U.S. patent application number 16/376834 was filed with the patent office on 2019-12-12 for neural interface system with edge array.
The applicant listed for this patent is NeuroNexus Technologies, Inc.. Invention is credited to Jamille Farraye Hetke, Daryl R. Kipke, KC Kong, David S. Pellinen, John P. Seymour, Rio J. Vetter.
Application Number | 20190374770 16/376834 |
Document ID | / |
Family ID | 46798580 |
Filed Date | 2019-12-12 |
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United States Patent
Application |
20190374770 |
Kind Code |
A1 |
Seymour; John P. ; et
al. |
December 12, 2019 |
NEURAL INTERFACE SYSTEM WITH EDGE ARRAY
Abstract
The neural interface system of one embodiment includes a
cylindrical shaft, a lateral extension longitudinally coupled to at
least a portion of the shaft and having a thickness less than a
diameter of the shaft, and an electrode array arranged on the
lateral extension and radially offset from the shaft, including
electrode sites that electrically interface with their
surroundings. The method of one embodiment for making the neural
interface system includes forming a planar polymer substrate with
at least one metallization layer, patterning on at least one
metallization layer an electrode array on a first end of the
substrate, patterning conductive traces on at least one
metallization layer, rolling a portion of the substrate toward the
first end of the substrate, and securing the rolled substrate into
a shaft having the first end of the substrate laterally extending
from the shaft and the electrode array radially offset from the
shaft.
Inventors: |
Seymour; John P.; (Ann
Arbor, MI) ; Hetke; Jamille Farraye; (Brooklyn,
MI) ; Vetter; Rio J.; (Van Buren Twp, MI) ;
Kipke; Daryl R.; (Dexter, MI) ; Pellinen; David
S.; (Ann Arbor, MI) ; Kong; KC; (Ann Arbor,
MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NeuroNexus Technologies, Inc. |
Ann Arbor |
MI |
US |
|
|
Family ID: |
46798580 |
Appl. No.: |
16/376834 |
Filed: |
April 5, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14685661 |
Apr 14, 2015 |
10252047 |
|
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16376834 |
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13416775 |
Mar 9, 2012 |
9008747 |
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14685661 |
|
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61451083 |
Mar 9, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2005/0632 20130101;
A61M 25/0023 20130101; A61N 1/0534 20130101; A61N 5/0601 20130101;
H05K 1/118 20130101; Y10T 29/49155 20150115; Y10T 29/4913 20150115;
A61N 1/0553 20130101; A61B 1/07 20130101; H05K 2201/051 20130101;
H05K 3/10 20130101; A61M 25/0009 20130101; H05K 1/028 20130101;
Y10T 29/49147 20150115 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61B 1/07 20060101 A61B001/07; A61M 25/00 20060101
A61M025/00; H05K 3/10 20060101 H05K003/10; A61N 5/06 20060101
A61N005/06 |
Claims
1. A method for providing a neural interface system, comprising the
steps of: a) providing a substrate by: i) forming a substantially
cylindrical shaft as a rolled portion of the substrate; and ii)
providing a lateral extension portion of the substrate, the lateral
extension extending longitudinally from at least a portion of the
shaft and having a thickness less than a diameter of the shaft; and
b) supporting at least a portion of an electrode array on the
lateral extension, the portion of the electrode array supported on
the lateral extension being radially offset from the shaft, c)
wherein the electrode array comprises a plurality of electrode
sites that are configured to electrically interface with their
surroundings.
2. The method of claim 1, including providing the lateral extension
as a trailing end of the rolled substrate.
3. The method of claim 1, including providing the lateral extension
being tangent to the shaft.
4. The method of claim 1, including providing the rolled substrate
defining a lumen.
5. The method of claim 4, including configuring the lumen to
receive and transport a fluid.
6. The method of claim 5, including disposing an optical light
source within the lumen.
7. The method of claim 1, including providing the substrate having
conductive traces coupled to the electrode array.
