DEVICE FOR INTERACTING WITH NEUROLOGICAL TISSUE AND METHODS OF MAKING AND USING THE SAME

• US 20130085361A1
• Filed: 03/31/2011
• Published: 04/04/2013
• Est. Priority Date: 04/01/2010
• Status: Active Grant

• Current Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Original Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Inventors: Renaud, Philippe, Pollo, Claudio, Mercanzini, Andr
• Granted Patent: US 9,549,708 B2
• Time in Patent Office: Days
• US Class Current: 600/377
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6877 Nerve
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/501 for diagnosis of the head, e.g. neuroimaging or craniography
• CPC Class Codes: A61B 6/506 for diagnosis of nerves
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Described herein are microelectrode array devices, and methods of fabrication, assembly and use of the same, to provide highly localized neural recording and/or neural stimulation to a neurological target. The device includes multiple microelectrode elements arranged protruding shafts. The protruding shafts are enclosed within an elongated probe shaft, and can be expanded from their enclosure. The microelectrode elements, and elongated probe shafts, are dimensioned in order to target small volumes of neurons located within the nervous system, such as in the deep brain region. Beneficially, the probe can be used to quickly identify the location of a neurological target, and remain implanted for long-term monitoring and/or stimulation.

Claims

1. An implantable neurological probe comprising:

an elongated shaft having a distal end and an internal lumen;

a support cylinder slidingly disposed in only a distal portion of the internal lumen;

a plurality of shafts coupled to the support cylinder and arranged to be selectively extended from the distal end of the elongated shaft;

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

a stylet removably disposed in the internal lumen and configured to contact the support cylinder to selectively extend the plurality of shafts during implantation; and

a pull wire coupled to the support cylinder to selectively retract the support cylinder and plurality of shafts within the internal lumen.

2. The implantable neurological probe of claim 1, comprising a push-pull rod which comprises the pull wire and the stylet.

3. The implantable neurological probe of claim 1, wherein the elongated shaft is configured for insertion into a human body using an accepted procedure for insertion of deep brain stimulation leads.

4. The implantable neurological probe of claim 1, wherein the diameter of the elongated shaft is between 1 mm and 3 mm

5. The implantable neurological probe of claim 1, wherein at least one of the plurality of microelectrode elements is a stimulating electrode and at least one of the plurality of microelectrode elements is a detecting electrode.

6. The implantable neurological probe of claim 1, wherein at least one of the plurality of microelectrodes elements is both a stimulating electrode and a detecting electrode.

7. The implantable neurological probe of claim 1, wherein each microelectrode element is formed on a conductive film, and wherein each microelectrode element is embedded within two isolating substrates.

8. The implantable neurological probe of claim 7, wherein the microelectrode embedded substrate is formable into a cylindrical assembly.

9. The implantable neurological probe of claim 8, where the protruding shafts can be formed to bend radially from the longitudinal axis of the cylindrical assembly.

10. The implantable neurological probe of claim 8, where one of the protruding shafts extends and is centered along the longitudinal axis of the cylindrical assembly.

11. The implantable neurological probe of claim 9, where the protruding shafts are stiffened by a supporting member.

12. The implantable neurological probe of claim 10, where the longitudinal protruding shaft is stiffened by a supporting member.

13. An implantable neurological probe comprising:

an elongated shaft having a distal end and an internal lumen;

a plurality of shafts arranged to be selectively extended from the distal end of the elongated shaft; and

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

wherein the plurality of shafts define a substantially cylindrical volume when fully extended.

14. The implantable neurological probe of claim 13, wherein the elongated shaft is configured for insertion into a human body using an accepted procedure for insertion of deep brain stimulation leads.

15. The implantable neurological probe of claim 13, wherein the diameter of the elongated shaft is between 1 mm and 3 mm

16. The implantable neurological probe of claim 13, wherein at least one of the plurality of microelectrode elements is a stimulating electrode and at least one of the plurality of microelectrode elements is a detecting electrode.

