Closed loop cardiac resynchronization therapy using cardiac activation sequence information

• US 7,917,215 B2
• Filed: 11/21/2008
• Issued: 03/29/2011
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Meyer, Scott A., Ricci, Carlos A., McCabe, Aaron, Stahmann, Jeffrey E., Zhang, Yi, Yu, Yinghong, Ding, Jiang
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/276,070
• Publication Number:
  US 20090076557A1
• Time in Patent Office: 858 Days
• Field of Search: 607/9, 607/17
• US Class Current: 607/9
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

Cardiac monitoring and/or stimulation methods and systems that provide one or more of monitoring, diagnosing, defibrillation, and pacing. Cardiac signal separation is employed to detect, monitor, track and/or trend closed-loop cardiac resynchronization therapy using cardiac activation sequence information. Devices and methods involve sensing a plurality of composite cardiac signals using a plurality of electrodes, the electrodes configured for implantation in a patient. A source separation is performed using the sensed plurality of composite cardiac signals, producing one or more cardiac signal vectors associated with all or a portion of one or more cardiac activation sequences. A cardiac resynchronization therapy is adjusted using one or both of the one or more cardiac signal vectors and the signals associated with the one or more cardiac signal vectors. In further embodiments, the cardiac resynchronization therapy may be initiated, terminated, or one or more parameters of the resynchronization therapy may be altered.

Claims

1. A cardiac method, comprising:

sensing a plurality of composite signals using a plurality of implantable electrodes, the composite signals comprising signal content originating from a plurality of disparate sources and combining to define the composite signals;

performing a source separation using the sensed plurality of composite signals, the source separation separating components of the composite signals according to their respective origins;

producing one or more cardiac signal vectors associated with all or a portion of one or more cardiac activation sequences based on the source separation;

determining an orientation of the one or more cardiac signal vectors;

comparing the orientation to a baseline value, the comparison of the orientation to the baseline value providing an indication of heart failure status of a patient; and

adjusting a cardiac resynchronization therapy based on the heart failure status of the patient.

2. The method of claim 1, wherein adjusting the therapy comprises adjusting the therapy to mitigate heart failure of the patient.

3. The method of claim 1, wherein determining the orientation comprises determining an angle of the one or more cardiac signal vectors, and adjusting the therapy is based on the determined angle.

4. The method of claim 1, wherein determining the orientation comprises determining an angle of the orientation of the one or more cardiac signal vectors, and adjusting the therapy comprises adjusting the therapy such that an angle of a dominant QRS vector moves in a direction of an angle of a baseline QRS vector.

5. The method of claim 1, wherein determining the orientation comprises determining an angle of the one or more cardiac signal vectors, and adjusting the therapy comprises adjusting the therapy such that the determined angle moves toward a pre-determined vector angle.

6. The method of claim 5, further comprising establishing the pre-determined vector angle based on patient-specific information.

7. The method of claim 1, wherein determining the orientation comprises determining a first angle of the one or more cardiac signal vectors at a first time, and a second angle of the one or more cardiac signal vectors at a subsequent time, and adjusting the therapy comprises adjusting the therapy such that the magnitude of a difference between the first angle and second angle of the one or more cardiac signal vectors is smaller than a pre-determined threshold.

8. The method of claim 1, comprising:

determining a magnitude of cardiac asynchrony using the one or more cardiac signal vectors; and

adjusting the therapy to reduce the magnitude of cardiac asynchrony.

9. The method of claim 1, comprising:

storing information associated with the one or more cardiac signal vectors;

performing a subsequent source separation providing updated vector information; and

comparing the updated vector information to the stored information to determine a level of cardiac asynchrony.

10. The method of claim 1, comprising:

determining a dominant orientation of the one or more cardiac signal vectors;

comparing the dominant orientation to the baseline value; and

producing information related to the progression of heart failure of the patient based on the comparison.

11. The method of claim 1, comprising determining the patient'"'"'s response to the therapy based on a comparison of the one or more cardiac signal vectors to one or more baseline values.