8. The method of claim 7, including providing the conductive traces
extending from the electrode array to a bond pad region of the
substrate.
9. The method of claim 4, including providing an amplifier at least
partially disposed within the lumen.
10. The method of claim 7, including providing a multiplexer at
least partially disposed within the lumen.
11. The method of claim 5, including providing the substrate having
conductive traces electrically coupling from the electrode array to
a first electrical subsystem, and configuring the first electrical
subsystem to wirelessly communicate with a second electrical
subsystem.
12. The method of claim 1, including providing the lateral
extension having a slanted distal edge extending to a sharpened
distal end of the shaft.
13. The method of claim 1, including providing the electrode array
arranged at least partially along a longitudinal edge of the
lateral extension.
14. The method of claim 1, including providing the electrode array
comprising at least one of a recording electrode site and a
stimulation electrode site.
15. The method of claim 1, including providing the substrate as a
polymer substrate.
16. The method of claim 1, including providing the substrate as a
polymer substrate having three metallization layers interspersed
with silicon carbide insulation layers.
17. The method of claim 16, including providing the metallization
layers being from about 0.7 .mu.m to 1.3 .mu.m thick.
18. The method of claim 1, including providing at least one rib
bridging from the lateral extension to the shaft.
19. The method of claim 18, including providing the lateral
extension being coupled to the shaft by at least two bridging ribs,
thereby forming a perforated framework between the shaft and
lateral extension with at least one opening bounded by the ribs.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 14/685,661, filed Apr. 14, 2015, which is a
divisional of U.S. patent application Ser. No. 13/416,775, filed on
Mar. 9, 2012, now U.S. Pat. No. 9,008,747, which claims the benefit
of U.S. Provisional Patent Application No. 61/451,083, filed Mar.
9, 2011, the disclosures of each are incorporated herein in their
entirety and for all applicable purposes.
TECHNICAL FIELD
[0002] This invention relates generally to the neural interface
field, and more specifically to a new and useful neural interface
system with an edge array in the neural interface field.
BACKGROUND
[0003] Neural interface systems are typically implantable devices
that are placed into biological tissue (e.g., brain or other neural
tissue) and have the ability through electrode sites, to record
electrical signals from and/or electrically stimulate the tissue.
Such neural interface systems may be used, for example, in
treatment of neurological and psychiatric disorders. For instance,
deep brain stimulation devices may provide controllable electrical
stimulation of selected regions of neural tissue through strategic
positioning and activation of electrode sites.
[0004] A neural interface system including a high-density array of
electrode sites would he useful in many applications for
exceptional control, but utilizing current conventional technology,
including more electrode sites typically means a significant
increase in thickness and overall size of the implantable device.
Generally speaking, the larger the implantable device is, the more
damage to tissue (e.g., cortical blood vessels and local tissue in
and around the region of interest) the devices inflicts during
implantation into the tissue. Furthermore, larger devices typically
experience increased incidence of tissue encapsulation, as a result
of foreign body response, thereby leading to decreased electrode
sensitivity.
[0005] Thus, there is a need in the neural interface field to
create a new and useful neural interface system that ameliorates or
eliminates the issues created by larger devices. High-channel count
neural interfaces especially tend to be larger given the cost of
decreasing the feature size during fabrication. This invention
provides such a neural interface system, which is described in
detail below in its preferred embodiments with reference to the
appended drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0006] FIG. 1 is a schematic of the system of a preferred
embodiment;
[0007] FIG. 2 is a schematic of a cross-sectional view of the shaft
of the system of a preferred embodiment;
[0008] FIG. 3 is a schematic of the shaft of the system of a
preferred embodiment;
[0009] FIGS. 4A-4B are schematics of variations of the lateral
extension of the system of a preferred embodiment;
[0010] FIGS. 5A-5C are schematics of variations of electrical
subsystems of the system of a preferred embodiment;
[0011] FIGS. 6 and 7 are flowcharts depicting the method of a
preferred embodiment and variations thereof;
[0012] FIG. 8A is a schematic view depicting the step of forming a
planar polymer substrate (S210) having an electrode array and
conductive traces patterned on a metallization layer for a neural
interface system 200;
[0013] FIG. 8B is an enlarged view of the indicated area in FIG.
