Cardiac therapy including vagal stimulation

• US 10,207,112 B2
• Filed: 04/06/2017
• Issued: 02/19/2019
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhou, Xiaohong, Kornet, Lilian, Cornelussen, Richard N. M., Stadler, Robert W.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/480,929
• Publication Number:
  US 20170216601A1
• Time in Patent Office: 684 Days
• 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 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3937 Monitoring output parameters
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Methods of nerve signal differentiation, methods of delivering therapy using such nerve signal differentiation, and to systems and devices for performing such methods. Nerve signal differentiation may include locating two electrodes proximate nerve tissue and differentiating between efferent and afferent components of nerve signals monitored using the two electrodes.

Claims

1. A device for delivering cardiac therapy 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 to deliver electrical pacing therapy to the patient'"'"'s heart; and

a control module coupled to the sensing module and to the therapy delivery module and configured to control the delivery of electrical stimulation to the patient'"'"'s vagus nerve and to control the delivery of electrical pacing therapy to the patient'"'"'s heart, wherein the control module is further configured to;

monitor the V-V interval of the electrical activity of the patient'"'"'s heart,

switch between electrical stimulation to the patient'"'"'s vagus nerve and electrical pacing therapy to the patient'"'"'s heart based on the monitored V-V interval and an optimal V-V range,

determine whether electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve,

initiate the delivery of electrical stimulation to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being higher than the optimal V-V range and determination that electrical stimulation is not currently being delivered to the patient'"'"'s vagus nerve, and

increase the electrical stimulation energy being delivered to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being higher than the optimal V-V range and determination that electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve.

2. The device of claim 1, wherein the at least one electrode comprises at least one subcutaneous electrode.

3. The device of claim 1, wherein the monitoring apparatus further comprises at least one sensor to monitor a pressure of a ventricle of the patient'"'"'s heart, and wherein the control module is further configured to initiate the delivery of electrical stimulation to the patient'"'"'s vagus nerve in response to a monitored P-R interval of the electrical activity of the patient'"'"'s being less than a selected P-R value and the monitored ventricular pressure of the patient'"'"'s heart being less than a selected pressure value.

4. 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 or electrical pacing therapy; and

terminate the delivery of electrical stimulation or electrical pacing therapy in response to determination that the patient'"'"'s cardiac condition is worsening.

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

6. The device of claim 5, wherein the electrical activity of the patient'"'"'s heart is indicative of heart failure in response to the monitored P-R interval of the 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 or adjust the delivery of electrical pacing therapy to the patient'"'"'s heart in response to the monitored P-R interval of the electrical activity of the patient'"'"'s heart being less than a selected minimum P-R interval value.

8. The device of claim 1, wherein the control module is further configured to initiate the delivery of electrical pacing therapy to the patient'"'"'s heart in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being lower than the optimal V-V range and determination that electrical stimulation is not currently being delivered to the patient'"'"'s vagus nerve.

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

reduce electrical stimulation energy being delivered to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being lower than the optimal V-V range and determination that electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve.

10. The device of claim 1, wherein control module is configured to modify the optimal V-V range based on one or more of activity level and stress of the patient.

11. A device for delivering cardiac therapy 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 to deliver electrical pacing therapy to the patient'"'"'s heart; and

a control module coupled to the sensing module and to the therapy delivery module and configured to control the delivery of electrical stimulation to the patient'"'"'s vagus nerve and to control the delivery of electrical pacing therapy to the patient'"'"'s heart, wherein the control module is further configured to;

monitor the V-V interval of the electrical activity of the patient'"'"'s heart,

switch between electrical stimulation to the patient'"'"'s vagus nerve and electrical pacing therapy to the patient'"'"'s heart based on the monitored V-V interval and an optimal V-V range,

determine whether electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve,

initiate the delivery of electrical pacing therapy to the patient'"'"'s heart in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being lower than the optimal V-V range and determination that electrical stimulation is not currently being delivered to the patient'"'"'s vagus nerve, and

reduce electrical stimulation energy being delivered to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being lower than the optimal V-V range and determination that electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve.

12. The device of claim 11, wherein the at least one electrode comprises at least one subcutaneous electrode.

13. The device of claim 11, wherein the monitoring apparatus further comprises at least one sensor to monitor a pressure of a ventricle of the patient'"'"'s heart, and wherein the control module is further configured to initiate the delivery of electrical stimulation to the patient'"'"'s vagus nerve in response to a monitored P-R interval of the electrical activity of the patient'"'"'s being less than a selected P-R value and the monitored ventricular pressure of the patient'"'"'s heart being less than a selected pressure value.

14. The device of claim 11, wherein the control module is further configured to:

determine whether the patient'"'"'s cardiac condition is worsening after the delivery of electrical stimulation or electrical pacing therapy; and

terminate the delivery of electrical stimulation or electrical pacing therapy in response to determination that the patient'"'"'s cardiac condition is worsening.

15. The device of claim 11, wherein the control module is further configured to initiate the delivery of electrical pacing therapy to the patient'"'"'s heart in response to the electrical activity of the patient'"'"'s heart being indicative of heart failure.

16. The device of claim 15, wherein the electrical activity of the patient'"'"'s heart is indicative of heart failure in response to the monitored P-R interval of the electrical activity of the patient'"'"'s heart is greater than a selected maximum P-R interval value.

17. The device of claim 15, wherein the control module is further configured to terminate or adjust the delivery of electrical pacing therapy to the patient'"'"'s heart in response to the monitored P-R interval of the electrical activity of the patient'"'"'s heart being less than a selected minimum P-R interval value.

18. The device of claim 11, wherein the control module is further configured to initiate the delivery of electrical stimulation to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being higher than the optimal V-V range and determination that electrical stimulation is not currently being delivered to the patient'"'"'s vagus nerve.

19. The device of claim 11, wherein the control module is further configured increase the electrical stimulation energy being delivered to the patient'"'"'s vagus nerve in response to the monitored V-V interval of the electrical activity of the patient'"'"'s heart being higher than the optimal V-V range and determination that electrical stimulation is currently being delivered to the patient'"'"'s vagus nerve.

20. The device of claim 11, wherein control module is configured to modify the optimal V-V range based on one or more of activity level and stress of the patient.