Method and apparatus for management of heart failure hospitalization

• US 9,138,151 B2
• Filed: 01/28/2014
• Issued: 09/22/2015
• 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: Wariar, Ramesh, Stahmann, Jeffrey E., Thompson, Julie A., Reeve-Stoffer, Helen L.
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/166,417
• Publication Number:
  US 20140142440A1
• Time in Patent Office: 602 Days
• Field of Search: 600/508, 607/2, 607/18, 128/906, 128/902
• US Class Current: 1/1
• 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 system for managing a heart failure patient, the system comprising:

a sensor processing circuit configured to receive one or more physiological signals and produce sensor data representative of the one or more physiological signals; and

a heart failure analyzer circuit coupled to the sensor processing circuit, the heart failure analyzer configured to operate in a post-hospitalization mode including to;

receive diagnostic data including information about the sensor data, the diagnostic data indicative of one or more conditions associated with heart failure decompensation, wherein the diagnostic data includes post-hospitalization respiration data associated with the patient; and

produce a risk class parameter classifying a level of risk for rehospitalization within a specified period using the diagnostic data.

2. The system of claim 1, wherein the sensor processing circuit is configured to include or to be coupled to an impedance sensor configured to sense a thoracic impedance, and wherein the sensor processing circuit is configured to determine the respiration data using information about the thoracic impedance.

3. The system of claim 2, wherein the sensor processing circuit is configured to determine the respiration data including a respiration characteristic comprising a respiration rate.

4. The system of claim 1, wherein the heart failure analyzer is configured to operate in the post-hospitalization discharge mode upon being triggered by heart failure analyzer circuit determining that the sensor data has met at least one specified criterion.

5. The system of claim 1, wherein the heart failure analyzer is configured to operate in the post-hospitalization discharge mode upon being triggered by a user command being received after a decision to discharge the patient from a hospitalization.

6. The system of claim 1, wherein the heart failure analyzer circuit includes at least one specified re-hospitalization criterion and at least one specified hospitalization criterion, wherein the at least one specified re-hospitalization criterion is easier to meet than the at least one specified hospitalization criterion.

7. The system of claim 1, wherein the heart failure analyzer is configured to include respiration data obtained outside of the post-hospitalization mode in the diagnostic data used to produce the risk class parameter classifying the level of risk for rehospitalization.

8. The system of claim 7, wherein the heart failure analyzer is configured to include respiration data obtained in a hospitalization mode in the diagnostic data used to produce the risk class parameter classifying the level of risk for rehospitalization.

9. The system of claim 8, wherein the heart failure analyzer is configured to include respiration data obtained in a non-hospitalization mode in the diagnostic data used to produce the risk class parameter classifying the level of risk for rehospitalization.

10. The system of claim 1, comprising an implantable medical device including the sensor processing circuit, and a remotely-accessible external patient management system including or coupled to at least a portion of the heart failure analyzer circuit to permit a caregiver to monitor the patient from a remote location.

11. The system of claim 6, wherein the heart failure analyzer circuit is configured to receive the patient'"'"'s medical history information including patient demographics and history of cardiac and produce the one or more parameters indicative of heart failure decompensation using the diagnostic data including the sensor data and the medical history information.

12. A system for managing a patient, the system comprising:

a heart failure analyzer circuit configured to operate in a post-hospitalization mode including to;

receive diagnostic data including information about patient physiological sensor data, the diagnostic data indicative of one or more conditions associated with heart failure decompensation, wherein the diagnostic data includes post-hospitalization respiration data associated with the patient; and

classify a level of risk for rehospitalization using the diagnostic data including using a respiration characteristic comprising a respiration rate.

13. The system of claim 12, wherein the heart failure analyzer is configured to operate in the post-hospitalization discharge mode:

upon being triggered by heart failure analyzer circuit determining that the sensor data has met at least one specified criterion; and

upon being triggered by a user command being received after a decision to discharge the patient from a hospitalization.

14. The system of claim 12, wherein the heart failure analyzer circuit includes at least one specified re-hospitalization criterion and at least one specified hospitalization criterion, wherein the at least one specified re-hospitalization criterion is easier to meet than the at least one specified hospitalization criterion.

15. The system of claim 12, wherein the heart failure analyzer is configured to:

use respiration data obtained in a hospitalization mode in the diagnostic data used to classify the level of risk for rehospitalization; and

use respiration data obtained in a non-hospitalization mode in the diagnostic data used to classify the level of risk for rehospitalization.

16. The system of claim 12, comprising an implantable medical device including:

a sensor processing circuit configured to receive one or more physiological signals and produce the sensor data as representative of the one or more physiological signals; and

a remotely-accessible external patient management system including or coupled to at least a portion of the heart failure analyzer circuit to permit a caregiver to monitor the patient from a remote location.

17. The system of claim 12, wherein the heart failure analyzer circuit is configured to produce one or more parameters indicative of heart failure decompensation using the diagnostic data, and produce a trend indicative of progression of heart failure using at least one parameter of the one or more parameters.

18. The system of claim 17, further comprising a presentation device configured to present the trend.

19. A system for managing a heart failure patient, the system comprising an implantable medical device comprising:

a sensor processing circuit configured to receive one or more physiological signals and produce sensor data representative of the one or more physiological signals; and

a heart failure analyzer circuit coupled to the sensor processing circuit, the heart failure analyzer configured to operate in a post-hospitalization mode including to;

receive diagnostic data including information about the sensor data, the diagnostic data indicative of one or more conditions associated with heart failure decompensation, wherein the diagnostic data includes post-hospitalization respiration data associated with the patient; and

classify a level of risk for rehospitalization within a specified period using the diagnostic data including respiration rate determined from thoracic impedance.

20. The system of claim 19, wherein the heart failure analyzer circuit includes at least one specified re-hospitalization criterion and at least one specified hospitalization criterion, wherein the at least one specified re-hospitalization criterion is easier to meet than the at least one specified hospitalization criterion.