8A;
[0014] FIG. 9 is a schematic view illustrating coupling an insert
to the substrate (S242) shown in FIGS. 8A and 8B and then rolling
the substrate around the insert (S244);
[0015] FIG. 10A is a schematic view illustrating securing the
rolled substrate shown in FIG. 9 into a shaft (S250);
[0016] FIG. 10B is an enlarged view of the indicated area in FIG.
10A; and
[0017] FIGS. 11A, 11B, 11C(i)-(iii), 11D and 11E are schematics
comparing tissue damage imparted by an exemplary neural interface
system of a preferred embodiment to tissue damage imparted by
conventional planar and microwire neural devices.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0018] The following description of preferred embodiments of the
invention is not intended to limit the invention to these preferred
embodiments, but rather to enable any person skilled in the art to
make and use this invention.
Neural Interface System
[0019] As shown in FIGS. 1 and 2, in a preferred embodiment, the
neural interface system 100 of a preferred embodiment includes: a
substantially cylindrical shaft 110; a lateral extension 140
longitudinally coupled to at least a portion of the shaft 110 along
a longitudinal direction of the shaft 110 and having a thickness
less than a diameter of the shaft 110; and an electrode array 150,
at least partially arranged on the lateral extension 140 and
radially offset from the shaft 110, comprising a plurality of
electrode sites 152 that electrically interface with their
surroundings. The neural interface system 100 of the preferred
embodiment preferably provides ultra-high density, high-resolution
microelectrodes on a shaft 110 implantable in tissue for
electrically communicating with and interfacing with tissue, such
as for recording and/or stimulation of targeted tissue. The neural
interface system 100 is preferably used to interact with brain
tissue or other neural tissue for research and/or clinical
purposes, but additionally or alternatively can be used to interact
with any suitable tissue for any suitable application. The
electrode array 150 is preferably radially offset from and is
smaller than the shaft 110, such that the degree of any tissue
damage incurred by implantation of the shaft 110 will preferably
have reduced effect on the electrode recording and/or stimulation
quality and longevity. The neural interface system 100 preferably
reduces local tissue damage, such as to cortical blood vessels and
damage in the dendritic arbor of local neurons, such as during
implantation. The neural interface system 100 preferably further
reduces the occurrence of tissue encapsulation (arid associated
biofouling and impedance effects) around the device, which would
otherwise degrade the capabilities of the neural interface system
100. Furthermore, in one preferred embodiment, the components of
the neural interface system are modular, which may help to reduce
costs.
[0020] The shaft 110 of the preferred neural interface system 100
preferably functions to provide structural support for the neural
interface system. As shown in FIG. 2, the shaft 110 of the
preferred system 100 can be configured as a rolled substrate 120.
The substrate 120 is preferably a substantially planar substrate
120 that is rolled into a cylindrical shaft 110. Alternatively, the
shaft 110 can be any suitable shape formed by processes other than
rolling; for example, the shaft 110 can be folded into a particular
shape, or the shaft 110 can include a single tube or plurality of
nested tubes. The shaft 110 preferably has substantially circular
cross-section taken along a radial direction, but can alternatively
have an elliptical or any suitable cross-sectional shape.
[0021] In the preferred system 100, the substrate 120 includes a
polymer or other suitable material that is flexible enough to be
rolled or similarly manipulated. The substrate 120 preferably
includes one or more metallization layers and/or one or more
insulation layers interspersed between the metallization layers. As
shown in FIG. 1, one or more metallization layers are preferably
patterned into conductive traces 126 within the substrate 120. The
metallization layers are preferably further patterned into the
electrode sites 152 of the electrode array 150, as further
described below. In a preferred embodiment, the substrate 120
includes at least one metallization layer, but the substrate can
alternatively include any suitable number of metallization layers.
