System and method for evaluating a patient status for use in heart failure assessment

• US 9,526,456 B2
• Filed: 08/20/2007
• Issued: 12/27/2016
• Est. Priority Date: 06/03/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US11/894,281
• Publication Number:
  US 20070293738A1
• Time in Patent Office: 3,417 Days
• Field of Search: 600/301
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 : characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: 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
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 128/92 : Computer assisted medical diagnostics

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

1. A computer-implemented system for evaluating a patient status for use in heart failure assessment, comprising:

a data module configured to assemble physiological measures which were electronically stored in a memory and directly recorded as data on a substantially continuous basis by medical device for a patient or indirectly derived from the data, wherein the physiological measures comprise measures for the patient and one or more of measures for a peer group of disease specific patients and measures for an overall patient population;

a status module configured to sample the physiological measures over a plurality of data assembly points;

an evaluation module configured to evaluate and match at each data assembly point the sampled physiological measures to determine a patient status indicator;

a diagnosis module configured to determine one of a status quo and a change in cardiac performance of the patient and compare the change in the cardiac performance to worsening heart failure indications;

a quality of life module configured to query the patient on a regular basis and collect quality of life measures and to chronicle the quality of life measures with the physiological measures; and

a feedback module configured to provide tiered feedback based on the patient status indicator comprising;

a first level module configured to communicate, at a first level, an interpretation of the change in the cardiac performance;

a second level module configured to communicate, at a second level, a notification of potential medical concern based on the change in the cardiac performance to the patient;

a third level module configured to communicate, at a third level, a notification of potential medical concern based on the change in the cardiac performance to medical personnel; and

a fourth level module configured to communicate to a patient medical device of the patient, at a fourth level, a set of reprogramming instructions based on the change in the cardiac performance;

wherein the tiered feedback has increasing levels of patient involvement and medical care intervention.

2. A system according to claim 1, wherein the change in cardiac performance is selected from the group comprising an onset, progression, and regression of a cardiac performance parameter.

3. A system according to claim 1, wherein the worsening heart failure indications are selected from the group comprising pulmonary artery pressure, left atrial pressure, dyspnea, orthopnea, pulmonary edema, peripheral edema, and fatigue.

4. A system according to claim 1, further comprising:

a measurement module configured to measure one or more of pulmonary artery pressure, heart rate, heart sounds, intrathoracic impedance, respiration, posture, lung fluid, activity, weight, and physiological response to activity.

5. A system according to claim 1, further comprising:

a reprogramming module configured to reprogram the patient medical device based on the patient status indicator.

6. A system according to claim 5, wherein the worsening heart failure indications are factored into the reprogramming of the patient medical device.

7. A system according to claim 1, wherein respiration rate is tracked through the patient medical device, further comprising:

a notification module configured to generate a notification triggered by a parameter assigned to the respiration rate.

8. A system according to claim 7, wherein the parameter comprises one or more of an upper limit parameter applied over a short term and a counter parameter applied over a long term.

9. A system according to claim 1, wherein the medical device comprises one of an implantable medical device and an external medical device.

10. A computer-implemented method for evaluating a patient status for use in heart failure assessment, comprising:

assembling physiological measures electronically stored in a memory and directly recorded as data on a substantially continuous basis by a medical device for a patient or indirectly derived from the data, wherein the physiological measures comprise measures for the patient and one or more of measures for a peer group of disease specific patients and measures for an overall patient population;

sampling the physiological measures over a plurality of data assembly points;

at each data assembly point, evaluating and matching the sampled physiological measures to form a patient status indicator;

determining one of a status quo and a change in cardiac performance of the patient and comparing the change in the cardiac performance to worsening heart failure indications;

querying the patient on a regular basis to collect quality of life measures;

chronicling the quality of life measures with the physiological measures; and

providing tiered feedback based on the patient status indicator comprising;

at a first level, communicating an interpretation of the change in the cardiac performance;

at a second level, communicating a notification of potential medical concern based on the change in the cardiac performance to the patient;

at a third level, communicating a notification of potential medical concern based on the change in the cardiac performance to medical personnel; and

at a fourth level, communicating to a patient medical device a set of reprogramming instructions based on the change in the cardiac performance;

wherein the tiered feedback has increasing levels of patient involvement and medical care intervention.

11. A method according to claim 10, wherein the change in cardiac performance is selected from the group comprising an onset, progression, and regression of a cardiac performance parameter.

12. A method according to claim 10, wherein the worsening heart failure indications are selected from the group comprising pulmonary artery pressure, left atrial pressure, dyspnea, orthopnea, pulmonary edema, peripheral edema, and fatigue.

13. A method according to claim 10, further comprising:

measuring one or more of pulmonary artery pressure, heart rate, heart sounds, intrathoracic impedance, respiration, posture, lung fluid, activity, weight, and physiological response to activity.

14. A method according to claim 10, further comprising:

reprogramming the patient medical device based on the patient status indicator.

