System and method for determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system

• US 6,280,380 B1
• Filed: 12/31/1999
• Issued: 08/28/2001
• Est. Priority Date: 07/26/1999
• 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): Kamm, William E.
• Application Number:
  US09/476,601
• Time in Patent Office: 606 Days
• Field of Search: 600/300, 128/920
• US Class Current: 600/300
• 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 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• 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 determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system is described. A set of measures collected from a medical device having a sensor for monitoring at least one physiological measure of an individual patient is received. The collected device measures set includes individual measures which each relate to patient information recorded by the medical device during an initial time period. The collected device measures set are stored into a patient care record for the individual patient within a database organized to store one or more patient care records. The collected device measures set is processed into a set of reference measures. Each reference measure is representative of at least one of measured or derived patient information. The reference measures set is stored into the patient care record as data in a reference baseline indicating an initial patient status.

Claims

1. A system for determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system;

comprising;

medical device having a sensor for monitoring at least one physiological measure of an individual patient, the collected measures set comprising individual measures which each relate to patient information recorded by the medical device;

a network server receiving a set of measures collected from a medical device having a sensor for monitoring at least one physiological measure of an individual patient, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device during an initial time period;

a database storing the collected device measures set into a patient care record for the individual patient within a database organized to store one or more patient care records; and

an application server processing the collected device measures set into a set of reference measures, each reference measure being representative of at least one of measured or derived patient information, and storing the reference measures set into the patient care record as data in a reference baseline indicating an initial patient status.

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

the network device repeatedly receiving one or more collected measures sets which are each recorded by a sensor which monitors at least one physiological measure of the individual patient, each such sensor monitoring a site within the individual patient unique from the site monitored by any other such sensor;

the database storing each collected measures set organized by specific site into the patient care record for the individual patient within the database; and

the application server analyzing one or more of the site specific collected measures sets in the patient care record for each site within the individual patient relative to one or more other site specific collected measures sets stored in the database to determine a patient status indicator.

3. A system according to claim 2, wherein the one or more site specific collected measures sets and the one or more other site specific collected measures sets both store measures collected from the same relative site.

4. A system according to claim 2, wherein the one or more site specific collected measures sets and the one or more other site specific collected measures sets both store measures collected from a different site.

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

a remote client recording a set of quality of life measures during the initial time period;

the network server receiving the quality of life measures set from the remote client;

the database storing the collected quality of life measures set into the patient care record for the individual patient; and

the application server assimilating the collected quality of life measures set into the reference baseline data stored in the patient care record.

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

the medical device monitoring the individual patient while the individual patient is performing a prescribed set of timed physical stressors during the initial time period.

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

a programmer reprogramming at least one of pacing interventions and pacing modes of the medical device during the initial time period; and

the medical device monitoring the individual patient subsequent to the reprogramming during the initial time period.

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

a feedback recorder recording feedback from the individual patient during the initial time period;

the network server receiving the recorded feedback from the remote client;

the database storing the recorded feedback into the patient care record for the individual patient; and

the application server assimilating the recorded feedback into the reference baseline data stored in the patient care record.

9. A system according to claim 8, wherein the feedback recorder comprises at least one of an audio recorder, a digital camera, or a video camera.

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

a set of acceptance parameters stored within the database with each acceptance parameter corresponding to the same type of patient information to which at least one of the reference measures relates;

the application server further comprising;

an evaluation module analyzing the reference measures set for each patient care record against the acceptance parameters set; and

an acceptance module identifying each patient care record storing a reference measures set having at least one reference measure substantially non-conforming to the corresponding acceptance parameter.

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

an analysis module analyzing one or more collected device measures sets in the patient care record for the individual patient relative to the reference measures sets in the reference baseline to determine a patient status indicator.

12. A system according to claim 11, the application server further comprising:

the analysis module analyzing one or more of the collected device measures sets in the patient care record for the individual patient relative to one or more other collected device measures sets stored in the database to further determine the patient status indicator.

13. A system according to claim 1, wherein each of the set of reference measures is selected from the group comprising patient activity score, posture, atrial electrical activity, ventricular electrical activity, cardiovascular pressures, cardiac output, oxygenation, pulmonary measures, body temperature, PR interval, QRS measures, QT interval, ST-T wave measures, potassium [K+] level, sodium [Na+] level, glucose level, blood urea nitrogen and creatinine, acidity (pH) level, hematocrit, hormonal levels, cardiac injury chemical tests, myocardial blood flow, central nervous system injury chemical tests, central nervous system (CNS) blood flow, and time of day and combinations and derivatives thereof.

14. A method for determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system, comprising:

receiving a set of measures collected from a medical device having a sensor for monitoring at least one physiological measure of an individual patient, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device during an initial time period;

storing the collected device measures set into a patient care record for the individual patient within a database organized to store one or more patient care records; and

processing the collected device measures set into a set of reference measures, each reference measure being representative of at least one of measured or derived patient information, and storing the reference measures set into the patient care record as data in a reference baseline indicating an initial patient status.

