Device for interacting with neurological tissue and methods of making and using the same

• US 9,549,708 B2
• Filed: 03/31/2011
• Issued: 01/24/2017
• 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: Mercanzini, Andr, Renaud, Philippe, Pollo, Claudio
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/638,435
• Publication Number:
  US 20130085361A1
• Time in Patent Office: 2,126 Days
• Field of Search: 600372-374, 600377-378, 600544-545, 607115-119, 607122-123
• US Class Current: 1/1
• 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 for selective extension from the distal end of the elongated shaft;

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable that separates the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable couples each of the plurality of microelectrode elements with a respective proximal contact pad;

a planar substrate having an insulative layer; and

a plurality of conductive traces disposed on the insulative layer; and

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

2. The implantable neurological probe of claim 1, comprising a push-pull rod which comprises a 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 a 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 of the plurality of microelectrode elements is disposed on the insulative layer.

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

9. The implantable neurological probe of claim 8, wherein each of the plurality of shafts can be formed to bend radially from a longitudinal axis of the elongated shaft.

10. The implantable neurological probe of claim 8, where one of the plurality of shafts extends and is centered along a longitudinal axis of the elongated shaft.

11. The implantable neurological probe of claim 9, where each of the plurality of microelectrode film shafts are stiffened by one of the plurality of shafts.

12. An implantable neurological probe, comprising:

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

a plurality of shafts coupled to a support cylinder, the plurality of shafts arranged for selective extension from the distal end of the elongated shaft; and

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable separating the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable coupling each of the plurality of microelectrode elements with a respective proximal contact pad;

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.

13. The implantable neurological probe of claim 12, wherein the elongated shaft is configured for insertion into a human body using an accepted procedure for insertion of deep brain stimulation leads.

14. The implantable neurological probe of claim 12, wherein a diameter of the elongated shaft is between 1 mm and 3 mm.

15. The implantable neurological probe of claim 12, 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.

16. The implantable neurological probe of claim 12, wherein at least one of the plurality of microelectrodes elements is both a stimulating electrode and a detecting electrode.

17. The implantable neurological probe of claim 12, wherein each of the plurality of microelectrode elements is disposed on the insulative layer.

18. The implantable neurological probe of claim 17, wherein the microelectrode array film is formable into a cylindrical assembly.

19. The implantable neurological probe of claim 18, where at least one of the plurality of shafts can be formed to bend radially from a longitudinal axis of the elongated shaft.

20. The implantable neurological probe of claim 18, where one of the plurality of shafts is centered along a longitudinal axis of the elongated shaft.

21. The implantable neurological probe of claim 18, where each of the plurality of microelectrode shafts are stiffened by one of the plurality of shafts.

22. A method of 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 for selective extension from the distal end of the elongated shaft;

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable separating the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable coupling each of the plurality of microelectrode elements with a respective proximal contact pad;

a planar substrate having an insulative layer; and

a plurality of conductive traces disposed on the insulative layer; and

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

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 plurality of microelectrode elements; and

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

23. The method of claim 22, 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.

24. The method of claim 22, wherein the plurality of shafts are retracted using a pull wire.

25. The method of claim 22, wherein the plurality of shafts are extended using the stylet.

26. The method of claim 22, wherein the neurological probe comprises a push-pull rod which comprises a pull wire and the stylet.

27. The method of claim 22, 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.

28. The method of claim 22, comprising:

stimulating neural activity at a stimulation site by applying electrical signals to at least one of the plurality of microelectrode elements;

performing a clinical evaluation of the efficacy on the stimulation site in a 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.

29. The method of claim 22, comprising:

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

performing a clinical evaluation of the efficacy on the inhibition site in a 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.

30. A method of 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 for selective extension from the distal end of the elongated shaft;

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable separating the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable coupling each of the plurality of microelectrode elements with a respective proximal contact pad;

a planar substrate having an insulative layer; and

a plurality of conductive traces disposed on the insulative layer; and

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

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 plurality of microelectrode elements; and

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

31. The method of claim 30, further comprising:

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

32. The method of claim 30, 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.

33. The method of claim 30, wherein the neurological probe comprises a push-pull rod which comprises a pull wire and the stylet.

44. 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. A method of 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 coupled to a support cylinder, the plurality of shafts arranged for selective extension from the distal end of the elongated shaft; and

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable separating the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable coupling each of the plurality of microelectrode elements with a respective proximal contact pad;

a planar substrate having an insulative layer; and

a plurality of conductive traces disposed on the insulative layer; and

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 plurality of microelectrode elements; and

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

35. The method of claim 34, wherein the protruding shafts are retracted using a pull wire.

36. The method of claim 35, wherein the plurality of shafts are extended using a stylet.

37. The method of claim 36, wherein the neurological probe comprises a push-pull rod which comprises the pull wire and the stylet.

38. The method of claim 34, 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.

39. The method of claim 34, 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.

40. The method of claim 34, comprising:

stimulating neural activity at a stimulation site by applying electrical signals to at least one of the plurality of microelectrode elements;

performing a clinical evaluation of the efficacy on the stimulation site in a 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.

41. The method of claim 34, comprising:

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

performing a clinical evaluation of the efficacy on the inhibition site in a 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.

42. A method of 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 coupled to a support cylinder, the plurality of shafts arranged for selective extension from the distal end of the elongated shaft; and

a microelectrode array film comprising a first portion coupled toward the distal end of the elongated shaft and a second portion coupled with the support cylinder, the microelectrode array film comprising a plurality of microelectrode film shafts disposed on each of the plurality of shafts, each of the plurality of microelectrode film shafts comprising a plurality of microelectrode elements, the microelectrode array film further comprising;

a helical ribbon cable separating the first portion of the microelectrode array film from the second portion of the microelectrode array film, the helical ribbon cable coupling each of the plurality of microelectrode elements with a respective proximal contact pad;

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;

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

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

43. The method of claim 42, 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.