Automated system and method for establishing a patient status reference baseline

• US 7,248,916 B2
• Filed: 02/20/2001
• Issued: 07/24/2007
• 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): Layno; Carl
• Application Number:
  US09/789,416
• Publication Number:
  US 20010011153A1
• Time in Patent Office: 2,345 Days
• Field of Search: None
• 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 collected measures is retrieved from a medical device adapted to be implanted in a patient. The collected device measures set includes individual measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period. The collected device measures set is received from the medical device adapted to be implanted over a communications link which is interfaced to a network server. The collected device measures set is stored into a patient care record for the individual patient within a database server 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 patient wellness status reference baseline, comprising:

a medical device autonomously monitoring at least one of telemetered and derived physiological measures providing quantitative health care data indicators continuously and directly during an initial observation period;

a database periodically storing and processing the monitored physiological measures;

a reference baseline generated from the stored physiological measures upon completion of the initial observation period indicating an initial patient wellness status; and

the medical device obtaining the physiological measures provided at least one of in situ, exogenous, and proximate to a patient monitoring point.

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

a terminal monitoring quality of life measures providing qualitative health care data indicators; and

the database consolidating the monitored quality of life measures into the reference baseline.

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

the medical device providing at least one of electrical or drug interventions during the initial observation period.

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

the medical device being dynamically reprogrammed to provide modified at least one of electrical or drug interventions.

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

the database defining acceptance parameters comprising normalized physiological measures substantially conforming to a wellness status acceptance criteria and identifying substantial non-conformity by comparing each stored physiological measure to a corresponding acceptance parameter.

6. A method for determining a patient wellness status reference baseline, comprising:

autonomously monitoring at least one of telemetered and derived physiological measures providing quantitative health care data indicators continuously and directly during an initial observation period;

periodically storing and processing the monitored physiological measures into a database;

generating a reference baseline from the stored physiological measures upon completion of the initial observation period indicating an initial patient wellness status; and

obtaining the physiological measures through a medical device provided at least one of in situ, exogenous, and proximate to a patient monitoring point.

7. A method according to claim 6, further comprising:

monitoring quality of life measures providing qualitative health care data indicators; and

consolidating the monitored quality of life measures into the reference baseline.

8. A method according to claim 6, further comprising:

providing at least one of electrical or drug interventions through the medical device during the initial observation period.

9. A method according to claim 6, further comprising:

dynamically reprogramming the medical device to provide modified at least one of electrical or drug interventions.

10. A method according to claim 6, further comprising:

defining acceptance parameters comprising normalized physiological measures substantially conforming to a wellness status acceptance criteria; and

identifying substantial non-conformity by comparing each stored physiological measure to a corresponding acceptance parameter.

11. A computer-readable storage medium holding code for determining a patient wellness status reference baseline, comprising:

autonomously monitoring at least one of telemetered and derived physiological measures providing quantitative health care data indicators continuously and directly during an initial observation period;

periodically storing and processing the monitored physiological measures into a database;

generating a reference baseline from the stored physiological measures upon completion of the initial observation period indicating an initial patient wellness status; and

obtaining the physiological measures through a medical device provided at least one of in situ, exogenous, and proximate to a patient monitoring point.

12. An automated system for establishing a patient status reference baseline, comprising:

a database storing a data set over a pre-defined observation time period, comprising;

telemetered physiological measures autonomously monitored continuously and directly by a medical device provided at least one of in situ, exogenous, and proximate to a patient monitoring point;

derived physiological measures based at least in part on one or more of the telemetered physiological measures; and

quality of life measures obtained substantially current to the monitoring of one or more of the telemetered physiological measures; and

a processor assimilating the data set into a reference baseline for a monitored patient.

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

a monitor introducing a standardized regiment of patient activities to be performed by the monitored patient during the observation time period.

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

the medical device including a performance profile modified during the observation time period to present interventive measures.

15. An automated method for establishing a patient status reference baseline, comprising:

storing a data set over a pre-defined observation time period, comprising;

telemetered physiological measures autonomously monitored continuously and directly by a medical device provided at least one of in situ, exogenous, and proximate to a patient monitoring point;

derived physiological measures based at least in part on one or more of the telemetered physiological measures; and

quality of life measures obtained substantially current to the monitoring of one or more of the telemetered physiological measures; and

assimilating the data set into a reference baseline for a monitored patient.

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

introducing a standardized regiment of physiological activities to be performed by the monitored patient during the observation time period.

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

modifying a performance profile of the medical device to present interventive measures during the observation time period.

18. A computer-readable storage medium holding code for establishing a patient status reference baseline, comprising:

storing a data set over a pre-defined observation time period, comprising;

telemetered physiological measures autonomously monitored continuously and directly by a medical device provided at least one of in situ, exogenous, and proximate to a patient monitoring point;

derived physiological measures based at least in part on one or more of the telemetered physiological measures; and

quality of life measures obtained substantially current to the monitoring of one or more of the telemetered physiological measures; and

assimilating the data set into a reference baseline for a monitored patient.