# US 10,441,179 B2 · Method and apparatus for management of heart failure hospitalization

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- Number: US 10,441,179 B2
- Document ID: US10441179B2
- Status: Granted
- Kind: B2
- Application number: 15/646,846
- Filed: 2017-07-11
- Published: 2017-10-26
- Granted: 2019-10-15
- Earliest claimed: 2007-03-14
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Ramesh Wariar; Jeffrey E. Stahmann; Julie A. Thompson; Helen L. Reeve-Stoffer
- Web page: https://patentgrep.com/patent/US10441179B2

## CPC

- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/0031: {Implanted circuitry}
- A61B 5/0215: by means inserted into the body
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4839: {combined with drug delivery}
- 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}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36585: {controlled by two or more physical parameters}
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 5/7239: {using differentiation including higher order derivatives}
- A61B 7/00: Instruments for auscultation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## 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

### Claim 1

A system for managing a heart failure patient, comprising:
a sensor data input configured to receive sensor data representative of one or more physiological signals, the one or more physiological signals including a heart sound signal; and
a heart failure management circuit configured to:
analyze the sensor data;
generate a rehospitalization alarm in response to a need for rehospitalization indicated by the analysis of the sensor data during a post-hospitalization period after a hospitalization of the patient; and
generate a hospitalization alarm in response to a need for hospitalization indicated by the analysis of the sensor data outside of the post-hospitalization period.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a diagnostic data processor configured to produce one or more parameters indicative of one or more conditions associated with heart failure using the sensor data, the one or more parameters including an amplitude of third heart sounds (S3).

### Claim 3 (depends on 2)

The system of claim 2, 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.

### Claim 4 (depends on 2)

The system of claim 2, comprising a heart failure analyzer circuit including the sensor data input, the heart failure management circuit, and the diagnostic data processor, 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 during the post-hospitalization period and to operate in a second mode by executing a second heart failure management algorithm to analyze the sensor data after the post-hospitalization period, the first heart failure management algorithm monitoring the heart failure patient more closely than the second heart failure management algorithm.

### Claim 5 (depends on 2)

The system of claim 2, further comprising:
a heart sound sensor configured to sense the heart sound signal; and
a sensor processing circuit configured to receive the heart sound signal and produce sensor data representative of the heart sound signal.

### Claim 6 (depends on 5)

The system of claim 5, wherein the heart sound signal sensor comprises a microphone.

### Claim 7 (depends on 5)

The system of claim 5, wherein the heart sound sensor comprises an accelerometer.

### Claim 8 (depends on 5)

The system of claim 5, comprising an implantable medical device including the heart sound sensor and the sensor processing circuit.

### Claim 9 (depends on 8)

The system of claim 8, comprising an external system communicatively coupled to the implantable medical device via telemetry, the external system including the heart failure analyzer circuit.

### Claim 10 (depends on 2)

The system of claim 2, wherein the diagnostic data processor is configured to produce one or more heart failure decompensation indicating parameters of the one or more parameters, and the heart failure management circuit comprises a risk analyzer configured to produce a risk class parameter during the hospitalization of the patient using the one or more heart failure decompensation indicating parameters, the risk class parameter classifying a level of risk for rehospitalization within a specified period.

### Claim 11

A method of heart failure hospitalization management, comprising:
receiving sensor data representative of one or more physiological signals, the one or more physiological signals including a heart sound signal;
analyzing the sensor data;
timing a post-hospitalization period after a hospitalization of a patient;
generating a rehospitalization alarm in response to a need for rehospitalization indicated by the analysis of the sensor data during the post-hospitalization period; and
generating a hospitalization alarm in response to a need for hospitalization indicated by the analysis of the sensor data outside of the post-hospitalization period.

### Claim 12 (depends on 11)

The method of claim 11, further comprising programming the post-hospitalization period.

### Claim 13 (depends on 11)

The method of claim 11, further comprising producing one or more parameters indicative of one or more conditions associated with heart failure using the sensor data, the one or more parameters including an amplitude of third heart sounds (S3).

### Claim 14 (depends on 13)

The method of claim 13, further comprising producing a trend using at least one of the one or more parameters, the trend indicative of progression of heart failure.

### Claim 15 (depends on 13)

The method of claim 13, wherein analyzer the sensor data comprises:
executing a first heart failure management algorithm to analyze the sensor data during the post-hospitalization period; and
executing a second heart failure management algorithm to analyze the sensor data after the post-hospitalization period,
wherein the first heart failure management algorithm monitoring the heart failure patient more closely than the second heart failure management algorithm.

### Claim 16 (depends on 15)

The method of claim 15, further comprising
sensing the heart sound signal using a heart sound sensor; and
processing the heart sound signal to produce sensor data representative of the heart sound signal.

### Claim 17 (depends on 13)

The method of claim 13, further comprising:
producing one or more heart failure decompensation indicating parameters of the one or more parameters; and
producing a risk class parameter during the hospitalization of the patient using the one or more heart failure decompensation indicating parameters, the risk class parameter classifying a level of risk for rehospitalization within a specified period.

### Claim 18 (depends on 17)

The method of claim 17, further comprising producing a discharge recommendation signal using the risk class parameter during the hospitalization of the patient.

### Claim 19 (depends on 13)

The method of claim 13, further comprising analyzing efficacy of a therapy during the hospitalization of the patient using the one or more parameters and one or more expected values of the one or more parameters associated with the therapy applied.

### Claim 20 (depends on 13)

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