The metallization layers preferably include platinum and/or
iridium, but can additionally or alternatively include any suitable
conductive or semi-conductive material. The insulation layers
preferably include silicon carbide, but may additionally or
alternatively include any suitable electrically insulating material
such as silicon dioxide, silicon nitride, parylene, polyimide, LCP,
and/or silicone. At least some of the layers of the substrate 120,
such as the metallization layers, may be planarized by
chemical-mechanical planarization or another smoothing process. Any
additional suitable photolithographic processes can be performed on
the substrate as desired.
[0022] As shown in FIG. 1, the substrate 120 can further include a
bond pad region 128 that electrically communicates with the
conductive traces 126 and/or electrode array 150, and with other
circuitry and electronic devices (e.g., controller and/or signal
processing devices). The bond pad region 128 is preferably on a
proximal portion of the substrate 120 (with respect to the system
when the system is implanted in tissue). For example, in a
preferred embodiment, in an application in which the neural
interface system is implanted in brain tissue, the bond pad region
128 is on or near a proximal end of the shaft 110, near or outside
the surface of the brain. However, the bond pad region 128 can
alternatively be located in any suitable portion of the substrate,
or may be arranged in any suitable position relative to the shaft
110.
[0023] In a variation of the preferred system 100 shown in FIG. 3,
the shaft 110 defines a lumen 130 within its interior space. The
lumen 130 preferably passes longitudinally within the shaft 110. In
some variations of the preferred system 100, the lumen 130 is
centered within the shaft 110, and in some variations, the lumen
130 is offset within the shaft 110. The lumen 130 can function to
deliver and/or receive substances or items in different manners in
one or more different variations. In another variation of the
preferred system, the lumen 130 is configured to receive and
transport a fluid 132, such as for fluidic delivery of drugs or
other therapeutic molecules to tissue surrounding the implanted
shaft 110.
[0024] In another variation of the preferred system 100 shown in
FIG. 3, the system 100 includes a stylet 134 that is insertable in
the lumen 130 and preferably functions to at least provide
structural support for the shaft 110 during implantation. The
stylet 134 preferably includes a sharpened, pointed distal end to
aid insertion into tissue and/or adjustment within tissue. In
another variation of the preferred system 100, the stylet 134
includes a microwire that is insertable in the lumen 130 and
preferably functions as a single channel microelectrode. In another
variation of the preferred system 100, the stylet 134 functions as
a mandrel, around which the substrate 120 is wrapped to form the
shaft 110, as further described below.
[0025] In another variation of the preferred system 100 shown in
FIG. 3, the system 100 further includes an optical light source 136
that is insertable in the lumen 130 and preferably functions to
facilitate optogenetic stimulation. In particular the optical light
source 136 facilitates optogenetic stimulation using optogenetic
tools with light-sensitive ion channels in tissue to perturb neural
circuits with cell-type specificity. The optical light source 136
is preferably an optical fiber, but may alternatively be any
suitable light source. In this variation, the optical light source
may operate within the neural interface system 100 similar to that
described in U.S. Patent Publication No. 2011/0112591 entitled
"Waveguide neural interface device", the entirety of which is
incorporated herein by this reference.
[0026] Other variations of the preferred system 100 can include any
other suitable substance, material, insert, and/or machine
insertable within the lumen 130. Preferably, the substance or
insert disposed within the lumen 130 includes a bioresorbable
material that is absorbed into the surrounding tissue after a
period of time. Furthermore, in some embodiments, the substance or
insert disposed within the lumen 130 is permanently coupled to the
shaft 110. However, in some embodiments the substance or insert
disposed within the lumen 130 is temporarily coupled to the shaft
110. For example, in one embodiment, the stylet 134 is decoupled
from the shaft 110 after the substrate 120 is wrapped into a shaft
110, or retracted and/or removed from the shaft 110 after the
neural interface system 100 is implanted in tissue. In some
embodiments, the system 100 includes multiple substances or inserts
disposed within the lumen 130.
