Simultaneous physiological sensing and stimulation with saturation detection

• US 10,080,898 B2
• Filed: 05/29/2015
• Issued: 09/25/2018
• Est. Priority Date: 05/29/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Denison, Timothy J., Afshar, Pedram, Stanslaski, Scott R.
• Primary Examiner(s): Weston, Tiffany
• Assistant Examiner(s): KINGSLEY, SARAH R
• Application Number:
  US14/725,998
• Publication Number:
  US 20160346548A1
• Time in Patent Office: 1,215 Days
• Field of Search: 607 45
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

Systems and method may be used for interfacing with a patient. Systems may include a plurality of electrodes in electrical communication with a processor. The processor may be configured to receive sense signals from electrodes and to determine the reliability of the received signal. A test tone signal comprising a test tone frequency may be applied, and the magnitude of the test tone frequency may be analyzed in the received signal. If it is determined that the magnitude of the test tone frequency is below a threshold, the system may take action, such as lowering the gain on an amplifier. Stimulation signals may be applied to the patient at a stimulation frequency simultaneously with one or both of receiving sense signals and providing the test tone signal.

Claims

1. A method comprising:

applying a stimulation signal to a patient, the stimulation signal comprising a stimulation frequency within a first frequency band;

while applying the stimulation signal, simultaneously receiving a signal from the patient, wherein the received signal comprises a sense signal comprising frequency content within a second frequency band, the second frequency band being distinct from the first frequency band;

applying a test tone signal simultaneously with the stimulation signal, the test tone signal comprising a test frequency outside of the first and second frequency bands;

in real time, using a processor, processing the received signal to produce a processed signal, wherein the processed signal comprises at least a first signal component from the sense signal and a second signal component caused by applying the test tone signal;

using the processor, monitoring at least one reliability signal indicative of the reliability of the processed signal,

wherein monitoring the at least one reliability signal comprises monitoring a magnitude of the second signal component, caused by applying the test tone signal, at the test frequency in the processed signal; and

in response to the reliability signal meeting at least one predetermined criterion, using the processor, automatically performing at least one action to improve the reliability of the processed signal,

wherein the reliability signal meeting the at least one predetermined criterion comprises the magnitude of the second signal component, caused by applying the test tone signal, at the test frequency being less than a predetermined threshold, and

wherein performing at least one action to improve the reliability of the processed signal comprises adjusting at least one of (i) the stimulation signal, (ii) the processing of the sense signal, and (iii) the test tone.

2. The method of claim 1, wherein:

processing the received signal comprises amplifying the received signal via an amplifier;

and

performing at least one action to improve the reliability of the processed signal comprises reducing the gain of the amplifier.

3. The method of claim 1, wherein the first frequency band comprises frequencies between 120 Hz and 160 Hz, and the second frequency band comprises frequencies between 0 and 100 Hz.

4. The method of claim 3, wherein the test tone frequency is approximately 105 Hz.

5. The method of claim 3, further comprising generating a graphical display for user analysis, the graphical display including representation of the frequency content of the sense signal over time.

6. The method of claim 1, wherein:

applying the stimulation signal to the patient comprises applying the stimulation signal to a patient'"'"'s brain;

receiving the signal from the patient comprises receiving the signal from the patient'"'"'s brain; and

applying the test tone signal comprises applying the test tone signal to the patient'"'"'s brain.

7. The method of claim 6, wherein applying the stimulation signal to the patient comprises applying a signal of sufficient magnitude in order to effect a desired change in the sense signal.

8. The method of claim 7, wherein the desired change in the sense signal comprises reducing the magnitude of beta waves in the sense signal.

9. The method of claim 7, wherein the desired change in the sense signal comprises increasing the magnitude of delta waves in the sense signal.

