Demand-based cardiac function therapy

• US 8,065,003 B2
• Filed: 05/27/2008
• Issued: 11/22/2011
• Est. Priority Date: 09/23/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhu, Qingsheng, KenKnight, Bruce H.
• Primary Examiner(s): Schaetzle; Kennedy
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US12/154,746
• Publication Number:
  US 20080234776A1
• Time in Patent Office: 1,274 Days
• Field of Search: 607 4- 6, 607/9, 607/14, 607 17- 27, 607/50, 600/513, 600/520, 600526-527
• US Class Current: 607/18
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

A method and device for delivering cardiac function therapy on a demand basis. An implantable device for delivering cardiac function therapy is programmed to suspend such therapy at periodic intervals or upon command from an external programmer. Measurements related to hemodynamic performance are then taken using one or more sensing modalities incorporated into the device. Based upon these measurements, the device uses a decision algorithm to determine whether further delivery of the cardiac function therapy is warranted.

Claims

1. A implantable cardiac pacing device, comprising:

one or more pulse generators for incorporation into a plurality of pacing channels;

one or more cardiac sensing amplifiers for incorporation into sensing channels for detecting cardiac activity;

a controller for controlling the delivery of paces in accordance with a programmed pacing mode;

wherein the controller is programmed to deliver cardiac function therapy for effecting reversal of ventricular remodeling by delivering pacing pulses to one or more stressed or hypertrophied ventricular regions in a manner that pre-excites those region(s) relative to other ventricular regions;

a thoracic impedance sensor configured to measure cardiac output of a patient;

a sensor for measuring an exertion level of the patient;

wherein the controller is programmed to assess the patient'"'"'s cardiac function by comparing the measured cardiac output with the measured exertion level and computing a cardiac function parameter indicative as to whether the patient'"'"'s cardiac output is adequate for the measured exertion level; and

,

wherein the controller is programmed to temporarily suspend delivery of cardiac function therapy, assess the patient'"'"'s cardiac function while no cardiac function therapy is being delivered by comparing the cardiac function parameter to a threshold value, continue delivery of cardiac function therapy if the patient'"'"'s cardiac function is determined to be inadequate, and cease delivery of cardiac function therapy if the patient'"'"'s cardiac function is determined to have improved to a specified extent.

2. The device of claim 1 wherein the thoracic impedance sensor is further configured to measure cardiac blood volume and wherein the controller is further programmed to compute the cardiac function parameter based upon an ejection fraction derived from measurements of end-diastolic and end-systolic volumes.

3. The device of claim 1 wherein the thoracic impedance sensor is further configured to measure diastolic filling pressures and systolic pulse pressures and wherein the controller is further programmed to compute the cardiac function parameter based upon the measured diastolic filling pressures and systolic pulse pressures.

4. The device of claim 1 wherein the device is configured to measure cardiac output by measuring a trans-thoracic impedance and heart rate.

5. The device of claim 1 wherein the exertion level sensor is a minute ventilation sensor.

6. The device of claim 1 wherein the exertion level sensor is an activity level sensor.

7. The device of claim 1 wherein the controller is further programmed to compute the cardiac function assessment based upon the patient'"'"'s autonomic balance as determined by measuring the patient'"'"'s heart rate variability.

8. The device of claim 7 wherein the controller is further programmed to:

measure and collect time intervals between successive chamber senses and storing the collected intervals as a discrete RR interval signal, filter the RR interval signal into defined high and low frequency bands, and determine the signal power of the RR interval signal in each of the low and high frequency bands, referred to LF and HF, respectively; and

,

compute an LF/HF ratio and assessing cardiac function by comparing the LF/HF ratio to a specified ratio threshold value.

9. The device of claim 1 wherein controller is programmed to perform the suspension of cardiac function therapy and assessment of the patient'"'"'s cardiac function at periodic intervals.

10. The device of claim 1 wherein controller is programmed to perform the suspension of cardiac function therapy and assessment of the patient'"'"'s cardiac function upon receiving a command from an external device via telemetry.

11. A device, comprising:

means for delivering cardiac function therapy for effecting reversal of ventricular remodeling by delivering pacing pulses to one or more stressed or hypertrophied ventricular regions in a manner that pre-excites those region(s) relative to other ventricular regions;

means for measuring cardiac output of a patient;

means for measuring an exertion level of the patient;

means for assessing the patient'"'"'s cardiac function by comparing the measured cardiac output with the measured exertion level and computing a cardiac function parameter indicative as to whether the patient'"'"'s cardiac output is adequate for the measured exertion level; and

,

means for temporarily suspending delivery of cardiac function therapy, assessing the patient'"'"'s cardiac function while no cardiac function therapy is being delivered by comparing the cardiac function parameter to a threshold value, continuing delivery of cardiac function therapy if the patient'"'"'s cardiac function is determined to be inadequate, and ceasing delivery of cardiac function therapy if the patient'"'"'s cardiac function is determined to have improved to a specified extent.

12. The device of claim 11 wherein the cardiac output sensing means is further configured to measure cardiac blood volume and wherein the cardiac function assessing means is further programmed to compute the cardiac function parameter based upon an ejection fraction derived from measurements of end-diastolic and end-systolic volumes.

13. The device of claim 11 wherein the cardiac output sensing means is further configured to measure diastolic filling pressures and systolic pulse pressures and wherein the cardiac function assessing means is further programmed to compute the cardiac function parameter based upon the measured diastolic filling pressures and systolic pulse pressures.

14. The device of claim 11 wherein the device is configured to measure cardiac output by measuring a trans-thoracic impedance and heart rate.

15. The device of claim 11 wherein the exertion level sensing means is a minute ventilation sensor.

16. The device of claim 11 wherein the exertion level sensing means is an activity level sensor.

17. The device of claim 11 wherein the cardiac function assessing means is further programmed to compute the cardiac function assessment based upon the patient'"'"'s autonomic balance as determined by measuring the patient'"'"'s heart rate variability.

18. The device of claim 17 wherein the cardiac function assessing means is further programmed to:

measure and collect time intervals between successive chamber senses and storing the collected intervals as a discrete RR interval signal, filter the RR interval signal into defined high and low frequency bands, and determine the signal power of the RR interval signal in each of the low and high frequency bands, referred to LF and HF, respectively; and

,

compute an LF/HF ratio and assessing cardiac function by comparing the LF/HF ratio to a specified ratio threshold value.

19. The device of claim 11 further comprising means for performing the suspension of cardiac function therapy and assessment of the patient'"'"'s cardiac function at periodic intervals.

20. The device of claim 11 further comprising means for performing the suspension of cardiac function therapy and assessment of the patient'"'"'s cardiac function upon receiving a command from an external device via telemetry.