Tissue characterization using intracardiac impedances with an implantable lead system

• US 8,065,005 B1
• Filed: 03/12/2007
• Issued: 11/22/2011
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Panescu, Dorin, Shaquer, Cem, Shahparnia, Shahrooz, Bornzin, Gene A., Wong, Louis, Park, Euljoon, Walker, Andre, Xia, Jiong
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bays; Pamela M
• Application Number:
  US11/684,688
• Time in Patent Office: 1,716 Days
• Field of Search: 600/442, 600/547, 607/2, 607/8, 607/9, 607/28, 607/45, 607/4, 607/17
• US Class Current: 607/28
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An implantable system acquires intracardiac impedance with an implantable lead system. In one implementation, the system generates frequency-rich, low energy, multi-phasic waveforms that provide a net-zero charge and a net-zero voltage. When applied to bodily tissues, current pulses or voltage pulses having the multi-phasic waveform provide increased specificity and sensitivity in probing tissue. The effects of the applied pulses are sensed as a corresponding waveform. The waveforms of the applied and sensed pulses can be integrated to obtain corresponding area values that represent the current and voltage across a spectrum of frequencies. These areas can be compared to obtain a reliable impedance value for the tissue. Frequency response, phase delay, and response to modulated pulse width can also be measured to determine a relative capacitance of the tissue, indicative of infarcted tissue, blood to tissue ratio, degree of edema, and other physiological parameters.

Claims

1. An implantable device, comprising:

one or more electrodes for implanting in contact with a bodily tissue;

a pulse generator configured to produce pulses that are applied to the bodily tissue, wherein the pulses are used to measure a physiological parameter, and the pulses are applied via the one or more electrodes;

wherein each pulse has a multi-phasic waveform consisting of positive phases and negative phases;

wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and the amplitude is defined as the length of the phase, further wherein the alternating positive and negative phases have different absolute amplitudes; and

wherein each pulse has a duration less than a charging time constant of an electrode-electrolyte interface between the electrode and the bodily tissue.

2. The implantable device as recited in claim 1, wherein each multi-phasic waveform has alternating positive phases and negative phases that are charge-balanced and voltage-balanced.

3. The implantable device as recited in claim 1, further comprising a circuit in the pulse generator to vary the duration of the pulses.

4. The implantable device as recited in claim 3, further comprising a signal processor to detect a change in the shape of sensed response waveforms resulting from application of the pulses of various durations.

5. The implantable device as recited in claim 4, wherein the implantable device processes an indicator to indicate the presence of a condition associated with a decreased capacitance of the bodily tissue if a negligible change is sensed in the shape of the response waveforms.

6. The implantable device as recited in claim 5, wherein the decreased capacitance indicates a presence of a condition comprising at least in part infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

7. The implantable device as recited in claim 1, further comprising a signal processor to determine a phase delay between the applied pulses and sensed response waveforms.

8. The implantable device as recited in claim 7, wherein the implantable device processes an indicator to indicate a presence of a condition associated with a decreased capacitance of the bodily tissue if a negligible phase delay is determined.

9. The implantable device as recited in claim 8, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

10. The implantable device as recited in claim 1, further comprising a signal processor to determine a frequency response of the bodily tissue resulting from application of the pulses.

11. The implantable device as recited in claim 10, wherein the implantable device processes an indicator to indicate a presence of a condition associated with a decreased capacitance of the bodily tissue if the frequency response is substantially flat over a spectrum of frequencies.

12. The implantable device as recited in claim 11, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

13. A system, comprising:

means for delivering a multi-phasic pulse waveform to bodily tissue via one or more electrodes, wherein the pulse waveform has a duration less than the a charging time constant of an electrode-electrolyte interface between one of the electrodes and the bodily tissue, and wherein the multi-phasic waveform consists of positive phases and negative phases, wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and the amplitude is defined as the length of the phase, further wherein the alternating positive and negative phases have different absolute amplitudes;

means for sensing a response waveform resulting from application of the pulse waveform in the bodily tissue; and

means for determining a characteristic of the bodily tissue based on the sensed response waveform.

14. The system as recited in claim 13, further comprising:

means for varying the duration of the pulse waveforms, and

means for sensing resulting waveform shapes from applying the pulse waveforms of various durations in the bodily tissue.

15. The system as recited in claim 14, further comprising means for indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if the means for sensing resulting waveform shapes senses a negligible change in a shape of the response waveform.

16. The system as recited in claim 15, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

17. The system as recited in claim 13, further comprising:

means for determining a phase delay between the delivered pulse waveforms and the sensed response waveforms.

18. The system in claim 17, further comprising means for indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if a negligible phase delay is determined.

19. The system as recited in claim 18, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

20. The system as recited in claim 13, further comprising:

means for determining a frequency response of the bodily tissue resulting from delivery of the pulse waveforms.

21. The system as recited in claim 20, further comprising means for indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if the frequency response is substantially flat over a spectrum of frequencies.

22. The system as recited in claim 21, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

23. A method, comprising:

delivering a multi-phasic pulse waveform to bodily tissue via one or more electrodes, wherein the pulse waveform has a duration less than a charging time constant of an electrode-electrolyte interface between one of the electrodes and the bodily tissue, and wherein the multi-phasic waveform consists of positive phases and negative phases, wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and the amplitude is defined as the length of the phase, further wherein the alternating positive and negative phases have different absolute amplitudes;

sensing a response waveform resulting from application of the pulse waveform in the bodily tissue; and

determining a characteristic of the bodily tissue based on the sensed response waveform.

24. The method as recited in claim 23, further comprising:

varying the duration of the pulse waveforms, and

sensing resulting waveform shapes from applying the pulse waveforms of various durations in the bodily tissue.

25. The method as recited in claim 24, further comprising indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if a negligible change in a shape of the response waveform is determined.

26. The method as recited in claim 25, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

27. The method as recited in claim 23, further comprising determining a phase delay between the delivered pulse waveforms and the sensed response waveforms.

28. The method in claim 27, further comprising indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if a negligible phase delay is determined.

29. The method as recited in claim 28, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.

30. The method as recited in claim 23, further comprising determining a frequency response of the bodily tissue resulting from delivery of the pulse waveforms.

31. The method as recited in claim 30, further comprising indicating a presence of a condition associated with a decreased capacitance of the bodily tissue if the frequency response is substantially flat over a spectrum of frequencies.

32. The method as recited in claim 31, wherein the decreased capacitance of the bodily tissue is at least in part indicative of infarcted tissue, an enlarged heart chamber, and/or an increased degree of edema.