17. The implantable neurological probe of claim 13, wherein at least one of the plurality of microelectrodes elements is both a stimulating electrode and a detecting electrode.

18. The implantable neurological probe of claim 13, wherein each microelectrode element is formed on a conductive film, and wherein each microelectrode element is embedded within two isolating substrates.

19. The implantable neurological probe of claim 18, wherein the microelectrode embedded substrate is formable into a cylindrical assembly.

20. The implantable neurological probe of claim 19, where the protruding shafts can be formed to bend radially from the longitudinal axis of the cylindrical assembly.

21. The implantable neurological probe of claim 19, where one of the protruding shafts extends and is centered along the longitudinal axis of the cylindrical assembly.

22. The implantable neurological probe of claim 19, where the protruding shafts are stiffened by a supporting member.

23. The implantable neurological probe of claim 21, where the longitudinal protruding shaft is stiffened by a supporting member.

24. A method for finding a neurological target comprising:

implanting a neurological probe within a vicinity of a neurological target site, the neurological probe comprising;

an elongated shaft having a distal end and an internal lumen;

a support cylinder slidingly disposed in only a distal portion of the internal lumen;

a plurality of shafts coupled to the support cylinder and arranged to be selectively extended from the distal end of the elongated shaft;

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

a stylet removably disposed in the internal lumen and configured to contact the support cylinder to selectively extend the plurality of shafts during implantation; and

a pull wire coupled to the support cylinder to selectively retract the support cylinder and plurality of shafts within the internal lumen;

retracting the plurality of shafts within the internal lumen before surgical implantation;

extending the plurality of shafts in the vicinity of the neurological target site following implantation;

recording electrophysiological signals from the neurological target site using at least one of the microelectrode elements on at least one of the protruding shafts; and

stimulating the neurological target using at least one of the microelectrode elements on at least one of the plurality of shafts.

25. The method of claim 24, further comprising:

after the acts of recording and stimulating, retracting the plurality of shafts within the internal lumen and removing the neurological probe from a subject.

26. The method of claim 24, wherein the protruding shafts are retracted using the pull wire.

27. The method of claim 24, wherein the plurality of shafts are extended using the stylet.

28. The method of claim 24, wherein the neurological probe comprises a push-pull rod which comprises the pull wire and the stylet

29. The method of claim 24, wherein the act of recording neurophysiological signals comprises recording neural activity detected by at least one of the plurality of microelectrode elements and repositioning the distal end of the elongated shaft as required, until the recorded activity is indicative of the distal end of the elongated probe shaft being located sufficiently at the neurological target site.

30. The method of claim 24, comprising:

stimulating neural activity by applying electrical signals to at least one of the plurality of microelectrode elements on at least one of the plurality of shafts,

performing a clinical evaluation of the efficacy on the stimulation site in the implanted patient, and

repositioning the distal end of the elongated shaft as required, until the patient'"'"'s response is indicative of the distal end of the elongated shaft being located sufficiently at the neurological target site.

31. The method of claim 24, comprising:

inhibiting neural activity by applying electrical signals to at least one of the plurality of microelectrode elements on at least one of the plurality of shafts,

performing a clinical evaluation of the efficacy on the inhibition site in the implanted patient, and

repositioning the distal end of elongated shaft as required, until the patient'"'"'s response is indicative of the distal end of the elongated shaft being located sufficiently at the neurological target site.

32. A method for finding a neurological target comprising:

implanting a neurological probe within a vicinity of a neurological target site, the neurological probe comprising;

an elongated shaft having a distal end and an internal lumen;

a support cylinder slidingly disposed in only a distal portion of the internal lumen;

a plurality of shafts coupled to the support cylinder and arranged to be selectively extended from the distal end of the elongated shaft;

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

a stylet removably disposed in the internal lumen and configured to contact the support cylinder to selectively extend the plurality of shafts during implantation; and

a pull wire coupled to the support cylinder to selectively retract the support cylinder and plurality of shafts within the internal lumen;

retracting the plurality of shafts within the internal lumen before surgical implantation;

expanding the plurality of shafts in the vicinity of the neurological target site following implantation;

applying an oscillating electric current between at least two of the microelectrode elements on at least one of the plurality of shafts;

detecting an electric voltage between at least two of the microelectrode elements on at least one of the plurality of shafts.

