U.S. patent application number 17/586103 was filed with the patent office on 2022-06-02 for universal power supply for a functional cranial implant.
The applicant listed for this patent is Longeviti Neuro Solutions LLC. Invention is credited to Jesse Christopher, Corbin Clawson, Chad R. Gordon, Jimmy Shah.
Application Number | 20220168562 17/586103 |
Document ID | / |
Family ID | 1000006140412 |
Filed Date | 2022-06-02 |
United States Patent
Application |
20220168562 |
Kind Code |
A1 |
Gordon; Chad R. ; et
al. |
June 2, 2022 |
UNIVERSAL POWER SUPPLY FOR A FUNCTIONAL CRANIAL IMPLANT
Abstract
A low-profile intercranial device with universal power supply
includes a static cranial implant adapted for the selective
integration of a functional neurological implant. It also includes
a universal power supply having a universal implantable power
source with a connector.
Inventors: |
Gordon; Chad R.;
(Cockeysville, MD) ; Christopher; Jesse; (Hunt
Valley, MD) ; Clawson; Corbin; (Hampstead, MD)
; Shah; Jimmy; (Hunt Valley, MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Longeviti Neuro Solutions LLC |
Hunt Valley |
MD |
US |
|
|
Family ID: |
1000006140412 |
Appl. No.: |
17/586103 |
Filed: |
January 27, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16590930 |
Oct 2, 2019 |
11266829 |
|
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17586103 |
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62740106 |
Oct 2, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/37514 20170801;
H02J 7/025 20130101; A61N 1/3787 20130101; A61N 1/378 20130101;
A61N 1/36064 20130101; A61N 1/0539 20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61N 1/378 20060101 A61N001/378; A61N 1/36 20060101
A61N001/36; A61N 1/375 20060101 A61N001/375 |
Claims
1. A low-profile intercranial device with universal power supply,
comprising: a static cranial implant; a universal power supply
including a universal implantable power source with a connector
adapted for connection to a functional neurosurgical implant,
wherein the universal implantable power source is a solid-state
battery.
2. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant is adapted
for the selective integration of a functional neurological
implant.
3. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant includes
no encapsulated inner working.
4. (canceled)
5. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant includes a
cavity shaped and dimensioned for the functional neurosurgical
implant.
6. The low-profile intercranial device with universal power supply
according to claim 1, wherein the solid-state battery is a
malleable solid-state battery.
7-8. (canceled)
9. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant is
fabricated from clear and/or opaque PMMA (Poly(methyl
methacrylate)), PEEK (Polyether ether ketone), PEKK
(Polyetherketoneketone), porous polyethylene, titanium alloy, bone
allograft, bone autograft, bone xenograft, and/or various other
tissue-engineered bone constructs.
10. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant is fully
lucent and transparent.
11. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant is fully
translucent to light, sonolucent to ultrasound, radiolucent to ECOG
signals, and transparent for ideal visualization.
12. The low-profile intercranial device with universal power supply
according to claim 1, wherein the static cranial implant comprises
part of a multiple-part intercranial assembly.
13. The low-profile intercranial device with universal power supply
according to claim 12, wherein the universal power supply is
connected to a functional neurosurgical implant contained in a
separate portion of the multiple-part intercranial assembly.
14. The low-profile intercranial device with universal power supply
according to claim 1, wherein the universal power supply is
configured to be connected to a functional neurosurgical implanted
which is implantable directly in the brain.
15. A system for remote powering of a functional neurosurgical
implant, comprising: a static cranial implant housing a power
supply, the power supply including an implantable power source and
a wireless charging system; a functional neurosurgical implant in
communication with the wireless charging system for powering the
functional neurosurgical implant.
16. The system according to claim 15, wherein the implantable power
source is a lithium-ion battery, a solid-state battery, a
microbiology battery, a glucose powered system, or a piezoelectric
battery.
17. The system according to claim 15, wherein the static cranial
implant is fully lucent and transparent.
18. The system according to claim 17, wherein the static cranial
implant is fully translucent to light, sonolucent to ultrasound,
radiolucent to ECOG signals, and transparent for ideal
visualization.
19. The system according to claim 15, wherein the cranial implant
comprises part of a multiple part cranial implant.
20. The system according to claim 15, wherein the power supply is
configured to be connected to the functional neurosurgical implant
which is implantable directly in the brain.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/590,930, entitled "UNIVERSAL POWER SUPPLY
FOR A FUNCTIONAL CRANIAL IMPLANT," filed Oct. 2, 2019, which claims
the benefit of U.S. Patent Application Publication No. 62/740,106,
entitled "UNIVERSAL POWER SUPPLY FOR A FUNCTIONAL CRANIAL IMPLANT,"
filed Oct. 2, 2018, both of which are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates to a universal power supply
for a functional cranial implant.
2. Description of the Related Art
[0003] Fabricating a power supply for a functional cranial implant
can be as complicated as actually designing the implant itself or
the functional neurological implant mounted therein. With this in
mind, the present invention provides a universal power supply
specifically adapted for use in conjunction with a wide variety of
functional cranial implants.
SUMMARY OF THE INVENTION
[0004] In an embodiment, a low-profile intercranial device with
universal power supply includes a static cranial implant and a
universal power supply. The universal power supply includes a
universal implantable power source with a connector adapted for
connection to a functional neurosurgical implant.
