Vagal stimulation

• US 8,781,583 B2
• Filed: 01/19/2012
• Issued: 07/15/2014
• Est. Priority Date: 01/19/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Cornelussen, Richard N. M., Zhou, Xiaohong, Kornet, Lilian, Stadler, Robert
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/353,919
• Publication Number:
  US 20120185011A1
• Time in Patent Office: 908 Days
• Field of Search: None
• US Class Current: 607/18
• 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 1/36585 controlled by two or more physical parameters

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 delivering cardiac therapy comprising:

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

monitor P-R intervals within the electrical activity of the patient'"'"'s heart and ventricular pressure of the patient'"'"'s heart prior to initiation of delivery of electrical stimulation to the patient'"'"'s vagus nerve, and

regulate preload and cardiac contractility of the patient'"'"'s heart by initiating delivery of electrical stimulation to the patient'"'"'s vagus nerve if a P-R interval monitored within the electrical activity of the patient'"'"'s heart is less than a P-R interval threshold value and the monitored ventricular pressure of the patient'"'"'s heart is greater than a pressure threshold value, wherein monitored P-R intervals less than the P-R interval threshold value are indicative of unhealthy preload and cardiac contractility, and wherein monitored ventricular pressures greater than pressure threshold value are indicative of unhealthy preload and cardiac contractility.

2. The device of claim 1, wherein the control module is further configured to control the delivery of 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.

3. The device of claim 1, wherein the control module is further configured to:

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

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

4. The device of claim 3, 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.

5. The device of claim 1, wherein the therapy delivery module is further configured to deliver electrical pacing therapy to the patient'"'"'s heart, and wherein the control module is further configured to initiate the delivery of electrical pacing therapy to the patient'"'"'s heart if the electrical activity of the patient'"'"'s heart is indicative of heart failure.

6. The device of claim 5, wherein the electrical activity of the patient'"'"'s heart is indicative of heart failure if a P-R interval within the monitored electrical activity of the patient'"'"'s heart is greater than a selected maximum P-R interval value.

7. The device of claim 5, wherein the control module is further configured to terminate the delivery of electrical pacing therapy to the patient'"'"'s heart if a P-R interval within the monitored electrical activity of the patient'"'"'s heart is less than a selected minimum P-R interval value.

8. A method for delivering cardiac therapy comprising:

monitoring P-R intervals within the electrical activity of a patient'"'"'s heart prior to initiation of delivery of electrical stimulation to the patient'"'"'s vagus nerve;

monitoring ventricular pressure of the patient'"'"'s heart prior to initiation of delivery of electrical stimulation to the patient'"'"'s vagus nerve; and

regulating preload and cardiac contractility of the patient'"'"'s heart by initiating delivery of electrical stimulation to the patient'"'"'s vagus nerve if a P-R interval monitored within the electrical activity of the patient'"'"'s heart is less than a P-R interval threshold value and the monitored ventricular pressure of the patient'"'"'s heart is greater than a pressure threshold value, wherein monitored P-R intervals less than the P-R interval threshold value are indicative of unhealthy preload and cardiac contractility, and wherein monitored ventricular pressures greater than pressure threshold value are indicative of unhealthy preload and cardiac contractility.

9. 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.

10. The method of claim 8, wherein the method further comprises:

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

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

11. The method of claim 10, 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.

12. The method of claim 8, wherein the method further comprises delivering electrical pacing therapy to the patient'"'"'s heart if the electrical activity of the patient'"'"'s heart is indicative of heart failure.

13. The method of claim 12, wherein the electrical activity of the patient'"'"'s heart is indicative of heart failure if a P-R interval within the monitored electrical activity of the patient'"'"'s heart is greater than a selected maximum P-R interval value.

14. The method of claim 12, wherein the method further comprises terminating the delivery of electrical pacing therapy to the patient'"'"'s heart if a P-R interval within the monitored electrical activity of the patient'"'"'s heart is less than a selected minimum P-R interval value.