Methods and systems for controlling a state of a neurostimulator

• US 10,188,862 B2
• Filed: 09/06/2016
• Issued: 01/29/2019
• Est. Priority Date: 09/28/2012
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Wingeier, Brett, Gibb, Barbara, Baysinger, Craig, Tcheng, Thomas, Gurunathan, Suresh
• Primary Examiner(s): Bockelman, Mark W
• Application Number:
  US15/257,890
• Publication Number:
  US 20160375247A1
• Time in Patent Office: 875 Days
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2560/0266 for monitoring or limiting apparatus function
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/384 Recording apparatus or displays specially adapted therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

A method and system is described for ensuring a state of an active implantable medical device based on the presence and persistence of a magnetic field. The output of a magnetic field sensor is monitored. The active implantable medical device is maintained in a first state, for so long as the presence of a magnetic field is detected by the magnetic field sensor, until a first interval is surpassed. If the first interval is surpassed, then a determination is made as to whether a second interval has been surpassed. If it is determined that the second interval has not been surpassed, then the active implantable medical device is transitioned into a second state. If it is determined that the second interval has been surpassed, then it is ensured that the active implantable medical device is in a predetermined one of the first and second states.

Claims

1. An active implantable medical device comprising:

a sensor for detecting a presence of a magnetic field;

a timer configured to keep track of the amount of time the sensor detects the magnetic field uninterrupted;

a magnet tracking subsystem including a magnet tracking software object configured to exist in one of a plurality of software object states, and to transition to and from software object states based on one or more of a detection of a magnetic field, a duration of a detection of a magnetic field, and a state of the timer; and

an interface for passing messages and information from the magnet tracking software object to at least one other software object that controls the state of the active implantable medical device, which state is one of a plurality of states comprising a first medical device activity state or a second, different medical device activity state,

wherein the magnet tracking subsystem is configured to;

monitor a number of times the state of the active implantable medical device has transitioned from a designated one of the plurality of states to another one of the plurality of states within a period of time, and

prevent the state of the active implantable medical device from transitioning from the designated one of the plurality of states to the other one of the plurality of states when the number of times exceeds a threshold value.

2. The device of claim 1, wherein the plurality of software object states comprises:

a first software object state corresponding to a condition when no magnetic field is detected by the sensor;

a second software object state corresponding to the condition when a magnetic field has begun to be detected by the sensor and the timer has been initiated;

a third software object state corresponding to the condition when a magnetic field has been detected by the sensor for longer than a first interval; and

a fourth software object state corresponding to the condition when a magnetic field has been detected by the sensor for longer than both a first interval and a second interval.

3. The device of claim 2, wherein, the magnet tracking subsystem is configured to respond to a condition when a magnetic field ceases to be detected within the first interval by stopping the timer.

4. The device of claim 2, wherein the magnet tracking subsystem is configured to stop the timer upon a transition from the second software object state to the first software object state.

5. The device of claim 2, wherein the magnet tracking subsystem is configured to respond to a condition when a magnetic field is detected for the duration of the first interval by transitioning from the second software object state to the third software object state.

6. The device of claim 2, wherein the magnet tracking subsystem is configured to respond to a condition when a magnetic field ceases to be detected within the second interval by toggling the state of the active implantable medical device from the first medical device activity state to the second, different medical device activity.

7. The device of claim 2, wherein the magnet tracking subsystem is configured to toggle the state of the active implantable medical device from the first medical device activity state to the second, different medical device activity state upon a transition from the third software object state to the first software object state.

8. The device of claim 2, wherein, the magnet tracking subsystem is configured to respond to a condition when a magnetic field is detected throughout the entirety of the second interval by setting the state of the active implantable medical device to the designated one of the plurality of states.

9. The device of claim 2, wherein, the magnet tracking subsystem is configured to set the state of the active implantable medical device to the designated one of the plurality of states upon a transition from the third software object state to the fourth software object state.

10. The device of claim 2 wherein the magnet tracking subsystem is configured to respond to the condition when the second interval has been exceeded by ensuring that the active implantable medical device is in a predetermined one of the first medical device activity state or the second medical device activity state.

11. The device of claim 2, wherein the magnet tracking subsystem is configured to ensure that the active implantable medical device is in a predetermined one of the first medical device activity state or the second medical device activity state upon a transition from the third software object state to the fourth software object state.

12. The device of claim 2, further comprising:

a feedback signal generator, the feedback signal generator configured to generate;

a first audible tone whenever the magnet tracking subsystem is in the second software object state;

a second, different audible tone whenever the active implantable medical device is susceptible of transitioning from the first medical device activity state to the second medical device activity state between the end of the first interval and the end of the second interval; and

whichever of the first or second audible tones that corresponds to a predetermined one of the first or second medical device activity states if the sensor still detects the presence of the magnetic field after the second interval.

13. The device of claim 1, wherein:

the first medical device activity state corresponds to a state in which a therapy the active implantable medical device is configured to deliver is disabled, and

the second medical device activity state corresponds to a state in which a therapy the active implantable medical device is configured to deliver is enabled.

14. The device of claim 2, further comprising:

a feedback signal generator, the feedback signal generator configured to generate;

a first audible tone when the magnet tracking subsystem is in the second software object state;

a second, different audible tone when the magnet tracking subsystem is in the third software object state; and

a third, different audible tome when the magnet tracking subsystem is in the fourth software object state.

15. An active implantable medical device comprising:

a sensor for detecting a presence of a magnetic field;

a timer configured to keep track of the amount of time the sensor detects the magnetic field uninterrupted;

a magnet tracking subsystem including a magnet tracking software object configured to exist in one of a plurality of software object states, and to transition to and from software object states based on one or more of a detection of a magnetic field, a duration of a detection of a magnetic field, and a state of the timer; and

an interface for passing messages and information from the magnet tracking software object to at least one other software object that controls the state of the active implantable medical device, which state is one of a therapy enabled state or a therapy disabled state,

wherein the plurality of software object states comprises a first software object state corresponding to a condition when no magnetic field is detected by the sensor, a second software object state corresponding to the condition when a magnetic field has begun to be detected by the sensor and the timer has been initiated, a third software object state corresponding to the condition when a magnetic field has been detected by the sensor for longer than a first interval, and a fourth software object state corresponding to the condition when a magnetic field has been detected by the sensor for longer than both a first interval and a second interval

wherein the magnet tracking subsystem is configured to;

set the state of the active implantable medical device to the therapy disabled state upon a transition from the third software object state to the fourth software object state;

monitor a number of times there has been a transition from the third software object state to the fourth software object state within a period of time, and

prevent the state of the active implantable medical device from being changed from the therapy disabled state to the therapy enabled state when there is a transition from the third software object state to the first software object state, and the number of times exceeds a threshold value.