Controlled titration of neurostimulation therapy

• US 8,725,250 B2
• Filed: 06/04/2012
• Issued: 05/13/2014
• Est. Priority Date: 08/29/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Brockway, Marina V., Libbus, Imad, Siejko, Krzysztof Z., Sweeney, Robert J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/487,877
• Publication Number:
  US 20120245656A1
• Time in Patent Office: 708 Days
• Field of Search: None
• US Class Current: 607/3
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Described herein are methods and devices that utilize electrical neural stimulation to treat heart failure by modulating a patient'"'"'s autonomic balance in a manner that inhibits sympathetic activity and/or augments parasympathetic activity. Because other therapies for treating heart failure may also affect a patient'"'"'s autonomic balance, a device for delivering neural stimulation is configured to appropriately titrate such therapy in either an open-loop or closed-loop fashion.

Claims

1. An implantable device for delivering neurostimulation, comprising:

a pulse generator for outputting neural stimulation pulses to one or more stimulation electrodes for delivering electrical stimulation to a selected neural site;

a controller connected to the pulse generator for controlling the output of neural stimulation pulses in accordance with a defined schedule and in accordance with specified stimulation parameters;

one or more sensing modalities for sensing a physiological variable reflective of a patient'"'"'s autonomic balance; and

,

wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with a determination of the patient'"'"'s autonomic balance; and

,

wherein the controller is programmed to monitor the impedance of a lead connecting the stimulation electrode to the pulse generator by charging an output capacitor of the pulse generator to a specified voltage level, delivering a stimulation pulse, and measuring the time it takes for the capacitor voltage to decay by a specified amount.

2. The device of claim 1 wherein the controller is further programmed to monitor the lead impedance by charging the output capacitor to a first voltage amplitude, comparing the output capacitor decay time to a specified minimum value, and, if the capacitor decay time is below the specified minimum value, charging the output capacitor to a higher second voltage and comparing the comparing the capacitor decay time to the specified minimum value.

3. The device of claim 1 further comprising a telemetry unit interfaced to the controller for enabling user input of a defined schedule for delivering neurostimulation and specified stimulation parameters.

4. The device of claim 3 wherein the controller is further programmed to receive medication dosage information via telemetry and modify the schedule for delivering neurostimulation accordingly.

5. The device of claim 3 wherein the controller is further programmed to modify the stimulation parameters in accordance with the medication dosage information.

6. The device of claim 5 wherein the controller is programmed to reduce the amount of neurostimulation delivered when the medication dosage information indicates a dose of a beta-blocker.

7. The device of claim 5 wherein the controller is programmed to increase the amount of neurostimulation delivered when the medication dosage information indicates a dose of a diuretic.

8. The device of claim 5 wherein the controller is programmed to receive medication dosage information from an electronic pill counter.

9. The device of claim 1 wherein the one or more sensing modalities include a sensing amplifier for sensing cardiac electrical activity and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with the patient'"'"'s measured heart rate.

10. The device of claim 1 further comprising:

circuitry for measuring and collecting time intervals between successive intrinsic beats, referred to as a BB interval, and storing the collected intervals as a discrete BB interval signal, filtering the BB interval signal into defined high and low frequency bands, and determining the signal power of the BB interval signal in each of the low and high frequency bands, referred to LF and HF, respectively; and

,

circuitry for computing an LF/HF ratio and assessing autonomic balance by comparing the LF/HF ratio to a specified threshold value.

11. The device of claim 1 wherein the one or more sensing modalities include an accelerometer for measuring a patient'"'"'s activity level and further comprising circuitry for computing an LF/HF ratio and assessing autonomic balance by comparing the LF/HF ratio to a specified threshold value and comparing the measured activity level to a specified activity threshold value.

12. The device of claim 1 wherein the one or more sensing modalities include a minute ventilation sensor for sensing respiratory rate and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with the patient'"'"'s measured respiratory rate.

13. The device of claim 1 wherein the one or more sensing modalities include an accelerometer for sensing heart sounds and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with the intensity of the patient'"'"'s heart sounds reflective of myocardial contractility.

14. The device of claim 1 wherein the one or more sensing modalities include a pressure sensor for sensing pulse pressure and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with a measurement of the rate of change of pressure dP/dt reflective of myocardial contractility.

15. The device of claim 1 wherein the one or more sensing modalities include an accelerometer for sensing coughing and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with a detection of persistent coughing.

16. The device of claim 1 wherein the one or more sensing modalities include sensing amplifiers for sensing atrial and ventricular electrical activity and wherein the controller is programmed to adjust the amount of neurostimulation delivered in accordance with a measured intrinsic PR interval.

17. A method for operating an implantable device to deliver neurostimulation, comprising:

outputting neural stimulation pulses to one or more stimulation electrodes connected to a pulse generator for delivering electrical stimulation to a selected neural site;

controlling the output of neural stimulation pulses in accordance with a defined schedule and in accordance with specified stimulation parameters;

enabling user input of a defined schedule for delivering neurostimulation and specified stimulation parameters;

sensing a physiological variable reflective of a patient'"'"'s autonomic balance; and

,

adjusting the amount of neurostimulation delivered in accordance with a determination of the patient'"'"'s autonomic balance; and

,

monitoring the impedance of a lead connecting the stimulation electrode to the pulse generator by charging an output capacitor of the pulse generator to a specified voltage level, delivering a stimulation pulse, and measuring the time it takes for the capacitor voltage to decay by a specified amount.

18. The method of claim 17 further comprising to monitoring the lead impedance by charging the output capacitor to a first voltage amplitude, comparing the output capacitor decay time to a specified minimum value, and, if the capacitor decay time is below the specified minimum value, charging the output capacitor to a higher second voltage and comparing the comparing the capacitor decay time to the specified minimum value.

19. The method of claim 17 further comprising receiving medication dosage information via telemetry and modifying the schedule for delivering neurostimulation accordingly.

20. The method of claim 17 further comprising adjusting the amount of neurostimulation delivered in accordance with the patient'"'"'s measured heart rate.