[0005] In another embodiment, a system for remote powering of a
functional neurosurgical implant includes a static cranial implant
housing a power supply and a functional neurosurgical implant. The
power supply includes an implantable power source and a wireless
charging system. The functional neurosurgical implant is in
communication with the wireless charging system for powering the
functional neurosurgical implant.
[0006] Other advantages of the present invention will become
apparent from the following detailed description when viewed in
conjunction with the accompanying drawings, which set forth certain
embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a perspective view of a low-profile intercranial
device with a universal power supply.
[0008] FIG. 2 is an exploded view of the low-profile intercranial
device with a universal power supply as shown in FIG. 1.
[0009] FIG. 2A is an exploded view of the low-profile intercranial
device with a universal power supply in accordance with an
alternate embodiment.
[0010] FIG. 3 is a cross sectional view of the low-profile
intercranial device with a universal power supply along the line
3-3 in FIG. 1 and installed within the cranium of a patient.
[0011] FIG. 4 is a perspective of the low-profile intercranial
device with a universal power supply installed within the cranium
of a patient.
[0012] FIG. 5 is an exploded view of the low-profile intercranial
device with a universal power supply in accordance with another
embodiment.
[0013] FIGS. 6A and 6B are schematics of embodiments of the
universal power supply that may be used in conjunction with the
embodiment shown in FIG. 5.
[0014] FIG. 7 is a perspective view of an embodiment of the
low-profile intercranial device with a universal power supply.
[0015] FIG. 8 is a perspective view of another embodiment of the
low-profile intercranial device with a universal power supply.
[0016] FIG. 9 is a schematic showing use of the low-profile
intercranial device with a universal power supply.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] The detailed embodiments of the present invention are
disclosed herein. It should be understood, however, that the
disclosed embodiments are merely exemplary of the invention, which
may be embodied in various forms. Therefore, the details disclosed
herein are not to be interpreted as limiting, but merely as a basis
for teaching one skilled in the art how to make and/or use the
invention.
[0018] With reference to the various embodiments disclosed below
with reference to FIGS. 1 to 9, a low-profile intercranial device
with a universal power supply is disclosed. In accordance with one
embodiment disclosed with reference to FIGS. 1 to 5, 6A and 6B, the
low-profile intercranial device 10, 10' with a universal power
supply 12, 12' includes a static cranial implant 14 adapted for the
selective integration of a functional neurological implant 16, 16'
therein. In accordance with another embodiment disclosed with
reference to FIG. 7 the low-profile intercranial device 110
includes a universal power supply 112 housed within a static
cranial implant 114 of an intercranial assembly 111, while the
functional neurological implant 116 is housed within a mounting
plate 150 of the intercranial assembly 111. In accordance with yet
another embodiment as disclosed with reference to FIGS. 8 and 9,
the low-profile intercranial device 210 with a universal power
supply 212 includes a static cranial implant 214 adapted for
interaction with a functional neurological implant 216, 216' which
is located external to the static cranial implant 214 which
contains the universal power supply 212; that is, the static
intercranial implant 212 contains only the universal power supply
212 and is electrically connected to a functional neurological
device 216, 216' which is part of a separate and distinct
intercranial device 214' or is directly implanted into the body
(e.g., a microchip implanted directly within the skull).
[0019] As is explained below in greater detail, the universal power
supply of the present invention is adapted for using in conjunction
with a wide array of functional neurological devices. In accordance
with one embodiment, this is achieved by providing a power source
with a power output profile standardized for use in conjunction
with a wide array of functional neurological devices through
interconnection via industry standard wired connections or industry
standard wireless power transfer protocols (for example, via
inductive coupling or capacitive coupling).
[0020] As used within this disclosure, the term "intercranial"
means situated or occurring within the cranium itself such that
such devices are positioned within the space existing between the
inner surface of the scalp and the outer surface of the dura. As
such, intercranial devices are those devices intended for
positioning within the cranium itself as opposed to devices that
may be positioned on or adjacent to the cranium or positioned along
the interior of the cranium, for example, between the cerebral
cortex and the interior surface of the cranium. With this in mind,
intercranial devices such as those discussed below replace resected
portions of the cranium due to abnormalities in the cranium, damage
to the cranium, or other medically sufficient reasons for resecting
portions of the cranium.
[0021] As those skilled in the art will appreciate, it is often
desirable that "intercranial" implants have the exact thickness and
width, and/or shape and contour to replace all bone missing, as a
method to avoid three suboptimal sequelae including 1) prevent dead
space underneath (if the implant was thinner than missing bone), 2)
causing inadvertent and detrimental pressure on the scalp above if
and when the implant went beyond the outer cortex limits of the
missing bone (if the implant was thicker than missing bone), and 3)
causing inadvertent and detrimental pressure on the dura/brain
underneath if and when the implant went beyond the inner cortex
limits of the missing bone (if the implant was thicker than missing
bone). Such "intercranial" implants have three potential
indications for use including either replacing bone which has
already been removed previously (at a previous surgical date, known
as delayed cranioplasty), replacing diseased bone at time of
surgical resection (referred to as single-stage cranioplasty), or
replacing normal bone and simply being used for its inherent
function and universal power supply. Furthermore, the term
"intercranial" is opposed to devices that may be positioned on or
adjacent to the cranium or positioned along the interior of the
cranium, for example, between the cerebral cortex and the interior
surface of the cranium.