[0027] In another variation of the preferred system 100 shown in
FIGS. 5B and 5C, at least the first electrical subsystem 160 is
disposed within the lumen 130 of the shaft 110. At least a portion
of the conductive traces 126 preferably extend radially inward
toward the lumen 130 and are coupled to the first electrical
subsystem 160 within the lumen 130. In another variation of the
preferred system 100, the conductive traces 126 pass approximately
circumferentially around the shaft 110 within the substrate 120,
spiraling and approaching radially inward. The first electrical
subsystem 160 (and/or any other electrical components) within the
lumen 130 is preferably coupled to the second electrical subsystem
180 or other suitable components positioned external to the shaft)
through the lumen 130, such as on or within the substrate 120,
through a hardwired connection 170 (FIG. 5B), or through a wireless
connection (FIG. 5C). In an alternative embodiment, both the first
and second electrical subsystems 160, 180 can be disposed within
the lumen.
[0028] As shown in FIGS. 4A and 4B, the system 100 can also include
a lateral extension 140. The lateral extension 140 preferably
functions to radially or laterally offset the electrode array 150
from the shaft 110. The lateral extension 140 is preferably
longitudinally coupled to at least a portion of the shaft 110, such
as along the entire length of the shaft 110, a distal portion of
the shaft 110 (FIG. 4A), or any suitable portion of the shaft 110.
As shown in FIG. 4A, the lateral extension 140 is preferably
coupled in a continuous manner with the shaft 110. Alternatively,
as shown in FIG. 4B, the lateral extension 140 can be coupled to
the shaft by a series of one or more ribs bridging the lateral
extension and shaft, which thereby form a perforated framework 142
between the shaft and lateral extension with openings 144.
[0029] As shown in the FIGURES, the lateral extension 140 is
preferably a trailing end of the rolled substrate 120 of the shaft
110. In other words, the lateral extension 140 is preferably an
unrolled portion of the substrate 120 left outside of the rolled
portion of the substrate 120. For example, as shown in FIGS. 1A and
1B, the lateral extension 140 can project substantially
tangentially from the shaft 110 in a roll direction of the rolled
substrate of the shaft 110. In another alternative embodiment, the
lateral extension 140 can be originally separate from the shaft
110, and coupled to the shaft 110 to laterally extend tangentially
from the shaft 110, or extend in any suitable direction.
[0030] The lateral extension 140 preferably has a thickness that is
less than the diameter of the shaft 110. Preferably, the lateral
extension 140 has a subcellular thickness, such as approximately
five .mu.m thick, which preferably reduces damage to local tissue
during implantation. Furthermore, reactive tissue cells are less
likely to adhere to the lateral extension 140 of subcellular
thickness as part of a typical foreign body response of the tissue,
such that the lateral extension 140 and the electrode array 150
preferably experience a reduced amount of tissue encapsulation,
which typically interferes with system operation.
[0031] As shown in the FIGURES, the preferred system 100 can also
include an electrode array 150. The electrode array 150 preferably
functions to electrically interface with surrounding tissue. In a
preferred embodiment, the electrode array 150 is a high-density
array with approximately one hundred, and more preferably at least
several hundred, microelectrode sites 152. Alternatively, the
electrode array 150 can include any suitable number of electrode
sites. As shown in FIGS. 1A and 1B, the electrode array 150 is
preferably at least partially arranged on the lateral extension
140, more preferably along a longitudinal edge of the lateral
extension 140, and is radially offset from the shaft 110. The
electrode array 150 preferably includes recording electrode sites
and/or stimulation electrode sites that are formed in any suitable
photolithographic process on the lateral extension 140. Preferably,
the electrode sites 152 are formed by patterning and selectively
exposing portions of the lateral extension 140 to reveal underlying
metallization layers, and/or by building and patterning additional
metallization layers on the lateral extension 140. However, the
specific structure and formation, of the electrode sites 152 may
depend on the particular application of the neural interface
system.
