Congestive heart failure monitor

• US 6,829,503 B2
• Filed: 05/25/2002
• Issued: 12/07/2004
• Est. Priority Date: 10/01/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: SciCo Tec GmbH
• Inventors: Alt, Eckhard
• Primary Examiner(s): Marmor, Charles
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/155,771
• Publication Number:
  US 20030220580A1
• Time in Patent Office: 927 Days
• Field of Search: 600/547, 600/508, 600/485, 600/300, 600/510, 600/481, 600/301, 607/9, 128/903, 128/904
• US Class Current: 600/547
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• 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 device-implemented method is disclosed for early detection and monitoring of congestive heart failure in a patient. Ongoing measurements of impedance of a portion of the patient'"'"'s body generally occupied by the lungs are performed by an implanted device, and, when the impedance measurements are determined by internal circuit components of the device to exceed a predetermined threshold value indicative of a need for immediate attention to a condition of congestive heart failure, a patient and/or physician alert is emitted by the device. An implant site at the left lower anterior lateral hemithorax is preferred.

Claims

1. An implantable device-implemented method of detecting and monitoring congestive heart failure in a patient, which comprises the steps of:

measuring local impedance of a portion of the patient'"'"'s body generally occupied by the lungs solely through surface mounted electrodes on the device with the device implanted subcutaneously in the patient'"'"'s body at the locality where the impedance measurements are to be performed, and

determining when the impedance measurements are indicative of a condition of congestive heart failure other than from the existence of a state of edema of the patient.

2. The device-implemented method of claim 1, including performing said measurements continuously.

3. The device-implemented method of claim 1, including performing said measurements periodically to reduce power consumption of the device.

4. The device-implemented method of claim 1, including performing said measurements from sporadically to reduce power consumption of the device.

5. The device-implemented method of claim 1, including performing said impedance measurements in part by injecting electrical current into said body portion.

6. The device-implemented method of claim 5, including injecting said electrical current into said body portion through at least one of said surface mounted electrodes of the device.

7. The device-implemented method of claim 5, including performing said impedance measurements in part by monitoring said injected electrical current returning via at least one other of said surface mounted electrodes of the device positioned in said body portion.

8. The device-implemented method of claim 5, including injecting said electrical current in the form of a biphasic pulse wave.

9. The device-implemented method of claim 1, including averaging said impedance measurements over long term and short term periods, and calculating the difference between the long term and short term averages representative of the slope of the reciprocal of impedance over time.

10. The device-implemented method of claim 9, including comparing said slope of the reciprocal of impedance over time against said predetermined threshold value, and triggering a patient alert signal when said slope exceeds the predetermined threshold value.

11. The device-implemented method of claim 1, including using said surface mounted electrodes of the device additionally to monitor the patient'"'"'s EGG.

12. The device-implemented method of claim 11, wherein the device is implanted subcutaneously at the lower left side of the thoracic cage.

13. The device-implemented method of claim 1, including performing said impedance measurements with the device implanted on the lower left side of the thoracic cage.

14. The device-implemented method of claim 1 wherein said body portion further encompasses the patient'"'"'s heart, including performing said impedance measurements by means of a signal injected into said body portion from the device and retrieved as a signal subdivided into a cardiovascular portion, a ventilation portion, and a total impedance portion.

15. The device-implemented method of claim 1, including determining when the impedance measurements exceed a predetermined threshold value indicative of a need for immediate attention to a condition of congestive heart failure.

16. A body-implantable device to detect and monitor congestive heart failure in a patient, comprising a circuit module having surface mounted electrodes of the device arranged, when the device is implanted subcutaneously, for exposing said electrodes to tissue in a portion of the patient'"'"'s body generally occupied by the lungs, said circuit module including circuitry that measures impedance of said body portion through said surface mounted electrodes and determines when the impedance measurements are indicative of a condition of congestive heart failure wherein the determination of congestive heart failure is based on factors other than the existence of edema of the patient.

17. The device of claim 16, wherein said circuit module includes an excitation pair and a measurement pair of said surface-mounted electrodes, and a current generator for injecting current into said body portion through said excitation pair.

