Patient health improvement monitor

• US 10,098,584 B2
• Filed: 02/06/2012
• Issued: 10/16/2018
• Est. Priority Date: 02/08/2011
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Sweeney, Robert J., Wariar, Ramesh, Thompson, Julie A.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/366,473
• Publication Number:
  US 20120203092A1
• Time in Patent Office: 2,444 Days
• Field of Search: 600390, 600382, 600373, 600372, 600391-392, 600301, 600547, 128898
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Systems and methods to monitor an improvement of a subject'"'"'s physiological condition using a goal improvement profile are described. In an example, a physiological condition of a subject can be compared to a goal improvement profile, where the profile includes at least one target condition indicative of an improved physiological condition detectable using a physiological sensor signal, and a target time when the subject is expected to reach the target condition, where the comparison can be used to indicate whether the subject has met the target condition by the target time.

Claims

1. A system for managing a chronic disease of a subject, the system comprising:

a comparison circuit, configured to determine a progress parameter using a comparison between a physiological condition of the subject detected at a specified time and a goal improvement profile at the specified time, the goal improvement profile including (1) at least one target condition indicative of an improved physiological condition detectable using a physiological sensor signal, (2) a target time when the subject is expected to reach the at least one target condition, (3) one or more predetermined intermediate target physiological conditions different than the at least one target condition and not indicating the improved physiological condition, and (4) one or more intermediate times, before the target time, when the subject is expected to reach the one or more predetermined intermediate target physiological conditions, the determined progress parameter indicating whether the physiological condition of the subject at the one or more intermediate times progresses towards reaching the target condition by the target time; and

an indication generator circuit, configured to generate an improvement indication indicating an improvement of a heart failure status based on the determined progress parameter;

wherein the comparison circuit is configured to receive the goal improvement profile prior to the indication generator circuit generating the improvement indication.

2. The system of claim 1, further comprising a goal improvement profile generator, configured to create, in the absence of the improvement indication generated by the indicator generator circuit, the goal improvement profile for the subject using at least one of a physiological data history of the subject, physiological data of a population that is comparable to the subject, or clinician input.

3. The system of claim 2, wherein the goal improvement profile generator is configured to create the goal improvement profile including an expected improvement to the physiological condition of the subject in response to a therapy provided by a caregiver.

4. The system of claim 3, wherein the goal improvement profile generator is configured to create the goal improvement profile including an improvement to the physiological condition of the subject in response to a treatment for a heart failure event.

5. The system of claim 3, wherein the goal improvement profile includes a thoracic impedance increase profile indicating an improvement of the heart failure in response to the therapy, the thoracic impedance increase profile including a target elevated thoracic impedance the subject is expected to reach at a target time elapsed after delivery of the therapy, and one or more predetermined intermediate thoracic impedance the subject is expected to reach at corresponding one or more intermediate times before the target time.

6. The system of claim 1, wherein the goal improvement profile comprises a goal improvement path over time between a start time and the target time, wherein the goal improvement path includes the at least one target condition.

7. The system of claim 1, wherein the indication generator circuit is configured to generate an indication to maintain or adjust a heart failure therapy based on the determined progress parameter.

8. The system of claim 1, wherein the determined progress parameter is determined as a weighting function of one or more comparisons between the physiological condition of the subject and the goal improvement profile at one or more of the target time or the intermediate times, and the indication generator circuit is configured to generate the improvement indication using the determined progress parameter.

9. The system of claim 1, further comprising:

an ambulatory physiological sensor, configured to determine a physiological condition of the subject using an excitation signal, the excitation signal capable of being received at one or more locations;

a communication circuit, configured to receive one or more physiological sensor signals, wherein the physiological sensor signals are representative of the physiological condition of the subject; and

a memory circuit, configured to store the goal improvement profile.

10. The system of claim 9, wherein the ambulatory physiological sensor is configured to communicate at least one of the one or more physiological sensor signals representative of the physiological condition of the subject determined from the excitation signal, wherein the physiological sensor signal is communicated using the excitation signal as a carrier.

