Touch screen safety controls for clinician programmer

• US 9,375,582 B2
• Filed: 08/31/2012
• Issued: 06/28/2016
• Est. Priority Date: 08/31/2012
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Iyassu, Yohannes
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US13/601,504
• Publication Number:
  US 20140067013A1
• Time in Patent Office: 1,397 Days
• Field of Search: 600/300, 607/2, 607/32, 607/59, 607/60, 607/63
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The present disclosure involves an electronic apparatus for programming an implantable medical device to provide a stimulation therapy for a patient. The electronic apparatus includes a user interface configured to communicate with a user, a memory storage configured to store executable instructions, and a computer processor configured to execute the instructions to implement a plurality of safety controls. The safety controls include: starting/stopping the stimulation therapy by starting the stimulation therapy after a predefined time delay but stopping the stimulation therapy instantaneously; disabling programming of the electronic apparatus and terminating any existing stimulation therapy in response to a low-battery status of the electronic apparatus; adjusting a value of a stimulation parameter of the stimulation therapy one predetermined step at a time, each adjustment corresponding to a separate user input; and restricting a range in which the user can set an upper limit and a lower limit of the stimulation parameter.

Claims

1. An electronic device configured to program a medical device implantable in a patient, the electronic device comprising:

a touch screen display configured to communicate with a user;

a memory storage component configured to store programming code; and

a computer processor configured to execute the programming code to perform the following tasks;

detecting a user input through the touch screen display, wherein the detecting is performed at least in part by measuring an amount of time the touch screen display is engaged as a part of the user input;

determining whether the medical device is running a treatment for the patient when the user input is detected;

instructing the medical device to stop the treatment if the treatment is running, wherein the stopping of the treatment is performed immediately after the user input is detected;

instructing the medical device to start the treatment if no treatment is running and if the amount of time the touch screen display is engaged as a part of the user input exceeds a predetermined limit;

instructing the medical device to perform no treatment if the amount of time the touch screen display is engaged as a part of the user input does not exceed the predetermined limit;

determining whether the electronic device has a low-battery status; and

implementing one of the following measures in response to the low-battery status of the electronic device;

disabling programming of the electronic device;

stopping an ongoing treatment; and

preventing a prospective treatment.

2. The electronic device of claim 1, wherein the treatment comprises one or more stimulation parameters, and further comprising:

changing a value of the one or more stimulation parameters by one predefined step at a time in response to one or more user actions.

3. The electronic device of claim 2, wherein each change of the value of the one or more stimulation parameters corresponds to a different one of the user actions.

4. The electronic device of claim 1, wherein the treatment comprises one or more stimulation parameters, and further comprising:

restricting a configurable range of an upper limit or a lower limit of one of the stimulation parameters.

5. The electronic device of claim 4, wherein the restricting comprises:

restricting the configurable range of the upper limit of the stimulation parameter to be greater than or equal to a current value of the stimulation parameter; and

restricting the configurable range of the lower limit of the stimulation parameter to be less than or equal to the current value of the stimulation parameter.

6. The electronic device of claim 1, wherein the detecting the user input comprises detecting a click of a virtual button on the touch screen display.

7. The electronic device of claim 1, wherein the determining whether the electronic device has a low-battery status comprises:

continuously monitoring an amount of charge of a battery of the electronic device; and

deeming that the low-battery status has been achieved if the amount of charge of the battery is less than a predetermined amount of charge.

8. The electronic device of claim 1, wherein:

the electronic device includes a portable handheld clinician programmer;

the user includes a healthcare personnel; and

the medical device includes a neurostimulator.

9. An electronic apparatus for programming an implantable medical device to provide a stimulation therapy for a patient, the electronic apparatus comprising:

user interface means for communicating with a user;

memory storage means for storing executable instructions; and

computer processor means executing the instructions for implementing a plurality of safety controls including;

starting and stopping the stimulation therapy by starting the stimulation therapy after a predefined time delay but stopping the stimulation therapy instantaneously;

restricting stimulation therapy programming in response to a low-battery status of the electronic apparatus;

wherein the low-battery status is triggered when a battery level of the electronic apparatus falls below a predetermined threshold that is above zero, and wherein the restricting comprises one or more of the following;

preventing the user from programming stimulation parameters;

preventing the user from activating a stimulation test; and

automatically stopping any existing stimulation test by shutting down the existing stimulation test gradually;

adjusting a value of a stimulation parameter of the stimulation therapy one predetermined step at a time, each adjustment corresponding to a separate user input; and

restricting a range in which the user can set an upper limit and a lower limit of the stimulation parameter.

10. The electronic apparatus of claim 9, wherein the user interface means comprises means for displaying a plurality of virtual objects and means for detecting a touch from the user, the touch corresponding to user engagement of one or more of the virtual objects.

11. The electronic apparatus of claim 10, wherein the starting and stopping the stimulation therapy comprises:

measuring an amount of time in which the user engages one of the virtual objects representing a starting of the stimulation therapy; and

starting the stimulation therapy after the amount of time exceeds the predefined time delay.

12. The electronic apparatus of claim 10, wherein the adjusting the value of a stimulation parameter is performed such that each separate user input includes a re-engagement of a respective one of the virtual objects by the user.

