System and method for collection and analysis of regularly retrieved patient information for automated remote patient care

• US 7,104,955 B2
• Filed: 08/22/2003
• Issued: 09/12/2006
• Est. Priority Date: 06/03/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): Petzuto, Robert E.
• Assistant Examiner(s): Oropeza, Frances P.
• Application Number:
  US10/646,035
• Publication Number:
  US 20040147979A1
• Time in Patent Office: 1,117 Days
• Field of Search: 600/300, 600/301, 600/509, 600/513, 379/106.2, 128/903
• 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 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 : characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 : ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/00 : ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• 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 for collection and analysis of regularly retrieved patient information for automated remote patient care is presented. A medical device having a sensor for monitoring at least one physiological measure of an individual patient regularly records and stores measures sets including individual measures relating to patient information. A database collects one or more patient care records by organizing one or more patient care records with a plurality of the collected measures sets and storing the collected measures set into a patient care record for the individual patient. A server periodically receives a set of the collected measures retrieved on a substantially regular basis from the medical device, and analyzes one or more of the collected measures sets in the patient care record for the individual patient relative to one or more other collected measures sets stored in the database server to determine a patient status indicator.

Claims

1. A system for collection and analysis of regularly retrieved patient information for automated remote patient care, comprising:

a medical device having a sensor for autonomously monitoring at least one physiological measure of an individual patient and regularly recording measures sets that each comprise patient information; and

a server, comprising;

a database module periodically collecting one or more patient care records, comprising organizing one or more patient care records which each comprise a plurality of the collected the measures sets and storing the collected measures set on a substantially regular basis from the medical device into a patient care record for the individual patient in a database; and

an analysis module analyzing one or more of the collected measures sets in the patient care record for the individual patient relative to one or more other collected measures sets stored in the database to determine a patient status indicator of patient wellness to automatically recognize a trend indicating disease onset, progression, regression, and status quo in patient well being and to automatically determine whether medical intervention is necessary.

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

the server receiving a set of quality of life measures recorded by the individual patient, and determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure; and

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

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

the server 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, 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; and

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

4. A system according to claim 3, 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.

5. A system according to claim 3, 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.

6. A system according to claim 3, the server further comprising:

a comparison module comparing an initial measure selected from the one or more site specific collected measures sets to a sibling measure selected from the one or more other site specific collected measures sets, the initial measure and the sibling measure both relating to the same type of patient information.

7. A system according to claim 3, the server further comprising:

a derivation module determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets and determining a sibling derived measure using at least one measure selected from the one or more other site specific collected measures sets, the initial derived measure and the sibling derived measure both relating to the same type of derived patient information; and

a comparison module comparing the initial derived measure to the sibling derived measure.

8. A system according to claim 3, the server further comprising:

a comparison module comparing an initial measure selected from the one or more site specific collected measures sets to a peer measure selected from the one or more other site specific collected measures sets, the initial measure relating to a different type of patient information than the peer measure.

9. A system according to claim 3, the server further comprising:

a derivation module determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

a comparison module comparing an initial measure selected from the one or more site specific collected measures sets to the peer derived measure, the initial measure relating to a different type of patient information than the derived patient information to which the peer derived measure relates.

10. A system according to claim 3, the server further comprising:

a derivation module determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets; and

a comparison module comparing the initial derived measure to a peer measure selected from the one or more other site specific collected measures sets, the initial derived measure relating to a different type of derived patient information than the patient information to which the peer measure relates.

11. A system according to claim 3, the server further comprising:

a derivation module determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets and determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

a comparison module comparing the initial derived measure to the peer derived measure, the initial derived measure relating to a different type of derived patient information than the derived patient information to which the peer derived measure relates.

12. An system according to claim 1, further comprising:

the database further storing a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom

wherein the database module obtains at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

13. A system according to claim 1, wherein the one or more other site specific collected measures sets are stored in the patient care record for the individual patient for whom the patient care indicator has been determined.

14. A system according to claim 1, wherein the one or more other site specific collected measures sets are stored in the patient care records for a group of one or more other individual patients.

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

a collection client communicatively interposed between the medical device and network server, the collection client retrieving the collected measures set and downloading the collected measures set from the collection client into the server.

16. A system according to claim 15, wherein the collection client is selected from the group consisting of a programmer, interrogator, recorder, monitor, telemetered signals transceiver, personal computer, digital data processor, and combinations thereof.

