Implantable device and method for long-term detection and monitoring of congestive heart failure

• US 6,473,640 B1
• Filed: 01/20/2000
• Issued: 10/29/2002
• Est. Priority Date: 01/25/1999
• Status: Expired due to Fees

• Current Assignee: Erlebacher, Jay
• Original Assignee: Erlebacher, Jay
• Inventors: Erlebacher, Jay
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/488,101
• Time in Patent Office: 1,013 Days
• Field of Search: 607/22, 607/62, 600/506, 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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

Abstract

The implantable device for long term monitoring of congestive heart failure employs a signal generator, such as within a pacemaker, to generate an electrical signal which is monitored to obtain a single or dual frequency measurement that can independently measure systemic venous and pulmonary (lung) impedance. The device is able to detect changes in resistance to a flow of current in the systemic venous system and changes in impedance to a flow of current through a lung to thereby indicate separate detection of systemic venous and pulmonary congestion.

Claims

1. An implantable device for long term monitoring of congestive heart failure comprising

a first electrode for implanting in a right heart of a patient;

a second electrode for implanting in the patient;

a signal generator for emitting an electrical signal from said first electrode to said second electrode through at least a first current path extending through the blood of a systemic venous system of the patient and through a second current path extending through a lung of a patient; and

means for measuring at least one of systemic venous congestion and pulmonary congestion whereby changes in the resistance and conductance of current in said first current path are indicative of said systemic venous congestion and changes in at least one of complex impedance, complex admittance and capacitance in said second current path over a period of time are indicative of said pulmonary congestion.

2. An implantable device as set forth in claim 1 wherein said means for measuring includes a current measuring resistor for measuring the current passing between said signal generator and said first electrode and an operational amplifier for measuring the voltage across said resistor and emitting a responsive signal indicating the current measured.

3. An implantable device as set forth in claim 2 wherein said means for measuring further includes a pair of electrodes for implanting in the patient for measuring the voltage generated by said signal in said current paths and a second operational amplifier for amplifying the measurement of voltage from said current paths.

4. An implantable device as set forth in claim 3 wherein said means for measuring further includes a phase detector connected to each said amplifier to measure the phase angle between the measured voltage and the indicated current in said resistor, and a microprocessor electrically connected to said phase detector and to each said amplifier to receive values corresponding to the measured phase angle, the detected voltage and the indicated current and to measure the impedance of the body tissues based on said received values.

5. An implantable device as set forth in claim 1 wherein said signal is a direct current signal.

6. An implantable device as set forth in claim 1 wherein said signal has a low frequency sufficient to encourage transmission through a central systemic venous system.

7. An implantable device as set forth in claim 1 wherein said signal has a high frequency to permit transmission through a lung.

8. An implantable device as set forth in claim 1 wherein said means for measuring measures the magnitude and phase angle of impedance and calculates a real component of said impedance as an indication of congestion in the systemic venous system and a complex component of said impedance as an indication of congestion in the lung.

9. An implantable device for long term monitoring of congestive heart failure comprising

a signal generator for generating an electrical signal at least two different frequencies;

a current measuring resistor electrically connected to said signal generator for passage of said electrical signal therethrough;

a first electrode connected to said resistor for implanting in a right ventricle of a patient to deliver said signal through a first current path extending from the right ventricle through the blood of a systemic venous system and subclavian vein of the patient and to a second path extending through a lung of the patient;

a second electrode for implanting in a right atrium of the patient and connected to said signal generator to complete a circuit with said first electrode to said signal generator;

a first operational amplifier for measuring the voltage across said resistor and emitting a signal indicative of the current flowing through said resistor;

a pair of electrodes for implanting in the patient for detecting the voltage generated by said signal through the body tissue of the patient;

a second operational amplifier connected to said pair of electrodes to amplify the detected voltage;

a phase detector connected to each said amplifier to measure a phase angle between the detected voltage and the indicated current in said resistor; and

a microprocessor connected to said phase detector and to each said amplifier to receive values corresponding to the measured phase angle, the detected voltage and the indicated current and to calculate the impedance of the body tissues based on said received values whereby a calculated resistance or conductance at DC or a calculated impedance at a lower frequency of said electrical signal from said signal generator is indicative of systemic venous congestion and a calculated complex impedance at a higher frequency of said electrical signal from said signal generator is indicative of pulmonary congestion.

10. An implantable device as set forth in claim 9 wherein one of said signals is a direct current signal.

11. An implantable device as set forth in claim 9 wherein said means for measuring measures the magnitude and phase angle of impedance and calculates a real component of said impedance as an indication of congestion in the systemic venous system and a complex component of said impedance as an indication of congestion in the lung.