13. The electronic apparatus of claim 9, wherein the restricting the range in which a user can set the upper limit and the lower limit of the stimulation parameter comprises:

precluding the user from setting the upper limit to be less than a currently-set value of the stimulation parameter; and

precluding the user from setting the lower limit to be greater than the currently-set value of the stimulation parameter.

14. The electronic apparatus of claim 9, wherein:

the electronic apparatus is a clinician programmer;

the implantable medical device is a pulse generator; and

the user is a medical professional.

15. The electronic apparatus of claim 11, wherein the starting and the stopping of the stimulation therapy are performed in response to the same virtual object being engaged by the user.

16. The electronic apparatus of claim 9, wherein the starting of the stimulation therapy is always after the predefined time delay.

17. A method, comprising:

detecting a user input through a touch screen display of an electronic device configured to program a medical device implantable in a patient, wherein the detecting is performed at least in part by measuring an amount of time the touch screen display is engaged as a part of the user input;

determining whether the medical device is running a treatment for the patient when the user input is detected;

instructing the medical device to stop the treatment if the treatment is running, wherein the stopping of the treatment is performed immediately after the user input is detected;

instructing the medical device to start the treatment if no treatment is running and if the amount of time the touch screen display is engaged as a part of the user input exceeds a predetermined limit;

instructing the medical device to perform no treatment if the amount of time the touch screen display is engaged as a part of the user input does not exceed the predetermined limit;

determining whether the electronic device has a low-battery status; and

implementing one of the following measures in response to the low-battery status of the electronic device;

disabling programming of the electronic device;

stopping an ongoing treatment; and

preventing a prospective treatment.

18. The method of claim 17, wherein the treatment comprises one or more stimulation parameters, and further comprising:

changing a value of the one or more stimulation parameters by one predefined step at a time in response to one or more user actions.

19. The method of claim 18, wherein each change of the value of the one or more stimulation parameters corresponds to a different one of the user actions.

20. The method of claim 17, wherein the treatment comprises one or more stimulation parameters, and further comprising:

restricting a configurable range of an upper limit or a lower limit of one of the stimulation parameters.

21. The method of claim 20, wherein the restricting comprises:

restricting the configurable range of the upper limit of the stimulation parameter to be greater than or equal to a current value of the stimulation parameter; and

restricting the configurable range of the lower limit of the stimulation parameter to be less than or equal to the current value of the stimulation parameter.

22. The method of claim 17, wherein the detecting the user input comprises detecting a click of a virtual button on the touch screen display.

23. The method of claim 17, wherein the determining whether the electronic device has a low-battery status comprises:

continuously monitoring an amount of charge of a battery of the electronic device; and

deeming that the low-battery status has been achieved if the amount of charge of the battery is less than a predetermined amount of charge.

24. The method of claim 17, wherein:

the electronic device includes a portable handheld clinician programmer;

the user includes a healthcare personnel; and

the medical device includes a neurostimulator.

25. A method of implementing a plurality of safety controls via an electronic apparatus that is configured to program an implantable medical device to provide a stimulation therapy for a patient, the method comprising:

starting and stopping the stimulation therapy by starting the stimulation therapy after a predefined time delay but stopping the stimulation therapy instantaneously;

restricting stimulation therapy programming in response to a low-battery status of the electronic apparatus, wherein the low-battery status is triggered when a battery level of the electronic apparatus falls below a predetermined threshold that is above zero, and wherein the restricting comprises one or more of the following;

preventing the user from programming stimulation parameters;

preventing the user from activating a stimulation test; and

automatically stopping any existing stimulation test by shutting down the existing stimulation test gradually;

adjusting a value of a stimulation parameter of the stimulation therapy one predetermined step at a time, each adjustment corresponding to a separate input from a user; and

restricting a range in which the user can set an upper limit and a lower limit of the stimulation parameter.

26. The method of claim 25, further comprising:

displaying a plurality of virtual objects; and

detecting a touch from the user, the touch corresponding to a user engagement of one or more of the virtual objects.

27. The method of claim 26, wherein the starting and stopping the stimulation therapy comprises:

measuring an amount of time in which the user engages one of the virtual objects representing a starting of the stimulation therapy; and

starting the stimulation therapy after the amount of time exceeds the predefined time delay.

28. The method of claim 26, wherein the adjusting the value of a stimulation parameter is performed such that each separate user input includes a re-engagement of a respective one of the virtual objects by the user.

29. The method of claim 26, wherein the starting and the stopping of the stimulation therapy are performed in response to the same virtual object being engaged by the user.

30. The method of claim 25, wherein the restricting the range in which a user can set the upper limit and the lower limit of the stimulation parameter comprises:

precluding the user from setting the upper limit to be less than a currently-set value of the stimulation parameter; and

precluding the user from setting the lower limit to be greater than the currently-set value of the stimulation parameter.

31. The method of claim 25, wherein:

the electronic apparatus is a clinician programmer;

the implantable medical device is a pulse generator; and

the user is a medical professional.

32. The method of claim 25, wherein the starting of the stimulation therapy is always after the predefined time delay.