Implantable systems and methods for identifying a contra-ictal condition in a subject

• US 9,445,730 B2
• Filed: 09/09/2013
• Issued: 09/20/2016
• Est. Priority Date: 03/21/2007
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Snyder, David, Leyde, Kent W., Harris, John F.
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US14/021,651
• Publication Number:
  US 20140012111A1
• Time in Patent Office: 1,107 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

Systems and methods of monitoring a subject'"'"'s neurological condition are provided. In some embodiments, the method includes the steps of analyzing a physiological signal (such as an EEG) from a subject to determine if the subject is in a contra-ictal condition; and if the subject is in a contra-ictal condition, providing an indication (e.g., to the subject and/or to a caregiver) that the subject is in the contra-ictal condition. The systems and methods may utilize a minimally invasive, leadless device to monitor the subject'"'"'s condition. In some embodiments, if the subject is in a pro-ictal condition, the method includes the step of providing an indication (such as a red light) that the subject is in the pro-ictal condition.

Claims

1. A physiological monitoring system comprising:

an electrode configured to detect a physiological signal from a subject;

a processing assembly for sampling the physiological signal, the processing assembly being configured to process the physiological signal to determine whether the subject is in a contra-ictal state and generate an output indicating the determination, said contra-ictal state being a neurological state in which the subject is unlikely to transition into an ictal state within a time period; and

a therapy device that receives the output and selectively applies therapy in response to the output.

2. The physiological monitoring system of claim 1, further comprising:

a user interface configured to provide an output to the subject regarding the contra-ictal state of the subject.

3. The physiological monitoring system of claim 1, the processing assembly being further configured to process the physiological signal to determine whether the subject transitions into or from the contra-ictal state.

4. The physiological monitoring system of claim 1, the processing assembly being further configured to process the physiological signal to determine whether the subject transitions from the contra-ictal state to an inter-ictal state different than the contra-ictal state.

5. The physiological monitoring system of claim 1, the processing assembly being further configured to process the physiological signal to determine whether the subject transitions from the contra-ictal state to the ictal state.

6. The physiological monitoring system of claim 1, wherein the processing assembly is adapted to determine if the subject is in a contra-ictal condition by:

extracting N features from the sampled physiological signal;

generating an N-dimensional feature vector of the extracted N features for time points of the sampled physiological signal; and

determining if the N-dimensional feature vector is within a contra-ictal cluster or region in an N-dimensional space.

7. The physiological monitoring system of claim 1, wherein the physiological signal is at least one of an EEG signal, a heart rate signal, and a respiratory signal.

8. The physiological monitoring system of claim 1, wherein the physiological signal corresponds to at least one of a blood pressure, a blood oxygenation, a temperature, a blood flow, an ECG, an EKG, a chemical concentration of a neurotransmitter, a chemical concentration of a medication, and a pH in the blood.

9. The physiological monitoring system of claim 1, wherein the electrode is configured to detect the physiological signal through the skin of the subject.

10. The physiological monitoring system of claim 1, wherein the therapy device comprises an implanted stimulator.

11. A method of monitoring physiological signals from a subject, said method comprising:

detecting a physiological signal from the subject with an electrode;

analyzing the physiological signal from the subject using a processor to determine whether the subject is in a contra-ictal state and generate an output indicating the determination, said contra-ictal state being a neurological state in which the subject is unlikely to transition into an ictal state within a time period; and

selectively applying therapy in response to the output using a therapy device.

12. The method of claim 11, further comprising:

reporting an output to the subject regarding the contra-ictal state of the subject.

13. The method of claim 11, further comprising:

analyzing the physiological signal to determine whether the subject transitions into or from the contra-ictal state.

14. The method of claim 11, further comprising:

analyzing the physiological signal to determine whether the subject transitions from the contra-ictal state to an inter-ictal state different than the contra-ictal state.

15. The method of claim 11, further comprising:

analyzing the physiological signal to determine whether the subject transitions from the contra-ictal state to the ictal state.

16. The method of claim 11, wherein the analyzing the physiological signal comprises:

extracting N features from the sampled physiological signal;

generating an N-dimensional feature vector of the extracted N features for time points of the sampled physiological signal; and

determining if the N-dimensional feature vector is within a contra-ictal cluster or region in an N-dimensional space.

17. The method of claim 11, wherein the physiological signal is at least one of an EEG signal, a heart rate signal, and a respiratory signal.

18. The method of claim 11, wherein the physiological signal corresponds to at least one of a blood pressure, a blood oxygenation, a temperature, a blood flow, an ECG, an EKG, a chemical concentration of a neurotransmitter, a chemical concentration of a medication, and a pH in the blood.

19. The method of claim 11, wherein the electrode is configured to detect the physiological signal through the skin of the subject.

20. The method of claim 11, wherein selectively applying therapy in response to the output using a therapy device comprises applying the therapy using an implanted stimulator.

21. A physiological monitoring system comprising:

an electrode configured to detect a physiological signal from a subject;

a processing assembly for sampling the physiological signal, the processing assembly being configured to process the physiological signal to determine whether the subject is in a contra-ictal state and generate an output indicating the determination, said contra-ictal state being a neurological state in which the subject is unlikely to transition into an ictal state within a time period;

a therapy device that receives the output and selectively applies therapy in response to the output; and

a user interface in communication with the processing assembly, the user interface generating an output based on the physiological signal, the output indicating whether the subject is in a contra-ictal state.

22. The physiological monitoring system of claim 21, the output further indicating at least one of whether the subject transitions into the contra-ictal state, the subject transitions from the contra-ictal state, the subject transitions from the contra-ictal state to an inter-ictal state different than the contra-ictal state, and the subject transitions from the contra-ictal state to the ictal state.

23. The physiological monitoring system of claim 21, wherein the therapy device comprises an implanted stimulator.