Method and apparatus to trend and optimize an implantable medical device using a patient management system

• US 8,768,466 B2
• Filed: 10/10/2008
• Issued: 07/01/2014
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Dong, Yanting, Wei, Xuan, Garg, Ankur, Ni, Quan
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US12/249,856
• Publication Number:
  US 20090105777A1
• Time in Patent Office: 2,090 Days
• Field of Search: 607/27, 607/9, 607/48, 607/30
• US Class Current: 607/30
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A remote external interface for an implantable cardiac function management device is configured to be communicatively coupled to the implantable cardiac function management device via a network to a local external interface and via telemetry between the local external interface and the implantable cardiac function management device. The remote external interface includes a communication circuit and a processor circuit. The communication circuit is configured to communicate with the implantable cardiac function management device. The processor circuit is configured to perform an analysis of physiologic data received from the implantable cardiac function management device in response to operation of the implantable cardiac function management device using a plurality of therapy control parameter sets. The processor circuit can be further configured to select a particular therapy control parameter set using the analysis.

Claims

1. An apparatus comprising:

an implantable cardiac function management device including a programmable controller, the programmable controller configured to include a plurality of user-specifiable therapy control parameter sets, wherein a therapy control parameter set is configured to include at least one of a rate response parameter, a tachy detection parameter, and a tachy therapy parameter, and wherein the programmable controller is configured to initiate a switch from a first therapy control parameter set to a second therapy control parameter set upon expiration of a user-configurable time duration; and

a remote external interface for the implantable cardiac function management device, configured to be communicatively coupled to the implantable cardiac function management device via a network to a local external interface and via telemetry between the local external interface and the implantable cardiac function management device, the remote external interface comprising;

a communication circuit, configured to communicate with the implantable cardiac function management device; and

a processor circuit, configured to perform an analysis of physiologic data received from the implantable cardiac function management device in response to operation of the implantable cardiac function management device using a plurality of the therapy control parameter sets, the processor circuit configured to select a particular therapy control parameter set using the analysis, wherein at least one of the implantable medical device or the processor is configured to analyze physiologic data resulting from using the first therapy control parameter set and to generate a search set of candidate values of a therapy parameter for the second therapy parameter set or a subsequent parameter set by reducing a set of possible values to the search set of candidate values according to the analyzed physiological and previous values of the therapy parameter set used to produce the physiologic data.

2. The apparatus of claim 1, wherein the controller is configured to obtain at least one physiological measure for each combination of parameter values of the therapy control parameter set.

3. The apparatus of claim 2, wherein the at least one physiological measure includes information from a separate and unattached physiological sensor.

4. The apparatus of claim 2, wherein the controller is configured to determine which combination of parameter values contributed to a particular outcome as evidenced by at least one physiological measure.

5. The apparatus of claim 4, wherein the controller is configured to determine which of the first and second parameter values contributed more to the at least one physiological measure.

6. The apparatus of claim 4, wherein the controller is configured to suggest at least one combination of parameter values as a function of past physiological measures.

7. The apparatus of claim 1, wherein the device includes multiple therapy control parameter sets, and wherein the device is configured to sequence through two or more of the therapy control parameter sets.

8. The apparatus of claim 1, comprising one or more of the implantable cardiac function management device, the local external interface, and an external sensor device.

9. The apparatus of claim 1, wherein the remote external interface is configured to program the implantable cardiac function management device with one or more of the particular therapy control parameter sets and a particular physiological response to store.

10. The apparatus of claim 1, wherein the remote external interface is configured to program the implantable cardiac function management device with an original therapy control parameter set or a default therapy control parameter set.

11. The apparatus of claim 1, wherein the local external interface, the network, or the remote external interface is configured to suggest to a third party the particular therapy control parameter set to program into the implantable cardiac function management device.

12. The apparatus of claim 11, wherein the suggestion is based on at least one of an analysis of an aggregation of historic patient data or device performance data.

