Systems for patient control of implantable medical device therapy

• US 9,242,104 B2
• Filed: 05/10/2011
• Issued: 01/26/2016
• Est. Priority Date: 05/11/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hamann, Jason J., Ruble, Stephen, Carbunaru, Rafael, Ternes, David J.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US13/104,635
• Publication Number:
  US 20110282416A1
• Time in Patent Office: 1,722 Days
• Field of Search: 607/7, 607/11, 607/14, 607/15, 607/17, 607/59, 607/62
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Various embodiments provide a method performed by an IMD to deliver a therapy to a patient. In some embodiments of the method, the therapy is delivered to the patient, and a trigger that is controlled by the patient is detected by the IMD. The therapy is automatically interrupted in response to the detected trigger, and is automatically restored after a defined period after the detected trigger. In some embodiments of the method, a trigger that is controlled by the patient is detected. The therapy is automatically initiated in response to the detected trigger, and is automatically stopped after a defined period after the detected trigger.

Claims

1. A method performed by an implantable medical device to deliver a therapy to a patient, the method comprising:

delivering the therapy to the patient;

detecting a therapy interruption trigger that is controlled by the patient;

automatically interrupting the therapy in response to the detected therapy interruption trigger;

automatically restoring the therapy after a defined restoration period after the detected therapy interruption trigger;

counting a number of detected therapy interruption triggers over a defined therapy interruption trigger count period, the counted number of detected therapy interruption triggers over the defined interruption trigger count period being greater than one, and each of the counted number of detected therapy interruption triggers corresponding to an automatic interruption in the therapy; and

when the counted number of detected therapy interruption triggers over the defined trigger count period reaches a defined number of detected therapy interruption triggers greater than one trigger, automatically interrupting the therapy in response to the detected therapy interruption trigger includes automatically interrupting the therapy until an authorized individual resets the therapy.

2. The method of claim 1, wherein delivering the therapy includes delivering neural stimulation for a cardiovascular therapy.

3. The method of claim 1, wherein automatically interrupting the therapy includes automatically stopping the therapy in response to the detected therapy interruption trigger.

4. The method of claim 1, wherein automatically interrupting the therapy includes automatically adjusting an intensity of the therapy in response to the detected therapy interruption trigger.

5. The method of claim 4, wherein automatically adjusting an intensity of the therapy includes automatically reducing the intensity of the therapy in response to the detected therapy interruption trigger.

6. The method of claim 4, wherein automatically adjusting an intensity of the therapy includes automatically increasing the intensity of the therapy in response to the detected therapy interruption trigger.

7. The method of claim 1, wherein:

the defined restoration period is a defined time period;

the method includes using a timer to determine an end of the defined time period; and

automatically restoring the therapy includes automatically restoring the therapy at the end of the defined time period.

8. The method of claim 1, wherein:

the defined restoration period is a defined count of a recurring event that is identifiable by the implantable medical device;

the method includes detecting recurring events and using a counter to determine when a number of recurring events reaches the defined count; and

automatically restoring the therapy includes automatically restoring the therapy when the number of recurring events reaches the defined count.

9. The method of claim 8, wherein the recurring event is a neural stimulation pulse or a neural stimulation burst.

10. The method of claim 8, wherein the recurring event is a cardiac event within a cardiac cycle.

11. The method of claim 1, further comprising:

determining an amount of the therapy over a defined therapy window;

comparing the amount of the therapy over the defined therapy window to a defined therapy amount; and

changing the response to the detected interruption trigger if the amount of the therapy over the defined therapy window is less than the defined therapy amount.

12. The method of claim 1, wherein detecting the interruption trigger that is controlled by the patient includes detecting a therapy interruption trigger indicative of an environment of the patient.

13. The method of claim 1, further comprising detecting a signal indicative of an environment of the patient, wherein automatically interrupting the therapy includes automatically adjusting the therapy if the detected therapy interruption trigger and the signal indicative of the environment occur together.

14. The method of claim 1, further comprising performing a ladder response to more than one detected therapy interruption trigger, wherein a first detected therapy interruption trigger is associated with a first time period that functions as the defined time period for the first detected therapy interruption trigger and a second detected therapy interruption trigger is associated with a second time period longer than the first time period that functions as the defined period for the second detected therapy interruption trigger.

15. An implantable medical device for implantation in a patient, comprising:

a neural stimulation circuit configured for use to deliver a neural stimulation therapy to the patient; and

a controller configured to;

control the neural stimulator to deliver the neural stimulation therapy;

detect a therapy interruption trigger that is controlled by the patient;

automatically interrupt the therapy in response to the detected therapy interruption trigger; and

automatically restore the therapy after a defined restoration period after the detected therapy interruption trigger,

wherein the controller includes an override controller configured to;

count a number of detected therapy interruption triggers over a defined therapy interruption trigger count period, the counted number of detected therapy interruption triggers over the defined interruption trigger count period being greater than one, and each of the counted number of detected therapy interruption triggers corresponding to an automatic interruption in the therapy;

compare the counted number of detected therapy interruption triggers over the defined trigger count period to a defined number of detected therapy interruption triggers greater than one trigger; and

automatically interrupt the therapy until an authorized individual resets the therapy when the counted number of detected therapy interruption triggers over the defined trigger count period reaches the defined number of detected therapy interruption triggers.

16. The device of claim 15, wherein the controller is configured to automatically stop the therapy in response to the detected therapy interruption trigger.

17. The device of claim 15, wherein the controller is configured to automatically adjust an intensity of the therapy in response to the detected therapy interruption trigger.

18. The device of claim 15, wherein:

the defined restoration period is a defined time period;

the controller includes a timer configured to determine an end of the defined time period; and

the controller is configured to automatically restore the therapy at the end of the defined time period.

19. The device of claim 15, wherein:

the device includes a recurring event detector, and a counter configured to count the detected recurring events;

the defined restoration period is a defined count of the detected recurring events; and

the controller is configured to determine when the detected number of recurring events reaches the defined count, and automatically restore the therapy when the number of recurring events reaches the defined count.

20. The device of claim 19, wherein the recurring event is a neural stimulation pulse or a neural stimulation burst.

21. The device of claim 19, wherein the recurring event is a cardiac event within a cardiac cycle.

22. The device of claim 15, wherein the controller includes a therapy dose controller configured to determine an amount of the therapy over a defined therapy window, compare the amount of the therapy over the defined therapy window to a defined therapy amount, and change the response to the therapy detected interruption trigger if the amount of the therapy over the defined therapy window is less than the defined therapy amount.

23. The device of claim 15, the controller is configured to perform a ladder response to more than one detected therapy interruption trigger, wherein a first detected therapy interruption trigger is associated with a first time period that functions as the defined time period for the first detected therapy interruption trigger and a second detected therapy interruption trigger is associated with a second time period longer than the first time period that functions as the defined period for the second detected therapy interruption trigger.