Pacemaker with vagal surge monitoring and response

• US 8,412,326 B2
• Filed: 02/22/2010
• Issued: 04/02/2013
• Est. Priority Date: 10/30/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Arcot-Krishnamurthy, Shantha, Mokelke, Eric A., Shuros, Allan C.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US12/709,867
• Publication Number:
  US 20110106197A1
• Time in Patent Office: 1,135 Days
• Field of Search: 607/9
• US Class Current: 607/14
• 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 1/36514 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 1/36585 controlled by two or more physical parameters

Abstract

A pacemaker initiates and times a monitoring interval in response to an event such as a therapy delivery to a patient. The monitoring interval is specified to include a duration of an anticipated acute response to the event, such as vagal surge. One or more physiological parameters indicative of the acute response are detected during the monitoring interval for analyzing therapeutic effect of the event. In various embodiments, one or more pacing parameters are adjusted for a response interval specified to include the duration of the anticipated acute response to allow for the analysis and maximization of the therapeutic effect. In various embodiments, the event includes a session of pacing therapy delivered according to an intermittent cardiac stress augmentation pacing protocol, and the therapeutic effect is analyzed to adjust that protocol.

Claims

1. A system for pacing a heart, comprising:

a monitoring circuit including;

a monitoring timer configured to initiate and time a monitoring interval including an anticipated duration of vagal surge resulting from a delivery of a first therapy;

a sensing circuit configured to sense one or more physiological signals each indicative of a level of the vagal surge, the one or more physiological signals including at least a cardiac signal; and

a detection circuit configured to detect one or more parameters each indicative of the level of the vagal surge using the sensed one or more physiological signals, the one or more parameters including at least an intrinsic heart rate;

a pacing output circuit configured to deliver a second therapy including delivering pacing pulses, the second therapy different from the first therapy; and

a pacing control circuit coupled to the monitoring circuit and the pacing output circuit, the pacing control circuit configured to control the delivery of the second therapy using pacing parameters and including;

a response timer configured to initiate and time a response interval following the delivery of the first therapy, the response interval including the anticipated duration of the vagal surge; and

a parameter adjustment module configured to adjust one or more pacing parameters of the pacing parameters to allow the heart to beat at the intrinsic heart rate during the response interval.

2. The system of claim 1, wherein the response timer is configured to initiate the response interval upon expiration of a delay interval starting at an end of the delivery of the first therapy, and the parameter adjustment module is configured to lower a lower rate limit (LRL) of the pacing parameters by a specified margin below the detected intrinsic heart rate during the response interval.

3. The system of claim 1, comprising a therapy device configured to perform delivery of the first therapy, and wherein the monitoring timer is configured to initiate the monitoring interval in response to the delivery of the first therapy.

4. The system of claim 3, wherein the response timer is configured to initiate the response interval upon expiration of a delay interval starting at an end of the delivery of the first therapy.

5. The system of claim 3, comprising:

a first implantable medical device including the monitoring circuit, the pacing circuit, and the pacing control circuit; and

a second implantable or non-implantable medical device including the therapy device.

6. The system of claim 3, comprising an implantable medical device including the monitoring circuit, the pacing circuit, the pacing control circuit, and the therapy device.

7. The system of claim 6, wherein the therapy device is configured to deliver a neurostimulation therapy.

8. The system of claim 6, wherein the therapy device comprises the pacing circuit and the pacing control circuit, and the pacing control circuit comprises:

a memory circuit;

an intermittent cardiac stress augmentation pacing protocol stored in the memory circuit, the intermittent cardiac stress augmentation pacing protocol specifying stress augmentation pacing sessions each being the first therapy and including alternating non-pacing and pacing periods, the non-pacing periods each having a non-pacing duration during which no pacing pulse is timed to be delivered, the pacing periods each having a specified pacing duration during which a plurality of the pacing pulses is timed to be delivered using pacing parameters selected to augment cardiac stress to the level effective in slowing or stopping progression of the cardiac disorder; and

a pacing protocol execution module configured to control the delivery of the pacing pulses by executing the intermittent cardiac stress augmentation pacing protocol.

9. The system of claim 6, wherein the detection circuit is configured to produce a pre-event value of each of the one or more parameters before the delivery of the first therapy, a post-event value of the each of the one or more parameters after the delivery of the first therapy during the monitoring interval, and a change value of each of the one or more parameters, the change value being a difference between the post-event value and the pre-event value of the each of the one or more parameters.

10. The system of claim 9, wherein the sensing circuit is configured to sense the cardiac signal and one or more of a signal indicative of respiration, a pulmonary artery pressure (PAP) signal, and a signal indicative of heart sounds, and the detection circuit is configured to detect the intrinsic heart rate and one or more of an atrioventricular (AV) interval, a short-term heart rate variability (HRV) indicative of heart rate turbulence (HRT), a minute ventilation, a PAP, or rate of change in the PAP (dPAP/dt), and a heart sound parameter.

11. The system of claim 1, wherein the pacing output circuit is configured to deliver the first therapy and the second therapy, the first therapy being a temporary pacing therapy, the second therapy being a chronic pacing therapy, and the pacing control circuit is configured to control the delivery of the first therapy and the delivery of the second therapy.

12. The system of claim 11, comprising an implantable medical device including the monitoring circuit, the pacing output circuit, and the pacing control circuit.

13. The system of claim 1, further comprising a therapy device configured to deliver a neurostimulation therapy as the first therapy.

