Automated patient care system and method for diagnosing and monitoring respiratory insufficiency

• US 8,231,539 B2
• Filed: 07/17/2007
• Issued: 07/31/2012
• Est. Priority Date: 11/16/1999
• 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): Natnithithadha, Navin
• Application Number:
  US11/879,654
• Publication Number:
  US 20070265542A1
• Time in Patent Office: 1,841 Days
• Field of Search: 600529-543, 600/484, 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

An automated patient care system and method for diagnosing and monitoring respiratory insufficiency is presented. A plurality of monitoring sets are stored into a database. Each monitoring set includes recorded measures, which each relate to patient information and contain medical device measures recorded on a substantially continuous basis or derived measures calculable therefrom. The monitoring sets are retrieved from the database. A set of indicator thresholds are defined. Each indicator threshold corresponds to a quantifiable physiological measure of a pathophysiology indicative of respiratory insufficiency. A respiratory insufficiency finding is diagnosed. A change in patient status is determined by comparing at least one recorded measure to at least one other recorded measure with both recorded measures relating to the same type of patient information. Each patient status change is compared to the indicator threshold corresponding to the same type of patient information as the recorded measures.

Claims

1. An automated collection and analysis patient care system for diagnosing and monitoring respiratory insufficiency and outcomes thereof, comprising:

a database storing patient monitoring information, comprising;

a plurality of monitoring sets, each monitoring set comprising recorded measures which each relate to patient information and comprise either medical device measures or derived measures calculable therefrom, the medical device measures having been recorded on a substantially continuous basis;

a set of stored indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology indicative of respiratory insufficiency and relating to a same type of patient information as at least one of the recorded measures, the database further storing a reference baseline comprising recorded measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period and comprise either device measures recorded by the medical device adapted to be implanted or derived measures calculable therefrom, and recorded measures relating to patient information for one of the individual patients solely, a peer group of patients to which the individual patient belongs, and a general population of patients;

a server diagnosing a respiratory insufficiency finding, comprising;

an analysis module determining a change in patient wellness by comparing at least one recorded measure to at least one other recorded measure with both recorded measures relating to the same type of patient information; and

a comparison module comparing each patient wellness change to at least one of the stored indicator thresholds corresponding to the same type of patient information as the recorded measures which were compared; 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.

2. A system according to claim 1, wherein the device measures are 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.

3. A system according to claim 1, wherein each of the monitoring sets comprises recorded measures relating to patient information solely for the individual patient, further comprising:

the database module further retrieving each monitoring set from a patient care record for the individual patient and obtaining the at least one recorded measure and the at least one other recorded measure from the retrieved monitoring sets.

4. A system according to claim 1, wherein each of the monitoring sets comprises recorded measures relating to patient information for a peer group of patients to which the individual patient belongs, further comprising:

the database module further retrieving at least one monitoring set from a patient care record for the individual patient, retrieving at least one other monitoring set from a patient care record in the same patient peer group, and obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

5. A system according to claim 1, wherein each of the monitoring sets comprises recorded measures relating to patient information for the general population of patients, further comprising:

the database module retrieving at least one monitoring set from a patient care record for the individual patient, retrieving at least one other monitoring set from a patient care record in the overall patient population, and obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

6. A system according to claim 1, wherein the indicator thresholds relate to at least one of reduced exercise capacity selected from the group comprising decreased cardiac output, decreased mixed venous oxygen score, decreased patient activity score and decreased exercise tolerance and respiratory distress 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.

7. A system according to claim 1, the comparison module further comprising at least one of:

a graded comparison module to perform a graded comparison, comprising;

a submodule grading the comparisons between each patient wellness change and corresponding indicator threshold on a fixed scale based on a degree of deviation from the indicator threshold; and

the comparison module determining an overall patient wellness change by performing a summation over individual graded comparisons; and

a weighted comparison module to perform a weighted comparison, comprising;

a submodule determining probabilistic weightings of the comparisons between each patient wellness change and corresponding indicator threshold based on a statistical deviation and trends via linear fits from the indicator threshold; and

the comparison module determining an overall patient wellness change by performing a summation over individual weightings of the comparisons.

