Systems and methods for monitoring pulmonary edema dynamics

• US 8,417,463 B2
• Filed: 07/20/2009
• Issued: 04/09/2013
• Est. Priority Date: 07/22/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wariar, Ramesh, Hatlestad, John D., Beck, Kenneth C., Lewicke, Aaron
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US12/505,926
• Publication Number:
  US 20100022911A1
• Time in Patent Office: 1,359 Days
• Field of Search: 600483-488, 600504-507, 600/547, 600/561, 600/300, 600/301, 702/187, 702/19, 607/17, 607/18, 607/23
• US Class Current: 702/19
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/4878 Evaluating oedema

Abstract

This document discusses, among other things, systems and methods for measuring the dynamics of pulmonary congestion in heart failure subjects over time to monitor the subjects susceptibility to pulmonary edema, including sensing and receiving information indicative of a bodily pressure and information indicative of pulmonary fluid, and using the transient responses of these measurements to compute parameters related to the dynamics of thoracic fluid accumulation, such as a critical pressure (P_c), a critical time (T_c), or a filtration index (K_fi).

Claims

1. A system for use with a physiologic pressure sensor, the system comprising:

a processor comprising;

a pressure sensor input configured to receive information indicative of a bodily pressure from the physiologic pressure sensor; and

an impedance sensor input configured to receive impedance information indicative of a pulmonary fluid level;

wherein the processor is configured to generate a pressure baseline using the information indicative of the bodily pressure received from the physiologic pressure sensor;

wherein the processor is configured to generate a pulmonary fluid level baseline using the impedance information indicative of the pulmonary fluid level;

wherein the processor is configured to identify a critical pressure (P_c) using the information indicative of the bodily pressure received from the physiologic pressure sensor and the received impedance information indicative of the pulmonary fluid level information, wherein the critical pressure (P_c) is the pressure at which the received impendence falls below the pulmonary fluid level baseline; and

wherein the processor is configured to compute a critical time (Tc) using the information indicative of the bodily pressure received from the physiologic pressure sensor and the received impedance information indicative of the pulmonary fluid level, wherein the critical time (Tc) defines a duration beginning when the information indicative of the bodily pressure deviates from the pressure baseline and ending when the pressure reaches the critical pressure (Pc).

2. The system of claim 1, wherein the processor comprises an event detector input configured to receive information about a detected pulmonary fluid overload event, and wherein the processor is configured to identify the critical pressure (P_c) using the information indicative of the bodily pressure received from the physiologic pressure sensor leading up to or during the detected event and the received impedance information indicative of the pulmonary fluid level leading up to or during the detected event.

3. The system of claim 1, wherein the processor comprises an event detector input configured to receive information about a detected pulmonary fluid overload event, and wherein the processor is configured to compute the critical time (T_c) using the information indicative of a bodily pressure received from the physiologic pressure sensor leading up to or during the detected event and the received impedance information indicative of the pulmonary fluid level leading up to or during the detected event.

4. The system of claim 1, wherein the processor is configured to compute an estimated pressure slop (Pes) using the information indicative of the bodily pressure received from the physiologic pressure sensor, and wherein the processor is configured to compute an estimated critical time (Tec) using a current pressure determined using the information indicative of the bodily pressure received from the physiologic pressure sensor, the critical pressure (Pc), and the computed estimated pressure slope (Pes).

5. The system of claim 4, wherein the processor is configured to use the estimated critical time (Tec) to predict an impending patient event.

6. The system of claim 1, wherein the processor is configured to compute a filtration index (K_fi) as a function of a slope of the information indicative of the bodily pressure received from the physiologic pressure sensor and a slope of the impendence information indicative of the pulmonary fluid level.

7. The system of claim 6, including an event detector input configured to detect a pulmonary fluid overload event, wherein the processor is configured to compute the filtration index (K_fi) using the information indicative of the bodily pressure received from the physiologic pressure sensor leading up to or during the detected event and the received impedance information indicative of the pulmonary fluid level leading up to or during the detected event.

8. The system of claim 7, wherein the detected pulmonary fluid overload event includes at least one of a user-confirmed pulmonary fluid overload event or an automatically detected pulmonary fluid overload event, wherein the user-confirmed event includes at least one of a hospitalization or a change in medication, and wherein the automatically detected event includes at least one of information exceeding a threshold or a baseline, the information including at least one of a value or a slope.

9. The system of claim 1, comprising the physiologic pressure sensor, wherein the physiologic pressure sensor is an implantable chronic pulmonary artery pressure sensor configured to be fixed to a location within the pulmonary artery;

wherein the pressure sensor input is configured to chronically receive information indicative of a pulmonary artery pressure of a pulmonary artery using the implantable chronic pulmonary artery pressure sensor.

10. The system of claim 1, wherein the processor is configured to provide a critical pressure (Pc) alert to a user when the information indicative of the bodily pressure received from the physiologic pressure sensor indicates that the pressure is approaching the critical pressure (P_c) or that the critical pressure (Pc) has been reached.

