Cardiac pacing sensing and control

• US 10,315,036 B2
• Filed: 04/21/2017
• Issued: 06/11/2019
• Est. Priority Date: 09/04/2014
• Status: Active Grant

• Current Assignee: Atacor Medical Inc.
• Original Assignee: Atacor Medical Inc.
• Inventors: Sanghera, Rick, Marcovecchio, Alan, McGeehan, Sean
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/494,126
• Publication Number:
  US 20170224995A1
• Time in Patent Office: 781 Days
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A cardiac pacing system having a pulse generator for generating therapeutic electric pulses, a lead electrically coupled with the pulse generator having an electrode, a first sensor configured to monitor a physiological characteristic of a patient, a second sensor configured to monitor a second physiological characteristic of a patient and a controller. The controller can determine a pacing vector based on variables including a signal received from the second sensor, and cause the pulse generator to deliver the therapeutic electrical pulses according to the determined pacing vector. The controller can also modify pacing characteristics based on variables including a signal received from the second sensor.

Claims

1. A cardiac pacing system comprising:

a pulse generator including a housing, the pulse generator configured to generate therapeutic electric pulses to a heart of a patient;

at least one lead, wherein a proximal end of the at least one lead is configured to electrically couple with the pulse generator, the at least one lead including at least one electrode;

a first sensor configured to monitor a physiological characteristic of the patient;

an accelerometer configured to monitor mechanical movement of the heart; and

a controller configured to;

determine a pacing vector based on variables including a capture assessment utilizing a signal received from the accelerometer indicating mechanical movement of the heart; and

cause the pulse generator to deliver the therapeutic electrical pulses according to the determined pacing vector.

2. The cardiac pacing system of claim 1 wherein the first sensor is an electrode configured to sense heart rate and wherein the controller is further configured to determine the pacing vector based on variables including a signal received from the first sensor.

3. The cardiac pacing system of claim 2 wherein the housing includes at least one housing electrode configured to act as a sensor or as an electrode and the controller is configured to determine the pacing vector based on at least a signal transmitted from the housing electrode.

4. The cardiac pacing system of claim 2 wherein the therapeutic electrical pulses are delivered by a plurality of electrodes in a manner where more than one electrode acts as a cathode and more than one electrode acts as an anode.

5. The cardiac pacing system of claim 2 wherein the variables include a sensed amount of skeletal muscle stimulation during pacing.

6. The cardiac pacing system of claim 2 wherein the variables include the energy required by potential pacing vectors.

7. The cardiac pacing system of claim 2 wherein the variables include the distance between an electrode utilized for delivery of the therapeutic electrical pulses and a sensor.

8. The cardiac pacing system of claim 2 wherein the controller is further configured to utilize a weighted scoring method in determining the pacing vector.

9. The cardiac pacing system of claim 2 wherein the controller is further configured for a vector selection assessment.

10. The cardiac pacing system of claim 9 wherein a patient perception of discomfort is considered in the vector selection assessment.

11. The cardiac pacing system of claim 9 wherein the controller is further configured to determine the pacing vector based on results of the vector selection assessment.

12. The cardiac pacing system of claim 2, the controller further configured to:

reduce an energy level of the therapeutic electrical pulses until a loss of cardiac capture is suspected based on the capture assessment utilizing the signal received from the accelerometer; and

increase the energy level of the therapeutic electrical pulses until cardiac capture is regained.

13. The cardiac pacing system of claim 2, wherein the accelerometer is on a lead.

14. The cardiac pacing system of claim 2, further comprising a subcutaneous accelerometer, wherein the pacing vector is further determined based on signals from the accelerometer and the subcutaneous accelerometer.

15. The cardiac pacing system of claim 2, further configured to filter exogenous motion from signals received from the accelerometer, wherein the exogenous motion includes one or more of:

movement of the patient, breathing, and exogenous motion attributable to sound waves.

16. A cardiac pacing system comprising:

a pulse generator configured to generate therapeutic electric pulses to a heart of a patient;

at least one lead, wherein a proximal end of the at least one lead is configured to electrically couple with the pulse generator, the at least one lead including at least one electrode;

a first sensor configured to monitor a characteristic of the patient;

an accelerometer configured to monitor mechanical movement of the heart; and

a controller configured to;

modify pacing characteristics based on variables including a capture assessment utilizing a signal received from the accelerometer indicating mechanical movement of the heart, the pacing characteristics including a pacing vector, and

cause the pulse generator to deliver the therapeutic electrical pulses according to the determined modified pacing characteristics.

17. The cardiac pacing system of claim 16 wherein the pacing characteristics are selected from the group consisting of pacing vector, pulse energy and pulse width.

