Respiration as a trigger for therapy optimization

• US 9,079,033 B2
• Filed: 01/20/2009
• Issued: 07/14/2015
• Est. Priority Date: 01/22/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kuenzler, Richard O., Hopper, Donald, Rasmussen, Mary Jane, McCabe, Aaron, Layton, John
• Primary Examiner(s): Blumel, Benjamin P
• Application Number:
  US12/356,289
• Publication Number:
  US 20090234240A1
• Time in Patent Office: 2,366 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• 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 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Changes in patient status are assessed based at least in part on respiration parameters. A user can make selections regarding alert criteria options to be used in assessing patient status. Respiration is implantably sensed and respiration data is stored by an implantable device. A respiration parameter, such as respiration rate, is measured from the respiration data. The change in patient status is assessed by comparing the respiration parameter to the configured alert criteria. If the comparison of the respiration parameter and the configured alert criteria indicates a significant change in patient status, an alert signal is generated.

Claims

1. A method of operating a medical system, the method comprising:

displaying a preprogrammed menu on a display, the menu displaying an alert criteria used to assess a change in patient status and further displaying one or more corresponding alert criteria setting for the displayed alert criteria;

the displayed alert criteria settings including at least a baseline respiration rate displayed in a first pull-down menu and an allowed increase over the baseline respiration rate displayed in a second pull-down menu;

receiving an input from a user to change one or more of the alert criteria settings via the corresponding pull-down menu, and displaying the changed alert criteria settings via the menu;

configuring alert criteria for assessing the change in patient status based at least in part on the alert criteria settings;

sensing respiration and storing respiration data;

determining a respiration parameter from the respiration data;

assessing the change in patient status including comparing a measure related to the respiration parameter to the configured alert criteria; and

generating a signal indicating the change in patient status responsive to the comparison.

2. The method of claim 1, wherein generating the signal indicating the change in patient status comprises generating the signal according to a periodic schedule or generating the signal in real-time.

3. The method of claim 1, further comprising:

determining at least one additional physiological parameter; and

comparing both the additional physiological parameter and the respiration parameter to one or more alert criteria.

4. The method of claim 3, wherein the additional physiological parameter comprises a physiological parameter related to left ventricular function.

5. The method of claim 1, further comprising assessing therapy effectiveness based on the change in patient status.

6. The method of claim 1, wherein generating the signal comprises generating a multi-level alert indicating a criticality of the change in patient status or a need for therapy optimization.

7. The method of claim 1, further comprising initiating presentation of recommended therapy optimization options or automatically optimizing therapy responsive to the signal.

8. The method of claim 7, wherein the recommended therapy optimization options comprise a recommended change in pharmacological treatment.

9. The method of claim 7, wherein the recommended therapy optimization options comprise a recommended change in device programming.

10. The method of claim 7, wherein the recommended therapy optimization options comprise a recommended change in a type of cardiac device used to deliver therapy.

11. A system for evaluating patient status, the system comprising:

input and output circuitry configured to display alert criteria threshold values on a display, wherein the alert criteria threshold values are displayed in a menu on the display, the input and output circuitry further configured to receive input from a user to change at least one of the displayed alert criteria threshold values using the menu, and to display the at least one changed alert criteria threshold value in the menu;

sensors configured to implantably sense one or more physiological signals, including respiration;

circuitry configured to determine one or more parameters of the physiological signals, the one or more parameters comprising at least two of a maximum respiration rate, a minimum respiration rate, and a median respiration rate; and

an alert module configured to compare the one or more parameters to corresponding ones of the alert criteria threshold values, and to generate an alert signal based on the comparison.

12. The system of claim 11, wherein the alert signal initiates analysis of therapy parameters and recommendations for modification of therapy parameters.

13. The system of claim 11, wherein the alert signal initiates automatic therapy optimization.

14. The system of claim 11, wherein the alert criteria is automatically modified based on the measured parameters.

15. The system of claim 11, wherein the alert module is configured to take into account contextual information before generating the alert.

16. The system of claim 11, wherein the input and output circuitry is further configured to display parameter trends selected by a user for graphical representation on the display.

17. The system of claim 16, wherein two or more parameter trends are graphically represented on the display and are correlated and displayed on a common time scale.

18. The system of claim 11, wherein additional data is input by a user via the input circuitry or automatically generated by the system and the additional data is appended to a database of parameter trends.

19. The system of claim 18, wherein the additional data is displayed as a marker on a graphical representation along with the parameter trends, the marker indicating a time associated with the additional data.

20. A system for evaluating a patient'"'"'s status, the system comprising:

one or more sensors configured to implantably sense one or more physiological signals;

hardware configured to;

determine one or more parameters of the physiological signals;

display alert criteria settings for an alert in an alert criteria settings menu displayed on a display, wherein the alert criteria setting menu allows a user to change one or more of the alert criteria settings by interacting with the menu, and then displaying the changed alert criteria settings on the menu;

compare the one or more determined parameters to the alert criteria settings set by the user via the menu, and to generate an alert signal based on the comparison; and

display a menu item that allows the user to enable or disable the alert.

21. The system of claim 20, wherein the one or more sensors includes one or of an impedance sensor, a heart sound sensor, and an activity sensor.

22. The system of claim 20, wherein the one or more physiological signals includes a respiration signal, the one or more parameters includes a respiration rate, and the patient'"'"'s status relates to a patient'"'"'s Chronic Heart Failure (CHF) decompensation status.