System and method for diagnosing and monitoring respiratory insufficiency for automated remote patient care

• US 7,258,670 B2
• Filed: 08/22/2003
• Issued: 08/21/2007
• 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): Natnithithadha; Navin
• Application Number:
  US10/646,243
• Publication Number:
  US 20040039263A1
• Time in Patent Office: 1,460 Days
• Field of Search: 600/481, 600/484, 600/300, 600/301, 600529-543, 128920-925
• US Class Current: 600/529
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• 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 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• 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 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• 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 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 : for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/60 : relating to pathologies
• CPC Class Codes: Y10S 128/92 : Computer assisted medical diagnostics
• CPC Class Codes: Y10S 128/923 : by comparison of patient data to other data

Abstract

A system for diagnosing and monitoring respiratory insufficiency for automated remote patient care is presented. A database stores monitoring sets containing recorded measures relating to patient information recorded on a substantially continuous basis. A server retrieving and processing the monitoring sets includes a comparison module determining a patient status change by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure with both recorded measures relating to a same type of patient information; and an analysis module testing each patient status change against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology indicative of respiratory insufficiency.

Claims

1. A system for diagnosing and monitoring respiratory insufficiency for automated remote patient care, comprising:

a database storing a plurality of monitoring sets which each comprise recorded measures relating to patient information recorded on a substantially continuous basis; and

a server retrieving and processing a plurality of the monitoring sets, comprising;

a comparison module determining a patient status change by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure with both recorded measures relating to a same type of patient information; and

an analysis module testing the patient status change against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a pathophysiology indicative of;

an onset of respiratory insufficiency if a finding of respiratory insufficiency was not previously diagnosed, a progression or regression of respiratory insufficiency if respiratory insufficiency was previously diagnosed, and a status quo of respiratory insufficiency if no such patient status change is detected.

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

an outcome analysis module managing the respiratory insufficiency and outcomes thereof through administration of at least one of antibiotic and antiviral therapies, bronchodilator therapies, oxygen therapies, anti inflammation therapies, electrical therapies, and mechanical therapies.

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

a database module periodically receiving a monitoring set for an individual patient, each recorded measure in the monitoring set having been recorded by at least one of a medical device adapted to be implanted in an individual patient and an external medical device proximal to the individual patient when the device measures are recorded and storing the received monitoring set in the database as part of a patient care record for the individual patient.

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

a set of further indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure used to detect a pathophysiology indicative of diseases other than respiratory insufficiency;

a status comparison module comparing each patient status change to each such further indicator threshold corresponding to the same type of patient information as the at least one recorded measure and the at least one other recorded measure; and

an analysis testing module testing each patient status change against each such further indicator threshold corresponding to the same type of patient information as the recorded measures which were compared.

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

a status comparison module determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure.

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

a set of stickiness indicators for each type of patient information, each stickiness indicator corresponding to a temporal limit related to a program of patient diagnosis or treatment;

a time comparison module comparing a time span occurring between each patient status change for each recorded measure to the stickiness indicator relating to the same type of patient information as the recorded measure being compared; and

a program analysis module determining a revised program of patient diagnosis or treatment responsive to each patient status change occurring subsequent to a time span exceeding the stickiness indicator.

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

a database module retrieving the plurality of monitoring sets from one of a patient care record for an individual patient, a peer group, and a overall patient population.

8. A system according to claim 1, wherein:

the database further stores a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom; and

a database module obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

9. A system according to claim 1, wherein the indicator thresholds relate to at least one of a finding of reduced exercise capacity and respiratory distress.

10. A system according to claim 9, wherein the indicator thresholds relating to the finding of reduced exercise capacity are selected from the group comprising decreased cardiac output, decreased mixed venous oxygen score, decreased patient activity score and decreased exercise tolerance.

11. A system according to claim 9, wherein the indicator thresholds relating to the finding of respiratory distress are selected from the group comprising a spike in patient activity score, a spike in pulmonary artery pressure, a spike in right ventricular pressure, a spike in transthoracic impedance, increased respiratory rate, increased minute ventilation, increased temperature, decreased QT interval, decreased arterial oxygen and decreased arterial carbon dioxide.

12. A method for diagnosing and monitoring respiratory insufficiency for automated remote patient care, comprising:

storing a plurality of monitoring sets which each comprise recorded measures relating to patient information recorded on a substantially continuous basis in a database;

retrieving a plurality of the monitoring sets from the database;

determining a patient status change by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure with both recorded measures relating to a same type of patient information; and

testing the patient status change against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a pathophysiology indicative of;

an onset of respiratory insufficiency if a finding of respiratory insufficiency was not previously diagnosed, a progression or regression of respiratory insufficiency if respiratory insufficiency was previously diagnosed, and a status quo of respiratory insufficiency if no such patient status change is detected.

