Microfabricated surface neurostimulation device and methods of making and using the same

• US 8,774,937 B2
• Filed: 12/01/2010
• Issued: 07/08/2014
• Est. Priority Date: 12/01/2009
• 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
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/512,936
• Publication Number:
  US 20120277834A1
• Time in Patent Office: 1,315 Days
• Field of Search: 607115-119, 607/152
• US Class Current: 607/116
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• 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 5/24 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 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: Y10T 29/49147 Assembling terminal to base

Abstract

Described herein are microelectrode array devices, and methods of fabrication and use of the same, to provide highly localized and efficient electrical stimulation of a neurological target. The device includes multiple microelectrode elements arranged along an supportive backing layer. The microelectrode elements are dimensioned and shaped so as to target individual neurons, groups of neurons, and neural tissue as may be located in an animal nervous system, such as along a region of a cortex of a human brain. Beneficially, the neurological probe can be used to facilitate location of the neurological target and remain implanted for long-term monitoring and/or stimulation.

Claims

1. An implantable neurological probe comprising:

a supportive backing layer comprising a substantially planar surface and defining a plurality of cutouts distributed over the substantially planar surface, the supportive backing layer having a protrusion extending into each of the plurality of cutouts of the supportive backing layer; and

a flexible substrate disposed on the supportive backing layer and comprising an insulative layer, a conductive layer comprising one or more conductive traces disposed on the insulative layer, at least one microelectrode element disposed on the insulative layer and coupled to the one or more conductive traces, and a second insulative layer disposed on the conductive layer, the at least one microelectrode element arranged along the at least one protrusion.

2. The implantable neurological probe of claim 1, further comprising a microelectrode layer disposed along at least a portion of at least one surface of the supportive backing layer and the at least one protrusion, the at least one microelectrode element being formed thereon.

3. The implantable neurological probe of claim 2, comprising at least one feature to promote flexibility of the supportive backing layer.

4. The implantable neurological probe of claim 3, wherein the at least one feature includes an aperture promoting flexibility in a preferred direction.

5. The implantable neurological probe of claim 1, wherein the length of the at least one protrusion is not more than about 4 mm.

6. The implantable neurological probe of claim 1, comprising a plurality of microelectrode elements, wherein at least one of the plurality of microelectrode elements is shaped substantially different from another microelectrode element of the plurality of microelectrode elements.

7. The implantable neurological probe of claim 1, comprising a plurality of microelectrode elements, 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.

8. The implantable neurological probe of claim 7, wherein the at least one stimulating electrode is shaped substantially different from the at least one detecting electrode.

9. The implantable neurological probe of claim 8, wherein the at least one of the stimulating electrode and the detecting electrode comprises a plurality of electrically conducting sub-elements.

10. The implantable neurological probe of claim 9, wherein the at least one of the stimulating electrode and the detecting electrode comprises a tetrode arrangement of electrically conducting sub-elements.

11. The implantable neurological probe of claim 1, wherein the at least one microelectrode element is configured as a micro-electromechanical system (MEMS).

12. The implantable neurological probe of claim 1, further comprising at least one electronic circuit element in electrical communication with the at least one microelectrode element.

13. The implantable neurological probe of claim 12, wherein the at least one electronic circuit element is selected from the group consisting of:

a switch;

a router;

an amplifier;

a controller;

a microprocessor;

memory;

a multiplexer;

a filter;

an attenuator;

a resistor;

a capacitor;

an inductor;

a diode;

a transistor; and

combinations thereof.

14. The implantable neurological probe of claim 1 wherein the supportive backing layer is semi-rigid.

15. The implantable neurological probe of claim 14, wherein the supportive backing layer includes medical grade stainless steel.

16. A method for stimulating a neurological target comprising:

implanting a neurological probe within a vicinity of a neurological target site, the neurological probe comprising a supportive backing layer comprising a substantially planar surface and defining a plurality of cutouts distributed over the substantially planar surface, the supportive backing layer having a protrusion extending into each of the plurality of cutouts of the supportive backing layer, and a flexible substrate disposed on the supportive backing layer and comprising an insulative layer, a conductive layer comprising one or more conductive traces disposed on the insulative layer, at least one microelectrode element disposed on the insulative layer and coupled to the one or more conductive traces, and a second insulative layer disposed on the conductive layer, the at least one microelectrode element arranged along the at least one protrusion; and

energizing by a supplied electrical signal, the at least one microelectrode element, wherein the at least one microelectrode element produces an electric field adapted to stimulate the neurological target site.

17. The method of claim 16, wherein the act of implanting comprising:

positioning a surface of the supportive backing layer along a surface of a brain;

inserting the at least one protrusion through the surface of the brain, such that the at least one microelectrode element is arranged at a depth measured from the surface.

18. The method of claim 17, wherein the act of positioning and inserting the neurological probe comprises recording neurological activity detected by the at least one microelectrode element and repositioning the neurological probe as required, until the recorded activity is indicative of the neurological probe being located sufficiently at the neurological target site.

19. The method of claim 16, wherein the supplied electrical signal is obtained from an implanted pulse generator.

20. An implantable neurological surface probe comprising:

a supportive backing layer comprising a substantially planar surface and defining a plurality of cutouts distributed over the substantially planar surface;

a plurality of protrusions, each attached at one end to the supportive backing layer and extending into one of the plurality of cutouts of the supportive backing layer;

a microelectrode film disposed along at least a portion of the supportive backing layer;

a plurality of microelectrode elements disposed on the microelectrode film and arranged along each of the plurality of protrusions, each microelectrode element disposed at a respective depth measured from the surface of the supportive backing layer.

21. The implantable neurological surface probe of claim 20, further comprising an electronic circuit in electrical communication with at least some of the plurality of microelectrode elements.

22. A method of making an implantable neurological surface probe comprising:

shaping a supportive backing layer comprising a substantially planar surface and defining a plurality of cutouts distributed over the substantially planar surface;

defining within the supportive backing layer a plurality of rigid backing members each having a tip at one end and attached at another end, each one of the plurality of rigid backing members extending into one of the plurality of cutouts distributed over the substantially planar surface;

bending each rigid backing member away from a surface of the supportive backing layer, thereby forming a plurality of protrusions;

forming a plurality of microelectrode elements on a microelectrode film;

fastening the microelectrode film along at least a portion of the surface the supportive backing layer, such that respective subsets of the plurality of microelectrode elements are arranged along each of the plurality of protrusions, each microelectrode element of each respective subset disposed at a respective depth measured from the surface of the supportive backing layer.

23. The method of claim 22, wherein shaping the supportive backing layer comprises one or more of laser cutting, water-jet cutting, chemical etching using a photosensitive mask.