Neural device with modular electrode array

• US 9,248,269 B2
• Filed: 07/24/2012
• Issued: 02/02/2016
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Original Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Inventors: Kipke, Daryl R., Vetter, Rio J., Kong, Kc, Hetke, Jamille, Anderson, David
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/556,715
• Publication Number:
  US 20130144365A1
• Time in Patent Office: 1,288 Days
• Field of Search: 600/373, 600/377, 600/378, 600/393, 607/118, 298/25
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 5/06 using light
• CPC Class Codes: A61N 5/0622 Optical stimulation for exciting neural tissue
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An apparatus comprises a flexible substrate including a modular electrode array disposed on the flexible substrate. The modular electrode array includes a plurality of electrode modules, where an electrode module includes a plurality of electrodes. The flexible substrate also includes a spatial separation between the electrode modules of the modular electrode array, and conductive interconnect coupled to the electrodes of the plurality of electrodes.

Claims

1. A modular electrode array, comprising:

a) a first electrode module, comprising;

i) a first flexible substrate comprising a first perimeter; and

ii) at least two first electrodes supported on a first side of the first substrate,

iii) wherein the at least two first electrodes are spaced apart from each other by a first pitch length of the first substrate;

b) a second electrode module, comprising;

i) a second flexible substrate comprising a second perimeter; and

ii) at least two second electrodes supported on a first side of the second substrate,

iii) wherein the at least two second electrodes are spaced apart from each other by a second pitch length of the second substrate;

c) a first connector substrate extending along a first longitudinal axis from a first connector end to a second connector end, wherein;

i) the first connector end is connected to the first substrate perimeter and the second connector end is connected to the second substrate perimeter to thereby provide a spatial separation between the first and second modules, and

ii) wherein the first longitudinal axis of the first connector substrate intersects both the first pitch between and spaced from the two first electrodes and the second pitch between and spaced from the two second electrodes; and

d) at least two first conductive interconnects and at least two second conductive interconnects, each of the first and second conductive interconnects extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal portions of the first conductive interconnects are supported by the first flexible substrate with the first distal interconnect ends electrically coupled to respective ones of the at least two first electrodes, and

iii) wherein the distal portions of the second conductive interconnects are supported by the first flexible substrate, the first connector substrate, and the second flexible substrate with the second distal interconnect ends electrically coupled to respective ones of the at least two second electrodes; and

e) a backing supporting the first and second substrates and the intermediate first connector substrate on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first and second modules.

2. The modular electrode array of claim 1, including:

a) a multiplexer circuit having signal inputs, select inputs, and one or more signal outputs, wherein the signal inputs to the multiplexer circuit are electrically coupled to the at least two first and second conductive interconnects; and

b) a selector circuit electrically coupled to the select inputs of the multiplexer circuit and configured to activate the select inputs to direct a signal from an input of the multiplexer circuit received from at least one of the at least two first and second electrodes electrically coupled to the respective at least two first and second conductive interconnects to an output of the multiplexer circuit.

3. The modular electrode array of claim 1, wherein at least one of the at least two first and second conductive interconnects comprises a conductive trace arranged in a serpentine pattern.

4. The modular electrode array claim 1, wherein there are a plurality of first and second conductive interconnects electrically connected to respective ones of a plurality of first and second electrodes and wherein the plurality of conductive interconnects include at least one group of helically coiled conductive traces.

5. The modular electrode array of claim 4, wherein the at least one group of conductive traces are helically coiled around a tube comprising flexible material.

6. The modular electrode array of claim 1, wherein at least one of the first and second flexible substrates comprises a flexible thin-film substrate.

7. The modular electrode array of claim 1, further comprising at least one electrical signal filter electrically coupled to at least one of the at least two first and second conductive interconnects.

8. The modular electrode array of claim 1, wherein at least one of the first and second electrode modules comprises at least one aperture through the respective first and second flexible substrate.

9. The modular electrode array of claim 8, including a wave guide configured to deliver light to the at least one aperture through the respective first and second flexible substrate.