15. A method according to claim 14, further comprising:

factoring the worsening heart failure indications into the reprogramming of the patient medical device.

16. A method according to claim 10, further comprising:

tracking respiration rate through the patient medical device; and

generating a notification triggered by a parameter assigned to the respiration rate.

17. A method according to claim 16, wherein the parameter comprises one or more of an upper limit parameter applied over a short term and a counter parameter applied over a long term.

18. A method according to claim 10, wherein the medical device comprise one of an implantable medical device and an external medical device.

19. A computer-implemented system for evaluating a patient status indicator from sampled physiometry for use in heart failure assessment, comprising:

a storage module configured to electronically store physiological measures in a memory, the physiological measures comprising at least one of direct measures regularly recorded on a substantially continuous basis by a medical device for a patient and measures derived from the direct measures, wherein the physiological measures comprise measures for the patient and one or more of measures for a peer group of disease specific patients and measures for an overall patient population;

a sampling module configured to sample at least one of those of the physiological measures, which each relate to a same type of physiometry, and those of the physiological measures, which each relate to a different type of physiometry;

a status module configured to analyze the sampled physiological measures assembled from a plurality of recordation points;

an evaluation module configured to evaluate each of a status quo and a change in the sampled physiological measures affecting cardiac performance of the patient;

a diagnostic module configured to determine one of a status quo and a change in cardiac performance of the patient and compare the change in the cardiac performance to worsening heart failure indications;

a quality of life module configured to query the patient on a regular basis and collect quality of life measures and to chronicle the quality of life measures with the physiological measures; and

a feedback module configured to provide tiered feedback based on the change in cardiac performance comprising;

a first level module configured to communicate, at a first level, an interpretation of the change in the sampled physiological measures affecting cardiac performance;

a second level module configured to communicate, at a second level, a notification of potential medical concern based on the change in the sampled physiological measures affecting cardiac performance to the patient;

a third level module configured to communicate, at a third level, a notification of potential medical concern based on the change in the sampled physiological measures affecting cardiac performance to medical personnel; and

a fourth level module configured to communicate to a patient medical device, at a fourth level, a set of reprogramming instructions based on the change in the sampled physiological measures affecting cardiac performance;

wherein the tiered feedback has increasing levels of patient involvement and medical care intervention; and

an alerting module configured to generate a notification of parameter violations by the change in the sampled physiological measures affecting at least one of pulmonary artery pressure, left atrial pressure, dyspnea, orthopnea, pulmonary edema, peripheral edema, and fatigue.

20. A system according to claim 19, further comprising:

a reprogramming module configured to reprogram the patient medical device based on extended evaluation of the direct measures and the derived measures.

21. A system according to claim 19, further comprising:

a tracking module configured to track respiration rate of the patient on a regular basis through the medical device; and

a notification module configured to generate a notification triggered by one or more of an upper limit parameter applied over a short term and a counter parameter applied over a long term.

22. A computer-implemented method for evaluating a patient status indicator from sampled physiometry for use in heart failure assessment, comprising:

electronically storing physiological measures in a memory, the physiological measures comprising at least one of direct measures regularly recorded on a substantially continuous basis by a medical device for a patient and measures derived from the direct measures, wherein the physiological measures comprise measures for the patient and one or more of measures for a peer group of disease specific patients and measures for an overall patient population;

sampling at least one of those of the physiological measures, which each relate to a same type of physiometry, and those of the physiological measures, which each relate to a different type of physiometry;

matching the sampled physiological measures assembled from a plurality of recordation points;

evaluating each of a status quo and a change in the sampled physiological measures affecting cardiac performance of the patient;

determining one of a status quo and a change in cardiac performance of the patient and comparing the change in the cardiac performance to worsening heart failure indications;

querying the patient on a regular basis to collect quality of life measures;

chronicling the quality of life measures with the physiological measures; and

providing tiered feedback based on the change in the cardiac performance comprising;

at a first level, communicating an interpretation of the change in the sampled physiological measures affecting cardiac performance;

at a second level, communicating a notification of potential medical concern based on the change in the sampled physiological measures affecting cardiac performance to the patient;

at a third level, communicating a notification of potential medical concern based on the change in the sampled physiological measures affecting cardiac performance to medical personnel; and

at a fourth level, communicating to a patient medical device a set of reprogramming instructions based on the change in the sampled physiological measures affecting cardiac performance;

wherein the tiered feedback has increasing levels of patient involvement and medical care intervention; and

generating a notification of parameter violations by the change in the sampled physiological measures affecting at least one of pulmonary artery pressure, left atrial pressure, dyspnea, orthopnea, pulmonary edema, peripheral edema, and fatigue.

23. A method according to claim 22, further comprising:

reprogramming the patient medical device based on extended evaluation of the direct measures and the derived measures.

24. A method according to claim 22, further comprising:

tracking respiration rate of the patient on a regular basis through the patient medical device; and

generating a notification triggered by one or more of an upper limit parameter applied over a short term and a counter parameter applied over a long term.