Vagal stimulation

• US 8,725,259 B2
• Filed: 01/19/2012
• Issued: 05/13/2014
• Est. Priority Date: 01/19/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kornet, Lilian, Cornelussen, Richard N. M., Ziegler, Paul D., Zhou, Xiaohong, Warman, Eduardo, Kleckner, Karen J., Nichols, Lucy, Della Scala, Alberto
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/353,861
• Publication Number:
  US 20120185009A1
• Time in Patent Office: 845 Days
• Field of Search: 607/23, 607 14- 25
• US Class Current: 607/14
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

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 providing vagal stimulation comprising:

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

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

detect a supraventricular tachycardia using the monitored physiological parameters,

analyze, upon detecting the supraventricular tachycardia, the monitored physiological parameters for predetermined criteria before delivering electrical stimulation to the patient'"'"'s vagus nerve, wherein analyzing the monitored physiological parameters comprises;

determining whether the electrical activity of the patient'"'"'s heart is indicative of a ventricular arrhythmia, and

determining whether the lead configured to deliver electrical stimulation to the patient'"'"'s vagus nerve is dislodged,

prevent delivery of electrical stimulation to the patient'"'"'s vagus nerve if the electrical activity of the patient'"'"'s heart indicates a ventricular arrhythmia or if the lead configured to deliver electrical stimulation to the patient'"'"'s vagus is dislodged,

deliver, if not prevented, electrical stimulation to the patient'"'"'s vagus nerve upon detecting the supraventricular tachycardia,

determining whether a cardiac condition of the patient is worsening after delivering electrical stimulation to the patient'"'"'s vagus nerve upon detecting the supraventricular tachycardia,

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

store the physiologic parameters of the patient monitored prior to the delivery of the electrical stimulation to the patient'"'"'s vagus nerve associated with the worsening of the cardiac condition of the patient after delivering electrical stimulation to the patient'"'"'s vagus nerve, and

prevent, at a later time, delivery of electrical stimulation to the patient'"'"'s vagus nerve if the presently monitored physiological parameters of the patient are similar to the stored physiological parameters of the patient associated with the worsening of the cardiac condition.

2. The device of claim 1, wherein determining whether the lead configured to deliver electrical stimulation to the patient'"'"'s vagus nerve is dislodged comprises comparing the rhythm of the electrical activity monitored in the atria of the patient'"'"'s heart to the rhythm of the electrical activity monitored in the ventricles of the patient'"'"'s heart.

3. The device of claim 1, wherein determining whether a cardiac condition of the patient 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 cardiac condition of the patient 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.

4. The device of claim 1, wherein analyzing the monitored physiological parameters comprises:

determining whether the R-R intervals within the electrical activity of the patient'"'"'s heart have increased, and

determining whether the P-R intervals within the electrical activity of the patient'"'"'s heart have increased, and

wherein the control module is further configured to;

terminate the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the electrical activity of the patient'"'"'s heart indicates ventricular arrhythmia, if the R-R intervals within the electrical activity of the patient'"'"'s heart have not increased, or if the P-R intervals within the electrical activity of the patient'"'"'s heart have not increased.

5. 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.

6. A method of providing vagal stimulation comprising:

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

detecting a supraventricular tachycardia using the monitored physiological parameters;

analyzing, upon detecting the supraventricular tachycardia, the monitored physiological parameters for predetermined criteria before delivering electrical stimulation to the patient'"'"'s vagus nerve, wherein the analyzing the monitored physiological parameters comprises;

determining whether the electrical activity of the patient'"'"'s heart is indicative of a ventricular arrhythmia, and

determining whether the lead configured to deliver electrical stimulation to the patient'"'"'s vagus nerve is dislodged;

preventing delivery of electrical stimulation to the patient'"'"'s vagus nerve if the electrical activity of the patient'"'"'s heart indicates a ventricular arrhythmia or if the lead configured to deliver electrical stimulation to the patient'"'"'s vagus is dislodged;

delivering, if not prevented, electrical stimulation to the patient'"'"'s vagus nerve, upon detecting the supraventricular tachycardia;

determining whether a cardiac condition of the patient is worsening after delivering electrical stimulation to the patient'"'"'s vagus nerve upon detecting the supraventricular tachycardia;

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

storing the physiologic parameters of the patient monitored prior to the delivery of the electrical stimulation to the patient'"'"'s vagus nerve associated with the cardiac condition of the patient worsening after delivering electrical stimulation to the patient'"'"'s vagus nerve; and

preventing, at a later time, delivery of electrical stimulation to the patient'"'"'s vagus nerve if the presently monitored physiological parameters of the patient are similar to the stored physiological parameters of the patient associated with the cardiac condition of the patient worsening.

7. The method of claim 6, wherein determining whether the lead configured to deliver electrical stimulation to the patient'"'"'s vagus nerve is dislodged comprises comparing the rhythm of the electrical activity monitored in the atria of the patient'"'"'s heart to the rhythm of the electrical activity monitored in the ventricles of the patient'"'"'s heart.

8. The method of claim 6, wherein determining whether a cardiac condition of the patient 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 cardiac condition of the patient 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.

9. The method of claim 6, wherein the method further comprises:

analyzing the monitored physiological parameters for termination criteria, wherein analyzing the monitored physiological parameters comprises;

determining whether the R-R intervals of the electrical activity of the patient'"'"'s heart have increased, and

determining whether the P-R intervals of the electrical activity of the patient'"'"'s heart have increased; and

terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the electrical activity of the patient'"'"'s heart indicates ventricular arrhythmia, if the R-R intervals of the electrical activity of the patient'"'"'s heart have not increased, or if the P-R intervals of the electrical activity of the patient'"'"'s heart have not increased.