10. The modular electrode array of claim 1, wherein at least one of the at least two first and second electrodes is a penetrating electrode.

11. The modular electrode array of claim 1, wherein at least one of the at least two first and second electrodes is configured to both receive a neural signal from a neural signal source and provide electrical stimulation energy to a neural stimulation target.

12. The modular electrode array of claim 1 comprising an electronic subsystem electrically coupled to the at least two first and second proximal conductive interconnect ends, and wherein the electronic subsystem is configured to transfer sensed electrical signals from the at least two first and second electrodes and respective conductive interconnects to at least one electrically conductive lead.

13. The modular electrode array of claim 12, wherein there are a plurality of first and second electrodes electrically connected to respective conductive interconnects comprising a plurality of conductive traces, and wherein the number of electrically conductive leads is less than the number of conductive traces, and wherein the electronic subsystem includes a multiplexer circuit configured to selectively transfer signals from a subset of the plurality of first and second electrodes and respective plurality of conductive traces to the electrically conductive leads.

14. The modular electrode array of claim 12, wherein the electronic subsystem includes a noise reduction circuit.

15. The modular electrode array of claim 12, including a recording system electrically coupled to the at least one electrically conductive lead.

16. The modular electrode array of claim 1 wherein the longitudinal axis of the first connector substrate is substantially aligned perpendicular to the first and second pitch lengths.

17. The modular electrode array of claim 1 wherein there are X by Y electrode modules connected by intermediate connector substrates with X by Y conductive interconnects electrically connected to at least two electrodes supported on the respective flexible substrates, and wherein X and Y are positive integers.

18. The modular electrode array of claim 1 wherein:

a) a first width where the first connector end connects to the first perimeter is less than the first pitch length between the at least two first electrodes supported on the first substrate, and

b) wherein a second width where the second connector end of the first connector substrate connects to the second perimeter is less than the second pitch length between the at least two second electrodes supported on the second substrate.

19. The modular electrode array of claim 1 wherein:

a) the at least two first electrodes are aligned along a second axis;

b) the at least two second electrodes are aligned along a third axis; and

c) the first longitudinal axis is substantially perpendicular to the second and third axes of the respective at least two first and second electrodes.

20. The modular electrode array of claim 1 wherein the backing has a backing perimeter that extends laterally out beyond the respective first and second perimeters of the first and second substrates.

21. The modular electrode array of claim 1 wherein at least one of the first and second substrates is comprised of a polymeric material selected from the group consisting of parylene and polyimide, and wherein the backing comprises silicone.

22. A modular electrode array, comprising:

a) a first electrode module, comprising;

i) a first flexible substrate comprising a first perimeter; and

ii) a plurality of first electrodes supported on a first side of the first substrate,

iii) wherein at least two of the plurality of first electrodes are spaced apart from each other by a first pitch length of the first substrate;

b) a second electrode module, comprising;

i) a second flexible substrate comprising a second perimeter; and

ii) a plurality of second electrodes supported on a first side of the second substrate,

iii) wherein at least two of the plurality of second electrodes are spaced apart from each other by a second pitch length of the second substrate;

c) a connector substrate extending along a longitudinal axis from a first connector end to a second connector end, wherein;

i) the first connector end is connected to the first substrate perimeter of the first electrode module and the second connector end is connected to the second substrate perimeter of the second electrode module, and

ii) wherein a first width where the first connector end connects to the first perimeter is less than the first pitch length between the at least two first electrodes supported on the first substrate, and

iii) wherein a second width where the second connector end of the first connector substrate connects to the second perimeter is less than the second pitch length between the at least two second electrodes supported on the second substrate, and

iv) wherein the longitudinal axis of the first connector substrate intersects both the first pitch between and spaced from the two first electrodes and the second pitch between and spaced from the two second electrodes;

d) a plurality of first conductive interconnects and a plurality of second conductive interconnects, each of the first and second conductive interconnect extending from a proximal interconnect end to a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal interconnect ends of the first conductive interconnects are supported by the first flexible substrate and electrically coupled to a respective one of the plurality of first electrodes, and

iii) wherein the distal interconnect ends of the second conductive interconnects are supported by the first flexible substrate, the connector substrate, and the second flexible substrate and electrically coupled to a respective one of the plurality of second electrodes; and

e) a backing supporting the first and second substrates and the intermediate first connector substrate on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first and second modules.