11. The system of claim 1, including:

a display, communicatively coupled to the processor, the display configured to receive information about at least one of the information indicative of the bodily pressure received from the physiologic pressure sensor, the received information indicative of the pulmonary fluid level, or the critical pressure (P_c), and wherein the display is configured to provide the received information to a user.

12. The system of claim 1, wherein the processor is configured to use the critical time (Tc) to generate a therapy requirement alert.

13. The system of claim 1, wherein the processor is configured to trend the critical time (Tc) over time, wherein the trend of the critical time (Tc) over time is indicative of a patient disease status progression.

14. The system of claim 1, wherein the critical time (Tc) indicates a time-to-failure of a patient pulmonary compensatory mechanism.

15. The system of claim 1, wherein the critical time (Tc) defines a duration beginning when the information indicative of the bodily pressure exceeds the pressure baseline by a threshold amount and ending when the pressure reaches the critical pressure (Pc).

16. A system for use with a physiologic pressure sensor, the system comprising:

a processor comprising;

a pressure sensor input configured to receive information indicative of a bodily pressure from the physiologic pressure sensor; and

an impedance sensor input configured to receive impedance information indicative of a pulmonary fluid level;

wherein the processor is configured to generate a pressure baseline using the information indicative of the bodily pressure received from the physiologic pressure sensor;

wherein the processor is configured to generate a pulmonary fluid level baseline using the impedance information indicative of the pulmonary fluid level;

wherein the processor is configured to identify a critical pressure (P_c) using the information indicative of the bodily pressure received from the physiologic pressure sensor and the received impedance information indicative of the pulmonary fluid level information, wherein the critical pressure (P_c) is a pressure at which the received impedance information indicative of the pulmonary fluid level falls below the pulmonary fluid level baseline; and

wherein the processor is configured to compute an estimated pressure slope (Pes) using the information indicative of the bodily pressure received from the physiologic pressure sensor, and wherein the processor is configured to compute an estimated critical time (Tec) using a current pressure determined using the information indicative of the bodily pressure received from the physiologic pressure sensor, the critical pressure (Pc), and the computed estimated pressure slope (Pes), and wherein the processor is configured to use the estimated critical time (Tec) to predict an impending patient event.

17. The system of claim 16, wherein the processor is further configured to output a signal representing the computed estimated critical time (Tec) to a display.

18. The system of claim 16, wherein the processor is configured to compute an estimated pulmonary fluid slope (Zes), wherein the processor is configured to compute an estimated time-to-hospitalization (Teh) using the estimated pulmonary fluid slope (Zes), and wherein the processor is further configured to output a signal representing the computed estimated time-to-hospitalization (Teh) to a display.

19. The system of claim 18, wherein the processor is configured to compute a filtration index (K_fi) as a function of a slope of the information indicative of the bodily pressure received from the physiologic pressure sensor and a slope of the received impedance information indicative of the pulmonary fluid level, and wherein the estimated pulmonary fluid slope (Zes) equals the filtration index (K_fi) multiplied by the estimated pressure slope (Pes).

20. A system for use with a physiologic pressure sensor, the system comprising:

a processor comprising;

a pressure sensor input configured to receive information indicative of a bodily pressure from the physiologic pressure sensor; and

an impedance sensor input configured to receive impedance information indicative of a pulmonary fluid level;

wherein the processor is configured to generate a pressure baseline using the information indicative of the bodily pressure received from the physiologic pressure sensor;

wherein the processor is configured to generate a pulmonary fluid level baseline using the impedance information indicative of the pulmonary fluid level;

wherein the processor is configured to identify a critical pressure (P_c) using the information indicative of the bodily pressure received from the physiologic pressure sensor and the received impedance information indicative of the pulmonary fluid level information, wherein the critical pressure (P_c) is a pressure at which the received impedance information indicative of the pulmonary fluid level falls below the pulmonary fluid level baseline; and

wherein the processor is configured to compute a critical time (Tc) using the information indicative of the bodily pressure received from the physiologic pressure sensor and the received impedance information indicative of the pulmonary fluid level, wherein the critical time (Tc) defines a duration beginning when the information indicative of the bodily pressure deviates from the pressure baseline and ending when the pressure reaches the critical pressure (Pc);

wherein the processor is configured to compute a filtration index (K_fi) as a function of a slope of the information indicative of the bodily pressure received from the physiologic pressure sensor leading up to or during a pulmonary fluid overload event and a slope of the impedance information indicative of the pulmonary fluid level leading up to or during the pulmonary fluid overload event, wherein the pulmonary fluid overload event includes at least one of a user-confirmed pulmonary fluid overload event or an automatically detected pulmonary fluid overload event, wherein the user-confirmed event includes at least one of a hospitalization or a change in medication, and wherein the automatically detected event includes at least one of information exceeding a threshold or a baseline, the information including at least one of a value or a slope.