[0022] The term "static" is used in the description of the present
invention because the static cranial implant 14, has no
encapsulated inner working (i.e., "functional") parts, batteries,
wires, or computers, and is essentially an improved "empty-shell"
which optimizes the inter-implant positioning within the confines
of the skull and the neighboring functional neurosurgical implant
16.
[0023] The static cranial implant 14 of the present invention is
preferably a low-profile static cranial implant 14 as described in
Applicant's own U.S. Patent Application Publication No.
2018/0055640, entitled "METHOD FOR MANUFACTURING A LOW-PROFILE
INTERCRANIAL DEVICE AND THE LOW-PROFILE INTERCRANIAL DEVICE
MANUFACTURED THEREBY," filed Aug. 4, 2017, and PCT Publication No.
WO 2017/039762, entitled "LOW-PROFILE INTERCRANIAL DEVICE," filed
May 2, 2016, which are incorporated herein by reference. The static
cranial implant 14 is, therefore, designed for maximal
interdigitating of the static cranial implant 14 with a functional
neurosurgical implant 16 to be selected based upon the specific
needs of the patient. The term "interdigitating" is meant to refer
to the interlocking of two distinct elements (that is, the static
cranial implant 14 and the functional neurosurgical implant 16)
such that the two distinct elements mesh together to ultimately
define a single product. It is appreciated that while the various
embodiments disclosed herein only show a single functional
neurosurgical implant 16 in conjunction with a static cranial
implant 14, multiple functional neurosurgical implants 16 may be
used in a single static cranial implant 14 in accordance with the
present invention. The static cranial implant 14 is adapted for
ideal functional and aesthetic benefits, thereby minimizing
unnecessary spaces, inter-implant gaps, and sharp irregular angles.
This helps to minimize risk of scalp pain, visible deformity, and
implant micromotion--all of which often leads to treatment failure
and surgical explantation (that is, premature removal of the
implant).
[0024] As briefly mentioned above, the low-profile intercranial
device 10 with a universal power supply 12 includes a universal
power supply 12 integrated with the static cranial implant 14. As
will be explained below in greater detail, the static cranial
implant 14 is formed with a power supply recess 18 (and associated
passageways) adapted for the placement of the universal power
supply 12 within the static cranial implant 14. As with the
incorporation of the functional neurological implant 16 into the
static cranial implant 14, the power supply recess 18 is formed to
provide for maximal interdigitating of the static cranial implant
14 with the universal power supply 12.
[0025] In order to achieve ideal fit amongst the static cranial
implant 14, the functional neurological implant 16 and the
universal power supply 12, the static cranial implant 14 of the
present invention employs a CT (Computed Tomography) scan-based,
virtual design session performed pre-operatively based on the
brain-specific geographical location (as opposed to the standard
method of using the skull-specific geographic location) in the
manufacture of the low-profile intercranial device 10. In addition,
a plain X-ray or MRI (Magnetic Resonance Imaging) would fail to
provide enough bone data for manufacturing and designing this type
of intercranial implant. As a result, and for the first time, the
methodology employed in accordance with the present invention
accommodates both brain and skull pathology in three-dimensional
space, in all three axes, prior to surgery.
[0026] With this information, as well as knowledge regarding the
dimensions of the functional neurosurgical implant 16 and universal
power supply 12, the static cranial implant 14 is produced. The
static cranial implant 14 is augmented, reduced and/or modified to
include a cavity 20 for the functional neurosurgical implant 16. It
is appreciated multiple cavities may be employed where the
functional neurosurgical implant(s) 16 being used dictates and that
the cavity 20 need not be directly in the center of the static
cranial implant 14 but may be offset as dictated by the procedure
being performed. The static cranial implant 11 is also augmented,
reduced and/or modified to include other structural elements 22
(for example, wire tunnel(s), pocket(s), etc.), shaped and
dimensioned for optimal anatomical placement of the functional
neurosurgical implant 16 that is ultimately positioned within the
confines of the cavity 20 (and other structural element(s)) of the
static cranial implant 14 (i.e., like an empty shell case but with
exact negative and positive enhancements to optimize anatomical
positioning of both the static cranial implant 14 and the
functional neurosurgical implant 16).
[0027] The static cranial implant 14 is also augmented, reduced
and/or modified to include the power supply recess 18 for the
universal power supply 12 (it is appreciated multiple recesses may
be employed where the universal power supply(ies) 12 being used
dictates), as well as other structural elements 24 (for example,
wire tunnel(s), pocket(s), etc.), shaped and dimensioned for
optimal anatomical placement of the universal power supply 12 that
is ultimately positioned within the confines of the power supply
recess 18 (and other structural element(s)) of the static cranial
implant 14 (i.e., like an empty shell case but with exact negative
and positive enhancements to optimize anatomical positioning of
both the static cranial implant 14 and the universal power supply
12).
[0028] Depending upon the specifics of the functional neurosurgical
implant 16 and the universal power supply 12 positioned within the
cavities 18, 20 of the of static cranial implant 14, various
mechanical coupling mechanisms, for example, screws, plates, etc.
(not shown), are used to ensure that the functional neurosurgical
implant 16 and the universal power supply 12 are securely held in
place. As will be explained below in greater detail, the
manufacture of the low-profile intercranial device 10 utilizes
computer-based designs and modeling (CAD/CAM) of both the static
cranial implant 14, the functional neurosurgical implant 16, and
the universal power supply 12.