23. The modular electrode array of claim 22 wherein the longitudinal axis of the connection substrate is substantially aligned perpendicular to the first and second pitch lengths.

24. The modular electrode array of claim 22, further comprising:

a) a third electrode module, comprising;

i) a third flexible substrate comprising a third perimeter; and

ii) a plurality of third electrodes supported on a first side of the third substrate,

iii) wherein at least two of the plurality of third electrodes are spaced apart from each other by a third pitch length of the third substrate;

b) a second connector substrate extending along a second longitudinal axis from a third connector end to a fourth connector end, wherein;

i) the third connector end is connected to the second substrate perimeter and the fourth connector end is connected to the third substrate perimeter, and

ii) wherein a third width where the third connector end connects to the second perimeter is less than the second pitch length between the at least two second electrodes supported on the second substrate, and

iii) wherein a fourth width where the fourth connector end of the second connector substrate connects to the third perimeter is less than the third pitch length between the at least two third electrodes supported on the third substrate; and

iv) wherein the second longitudinal axis of the second connector substrate intersects both the second pitch between and spaced from the two second electrodes and the third pitch between and spaced from the two second electrodes, and

c) at least two third conductive interconnects, each extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal third interconnect ends are configured for electrical connection to the external electrical device, and

ii) wherein the distal portions of the third conductive interconnects are supported by the first flexible substrate, the first connector substrate, the second flexible substrate, the second connector substrate, and the third flexible substrate with the third distal interconnect ends electrically coupled to respective ones of the at least two third electrodes; and

d) wherein the backing supports the first, second and third substrates and the intermediate first and second connector substrates on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first, second and third modules.

25. The modular electrode array of claim 24, further comprising:

a) a fourth electrode module, comprising;

i) a fourth flexible substrate comprising a fourth perimeter; and

ii) a plurality of fourth electrodes supported on a first side of the fourth substrate,

iii) wherein at least two of the plurality of fourth electrodes are spaced apart from each other by a fourth pitch of the fourth substrate;

b) a third connector substrate extending along a third longitudinal axis from a fifth connector end to a sixth connector end, wherein;

i) the fifth connector end is connected to the third substrate perimeter and the sixth connector end is connected to the fourth substrate perimeter, and

ii) wherein a fifth width where the fifth connector end connects to the third perimeter is less than the third pitch length between the at least two third electrodes supported on the third substrate, and

iii) wherein a sixth width where the sixth connector end of the third connector substrate connects to the fourth perimeter is less than the fourth pitch length between the at least two fourth electrodes supported on the fourth substrate, and

iv) wherein the third longitudinal axis of the third connector substrate intersects both the third pitch between and spaced from the two third electrodes and the fourth pitch between and spaced from the two fourth electrodes; and

c) at least two fourth conductive interconnects, each extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal fourth interconnect ends are configured for electrical connection to the external electrical device, and

ii) wherein the distal portions of the fourth conductive interconnects are supported by the first flexible substrate, the first connector substrate, the second flexible substrate, the second connector substrate, the third flexible substrate, the third connector substrate, and the fourth flexible substrate with the fourth distal interconnect ends electrically coupled to respective ones of the at least two fourth electrodes,

d) wherein the backing supports the first, second, third and fourth substrates and the intermediate first, second and third connector substrates on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first, second, third and fourth modules.

26. The modular electrode array of claim 22 wherein at least one of the first and second substrates is comprised of a polymeric material selected from the group consisting of parylene and polyimide, and wherein the backing is comprised of silicone.