12. In combination

an implantable device having at least a first electrode for implanting in a right heart of a patient;

at least a second electrode for implanting in the patient;

a signal generator for emitting an electrical signal from said first electrode to said second electrode through at least a first current path extending through the blood of a systemic venous system of the patient and through a second current path extending through a lung of a patient; and

means for measuring at least one of systemic venous congestion and pulmonary congestion whereby changes in the resistance and conductance of current in said first current path are indicative of said systemic venous congestion and changes in at least one of complex impedance, complex admittance and capacitance in said second current path over a period of time are indicative of said pulmonary congestion; and

an accelerometer for sensing a direction of gravitational acceleration as an indication of patient position and for sensing body activity for correlation with a measurement of congestion from said implantable device.

13. The combination as set forth in claim 12 further comprising means for monitoring the respiratory rate, respiratory cycle and volume of the patient for correlation with a measurement of congestion from said implantable device.

14. In combination

an implantable device having at least a first electrode for implanting in a right heart of a patient;

at least a second electrode for implanting in the patient;

a signal generator for emitting an electrical signal from said first electrode to said second electrode through at least a first current path extending through the blood of a systemic venous system of the patient and through a second current path extending through a lung of a patient; and

means for measuring at least one of systemic venous congestion and pulmonary congestion whereby changes in the resistance and conductance of current in said first current path are indicative of said systemic venous congestion and changes in at least one of complex impedance, complex admittance and capacitance in said second current path over a period of time are indicative of said pulmonary congestion; and

an electrocardiogram for measuring variations in a cardiac cycle for correlation with a measurement of congestion from said implantable device.

15. A method of measuring bioimpedance to assess congestive heart failure comprising the steps of

passing a electrical signal of high frequency into a first path extending through a systemic venous system from a right ventricle to a subclavian vein of a patient;

and a second path electrically parallel to said first path and extending through a lung of the patient;

measuring the resistance to current flow of said signal in said first path whereby a decrease in measured resistance is indicative of congestion of the venous system; and

measuring the capacitive impedance or admittance to current flow of said signal in said second path whereby a change in measured capacitive impedance or admittance is indicative of congestion of the lung.

16. A method as set forth in claim 15 which further comprises the steps of

measuring the magnitude of impedance to said signal in said paths and the phase angle of said impedance;

obtaining the real component of said impedance as a measure of the resistance to current flow in said first path; and

obtaining the complex component of said impedance as a measure of capacitive reactance in said second path.

17. In combination

an implantable device for long term monitoring of congestive heart failure comprising a first electrode for implanting in a right heart of a patient, a second electrode for implanting in the patient, a signal generator for emitting a signal from said first electrode to said second electrode through at least one of a current path extending through the blood of a systemic venous system and through a second current path extending through a lung of a patient, and means for measuring changes in impedance in at least one of the systemic venous system and the lung as a measure of at least one of systemic venous congestion and pulmonary congestion;

an accelerometer for sensing gravitational acceleration as an indication of patient position;

means for monitoring the respiratory cycle of the patient; and

electrocardiographic means for monitoring the cardiac cycle of the patient whereby measurements of impedance made during particular phases of said respiratory cycle and said cardiac cycle and at reproducible body positions are indicative of the degree of congestion of the patient.

18. The combination as set forth in claim 17 wherein said means for measuring changes in impedance measures the magnitude and phase angle of impedance and calculates a real component of said impedance as an indication of systemic venous congestion and a complex component of said impedance as an indication of pulmonary congestion.

19. In combination

an implantable device for long term monitoring of congestive heart failure comprising a first electrode for implanting in a right heart of a patient, a second electrode for implanting in the patient, a signal generator for emitting a signal from said first electrode to said second electrode through at least one of a current path extending through the blood of a systemic venous system and through a second current path extending through a lung of a patient, means for measuring changes in impedance in at least one of the systemic venous system and the lung as a measure of at least one of systemic venous congestion and pulmonary congestion;

an accelerometer for sensing gravitational acceleration as an indication of patient position; and

electrocardiographic means for monitoring the cardiac cycle of the patient whereby measurements of impedance made during particular phases of said cardiac cycle and at reproducible body positions are indicative of the degree of congestion of the patient.

20. In combination

an implantable device for long term monitoring of congestive heart failure comprising a first electrode for implanting in a right heart of a patient, a second electrode for implanting in the patient, a signal generator for emitting a signal from said first electrode to said second electrode through at least one of a current path extending through the blood of a systemic venous system and through a second current path extending through a lung of a patient, means for measuring changes in impedance in at least one of the systemic venous system and the lung as a measure of at least one of systemic venous congestion and pulmonary congestion;

an accelerometer for sensing gravitational acceleration as an indication of patient position; and

means for monitoring the respiratory cycle of the patient whereby measurements of impedance made during particular phases of said respiratory cycle and at reproducible body positions are indicative of the degree of congestion of the patient.