[0029] The computer-based designs of the static cranial implant 14,
the functional neurosurgical implant 16, and the universal power
supply 12 are optimized in the manner described in Applicant's own
U.S. Patent Application Publication No. 2018/0055640, entitled
"METHOD FOR MANUFACTURING A LOW-PROFILE INTERCRANIAL DEVICE AND THE
LOW-PROFILE INTERCRANIAL DEVICE MANUFACTURED THEREBY," filed Aug.
4, 2017, and PCT Publication No. WO 2017/039762, entitled
"LOW-PROFILE INTERCRANIAL DEVICE," filed May 2, 2016, which are
incorporated herein by reference.
[0030] Briefly, and as will be appreciated based upon the following
disclosure, the static cranial implant 14 of the present invention
is a modified version of a low-profile cranial implant commonly
used and known by those skilled in the art of cranial surgical
procedures. Such implants may take a variety of forms and are most
commonly shaped and dimensioned for integration into the structure
of a patient's skull; that is, the static cranial implant 14 has a
geometry that substantially conforms to a resected portion of the
patient's anatomy to which the implant is to be secured. Briefly,
the static cranial implant 14 of the present invention includes an
outer (commonly convex) first surface 14o, an inner (commonly
concave) second surface 14i, and a peripheral edge 14p extending
between the outer first surface 14o and the inner second surface
14i. The static cranial implant 14 is shaped and dimensioned for
engagement with the skull of the patient upon implantation in a
manner well known to those skilled in the field of neurosurgical
procedures. The outer first surface 14o and inner second surface
14i of the static cranial implant 14 are preferably curved in a
superior to inferior direction, a posterior to anterior direction,
and a medial to lateral direction. In addition, the peripheral edge
14p has a substantial taper for resting upon a matching taper
formed along the skull. It is, however, appreciated that this taper
may vary (or not exist at all, that is, the peripheral edge 14p may
be substantially perpendicular relative to the outer first surface
14o and the inner second surface 14i) depending upon the specific
needs of the procedure.
[0031] In accordance with a preferred embodiment, the static
cranial implant 14 has a preselected thickness not exceeding the
space between the inner surface of the scalp and the outer surface
of the dura, for example, in the range of around 1 millimeter to 25
millimeters (with areas of strategic bulking and/or thinning) and
depending upon the strength of the materials used in the
construction of the static cranial implant 14. Preferably, the
static cranial implant 14 will have a thickness of 1 millimeter to
12 millimeters. These lower and upper limits are of significance.
One millimeter is the smallest thickness for which most alloplastic
materials can remain protective of the brain related to tensile
strength, one example being poly-methyl-methacrylate. Twelve
millimeters is the estimated size for which one should consider
abnormal impingement of the underlying brain, for which may cause
pressure-related paralysis upon the motor cortex of the brain.
[0032] As mentioned above, the static cranial implant 14 also
includes a cavity 20 (for example, formed along the inner surface)
and optional structural elements 22, for example, channels,
pockets, access holes, and/or other structural elements, designed
to accommodate various features of the functional neurosurgical
implant 16. In the disclosed embodiment, structural elements 22 in
the form of channels are provided. The channels 22 have a first end
22a in communication with the cavity 20 and a second end 22b
extending to the inner second surface 14i of the static cranial
implant 14 for the passage of electrodes of the functional
neurosurgical implant 16 for applying stimulation to the brain.
Since many functional neurosurgical implants 16 interact with a
control device (not shown) via wireless mechanisms, access between
the outer first surface 14o (or top surface) and the center cavity
20 may not be required, although it is appreciated channels or
other structural elements 22 could certainly be provided for
external contact as needed.
[0033] As is also mentioned above, the static cranial implant 14
also includes a power supply recess 18 (for example, formed along
the inner surface) and optional structural elements 24, for
example, channels, pockets, access holes, and/or other structural
elements, designed to accommodate various features of the universal
power supply 12, and connections between the universal power supply
12 and the functional neurosurgical implant 16. In the disclosed
embodiment, structural elements 24 in the form of channels are
provided.
[0034] In accordance with a first embodiment, and as briefly
discussed above, the universal power supply 12 includes a universal
implantable power source 30 with a standard (or proprietary) wired
connector 32 for connection of the power source 30 with the
functional neurosurgical implant 16 (via wires 29 extending between
the universal power supply 12 and the functional neurosurgical
implant 16) so as to provide power thereto. The power source 30 has
a power output profile standardized for use in conjunction with a
wide array of functional neurological devices and includes an
industry standard connector.
[0035] In accordance with an alternate embodiment as shown with
reference to FIG. 2A, the universal power supply 12 may include a
wireless communication and/or charging system 31 (for example, a
wireless communication and/or charging system employing standard
wireless power transfer protocols (for example, via inductive
coupling or capacitive coupling)), alone or in conjunction with the
standard connector 32 discussed above. Such a wireless
communication and/or charging system 31 functions in conjunction
with a functional neurosurgical implant 16', which has been
designed to allow for wireless electrical power transfer thereto,
to provide for the wireless transfer of electrical power from the
universal power supply 12 to the functional neurosurgical implant
16.
[0036] Through the provision of such a universal power supply 12,
specific medical devices that require power will have a known
standard to employ for the baseline of the design. For example, if
one were to develop a brain stimulator, he/she would take the
present universal power supply 12 into consideration as he/she
designed the brain simulator. Therefore, the brain simulator would
be designed to function in a "plug and play" manner with the
universal power supply so as to reduce the regulatory and
engineering burden on the stimulator development.
