System and method for determining a reference baseline of patient information

• US 7,147,600 B2
• Filed: 03/18/2005
• Issued: 12/12/2006
• 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:
  US11/084,403
• Publication Number:
  US 20050165286A1
• Time in Patent Office: 634 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 for determining a reference baseline of patient information for automated remote patient care is presented. A medical device regularly records and stores measures sets including individual measures relating to patient information by a medical device adapted to be implanted during an initial time period. A database collects one or more patient care records containing the collected measures sets. A database module stores the collected measures set into a patient care record within the database. A server receives the collected device measures set from the medical device via a receiver. An analysis module within the server processes the collected device measures set into a set of reference measures. Each reference measure is representative 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 stored physiometry reference baseline for use in remote automated patient management, comprising:

information to identify a candidate patient for automated patient care and comprising at least one of treatment profile and medical history;

collected device measures to provide raw physiometry for the candidate patient that was regularly monitored and recorded by an implantable medical device over a fixed time period;

derived device measures to provide derivative physiometry based on the collected device measures, wherein the collected and derived device measures quantify a baseline pathophysiology;

acceptance parameters to define a threshold for the pathophysiology in terms of automated patient care eligibility; and

a wellness indicator determined by analyzing one or more of the collected and derived device measures against the acceptance parameters.

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

non-acceptance parameters to define a threshold for the pathophysiology in terms of one or more of substantially normal activity and exercise; and

a rejection indicator determined by analyzing one or more of the collected and derived device measures against the non-acceptance parameters.

3. A stored physiometry reference baseline according to claim 1, wherein a set of timed physical stressors are performed by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

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

quality of life measures to provide qualified voice feedback data electronically recorded by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

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

reprogramming parameters for the implantable medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

6. An implantable medical device providing a physiometry reference baseline for use in remote automated patient management, comprising:

one or more sensors to directly sense raw physiometry for a candidate patient for automated patient care;

sensing circuitry to regularly monitor and record the raw physiometry over a fixed time period as collected device measures;

memory to temporarily store the collected device measures pending interrogation by an externally interfaceable device;

a telemetry interface to provide access to the collected device measures, wherein the collected and derived device measures quantify a baseline pathophysiology; and

reprogramming parameters for the implantable medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

7. An analysis system for determining a physiometry reference baseline for use in remote automated patient management, comprising:

a database to store patient records that each comprise;

information to identify a candidate patient for automated patient care and comprising at least one of treatment profile and medical history; and

collected device measures to provide raw physiometry for the candidate patient that was regularly monitored and recorded by an implantable medical device over a fixed time period;

an interface to periodically receive the collected device measures; and

a processing module, comprising;

a data processor to determine derived device measures based on the collected device measures to provide derivative physiometry; and

an analyzer to evaluate the collected and derived device measures to quantify a baseline pathophysiology.

8. An analysis system according to claim 7, further comprising:

acceptance parameters to define a threshold for the pathophysiology in terms of automated patient care eligibility; and

a wellness indicator determined by analyzing one or more of the collected and derived device measures against the acceptance parameters.

9. An analysis system according to claim 7, further comprising:

non-acceptance parameters to define a threshold for the pathophysiology in terms of one or more of substantially normal activity and exercise; and

a rejection indicator determined by analyzing one or more of the collected and derived device measures against the non-acceptance parameters.

10. An analysis system according to claim 7, wherein a set of timed physical stressors are performed by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

11. An analysis system according to claim 7, further comprising:

quality of life measures to provide qualified voice feedback data electronically recorded by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

12. An analysis system according to claim 7, further comprising:

reprogramming parameters for the implantable medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

13. A structured record to store a physiometry reference baseline for use in remote automated patient management, comprising:

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

collected device measures to provide raw physiometry for the candidate patient that was regularly monitored and recorded by an implantable medical device over a fixed time period; and

derived device measures to provide derivative physiometry based on the collected device measures,

wherein the collected and derived device measures quantify a baseline pathophysiology.

14. A structured record according to claim 13, further comprising:

a wellness indicator determined by analyzing one or more of the collected and derived device measures against acceptance parameters that define a threshold for the pathophysiology in terms of automated patient care eligibility.

15. A structured record according to claim 13, further comprising:

quality of life measures to provide qualified voice feedback data electronically recorded by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

16. A structured record according to claim 13, further comprising:

reprogramming parameters for the implantable medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

17. A method for determining a physiometry reference baseline for use in remote automated patient management comprising:

identifying a candidate patient for automated patient core with information comprising at least one of treatment profile and medical history;

receiving collected device measures to provide raw physiometry for the candidate patient that was regularly monitored and recorded by an implantable medical device over a fixed time period;

determining derived device measures to provide derivative physiometry based on the collected device measures, wherein the collected and derived device measures quantify a baseline pathophysiology;

specifying acceptance parameters to define a threshold for the pathophysiology in terms of automated patient care eligibility; and

determining a wellness indicator determined by analyzing one or more of the collected and derived device measures against the acceptance parameters.

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

specifying non-acceptance parameters to define a threshold for the pathophysiology in terms of one or more of substantially normal activity and exercise; and

determining a rejection indicator by analyzing one or more of the collected and derived device measures against the non-acceptance parameters.

19. A method according to claim 17, wherein a set of timed physical stressors are performed by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

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

receiving quality of life measures to provide qualified voice feedback data electronically recorded by the candidate patient over the fixed time period contemporaneous to recordation of the collected device measures.

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

generating reprogramming parameters for the implantable medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

22. A computer-readable storage medium holding code for determining a physiometry reference baseline for use in remote automated patient management, comprising:

code for identifying a candidate patient for automated patient care with information comprising at least one of treatment profile and medical history;

code for receiving collected device measures to provide raw physiometry for the candidate patient that was regularly monitored and recorded by an implantable medical device over a fixed time period;

code for determining derived device measures to provide derivative physiometry based on the collected device measures, wherein the collected and derived device measures quantify a baseline pathophysiology;

code for specifying acceptance parameters to define a threshold for the pathophysiology in terms of automated patient care eligibility; and

code for determining a wellness indicator determined by analyzing one or more of the collected and derived device measures against the acceptance parameters.