12. The method of claim 1, wherein adjusting the therapy comprises recalculating one or more cardiac resynchronization therapy parameters and adjusting the therapy using the recalculated one or more cardiac resynchronization therapy parameters.

13. The method of claim 1, wherein adjusting the therapy comprises adjusting at least one of an inter-ventricular delay, an inter-atrial delay, an intra-ventricular delay, an atrial-ventricular delay, a stimulation site, a pacing chamber, a rate limiter, or a pacing mode.

14. The method of claim 1, wherein producing the one or more cardiac signal vectors comprises producing the cardiac signal vector associated with at least one complete cardiac signal cycle.

15. The method of claim 1, comprising one or more of storing parameters associated with the therapy and adjustments to the therapy and communicating the stored parameters to a patient-external device.

16. A system, comprising:

a plurality of implantable electrodes configured for sensing a composite signal, thereby providing a plurality of composite signals comprising signal content originating from a plurality of disparate sources and combining to define the composite signals;

a housing configured for implantation in a patient;

a controller provided in the housing and coupled to the plurality of implantable electrodes; and

a memory provided in the housing and coupled to the controller;

wherein the controller is configured to perform a source separation using the sensed composite signals such that the source separation separates components of the composite signals according to their respective origins, and produce one or more cardiac signal vectors associated with all or a portion of one or more cardiac activation sequences based on the source separation, the controller configured to determine an orientation of the one or more cardiac signal vectors, compare the orientation to a baseline value and produce an output indicative of heart failure status of a patient based on the comparison, and adjust a cardiac resynchronization therapy based on the output.

17. The system of claim 16, wherein the controller is configured to determine an angle of the one or more cardiac signal vectors and adjust the therapy based on the determined angle.

18. The system of claim 16, wherein the controller is configured to determine an angle of the orientation of the one or more cardiac signal vectors and adjust the therapy such that an angle of a dominant QRS vector moves in a direction of an angle of a baseline QRS vector.

19. The system of claim 16, wherein the controller is configured to determine an angle of the one or more cardiac signal vectors and adjust the therapy such that the determined angle moves toward a pre-determined vector angle.

20. The system of claim 19, wherein the pre-determined vector angle is based on patient-specific information.

21. The system of claim 16, wherein the controller is configured to determine a first angle of the one or more cardiac signal vectors at a first time and a second angle of the one or more cardiac signal vectors at a subsequent time, and adjust the therapy such that the magnitude of a difference between the first angle and second angle of the one or more cardiac signal vectors is smaller than a pre-determined threshold.

22. The system of claim 16, wherein the controller is configured to determine a magnitude of cardiac asynchrony using the one or more cardiac signal vectors and adjust the therapy to reduce the magnitude of cardiac asynchrony.

23. The system of claim 16, wherein the controller is configured to store information associated with the one or more cardiac signal vectors in the memory, perform a subsequent source separation providing updated vector information, and compare the updated vector information to the stored information to determine a level of cardiac asynchrony.

24. The system of claim 16, wherein the controller is configured to determine a dominant orientation of the one or more cardiac signal vectors and compare the dominant orientation to the baseline value, the controller configured to produce an output that provides information related to the progression of heart failure of the patient.

25. The system of claim 16, wherein the controller is configured to determine a patient'"'"'s response to the therapy using the one or more cardiac signal vectors.

26. The system of claim 16, wherein the controller is configured to recalculate one or more cardiac resynchronization therapy parameters based on the output and adjust the therapy using the recalculated one or more cardiac resynchronization therapy parameters.

27. The system of claim 16, wherein the controller is configured to adjust at least one of an inter-ventricular delay, an inter-atrial delay, an intra-ventricular delay, an atrial-ventricular delay, a stimulation site, a pacing chamber, a rate limiter, or a pacing mode based on the output.

28. The system of claim 16, comprising communication circuitry, wherein the controller is configured to store parameters associated with the therapy and adjustments to the therapy in the memory, transmit the stored parameters to a patient-external device.