[0037] The power source 30 may take the form of a lithium-ion
battery, a solid-state battery, a microbiology battery, a glucose
powered system, or a piezoelectric battery. Such batteries as are
preferably rechargeable through mechanisms known to those skilled
in the art. The power source could also take the form of malleable
solid-state batteries. Still further, the universal power supply
could be constructed such that batteries and components making up
the power source are housed through a process in which they are
suspended and fully encapsulated (for example, like a fossil in
sap) or built around with a top and bottom enclosure (that is,
sandwiched). Such a sandwich process will allow later replacement
of batteries, indefinitely. It is also contemplated, the power
source might take the form of a perpetual battery run by kinetic
energy (for example, like the automatic mechanical systems employed
in various watches, for example, a Rolex.RTM. watch). For the
purposes of disclosure, the terms "battery" or "batteries" is used
below interchangeably with the term power source when describing
various embodiment of the present invention. In accordance with
such an embodiment, the power source provides an output voltage
that can be a multiple of the nominal voltage of the cells of the
power source. If a voltage regulation device is used as discussed
below, the output voltage can be amplified to any value to meet the
power demands of the functional device.
[0038] As to the wired connector 32, it will take the form of a
universally accepted form, for example, Lightning connector, USB
connector, other connector structures well known to those skilled
in the art. With 3-D printing, it is further appreciated the
connection to the functional neurosurgical implant could be
achieved via soldering, laser welding or other mechanisms for
hardwiring of the power source to the functional neurosurgical
implant.
[0039] Regardless of whether the universal power supply disclosed
with reference to FIGS. 1, 2, 3 and 4 or with reference to FIGS. 2A
is employed, it is appreciated the universal power supply could
include multiple batteries as the power source 30.
[0040] In accordance with an alternate embodiment, as shown with
reference to FIGS. 5, 6A, and 6B, the universal power supply 12' is
a variable power device accommodating various power demands. The
power supply 12' includes an output control system 33' integrated
with the implantable power source 30' for selectively adjusting the
output of the universal power supply 12' to accommodate the needs
of the functional neurosurgical implant 16'. As with the prior
embodiment, such a universal power supply 12' would include a wired
connector 32 and/or a wireless communication and/or charging system
31 (please note the wireless communication and/or charging system
31' is shown in FIGS. 5, 6A, and 6B, although it is appreciated
wireless or wired electrical power transfer could be used, alone or
in combination, in accordance with the present embodiment).
[0041] In accordance with a first embodiment of the universal power
supply 12' adapted to accommodate various power demands, and as
shown in detail with reference to FIG. 6A, the output control
system 33' is an adjustable voltage regulator (or controller). Such
voltage regulators (or controllers) are known in the art and are
composed of variable resistors, diodes, transistors, operational
amplifiers, switches, or combinations of such components. The
voltage regulator (or controller) 33' is used to maintain a
specified input voltage to the functional neurosurgical implant
16', which has been designed to allow for wireless electrical power
transfer thereto, to ensure the functional neurosurgical implant
16' will function properly. If the functional neurosurgical implant
16' were to unexpectedly draw excessive current, the voltage
regulator (or controller) 33' is provided with a safety and
protection mechanism to prevent the functional neurosurgical
implant 16' from damaging itself or harming the patient.
[0042] In addition to the voltage regulator (or controller) 33',
the output control system 33' also includes a power management
system 35' integrated with the universal power supply 30' to
control the voltage regulator (or controller) 33' and, thereby,
manage the power delivery and charging of the power source 30', for
example, implanted battery(ies). The power management system 35' is
able to receive information, either wirelessly or by direct
connection, about the power needs of the functional neurosurgical
implant 16' in order to deliver appropriate power. For example, it
is contemplated the power management system 35' could interrogate
the functional neurosurgical implant 16 to determine the power
requirements thereof and subsequently adjust the power output to
accommodate the specific needs of the functional neurosurgical
implant 16'. Further, it is also contemplated the power management
system 35' could interrogate the functional neurosurgical implant
16' to ensure compatibility and provide a warning where, for
whatever reasons, the power source is not compatible with the
functional neurosurgical implant.
[0043] The power management system 35' is also able to transmit
information, either wirelessly or by direct connection, about the
state of the battery(ies) 30' and supply of power to the functional
neurosurgical implant 16' (or to an external receiver). The power
management system 35' also controls the power output and power
input to and from the battery(ies) 30' for the purposes of
providing power to the functional neurosurgical implant 16' or
charging the battery(ies) 30'.
[0044] As discussed above, the universal power supply is
contemplated to include an implantable power source composed of
multiple batteries as the power source. Where multiple batteries
30b' are used as the implantable power source 30', and with
reference to FIG. 6B, the configuration of the batteries 30b' can
be customized to achieve desired power characteristics and thereby
provide an another embodiment for the provision of a variable power
device accommodating various power demands. By altering the
batteries' configuration from series to parallel, or any
combination thereof, the capacity and output voltage of the
batteries 30b' can be tailored to meet the demands of the
functional neurosurgical implant 16'. It is appreciated the
configuration of the batteries 30b' can be changed wirelessly
on-demand through the use of a power management system 35'
controlling circuit switching components and circuits 37', for
example, through the integration of electromechanical regulators
that wirelessly open and close circuits so as to alter the battery
configuration.
