Method and apparatus for management of heart failure hospitalization

• US 8,052,611 B2
• Filed: 03/14/2007
• Issued: 11/08/2011
• Est. Priority Date: 03/14/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Reeve, Helen L., Wariar, Ramesh, Stahmann, Jeffrey E., Thompson, Julie
• Primary Examiner(s): Getzow; Scott
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/685,949
• Publication Number:
  US 20080228090A1
• Time in Patent Office: 1,700 Days
• Field of Search: 607/2, 607/18, 128/906, 128/920, 600/508
• US Class Current: 600/508
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A hospitalization management system including a heart failure analyzer that receives diagnostic data including at least sensor data representative of one or more physiological signals sensed from a hospitalized patient using one or more sensors and assesses risk of rehospitalization for the patient using the diagnostic data. The outcome of the risk assessment is used during and following the patient'"'"'s hospitalization for reducing the risk of rehospitalization.

Claims

1. A heart failure hospitalization management system, comprising:

one or more sensors to sense one or more physiological signals;

a sensor processing circuit, coupled to the one or more sensors, to produce sensor data representative of the sensed one or more physiological signals; and

a heart failure analyzer coupled to the sensor processing circuit, the heart failure analyzer including;

a data input adapted to receive diagnostic data indicative of one or more conditions associated with heart failure decompensation, the data input including a sensor data input configured to receive the sensor data;

a diagnostic data processor adapted to produce one or more heart failure decompensation indicating parameters using the diagnostic data indicative of the one or more conditions associated with heart failure decompensation;

a mode switch adapted to switch an operational mode of the heart failure analyzer to a hospitalization mode in response to a mode change command; and

a risk analyzer adapted to produce a risk class parameter during the hospitalization mode, the risk class parameter classifying a level of risk for rehospitalization within a specified period using the one or more heart failure decompensation indicating parameters.

2. The system of claim 1, wherein the diagnostic data processor is adapted to produce a trend using at least one of the one or more parameters, the trend indicative of progression of heart failure.

3. The system of claim 1, comprising an implantable medical device including at least the sensor processing circuit and one or more portions of the heart failure analyzer.

4. The system of claim 3, comprising an external system communicatively coupled to the implantable medical device, the external system including a user interface adapted to receive the mode-change command, and wherein the mode switch is included in the implantable medical device and comprises a command receiver adapted to receive the mode-change command.

5. The system of claim 3, comprising an external system including:

an external device communicatively coupled to the implantable medical device;

a remote device; and

a telecommunication network, coupled between the external device and the remote device, to provide communication between the external device and the remote device.

6. The system of claim 5, wherein the data input further comprises an external data input adapted to receive the external data representative of patient information from the external system.

7. The system of claim 5, wherein the diagnostic data processor is adapted to produce a trend using at least one of the one or more parameters, the trend indicative of progression of heart failure, and the external system comprises a presentation device configured to present the trend.

8. The system of claim 1, wherein the mode switch comprises a mode selector adapted to produce the mode-change command automatically using the one or more parameters.

9. The system of claim 1, wherein the heart failure analyzer further comprises a therapy monitor adapted to analyze efficacy of therapy during the hospitalization mode using the one or more parameters and expected values of the one or more parameters associated with the therapy applied.

10. The system of claim 1, wherein the risk analyzer comprises a discharge planning analyzer adapted to produce a discharge recommendation signal using the risk class parameter during the hospitalization mode.

11. The system of claim 1, wherein the mode switch is adapted to switch the operational mode of the heart failure analyzer to one of the hospitalization mode and a post-hospitalization mode according to the mode-change command, and the heart failure analyzer further comprises a post-hospitalization monitor adapted to monitor the one or more parameters and produce one or more signals indicative of need for medical intervention using the one or more parameters and one or more criteria associated with the one or more parameters during the post-hospitalization mode.

12. The system of claim 11, wherein the mode switch comprises a post-hospitalization timer adapted to time a predetermined post-hospitalization period, and the mode switch is adapted to switch the operational mode of the heart failure analyzer from the post-hospitalization mode to another operational mode in response to an expiration of the post-hospitalization period.