10. A system for providing and confirming treatment to a patient comprising:

a stimulation processor coupled to at least one stimulating electrode and configured to provide a stimulation signal to a patient for providing treatment to the patient, the stimulation signal comprising a stimulation frequency within a first frequency band;

a test electrode, the test electrode configured to apply a test tone signal simultaneously with the stimulation signal to the patient, the test tone signal having frequency content comprising a test frequency separate from the first frequency band;

at least one sensing electrode configured to receive signals from within the patient;

a signal chain in communication with and configured to receive a signal from the at least one sensing electrode, process the received signal, and in real time, output a processed signal,

wherein the processed signal comprises at least a first signal component from a sense signal and a second signal component caused by applying the test tone signal, and

wherein the sense signal comprises frequency content within a second frequency band, the second frequency band being distinct from the first frequency band and the test frequency;

and

a processor in communication with the signal chain and configured to;

(i) receive the processed signal from the signal chain, the processed signal including real-time data indicative of the effectiveness of the simultaneous stimulation signal during the application of the stimulation signal by the stimulation processor;

(ii) analyze a reliability signal based on one or both of signal chain operation and the content of the processed signal, the reliability signal being indicative of the reliability of the processed signal, wherein analyzing the reliability signal comprises comparing the magnitude of the second signal component, caused by applying the test tone signal, at the test frequency in the processed signal to a predetermined threshold; and

(iii) in the event that the reliability signal meets at least one predetermined criterion, automatically performing at least one action to improve the reliability of the processed signal, wherein the at least one action comprises adjusting at least one of (i) the stimulation signal, (ii) the processing of the sense signal, and (iii) the test tone.

11. The system of claim 10, wherein the real-time data indicative of the effectiveness of the stimulation signal comprises the magnitudes of one or more components of the processed signal at least one frequency band, and wherein a change in magnitude of the one or more components of the processed signal at least one target frequency band is indicative of the effectiveness of the simultaneous stimulation signal, wherein the at least one target frequency band comprises a frequency separate from the first frequency band and separate from the test frequency.

12. The system of claim 11, wherein the at least one action performed to improve the reliability of the processed signal comprises adjusting at least one component of the signal chain.

13. The system of claim 12, wherein the signal chain comprises at least one amplifier, and wherein adjusting at least one component of the signal chain comprises adjusting the gain of at least one of the at least one amplifier of the signal chain.

14. The system of claim 10, further comprising a display configured to present a graphical representation of the frequency content of the sense signal over time.

15. The system of claim 10, wherein the entire system is implantable into the body of the patient.

16. An automated system for simultaneously stimulating tissue of a patient and sensing physiological effects of the stimulation on the patient comprising:

a processor configured to provide (i) a stimulation signal patient via at least one stimulation electrode and (ii) a test tone signal to the patient via at least one test electrode, the stimulation signal comprising a stimulation frequency included in a first frequency band and the test tone signal comprising a test tone frequency outside of the first frequency band;

at least one sense electrode configured to receive a sense signal from the patient;

at least one amplifier configured to amplify the sense signal received from the at least one sense electrode, the at least one amplifier having an adjustable gain;

a processor in communication with the at least one amplifier and configured to;

(i) receive the amplified sense signal from the at least one amplifier;

(ii) determine the magnitude of a component in the amplified sense signal at the test tone frequency component;

(iii) compare the magnitude of the component in the amplified sense signal at the test tone frequency in the amplified sense signal to a predetermined threshold; and

(iv) if the magnitude of the component in the amplified sense signal at the test tone frequency in the amplified sense signal falls below a predetermined threshold, automatically lower the gain on the at least one amplifier.

17. The automated system of claim 16, wherein the processor in step (iv) incrementally lowers the gain until the magnitude of the component in the amplified sense signal at the test tone frequency until the amplified sense signal returns above the predetermined threshold.

18. The automated system of claim 17, wherein the processor saves the gain at which the amplified sense signal returns above the predetermined threshold in memory.

19. The automated system of claim 16, further configured to monitor a change in the sense signal in at least a second frequency band separate from the first frequency band and the test frequency.

20. The automated system of claim 19, wherein the first frequency band comprises frequencies between 120 Hz and 160 Hz, the second frequency band comprises frequencies between 0 and 100 Hz, and the test tone frequency is approximately 105 Hz.