13. The apparatus of claim 1, wherein the processor circuit is configured to perform an analysis of at least one of device performance data or patient feedback data.

14. The apparatus of claim 1, wherein the processor circuit is configured to adjust one or more therapy control parameter sets using the analysis of the physiologic data.

15. The apparatus of claim 14, wherein the adjustment of the one or more therapy control parameter sets comprises using the analysis of the physiologic data to reduce a parameter space for which the processor circuit then analyzes the physiologic data.

16. The apparatus of claim 15, wherein the optimization algorithm includes at least one of a gradient search, an evolution algorithm, a simulated annealing method, or a simplex algorithm.

17. The apparatus of claim 1, wherein:

the rate response parameter includes at least one of an activity threshold, a reaction time, a recovery time for an accelerometer-based method, and a response factor for a minute ventilate-based method;

the tachy detection parameter includes at least one of a tachy detection zone threshold and a tachy detection enhancement; and

the tachy therapy parameter includes at least one of a shock energy level or an anti-tachy pacing (ATP) scheme.

18. A method comprising:

receiving user input to program an implantable cardiac function management device including receiving a plurality of therapy control parameter sets, a therapy control parameter set including at least one of a rate response parameter, a tachy detection parameter, or a tachy therapy parameter;

initiating, using the implantable cardiac function management device and upon expiration of a user-configurable time duration, a switch from a first therapy control parameter set to a second therapy control parameter set;

analyzing, using at least one of the implantable medical device or a remote external interface, physiologic data resulting from using the first therapy control parameter set;

generating, using the at least one of the implantable medical device or the external interface, a search set of candidate values of a therapy parameter for the second therapy parameter set or a subsequent parameter set according to the analyzed physiological data, wherein the search set of candidate values are reduced from a set of possible values according to the analyzed physiological data and previous values of the therapy parameter set used to produce the physiologic data;

receiving over a network at the external interface physiologic data from the cardiac function management device, the physiologic data resulting from operation of the cardiac function management device using a plurality of the therapy control parameter sets;

analyzing the physiologic data resulting from using the plurality of therapy control parameter sets; and

selecting a particular therapy control parameter set using the analysis.

19. The method of claim 18, comprising obtaining at least one physiological measure for each combination of parameter values of the therapy control parameter set.

20. The method of claim 18, comprising determining which of the combination of parameter values contributed to a particular outcome as evidenced by at least one physiological measure.

21. The method of claim 18, comprising using the user input for automatically sequencing through multiple therapy control parameter sets at times occurring between separate user-programming sessions.

22. The method of claim 18, comprising programming the implantable cardiac function management device with the particular therapy control parameter set.

23. The method of claim 18, comprising providing to a third party a suggestion of the particular therapy control parameter set to program into the implantable cardiac function management device.

24. The method of claim 18, comprising automatically adjusting the particular therapy control parameter set or a particular therapy control parameter and automatically programming the adjusted particular therapy control parameter set or the particular therapy control parameter into the implantable cardiac function management device.

25. The method of claim 18, comprising receiving, at the remote external interface, from a third party, the one or more therapy control parameter sets.

26. The method of claim 18, comprising receiving, at the remote external interface, an interval range for at least one parameter in the therapy control parameter sets, a time interval that the cardiac function management device is configured to operate with at least one of the therapy control parameter sets, or a value for a physiological parameter.

27. The method of claim 18, comprising adjusting the therapy control parameter sets using the analysis of the physiologic data.

28. The method of claim 18, comprising using the analysis of the physiologic data to reduce a parameter space in which the physiologic data is then analyzed.

29. The method of claim 18, wherein

the rate response parameter includes at least one of an activity threshold, a reaction time, a recovery time for an accelerometer-based method, and a response factor for a minute ventilate-based method;

the tachy detection parameter includes at least one of a tachy detection zone threshold and a tachy detection enhancement; and

the tachy therapy parameter includes at least one of a shock energy level or an anti-tachy pacing (ATP) scheme.