Automated system and method for establishing a patient status reference baseline

• US 20010011153A1
• Filed: 02/20/2001
• Published: 08/02/2001
• Est. Priority Date: 07/26/1999
• Status: Active Grant

• Current Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Original Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Granted Patent: US 7,248,916 B2
• Time in Patent Office: Days
• 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 reference baseline of individual patient status for use in an automated collection and analysis patient care system, comprising:

a medical device adapted to be implanted in a patient recording a set of collected measures comprising individual measures which each relate to patient information during an initial time period;

a network server receiving the collected device measures set from the medical device adapted to be implanted over a communications link;

a database server storing the collected device measures set into a patient care record for the individual patient, the database server being 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:

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 over the communications link from the remote client;

the database server 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.

3. A system according to

claim 1

, further comprising:

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

4. A system according to

claim 1

, further comprising:

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

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

5. 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 over the communications link from the remote client;

the database server 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.

6. A system according to

claim 5

, wherein the feedback recorder comprises at least one of an audio recorder, a digital camera, or a video camera.

7. A system according to

claim 1

, further comprising:

a set of acceptance parameters stored within the database server 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 nonconforming to the corresponding acceptance parameter.

8. 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.

9. A system according to

claim 8

, 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 server to further determine the patient status indicator.

10. 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.

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

retrieving a set of collected measures from a medical device adapted to be implanted in a patient, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period;

receiving the collected device measures set from the medical device adapted to be implanted over a communications link which is interfaced to a network server;

storing the collected device measures set into a patient care record for the individual patient within a database server 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.

12. A method according to

claim 11

, further comprising:

receiving a set of quality of life measures recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server;

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

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

13. A method according to

claim 11

, further comprising:

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

14. A method according to

claim 11

, further comprising:

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

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

15. A method according to

claim 11

, further comprising:

receiving feedback recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server;

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

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

16. A method according to

claim 15

, wherein the patient feedback comprises at least one of audio, digitized imagery, or video feedback.

17. A method according to

claim 11

, 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.

18. A method according to

claim 11

, 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.

19. A method according to

claim 18

, 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 server to further determine the patient status indicator.

20. A method according to

claim 11

, 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.

21. 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:

retrieving a set of collected measures from a medical device adapted to be implanted in a patient, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted during an initial time period;

receiving the collected device measures set from the medical device adapted to be implanted over a communications link which is interfaced to a network server;

storing the collected device measures set into a patient care record for the individual patient within a database server 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.

22. A storage medium according to

claim 21

, further comprising:

receiving a set of quality of life measures recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server;

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

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

23. A storage medium according to

claim 21

, further comprising:

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

24. A storage medium according to

claim 21

, further comprising:

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

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

25. A storage medium according to

claim 21

, further comprising:

receiving feedback recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server;

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

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

26. A storage medium according to

claim 21

, 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.

27. A storage medium according to

claim 21

, 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.

29. A system for monitoring a patient status for an individual patient using a reference baseline in an automated collection and analysis patient care system, comprising:

an application server processing a set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a set of reference measures, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted throughout an initial time period, each reference measure being representative of at least one of measured or derived patient information;

database server storing the reference measures set into a patient care record as data in a reference baseline indicating an initial patient status;

a network server periodically receiving a set of collected measures from the medical device adapted to be implanted over a communications link, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period;

the database server storing the subsequently collected device measures set into the patient care record for the individual patient; and

the application server comparing one or more of the subsequently collected device measures sets in the patient care record to the reference measures set and identifying any such subsequently collected measure substantially nonconforming to the corresponding reference measure.

28. A storage medium according to

claim 31

, 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 server to further determine the patient status indicator.

30. A system according to

claim 29

, the application server further comprising:

an analysis module analyzing one or more of the subsequently collected device measures sets in the patient care record for the individual patient relative to one or more other subsequently collected de ice measures sets stored in the database server to determine a patient status indicator.