[0045] As with the embodiment discussed above, and as briefly
discussed above, the power management system 35' is integrated with
the implantable power source 30' to manage the power delivery and
charging of the implanted batteries 30b'. The power management
system 35' is able to receive information, either wirelessly or by
direct connection, about the power needs of the functional
neurosurgical implant 16' in order to deliver appropriate power.
For example, it is contemplated the power management system 35'
could interrogate the functional neurosurgical implant 16 to
determine the power requirements thereof and subsequently adjust
the power output to accommodate the specific needs of the
functional neurosurgical implant 16'. Further, it is also
contemplated the power management system 35' could interrogate the
functional neurosurgical implant 16' to ensure compatibility and
provide a warning where, for whatever reasons, the power source 30'
is not compatible with the functional neurosurgical implant
16'.
[0046] The power management system is also able to transmit
information, either wirelessly or by direct connection, about the
state of the batteries 30b' and power supply to the functional
neurosurgical implant 16' or to an external receiver. The power
management system also controls the power output and power input to
and from the batteries 30b' for the purposes of providing power to
the functional neurosurgical implant 16' or charging the
batteries.
[0047] By altering the batteries' configuration under the control
of power management system 35' it is possible to selectively
provide higher voltage by configuring batteries 30b' in series or
higher current and capacity by configuring batteries 30b' in
parallel. Further still, through the use of multiple batteries 30b'
it is possible to address long-term patient needs. For example, if
a functional neurosurgical implant 16' intended to be implanted for
an extended length of time only requires one battery to functional
properly, additional back-up batteries can remain idle within the
static cranial implant 14 until their needs are called upon. This
allows, for example, through the integration of electromechanical
regulators that wirelessly open and close circuits as discussed
above, old, spent batteries to be wirelessly disconnected from the
circuit while the idle, fresh batteries are integrated into the
circuit without the need for surgical intervention, thus extending
the lifespan of the universal power supply.
[0048] In accordance with a preferred embodiment, the cranial
implant 14 is fabricated from a wide array of commonly-available
biomaterials including, but not limited to, clear and/or opaque
PMMA (Poly(methyl methacrylate)), PEEK (Polyether ether ketone),
PEKK (Polyetherketoneketone), porous polyethylene, titanium alloy,
bone allograft, bone autograft, bone xenograft, and/or various
other tissue-engineered bone constructs. In accordance with one
embodiment, the static cranial implant 14 is ideally made of clear
PMMA since it's fully lucent and transparent. This allows for novel
inspection of the interdigitated functional neurosurgical implant
16 and neighboring components. As will be explained below in
greater detail, it also allows for the critical transmission of
vital imaging with minimal distortion, such as ultrasound waves for
brain pathology detection, and wireless signal communication (i.e.,
electroencephalography or ECOG)--essential for various
neuromodulation devices such as NeuroPace.RTM., for example--as
first described by Gordon et al. in Operating Surgery in 2017 (full
citation below). Another clear material that may be readily used in
accordance with the present invention is cubic zirconium While
clear material is disclosed in accordance with a preferred
embodiment, it is appreciated the underlying concepts of the
present invention may be achieved through the utilization of an
opaque static cranial implant 14.
[0049] The optical clarity of the static cranial implant 14 is
important in expanding the potential uses of the low-profile
intercranial device 10 and in expanding the potential functional
neurosurgical implants 16 that may be used in conjunction with the
present invention. For example, the provision of high optical
clarity allows for wireless optical links between the functional
neurosurgical implants 16 and remote devices or between functional
devices on the interior of the cranium and the exterior of the
low-profile intercranial device 10 (for example, transmitting
between the cortex and the other side of the low-profile
intercranial device). Enhanced optical clarity similarly allows for
power transmission and/or receipt between the functional
neurosurgical implants 16 and devices outside of the static cranial
implant 14. Potential operations that may be achieved through the
utilization of optical links through a high clarity static cranial
implant 14 include, but are not limited to, device start-up, device
calibration, and device operational control.
[0050] Still further, the static cranial implant 14 is constructed
of a material allowing for imaging of the brain through the static
cranial implant 14, for example, via ultra-sound. It is known that
clear PMMA will provide the ability to permit ultra-sound imaging
of the brain therethrough so long as it is manufactured without
additives that might function to block the frequency and amplitude
of the ultrasound transducer. In accordance with one embodiment,
the static cranial implant 14 is ideally made of clear PMMA since
it's fully translucent to light, sonolucent to ultrasound,
radiolucent to ECOG signals (as first described by Gordon et al. in
"First in-human experience with complete integration of
neuromodulation device within a customized cranial implant."
Operative Neurosurg 2017), and transparent for ideal visualization
necessary for brain lead placement, catheter positioning, etc.
[0051] In addition to the optimal material choice, the preferred
static cranial implant may be 3D printed, direct digital
manufacturing, or a combination thereof. In this way necessary
circuitry can be printed into or added to the implant at the
optimal location(s) during the additive manufacturing process.
[0052] While a preferred static cranial implant 14 is disclosed in
accordance with the present invention, the static cranial implant
14 used in conjunction with the present invention may take a
variety of forms so long as the static cranial implant 14 includes
a cavity 20 (and, optionally, other structural elements) configured
to conform to the exact requirements of the functional
neurosurgical implant 16 and a power supply recess 18 (and,
optionally, other structural elements) configured to confirm to the
exact requirements of the universal power supply 12 in accordance
with the present invention.