18. The device of claim 17, wherein said circuit module includes detection apparatus for monitoring at said measurement pair of said surface mounted electrodes an electrical parameter attributable to said injected current, reflecting impedance changes.

19. The device of claim 18, wherein the electrodes of said measurement pair of surface mounted electrodes are spaced apart by at least 4 cm.

20. The device of claim 16, wherein said circuit module performs said impedance measurements according to an algorithm in which the measured impedance is averaged over long term and short term periods.

21. The device of claim 16, wherein said circuit module is contained within a case having a curvilinear shape adapted to conform to the shape of a portion of the patient'"'"'s body at the implant site.

22. The device of claim 21, wherein said curvilinear shape of the case conforms to the curvature of the patient'"'"'s rib cage in the vicinity of the implant site.

23. A body-implantable medical device for monitoring the condition of a patient at risk for congestive heart failure, comprising circuitry, including plural surface electrodes on the device, that measures impedance between a measurement pair of said electrodes from a predetermined electrical parameter injected in a circuit path between an excitation pair of said electrodes, such that when said device is implanted at a site where said circuit path includes the patient'"'"'s cardiovascular and pulmonary system through said plural surface electrodes only, said impedance measurements indicate a state of lung congestion of the patient.

24. The device of claim 23, wherein said device is designed to be implanted at a site on the left lower hemithorax of the patient'"'"'s body.

25. An implantable device-implemented method of detecting and monitoring congestive heart failure in a patient, which comprises the steps of:

performing impedance-derived ventilation measurements of a portion of the patient'"'"'s body generally occupied by the lungs through surface mounted electrodes on the device with the device implanted subcutaneously in the patient'"'"'s body at the locality where the impedance measurements are to be performed, and

determining when the impedance-derived ventilation measurements are indicative of a condition of congestive heart failure based on factors other than the existence of edema.

26. A body-implantable device to detect and monitor congestive heart failure in a patient, comprising a circuit module having surface electrodes of the device arranged, when the device is implanted, for exposing said electrodes to tissue in a portion of the patient'"'"'s body generally occupied by the lungs, said circuit module including circuitry that performs impedance-derived ventilation measurements of said body portion solely through said surface electrodes of the device and determines directly from said impedance-derived ventilation measurements whether the patient is exhibiting a condition of congestive heart failure.

27. A body-implantable medical device for monitoring the condition of a patient at risk for congestive heart failure, comprising circuitry, including plural surface electrodes on the devices for making impedance-derived ventilation measurements between a measurement set of said electrodes from a predetermined electrical parameter injected in a circuit path between an excitation set of said electrodes and for determining, when said device is implanted at a site where said circuit path includes the patient'"'"'s cardiovascular and pulmonary system through said plural surface electrodes, whether said impedance-derived ventilation measurements are indicative of a state of congestive heart failure of the patient.

28. The body-implantable device of claim 27, wherein said circuitry also serves to monitor the patient'"'"'s ECG through said measurement set of the electrodes.

29. A body-implantable device to detect and monitor congestive heart failure in a patient, comprising a circuit module having surface-mounted electrodes of the device arranged, when the device is implanted, for positioning outside the thoracic cage and for exposing said electrodes to tissue in a portion of the patient'"'"'s body generally occupied by the lungs, said circuit module including circuitry that measures impedance of said body portion exclusively through said electrodes and detects from the impedance measurements of a condition of congestive heart failure other than solely from the existence of a state of edema of the patient.

30. The body-implantable device of claim 29, wherein said circuit module performs said impedance measurements according to an algorithm in which the measured impedance is analyzed with respect to ventilation and baseline impedance changes.

31. The body implantable device of claim 29, wherein said circuit module is contained within a case having a curvilinear shape that conforms to the shape of a portion of the patient'"'"'s body at the implant site.

32. The body-implantable device of claim 31, wherein said curvilinear shape of the case conforms to the curvature of the patient'"'"'s rib cage in the vicinity of the implant site, and said electrodes are located on a side of the case facing the vertical center of the body.