31. A system according to

claim 29

, the application server further comprising:

a feedback module providing automated feedback based on the patient status indicator to the individual patient over a feedback communications link configured between the network server and a feedback client.

32. A system according to

claim 29

, further comprising:

the network server receiving initially feedback recorded by the individual patient during the initial time period over the communications link and receiving feedback recorded by the individual patient subsequent to the initial time period over the communications link;

the database server storing the initially recorded feedback as reference feedback into the patient care record for the individual patient within the database server and storing the subsequently recorded feedback into the patient care record for the individual patient; and

the application server comparing the subsequently recorded feedback to the reference feedback in the patient care record and identifying any such subsequently recorded feedback substantially non-conforming to the reference feedback.

33. A system according to

claim 32

, wherein the patient feedback comprises at least one of audio, digitized imagery, or video feedback.

34. A system according to

claim 29

, further comprising:

the application server further comprising a reevaluation module processing a new set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a new set of reference measures, the new collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period, each new reference measure being representative of at least one of measured or derived patient information; and

the database server storing the new reference measures set into the patient care record as a new reference baseline indicating a revised patient status.

35. A system according to

claim 29

, further comprising:

the database server storing an initial set of quality of life measures recorded by the individual patient during the initial time period into the patient care record within the database server and storing a subsequently collected quality of life measures set received by the network server over the communications link into the patient care record for the individual patient;

the application server assimilating the initial quality of life measures set into the reference baseline data stored in the patient care record; and

the application server comparing one or more of the subsequently collected quality of life measures to the initial quality of life measures in the reference measures set and identifying any such subsequently collected quality of life measure substantially non-conforming to the corresponding quality of life reference measure.

36. A system according to

claim 29

, the application server further comprising:

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

37. A system according to

claim 36

, wherein the prescribed set of activities are representative of substantially normal activity, further comprising:

the application server determining relative abnormal activity response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.

38. A system according to

claim 36

, wherein the prescribed set of activities are representative of substantially normal exercise, further comprising:

the application server determining relative abnormal exercise response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.

39. A system according to

claim 29

, wherein the reference measures set comprises at least one of the following:

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.

40. A method for monitoring a patient status for an individual patient using a reference baseline in an automated collection and analysis patient care system, comprising:

processing a set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a set of reference measures and storing the reference measures set into a patient care record as data in a reference baseline indicating an initial patient status, the patient care record being stored within a database server, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted throughout an initial time period, each reference measure being representative of at least one of measured or derived patient information;

periodically receiving a set of collected measures from the medical device adapted to be implanted over a communications link which is interfaced to a network server, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period;

storing the subsequently collected device measures set into the patient care record for the individual patient; and

comparing one or more of the subsequently collected device measures sets in the patient care record to the reference measures set and identifying any such subsequently collected measure substantially non-conforming to the corresponding reference measure.

41. A method according to

claim 40

, further comprising:

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

42. A method according to

claim 40

, further comprising:

providing automated feedback based on the patient status indicator to the individual patient over a feedback communications link configured between the network server and a feedback client.

43. A method according to

claim 40

, further comprising:

receiving feedback recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server and storing the recorded feedback as reference feedback into the patient care record for the individual patient within the database server;

receiving feedback recorded by the individual patient subsequent to the initial time period over a communications link which is interfaced to the network server;

storing the subsequently recorded feedback into the patient rare record for the individual patient within the database server; and

comparing the subsequently recorded feedback to the reference feedback in the patient care record and identifying any such subsequently recorded feedback substantially non-conforming to the reference feedback.

44. A method according to

claim 43

, wherein the patient feedback comprises at least one of audio, digitized imagery, or video feedback.

45. A method according to

claim 40

, further comprising:

processing a new set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a new set of reference measures and storing the new reference measures set into the patient care record as a new reference baseline indicating a revised patient status, the new collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period, each new reference measure being representative of at least one of measured or derived patient information.

