System and method for providing diagnosis and monitoring of congestive heart failure for use in automated patient care

• US 6,811,537 B2
• Filed: 01/07/2002
• Issued: 11/02/2004
• Est. Priority Date: 11/16/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Original Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US10/042,402
• Publication Number:
  US 20020099302A1
• Time in Patent Office: 1,030 Days
• Field of Search: 600/508, 600/509, 600/513, 600/515-518, 600/300, 600/301, 128/920, 128/923-925, 607/4, 607/5, 607/9
• US Class Current: 600/508
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/486 : Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/686 : Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• 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 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: Y10S 128/923 : by comparison of patient data to other data

Abstract

A system and method for providing diagnosis and monitoring of congestive heart failure for use in automated patient care is described. At least one recorded physiological measure is compared to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information. An absence, an onset, a progression, a regression, and a status quo of congestive heart failure is evaluated dependent upon the change in patient pathophysiological status.

Claims

1. A system for providing diagnosis and monitoring of congestive heart failure for use in automated patient care, comprising:

a comparison module comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information;

a diagnostic module comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of congestive heart failure; and

an analysis module determining an onset, a progression, a regression, and a status quo of congestive heart failure dependent upon the comparison.

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

a database module retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.

3. A system according to claim 2, further comprising:

a server system collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.

4. A system according to claim 3, further comprising:

at least one of an implantable medical device and an external medical device recording the at least one recorded physiological measure and the at least one other recorded physiological measure.

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

the analysis module evaluating an onset, a progression, a regression, and a status quo of diseases other than congestive heart failure dependent upon the change in patient pathophysiological status.

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

a diagnostic module comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.

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

a stored stickiness indicator defined for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment;

a diagnostic module timing each change in patient pathophysiological status for the equivalent patient information and determining one of a revised patient diagnosis end treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.

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

a diagnostic module comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.

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

a diagnostic module comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.

10. A method for providing diagnosis and monitoring of congestive heart failure for use in automated patient care, comprising:

comparing at least one recorded physiological measure to at least one other recorded physiological measure on a substantially regular basis to quantify a change in patient pathophysiological status for equivalent patient information;

determining an onset, a progression, a regression, and a status quo of congestive heart failure dependent upon the change in patient pathophysiological status; and

comparing the change in patient pathophysiological status to an indicator threshold corresponding to a quantifiable physiological measure indicative of congestive heart failure; and

determining an onset, a progression, a regression, and a status quo of congestive heart failure dependent upon the comparison.

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

retrieving the at least one recorded physiological measure and the at least one other recorded physiological measure from monitoring sets stored in a database.

12. A method according to claim 11, further comprising:

collecting the at least one recorded physiological measure and the at least one other recorded physiological measure into each monitoring set recorded on a substantially continuous basis or derived therefrom.

13. A method according to claim 12, further comprising:

recording the at least one recorded physiological measure and the at least one other recorded physiological measure with at least one of an implantable medical device and an external medical device.

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

evaluating an onset, a progression, a regression, and a status quo of diseases other than congestive heart failure dependent upon the change in patient pathophysiological status.

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

comparing at least one recorded quality of life measure to at least one other recorded quality of life measure on a substantially regular basis to qualify a change in patient pathophysiological status.

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

defining a stickiness indicator for at least one physiological measure corresponding to a temporal boundary on one of patient diagnosis and treatment;

timing each change in patient pathophysiological status for the equivalent patient information; and

determining one of a revised patient diagnosis and treatment responsive to each change in patient pathophysiological status with a timing exceeding the stickiness indicator.

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

comparing the change in patient pathophysiological status to a reference baseline comprising recorded physiological measures recorded during an initial time period.

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

comparing the change in patient pathophysiological status to equivalent patient information from at least one of an individual patient, a peer group, and a overall patient population.

19. A computer-readable storage medium for a device holding code for performing the method according to claim 10.