[0032] As shown in FIGS. 5A-5C, the preferred neural interface
system 100 includes a first electrical subsystem 160 that functions
to communicate signals to and/or from the electrode array 150 and a
second electrical subsystem 180 that processes signals from the
electrode array 150. The first electrical subsystem 160 preferably
includes an amplifier that amplifies signals received from the
electrode array 150 and transmits amplified signals to the second
electrical subsystem 180. The first electrical subsystem 160
preferably further includes a multiplexer that multiplexes neural
signals to and/or from the electrode array 150, thereby enabling
the neural interface system 100 to include fewer conductive traces
than would otherwise be required. The second electrical subsystem
180 is preferably in communication with the first electrical
subsystem 160, and preferably includes a signal processor,
controller, and/or any suitable electronics.
[0033] As shown in FIG. 5A, in one preferred embodiment, the first
electrical subsystem 160 and/or second electrical subsystem 180 are
coupled to a proximal region of the substrate 120 of the shaft 110.
As shown, the conductive traces 126 preferably pass along the shaft
generally in a longitudinal direction toward the bond pad region
128 or other proximal region of the substrate 120. Electrical
signals are preferably communicated between the conductive traces
126 and the first electrical subsystem 160 and/or second electrical
subsystem 180 through the bond pad region 128 and a hardwire
connector 170 (e.g., a ribbon cable). However, the signals can
additionally or alternatively be communicated with a wireless
transmitter.
[0034] In another variation of the preferred system 100 shown in
FIGS. 5B and 5C, at least the first electrical subsystem 160 is
disposed within the lumen 130 of the shaft no. At least a portion
of the conductive traces 126 preferably extend radially inward
toward the lumen 130 and are coupled to the first electrical
subsystem 160 within the lumen 130. In another variation of the
preferred system 100, the conductive traces 126 pass approximately
circumferentially around the shaft no within the substrate 120,
spiraling and approaching radially inward. The first electrical
subsystem 160 (and/or any other electrical components) within the
lumen 130 is preferably coupled to the second electrical subsystem
180 or other suitable components positioned external to the shaft)
through the lumen 130, such as on or within the substrate 120,
through a hardwired connection 170 (FIG. 5B), or through a wireless
connection (FIG. 5C). In an alternative embodiment, both the first
and second electrical subsystems 160, 180 can be disposed within
the lumen.
[0035] Although omitted for clarity, the preferred embodiments of
the system 100 include every combination of the variations of the
shaft 110, lateral extension 140, electrode array 150, electrical
subsystems 160, 180, and other components described herein. The
preferred embodiments of the system 100 also include every
combination of the stylet 134 or other inserts into the lumen 130
of the shaft 110, including none, one, or a plurality of such
inserts into the lumen 130 of the shaft 110 as described above.
Method of Making a Neural Interface System
[0036] As shown in FIG. 6, a preferred method of making a neural
interface system 200 includes: forming a planar polymer substrate
in block S210; patterning a plurality of conductive traces in block
S220, patterning an electrode array on a first end of the substrate
in block S230, rolling a portion of the substrate towards the first
end of the substrate in block S240, and in block S250, securing the
rolled substrate into a shaft. The shaft preferably has the first
end of the substrate laterally extending from the shaft and the
electrode array radially offset from the shaft.