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

managing the respiratory insufficiency and outcomes thereof through administration of at least one of antibiotic and antiviral therapies, bronchodilator therapies, oxygen therapies, anti inflammation therapies, electrical therapies, and mechanical therapies.

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

periodically receiving a monitoring set for an individual patient, each recorded measure in the monitoring set having been recorded by at least one of a medical device adapted to be implanted in an individual patient and an external medical device proximal to the individual patient when the device measures are recorded; and

storing the received monitoring set in the database as part of a patient care record for the individual patient.

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

defining a set of further indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure used to detect a pathophysiology indicative of diseases other than respiratory insufficiency;

comparing each patient status change to each such further indicator threshold corresponding to the same type of patient information as the at least one recorded measure and the at least one other recorded measure; and

testing each patient status change against each such further indicator threshold corresponding to the same type of patient information as the recorded measures which were compared.

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

determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure.

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

defining a set of stickiness indicators for each type of patient information, each stickiness indicator corresponding to a temporal limit related to a program of patient diagnosis or treatment;

comparing a time span occurring between each patient status change for each recorded measure to the stickiness indicator relating to the same type of patient information as the recorded measure being compared; and

determining a revised program of patient diagnosis or treatment responsive to each patient status change occurring subsequent to a time span exceeding the stickiness indicator.

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

retrieving the plurality of monitoring sets from one of a patient care record for an individual patient, a peer group, and a overall patient population.

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

retrieving a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom; and

obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

20. A method according to claim 12, wherein the indicator thresholds relate to at least one of a finding of reduced exercise capacity and respiratory distress.

21. A method according to claim 20, wherein the indicator thresholds relating to the finding of reduced exercise capacity are selected from the group comprising decreased cardiac output, decreased mixed venous oxygen score, decreased patient activity score and decreased exercise tolerance.

22. A method according to claim 20, wherein the indicator thresholds relating to the finding of respiratory distress are selected from the group comprising a spike in patient activity score, a spike in pulmonary artery pressure, a spike in right ventricular pressure, a spike in transthoracic impedance, increased respiratory rate, increased minute ventilation, increased temperature, decreased QT interval, decreased arterial oxygen and decreased arterial carbon dioxide.

23. A computer-readable storage medium holding code for diagnosing and monitoring respiratory insufficiency for automated remote patient care, comprising:

code for storing a plurality of monitoring sets from a database which each comprise recorded measures relating to patient information recorded on a substantially continuous basis;

code for retrieving a plurality of the monitoring sets from the database;

code for determining a patient status change by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure with both recorded measures relating to a same type of patient information; and

code for testing the patient status change against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a pathophysiology indicative of;

an onset of respiratory insufficiency if a finding of respiratory insufficiency was not previously diagnosed, a progression or regression of respiratory insufficiency if respiratory insufficiency was previously diagnosed, and a status quo of respiratory insufficiency if no such patient status change is detected.

24. A storage medium according to claim 23, further comprising:

code for managing the respiratory insufficiency and outcomes thereof through administration of at least one of antibiotic and antiviral therapies, bronchodilator therapies, oxygen therapies, anti inflammation therapies, electrical therapies, and mechanical therapies.

25. A storage medium according to claim 23, further comprising:

code for periodically receiving a monitoring set for an individual patient, each recorded measure in the monitoring set having been recorded by at least one of a medical device adapted to be implanted in an individual patient and an external medical device proximal to the individual patient when the device measures are recorded; and

code for storing the received monitoring set in the database as part of a patient care record for the individual patient.

26. A storage medium according to claim 25, further comprising:

code for defining a set of further indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure used to detect a pathophysiology indicative of diseases other than respiratory insufficiency;

code for comparing each patient status change to each such further indicator threshold corresponding to the same type of patient information as the at least one recorded measure and the at least one other recorded measure; and

code for testing each patient status change against each such further indicator threshold corresponding to the same type of patient information as the recorded measures which were compared.

27. A storage medium according to claim 23, further comprising:

code for determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure.

28. A storage medium according to claim 23, further comprising:

code for defining a set of stickiness indicators for each type of patient information, each stickiness indicator corresponding to a temporal limit related to a program of patient diagnosis or treatment;

code for comparing a time span occurring between each patient status change for each recorded measure to the stickiness indicator relating to the same type of patient information as the recorded measure being compared; and

code for determining a revised program of patient diagnosis or treatment responsive to each patient status change occurring subsequent to a time span exceeding the stickiness indicator.

29. A storage medium according to claim 23, further comprising:

code for retrieving the plurality of monitoring sets from one of a patient care record for an individual patient, a peer group, and a overall patient population.

30. A storage medium according to claim 23, further comprising:

code for retrieving a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom; and

code for obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.