Automatic orientation determination for ECG measurements using multiple electrodes

• US 7,941,206 B2
• Filed: 01/27/2010
• Issued: 05/10/2011
• Est. Priority Date: 06/24/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Sweeney, Robert J., Zhang, Yi, McCabe, Aaron R., Ricci, Carlos Alberto, Daum, Douglas R., Brockway, Marina, Heil, Ronald W.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US12/694,833
• Publication Number:
  US 20100198283A1
• Time in Patent Office: 468 Days
• Field of Search: 600/509, 600511-513
• US Class Current: 600/512
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: G06F 18/2134 based on separation criteria, e.g. independent component analysis

Abstract

Cardiac monitoring and/or stimulation methods and systems provide monitoring, defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, separates a signal using a source separation algorithm, and identifies a cardiac signal using a selected vector. The signal processor may iteratively separate signals from the plurality of composite signals until the cardiac signal is identified. The selected vector may be updated if desired or necessary. A method of signal separation involves detecting a plurality of composite signals at a plurality of locations, separating a signal using source separation, and selecting a vector that provides a cardiac signal. The separation may include a principal component analysis and/or an independent component analysis. Vectors may be selected and updated based on changes of position and/or orientation of implanted components and changes in patient parameters such as patient condition, cardiac signal-to-noise ratio, and disease progression.

Claims

1. A system, comprising:

a plurality of implantable electrodes configured for sensing a plurality of composite signals associated with an unknown number of sources, the plurality of implantable electrodes comprising at least three spatially separated implantable electrodes;

a housing configured for implantation in a patient;

a control circuitry provided in the housing;

a memory provided in the housing;

a processing circuitry provided in the housing and coupled to the memory, the processing circuitry configured to perform a source separation that separates signal components of the sensed plurality of composite signals according to their sources to produce a set of signal vectors, the processing circuitry configured to;

select, from the set of signal vectors, a target vector associated with a target signal, the target vector representative of a signal vector of the set of signal vectors associated with higher quality cardiac data relative to other signal vectors of the set of signal vectors;

detect a change in a predetermined condition or an event occurrence indicating that changing which signal vector of the set of signal vectors is selected as the target vector may be useful in sensing cardiac activity; and

update, in response to the change in the predetermined condition or event occurrence, selection of the target vector by performing a subsequent source separation on the detected plurality of composite signals and reselecting the same or a different signal vector associated with higher quality cardiac data relative to other signal vectors of the set of signal vectors as the target vector based on the subsequent source separation; and

communications circuitry provided in the housing and configured to facilitate communication of information between the housing and a device external of the housing.

2. The system according to claim 1, wherein the at least three spatially separated implantable electrodes are provided at the housing.

3. The system according to claim 1, wherein the at least three spatially separated implantable electrodes comprise at least four electrodes, and wherein one of the at least four electrodes does not lie in the same plane as the other of the at least four electrodes.

4. The system according to claim 1, wherein at least one of the at least three spatially separated implantable electrodes is provided at the housing and at least two of the at least three spatially separated implantable electrodes are provided on a cardiac lead arrangement.

5. The system according to claim 1, wherein the processing circuitry is configured to perform blind source separation that separates signal components of the sensed plurality of composite signals according to their sources to produce the set of signal vectors.

6. The system according to claim 1, wherein the processing circuitry is configured to update selection of the target vector in response to at least one of a change in orientation of the housing and a change of a signal to noise ratio of the target signal associated with the target vector.

7. The system according to claim 1, wherein the processing circuitry is configured to update selection of the target vector in response to at least one of detection of a pathologic change, exceeding an arrhythmia detection rate zone or threshold, patient activity level, postural change, and a therapy change.

8. The system according to claim 1, wherein the processing circuitry is configured to:

detect the change in the predetermined condition or event occurrence using a local peak density algorithm, a curvature-based significant point algorithm, or physiologic sensor information; and

update selection of the target vector by performing the subsequent source separation in response to the detected change in the predetermined condition or event occurrence.

9. The system according to claim 1, wherein the processing circuitry is configured to:

perform a principal component analysis (PCA) on the sensed plurality of composite signals; and

determine if the principal component analysis achieves a sufficient level of source independence; and

perform an independent component analysis (ICA) on the sensed plurality of composite signals or on the PCA-transformed signals to determine the actual source direction if the principal component analysis does not achieve the sufficient level of source independence.

10. The system according to claim 1, wherein the system defines a subcutaneous, extrathoracic cardiac monitor devoid of a pacing pulse generator, a cardiovertor or a defibrillator.

11. The system according to claim 1, wherein the system defines a pacemaker, a cardiovertor, a defibrillator, or a cardiac resynchronizer.

12. A system, comprising:

a plurality of implantable electrodes configured for sensing a plurality of composite signals associated with an unknown number of sources, the plurality of implantable electrodes comprising at least three spatially separated implantable electrodes;

a housing configured for implantation in a patient;

control circuitry provided in the housing;

a memory;

processing circuitry coupled to the memory and configured to perform a source separation that separates signal components of the sensed plurality of composite signals according to their sources to produce a set of signal vectors, the processing circuitry configured to;

select, from the set of signal vectors, a target vector associated with a target signal, the target vector representative of a signal vector of the set of signal vectors associated with higher quality cardiac data relative to other signal vectors of the set of signal vectors;

detect a change in a predetermined condition or an event occurrence indicating that changing which signal vector of the set of signal vectors is selected as the target vector may be useful in sensing cardiac activity; and

update, in response to the change in the predetermined condition or event occurrence, selection of the target vector by performing a subsequent source separation on the detected plurality of composite signals and reselecting the same or a different signal vector associated with higher quality cardiac data relative to other signal vectors of the set of signal vectors as the target vector based on the subsequent source separation; and

communications circuitry provided in the housing and configured to facilitate communication of information between the housing and a device external of the housing.

13. The system according to claim 12, wherein:

the housing comprises a can, a header, and an antenna;

a first electrode of the at least three spatially separated implantable electrodes is provided at the can;

a second electrode of the at least three spatially separated implantable electrodes is provided at the header; and

a third electrode of the at least three spatially separated implantable electrodes is provided at the antenna.

14. The system according to claim 12, wherein:

the housing comprises at least two of a can, a header, and an antenna;

a first electrode of the at least three spatially separated implantable electrodes is provided at one of the can, the header, and the antenna; and

a second electrode of the at least three spatially separated implantable electrodes is provided at another of the can, the header, and the antenna.

15. The system according to claim 12, wherein the at least three spatially separated implantable electrodes comprise at least four electrodes, and wherein one of the at least four electrodes does not lie in the same plane as the other of the at least four electrodes.

16. The system according to claim 12, wherein at least one of the at least three spatially separated implantable electrodes is provided at the housing and at least two of the at least three spatially separated implantable electrodes are provided on a cardiac lead arrangement.

17. The system according to claim 12, wherein the processing circuitry is configured to perform blind source separation that separates signal components of the sensed plurality of composite signals according to their sources to produce the set of signal vectors.

18. The system according to claim 12, wherein the system defines a subcutaneous, extrathoracic cardiac monitor devoid of a pacing pulse generator, a cardiovertor or a defibrillator.

19. The system according to claim 12, wherein at least the source separation is performed by processing circuitry provided in a patient-external device or system.

20. The system according to claim 12, wherein at least the source separation is performed by processing circuitry provided in a network server system.