[0037] As shown in FIG. 6, block S210 recites forming a planar
polymer substrate. Forming a planar polymer substrate preferably
functions to prepare a structure from which the shaft, lateral
extension, conductive traces, and/or electrode array is formed. In
a preferred embodiment, block S210 includes depositing a plurality
of metallization layers and depositing a plurality of insulation
layers interspersed between the metallization layers. However, any
suitable number of metallization layers and/or insulation layers
can be deposited. Any suitable deposition technique or process
(e.g., chemical vapor deposition) can be used. The metallization
layers can be any suitable conductive material, such as platinum or
iridium or gold, including appropriate metal adhesion layers. In a
preferred embodiment, the insulation layers are silicon carbide,
but may alternatively be any suitable insulating material. In some
embodiments, the metallization layers and insulation layers are of
near equal thickness, but in other embodiments at least some of the
metallization layers and/or insulation layers may be of different
thicknesses. As shown in FIG. 7, one variation of the preferred
method can include depositing at least one metallization layer in
block S211, planarizing at least one metallization layer in block
S212, depositing at least one insulation layer in block S213,
and/or planarizing at least one insulation layer in block S214.
Planarizing preferably involves chemical-mechanical planarization,
but the preferred method may additionally or alternatively include
any suitable smoothing process. As shown in FIG. 6, block S220
recites patterning an electrode array on a first end of the
substrate, and block S230 recites patterning a plurality of
conductive traces.
[0038] As shown in FIGS. 8A and 8B, the electrode array and
conductive traces are preferably patterned on one or more
metallization layers of the substrate. Blocks S220 and S230
preferably function to form a plurality of electrode sites
configured to interface with tissue, and a plurality of conductive
traces configured to carry signals to and from the electrode sites.
Blocks S220 and S230 can include any suitable photolithographic
processes (e.g., masking, patterning, etching). Another variation
of the preferred the method further includes forming a bond pad
region on the substrate that is configured to communicate with
electrical subsystems and the conductive traces and/or electrode
array.
[0039] As shown in FIG. 6, the method preferably includes block
S232, which recites depositing an insulation layer onto the
conductive traces and electrode array. Similar to block S210, the
insulation layer can include silicon carbide, but may alternatively
include suitable insulating material, and can be deposited in any
suitable manner. Furthermore, any suitable number of insulation
layers can be deposited.
[0040] As shown in FIG. 6, block S240 recites rolling a portion of
the substrate toward the first end of the substrate. Block S240
preferably functions to form a shaft of the neural interface
device. As shown in FIG. 9, in a preferred embodiment, the method
includes block S242, which recites coupling an insert to a second
end of the substrate. The preferred method can further include
block S244, which recites rolling the portion of the substrate
around the insert from the second end toward the first end. The
insert is preferably an elongated insert, and more preferably
includes a stylet such as a microwire, an optical fiber, or any
suitable insert configured to serve as a mandrel around which the
shaft is formed. The insert is preferably coupled to the unrolled
substrate by any suitable fastening mechanism, such as tacking with
a biocompatible epoxy or another adhesive. In a preferred
embodiment, the method includes coupling the insert to a rotational
actuator and rolling the portion of the substrate around the insert
with the rotational actuator. The rotational actuator is preferably
a stepper motor, but may be a servomotor, crank, or any suitable
actuator. The actuator is preferably programmed to roll a
predetermined portion of the substrate (e.g., to include up to a
predetermined length of the substrate in the rolled shaft), thereby
leaving a portion of the substrate outside of the rolled shaft. In
this embodiment, a first end of the insert is preferably coupled
(e.g., with a shaft coupler) to the rotational actuator and a
second end of the insert opposite the first end may be mounted to a
fixture to help stabilize the insert as the substrate is rolled.
After the substrate is rolled, the insert is preferably decoupled
from the actuator such that the shaft of the neural interface
device is independent and separate from the actuator.
[0041] As shown in FIGS. 6 and 10A-10B, block S250 recites securing
the rolled substrate into a shaft. The shaft preferably has a
lateral extension with the electrode array radially offset from the
shaft. In a first variation, securing the rolled substrate includes
applying a biocompatible epoxy or other adhesive between at least
two rolled layers of the shaft. In a second variation, securing the
rolled substrate includes applying a biocompatible epoxy or other
adhesive on a proximal and/or distal end face of the shaft.
