Use of preventative vagal stimulation in treatment of acute myocardial infarction or ischemia

• US 9,155,893 B2
• Filed: 04/22/2014
• Issued: 10/13/2015
• Est. Priority Date: 01/19/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhou, Xiaohong, Kornet, Lilian, Cornelussen, Richard N. M., Ziegler, Paul D., Stadler, Robert, Warman, Eduardo, Kleckner, Karen J., Nichols, Lucy, Della Scala, Alberto
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/259,095
• Publication Number:
  US 20140316486A1
• Time in Patent Office: 539 Days
• Field of Search: 60/18
• 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 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

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 use in treating a patient using 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;

detect acute myocardial infarction or myocardial ischemia using the monitored physiological parameters,

initiate delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve upon detecting the acute myocardial infarction or myocardial ischemia to decrease at least one of workload and inflammation of the patient'"'"'s heart,

analyze the monitored physiological parameters after the delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve to at least determine whether the electrical activity of the patient'"'"'s heart indicates cessation of progression of the acute myocardial infarction or myocardial ischemia,

terminate the delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve when the electrical activity of the patient'"'"'s heart indicates cessation of the progression of the acute myocardial infarction or myocardial ischemia, and

initiate delivery of preventative electrical stimulation to the patient'"'"'s vagus nerve after terminating the delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve, wherein the preventative electrical stimulation is scheduled to be delivered at one or more selected times to the patient'"'"'s vagus nerve to decrease at least one of workload and inflammation of the patient'"'"'s heart.

2. The device of claim 1, wherein the control module is further configured to detect acute myocardial infarction or myocardial ischemia using the monitored physiological parameters by determining whether the electrical activity of the patient'"'"'s heart comprises a ST-deviation.

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

4. The device of claim 1, wherein the preventative electrical stimulation is controlled by a schedule programmed in memory to be delivered to the patient'"'"'s vagus nerve more than once a day.

5. The device of claim 1, wherein the control module is further configured to initiate the delivery of preventative electrical stimulation to the patient'"'"'s vagus nerve upon a determination that the monitored physiological parameters indicate that the patient has awaken from sleep.

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

analyze the monitored physiological parameters after delivering therapeutic electrical stimulation to the patient'"'"'s vagus nerve to at least determine whether the R-R intervals of the electrical activity of the patient'"'"'s heart have increased, and

terminate the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the R-R intervals of the electrical activity of the patient'"'"'s heart have not increased.

7. The device of claim 1, wherein the control module is further configured to adjust the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters until the P-R intervals within the electrical activity of the patient'"'"'s heart have increased to a level that reduces the workload of the patient'"'"'s heart.

8. The device of claim 1, wherein the control module is further configured to adjust the delivery of the therapeutic electrical stimulation if the ST-deviation of the electrical activity of the patient'"'"'s heart has not decreased.

9. The device of claim 1, wherein the device further comprises a telemetry module operably coupled to the control module and configured to receive input from a user indicating that the patient is undergoing symptoms of acute myocardial infarction or myocardial ischemia, and wherein the control module is further configured to initiate delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve upon the telemetry module receiving input from a user indicating that the patient is undergoing symptoms of acute myocardial infarction or myocardial ischemia.

10. A method for use in treating a patient using vagal stimulation comprising:

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

detecting acute myocardial infarction or myocardial ischemia using the monitored physiological parameters;

delivering therapeutic electrical stimulation to the patient'"'"'s vagus nerve upon detecting the acute myocardial infarction or myocardial ischemia to decrease at least one of workload and inflammation of the patient'"'"'s heart;

analyzing the monitored physiological parameters after delivering therapeutic 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 indicates cessation of the progression of the acute myocardial infarction or myocardial ischemia;

terminating the delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve if the electrical activity of the patient'"'"'s heart indicates cessation of the progression of the acute myocardial infarction or myocardial ischemia; and

delivering preventative electrical stimulation to the patient'"'"'s vagus nerve after terminating the delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve, wherein the preventative electrical stimulation is scheduled to be delivered at one or more selected times to the patient'"'"'s vagus nerve to decrease at least one of workload and inflammation of the patient'"'"'s heart.

11. The method of claim 10, wherein detecting acute myocardial infarction or myocardial ischemia using the monitored physiological parameters comprises determining whether the electrical activity of the patient'"'"'s heart comprises a ST-deviation.

12. The method of claim 10, wherein the preventative electrical stimulation is further delivered to the patient upon a detection of the patient waking from sleep to counter a surge of sympathetic electrical activity.

13. The method of claim 10, wherein analyzing the monitored physiological parameters after delivering therapeutic electrical stimulation to the patient'"'"'s vagus nerve further comprises determining whether the R-R intervals of the electrical activity of the patient'"'"'s heart have increased, and wherein the method further comprises terminating the delivery of electrical stimulation to the patient'"'"'s vagus nerve if the R-R intervals of the electrical activity of the patient'"'"'s heart have not increased.

14. The method of claim 10, wherein the method further comprises adjusting the electrical stimulation delivered to the patient'"'"'s vagus nerve based on the analysis of the monitored physiological parameters until the P-R intervals within the electrical activity of the patient'"'"'s heart have increased to a level that reduces the workload of the patient'"'"'s heart.

15. The method of claim 10, wherein the method further comprises adjusting the delivery of the therapeutic electrical stimulation if the ST-deviation of the electrical activity of the patient'"'"'s heart has not decreased.

16. The method of claim 10, wherein the method further comprises initiating delivery of therapeutic electrical stimulation to the patient'"'"'s vagus nerve upon receiving input from a user indicating that the patient is undergoing symptoms of acute myocardial infarction or myocardial ischemia.