Automated system and method for establishing a patient status reference baseline

• US 6,866,629 B2
• Filed: 12/27/2002
• Issued: 03/15/2005
• 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): LAYNO, CARL HERNANDZ
• Application Number:
  US10/330,608
• Publication Number:
  US 20030125611A1
• Time in Patent Office: 809 Days
• Field of Search: 600/300, 600/309, 600/481, 600508-509, 607/32, 607/60, 128903-904, 128/920, 128/923
• 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. The collected device measures set includes individual measures, which each relate to patient information recorded by the medical device during an initial time period, and is received from the medical device 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 patient within a database server organized to store one or more patient care records and is processed into a set of reference measures. Each reference measure is representative of at least one of measured or derived patient information and is stored into the patient care record as data in a reference baseline indicating an initial patient status.

Claims

1. A stored reference baseline for use in automated patient care, comprising:

patient information identifying a patient under evaluation for automated patient care and comprising at least one of treatment profile information and medical history; and

a reference measures set comprising a set of collected device measures providing quantitative physiological data regularly recorded by a medical device during the initial observation period and formed by processing the collected device measures set through derived measure determination and statistical value calculation into indicators of initial patient wellness upon completion of the initial observation period and further comprising a set of quality of life measures recorded during the initial observation period and processed with the collected device measures.

2. A stored reference baseline according to claim 1, further comprising:

acceptance parameters comprising indicator values consistent with a presence of some form of chronic yet stable disease which does not require immediate emergency care; and

analyzing the reference measures set against the acceptance parameters.

3. A stored reference baseline according to claim 1, wherein the patient identifying information and the reference measures set are organized as a structured record.

4. A stored reference baseline according to claim 3, wherein the structured record is maintained in a database.

5. A medical device providing a reference baseline for use in automated patient care, comprising:

one or more signal monitors sensing physiological data of a patient under evaluation for automated patient care as telemetered signals;

a memory store storing the telemetered signals sensed by the signal sensors for a short term upon completion of an initial observation period; and

an interface providing external access to the staged telemetered signals, wherein the staged telemetered signals are periodically retrieved and processed through derived measure determination and statistical value calculation into indicators of initial patient wellness.

6. A medical device according to claim 5, further comprising:

a patient device recording a set of quality of life measures during the initial observation period, wherein the quality of life measures set is processed with collected device measures.

7. A medical device according to claim 5, further comprising:

acceptance parameters comprising indicator values consistent with a presence of some form of chronic yet stable disease which does not require immediate emergency care, wherein the quality of life measures are analyzed against the acceptance parameters.

8. A medical device according to claim 5, wherein the medical device comprises at least one of a pacemaker, cardioverter defibrillator and event monitor.

9. An analysis system for providing a reference baseline for use in automated patient care, comprising:

a database storing a set of collected device measures collected upon completion of an initial observation period and providing quantitative health care data indicators regularly recorded by a medical device for a patient under evaluation for automated patient care and further storing a set of quality of life measures recorded during the initial observation period, wherein the quality of life measures set is processed with the collected device measures; and

a processor retrieving the collected device measures and forming a reference baseline measures set indicative of initial patient wellness through derived measure determination and statistical value calculation.

10. An analysis system according to claim 9, wherein the database stores acceptance parameters comprising indicator values consistent with a presence of some form of chronic yet stable disease which does not require immediate emergency care, wherein the reference measures set are analyzed against the acceptance parameters.

11. A structured record storing a reference baseline for use in automated patient care, comprising:

structured data for a patient under evaluation for automated patient care, comprising at least one of;

physiological measures directly recorded by a medical device;

physiological measures derived from the directly recorded physiological measures; and

a set of quality of life measures recorded during the initial observation period,

wherein the structured data is collected upon completion of an initial observation period and processed through derived measure determination and statistical value calculation into indicators of initial patient wellness.

12. A structured record according to claim 11, further comprising:

acceptance parameters comprising indicator values consistent with a presence of some form of chronic yet stable disease which does not require immediate emergency care, wherein the structured data is evaluated against the acceptance parameters.

13. A process for forming a reference baseline for use in automated patient care, comprising:

collecting device measures during an initial observation period for a patient under evaluation for automated patient care;

assembling the collected device measures into at least one of raw and derived physiological measures;

processing the raw and physiological measures through derived measure determination and statistical value calculation;

forming a reference baseline comprising indicators of initial patient wellness;

recording a set of quality of life measures during the initial observation period; and

processing the quality of life measures set with the collected device measures.

14. A process according to claim 13, further comprising:

defining acceptance parameters comprising indicator values consistent with a presence of some form of chronic yet stable disease which does not require immediate emergency care; and

analyzing the reference measures set against the acceptance parameters.

15. A computer-readable storage medium holding code for performing the process according to claim 13.