13. The system of claim 11, wherein the mode switch is adapted to switch the operational mode of the heart failure analyzer to one of the hospitalization mode, the post-hospitalization mode, and a non-hospitalization mode according to the mode-change command, wherein the heart failure analyzer further comprises a baseline analyzer adapted to produce one or more baseline values of the one or more parameters using baseline data including data representative of the one or more sensor signals sensed by the one or more implantable sensors within a clinically stable period during the non-hospitalization mode, and wherein the risk analyzer is adapted to produce the risk class parameter using the one or more parameters and the one or more baseline values of the one or more parameters.

14. The system of claim 13, wherein the heart failure analyzer comprises one or more of:

a hospitalization alarm generator adapted to produce a hospitalization alarm signal when the one or more parameters indicate a need for hospitalization during the non-hospitalization mode using one or more hospitalization threshold values determined using the one or more baseline values of the one or more parameters; and

a rehospitalization alarm generator adapted to produce a rehospitalization alarm signal when the one or more parameters indicate a need for rehospitalization during the post-hospitalization mode using one or more rehospitalization threshold values determined using the one or more baseline values of the one or more parameters.

15. The system of claim 13, wherein the heart failure analyzer comprises a hospitalization alarm generator adapted to produce a hospitalization alarm signal in response to the one or more parameters indicating a need for hospitalization during the non-hospitalization mode.

16. The system of claim 15, wherein the hospitalization alarm generator is adapted to produce the hospitalization alarm signal as an audible tone.

17. The system of claim 15, wherein the hospitalization alarm generator is adapted to produce the hospitalization alarm signal by comparing at least one of the one or more parameters to a corresponding hospitalization threshold value.

18. The system of claim 15, wherein the hospitalization alarm generator is adapted to produce the hospitalization alarm signal by comparing a time derivative of at least one of the one or more parameters to a corresponding hospitalization threshold derivative value.

19. The system of claim 15, wherein the mode switch is adapted to switch the operational mode of the heart failure analyzer from the non-hospitalization mode to the hospitalization mode in response to the hospitalization alarm signal.

20. The system of claim 13, wherein the heart failure analyzer comprises a rehospitalization alarm generator adapted to produce a rehospitalization alarm signal in response to the one or more parameters indicating a need for rehospitalization during the post-hospitalization mode.

21. The system of claim 20, wherein the rehospitalization alarm generator is adapted to produce the rehospitalization alarm signal by comparing at least one of the one or more parameters to a corresponding rehospitalization threshold value.

22. The system of claim 20, wherein the rehospitalization alarm generator is adapted to produce the rehospitalization alarm signal by comparing a time derivative of at least one of the one or more parameters to a corresponding rehospitalization threshold derivative value.

23. The system of claim 20, wherein the mode switch is adapted to switch the operational mode of the heart failure analyzer from the post-hospitalization mode to the hospitalization mode in response to the rehospitalization alarm signal.

24. The system of claim 1, wherein the mode switch is adapted to switch the operational mode of the heart failure analyzer to one of the hospitalization mode, the post-hospitalization mode, and a non-hospitalization mode selected according to the mode-change command, wherein the heart failure analyzer comprises a memory circuit configured to store heart failure management algorithms including a hospitalization algorithm, a post-hospitalization algorithm, and a non-hospitalization algorithm, and wherein the heart failure analyzer is adapted to execute one of the heart failure management algorithms selected according to the operational mode.

25. The system of claim 1, comprising a therapy circuit adapted to deliver one or more of an anti-bradycardia pacing therapy, an anti-tachycardia pacing therapy, a defibrillation therapy, a cardiac resynchronization therapy, and a neurostimulation therapy.

26. The system of claim 1, comprising an implantable medical device including at least the one or more sensors, the sensor processing circuit, and a therapy circuit adapted to deliver one or more therapies.

27. The system of claim 26, wherein the implantable medical device comprises the heart failure analyzer.

28. The system of claim 26, comprising an external system communicatively coupled to the implantable medical device, the external system including the heart failure analyzer.

29. The system of claim 26, wherein the one or more sensors comprise one or more of a heart sound sensor, an impedance sensor, a blood pressure sensor, and a chemical sensor.

30. The system of claim 26, wherein the therapy circuit comprises a neurostimulation circuit adapted to deliver neurostimulation.