27. A modular electrode array, comprising:

a) a first electrode module, comprising;

i) a first flexible substrate comprising a first perimeter; and

ii) at least two first electrodes supported on the first substrate,

iii) wherein the at least two first electrodes are spaced apart from each other by a first pitch;

b) a second electrode module, comprising;

i) a second flexible substrate comprising a second perimeter; and

ii) at least two second electrodes supported on the second substrate,

iii) wherein the at least two second electrodes are spaced apart from each other by a second pitch;

c) a first connector substrate extending from a first connector end to a second connector end, wherein;

i) the first connector end is connected to the first substrate perimeter and the second connector end is connected to the second substrate perimeter, and

ii) wherein a first width where the first connector end connects to the first perimeter is less than the first pitch between the at least two first electrodes supported on the first substrate, and

iii) wherein a second width where the second connector end of the first connector substrate connects to the second perimeter is less than the second pitch between the at least two second electrodes supported on the second substrate; and

d) at least two first conductive interconnects and at least two second conductive interconnects, each of the first and second conductive interconnects extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal portions of the first conductive interconnects are supported by the first flexible substrate with the first distal interconnect ends electrically coupled to respective ones of the at least two first electrodes, and

iii) wherein the distal portions of the second conductive interconnects are supported by the first flexible substrate, the first connector substrate, and the second flexible substrate with the second distal interconnect ends electrically coupled to respective ones of the at least two second electrodes; and

e) an aperture extending through at least one of the respective first and second flexible substrates of the first and second electrode modules; and

f) a wave guide configured to deliver light to the at least one aperture.

28. A modular electrode array, comprising:

a) a first electrode module, comprising;

i) a first flexible substrate comprising a first perimeter; and

ii) at least two first electrodes supported on the first substrate,

iii) wherein the at least two first electrodes are spaced apart from each other by a first pitch;

b) a second electrode module, comprising;

i) a second flexible substrate comprising a second perimeter; and

ii) at least two second electrodes supported on the second substrate,

iii) wherein the at least two second electrodes are spaced apart from each other by a second pitch;

c) wherein at least one of the two first and second electrodes is a penetrating electrode;

d) a first connector substrate extending from a first connector end to a second connector end, wherein;

i) the first connector end is connected to the first substrate perimeter and the second connector end is connected to the second substrate perimeter, and

ii) wherein a first width where the first connector end connects to the first perimeter is less than the first pitch between the at least two first electrodes supported on the first substrate, and

iii) wherein a second width where the second connector end of the first connector substrate connects to the second perimeter is less than the second pitch between the at least two second electrodes supported on the second substrate; and

e) at least two first conductive interconnects and at least two second conductive interconnects, each of the first and second conductive interconnects extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal portions of the first conductive interconnects are supported by the first flexible substrate with the first distal interconnect ends electrically coupled to respective ones of the at least two first electrodes, and

iii) wherein the distal portions of the second conductive interconnects are supported by the first flexible substrate, the first connector substrate, and the second flexible substrate with the second distal interconnect ends electrically coupled to respective ones of the at least two second electrodes.

29. A modular electrode array, comprising:

a) a first electrode module, comprising;

i) a first flexible substrate comprising a first perimeter; and

ii) at least one first electrode supported on a first side of the first substrate;

b) a second electrode module, comprising;

i) a second flexible substrate comprising a second perimeter; and

ii) at least one second electrode supported on a first side of the second substrate;

c) a first connector substrate extending from a first connector end to a second connector end, wherein the first connector end is connected to the first substrate perimeter and the second connector end is connected to the second substrate perimeter to thereby provide a spatial separation between the first and second modules;

d) at least one first conductive interconnect and at least one second conductive interconnect, the first and second conductive interconnects extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal portion of the first conductive interconnect is supported by the first flexible substrate with the first distal interconnect end electrically coupled to the at least one first electrode, and

iii) wherein the distal portion of the second conductive interconnect is supported by the first flexible substrate, the first connector substrate, and the second flexible substrate with the second distal interconnect end electrically coupled to the at least one second electrode; and

e) a backing supporting the first and second substrates and the intermediate first connector substrate on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first and second modules.