[0042] The preferred method can further include forming a sharpened
distal end on the shaft in block S260. Block S260 functions to
configure the shaft for insertion into tissue and/or adjustment
within tissue. In a preferred variation, as shown in FIG. 8B, block
S260 includes forming the substrate with at least one slanted edge.
In this variation, the slanted edge is formed into sharpened edge
or point when the substrate is rolled. In an alternative variation,
block S260 includes machining a sharpened edge or point onto the
substrate after the shaft is rolled. The preferred method can
further include reinforcing the distal end of the shaft to better
bear load, such as with a hardening treatment (e.g., chemical,
treatment) of the substrate material, forming the substrate to have
a thicker and/or stronger material at a distal end, and/or coupling
a reinforcing material to the distal end of the substrate and/or
shaft.
[0043] Although omitted for clarity, the preferred embodiments of
the method includes every combination and permutation of the
processes described herein. It should be understood that any of the
foregoing processes and/or blocks can be performed by any suitable
device, in any suitable order, in a serial or parallel manner.
Example Implementation of the Preferred System and Method
[0044] The following example implementation of the preferred system
and method is for illustrative purposes only, and should not be
construed as definitive or limiting of the scope of the claimed
invention. In one example, the shaft includes a polymer substrate
having three metallization layers that are approximately 0.7 .mu.m,
1.0. .mu.m, and 1.3. .mu.m thick. The metallization layers are
interspersed with silicon carbide insulation layers. A trailing end
of the substrate is patterned with photolithographic processes to
form a high-density electrode array including approximately 670
microelectrode sites. When the substrate is unrolled, at least a
portion of the planar substrate has a width of approximately 450
.mu.m and a thickness of approximately 5 .mu.m. A microwire having
a diameter of approximately 80 .mu.m is tacked onto an end of the
planar substrate opposite the trailing end, and the planar
substrate is rolled or wrapped around the microwire, toward the
trailing end, to form a shaft approximately 10 mm long and having a
lateral extension projecting tangentially from the shaft. The
high-density electrode array is arranged along the edge of the
lateral extension such that the electrode array is radially offset
from the rolled shaft.
[0045] The neural interface system is preferably strategically
implanted to minimize damage to a target region of interest in the
tissue, especially compared to conventional planar and microwire
neural devices. As shown in FIGS. 11A and 11B, a planar neural
device can sever portions of a neuron during implantation, and/or
can be forced to record and/or stimulate tissue further from a
desired target region in order to avoid excessive damage to the
target region. As shown in the schematics of FIGS. 11C(i)-(iii), an
exemplary planar neural device with a width of approximately 100
.mu.m (FIG. 11C(i)) and an exemplary microwire neural device with a
diameter of approximately 30 .mu.m (FIG. 11C(ii)) are estimated to
result in a larger area of damage (Ad) to a desired target region
due to their larger footprint area or "effective width" in the
target region, compared to the neural interface system with an edge
array with an effective width of 5 .mu.m (FIG. 11C(iii)). The shaft
of the neural interface system is preferably positioned relatively
distant from the target region, while the edge electrode array on
the lateral extension (which is preferably thinner than the shaft
and consequently causes less damage to the surrounding tissue than
the shaft) is preferably positioned in the target region of tissue
with less damage to the target region. In other words, in this
simulated comparison, the neural interface system with an edge
array preferably has a substantially smaller effective width, and
results in a substantially smaller area of damage (Ad) than the
exemplary planar array neural device (FIGS. 11D and 11E) or the
exemplary microwire neural device (FIG. 11E).
[0046] As a person skilled in the art will recognize from the
previous detailed description and from the figures and claims,
modifications and changes can be made to the preferred embodiments
of the invention without departing from the scope of this invention
defined in the following claims.
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