18. The cardiac pacing system of claim 17, the controller further configured to:

reduce an energy level of the therapeutic electrical pulses until a loss of cardiac capture is suspected based on the capture assessment utilizing the signal received from the accelerometer; and

increase the energy level of the therapeutic electrical pulses until cardiac capture is regained.

19. The cardiac pacing system of claim 17, wherein the accelerometer is on a lead.

20. The cardiac pacing system of claim 17, further comprising a subcutaneous accelerometer, wherein the pacing vector is further determined based on signals from the accelerometer and the subcutaneous accelerometer.

21. The cardiac pacing system of claim 17, further configured to filter exogenous motion from signals received from the accelerometer, wherein the exogenous motion includes one or more of:

movement of the patient, breathing, and exogenous motion attributable to sound waves.

22. The cardiac pacing system of claim 16 wherein the first sensor is an electrode configured to sense heart rate and wherein the controller is further configured to modify pacing characteristics based on variables including a signal received from the first sensor.

23. The cardiac pacing system of claim 22 wherein the controller being configured to modify pacing characteristics includes comparing the signal from the accelerometer during pacing to the signal from the accelerometer during intrinsic heartbeat activity.

24. The cardiac pacing system of claim 22 wherein the controller is further configured to operate with a programmer to develop empirical data to assist in modifying pacing characteristics based on skeletal muscle deflection.

25. The cardiac pacing system of claim 24 wherein the empirical data comprises pacing characteristics correlated with patient discomfort.

26. The cardiac pacing system of claim 22 wherein the second sensor is configured to determine R-wave intervals.

27. The cardiac pacing system of claim 26 wherein the controller is further configured to determine an interval threshold based on sensed R-wave intervals and wherein the controller being configured to modify pacing characteristics comprises providing for a pacing pulse when the interval threshold is reached without detection of an intrinsic R-wave.

28. The cardiac pacing system of claim 22 wherein the controller being configured to modify pacing characteristics comprises limiting the pacing characteristics to a ventricular pacing rate not exceeding a maximum ventricular tracking rate threshold.

29. The cardiac pacing system of claim 22 wherein the controller being configured to modify pacing characteristics comprises switching to a non-tracking mode in response to the sensing of a prolonged, highly variable or high rate atrial arrhythmia.

30. A computer program product comprising a non-transient, machine-readable medium storing instructions which, when executed by at least one programmable processor, cause the at least one programmable processor to perform operations comprising:

monitoring a first physiological characteristic of a patient through a first sensor;

monitoring mechanical movement of a heart of the patient through an accelerometer;

determining a pacing vector that utilizes at least one electrode, the pacing vector determination based on variables including a capture assessment utilizing a signal received from the accelerometer indicating mechanical movement of the heart; and

delivering, through a pulse generator, therapeutic electric pulses according to the pacing vector.

31. The computer program product of claim 30 wherein the pacing vector determination is also based on the first sensor and the first sensor is configured to sense heart rate.

32. The computer program product of claim 31 wherein the pacing vector determination is also based on a signal transmitted from an electrode on a housing of the pulse generator.

33. The computer program product of claim 31 wherein the delivery of therapeutic electrical pulses originates from more than one electrode.

34. The computer program product of claim 33 wherein the delivery of therapeutic electrical pulses are delivered in a manner where more than one electrode acts as a cathode and more than one electrode acts as an anode.

35. The computer program product of claim 31 wherein the pacing vector determination is based on variables including a sensed amount of skeletal muscle stimulation during pacing.

36. The computer program product of claim 31 wherein the pacing vector determination is based on variables including the energy required by potential pacing vectors.

37. The computer program product of claim 31 wherein the pacing vector determination is based on variables including the distance between an electrode utilized for delivery of the therapeutic electrical pulses and a sensor.

38. The computer program product of claim 31 wherein the pacing vector determination utilizes a weighted scoring method.

39. The computer program product of claim 31 further comprising assessing vector selection.

40. The computer program product of claim 39 wherein the vector selection assessment considers patient perception of discomfort.

41. The computer program product of claim 39 wherein the pacing vector determination is based on variables including results of the vector selection assessment.

42. The computer program product of claim 31, the controller further configured to:

reduce an energy level of the therapeutic electrical pulses until a loss of cardiac capture is suspected based on the capture assessment utilizing the signal received from the accelerometer; and

increase the energy level of the therapeutic electrical pulses until cardiac capture is regained.

43. The computer program product of claim 31, wherein the accelerometer is on a lead.

44. The computer program product of claim 31, wherein the pacing vector is further determined based on signals from the accelerometer and a subcutaneous accelerometer.

45. The computer program product of claim 31, the determining further comprising filtering exogenous motion from signals received from the accelerometer, wherein the exogenous motion includes one or more of:

movement of the patient, breathing, and exogenous motion attributable to sound waves.