System and apparatus for providing baseline data for automated patient management

• US 9,610,012 B2
• Filed: 01/31/2014
• Issued: 04/04/2017
• Est. Priority Date: 07/26/1999
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bardy, Gust
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US14/169,350
• Publication Number:
  US 20140309941A1
• Time in Patent Office: 1,159 Days
• Field of Search: 705 2- 5
• 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 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

A system and method for providing baseline data for automated patient management is disclosed. A patient is identified for enrollment in automated patient management with information including at least one of treatment profile and medical history. Device measures are collected to provide raw physiometry for the patient regularly recorded by a medical device, beginning with an initial observation period. Derived device measures are determined to provide derivative physiometry based on the collected device measures. Baseline data from the collected and derived device measures are quantified.

Claims

1. An apparatus for automated patient management, the apparatus comprising a processor configured to execute software modules, wherein the modules comprise the following:

a collected measures module configured to receive collected device measures as raw physiometry for the patient regularly recorded by a medical device, beginning with an initial observation period;

a derived measures module configured to receive derived device measures as derivative physiometry based on the collected device measures;

a processing module configured to process the collected and derived device measures into a reference baseline comprising a set of reference measures;

an acceptance module configured to analyze the reference measures set against acceptance parameters to determine whether a patient is eligible for automated patient care comprising continuous monitoring and analysis of patient medical device information; and

an analysis module configured to continuously monitor and analyze patient medical device information.

2. The apparatus according to claim 1,

wherein the analysis module is further configured to determine a wellness indicator determined by analyzing one or more of the collected and derived device measures against the acceptance parameters.

3. The apparatus according to claim 1, further comprising:

a non-acceptance module configured to receive non-acceptance parameters as a threshold for the baseline data in terms of one or more of substantially normal activity and exercise; and

a determination module configured to determine a rejection indicator by analyzing one or more of the collected and derived device measures against the non-acceptance parameters.

4. The apparatus according to claim 1, further comprising:

a programmer configured to define reprogramming parameters for the medical device, wherein the collected device measures are recorded subsequent to application of the reprogramming parameters.

5. The apparatus according to claim 1, further comprising a programmer configured to reprogram the medical device based on a patient status indicator, wherein the analysis module is further configured to determine the patient status indicator based on the monitoring and analyzing of patient medical device information, and wherein the analysis module is further configured to continuously monitor and analyze subsequent collected measures from the medical device during a subsequent observation period subsequent to reprogramming of the medical device.

6. The apparatus according to claim 5, further comprising an evaluation module configured to determine a new reference baseline for the subsequent observation period.

7. The apparatus of claim 5, wherein the analysis module is further configured to form a patient status indicator based on the subsequently collected measures and recognize trends in patient status.

8. A system, comprising:

a medical device configured for implantation in a patient and configured for regular collection of collected device measures comprising raw physiometry of the patient;

a database, comprising;

the collected device measures; and

derived device measures based on the collected device measures to provide derivative physiometry; and

a processor configured to execute software modules, wherein the modules comprise the following;

an interface module to periodically receive the collected device measures from the medical device;

a derivation module configured to derive the derived device measures from the collected device measures;

a processing module configured to process the collected and derived device measures into a reference baseline comprising a set of reference measures;

an acceptance module configured to receive acceptance parameters comprising a threshold for the reference measures in the reference baseline to determine automated patient care eligibility; and

an analysis module configured to execute automated patient care.

9. The system according to claim 8, wherein

the analysis module is configured to determine a wellness indicator by analyzing one or more of the collected and derived device measures against the acceptance parameters.

10. The system according to claim 8, further comprising:

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

11. The system according to claim 8, further comprising:

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

12. The system according to claim 8, wherein the medical device comprises an implantable cardiac medical device.

13. The system according to claim 8, wherein the acceptance parameters are indicator values consistent with the presence of some form of chronic yet stable disease, which does not require immediate emergency care.

14. The system according to claim 8, further comprising a programmer configured to define reprogramming parameters for the implantable medical device and reprogram the implantable medical device based on a patient status indicator, wherein the analysis module is further configured to determine a patient status indicator based on at least a portion of the collected and derived device measures.

15. The system according to claim 14, wherein the medical device is further configured for collection of collected device measures subsequent to reprogramming of the implantable medical device, and the processing module is further configured to process the subsequent collected device measures into a new reference baseline comprising a set of subsequent reference measures.

16. A method for automated patient management, comprising:

a medical device regularly collecting device measures comprising raw physiometry from a patient during an initial observation period;

a processor determining derived device measures to provide derivative physiometry based on the collected device measures;

the processor quantifying baseline data from the collected and derived device measures;

the processor comparing the baseline data to acceptance parameters comprising a threshold for the baseline data, wherein the acceptance parameters define a threshold for the baseline data in terms of automated patient care eligibility;

the processor determining a patient status indicator based on the comparison;

a programmer reprogramming the medical device based on the determination; and

the reprogrammed medical device monitoring the patient.

17. The method according to claim 16, further comprising:

collecting subsequent device measures by the reprogrammed medical device during a subsequent observation period; and

the processor quantifying new baseline data from the collected subsequent device measures.

18. The method according to claim 16, wherein the medical device is an implantable cardiac medical device.

19. The non-transitory computer-readable storage medium storing code for performing, when executed by a processor, the method according to claim 16.