11. An apparatus for managing a chronic disease of a subject, the apparatus comprising:

a comparison circuit, configured to determine a progress parameter using a comparison between a physiological condition of the subject detected at a specified time and a goal improvement profile at the specified time, the goal improvement profile including (1) at least one target condition indicative of an improved physiological condition detectable using a physiological sensor signal, (2) a target time when the subject is expected to reach the at least one target condition, (3) one or more predetermined intermediate target physiological conditions different than the at least one target condition and not indicating the improved physiological condition, and (4) one or more intermediate times, before the target time, when the subject is expected to reach the one or more predetermined intermediate target physiological conditions, the progress parameter indicating whether the physiological condition of the subject at the one or more intermediate times progresses towards reaching the target condition by the target time;

an indication generator circuit, configured to generate an improvement indication indicating an improvement of a heart failure status based on the determined progress parameter, and wherein the comparison circuit is configured to receive the goal improvement profile prior to the indication generator circuit generating the improvement indication;

at least two electrodes, configured to sense an impedance-indicating signal at the skin of the subject to provide the physiological sensor signal; and

an adhesive band, configured to secure the comparison circuit, the indication generator circuit, and the electrodes to the subject, such that the apparatus is configured to be capable of providing the improvement indication from an ambulatory subject and without requiring a tether to the subject.

12. The apparatus of claim 11, further comprising a communication circuit, configured to communicate the improvement indication using at least one of an audible or a visual indicator.

13. The apparatus of claim 12, wherein the communication circuit is configured to be remotely communicatively coupled, via a computer or communications network, to communicate the improvement indication.

14. The apparatus of claim 11, wherein:

the comparison circuit is configured to compare the sensed impedance-indicating signal to the goal improvement profile, the goal improvement profile including a thoracic impedance increase profile including a target elevated thoracic impedance the subject is expected to reach at a target time elapsed after delivery of a therapy, and one or more predetermined intermediate thoracic impedance the subject is expected to reach at corresponding one or more intermediate times before the target time; and

the indication generator circuit is configured to generate the improvement indication indicating an improvement of the heart failure in response to the therapy.

15. A method of using an apparatus to manage a chronic disease of a subject, the method comprising, via the apparatus:

receiving a goal improvement profile;

with a comparison circuit, automatically determining a progress parameter using a comparison between a physiological condition detected at a specified time and the goal improvement profile at the specified time, the goal improvement profile including (1) at least one target condition indicative of an improved physiological condition detectable using a physiological sensor signal, (2) a target time when the subject is expected to reach the at least one target condition, (3) one or more predetermined intermediate target physiological conditions different than the at least one target condition and not indicating the improved physiological condition, and (4) one or more intermediate times, before the target time, when the subject is expected to reach the one or more predetermined intermediate target physiological conditions, the determined progress parameter indicating whether the physiological condition of the subject at the one or more intermediate times progresses towards reaching the target condition by the target time;

with an indication generator circuit, automatically generating an improvement indication subsequent to the receiving of the goal improvement profile, the improvement indication indicating an improvement of a heart failure status based on the determined progress parameter.

16. The method of claim 15, further comprising creating, prior to automatically generating the improvement indication, the goal improvement profile for the subject using at least one of a physiological data history of the subject, physiological data of a population that is comparable to the subject, or clinician input.

17. The method of claim 16, wherein creating the goal improvement profile comprises creating a goal improvement path over time between a start time and the target time, wherein the goal improvement path includes the at least one target condition.

18. The method of claim 15, comprising automatically generating an indication to maintain or adjust a heart failure therapy based on the determined progress parameter.

19. The method of claim 15, wherein the determined progress parameter is determined as a weighting function of one or more comparisons between the physiological condition of the subject and the goal improvement profile at one or more of the target time or the intermediate times.

20. The method of claim 15, comprising determining a post-decompensation heart failure decompensation status of a subject using a physiological sensor signal.

21. The method of claim 15, comprising receiving the physiological sensor signal from a sensor configured to be associated with the subject.

22. The method of claim 21, wherein receiving the physiological sensor signal comprises extracting the physiological sensor signal from an excitation signal, the excitation signal configured to determine a characteristic associated with the physiological condition of the subject.