# US 2014/0155765 A1 · System and method for evaluating a patient status for use in heart failure assessment

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- Number: US 2014/0155765 A1
- Document ID: US20140155765A1
- Status: Published application
- Kind: A1
- Application number: 14/139,650
- Filed: 2013-12-23
- Published: 2014-06-05
- Earliest claimed: 1999-06-03
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Gust Bardy
- Web page: https://patentgrep.com/patent/US20140155765A1

## CPC

- 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 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/1116: {Determining posture transitions}
- A61B 5/1118: {Determining activity level}
- A61B 5/333: Recording apparatus specially adapted therefor
- A61B 5/4878: {Evaluating oedema}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/7246: {using correlation, e.g. template matching or determination of similarity}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61B 7/02: Stethoscopes
- A61N 1/37258: {Alerting the patient}
- A61N 1/39622: {Pacing therapy}
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/0215: by means inserted into the body
- A61B 5/0826: {Detecting or evaluating apnoea events (sleep apnoea A61B5/4818)}
- 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)
- A61N 1/37282: {characterised by communication with experts in remote locations using a network}
- G16H 50/00: ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- Y10S 128/92: Computer assisted medical diagnostics
- 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
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A system and method for evaluating a patient status from sampled physiometry for use in heart failure assessment is presented. Physiological measures, including at least one of direct measures regularly recorded on a substantially continuous basis by a medical device and measures derived from the direct measures are stored. At least one of those of the physiological measures, which relate to a same type of physiometry, and those of the physiological measures, which relate to a different type of physiometry are sampled. A status is determined for a patient through analysis of those sampled measures assembled from a plurality of recordation points. The sampled measures are evaluated. Trends that are indicated by the patient status, including one of a status quo and a change, which might affect cardiac performance of the patient, are identified. Each trend is compared to worsening heart failure indications to generate a notification of parameter violations.

## Claims

### Claim at position 1

1-32. (canceled)

### Claim 33

A system for evaluating a patient status for use in heart failure assessment, comprising:
an implantable medical device configured to collect patient data on a long-term, daily basis, wherein the implantable medical device is further configured to store a collected measures set containing the patient data;
an analysis module configured to receive the collected measures set and compare the collected measures set to a comparison measures set containing comparison data to generate a status indicator for the patient data, wherein the comparison measures set is based on at least one patient characteristic in the group consisting of: age, geographic region, and gender; and
a feedback module to provide notification of a potential medical concern based on the patient status indicator.

### Claim 34 (depends on 33)

The system of claim 33, wherein the implantable medical device comprises two or more sensors configured to collect the patient data at different locations in a patient's body.

### Claim 35 (depends on 33)

The system of claim 33, wherein the comparison data comprises averaged measures.

### Claim 36 (depends on 33)

The system of claim 33, further comprising a collection client and a network server, wherein the network client is configured to be communicatively interposed between the implantable medical device and a communication link, retrieve the collected measures set from the implantable medical device, and download the collected measures set into the network server over the communications link.

### Claim 37 (depends on 33)

The system of claim 33, wherein the implantable medical device is further configured to provide cardiac pacing and defibrillation.

### Claim 38 (depends on 37)

The system of claim 37, wherein the patient data comprises the number of device interventions made and the type of device interventions made.

### Claim 39 (depends on 38)

The system of claim 38, wherein the patient data further comprises the relative success of any interventions made.

### Claim 40 (depends on 33)

The system of claim 33, wherein the feedback module is further configured to provide tiered notifications comprising:
at a first level, an interpretation of the patient status;
at a second level, a notification of potential medical concern based on the patient status;
at a third level, a notification of potential medical concern based on the patient status to medical personnel; and
at a fourth level, a set of reprogramming instructions based on the patient status to an implantable medical device.

### Claim 41 (depends on 33)

The system of claim 33, wherein the implantable medical device comprises a battery and is configured to store data comprising battery status, and wherein the feedback module is configured to provide notification of the battery status.

### Claim 42 (depends on 33)

The system of claim 33, wherein the feedback module is further configured to provide the notification consistent with a particular level of patient involvement and medical care intervention from a plurality of levels of patient involvement and medical care intervention.

### Claim 43

A method for evaluating a patient status for use in heart failure assessment, comprising:
collecting patient data, by an implantable medical device, on a long-term, daily basis, and periodically sending a collected measures set containing the patient data;
receiving, by an analysis module, the collected measures set and comparing the collected measures set to a comparison measures set containing comparison data, wherein the comparison measures set is based on at least one patient characteristic in the group consisting of: age, geographic region, and gender;
generating a status indicator for the patient data based on the comparing; and
providing a notification of a potential medical concern, by a feedback module, based on the patient status indicator.

### Claim 44 (depends on 43)

The method of claim 43, wherein collecting patient data is by two or more sensors, each at different locations in a patient's body.

### Claim 45 (depends on 43)

The method of claim 43, wherein the comparison data in the second collected measures set comprises averaged measures.

### Claim 46 (depends on 43)

The method of claim 43, further comprising retrieving, by a collection client, the collected measures set from the implantable medical device and downloading the collected measures set into a network server over a communications link.

### Claim 47 (depends on 43)

The method of claim 43, providing cardiac pacing and defibrillation by the implantable medical device.

### Claim 48 (depends on 47)

The method of claim 47, wherein the patient data comprises the number of device interventions made and the type of device interventions made.

### Claim 49 (depends on 48)

The method of claim 48, wherein the patient data further comprises the relative success of any interventions made.

### Claim 50 (depends on 43)

The method of claim 43, wherein providing a notification comprises one or more of tiered notifications comprising:
at a first level, providing an interpretation of the patient status;
at a second level, providing a notification of potential medical concern based on the patient status;
at a third level, providing a notification of potential medical concern based on the patient status to medical personnel; and
at a fourth level, providing a set of reprogramming instructions based on the patient status to an implantable medical device.

### Claim 51 (depends on 43)

The method of claim 43, further comprising storing battery status data by the medical device and providing notification of the battery status by the feedback module.

### Claim 52 (depends on 43)

The method of claim 43, wherein providing the notification is consistent with a particular level of patient involvement and medical care intervention from a plurality of levels of patient involvement and medical care intervention.