Method and apparatus to monitor pulmonary edema

• US 6,931,272 B2
• Filed: 04/29/2003
• Issued: 08/16/2005
• Est. Priority Date: 04/29/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Burnes, John E.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/426,978
• Publication Number:
  US 20040220632A1
• Time in Patent Office: 840 Days
• Field of Search: 607/3, 607/28, 600/509, 600/547
• US Class Current: 600/509
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

In general, the invention is directed to monitoring fluid retention that may accompany congestive heart failure and pulmonary edema. A medical device, such as an implanted pacemaker or an external defibrillator, senses electrical signals associated with the periodic depolarization and re-polarization of a heart. The device processes the electrical signals to obtain one or more “cardiac parameters,” which reflect pulmonary edema. By monitoring the cardiac parameters, the device monitors pulmonary edema. Cardiac parameters comprise the amplitude of the QRS complex, the integral of the QRS complex, or the integral of the QRST segment and the like. When the device detects fluid buildup, the device may respond by taking remedial action and/or generating an alert.

Claims

1. A method comprising:

monitoring a cardiac parameter over a plurality of cardiac cycles, the cardiac parameter comprising at least one of;

an amplitude of a QRS complex generated by a heart;

an integral of the QRS complex,

an integral of a QRST segment; and

monitoring a pulmonary edema status of a patient as a function of the monitored cardiac parameter.

2. A method according to claim 1, further comprising taking a remedial action in response to the monitoring of the cardiac parameter.

3. A method according to claim 2, wherein taking remedial action comprises at least a one of:

delivering pacing stimuli to the heart;

delivering a drug to the patient;

controlling a device to deliver therapy to the patient;

generating an audible, tactile, visual alert signal.

4. A method according to claim 2, further comprising:

comparing a change in the monitored cardiac parameter to a threshold; and

taking the remedial action when the monitored cardiac parameter surpasses the threshold.

5. A method according to claim 1, further comprising monitoring at least one cardiac parameter over a second plurality of cardiac cycles.

6. A method according to claim 1, further comprising evaluating the monitored cardiac parameter to determine whether a change in the monitored cardiac parameter indicates a change in pulmonary edema.

7. A computer-readable medium comprising instructions for causing a programmable processor to:

monitor a cardiac parameter over a plurality of cardiac cycles, the cardiac parameter comprising at least one of an amplitude of a QRS complex generated by a heart, an integral of the QRS complex, and an integral of a QRST segment; and

monitor pulmonary edema in a patient as a function of the monitored cardiac parameter.

8. A medium according to claim 7, the instructions further causing the processor to take a remedial action in response to the monitoring of the cardiac parameter.

9. A medium according to claim 8, wherein the instructions causing the processor to take remedial action comprises instructions causing the processor to perform at least one of:

delivering pacing stimuli to the heart;

delivering a drug to the patient;

controlling a device to deliver therapy to the patient;

generating an alert.

10. A method according to claim 9, wherein generating an alert signal further comprises wirelessly communicating an alert to a remote transceiver unit.

11. A method according to claim 10, further comprising at least a one of:

uploading the pulmonary edema status of the patient to the remote transceiver unit;

downloading data or programming instructions to a patient transceiver unit.

12. A medium according to claim 8, the instructions further causing the processor to:

compare a change in the monitored cardiac parameter to a threshold; and

take the remedial action when the monitored cardiac parameter surpasses the threshold.

13. A medium according to claim 7, the instructions further causing the processor to monitor at least one cardiac parameter over a second plurality of cardiac cycles.

14. A medium according to claim 7, the instructions further causing the processor to evaluate the monitored cardiac parameter to determine whether a change in the monitored cardiac parameter indicates a change in pulmonary edema.

15. A device comprising:

a sensor to sense electrical signals from a heart of a patient; and

a processor to receive the electrical signals and to monitor a cardiac parameter over a plurality of cardiac cycles,

wherein the cardiac parameter comprises at least one of;

an amplitude of a QRS complex generated by a heart;

an integral of the QRS complex,

an integral of a QRST segment and

wherein the processor is further configured to monitor pulmonary edema in a body of a patient as a function of the cardiac parameter.

16. A device according to claim 15, further comprising:

at least one electrode disposed proximate to the heart; and

an implantable pulse generator to deliver pacing therapy to the heart via the at least one electrode;

wherein the processor is further configured to control the implantable pulse generator as a function of the pulmonary edema.

17. A device according to claim 16, wherein in addition to the at least one electrode at least two other electrodes are disposed in electrical communication with the heart and further comprising:

means for taking multiple measurements between the at least one electrode and the at least two other electrodes for detecting pulmonary edema.

18. A device according to claim 17, wherein the means for taking multiple measurements further comprises for at least one of said measurements, mathematically integrating or mathematically deriving said at least one of said measurements to render a new metric of edema.

19. A device according to claim 17, wherein the means for taking multiple measurements further comprises for at least two of said measurements, means for comparing said at least two of said measurements to render a new metric of edema.

20. A device according to claim 17, further comprising:

means for performing data validation to determine whether a change in cardiac parameters or the new metric for edema is due to pulmonary edema or other factors.

21. A device according to claim 15, further comprising a drug pump to administer a drug to the patient, wherein the processor is further configured to control the drug pump as a function of the pulmonary edema.

22. A device according to claim 15, further comprising an output device to generate an alert, wherein the processor is further configured to control the output device as a function of the pulmonary edema.

23. A device according to claim 15, wherein the device is implanted in the body of the patient.

24. A device according to claim 15, wherein the device is external to the body of the patient.

25. A device according to claim 15, wherein the processor is further configured to evaluate the monitored cardiac parameter to determine whether a change in the monitored cardiac parameter indicates a change in the pulmonary edema.

26. A system comprising:

cardiac monitoring means to monitor at least one cardiac parameter over a plurality of cardiac cycles, the cardiac parameter comprising at least one of an amplitude of a QRS complex generated by a heart, an integral of the QRS complex, and an integral of a QRST segment; and

fluid monitoring means to monitor pulmonary edema in a patient as a function of the monitored cardiac parameter.

27. A system according to claim 26, further comprising remedial means to take remedial action as a function of the pulmonary edema.

28. A system according to claim 27, wherein the remedial means comprises at least one of:

an implantable pulse generator means to deliver pacing therapy to a heart;

a drug pump means to administer a drug to the patient;

an output device means to generate an alert.