltage therapeutic waveforms to the heart of the patient and for controlling the impedance measuring means wherein the control means is adapted to periodically induce the impedance measuring means to obtain the first impedance measurement and wherein the control means compares the first impedance measurement to previously obtained first impedance measurements; and

annunciator means for providing the patient with a warning when the control means determines that the first impedance measurement exceeds previously obtained first impedance measurements.

2. The device of claim 1, wherein the means for delivering pacing pulses to the heart of a patient comprises a pacing lead and tip adapted to be implanted within the heart of the patient.

3. The device of claim 1, wherein the means for delivering high voltage therapeutic waveforms to the heart of the patient comprises a high voltage lead and a coil that are adapted to be implanted within the heart of a patient.

4. The device of claim 1, wherein the control means includes a microprocessor with an associated memory and the microprocessor is adapted to record the first impedance measurements in the memory.

5. The device of claim 4, wherein the microprocessor periodically induces the means for delivering pacing pulses to the heart to deliver a low voltage test pulse and wherein the microprocessor simultaneously induces the impedance measurement means to measure the electrical response on the means for delivering high voltage therapeutic waveforms to the heart of the patient occurring as a result of the delivery of the low voltage test pulse to thereby obtain the first impedance measurement.

6. The device of claim 5, further comprising an indifferent electrode that is adapted to be implanted within the body of the patient.

7. The device of claim 6, wherein the impedance measuring means is further adapted for obtaining a second impedance measurement between the means for delivering pacing pulses to the heart of a patient and the indifferent electrode.

8. The device of claim 7, wherein the microprocessor induces the impedance measuring means to obtain the second impedance measurement upon determining that the first impedance measurement exceeds previously obtained first impedance measurements.

9. The device of claim 8, wherein the microprocessor compares the first impedance to the second impedance and activates the annunciator means only upon determining that the first impedance measurement is greater than the second impedance measurement thereby indicating that the impedance of the means for delivering high voltage therapeutic waveforms to the heart of the patient has increased so as to provide an indication that the means for delivering the high voltage therapeutic waveform has been damaged.

10. The device of claim 9, wherein the microprocessor induces the means for delivering pacing pulses to the heart of the patient to deliver the low voltage test pulse and the microprocessor simultaneously induces the impedance measurement means to measure the electrical response resulting from the delivery of the low voltage test pulse on the indifferent electrode to obtain the second impedance measurement.

11. The device of claim 10, wherein the low voltage test pulse is comprised of a pacing pulse.

12. The device of claim 10, wherein the annunciator means is comprised of a piezoelectric annunciator that provides an audible signal to the patient upon activation of the annunciator means by the control means.

13. An implantable cardiac stimulating device comprising:

a pacing lead adapted to be implanted in the body of a patient so as to be able to provide pacing pulses to the heart of the patient;

a high voltage lead adapted to be implanted in the body of a patient so as to be able to provide high voltage cardioversion or defibrillation waveforms to the heart of the patient;

a control unit, adapted to be implanted in the body of the patient, the control unit being further adapted to periodically induce the pacing lead to emit a first pacing pulse and wherein the control unit is further adapted to measure the resulting electrical response occurring on the high voltage lead so as to be able to obtain a first impedance measurement, wherein the control unit records the first impedance measurement in a memory associated with the control unit and wherein the control unit compares the first impedance measurement to previously obtained first impedance measurements and provides an indication of a potential problem in the high voltage lead when the first impedance measurement exceeds previously obtained first impedance measurements.

14. The device of claim 13, further comprising an indifferent electrode that is adapted to be implanted within the body of the patient.

15. The device of claim 14, wherein the control unit, upon obtaining a first impedance measurement that exceeds previously recorded first impedance measurements, induces the pacing lead to emit the first pacing pulse and wherein the control unit measures the resulting electrical response occurring on the indifferent electrode so as to obtain a second impedance measurement.

16. The device of claim 15, further comprising an annunciator and the control unit enables the annunciator upon obtaining a first impedance measurement that is greater than the previously recorded first impedance measurements and is also greater than the second impedance measurement so that the patient is advised of the need to seek follow up care for a possibly damaged high voltage lead.

17. The device of claim 16, wherein the annunciator is comprised of a piezoelectric element that is adapted to be implanted within the body of the patient and wherein the piezoelectric element emits an audible tone to advise the patient of the need to seek follow up care for the possibly damaged high voltage lead.

18. The device of claim 15, the memory associated with the control unit is adapted to be accessible by a treating physician via a telemetry link so that the treating physician can review stored data including the stored first impedance measurements.

