Method and apparatus for management of heart failure hospitalization

• US 9,730,592 B2
• Filed: 07/30/2015
• Issued: 08/15/2017
• 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-Stoffer, Helen L., Stahmann, Jeffrey E., Thompson, Julie A., Wariar, Ramesh
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US14/814,135
• Publication Number:
  US 20150335255A1
• Time in Patent Office: 747 Days
• 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 coupled to the sensor processing circuit and configured to receive the sensor data from the sensor processing circuit, to analyze the sensor data, and to generate a rehospitalization alarm based on the analysis of the sensor data,

wherein the heart failure analyzer is configured to operate in a first mode by executing a first heart failure management algorithm to analyze the sensor data for a predetermined period of time after a hospitalization and to operate in a second mode by executing a second heart failure management algorithm to analyze the sensor data after the predetermined period of time, the first heart failure management algorithm monitoring the heart failure patient more closely than the second heart failure management algorithm.

2. The system of claim 1, comprising an implantable medical device including the sensor processing circuit.

3. The system of claim 2, wherein the implantable medical device comprises the heart failure analyzer.

4. The system of claim 2, comprising an external system communicatively coupled to the implantable medical device, the external system including the heart failure analyzer.

5. The system of claim 2, further comprising one or more implantable sensors configured to sense the one or more physiological signals.

6. The system of claim 2, wherein the heart failure analyzer is configured to receive diagnostic data including the sensor data, the diagnostic data indicative of one or more conditions associated with heart failure decompensation, to produce one or more parameters indicative of heart failure decompensation using the diagnostic data, and to produce the rehospitalization alarm based on the one or more parameters.

7. The system of claim 6, wherein the heart failure analyzer is configured to produce the rehospitalization alarm signal by comparing at least one parameter of the one or more parameters to a corresponding rehospitalization threshold value.

8. The system of claim 6, wherein the heart failure analyzer is configured to produce the rehospitalization alarm signal by comparing a time derivative of at least one parameter of the one or more parameters to a corresponding rehospitalization threshold derivative value.

9. The system if claim 6, wherein the heart failure analyzer circuit is configured to produce a trend indicative of progression of heart failure using at least one parameter of the one or more parameters.

10. The system of claim 6, wherein the implantable medical device further comprises a therapy circuit configured to apply a therapy to the heart failure patient, and wherein the heart failure analyzer circuit is configured to analyze efficacy of the applied therapy using the one or more parameters and expected values of the one or more parameters associated with the applied therapy.

11. A method for operating a heart failure analyzer for managing hospitalization of a heart failure patient, the method comprising:

receiving one or more physiological signals from one or more sensors;

producing sensor data representative of the one or more physiological signals;

operating the heart failure analyzer in a first mode by executing a first heart failure management algorithm to analyze the sensor data for a predetermined period of time after a hospitalization;

operating the heart failure analyzer in a second mode by executing a second heart failure management algorithm to analyze the sensor data after the predetermined period of time; and

generating a rehospitalization alarm based on the analysis of the sensor data,

wherein the first heart failure management algorithm monitors the heart failure patient more closely than the second heart failure management algorithm.

12. The method of claim 11, comprising:

receiving diagnostic data including the sensor data, the diagnostic data indicative of one or more conditions associated with heart failure decompensation; and

producing one or more parameters indicative of heart failure decompensation using the diagnostic data,

and wherein generating the rehospitalization alarm comprises generating the rehospitalization alarm using the one or more parameters.

13. The method of claim 12, wherein generating the rehospitalization alarm comprises comparing at least one parameter of the one or more parameters to a corresponding rehospitalization threshold value.

14. The method of claim 12, wherein generating the rehospitalization alarm comprises comparing a time derivative of at least one parameter of the one or more parameters to a corresponding rehospitalization threshold derivative value.

15. The method of claim 12, further comprising producing a trend indicative of progression of heart failure using at least one parameter of the one or more parameters.

16. The method of claim 12, further comprising:

applying a therapy to the heart failure patient; and

analyzing efficacy of the applied therapy using the one or more parameters and expected values of the one or more parameters associated with the applied therapy.

17. The method of claim 16, wherein applying the therapy comprises applying a cardiac resynchronization therapy.

18. The method of claim 16, wherein applying the therapy comprises applying a neurostimulation therapy.

19. The method of claim 12, wherein receiving the one or more physiological signals from the one or more sensors comprises receiving a heart sound signal indicative of third heart sounds (S3) from a heart sound sensor.

20. The method of claim 12, wherein receiving the one or more physiological signals from the one or more sensors comprises a thoracic impedance signal from an impedance sensor.