Method and apparatus for monitoring heart failure patients with cardiopulmonary comorbidities

• US 7,480,528 B2
• Filed: 07/23/2004
• Issued: 01/20/2009
• Est. Priority Date: 07/23/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Beck, Kenneth, Kadhiresan, Veerichetty, Carlson, Gerrard M., Hopper, Donald, Brockway, Marina
• Primary Examiner(s): Evanisko; George R
• Application Number:
  US10/897,856
• Publication Number:
  US 20060020295A1
• Time in Patent Office: 1,642 Days
• Field of Search: 600508-528, 607 4- 28
• US Class Current: 600/513
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• 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 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

A system receives signals indicative of cardiopulmonary conditions sensed by a plurality of sensors and provides for monitoring and automated differential diagnosis of the cardiopulmonary conditions based on the signals. Cardiogenic pulmonary edema is detected based on one or more signals sensed by implantable sensors. If the cardiogenic pulmonary edema is not detected, obstructive pulmonary disease and restrictive pulmonary disease are each detected based on a forced vital capacity (FVC) parameter and a forced expiratory volume (FEV) parameter measured from a respiratory signal sensed by an implantable or non-implantable sensor. In one embodiment, an implantable medical device senses signals indicative of the cardiopulmonary conditions, and an external system detects the cardiopulmonary conditions based on these signals by executing an automatic detection algorithm.

Claims

1. A system for detecting cardiopulmonary conditions, comprising:

a parameter input to receive parameters indicative of a plurality of cardiopulmonary conditions, the parameters including a forced vital capacity (FVC) parameter, a forced expiratory volume (FEV) parameter, and one or more edema-indicating parameters indicative of cardiogenic pulmonary edema;

a pulmonary edema detector coupled to the parameter input, the pulmonary edema detector adapted to detect the cardiogenic pulmonary edema based on the one or more edema- indicating parameters;

a low FVC detector coupled to the pulmonary edema detector, and adapted to detect low FVC if the pulmonary edema detector does not indicate a detection of the cardiogenic edema, the low FVC detector including a comparator having an output indicating a detection of the low FVC when the FVC parameter is below a predetermined threshold FVC parameter value; and

a pulmonary condition detector coupled to the low FVC detector, the pulmonary condition detector adapted to detect at least an obstructive pulmonary disease and a restrictive pulmonary disease based on the FVC parameter and the FEV parameter if the low FVC is detected.

2. The system of claim 1, wherein the pulmonary condition detector comprises an obstructive pulmonary disease detector adapted to detect the obstructive pulmonary disease when a ratio of the FEV parameter to the FVC parameter is below a predetermined obstructive pulmonary disease threshold ratio.

3. The system of claim 2, wherein the pulmonary condition detector further comprises a restrictive pulmonary disease detector adapted to detect the restrictive pulmonary disease when the ratio of the FEV parameter to the FVC parameter exceeds a predetermined restrictive pulmonary disease threshold ratio.

4. The system of claim 3, further comprising a respiratory parameter generator coupled to the parameter input, the respiratory parameter generator including:

an FVC measurement module to measure the FVC parameter from a respiratory signal; and

an FEV measurement module to measure the FEV parameter from the respiratory signal.

5. The system of claim 4, wherein the respiratory signal comprises a spirometry signal, and further comprising a spirometry signal input, coupled to the respiratory parameter generator, to receive the respiratory signal from a spirometer.

6. The system of claim 4, wherein the respiratory signal comprises impedance signal, and further comprising impedance signal input, coupled to the respiratory parameter generator, to receive the impedance signal from an implantable impedance sensor.

7. The system of claim 6, further comprising an activity signal input, coupled to the respiratory parameter generator, to receive an activity signal indicative of a physical activity level from an implantable activity sensor, and wherein the FVC measurement module is adapted to measure the FVC parameter when the activity level is below a predetermined threshold level representing a substantially resting state, and the FEV measurement module is adapted to measure the FIEV parameter when the activity level is below the predetermined threshold level representing the substantially resting state.

8. The system of claim 1, further comprising:

A cardiac signal input to receive one or more electrograms from an implantable sensing circuit; and

a heart rate variability (HRV) processor, coupled to the cardiac signal input and the parameter input, to produce one or more parameters of the one or more edema-indicating parameters based on the one or more electrograms, the HRV processor including an HRV measurement module to measure the HRV based on the one or more electrograms.

9. The system of claim 8, wherein the pulmonary edema detector comprises a low HRV detector adapted to indicate a detection of the cardiogenic pulmonary edema when the HRV is lower than a predetermined threshold HRV.

10. The system of claim 8, wherein the pulmonary edema detector comprises a low HRV detector adapted to indicate a detection of the cardiogenic pulmonary edema when a decrease in the HRV exceeds a predetermined margin.

11. The system of claim 8, wherein the HRV processor further comprises a very-low-frequency (VLF) HRV generator to produce a VLF HRV having a frequency band of about 0.0033Hz to 0.04Hz based on the HRV, and wherein the pulmonary edema detector comprises a high VLF HRV detector adapted to indicate a detection of the cardiogenic pulmonary edema when the VLF HRV exceeds a predetermined threshold VLF HRV.