[0053] Based upon the functional neurosurgical implant 16 used in
conjunction with the present invention, the functional
neurosurgical implant 16 may be useful in the treatment of various
patient conditions such as brain tumor management (drug delivery,
remote image monitoring), hydrocephalus (flow monitor, ICP pressure
sensors), epilepsy, movement disorders, chronic pain, spasticity,
cerebral palsy, multiple sclerosis, spinal cord injury (with or
without paralysis), traumatic brain injury,
attention-deficit/hyperactivity disorder, autism,
obsessive-compulsive disorders, etc.--and the potential to obtain
supra-normal levels of brain function in both military and civilian
situations for enhanced memory or physical activity. Furthermore,
incorporation of imaging devices within cranial implants 14 could
help to provide ongoing tumor bed monitoring for early detection of
disease recurrence.
[0054] By way of example, one potential functional neurosurgical
implant 16 that may be employed in accordance with the present
invention is a battery-powered functional neurosurgical implant 16
known as the NeuroPace.RTM. device, that is, a device for
responsive neurostimulation for epilepsy, which has a design flaw
in that it limits the visible aesthetic result due to its irregular
shape(s), causes undue pressure on the undersurface of the scalp,
and suffers significant implant micromotion thereby leading to
common device infection and bone flap osteomyelitis (See, Wei Z,
Gordon C R, Bergey G K, Sacks J M, Anderson W S. Implant Site
Infection and Bone Flap Osteomyelitis Associated with the NeuroPace
Responsive Neurostimulation System. World Neurosurg 2015 Dec. 29;
pii: s1878-8750(15)075-1.) These deficiencies are overcome in
accordance with the present invention by optimizing the static
cranial implant 14 for receipt of the NeuroPace.RTM. device and
improving its rigid placement within the intercranial space.
[0055] With the foregoing in mind, additional functional
neurosurgical implants 16 that may be used in conjunction with the
present invention include, but are not limited to the following:
Deep Brain Stimulators (DBS); Cortical Brain Stimulators (CBS);
neurologic medicines that are otherwise prevented from diffusing
through the blood-brain barrier via common delivery methods;
battery, passively, kinetically, or otherwise-powered functional
devices including neuromodulation devices, imaging devices,
radiation therapy devices, and remote sensing/monitoring devices;
monitoring devices for abnormal levels of intracranial pressure
(ICP) or brain activity (i.e., seizures), such as an electrical
array for motor/vision cortex control,
battery/passively/kinetically/or otherwise-based stimulation
hardware for epilepsy management (grids/batteries/wires);
low-profile remote imaging devices (e.g., optical coherence
tomography (OCT), duplex ultrasound); delivery/sensing devices for
electrical impulses; neurological and physiological systems
required for deep space/sleep functionalities enhancing the
monitoring and/or maintenance of bodily vital signs, nutrition,
cognition, etc.; convection enhanced delivery systems effectively
delivering therapeutics to substantial volumes of brain and brain
tumor; and remote neuro-imaging devices (i.e., electroencephalogram
(EEG).
[0056] The functional neurosurgical implants 16 of the present
invention may also incorporate high-precision and fully implantable
next-generation neural interface systems taking advantage of
microelectronics and photonics along with advances in scalable
neural encoding and processing algorithms to demonstrate the
transformation of high-definition sensory stimuli to and from
sensory cortex areas, bridging physiological and electronic neural
activity representations.
[0057] With this in mind, the term "functional neurosurgical
implant" is meant to reference any therapeutic hardware or
compositions including, but not limited to, medicines to treat any
patient- specific illness, or electronic, mechanical, imaging
modality and/or electro-mechanical device to remotely monitor
(e.g., via Wi-Fi connectivity) or intervene any specific neurologic
illness, including imaging, monitoring, electrostirnulation,
radiation therapy, polarized light/laser neuronal modulation
devices. The term "functional" denotes the fact that these implants
provide the low-profile intercranial device with the ability to
function as more than a safe custom-shaped skull replacement by
providing various functionalities, for example, local drug
delivery, monitoring (such as brain monitoring), or local electric
stimulation to the patient.
[0058] While the embodiment described above provides for a
universal power supply 14 that is connected to a functional
neurosurgical implant(s) 16 maintained within a unitary static
cranial implant 14, an alternate embodiment is disclosed in FIG. 5
wherein the universal power supply 114 and the functional
neurosurgical implant(s) 116 are maintained in different portions
of the intercranial device 110. In such an embodiment, the
intercranial device 110 is a multi-part intercranial assembly as
disclosed in Applicant's own U.S. patent application Ser. No.
16/203,357 (published as US2019/0209328) entitled "UNIVERSAL
LOW-PROFILE INTERCRANIAL ASSEMBLY," which is incorporated herein by
reference.
[0059] In accordance with this embodiment, the universal power
supply 112 is housed within the static cranial implant 114 of the
intercranial assembly 110 and the functional neurosurgical
implant(s) 116, which has been designed to allow for wireless
electrical power transfer thereto, is housed within the mounting
plate 150 intercranial assembly 110. Briefly, and as is disclosed
in detail the '328 publication, the intercranial assembly 110 is
composed of mounting plate 150 in which the functional
neurosurgical implant(s) 116 is housed and a static cranial implant
114 in which the universal power supply 112 is housed. Through use
of a static cranial implant 114 that may be selectively mounted and
dismounted from the mounting plate 150, it is possible to easily
replace the universal power supply 112 with removing, altering, or
otherwise changing the properly positioned functional neurosurgical
implant(s) 116.
