Preventing use of vagal stimulation parameters

• US 9,211,413 B2
• Filed: 07/14/2014
• Issued: 12/15/2015
• Est. Priority Date: 01/19/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ziegler, Paul D., Kornet, Lilian, Zhou, Xiaohong, Cornelussen, Richard N. M., Stadler, Robert, Warman, Eduardo, Kleckner, Karen J., Della Scala, Alberto
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/330,915
• Publication Number:
  US 20140324115A1
• Time in Patent Office: 519 Days
• Field of Search: 607/18
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

The disclosure herein relates generally to methods for treating heart conditions using vagal stimulation, and further to systems and devices for performing such treatment. Such methods may include monitoring physiological parameters of a patient, detecting cardiac conditions, and delivering vagal stimulation (e.g., electrical stimulation to the vagus nerve or neurons having parasympathetic function) to the patient to treat the detected cardiac conditions.

Claims

1. A device for delivery of vagal stimulation comprising:

monitoring apparatus configured to monitor physiological parameters of a patient, wherein the monitoring apparatus comprises at least one electrode to monitor the electrical activity of the patient'"'"'s heart;

a sensing module coupled to the monitoring apparatus and configured to receive the monitored physiological parameters;

a therapy delivery module configured to deliver electrical stimulation to the patient'"'"'s vagus nerve; and

a control module coupled to the sensing module and to the therapy delivery module and configured to;

analyze the monitored physiological parameters after delivery of electrical stimulation to the patient'"'"'s vagus nerve,

adjust the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters,

determine whether the patient'"'"'s cardiac condition is worsening after the delivery of electrical stimulation to the patient'"'"'s vagus nerve,

terminate the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the patient'"'"'s cardiac condition is worsening,

store the parameters of the electrical stimulation delivered to the patient'"'"'s vagus nerve associated with the worsening of the patient'"'"'s cardiac condition, and

deliver, at a later time following termination of the delivery of electrical stimulation to the patient'"'"'s vagus nerve, electrical stimulation to the patient'"'"'s vagus nerve at one or more stimulation parameters, wherein the control module is configured to prevent, at the later time following termination of the delivery of electrical stimulation, delivery of the electrical stimulation to the patient'"'"'s vagus nerve at the previously stored parameters associated with the worsening of the patient'"'"'s cardiac condition.

2. The device of claim 1, wherein determining whether the patient'"'"'s cardiac condition is worsening comprises determining whether the monitored physiological parameters of the patient indicate at least one of atrial fibrillation, ventricular arrhythmia, mechanical functional deterioration, and syncope, and wherein terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the patient'"'"'s cardiac condition is worsening comprises terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the monitored physiological parameters of the patient indicate at least one of atrial fibrillation, ventricular arrhythmia, mechanical functional deterioration, and syncope.

3. The device of claim 1, wherein the control module is further configured to control the delivery electrical stimulation to the patient'"'"'s vagus nerve to be synchronized to blanking periods associated with either of the P-waves or the R-waves within the electrical activity of the patient'"'"'s heart.

4. The device of claim 3, wherein the control module is further configured to adjust the electrical stimulation by changing the synchronization of the delivery of the electrical stimulation from synchronization with a blanking period associated with one of either of the P-waves or the R-waves to synchronization with the blanking period associated with the other.

5. The device of claim 4 further comprising determining existence of VT/VF.

6. The device of claim 1, wherein the control module is further configured to control the execution of at least one of:

adjusting the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart have not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve,

adjusting the electrical stimulation if the P-R intervals within the electrical activity of the patient'"'"'s heart have not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve, and

adjusting the electrical stimulation if the morphology of the R-waves of the electrical activity of the patient'"'"'s heart has not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve.

7. The device of claim 1, wherein the control module is further configured to control the execution of at least one of:

increasing the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart are less than a first selected value, wherein increasing the electrical stimulation comprises at least one of increasing the voltage of the electrical stimulation, increasing the frequency of the electrical stimulation, increasing the pulse width of each pulse of the electrical stimulation, and increasing the number of pulses per burst of pulses of the electrical stimulation, and

decreasing the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart are greater than a second selected value, wherein decreasing the electrical stimulation comprises at least one of decreasing the voltage of the electrical stimulation, decreasing the frequency of the electrical stimulation, decreasing the pulse width of each pulse of the electrical stimulation, and decreasing the number of pulses per burst of pulses of the electrical stimulation.

8. A method of delivering vagal stimulation comprising:

monitoring physiological parameters of a patient, wherein the physiological parameters comprise the electrical activity of the patient'"'"'s heart;

delivering electrical stimulation to the patient'"'"'s vagus nerve;

analyzing the monitored physiological parameters after delivering electrical stimulation to the patient'"'"'s vagus nerve;

adjusting the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters;

determining whether the patient'"'"'s cardiac condition is worsening after delivering electrical stimulation to the patient'"'"'s vagus nerve;

terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the patient'"'"'s cardiac condition is worsening;

storing the parameters of the electrical stimulation delivered to the patient'"'"'s vagus nerve associated with the worsening of the patient'"'"'s cardiac condition;

delivering, at a later time following termination of the delivery of electrical stimulation to the patient'"'"'s vagus nerve, electrical stimulation to the patient'"'"'s vagus nerve at one or more stimulation parameters; and

preventing, at the later time following termination of the delivery of electrical stimulation, delivery of the electrical stimulation to the patient'"'"'s vagus nerve at the previously stored parameters associated with the worsening of the patient'"'"'s cardiac condition.

9. The method of claim 8, wherein determining whether the patient'"'"'s cardiac condition is worsening comprises determining whether the monitored physiological parameters of the patient indicate at least one of atrial fibrillation, ventricular arrhythmia, mechanical functional deterioration, and syncope, and wherein terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the patient'"'"'s cardiac condition is worsening comprises terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the monitored physiological parameters of the patient indicate at least one of atrial fibrillation, ventricular arrhythmia, mechanical functional deterioration, and syncope.

10. The method of claim 8, wherein the delivery of electrical stimulation to the patient'"'"'s vagus nerve is synchronized to blanking periods associated with either of the P-waves or the R-waves within the electrical activity of the patient'"'"'s heart.

11. The method of claim 10, wherein adjusting the electrical stimulation comprises changing the synchronization of the delivery of the electrical stimulation from synchronization with a blanking period associated with one of either of the P-waves or the R-waves to synchronization with the blanking period associated with the other.

12. The method of claim 8, wherein adjusting the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters comprises at least one of:

adjusting the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart have not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve,

adjusting the electrical stimulation if the P-R intervals within the electrical activity of the patient'"'"'s heart have not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve, and

adjusting the electrical stimulation if the morphology of the R-waves of the electrical activity of the patient'"'"'s heart has not changed in response to the delivery of electrical stimulation to the patient'"'"'s vagus nerve.

13. The method of claim 8, wherein adjusting the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters comprises at least one of:

increasing the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart are less than a first selected value, wherein increasing the electrical stimulation comprises at least one of increasing the voltage of the electrical stimulation, increasing the frequency of the electrical stimulation, increasing the pulse width of each pulse of the electrical stimulation, and increasing the number of pulses per burst of pulses of the electrical stimulation, and

decreasing the electrical stimulation if the R-R intervals within the electrical activity of the patient'"'"'s heart are greater than a second selected value, wherein decreasing the electrical stimulation comprises at least one of decreasing the voltage of the electrical stimulation, decreasing the frequency of the electrical stimulation, decreasing the pulse width of each pulse of the electrical stimulation, and decreasing the number of pulses per burst of pulses of the electrical stimulation.