Tissue characterization using intracardiac impedances with an implantable lead system

• US 7,945,326 B1
• Filed: 03/12/2007
• Issued: 05/17/2011
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Shaquer, Cem, Walker, Andre, Panescu, Dorin, Bornzin, Gene A., Wong, Louis, Park, Euljoon
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bays; Pamela M
• Application Number:
  US11/684,677
• Time in Patent Office: 1,527 Days
• Field of Search: 600/442, 600/547, 607/2, 607/8, 607/26, 607/28, 607/45, 607/76, 607/4, 607/9, 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 a number of positive phases and a different number of negative phases, wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and amplitude is defined as the length of the phase, and wherein the absolute amplitude of the positive phases is different from the absolute amplitude of the negative phases;

wherein the positive phases and the negative phases transfer a net zero charge through the bodily tissue; and

wherein the pulses are configured to generate a voltage on one or more capacitors of the bodily tissue and/or the implantable device in series with the impedance load of the bodily tissue path that has a zero-volt mean value.

2. The implantable device as recited in claim 1, wherein the multi-phasic waveform has a duration less than the charging time constant of the electrode-electrolyte interface.

3. The implantable device as recited in claim 2 wherein the multi-phasic waveform has a duration of less than approximately 1 millisecond.

4. The implantable device as recited in claim 1, wherein the number of negative phases is greater than the number of positive phases and the absolute amplitude of the positive phases is greater than the absolute amplitude of the negative phases.

5. The implantable device as recited in claim 1, wherein the physiological parameter is an intracardiac impedance.

6. The implantable device as recited in claim 1, further comprising a signal processor to sense one or more of the pulse waveforms in the bodily tissue resulting from the applied pulses and to determine an impedance of the bodily tissue.

7. The implantable device as recited in claim 6, wherein the signal processor includes:

an integrator to determine an area associated with the sensed pulse waveform; and

a comparator to calculate the impedance by comparing the area associated with the sensed pulse waveforms with an area associated with applied pulse waveforms.

8. The implantable device as recited in claim 6, further comprising one or more filters to derive a respiration impedance from the impedance.

9. The implantable device as recited in claim 6, further comprising one or more filters to derive a cardiac impedance from the impedance.

10. The implantable device as recited in claim 6, further comprising one or more filters to derive a value from the impedance corresponding to a degree of edema in the bodily tissue.

11. The implantable device as recited in claim 1, further comprising a circuit in the pulse generator to vary the duration of one or more of the positive phases.

12. The implantable device as recited in claim 11, further comprising a signal processor including a circuit to sense a waveform shape resulting from applying pulses having positive phases of various durations, wherein the sensed waveform indicates a capacitance of the bodily tissue.

13. The implantable device as recited in claim 1, further comprising a signal processor including a phase detection circuit to determine a phase delay between the applied pulses and pulse waveforms sensed by the signal processor, wherein the magnitude of the phase delay indicates a capacitance of the bodily tissue.

14. The implantable device as recited in claim 1, further comprising a signal processor including a circuit to measure a frequency response of the bodily tissue resulting from application of the pulses, wherein a relatively flat frequency response of the bodily tissue over a spectrum of frequencies provided by the applied pulses indicates a lack of capacitance of the bodily tissue.

15. An implantable device, comprising:

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

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

wherein each pulse has a multi-phasic waveform consisting of a number of positive phases and a different number of negative phases, wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and amplitude is defined as the length of the phase;

wherein the number of negative phases is greater than the number of positive phases and the absolute amplitude of the positive phases is greater than the absolute amplitude of the negative phases;

wherein the multi-phasic waveform has a duration less than a charging time constant of an electrode-electrolyte interface;

wherein the positive phases and the negative phases transfer a net zero charge through the bodily tissue; and

wherein the pulses are configured to generate a voltage on one or more capacitors of the tissue and/or the implantable device in series with the impedance load of the bodily tissue that has a zero-volt mean value.

16. The implantable device as recited in claim 15 wherein the multi-phasic waveform has a duration of less than approximately 1 millisecond.

17. The implantable device as recited in claim 15, wherein the physiological parameter is an intracardiac impedance.

18. The implantable device as recited in claim 15, further comprising a signal processor to sense one or more of the pulse waveforms in the bodily tissue resulting from the applied pulses and to determine an impedance of the bodily tissue.

19. The implantable device as recited in claim 18, wherein the signal processor includes:

an integrator to determine an area associated with the sensed pulse waveform; and

a comparator to calculate the impedance by comparing the area associated with the sensed pulse waveforms with an area associated with applied pulse waveforms.

20. The implantable device as recited in claim 18, further comprising one or more filters to derive a respiration impedance from the impedance.

21. The implantable device as recited in claim 18, further comprising one or more filters to derive a cardiac impedance from the impedance.

22. The implantable device as recited in claim 18, further comprising one or more filters to derive a value from the impedance corresponding to a degree of edema in the bodily tissue.

23. The implantable device as recited in claim 15, further comprising a circuit in the pulse generator to vary the duration of one or more of the positive phases.

24. The implantable device as recited in claim 23, further comprising a signal processor including a circuit to sense a waveform shape resulting from applying pulses having positive phases of various durations, wherein the sensed waveform indicates a capacitance of the bodily tissue.

25. The implantable device as recited in claim 15, further comprising a signal processor including a phase detection circuit to determine a phase delay between the applied pulses and pulse waveforms sensed by the signal processor, wherein the magnitude of the phase delay indicates a capacitance of the bodily tissue.

26. The implantable device as recited in claim 15, further comprising a signal processor including a circuit to measure a frequency response of the bodily tissue resulting from application of the pulses, wherein a relatively flat frequency response of the bodily tissue over a spectrum of frequencies provided by the applied pulses indicates a lack of capacitance of the bodily tissue.

27. An implantable device, comprising:

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

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

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

wherein each phase comprises a duration and an amplitude, wherein duration is defined as the width of the phase and amplitude is defined as the length of the phase;

wherein the negative phases have an absolute amplitude that is different from the absolute amplitude of the positive phases;

wherein the number of negative phases is greater than the number of positive phases and the absolute amplitude of the positive phases is greater than the absolute amplitude of the negative phases;

wherein the multi-phasic waveform has a duration less than a charging time constant of an electrode-electrolyte interface;

wherein the multi-phasic waveform has null segments between the positive and negative phases, the null segments having a duration sufficient to allow processing circuit of the implantable device to complete processing of information from one phase before the next phase begins; and

wherein the positive phases and the negative phases transfer a net zero charge through the bodily tissue; and

wherein the positive phases and the negative phases transfer a voltage on capacitors of the bodily tissue and/or the implantable device in series with the impedance load of the bodily tissue path that has a zero-volt mean value.

28. The implantable device as recited in claim 27, wherein the physiological parameter is an intracardiac impedance.

29. The implantable device as recited in claim 27, further comprising a signal processor to sense one or more of the pulse waveforms in the bodily tissue resulting from the applied pulses and to determine an impedance of the bodily tissue.