System and method for determining a reference baseline record for use in automated patient care

• US 6,945,934 B2
• Filed: 05/18/2001
• Issued: 09/20/2005
• 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): Jastrzab, Jeffrey R.
• Assistant Examiner(s): Oropeza, Frances P.
• Application Number:
  US09/860,987
• Publication Number:
  US 20010021801A1
• Time in Patent Office: 1,586 Days
• Field of Search: 128/903, 379/106.02, 600/300, 600/301, 600/509, 600/513, 600/323, 600/324, 600/365, 600/485, 600/516, 600/549
• 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 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

A system and method for determining a reference baseline record for use in automated patient care. One or more physiological measures are retrieved. Each of the measures relates to individual patient information recorded during an initial observation period from a patient care record. One or more reference measures are determined from the physiological measures. Each reference measure is representative of at least one of measured and derived patient information. The reference measures are stored into the patient care record indicating a reference baseline patient status.

Claims

1. A system for determining a reference baseline record for use in automated patient care, comprising:

a database storing patient care records with each record containing one or more physiological measures regularly recorded by an implantable medical device and relating to individual patient information recorded during an initial observation period and receiving quality of life measures recorded by the individual patient during the initial observation period; and

an analysis module determining one or more reference measures, each reference measure representative of at least one of measured and derived patient information, from the physiological measures retrieved from one such patient care record, storing the reference measures into the one such patient care record indicating a reference baseline patient status, and combining the quality of life measures into the one such patient care record indicating an expanded reference baseline patient status.

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

an implantable medical device having a sensor for monitoring and recording the physiological measures at least one of directly and derivatively.

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

a reprogrammer reprogramming a performance profile of the medical device during the initial observation period; and

the database obtaining the physiological measures from the medical device subsequent to reprogramming.

4. A system according to claim 2, 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 observation period.

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

the database storing patient care records with each record containing physiological measures from sensors monitoring a plurality of anatomical sites within the individual patient; and

the analysis module analyzing the physiological measures from the one such patient care record relative to each anatomical site.

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

the database receiving feedback recorded by the individual patient during the initial observation period; and

the analysis module combining the feedback into the one such patient care record indicating an expanded reference baseline patient status.

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

the analysis module analyzing the one or more physiological measures from the one such patient care record relative to at least one of the reference measures and one or more other physiological measures to determine the reference baseline patient status.

8. A system according to claim 1, wherein each of the 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.

9. A method for determining a reference baseline record for use in automated patient care, comprising:

retrieving one or more physiological measures regularly recorded by an implantable medical device and relating to individual patient information recorded during an initial observation period from a patient care record, and receiving quality of life measures recorded by the individual patient during the initial observation period;

determining one or more reference measures, each reference measure representative of at least one of measured and derived patient information, from the physiological measures; and

storing the reference measures into the patient care record indicating a reference baseline patient status, and combining the quality of life measures into the one such patient care record indicating an expanded reference baseline patient status.

10. A method according to claim 9, further comprising:

obtaining the physiological measures from a medical device having a sensor for monitoring the physiological measures at least one of directly and derivatively.

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

reprogramming a performance profile of the medical device during the initial observation period; and

obtaining the physiological measures from the medical device subsequent to reprogramming.

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

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

13. A method according to claim 9, further comprising:

receiving the physiological measures from sensors monitoring a plurality of anatomical sites within the individual patient from a the patient care record; and

analyzing the physiological measures from the one such patient care record relative to each anatomical site.

14. A method according to claim 9, further comprising:

receiving feedback recorded by the individual patient during the initial observation period; and

combining the feedback into the one such patient care record indicating an expanded reference baseline patient status.

15. A method according to claim 9, further comprising:

analyzing the one or more physiological measures from the one such patient care record relative to at least one of the reference measures and one or more other physiological measures to determine the reference baseline patient status.

16. A method according to claim 9, wherein each of the 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.

17. A computer-readable storage medium for a device holding code for performing the method according to claims 9, 10, 13 and 14.

18. A system for applying a reference baseline record for use in automated patient care, comprising:

a database storing one or more reference measures regularly recorded by an implantable medical device in a patient care record indicating a reference baseline patient status, the reference measures each being representative of at least one of measured and derived patient information and being determined from physiological measures relating to individual patient information recorded during an initial observation period; and

an analysis module comparing the reference measures to acceptance parameters corresponding to the same type of patient information to which the reference measures relate for an absence, an onset, a progression, a regression, and a status quo of patient status.

19. A system according to claim 18, further comprising:

the analysis module identifying each patient care record storing reference measures substantially non-conforming to a corresponding acceptance parameter.

20. A system according to claim 18, further comprising:

the analysis module periodically recomparing the reference measures to the corresponding acceptance parameters.

21. A system according to claim 18, wherein each of the reference measures is selected from the group comprising a 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.

22. A method for applying a reference baseline record for use in automated patient care, comprising:

retrieving one or more reference measures regularly recorded by an implantable medical device and from a patient care record indicating a reference baseline patient status, the reference measures each being representative of at least one of measured and derived patient information and being determined from physiological measures relating to individual patient information recorded during an initial observation period; and

comparing the reference measures to acceptance parameters corresponding to the same type of patient information to which the reference measures relate for an absence, an onset, a progression, a regression, and a status quo of patient status.

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

identifying each patient care record storing reference measures substantially non-conforming to a corresponding acceptance parameter.

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

periodically recomparing the reference measures to the corresponding acceptance parameters.

25. A method according to claim 22, wherein each of the reference measures is selected from the group comprising a 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.

26. A computer-readable storage medium for a device holding code for performing the method according to claims 22, 23, and 24.