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

repeatedly receiving one or more collected measures sets which are each recorded by a sensor which monitors at least one physiological measure of the individual patient, each such sensor monitoring a site within the individual patient unique from the site monitored by any other such sensor;

storing each collected measures set organized by specific site into the patient care record for the individual patient within the database; and

analyzing one or more of the site specific collected measures sets in the patient care record for each site within the individual patient relative to one or more other site specific collected measures sets stored in the database to determine a patient status indicator.

16. A method according to claim 15, wherein the one or more site specific collected measures sets and the one or more other site specific collected measures sets both store measures collected from the same relative site.

17. A method according to claim 15, wherein the one or more site specific collected measures sets and the one or more other site specific collected measures sets both store measures collected from a different site.

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

receiving a set of quality of life measures recorded by the individual patient during the initial time period;

storing the collected quality of life measures set into the patient care record for the individual patient within the database; and

assimilating the collected quality of life measures set into the reference baseline data stored in the patient care record.

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

monitoring the individual patient using the medical device while the individual patient is performing a prescribed set of timed physical stressors during the initial time period.

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

reprogramming at least one of pacing interventions and pacing modes of the medical device during the initial time period; and

monitoring the individual patient using the medical device subsequent to the reprogramming during the initial time period.

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

receiving feedback recorded by the individual patient during the initial time period;

storing the recorded feedback into the patient care record for the individual patient within the database; and

assimilating the recorded feedback into the reference baseline data stored in the patient care record.

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

defining a set of acceptance parameters with each acceptance parameter corresponding to the same type of patient information to which at least one of the reference measures relates;

analyzing the reference measures set for each patient care record against the acceptance parameters set; and

identifying each patient care record storing a reference measures set having at least one reference measure substantially non-conforming to the corresponding acceptance parameter.

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

analyzing one or more collected device measures sets in the patient care record for the individual patient relative to the reference measures sets in the reference baseline to determine a patient status indicator.

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

analyzing one or more of the collected device measures sets in the patient care record for the individual patient relative to one or more other collected device measures sets stored in the database to further determine the patient status indicator.

25. A method according to claim 14, wherein each of the set of reference measures is selected from the group comprising patient activity score, posture, atrial electrical activity, ventricular electrical activity, cardiovascular pressures, cardiac output, oxygenation, pulmonary measures, body temperature, PR interval, QRS measures, QT interval, ST-T wave measures, potassium [K+] level, sodium [Na+] level, glucose level, blood urea nitrogen and creatinine, acidity (pH) level, hematocrit, hormonal levels, cardiac injury chemical tests, myocardial blood flow, central nervous system injury chemical tests, central nervous system (CNS) blood flow, and time of day and combinations and derivatives thereof.

26. A computer-readable storage medium holding code for determining a reference baseline of individual patient status for use in an automated collection and analysis patient care system, comprising:

receiving a set of measures collected from a medical device having a sensor for monitoring at least one physiological measure of an individual patient, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device during an initial time period;

storing the collected device measures set into a patient care record for the individual patient within a database organized to store one or more patient care records; and

processing the collected device measures set into a set of reference measures, each reference measure being representative of at least one of measured or derived patient information, and storing the reference measures set into the patient care record as data in a reference baseline indicating an initial patient status.

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

repeatedly receiving one or more collected measures sets which are each recorded by a sensor which monitors at least one physiological measure of the individual patient, each such sensor monitoring a site within the individual patient unique from the site monitored by any other such sensor;

storing each collected measures set organized by specific site into the patient care record for the individual patient within the database; and

analyzing one or more of the site specific collected measures sets in the patient care record for each site within the individual patient relative to one or more other site specific collected measures sets stored in the database to determine a patient status indicator.

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

receiving a set of quality of life measures recorded by the individual patient during the initial time period;

storing the collected quality of life measures set into the patient care record for the individual patient within the database; and

assimilating the collected quality of life measures set into the reference baseline data stored in the patient care record.

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

monitoring the individual patient using the medical device while the individual patient is performing a prescribed set of timed physical stressors during the initial time period.

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

reprogramming at least one of pacing interventions and pacing modes of the medical device during the initial time period; and

monitoring the individual patient using the medical device subsequent to the reprogramming during the initial time period.

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

receiving feedback recorded by the individual patient during the initial time period;

storing the recorded feedback into the patient care record for the individual patient within the database; and

assimilating the recorded feedback into the reference baseline data stored in the patient care record.

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

defining a set of acceptance parameters with each acceptance parameter corresponding to the same type of patient information to which at least one of the reference measures relates;

analyzing the reference measures set for each patient care record against the acceptance parameters set; and

identifying each patient care record storing a reference measures set having at least one reference measure substantially non-conforming to the corresponding acceptance parameter.

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

analyzing one or more collected device measures sets in the patient care record for the individual patient relative to the reference measures sets in the reference baseline to determine a patient status indicator.

34. A storage medium according to claim 33, further comprising:

analyzing one or more of the collected device measures sets in the patient care record for the individual patient relative to one or more other collected device measures sets stored in the database to further determine the patient status indicator.