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

a feedback module providing tiered feedback comprising;

at a first level of feedback, communicating an interpretation of the patient status indicator to the individual patient;

at a second level of feedback, communicating a notification of potential medical concern based on the patient status indicator to the individual patient;

at a third level of feedback, communicating a notification of potential medical concern based on the patient status indicator to medical personnel in local proximity to the individual patient; and

at a fourth level of feedback, communicating a set of reprogramming instructions based on the patient status indicator to the medical device.

18. A system according to claim 17, wherein the automated feedback comprises at least one of the group consisting of a peer group status indicator, a historical status indicator, a trend indicator, a medicinal efficacy indicator, and a wellness indicator.

19. A system according to claim 17, wherein the feedback module communicates over a communications link which comprises at least one of the following:

internetwork link, intranetwork link, serial link, data telephone link, satellite link, radio-frequency link, infrared link, fiber optic link, coaxial cable link, television link, and combinations thereof.

20. A system according to claim 17, wherein the feedback client is selected from the group consisting of a personal computer, facsimile machine, telephone instrument, network computer, wireless computer, personal data assistant, television, digital data processor, and combinations thereof.

21. A system according to claim 1,

wherein the analysis module dynamically analyzes the one or more of the collected measures sets in the patient care record for the individual patient.

22. A system according to claim 1,

wherein the analysis module analyzes the one or more of the collected measures sets in the patient care record for the individual patient in a batch comprising the one or more of the collected measures sets in patient care records for a plurality of individual patients.

23. A system according to claim 1, wherein the medical device communicates over a communications link which comprises at least one of the following:

internetwork link, intranetwork link, serial link, data telephone link, satellite link, radio-frequency link, infrared link, fiber optic link, coaxial cable link, television link, and combinations thereof.

24. A system according to claim 1, wherein the database comprises at least one of the following:

volatile storage, non-volatile storage, removable storage, fixed storage, random access storage, sequential access storage, permanent storage, erasable storage, and combinations thereof.

25. A system according to claim 24, wherein the organization of the database comprises at least one of the following:

flat file, hierarchical database, relational database, distributed database, and combinations thereof.

26. A system according to claim 1, wherein the medical device is selected from the group consisting of a pacemaker, cardioverter defibrillator, heart failure monitor, event monitor, cardiopulmonary monitor, metabolic monitor or device, endocrinology monitor or device, hematological monitor or device, neuromuscular monitor or device, gastrointestinal monitor or device, genitourinary monitor or device, and combinations thereof.

27. A system according to claim 1, wherein the set of collected measures comprises at least one of the following:

atrial electrical activity, ventricular electrical activity, time of day, activity level, cardiac output, oxygen level, cardiovascular pressure measures, pulmonary measures, interventions made, and combinations thereof.

28. A system according to claim 27, the set of collected measures further comprising derived measures selected from the group consisting of linear measures derived from the set of collected measures, non-linear measures derived from the set of collected measures, and combinations thereof.

29. A method for collection and analysis of regularly retrieved patient information for automated remote patient care, comprising:

providing a medical device having a sensor for autonomously monitoring at least one physiological measure of an individual patient;

regularly recording measures sets that each comprise patient information with the medical device;

periodically collecting the measures sets on a substantially regular basis from the medical device into a patient care record for the individual patient in a database; and

analyzing one or more of the collected measures sets in the patient care record for the individual patient relative to one or more other collected measures sets stored in the database to determine a patient status indicator of patient wellness to automatically recognize a trend indicating disease onset, progression, regression, and status quo in patient well being and to automatically determine whether medical intervention is necessary.

30. A method according to claim 29, further comprising:

receiving a set of quality of life measures recorded by the individual patient;

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

determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure.

31. A method according to claim 29, 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.

32. A method according to claim 31, 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.

33. A method according to claim 31, 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.

34. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

comparing an initial measure selected from the one or more site specific collected measures sets to a sibling measure selected from the one or more other site specific collected measures sets, the initial measure and the sibling measure both relating to the same type of patient information.

35. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets;

determining a sibling derived measure using at least one measure selected from the one or more other site specific collected measures sets, the initial derived measure and the sibling derived measure both relating to the same type of derived patient information; and

comparing the initial derived measure to the sibling derived measure.

36. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

comparing an initial measure selected from the one or more site specific collected measures sets to a peer measure selected from the one or more other site specific collected measures sets, the initial measure relating to a different type of patient information than the peer measure.

37. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

comparing an initial measure selected from the one or more site specific collected measures sets to the peer derived measure, the initial measure relating to a different type of patient information than the derived patient information to which the peer derived measure relates.

38. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets; and

comparing the initial derived measure to a peer measure selected from the one or more other site specific collected measures sets, the initial derived measure relating to a different type of derived patient information than the patient information to which the peer measure relates.

39. A method according to claim 31, the operation of analyzing the one or more site specific collected measures sets further comprising:

determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets;

determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

comparing the initial derived measure to the peer derived measure, the initial derived measure relating to a different type of derived patient information than the derived patient information to which the peer derived measure relates.

40. A method according to claim 39, further comprising:

retrieving a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom; and

obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

41. A method according to claim 39, wherein the one or more other site specific collected measures sets are stored in the patient care record for the individual patient for whom the patient care indicator has been determined.

42. A method according to claim 39, wherein the one or more other site specific collected measures sets are stored in the patient care records for a group of one or more other individual patients.

43. A method according to claim 39, further comprising:

providing tiered feedback comprising;

at a first level of feedback, communicating an interpretation of the patient status indicator to the individual patient;

at a second level of feedback, communicating a notification of potential medical concern based on the patient status indicator to the individual patient;

at a third level of feedback, communicating a notification of potential medical concern based on the patient status indicator to medical personnel in local proximity to the individual patient; and

at a fourth level of feedback, communicating a set of reprogramming instructions based on the patient status indicator to the medical device.

44. A computer-readable storage medium holding code for collection and analysis of regularly retrieved patient information for automated remote patient care, comprising:

code for a medical device having a sensor for autonomously monitoring at least one physiological measure of an individual patient;

code for regularly recording measures sets that each comprise patient information with the medical device;

code for periodically collecting the measures sets on a substantially regular basis from the medical device into a patient care record for the individual patient in a database; and

code for analyzing one or more of the collected measures sets in the patient care record for the individual patient relative to one or more other collected measures sets stored in the database to determine a patient status indicator of patient wellness to automatically recognize a trend indicating disease onset, progression, regression, and status quo in patient well being and to automatically determine whether medical intervention is necessary.

45. A storage medium according to claim 44, further comprising:

code for receiving a set of quality of life measures recorded by the individual patient;

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

code for determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure.

46. A storage medium according to claim 44, further comprising:

code for 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;

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

code for 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.

47. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for comparing an initial measure selected from the one or more site specific collected measures sets to a sibling measure selected from the one or more other site specific collected measures sets, the initial measure and the sibling measure both relating to the same type of patient information.

48. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets;

code for determining a sibling derived measure using at least one measure selected from the one or more other site specific collected measures sets, the initial derived measure and the sibling derived measure both relating to the same type of derived patient information; and

code for comparing the initial derived measure to the sibling derived measure.

49. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for comparing an initial measure selected from the one or more site specific collected measures sets to a peer measure selected from the one or more other site specific collected measures sets, the initial measure relating to a different type of patient information than the peer measure.

50. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

code for comparing an initial measure selected from the one or more site specific collected measures sets to the peer derived measure, the initial measure relating to a different type of patient information than the derived patient information to which the peer derived measure relates.

51. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets; and

code for comparing the initial derived measure to a peer measure selected from the one or more other site specific collected measures sets, the initial derived measure relating to a different type of derived patient information than the patient information to which the peer measure relates.

52. A storage medium according to claim 46, the operation of analyzing the one or more site specific collected measures sets further comprising:

code for determining an initial derived measure using at least one measure selected from the one or more site specific collected measures sets;

code for determining a peer derived measure using at least one measure selected from the one or more other site specific collected measures sets; and

code for comparing the initial derived measure to the peer derived measure, the initial derived measure relating to a different type of derived patient information than the derived patient information to which the peer derived measure relates.

53. An storage medium according to claim 44, further comprising:

code for retrieving a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures calculable therefrom; and

code for obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

54. A storage medium according to claim 44, further comprising:

code for providing tiered feedback comprising;

at a first level of feedback, communicating an interpretation of the patient status indicator to the individual patient;

at a second level of feedback, communicating a notification of potential medical concern based on the patient status indicator to the individual patient;

at a third level of feedback, communicating a notification of potential medical concern based on the patient status indicator to medical personnel in local proximity to the individual patient; and

at a fourth level of feedback, communicating a set of reprogramming instructions based on the patient status indicator to the medical device.