46. A method according to

claim 40

, further comprising:

storing a set of quality of life measures recorded by the individual patient during the initial time period into the patient care record and assimilating the quality of life measures into the reference baseline data stored in the patient care record;

receiving a quality of life measures set recorded by the individual patient subsequent to the initial time period over a communications link which is interfaced to the network server;

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

comparing one or more of the subsequently collected quality of life measures to the quality of life measures in the reference measures set and identifying any such subsequently collected quality of life measure substantially non-conforming to the corresponding quality of life reference measure.

47. A method according to

claim 40

, further comprising:

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

48. A method according to

claim 47

, wherein the prescribed set of activities are representative of substantially normal activity, further comprising:

determining relative abnormal activity response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.

49. A method according to

claim 47

, wherein the prescribed set of activities are representative of substantially normal exercise, further comprising:

determining relative abnormal exercise response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.

50. A method according to

claim 40

, wherein the reference measures set comprises at least one of the following:

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.

51. A computer-readable storage medium holding code for monitoring a patient status for an individual patient using a reference baseline in an automated collection and analysis patient care system, comprising:

processing a set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a set of reference measures and storing the reference measures set into a patient care record as data in a reference baseline indicating an initial patient status, the patient care record being stored within a database server, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted throughout an initial time period, each reference measure being representative of at least one of measured or derived patient information;

periodically receiving a set of collected measures from the medical device adapted to be implanted over a communications link which is interfaced to a network server, the collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period;

storing the subsequently collected device measures set into the patient care record for the individual patient; and

comparing one or more of the subsequently collected device measures sets in the patient care record to the reference measures set and identifying any such subsequently collected measure substantially non-conforming to the corresponding reference measure.

52. A storage medium according to

claim 51

, further comprising:

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

53. A storage medium according to

claim 51

, further comprising:

providing automated feedback based on the patient status indicator to the individual patient over a feedback communications link configured between the network server and a feedback client.

54. A storage medium according to

claim 51

, further comprising:

storing feedback recorded by the individual patient during the initial time period over a communications link which is interfaced to the network server and storing the recorded feedback as reference feedback into the patient care record for the individual patient within the database server;

receiving feedback recorded by the individual patient subsequent to the initial time period over a communications link which is interfaced to the network server;

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

comparing the subsequently recorded feedback to the reference feedback in the patient care record and identifying any such subsequently recorded feedback substantially non-conforming to the reference feedback.

55. A storage medium according to

claim 51

, further comprising:

processing a new set of collected measures recorded by a medical device adapted to be implanted in an individual patient into a new set of reference measures and storing the new reference measures set into the patient care record as a new reference baseline indicating a revised patient status, the new collected device measures set comprising individual measures which each relate to patient information recorded by the medical device adapted to be implanted subsequent to the initial time period, each new reference measure being representative of at least one of measured or derived patient information.

56. A storage medium according to

claim 51

, further comprising:

storing a set of quality of life measures recorded by the individual patient during the initial time period into the patient care record and assimilating the quality of life measures into the reference baseline data stored in the patient care record;

receiving a quality of life measures set recorded by the individual patient subsequent to the initial time period over a communications link which is interfaced to the network server;

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

comparing one or more of the subsequently collected quality of life measures to the quality of life measures in the reference measures set and identifying any such subsequently collected quality of life measure substantially non-conforming to the corresponding quality of life reference measure.

57. A storage medium according to

claim 51

, further comprising:

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

58. A storage medium according to

claim 57

, wherein the prescribed set of activities are representative of substantially normal activity, further comprising:

determining relative abnormal activity response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.

59. A storage medium according to

claim 57

, wherein the prescribed set of activities are representative of substantially normal exercise, further comprising:

determining relative abnormal exercise response based on any subsequently collected measure identified as being substantially non-conforming to the corresponding reference measure.