8. A system according to claim 1, wherein each monitoring set further comprises quality of life and symptom measures recorded by the individual patient, the server further comprising:

a quality of life module determining a change in patient wellness by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure; and

the server incorporating each patient wellness change in quality of life into the respiratory insufficiency finding to either refute or support a diagnosis.

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

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

the server diagnosing a finding of a disease other than respiratory insufficiency, the comparison module further comprising comparing each patient wellness 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.

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

a set of stickiness indicators, each stickiness indicator corresponding to a temporal limit related to a course of patient care; and

a feedback module comparing a time span between each patient wellness change for each recorded measure to one of the set of stickiness indicators corresponding to the same type of patient information as the recorded measure being compared.

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

a feedback module performing an interactive dialogue between the individual patient and the patient care system regarding a medical condition of the individual patient and providing automated feedback to the individual patient when a respiratory insufficiency finding is indicated.

12. A method for diagnosing and monitoring respiratory insufficiency using an automated collection and analysis patient care system, comprising:

storing a plurality of monitoring sets into a database, each monitoring set comprising recorded measures which each relate to patient information and comprise either medical device measures or derived measures calculable therefrom, the medical device measures having been recorded on a substantially continuous basis;

retrieving the plurality of monitoring sets from the database;

defining a set of indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology indicative of respiratory insufficiency and relating to a same type of patient information as at least one of the recorded measures; and

diagnosing a respiratory insufficiency finding, comprising;

determining a change in patient wellness by comparing at least one recorded measure to at least one other recorded measure with both recorded measures relating to the same type of patient information;

comparing each patient wellness change to one of the indicator thresholds corresponding to the same type of patient information as the recorded measures which were compared; and

retrieving a reference baseline comprising recorded measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period and comprise either device measures recorded by the medical device adapted to be implanted 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.

13. A method according to claim 12, recording the device measures 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.

14. A method according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information solely for an individual patient, further comprising:

retrieving each monitoring set from a patient care record for an individual patient; and

obtaining the at least one recorded measure and the at least one other recorded measure from the retrieved monitoring sets.

15. A method according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information for a peer group of patients to which an individual patient belongs, further comprising:

retrieving at least one monitoring set from a patient care record for an individual patient;

retrieving at least one other monitoring set from a patient care record in a same patient peer group; and

obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

16. A method according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information for a general population of patients, further comprising:

retrieving at least one monitoring set from a patient care record for an individual patient;

retrieving at least one other monitoring set from a patient care record in an overall patient population; and

obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

17. A method according to claim 12, wherein the reference baseline comprises recorded measures relating to patient information for one of the individual patients solely, a peer group of patients to which the individual patient belongs, and a general population of patients.

18. A method according to claim 12, wherein the indicator thresholds relate to at least one of reduced exercise capacity selected from the group comprising decreased cardiac output, decreased mixed venous oxygen score, decreased patient activity score and decreased exercise tolerance and respiratory distress 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.

19. A method according to claim 12, the operation of comparing each patient wellness change further comprising at least one of:

performing a graded comparison, comprising;

grading the comparisons between each patient wellness change and corresponding indicator threshold on a fixed scale based on a degree of deviation from the indicator threshold to form individual graded comparisons; and

determining an overall patient wellness change by performing a summation over the individual graded comparisons; and

performing a weighted comparison, comprising;

determining probabilistic individual weightings of the comparisons between each patient wellness change and the corresponding indicator threshold based on a statistical deviation and trends via linear fits from the indicator threshold; and

determining an overall patient wellness change by performing a summation over the individual weightings of the comparisons.

20. A method according to claim 12, wherein each monitoring set further comprises quality of life and symptom measures recorded by an individual patient, diagnosing a respiratory insufficiency finding further comprising:

determining a change in patient wellness by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure; and

incorporating each patient wellness change in quality of life into the respiratory insufficiency finding to either refute or support the diagnosis.

