Tissue characterization using intracardiac impedances with an implantable lead system

• US 9,107,585 B1
• Filed: 03/12/2007
• Issued: 08/18/2015
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Wong, Louis, Shaquer, Cem, Bornzin, Gene A., Park, Euljoon, Walker, Andre, Panescu, Dorin
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/684,664
• Time in Patent Office: 3,081 Days
• Field of Search: 600/442, 600/547, 607/2, 607/8, 607/28, 607/45, 607/76
• US Class Current: 1/1
• 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 for use in an implantable device, comprising:

generating pulses to apply to a bodily tissue via an electrode, wherein each pulse has an asymmetric amplitude waveform possessing alternating positive and negative phases that are charge-balanced and voltage-balanced, the asymmetric amplitude waveform having a duration less than a charging time constant of an electrode-electrolyte interface between the electrode and the bodily tissue;

applying the pulses having the waveform to the bodily tissue, wherein the pulses are applied at a frequency within a range of frequencies consisting of approximately 1 Hz to approximately 100 kHz; and

measuring an effect of the applied pulses to determine a physiological parameter.

2. The method as recited in claim 1, wherein generating pulses includes generating waveforms that include:

a number (n) of positive phases;

a number (n+1) of negative phases, the negative phases alternating with the positive phases.

3. The method as recited in claim 1, wherein the waveform has a duration of less than approximately 1 millisecond.

4. The method as recited in claim 1, wherein the waveform comprises one positive phase and two negative phases, one of the negative phases on each side of the positive phase.

5. The method as recited in claim 1, wherein each phase is a rectangular wave.

6. The method as recited in claim 1, wherein the phases are at least in part sinusoidal.

7. The method as recited in claim 1, wherein the waveform at least approximates a sine(x)/x waveform.

8. The method as recited in claim 2, wherein a null segment intervenes between each positive phase and each negative phase.

9. The method as recited in claim 1, wherein applying the pulses further comprises applying current pulses having the waveform, wherein the absolute magnitude of the positive phase(s) of the pulses is in the range of 0.125 milliamps to 1.00 milliamps, and the absolute magnitude of the negative phases of the pulses are approximately 0.03215 milliamps to 0.2500 milliamps.

10. The method as recited in claim 1, wherein applying the pulses further comprises applying voltage pulses having the waveform.

11. The method as recited in claim 1, wherein measuring an effect of the applied pulses includes measuring a voltage resulting from applying current pulses having the waveform.

12. The method as recited in claim 1, wherein measuring an effect of the applied pulses includes measuring a voltage waveform over time resulting from applying current pulses having the waveform.

13. The method as recited in claim 12, wherein measuring an effect of the applied pulses includes deriving an area of each voltage waveform resulting from applying current pulses having the waveform.

14. The method as recited in claim 13, wherein the area of each voltage waveform includes the voltage contribution of each frequency of a spectrum of frequencies provided by the applied pulses.

15. The method as recited in claim 1, wherein measuring an effect of the applied pulses includes:

deriving an area of voltage waveforms resulting from applying current pulses having the waveform; and

deriving an impedance value of the bodily tissue by dividing the area of the voltage waveforms by an area of the current pulses having the waveform.

16. The method as recited in claim 1, wherein measuring an effect of the applied pulses includes measuring a current waveform over time resulting from applying a voltage pulse having the waveform.

17. The method as recited in claim 16, wherein measuring an effect of the applied pulses includes deriving an area of each current waveform that results from applying the voltage pulses having the waveform.

18. The method as recited in claim 17, further comprising deriving an impedance value of the bodily tissue by dividing the area of the voltage pulses having the waveform by an area of the current waveforms.

19. A method for use in an implantable device, comprising:

generating pulses to apply to a bodily tissue via an electrode, wherein each pulse has a waveform possessing alternating positive and negative phases that are charge-balanced and voltage-balanced, the waveform having a duration less than a charging time constant of an electrode-electrolyte interface between the electrode and the bodily tissue, the waveform having a null segment having a duration sufficient to allow electronics in a processing circuit of the implantable device to settle intervenes between each positive phase and each negative phase;

applying the pulses having the waveform to the bodily tissue; and

measuring an effect of the applied pulses to determine a physiological parameter, wherein measuring an effect of the applied pulses includes;

deriving an area of voltage waveforms resulting from applying current pulses having the waveform; and

deriving an impedance value of the bodily tissue by dividing the area of the voltage waveforms by an area of the current pulses having the waveform.

20. The method as recited in claim 19, wherein the waveform has a duration of less than approximately 1 millisecond.

21. The method as recited in claim 19, wherein the waveform comprises one positive phase and two negative phases, one of the negative phases on each side of the positive phase.

22. The method as recited in claim 19, wherein each phase is a rectangular wave.

23. The method as recited in claim 19, wherein applying the pulses further comprises applying current pulses having the waveform, wherein the absolute magnitude of the positive phase(s) of the pulses is in the range of 0.125 milliamps to 1.00 milliamps, and the absolute magnitude of the negative phases of the pulses are approximately 0.03215 milliamps to 0.2500 milliamps.

24. A method for use in an implantable device, comprising:

generating pulses to apply to a bodily tissue via an electrode, wherein each pulse has a waveform possessing alternating positive and negative phases that are charge-balanced and voltage-balanced, at least one negative phase having an absolute amplitude less than an absolute amplitude of one of the positive phases, the waveform having a duration less than a charging time constant of en electrode-electrolyte interface between the electrode and the bodily tissue;

applying the pulses having the waveform to the bodily tissue; and

measuring an effect of the applied pulses to determine a physiological parameter, wherein measuring an effect of the applied pulses includes;

measuring a current waveform over time resulting from applying a voltage pulse having the waveform;

deriving an area of each current waveform that results from applying the voltage pulses having the waveform; and

deriving an impedance value of the bodily tissue by dividing the area of the voltage pulses having the waveform by an area of the current waveforms.

25. The method as recited in claim 24, wherein generating pulses includes generating waveforms that include:

a number (n) of positive phases;

a number (n+1) of negative phases, the negative phases alternating with the positive phases.

26. The method as recited in claim 24, wherein the waveform at least approximates a sine(x)/x waveform.

27. The method as recited in claim 24, wherein the waveform comprises a sine(x)/x waveform where at x=0 the waveform has a value of 1.

28. The method as recited in claim 24, wherein applying the pulses further comprises applying current pulses having the waveform, wherein the absolute magnitude of the positive phase(s) of the pulses is in the range of 0.125 milliamps to 1.00 milliamps, and the absolute magnitude of the negative phases of the pulses are approximately 0.03215 milliamps to 0.2500 milliamps.