19. The device of claim 18, wherein the control unit is adapted to store a warning in the memory after obtaining a first impedance measurement that is greater than previously recorded first impedance measurements but is less than the second impedance measurement so that a treating physician who is subsequently reviewing the contents of the memory can be advised of a potential pacing tip dislodgement or pacing lead damage.

20. The device of claim 14, wherein the indifferent electrode is comprised of a casing that contains the control unit.

21. The device of claim 13, wherein the high voltage lead is comprised of an RV electrode that is adapted to be implanted within the right ventricle of the heart to deliver defibrillation waveforms to the heart.

22. The device of claim 13, wherein the high voltage lead is comprised of a sub-vena cava electrode that is adapted to be implanted within the sub vena cava of the patient'"'"'s heart to deliver cardioversion waveforms to the heart.

23. An implantable cardiac stimulating device comprising:

a pacing lead adapted to be implanted in the body of a patient so as to be able to provide pacing pulses to the heart of the patient;

a high voltage lead adapted to be implanted in the body of a patient so as to be able to provide high voltage cardioversion or defibrillation waveforms to the heart of the patient;

an indifferent electrode that is adapted to be implanted within the body of the patient; and

a control unit, adapted to be implanted in the body of the patient, the control unit being further adapted to periodically induce the pacing lead to emit a first pacing pulse and wherein the control unit is further adapted to measure the resulting electrical response occurring on the high voltage lead so as to be able to obtain a first impedance measurement, wherein the control unit records the first impedance measurement in a memory associated with the control unit and wherein the control unit compares the first impedance measurement to previously obtained first impedance measurements and is adapted to further induce the pacing lead to emit a second pacing pulse and measure the resulting electrical response occurring on the indifferent electrode so as to be able to obtain a second impedance measurement and wherein the control unit is further adapted to provide an indication of a potential problem in the high voltage lead when the first impedance measurement exceeds previously obtained first impedance measurements and the second impedance measurement.

24. The device of claim 23, further comprising an annunciator and the control unit enables the annunciator upon obtaining a first impedance measurement that is greater than the previously recorded first impedance measurements and is also greater than the second impedance measurement so that the patient is advised of the need to seek follow up care for a possibly damaged high voltage lead.

25. The device of claim 24, wherein the annunciator is comprised of a piezoelectric element that is adapted to be implanted within the body of the patient and wherein the piezoelectric element emits an audible tone to advise the patient of the need to seek follow up care for a possibly damaged high voltage lead.

26. The device of claim 25, the memory associated with the control unit is adapted to be accessible by a treating physician via a telemetry link so that the treating physician can review stored data including the stored first impedance measurements.

27. The device of claim 26, wherein the control unit is adapted to store a warning in the memory after obtaining a first impedance measurement that is greater than previously recorded first impedance measurements but is less than the second impedance measurement so that a treating physician who is subsequently reviewing the contents of the memory can be advised of a potential pacing tip dislodgment or pacing lead damage.

28. The device of claim 23, wherein the indifferent electrode is comprised of a casing that contains the control unit.

29. The device of claim 23, wherein the high voltage lead is comprised of an RV electrode that is adapted to be implanted within the right ventricle of the heart to deliver defibrillation waveforms to the heart.

30. The device of claim 23, wherein the high voltage lead is comprised of a sub-vena cava electrode that is adapted to be implanted within the sub vena cava of the patient'"'"'s heart to deliver cardioversion waveforms to the heart.

31. A method of assessing the impedance of leads of an implanted cardiac stimulating device, the method comprising:

emitting a first pacing pulse from a pacing tip implanted in the heart of a patient;

measuring the resulting electrical response on a high voltage lead implanted in the heart of a patient;

determining a first impedance measurement indicative of the impedance of the high voltage lead;

comparing the first impedance measurement to previously obtained first impedance measurements; and

warning the patient of the existence of a potential problem with the high voltage lead when the first impedance measurement exceeds previously obtained first impedance measurements for the high voltage lead.

32. The method of claim 31, further comprising:

emitting a second pacing pulse form the pacing tip implanted in the heart of a patient when the first impedance measurements exceeds previously obtained first impedance measurements;

measuring the resulting electrical activity on a third electrode so as to obtain a second impedance measurement.

33. The method of claim 32, wherein warning the patient of the existence of a potential problem of the lead occurs only when the first impedance measurement exceeds the previously obtained first impedance measurements for the high voltage lead and further exceeds the second impedance measurement.

34. The method of claim 33, wherein the step of warning the patient comprises activating an annunciator so as to produce an audible tone.