Evoked response probe and method of use

• US 10,327,663 B2
• Filed: 09/02/2014
• Issued: 06/25/2019
• Est. Priority Date: 08/31/2013
• Status: Active Grant

• Current Assignee: All In Limited, Alpha Omega Engineering Ltd.
• Original Assignee: Alpha Omega Neuro Technologies Limited
• Inventors: Farah, Maroun, Bergman, Hagai
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/475,223
• Publication Number:
  US 20150065839A1
• Time in Patent Office: 1,757 Days
• Field of Search: 600383
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6868 Brain

Abstract

The disclosure relates to a surgical cranial drape, probe for mapping brain of a subject and their methods of use. Specifically, the disclosure relates to a sterile surgical cranial drape embedded with electrodes; an system for mapping physiologically functional brain regions using evoked electrophysiological responses in a first and a second region; and their methods of use in combination or separately.

Claims

1. A brain mapping system, comprising:

a. a first probe shaped as a needle, shaped and sized to be inserted into a brain of a subject, having a proximal end and a distal end and a longitudinal axis, the probe comprising a plurality of contacts operably coupled thereto, disposed along the longitudinal axis, wherein said probe is selectively operable for stimulating an electrophysiological evoked response;

b. at least one electrode configured to be placed near muscles or inserted into muscles of said subject, configured to record an evoked response caused by said stimulating;

and

c. an analysis module electrically connected to said probe, wherein said analysis module is operative for providing segmentation of the brain into a plurality of physiologically active brain regions along an insertion path of said first probe based on signals recorded by said at least one electrode.

2. The system of claim 1, wherein stimulating electrophysiological evoked response comprises stimulating unipolar signal, bipolar signal or both unipolar and a bipolar signal, and wherein said recording electrophysiological evoked response comprises recording single ended signal, or differential signal.

3. The system of claim 1, wherein at least two of the plurality of contacts of said first probe are macro-contacts configured to selectively perform localized stimulation.

4. The system of claim 3, wherein localized stimulation is configured to take place between two adjacent macro-contacts of said first probe.

5. The system of claim 1, wherein said at least one electrode configured to be placed near muscles or inserted into muscles of said subject is an EMG electrode.

6. The system of claim 1, wherein said recording evoked response comprises recording a single ended signal and/or a differential signal.

7. The system of claim 1, wherein said analysis module is operative for providing said segmentation based on signals recorded by said at least one electrode and a sedation level of said subject.

8. A method of mapping a plurality of physiologically functional brain regions in a sedated subject, comprising:

a. inserting a first probe shaped as a needle comprising a plurality of electrode contacts into the brain of a sedated subject;

b. stimulating at a first location in a manner suitable to evoke an electrophysiological response;

c. recording an evoked electrophysiological response at a second location;

d. analyzing the recorded evoked response; and

e. segmenting the brain to physiologically active regions along an insertion path of said first probe, thereby mapping the brain, based on the analyzed evoked response.

9. The method of claim 8, comprising:

obtaining a measurement related to a sedation level of said subject;

and wherein said segmenting comprises segmenting the brain to said physiologically active brain regions based on said measurement and the analysis of the recorded evoked response.

10. The method of claim 9, comprising normalizing the recorded evoked electrophysiological response according to said measurement.

11. The method of claim 8, wherein said stimulating comprises stimulating at a first location by at least one electrode contact on said probe to evoke said electrophysiological response;

and wherein said recording comprises recording said evoked response at said second location by at least one electrode configured to be positioned near muscles or inserted into muscles of said sedated subject.

12. The method of claim 11, comprising determining stimulation parameters based on the results of said analyzing the evoked response recorded by said at least one electrode.

13. The method of claim 11, wherein said at least one electrode associated with muscles of said sedated subject is an EMG electrode.

14. The method of claim 8, wherein said recording comprises recording said evoked electrophysiological response by an EEG electrode positioned over the head of a patient at said second location, and wherein said analyzing comprises analyzing the evoked electrophysiological response recorded by said EEG electrode in response to a stimulation delivered at said first location through at least one electrode contact of said probe during said stimulating.

15. The method of claim 14, comprising determining stimulation parameters based on the results of said analyzing the evoked electrophysiological response recorded by said EEG electrode.

16. The method of claim 8, wherein said stimulating comprises stimulating at the first location to evoke said electrophysiological response by at least one electrode configured to be positioned near muscles or inserted into muscles of said sedated subject, and wherein said recording comprises recording an evoked electrophysiological response at said second location by at least one electrode contact of said probe.

17. The method of claim 8, wherein said inserting comprises advancing said first probe through a plurality of brain regions, and wherein said segmenting comprises segmenting the brain to physiologically active regions within said plurality of brain regions along an insertion path of said probe.

18. The method of claim 8, wherein said analyzing comprises analyzing said evoked response while advancing said probe through said brain regions.

19. The method of claim 8, wherein said stimulating comprises stimulating a physiologically active brain region at said first location by an electrode contact of said probe according to established stimulation parameters sufficient to activate said physiologically active brain region thereby evoking said physiological response.

20. The method of claim 19, wherein said analyzing comprises detecting differences between evoked responses recorded along an insertion path of said probe, and wherein said segmenting comprises segmenting the brain to physiologically active brain regions, thereby mapping the brain based on said differences.

21. The method of claim 19, comprising determining the position of said probe or said at least one electrode contact used to stimulate said physiologically active brain region based on the analysis of said evoked response.

22. The method of claim 19 wherein said stimulation parameters comprise stimulation amplitudes, stimulation waveforms, stimulation frequencies, and/or stimulation pulse width.

23. The method of claim 19 comprising selecting said stimulation parameters based on said analysis of said evoked response.

24. The method of claim 8, wherein said recording comprises recording said evoked physiological response by said at least one electrode contact during DBS surgeries.

25. The method of claim 24, comprising determining a desired location for delivery of DBS stimulation based on the results of said segmenting.

26. The method of claim 8, wherein said stimulating comprises a selected configuration of one or more contacts on said probe to stimulate a physiologically active brain region at said first location thereby evoking said physiological response.

27. The method of claim 26, wherein said selected configuration of said one or more contacts comprises a unipolar configuration.

28. The method of claim 26, wherein said selected configuration of said one or more contacts comprises a bipolar or a multi-polar configuration.

29. A brain mapping system, comprising:

a. a probe shaped as a needle, shaped and sized to be inserted into a brain of a subject, having a proximal end and a distal end and a longitudinal axis, the probe comprising a plurality of contacts operably coupled thereto, disposed along the longitudinal axis, wherein said probe is selectively operable for recording an electrophysiological evoked response and for stimulating an electrophysiological evoked response;

b. at least one electrode configured to be placed near muscles or inserted into muscles of said subject, configured for recording an electrophysiological evoked response and for stimulating an electrophysiological evoked response; and

c. an analysis module electrically connected to said probe, wherein said analysis module is operative for providing segmentation of the brain into a plurality of physiologically active brain regions along an insertion path of said probe based on;

(1) an electrophysiological evoked response recorded by said at least one electrode and caused by stimulation with said probe;

or

(2) an electrophysiological evoked response recorded by said probe and caused by stimulation with said at least one electrode.

30. The system of claim 29, wherein said analysis module is operative for providing said segmentation based on a recorded electrophysiological evoked response and a sedation level of said subject.