Methods and systems for controlling a state of a neurostimulator

• US 9,345,884 B2
• Filed: 09/28/2012
• Issued: 05/24/2016
• 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
• Application Number:
  US13/631,820
• Publication Number:
  US 20140094876A1
• Time in Patent Office: 1,334 Days
• Field of Search: 607 30- 31, 607/59, 607/62
• US Class Current: 1/1
• 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. A method for selecting a state of operation of an active implantable medical device, the method comprising:

outputting a signal from a magnet sensor of the implantable medical device when a magnetic field is detected relative to the implantable medical device by the magnet sensor, the implantable medical device operating in a current state at the time of a first detection of the magnetic field;

initiating a timer of the implantable medical device that tracks an elapsed-magnet-detection time period over which the signal is continuously output;

comparing by a processor of the implantable medical device, the elapsed-magnet-detection time period to a first interval characterized by a first interval end point and a second interval characterized by a second interval end point that is different from the first interval end point;

if the elapsed-magnet-detection time period exceeds the second interval end point, outputting a signal from the processor that forces the state of operation of the active implantable medical device to a first state regardless of the current state, wherein the first state corresponds to a therapy disabled state;

if the elapsed-magnet-detection time period terminates between the first interval end point and the second interval end point, outputting a signal from the processor that toggles the state of the active implantable medical device from the current state to either the first state or to a different state;

if the elapsed-magnet-detection time period terminates before the first interval end point, maintaining the state of the active implantable medical device in the current state;

monitoring a number of times the state of operation of the implantable medical device has changed from a therapy enabled state to the therapy disabled state within a period of time due to terminations of the elapsed-magnetic-detection time period; and

preventing the state of the active implantable medical device from being changed from the therapy disabled state to the therapy enabled state when the elapsed-magnetic-detection time period terminates between the first interval end point and the second interval end point, and the number of times exceeds a threshold value.

2. The method of claim 1, wherein each of the states of the active implantable medical device corresponds to a level of activity of the active implantable medical device, and the level of activity of the first state is different from the level of activity of any other state.

3. The method of claim 1, wherein outputting a signal from the processor that toggles the state of the active implantable medical device further comprises:

when the current state is the first state, outputting a signal from the processor that toggles the current state to a second state; and

when the current state is the second state, outputting a signal from the processor that toggles the current state to the first state.

4. The method of claim 1, further comprising:

generating a first alert at the time of a first detection of the magnetic field; and

generating a different alert whenever the elapsed-magnet-detection time period exceeds the first interval end point.

5. The method of claim 1, further comprising:

generating a first alert at the time of a first detection of the magnetic field;

generating a second alert if the elapsed-magnet-detection time period terminates between the first interval end point and the second interval end point; and

generating a third alert if the elapsed-magnet-detection time period exceeds the second interval end point.

6. The method of claim 1, further comprising:

generating a magnet removal alert upon termination of the elapsed-magnet-detection time period.

7. The method of claim 1, further comprising:

determining a start time when the magnetic field is first detected.

8. The method of claim 7, further comprising:

storing the start time in the active implantable medical device for at least a predetermined length of time.

11. The method of claim 1, wherein preventing comprises disabling the processor from outputting a signal that toggles the state of the active implantable medical device from the therapy disabled state to the therapy enabled state when the elapsed-magnet-detection time period terminates between the first interval end point and the second interval end point.

12. The method of claim 1, wherein preventing comprises disabling the outputting of a signal from a magnet sensor of the implantable medical device when a magnetic field is detected relative to the implantable medical device by the magnet sensor.

9. A method for controlling a state of operation of an active implantable medical device comprising:

outputting a signal when a magnetic field is detected relative to the implantable medical device, wherein the implantable medical device is operating in a current state being one of a therapy enabled state or a therapy disabled state;

initiating a timer that tracks an elapsed-magnet-detection time period over which the signal is continuously output;

if the elapsed-magnet-detection time period terminates during a first time interval beginning at first detection of the magnetic field, maintaining the implantable medical device in the current state;

if the elapsed-magnet-detection time period terminates during a second time interval beginning at the end of the first time interval, setting the implantable medical device to a different state than the current state, the different state being;

     1) the therapy disabled state when the current state is the therapy enabled state, and

     2) the therapy enabled state when the current state is the therapy disabled state;

if the elapsed-magnet-detection time period does not terminate during the second time interval, upon termination of the second time interval, setting the implantable medical device to a predetermined one of the current state and the different state;

monitoring a number of times the state of operation of the implantable medical device has changed from a therapy enabled state to the therapy disabled state within a period of time due to terminations of the elapsed-magnetic-detection time period; and

preventing the state of the active implantable medical device from being changed from the therapy disabled state to the therapy enabled state when the elapsed-magnetic-detection time period terminates between the first interval end point and the second interval end point, and the number of times exceeds a threshold value.

10. The method of claim 9 wherein a first audible tone is associated with the current state and a second audible signal is associated with the different state and further comprising:

generating the first audible tone during the first time interval;

generating the second audible tone during the second time interval; and

generating whichever of the first or second audible tones is associated with the predetermined one of the current and different states upon termination of the second time interval.

13. A method for selecting a state of operation of an active implantable medical device, the method comprising:

outputting a signal from a magnet sensor of the implantable medical device when a magnetic field is detected relative to the implantable medical device by the magnet sensor, the implantable medical device operating in a current state at the time of a first detection of the magnetic field;

initiating a timer of the implantable medical device that tracks an elapsed-magnet-detection time period over which the signal is continuously output;

comparing by a processor of the implantable medical device, the elapsed-magnet-detection time period to a first interval characterized by a first interval end point and a second interval characterized by a second interval end point that is different from the first interval end point;

if the elapsed-magnet-detection time period exceeds the second interval end point, outputting a signal from the processor that forces the state of operation of the active implantable medical device to a first state regardless of the current state, wherein the first state corresponds to a therapy disabled state;

if the elapsed-magnet-detection time period terminates between the first interval end point and the second interval end point, outputting a signal from the processor that toggles the state of the active implantable medical device from the current state to either the first state or to a different state;

if the elapsed-magnet-detection time period terminates before the first interval end point, maintaining the state of the active implantable medical device in the current state;

monitoring a number of times the state of operation of the implantable medical device has changed from a therapy enabled state to the therapy disabled state within a period of time due to terminations of the elapsed-magnetic-detection time period; and

changing from the therapy disabled state to a nominal therapy enabled state when the elapsed-magnetic-detection time period terminates between the first interval end point and the second interval end point, and the number of times exceeds a threshold value,

wherein the nominal therapy enabled state corresponds to a therapy having a strength less than the therapy enabled state.