Systems and methods to monitor and treat heart failure conditions

• US 8,600,497 B1
• Filed: 11/09/2006
• Issued: 12/03/2013
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Yang, Weiqun, Ohlander, Malin, Wong, Louis, Holmstrom, Nils, Shaquer, Cem, Park, Euljoon, Panescu, Dorin, Shahparnia, Shahrooz, Walker, Andre, Pillai, Ajit, Naware, Mihir
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US11/558,088
• Time in Patent Office: 2,581 Days
• Field of Search: 600/547, 607/7, 607/8, 607/18, 607/20, 607/24, 607/28
• US Class Current: 607/7
• 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 device monitors and treats heart failure, pulmonary edema, and hemodynamic conditions and in some cases applies therapy. In one implementation, the implantable device applies a high-frequency multi-phasic pulse waveform over multiple-vectors through tissue. The waveform has a duration less than the charging time constant of electrode-electrolyte interfaces in vivo to reduce intrusiveness while increasing sensitivity and specificity for trending parameters. The waveform can be multiplexed over multiple vectors and the results cross-correlated or subjected to probabilistic analysis or thresholding schemata to stage heart failure or pulmonary edema. In one implementation, a fractionation morphology of a sensed impedance waveform is used to trend intracardiac pressure to stage heart failure and to regulate cardiac resynchronization therapy. The waveform also provides unintrusive electrode integrity checks and 3-D impedancegrams.

Claims

1. An implantable device, comprising:

multiple electrodes configured to apply a multi-phasic pulse waveform over multiple vectors, wherein the multi-phasic pulse waveform is generated from a source and a sink having different magnitudes;

a waveform generator for generating and applying the multi-phasic pulse waveform over the multiple vectors through tissue of a human being, wherein the multi-phasic pulse waveform has a duration less than a charging time constant of electrode-electrolyte interfaces in the tissue;

an impedance measurement module configured to obtain one impedance measurement for each of the multiple vectors; and

an evaluator configured to process impedance measurements for the multiple vectors in order to estimate a status of a bodily parameter of the human being.

2. The implantable device as recited in claim 1, wherein the bodily parameter comprises heart failure or tissue swelling.

3. The implantable device as recited in claim 1, wherein at least one of the multiple vectors is configured to pass through a heart or a pericardium of the human being and the bodily parameter comprises pulmonary edema.

4. The implantable device as recited in claim 1, further comprising a trender configured to estimate a trend of the bodily parameter over time.

5. The implantable device as recited in claim 4, wherein the trender relates the status of the bodily parameter estimated by the evaluator to a threshold.

6. The implantable device as recited in claim 1, further comprising a diagnostics module configured to evaluate a degree of heart failure based on the status of the bodily parameter.

7. The implantable device as recited in claim 6, wherein the diagnostics module is further configured to monitor a trend of the bodily parameter and to evaluate a progression of heart failure based on the trend of the bodily parameter over time.

8. The implantable device as recited in claim 6, wherein the diagnostics module is further configured to monitor a trend of the bodily parameter and to evaluate a late stage of heart failure based on the status or the trend of the bodily parameter over time.

9. The implantable device as recited in claim 1, further comprising a cross-correlator configured to process the impedance measurements obtained for each of the multiple vectors, wherein the multiple vectors comprise vectors between multiple different sets of electrodes.

10. The implantable device as recited in claim 1, further comprising a vector weighting engine configured to apply a weight to the impedance measurement associated with each vector according to a relevance of each vector to a hemodynamic parameter.

11. The implantable device as recited in claim 1, further comprising an alert module configured to provide a notification of a change in the bodily parameter.

12. The implantable device as recited in claim 11, wherein the notification is provided to the human being via at least one of the implantable device or via a device external to the human being.

13. The implantable device as recited in claim 1, wherein the waveform generator applies the multi-phasic pulse waveform over the multiple vectors between the multiple electrodes that include at least one of:

a right-atrial-ring-electrode to left-ventricular-ring-electrode vector;

a left-ventricular-ring-electrode to right-ventricular-ring-electrode vector;

or

a left-ventricular-ring-electrode to case-electrode vector.

14. The implantable device as recited in claim 1, wherein the multi-phasic pulse waveform possesses alternating positive and negative phases and having null phases located between successive ones of the alternating positive and negative phases.

15. An implantable device, comprising:

a waveform generator for generating and applying a multi-phasic pulse waveform over multiple vectors through tissue of a human being, wherein the multi-phasic pulse waveform possesses alternate positive and negative phases generated by a source and a sink having different magnitudes such that the multi-phasic pulse waveform also possesses an additive net-zero charge and an additive net-zero voltage and has a duration less than a charging time constant of electrode-electrolyte interfaces in the tissue;

an impedance measurement module configured to obtain one impedance measurement for each of the multiple vectors; and

an evaluator configured to process impedance measurements for the multiple vectors in order to estimate a status of a bodily parameter of the human being.

16. The implantable device as recited in claim 15, further comprising a trender configured to estimate a trend of the bodily parameter over time.

17. The implantable device as recited in claim 15, further comprising a diagnostics module configured to evaluate a degree of heart failure based on the status of the bodily parameter.

18. The implantable device as recited in claim 15, wherein the waveform generator applies the multi-phasic pulse waveform over multiple vectors that include at least one of:

a right-atrial-ring-electrode to left-ventricular-ring-electrode vector;

a left-ventricular-ring-electrode to right-ventricular-ring-electrode vector;

or

a left-ventricular-ring-electrode to case-electrode vector.

19. The implantable device as recited in claim 15, further comprising multiple electrodes configured to apply the multi-phasic pulse waveform over the multiple vectors.

20. The implantable device as recited in claim 15, wherein the multi-phasic pulse waveform possesses alternating positive and negative phases and having null phases located between successive ones of the alternating positive and negative phases.

21. An implantable device, comprising:

a processing circuit comprising electronics;

a waveform generator for generating and applying a multi-phasic pulse waveform over multiple vectors through a tissue of a human being, wherein the multi-phasic pulse waveform possesses alternating positive and negative phases and having null phases located between successive ones of the alternating positive and negative phases, the null phases having a duration sufficient to allow the electronics in the processing circuit of the implantable device to settle and the multi-phasic pulse waveform has a duration less than a charging time constant of electrode-electrolyte interfaces in the tissue;

an impedance measurement module configured to obtain one impedance measurement for each of the multiple vectors; and

an evaluator configured to process the multiple impedance measurements in order to estimate a status of a bodily parameter of the human being.

22. The implantable device as recited in claim 21, wherein the bodily parameter comprises heart failure or tissue swelling.

23. The implantable device as recited in claim 21, wherein at least one of the multiple vectors passes through a heart or a pericardium of the human being and the bodily parameter comprises pulmonary edema.

24. The implantable device as recited in claim 21, further comprising a vector weighting engine configured to apply a weight to the impedance measurement associated with each vector according to a relevance of each vector to a hemodynamic parameter.