30. The modular electrode array of claim 29 wherein at least one of the first and second substrates is comprised of a polymeric material selected from the group consisting of parylene and polyimide.

31. The modular electrode array of claim 29 wherein the backing comprises silicone.

32. A method for forming a modular electrode array, comprising the steps of:

a) disposing at least two first electrodes on a first side of a first flexible substrate having a first perimeter to form a first electrode module, wherein the at least two first electrodes are spaced apart from each other by a first pitch length;

b) disposing at least two second electrodes on a first side of a second flexible substrate having a second perimeter to form a second electrode module, wherein the at least two second electrodes are spaced apart from each other by a second pitch length;

c) providing a connector substrate extending along a longitudinal axis from a first connector end to a second connector end with the first connector end connected to the first substrate perimeter and the second connector end connected to the second substrate perimeter to thereby provide a spatial separation between the first and second modules; and

d) attaching a backing to the first and second substrates and the intermediate first connector substrate on respective second sides thereof opposite the first sides to thereby maintain the spatial separation between the first and second modules,

e) wherein the longitudinal axis of the first connector substrate intersects both the first pitch length between and spaced from the two first electrodes and the second pitch length between and spaced from the two second electrodes; and

f) providing at least two first conductive interconnects and at least two second conductive interconnects, each interconnect extending from a proximal interconnect end to a distal interconnect portion having a distal interconnect end,

i) wherein the proximal first and second interconnect ends are configured for electrical connection to an external electrical device, and

ii) wherein the distal portions of the first conductive interconnects are supported by the first flexible substrate with the first distal interconnect, ends electrically coupled to respective ones of the at least two first electrodes, and

iii) wherein the distal portions of the second conductive interconnects are supported by the first flexible substrate, the connector substrate, and the second flexible substrate with the second distal interconnect ends electrically coupled to respective ones of the at least two second electrodes.

33. The method of claim 32, including:

a) forming a plurality of X times Y electrode modules; and

b) connecting adjacent modules to each other with respective connector substrates and conductive interconnects to thereby form an X by Y modular electrode array, wherein X and Y are positive integers.

34. The method of claim 33, wherein X=Y.

35. The method of claim 32, wherein attaching the backing includes injection molding a silicone backing and attaching the first and second flexible substrates to the silicone backing.

36. The method of claim 32, wherein attaching the backing includes adhering a thin-film backing to the first and second flexible substrates.

37. The method of claim 32, including providing at least one of the two first and second conductive interconnects comprising a conductive trace arranged in a serpentine pattern.

38. The method of claim 32, including providing a plurality of first and second conductive interconnects electrically connected to respective ones of a plurality of first and second electrodes and further providing the plurality of conductive interconnects comprising at least one group of helically coiled conductive traces.

39. The method of claim 38, wherein providing the at least one group of helically coiled conductive traces includes helically coiling the conductive traces around a tube comprising a flexible material.

40. The method of claim 32, including forming at least one aperture in at least one of the first and second flexible substrates of the respective first and second electrode modules.

41. The method of claim 32 including providing:

a) a first width where the first connector end connects to the first perimeter being less than the first pitch length between the at least two first electrodes supported on the first substrate, and

b) a second width where the second connector end of the connector substrate connects to the second perimeter being less than the second pitch length between the at least two second electrodes supported on the second substrate.

42. The method of claim 32 including providing:

a) the at least two first electrodes being aligned along a second axis;

b) the at least two second electrodes being aligned along a third axis; and

c) the first longitudinal axis being substantially perpendicular to the second and third axes of the respective at least two first and second electrodes.

43. The method of claim 32 including forming at least one of the first and second substrates of a polymeric material selected from the group consisting of parylene and polyimide, and forming the backing of silicone.