14. The system of claim 13, comprising an implantable medical device including the monitoring circuit, the pacing output circuit, the pacing control circuit, and the therapy device.

15. The system of claim 1, wherein the monitoring timer is configured to initiate and time the monitoring interval being an interval programmable between approximately 2 and 3 hours.

16. The system of claim 15, wherein the response timer is configured to initiate the response interval in response to an end of the delivery of the first therapy.

17. The system of claim 16, wherein the response timer is configured to initiate and time the response interval being another interval programmable between approximately 2 and 3 hours.

18. The system of claim 17, wherein the response timer is configured to initiate the response interval upon expiration of a delay starting at the end of the delivery of the first therapy and programmable between approximately 0 and 10 minutes.

19. The system of claim 1, wherein the response timer is configured to terminate the response interval before a termination of the monitoring interval.

20. The system of claim 1, wherein the response timer is configured to terminate the response interval at a termination of the monitoring interval.

21. A method for operating a system for pacing a heart, comprising:

delivering a first therapy;

sensing a cardiac signal from the heart;

delivering a second therapy including delivery of pacing pulses to the heart, the second therapy different from the first therapy;

controlling the delivery of the second therapy using pacing parameters;

initiating a monitoring interval in response to the delivery of the first therapy, the monitoring interval including an anticipated duration of vagal surge resulting from the delivery of the first therapy;

detecting an intrinsic heart rate from the cardiac signal during the monitoring interval;

initiating a response interval in response to the delivery of the first therapy, the response interval including the anticipated duration of the vagal surge; and

adjusting one or more pacing parameters of the pacing parameters to allow the heart to beat at the intrinsic heart rate during the response interval.

22. The method of claim 21, wherein initiating the monitoring interval comprises initiating the monitoring interval in response to the delivery of the first therapy.

23. The method of claim 22, comprising programming the monitoring interval and the response time to terminate simultaneously at approximately 2 to 3 hours following an end of the delivery of the first therapy.

24. The method of claim 22, wherein initiating the response interval comprises initiating the response interval upon expiration of a delay interval starting at an end of the delivery of the first therapy, and comprising programming the delay interval to a time interval between approximately 0 and 10 minutes.

25. The method of claim 21, comprising:

sensing the cardiac signal and one or more additional physiological signals each indicative of a level of the vagal surge; and

detecting the intrinsic heart rate and one or more additional parameters each indicative of the level of the vagal surge.

26. The method of claim 21, comprising producing a pre-event value of the intrinsic heart rate before the delivery of the first therapy, a post-event value of the intrinsic heart rate after the delivery of the first therapy during the monitoring interval, and a change value of the intrinsic heart rate, the change value being a difference between the post-event value and the pre-event value.

27. The method of claim 21, wherein adjusting the one or more pacing parameters comprises lowering a lower rate limit (LRL) to a value below the detected intrinsic heart rate by a specified margin during the response interval if the lowered LRL exceeds a specified minimum.

28. The method of claim 27, wherein lowering the LRL comprises lowering the LRL to a value below the detected intrinsic heart rate by approximately 15 beats per minute.

29. The method of claim 21, comprising delivering an intermittent cardiac stress augmentation pacing therapy including stress augmentation pacing sessions each being the first therapy and including alternating non-pacing and pacing periods, the non-pacing periods each having a non-pacing duration during which no pacing pulse is timed to be delivered, the pacing periods each having a specified pacing duration during which a plurality of the pacing pulses is timed to be delivered using pacing parameters selected to augment cardiac stress to the level effective in slowing or stopping progression of a cardiac disorder.

30. The method of claim 21, comprising delivering an intermittent cardiac stress augmentation pacing therapy including stress augmentation pacing sessions each being the first therapy and including alternating first and second pacing periods, the first pacing periods each having a first pacing duration during which a plurality of the pacing pulses is timed to be delivered according to a first pacing mode, the second pacing periods each having a second pacing duration during which a plurality of the pacing pulses is timed to be delivered according to a second pacing mode including pacing parameters selected to augment cardiac stress to the level effective in slowing or stopping progression of a cardiac disorder.

31. The method of claim 21, wherein the first therapy is a temporary pacing therapy, and the second therapy is a chronic pacing therapy.

32. The method of claim 31, wherein delivering the first therapy comprises delivering the first therapy from an implantable medical device, and delivering the second therapy comprises delivering the second therapy from the implantable medical device.

33. The method of claim 21, wherein delivering the first therapy comprises delivering a neurostimulation therapy.

34. The method of claim 33, wherein delivering the first therapy comprises delivering the first therapy from a non-implantable medical device, and delivering the second therapy comprises delivering the second therapy from an implantable medical device.

35. The method of claim 33, wherein delivering the first therapy comprises delivering the first therapy from a first implantable medical device, and delivering the second therapy comprises delivering the second therapy from a second implantable medical device.

36. The method of claim 21, wherein delivering the first therapy comprises delivering a drug therapy.

37. The method of claim 21, wherein delivering the first therapy comprises delivering a therapy that enhances cardiac contractility.

38. The method of claim 25, wherein sensing the one or more additional physiological signals comprises sensing a respiration signal.

39. The method of claim 25, wherein sensing the one or more additional physiological signals comprises sensing a pulmonary artery pressure signal.

40. The method of claim 25, wherein sensing the one or more additional physiological signals comprises sensing a heart sound signal.