33. The method of claim 32, further comprising:

after the act of detecting, retracting the plurality of shafts within the internal lumen and removing the neurological probe from a subject.

34. The method of claim 32, comprising imaging the electrical characteristics of the volume of neurological tissue between the plurality of shafts based on the applied oscillating electric current and the detected electric voltage.

35. The method of claim 32, wherein the neurological probe comprises a push-pull rod which comprises the pull wire and the stylet.

46. The method of claim 34, further comprising:

after the act of detecting, retracting the plurality of shafts within the internal lumen and removing the neurological probe from a subject.

36. A method for finding a neurological target comprising:

implanting a neurological probe within a vicinity of a neurological target site, the neurological probe comprising;

an elongated shaft having a distal end and an internal lumen;

a plurality of shafts arranged to be selectively extended from the distal end of the elongated shaft; and

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

wherein the plurality of shafts define a substantially cylindrical volume when fully extended.

retracting the plurality of shafts within the internal lumen before surgical implantation;

extending the plurality of shafts in the vicinity of the neurological target site following implantation;

recording electrophysiological signals from the neurological target site using at least one of the microelectrode elements on at least one of the protruding shafts; and

stimulating the neurological target using at least one of the microelectrode elements on at least one of the plurality of shafts.

37. The method of claim 36, wherein the protruding shafts are retracted using a pull wire.

38. The method of claim 37, wherein the plurality of shafts are extended using a stylet.

39. The method of claim 38, wherein the neurological probe comprises a push-pull rod which comprises the pull wire and the stylet.

40. The method of claim 36, wherein the act of recording neurophysiological signals comprises recording neural activity detected by at least one of the plurality of microelectrode elements and repositioning the distal end of the elongated shaft as required, until the recorded activity is indicative of the distal end of the elongated probe shaft being located sufficiently at the neurological target site.

41. The method of claim 36, further comprising:

after the acts of recording and stimulating, retracting the plurality of shafts within the internal lumen and removing the neurological probe from a subject.

42. The method of claim 36, comprising:

stimulating neural activity by applying electrical signals to at least one of the plurality of microelectrode elements on at least one of the plurality of shafts,

performing a clinical evaluation of the efficacy on the stimulation site in the implanted patient, and

repositioning the distal end of the elongated shaft as required, until the patient'"'"'s response is indicative of the distal end of the elongated shaft being located sufficiently at the neurological target site.

43. The method of claim 36, comprising:

inhibiting neural activity by applying electrical signals to at least one of the plurality of microelectrode elements on at least one of the plurality of shafts,

performing a clinical evaluation of the efficacy on the inhibition site in the implanted patient, and

repositioning the distal end of elongated shaft as required, until the patient'"'"'s response is indicative of the distal end of the elongated shaft being located sufficiently at the neurological target site.

44. A method for finding a neurological target comprising:

implanting a neurological probe within a vicinity of a neurological target site, the neurological probe comprising;

an elongated shaft having a distal end and an internal lumen;

a plurality of shafts arranged to be selectively extended from the distal end of the elongated shaft; and

a plurality of microelectrode elements disposed on each of the plurality of shafts, the microelectrode elements comprising a planar substrate having an insulative layer and a plurality of conductive traces disposed on the insulative layer,

wherein the plurality of shafts define a substantially cylindrical volume when fully extended;

retracting the plurality of shafts within the internal lumen before surgical implantation;

expanding the plurality of shafts in the vicinity of the neurological target site following implantation;

applying an oscillating electric current between at least two of the microelectrode elements on at least one of the plurality of shafts;

detecting an electric voltage between at least two of the microelectrode elements on at least one of the plurality of shafts.

45. The method of claim 44, comprising imaging the electrical characteristics of the volume of neurological tissue between the plurality of shafts based on the applied oscillating electric current and the detected electric voltage.