21. A method according to claim 12, 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; and

diagnosing a finding of a disease other than respiratory insufficiency, comprising comparing each patient wellness 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.

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

defining a set of stickiness indicators, each stickiness indicator corresponding to a temporal limit related to a course of patient care; and

comparing a time span between each patient wellness change for each recorded measure to one of the stickiness indicators corresponding to the same type of patient information as the recorded measure being compared.

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

performing an interactive dialogue between an individual patient and the patient care system regarding a medical condition of the individual patient; and

providing automated feedback to the individual patient when a respiratory insufficiency finding is indicated.

24. A computer-readable storage medium holding code for diagnosing and monitoring respiratory insufficiency using an automated collection and analysis patient care system, comprising:

code for storing a plurality of monitoring sets into a database, each monitoring set comprising recorded measures which each relate to patient information and comprise either medical device measures or derived measures calculable therefrom, the medical device measures having been recorded on a substantially continuous basis;

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

code for defining a set of indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology indicative of respiratory insufficiency and relating to a same type of patient information as at least one of the recorded measures; and

code for diagnosing a respiratory insufficiency finding, comprising;

code for determining a change in patient wellness by comparing at least one recorded measure to at least one other recorded measure with both recorded measures relating to the same type of patient information; and

code for comparing each patient wellness change to an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, wherein comparing each patient wellness change further comprises at least one of;

code for performing a graded comparison, comprising;

code for grading the comparisons between each patient wellness change and corresponding indicator threshold on a fixed scale based on a degree of deviation from the indicator threshold to form individual graded comparisons; and

code for determining an overall patient wellness change by performing a summation over the individual graded comparisons; and

code for performing a weighted comparison, comprising;

code for determining probabilistic individual weightings of the comparisons between each patient wellness change and the corresponding indicator threshold based on a statistical deviation and trends via linear fits from the corresponding indicator threshold; and

code for determining an overall patient wellness change by performing a summation over the individual weightings of the comparisons.

25. A storage medium according to claim 24, wherein each of the monitoring sets comprises recorded measures relating to patient information solely for an individual patient, further comprising:

code for retrieving each monitoring set from a patient care record for an individual patient; and

code for obtaining the at least one recorded measure and the at least one other recorded measure from the retrieved monitoring set.

26. A storage medium according to claim 24, wherein each of the monitoring sets comprises recorded measures relating to patient information for a peer group of patients to which an individual patient belongs, further comprising:

code for retrieving at least one monitoring set from a patient care record for an individual patient;

code for retrieving at least one other monitoring set from a patient care record in the same patient peer group; and

code for obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

27. A storage medium according to claim 24, wherein each of the monitoring sets comprises recorded measures relating to patient information for a general population of patients, further comprising:

code for retrieving at least one monitoring set from a patient care record for an individual patient;

code for retrieving at least one other monitoring set from a patient care record in an overall patient population; and

code for obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

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

code for retrieving a reference baseline comprising recorded measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period and comprise either device measures recorded by the medical device adapted to be implanted 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.

29. A storage medium according to claim 24, wherein each monitoring set further comprises quality of life and symptom measures recorded by an individual patient, the operation of diagnosing a respiratory insufficiency finding further comprising:

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

code for incorporating each patient wellness change in quality of life into the respiratory insufficiency finding to either refute or support the diagnosis.

30. A storage medium according to claim 24, 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; and

code for diagnosing a finding of a disease other than respiratory insufficiency, comprising comparing each patient wellness 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.

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

code for defining a set of stickiness indicators, each stickiness indicator corresponding to a temporal limit related to a course of patient care; and

code for comparing a time span between each patient wellness change for each recorded measure to a stickiness indicator corresponding to the same type of patient information as the recorded measure being compared.

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

code for performing an interactive dialogue between the individual patient and the patient care system regarding a medical condition of an individual patient; and

code for providing automated feedback to the individual patient when a respiratory insufficiency finding is indicated.