12. The system of claim 8, wherein the HRV processor further comprises:

a low-frequency (LF) HRV generator to produce an LF HRV having a frequency band of about 0.04Hz to 0.15Hz based on the HRV;

a high-frequency (HF) HRV generator to produce an HF HRV having a frequency band of about 0.15Hz to 0.40Hz based on the HRV; and

a LF-HRV/HF-HRV ratio calculator to calculate a ratio of the LF HRV to the HF HRV,

wherein the pulmonary edema detector comprises a high LF-HRV/HF-HRV ratio detector adapted to indicate a detection of the cardiogenic pulmonary edema when the ratio of the LF HRV to the HF HRV exceeds a predetermined threshold ratio.

13. The system of claim 1, further comprising:

an impedance signal input to receive at least one impedance signal from an implantable impedance sensor; and

an impedance processor, coupled to the impedance signal input and the parameter input, to produce one or more parameters of the one or more edema-indicating parameters based on the at least one impedance signal.

14. The system of claim 13, wherein the impedance processor comprises a very-low-frequency (VLF) impedance signal generator to produce a VLF impedance having a frequency band of about 0.0033Hz to 0.0 16Hz based on the impedance signal, and wherein the pulmonary edema detector comprises a high VLF impedance detector adapted to indicate a detection of the cardiogenic pulmonary edema when the VLF impedance exceeds a predetermined threshold VLF impedance.

15. The system of claim 13, wherein the impedance processor comprises a direct current (DC) impedance signal generator to produce a DC impedance from the impedance signal, and wherein the pulmonary edema detector comprises a low DC impedance detector adapted to indicate a detection of the cardiogenic pulmonary edema when the DC impedance is below a predetermined threshold DC impedance.

16. The system of claim 1, further comprising:

a heart sound input to receive a heart sound signal from an implantable heart sound sensor; and

a third heart sound (S3) processor coupled to the heart sound input and the parameter input, the S3 processor including an S3 detector to detect occurrences of S3 and an S3 analyzer to produce one or more parameters of the one or more edema-indicating parameters based on the detected occurrences of S3.

17. The system of claim 16, wherein the S3 analyzer comprises an S3 amplitude measurement module to measure an S3 amplitude, and wherein the pulmonary edema detector comprises a high S3 amplitude detector adapted to indicate a detection of the cardiogenic pulmonary edema when the S3 amplitude exceeds a predetermined threshold amplitude.

18. The system of claim 16, wherein the S3 analyzer comprises an S3 index trending module to produce an S3 index being a ratio, or an estimate of the ratio, of a number of S3 beats to a number of all heart beats over a predetermined time interval, where the S3 beats are each a heart beat during which an occurrence of S3 is detected, and wherein the pulmonary edema detector comprises a high S3 index detector adapted to indicate a detection of the cardiogenic pulmonary edema when the S3 index exceeds a predetermined threshold index level.

19. The system of claim 1, wherein the one or more edema-indicating parameters comprise two or more of:

a heart rate variability (HRV);

a very-low-frequency (VLF) HRV suggestive of periodic breathing;

a ratio of low-frequency (LF) HRV to high-frequency (HF) HRV;

a very-low-frequency (VLF) impedance suggestive of periodic breathing;

a third heart sound (S3) amplitude;

an S3 index being a ratio, or an estimate of the ratio, of a number of S3 beats to a number of all heart beats over a predetermined time interval, where the S3 beats are each a heart beat during which an occurrence of S3 is detected; and

a DC impedance indicative of pulmonary fluid status,

wherein the pulmonary edema detector comprises two or more of;

a low HRV detector adapted to indicate a detection of the cardiogenic pulmonary edema when a measured HRV is lower than a predetermined threshold HRV;

a high VLF HRV detector adapted to indicate a detection of the cardiogenic pulmonary edema when the VLF HRV exceeds a predetermined threshold VLF HRV;

a high LF-HRV/HF-HRV ratio detector adapted to indicate a detection of the cardiogenic pulmonary edema when the ratio of the LF HRV to the HF HRV exceeds a predetermined threshold ratio;

a high VLF impedance detector adapted to indicate a detection of the cardiogenic pulmonary edema when the VLF impedance exceeds a predetermined threshold VLF impedance;

a high S3 amplitude detector adapted to indicate a detection of the cardiogenic pulmonary edema when the S3 amplitude exceeds a predetermined amplitude;

a high S3 index detector adapted to indicate a detection of the cardiogenic pulmonary edema when the S3 index exceeds a predetermined amplitude; and

a low DC impedance detector adapted to indicate a detection of the cardiogenic pulmonary edema when the DC impedance is below a predetermined threshold DC impedance.

20. The system of claim 19, wherein the pulmonary edema detector further comprises a cardiogenic pulmonary edema indicator coupled to the two or more of the low HRV detector, the high VLF HRV detector, the high LF-HRV/HF-HRV ratio detector, the high VLF impedance detector, the high S3 amplitude detector, the high S3 index detector, and the a low DC impedance detector, the cardiogenic pulmonary edema indicator adapted to indicate a detection of the cardiogenic pulmonary edema based on one or more detections of the cardiogenic pulmonary edema indicated by the two or more of the low HRV detector, the high VLF HRV detector, the high LF-HRV/HF-HRV ratio detector, the high VLF impedance detector, the high S3 amplitude detector, the high S3 index detector, and the low DC impedance detector.

21. The system of claim 1, further comprising a dispend detector coupled to the pulmonary edema detector, the dispend detector adapted to receive a respiratory signal and an activity signal and adapted to detect dispend manifested by rapid shallow breath based on the respiratory signal and the activity signal, and wherein the pulmonary edema detector is adapted to detect the cardiogenic pulmonary edema after each detection of the dispend.