Method and apparatus for monitoring tissue fluid content for use in an implantable cardiac device

• US 8,428,717 B2
• Filed: 10/14/2003
• Issued: 04/23/2013
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wang, Li, Cho, Yong K., Kuehn, Kevin, Zillmer, Glenn C., Sheth, Nirav V.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): ALTER, ALYSSA MARGO
• Application Number:
  US10/684,759
• Publication Number:
  US 20050080460A1
• Time in Patent Office: 3,479 Days
• Field of Search: 607/17
• US Class Current: 607/17
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/4869 Determining body composition
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• 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
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A fluid status monitoring system for use in implantable cardiac stimulation or monitoring devices is provided for monitoring changes in thoracic fluid content. A fluid status monitor includes excitation pulse generating and control circuitry, and voltage and current measurement and control circuitry for performing a series of cardiac-gated, intra-thoracic impedance measurements. The cardiac-gated measurements are filtered or time-averaged to provide a fluid status impedance value, with respiratory noise removed. Based on comparative analysis of the fluid status impedance value, a clinically relevant trend in fluid status may be tentatively diagnosed and a fluid status response provided. Cross-check intra-thoracic impedance measurements performed using the same or a different excitation pathway and a different measurement pathway than the primary intra-thoracic impedance measurement configuration may be used to verify a tentative diagnosis.

Claims

1. A method for monitoring intra-thoracic fluid content using an implanted cardiac stimulation device comprising at least two implanted electrodes, the method comprising:

responsive to occurrence of a cardiac event, delivering an impedance measurement pulse at a predetermined interval therefrom;

measuring impedance between the two electrodes using the delivered impedance measurement pulse;

performing the first three steps repeatedly over a period extending over multiple days to acquire a set of impedance data;

employing the set of impedance data to determine whether intra-thoracic fluid content is increasing or decreasing; and

wherein the device comprises leads carrying the electrodes and wherein the method further comprises employing the measured impedances to assess the integrity of the leads.

2. A method for monitoring intra-thoracic fluid content using an implanted cardiac stimulation device comprising at least two implanted electrodes, the method comprising:

responsive to occurrence of a cardiac event, delivering an impedance measurement pulse at a predetermined interval therefrom;

measuring impedance between the two electrodes using the delivered impedance measurement pulse;

performing the first three steps repeatedly over a period extending over multiple days to acquire a set of impedance data;

employing the set of impedance data to determine whether intra-thoracic fluid content is increasing or decreasing;

wherein the device comprises leads carrying the electrodes and wherein the method further comprises employing the measured impedances to assess the integrity of the leads and declaring the set of impedance data flawed responsive to the assessment of the integrity of the leads.

3. A method for monitoring intra-thoracic fluid content using an implanted cardiac stimulation device comprising at least two implanted electrodes, the method comprising:

responsive to occurrence of a cardiac event, delivering an impedance measurement pulse at a predetermined interval therefrom;

measuring impedance between the two electrodes using the delivered impedance measurement pulse;

performing the first three steps repeatedly over a period extending over multiple days to acquire a set of impedance data;

employing the set of impedance data to determine whether intra-thoracic fluid content is increasing or decreasing;

wherein the device comprises leads carrying the electrodes and wherein the method further comprises employing the measured impedances to assess the integrity of the leads and wherein assessment of the integrity of the leads comprises comparing a measured impedance to a prior measured impedance to determine whether the measured impedance differs from the prior measured impedance by more than a defined amount.

4. A method for monitoring intra-thoracic fluid content using an implanted cardiac stimulation device comprising at least two implanted electrodes, the method comprising:

responsive to occurrence of a cardiac event, delivering an impedance measurement pulse at a predetermined interval therefrom;

measuring impedance between the two electrodes using the delivered impedance measurement pulse;

performing the first three steps repeatedly over a period extending over multiple days to acquire a set of impedance data;

employing the set of impedance data to determine whether intra-thoracic fluid content is increasing or decreasing; and

declaring the set of impedance data flawed is performed responsive to a said measured impedance differing from a prior said measured impedance by more than a defined amount.

5. The method of claim 4, further comprising declaring the set of impedance data valid responsive to the said measured impedance differing from the said prior measured impedance by less than the defined amount.

6. A method for monitoring intra-thoracic fluid content using an implanted cardiac stimulation device comprising at least two implanted electrodes, the method comprising:

responsive to occurrence of a cardiac event, delivering an impedance measurement pulse at a predetermined interval therefrom;

measuring impedance between the two electrodes using the delivered impedance measurement pulse;

performing the first three steps repeatedly over a period extending over multiple days to acquire a set of impedance data;

employing the set of impedance data to determine whether intra-thoracic fluid content is increasing or decreasing; and

wherein the device comprises at least a third electrode and wherein the method further comprises performing a cross check of the measured impedance values by measuring an impedance using the third electrode.

7. The method of claim 6, wherein the method further comprises declaring the set of impedance data flawed is performed responsive to the impedance measured using the third electrode.

8. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

wherein the device comprises leads carrying the electrodes and wherein the device further comprises means for employing the measured impedances to assess the integrity of the leads.

9. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

wherein the device comprises leads carrying the electrodes and wherein the device further comprises means for employing the measured impedances to assess the integrity of the leads; and

further comprising means for declaring the set of impedance data flawed responsive to the assessment of the integrity of the leads.

10. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

wherein the device comprises leads carrying the electrodes and wherein the device further comprises means for employing the measured impedances to assess the integrity of the leads; and

wherein the means for assessment of the integrity of the leads comprises means for comparing a measured impedance to a prior measured impedance to determine whether the measured impedance differs from the prior measured impedance by more than a defined amount.

11. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

further comprising means for declaring the set of impedance data valid responsive to a measured impedance differing from a prior measured impedance by less than a defined amount.

13. The device of claim 11, further comprising means for declaring the set of impedance data valid responsive to a measured impedance differing from a prior measured impedance by less than the defined amount.

12. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

further comprising means for declaring the set of impedance data flawed responsive to a measured impedance differing from a prior measured impedance by more than a defined amount.

14. An implantable device capable of measuring intra-thoracic fluid content, comprising:

at least two implantable electrodes;

means for determining occurrences of cardiac events;

an impedance measurement means for measuring impedance between the electrodes repeatedly over a period extending over multiple days to acquire a set of impedance data, the impedance measurement means comprising;

means responsive to occurrence of a cardiac event, for delivering an impedance measurement pulse separated by a predetermined interval therefrom;

means for measuring impedance between the two electrodes using the delivered impedance measurement pulse; and

means responsive to the set of impedance data for determining whether intra-thoracic fluid content is increasing or decreasing; and

further comprising;

a third electrode;

means for measuring an impedance employing the third electrode and means for performing a cross check of the set of impedance data by measuring an impedance using the third electrode.

15. The device of claim 14, further comprising:

means for declaring the set of impedance data flawed responsive to the impedance measured using the third electrode.