Tissue characterization using intracardiac impedances with an implantable lead system

• US 8,010,196 B1
• Filed: 03/12/2007
• Issued: 08/30/2011
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• 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:
  US11/684,671
• Time in Patent Office: 1,632 Days
• Field of Search: 600/442, 600/547, 607/2, 607/8, 607/26, 607/28, 607/45, 607/66, 607/68, 607/69, 607/76
• 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. A method, comprising:

generating pulses in an implantable device, wherein a multi-phasic waveform of each pulse possesses alternating positive and 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 alternating positive and negative phases have an additive net-zero charge, wherein at least one negative phase has an absolute amplitude less than an absolute amplitude of one of the positive phases, 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;

applying the pulses to a bodily tissue;

measuring a frequency response of the bodily tissue to the applied pulses; and

determining a tissue characteristic based on the frequency response.

2. The method as recited in claim 1, wherein the tissue characteristic comprises a presence of infarcted tissue having a substantially flat frequency response over a spectrum of frequencies provided by the pulses.

3. The method as recited in claim 1, wherein the tissue characteristic comprises a blood to tissue ratio, wherein the blood has a relatively flat frequency response and the tissue has a capacitive frequency response over a spectrum of frequencies provided by the pulses.

4. The method as recited in claim 3, wherein the blood to tissue ratio indicates enlargement of a chamber of a patient'"'"'s heart.

5. The method as recited in claim 1, wherein the tissue characteristic comprises a degree of edema, wherein edematous fluid has a relatively flat frequency response over a spectrum of frequencies provided by the pulses compared to a frequency response of living tissue.

6. The method as recited in claim 1, further comprising measuring the frequency response of the bodily tissue to the applied pulses at various times and trending a hemodynamic parameter based on the multiple frequency responses.

7. The method as recited in claim 6, wherein the hemodynamic parameter comprises one of:

a congestive heart failure (CHF) index, a degree of pulmonary edema, a systolic slope, a cardiac contraction dZ/dt(max), a diastolic slope, a cardiac relaxation dZ/dt(min), a pre-ejection period, an ejection time, a left ventricular ejection fraction (LVEF), a diastolic heart failure index (DHFI), or a cardiac index.

8. A method, comprising:

generating pulses in an implantable device to apply to a bodily tissue via an electrode, wherein each pulse has a multi-phasic waveform having alternating positive and 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 alternating positive and negative phases have different absolute amplitudes, and wherein the multi-phasic waveform has a duration less than a charging time constant of an electrode-electrolyte interface between the electrode and the bodily tissue;

applying the pulses to the bodily tissue;

measuring a frequency response of the bodily tissue to the applied pulses; and

determining a tissue characteristic based on the frequency response.

9. The method as recited in claim 8, wherein the pulses possess a multi-phasic waveform that has alternating positive and negative phases that are charge-balanced and voltage-balanced.

10. The method as recited in claim 8, wherein determining the tissue characteristic comprises detecting a presence of infarcted tissue having a substantially flat frequency response over a spectrum of frequencies provided by the pulses.

11. The method as recited in claim 8, wherein determining the tissue characteristic comprises determining a blood-to-tissue ratio, wherein the blood has a substantially flat frequency response and the tissue has a capacitive frequency response over a spectrum of frequencies provided by the pulses.

12. The method as recited in claim 11, wherein the blood-to-tissue ratio is associated with an enlargement of a chamber of a patient'"'"'s heart.

13. The method as recited in claim 8, wherein determining the tissue characteristic comprises detecting a degree of edema, wherein edematous fluid has a substantially flat frequency response over a spectrum of frequencies provided by the pulses compared to a frequency response of normal tissue.

14. The method as recited in claim 8, further comprising measuring the frequency response of the bodily tissue to the applied pulses at various times and trending a hemodynamic parameter based on the multiple frequency responses.

15. The method as recited in claim 14, wherein the hemodynamic parameter comprises one of:

a congestive heart failure (CHF) index, a degree of pulmonary edema, a systolic slope, a cardiac contraction dZ/dt(max), a diastolic slope, a cardiac relaxation dZ/dt(min), a pre-ejection period, an ejection time, a left ventricular ejection fraction (LVEF), a diastolic heart failure index (DHFI), or a cardiac index.

16. A method, comprising:

generating pulses in an implantable device to apply to a bodily tissue via an electrode, wherein a multi-phasic waveform of each pulse possesses alternating positive and negative phases that have an additive net-zero charge and wherein the multi-phasic waveform is 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, wherein each phase of the multi-phasic waveform 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 at least one negative phase has an absolute amplitude less than an absolute amplitude of one of the positive phases, and each pulse has a duration less than a charging time constant of an electrode-electrolyte interface between the electrode and the bodily tissue;

applying the pulses to the bodily tissue;

measuring a frequency response of the bodily tissue to the applied pulses; and

determining a tissue characteristic based on the frequency response.

17. The method as recited in claim 16, wherein the tissue characteristic comprises a presence of infarcted tissue having a substantially flat frequency response over a spectrum of frequencies provided by the pulses.

18. The method as recited in claim 16, wherein the tissue characteristic comprises a blood to tissue ratio, wherein the blood has a relatively flat frequency response and the tissue has a capacitive frequency response over a spectrum of frequencies provided by the pulses.

19. The method as recited in claim 18, wherein the blood to tissue ratio indicates enlargement of a chamber of a patient'"'"'s heart.

20. The method as recited in claim 16, wherein the tissue characteristic comprises a degree of edema, wherein edematous fluid has a relatively flat frequency response over a spectrum of frequencies provided by the pulses compared to a frequency response of living tissue.

21. The method as recited in claim 16, further comprising measuring the frequency response of the bodily tissue to the applied pulses at various times and trending a hemodynamic parameter based on the multiple frequency responses.

22. The method as recited in claim 21, wherein the hemodynamic parameter comprises one of:

a congestive heart failure (CHF) index, a degree of pulmonary edema, a systolic slope, a cardiac contraction dZ/dt(max), a diastolic slope, a cardiac relaxation dZ/dt(min), a pre-ejection period, an ejection time, a left ventricular ejection fraction (LVEF), a diastolic heart failure index (DHFI), or a cardiac index.