Heart failure management system

• US 8,005,543 B2
• Filed: 05/08/2006
• Issued: 08/23/2011
• Est. Priority Date: 05/08/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Sweeney, Robert J., Siejko, Krzysztof Z., Brockway, Marina V., Libbus, Imad
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US11/382,128
• Publication Number:
  US 20070260285A1
• Time in Patent Office: 1,933 Days
• Field of Search: None
• US Class Current: 607/9
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• 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 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient

Abstract

Various system embodiments comprise a stimulator adapted to deliver a stimulation signal for a heart failure therapy, a number of sensors adapted to provide at least a first measurement of a heart failure status and a second measurement of the heart failure status, and a controller. The controller is connected to the stimulator and to the number of sensors. The controller is adapted to use the first and second measurements to create a heart failure status index, and control the stimulator to modulate the signal using the index. Other aspects and embodiments are provided herein.

Claims

1. A system, comprising:

a stimulator adapted to deliver a stimulation signal for a heart failure therapy;

a number of sensors adapted to sense at least a first parameter used to provide at least a first measurement of a heart failure status and sense at least a second parameter used to provide a second measurement of the heart failure status; and

a controller connected to the stimulator and to the number of sensors, the controller being adapted to use the first and second measurements of the heart failure status to create a heart failure status index, and control the stimulator to modulate the stimulation signal for the heart failure therapy using the index, wherein the controller is configured to;

use a dual feedback response to account for both long-term heart failure status changes and short-term heart failure status changes;

provide a short-term index indicative of a short-term heart failure status to account for short-term heart failure status changes, wherein in providing the short-term index the controller is configured to use at least two measurements including the first measurement of the heart failure status;

provide a long-term index indicative of a long-term heart failure status to account for long-term heart failure status changes, wherein providing the long-term index the controller is configured to use at least two measurements including the second measurement of the heart failure status to provide a long-term index indicative of a long-term heart failure status;

control the stimulator to modulate the stimulation signal for the heart failure therapy using the short-term index and control the stimulator to modulate the stimulation signal for the heart failure therapy using the long-term index.

2. The system of claim 1, wherein the stimulator includes a neural stimulator adapted to deliver a neural stimulation signal to a neural target for the heart failure therapy.

3. The system of claim 1, wherein the controller is adapted to control the stimulator to increase a parasympathetic response based on a comparison of the short-term index to a target indicating an approaching decompensation event.

4. The system of claim 1, wherein the controller is adapted to control the stimulator to reduce a parasympathetic response based on a comparison of the short-term index to a target.

5. The system of claim 1, wherein the controller is adapted to control the stimulator to increase a sympathetic response based on a comparison of the short-term index to a target.

6. The system of claim 1, wherein the controller is adapted to control the stimulator to increase a parasympathetic response when the long-term index is less than a first threshold and to decrease the parasympathetic response when the long-term index exceeds a second threshold.

7. The system of claim 1, wherein the controller is adapted to determine whether at least one of the first and second measurements trends upward or downward and to use the determination to control the stimulator to modulate the stimulation signal for the heart failure therapy.

8. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes a heart rate variability (HRV) measurement.

9. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes a heart rate turbulence (HRT) measurement.

10. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes a respiration measurement.

11. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes an activity measurement.

12. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes a heart sound measurement.

13. The system of claim 1, wherein the first measurement of the heart failure status or the second measurement of the heart failure status includes a blood pressure measurement.

14. The system of claim 1, wherein the first measurement of the heart failure status and the second measurement of the heart failure status includes measurements selected from a heart rate variability (HRV) measurement, a heart rate turbulence (HRT) measurement, a respiration measurement, a heart sound measurement, a blood pressure measurement, or a thoracic impedance measurement.

15. The system of claim 1, wherein the stimulation signal for the heart failure therapy includes a myocardial stimulation signal.

16. The system of claim 2, wherein circuitry in a single implantable device provides the neural stimulation signal and a myocardial stimulation signal.

17. The system of claim 16, wherein circuitry in a first implantable device provides the neural stimulation signal and circuitry in a second implantable device provides the myocardial stimulation signal.

18. The system of claim 1, wherein all of the number of sensors include implantable sensors.

19. The system of claim 1, wherein the number of sensors include an implantable sensor and an external sensor.

20. A system, comprising:

means for sensing at least a first parameter to obtain a first measurement of a heart failure status and sensing at least a second parameter to obtain a second measurement of the heart failure status;

means for creating a heart failure index using the first measurement of the heart failure status and the second measurement of the heart failure status; and

means for adjusting a heart failure therapy using the heart failure index as an indicator of the heart failure status, wherein the means for adjusting includes a controller configured to;

use a dual feedback response to account for both long-term heart failure status changes and short-term heart failure status changes;

provide a short-term index indicative of a short-term heart failure status to account for short-term heart failure status changes, wherein in providing the short-term index the controller is configured to use at least two measurements including the first measurement of the heart failure status;

provide a long-term index indicative of a long-term heart failure status to account for long-term heart failure status changes, wherein in providing the long-term index the controller is configured to use at least two measurements including the second measurement of the heart failure status; and

adjust the heart failure therapy using the short-term index and adjust the heart failure therapy using the long-term index.

21. The system of claim 20, wherein the means for adjusting a heart failure therapy includes means for adjusting a neural stimulation parameter.

22. The system of claim 20, wherein the means for adjusting a heart failure therapy includes means for adjusting a neural stimulation target.

23. The system of claim 20, wherein the means for creating a heart failure index using the first measurement of the heart failure status and the second measurement of the heart failure status includes means for creating the heart failure index using an inference engine.

24. The system of claim 20, wherein the means for creating a heart failure index using the first measurement of the heart failure status and the second measurement of the heart failure status includes means for using the first measurement of the heart failure status and the second measurement of the heart failure status to provide a probability density function.