[0060] As the universal power supply 114 and the functional
neurosurgical implant(s) 116 are separately housed, and it is
ultimately desirable to allow for removal of the universal power
supply 114 with disrupting the functional neurosurgical implant(s)
116, the universal power supply 114 is adapted for wireless
connection with the functional neurosurgical implant(s) 16 so as to
provide power to the functional neurosurgical implant(s) 116. As
such, it is preferred that the embodiment of the universal power
supply as disclosed with reference to FIG. 2A be used with this
embodiment, although it is appreciated a wired connection could
also be used within the spirit of the present invention.
[0061] While the embodiments described above provides for a
universal power supply that is connected to a functional
neurosurgical implant(s) maintained within the same implant or
implanted assembly, it is appreciate various other implementations
are possible. For example, and with reference to FIGS. 8 and 9, it
is contemplated that the intercranial device 210 composed of an
intercranial implant with universal power supply contemplated by
the present disclosure may take the form of an static cranial
implant 214 containing only the universal power supply 212, and not
the functional neurosurgical implant 216, 216'. In accordance with
such an embodiment, the neurosurgical functional implant 216, 216',
which has been designed to allow for wireless electrical power
transfer thereto, is located external to the static cranial implant
214 which contains the universal power supply 212, such as in a
separate static cranial implant 214' or directly implanted into the
body (see FIG. 9).
[0062] In implementing such an embodiment, either the cranial
implant of the embodiment disclosed with reference to FIGS. 1 to 4
or the multiple-part intercranial assembly disclosed with reference
to
[0063] FIG. 7 may be used to house the universal power supply 212.
The multiple-part intercranial assembly 210 disclosed with
reference to FIG. 7 is, however, shown in the disclosed embodiment
as this allows for ready replacement of the universal power supply
212.
[0064] Referring to FIGS. 8 and 9, the universal power supply 212
is housed within the static cranial implant 214 of the intercranial
assembly 210. The functional neurosurgical implant(s) 216 may be
housed within an alternate implant 214' (for example, a static
cranial implant as described in Applicant's own U.S. Patent
Application Publication No. 2018/0055640, entitled "METHOD FOR
MANUFACTURING A LOW-PROFILE INTERCRANIAL DEVICE AND THE LOW-PROFILE
INTERCRANIAL DEVICE MANUFACTURED THEREBY," filed Aug. 4, 2017, and
PCT Publication No. WO 2017/039762, entitled "LOW-PROFILE
INTERCRANIAL DEVICE," filed May 2, 2016, which are incorporated
herein by reference. The functional neurosurgical implant(s) 216'
may also be directly implanted into the body.
[0065] As with the embodiments disclosed with reference to FIGS.
2A, 5, 6A, and 6B, and considering the universal power supply 212
and the functional neurosurgical implant(s) 216, 216' are remotely
positioned within the body, the universal power supply 212 is
adapted for wireless connection with the functional neurosurgical
implant(s) 216, 216' so as to provide power to the functional
neurosurgical implant(s) 216, 216'. As such, it is preferred that
the embodiment of the universal power supply as disclosed with
reference to FIGS. 2A, 5, 6A, and 6B be used with this embodiment,
although it is appreciated a wired connection could also be used
within the spirit of the present invention.
[0066] Accordingly, the universal power supply 212 is contained in
one intercranial implant 214 with the functional neurological
implant 216 contained in a separate intercranial implant 214', that
is, an intercranial implant that does not nest with or otherwise
form a part of the intercranial implant 214 in which the universal
power supply 212 is housed. In this manner, the universal power
supply 212 may be implanted at one location and the functional
neurosurgical device 216 may be implanted at a different location,
which may be alongside the universal power supply 212 location or
at a location separate from the universal power supply 212
location. Such a configuration may provide many advantages. For
example, by separating the power supply 212 from the functional
neurosurgical implant 216 the surgeon is provided greater
flexibility in placing each device. It may be that the desired
location for one or both of the universal power supply 212 and
functional neurosurgical device 216 is not conducive to designing
and implanting an implant containing both devices, and by
separating the two to different locations, more suitable locations
for each may be used. The two merely need to communicate to deliver
power from the universal power supply 212 to the functional
neurosurgical device 216.
[0067] Where the universal power supply and functional
neurosurgical device are not mounted within the same implant, it is
contemplated that it may not be necessary to employ a universal
power supply to take advantage of concepts underlying the present
invention. Rather a power supply may be specifically matched to
operate in conjunction with the functional neurological device and
remotely linked thereto to provide power for the operation of the
functional neurological device.
[0068] As discussed above, it is further contemplated that the
functional neurosurgical device 216' may be directly implanted into
the body without being held in an intercranial implant. Thus, as
microchip-based devices become more sophisticated and efficient, it
may be possible to implant all or most of the functional
neurosurgical device directly into the desired body tissue. By way
of example, a microchip programmed to treat a disease or condition
may be directly implanted into the brain, and powered by a
universal power supply 212 implanted in the intercranial space as
part of an intercranial device 210, with the universal power supply
212 communicating power (wired or wirelessly) to the directly
implanted functional neurosurgical implant 216'.
[0069] By way of further example, the functional neurosurgical
implant 216 may be a brain mapping device, with the brain mapping
grid placed onto the brain and connected to the universal power
supply 212. After mapping, it is also contemplated the mapping grid
might be removed, and the universal power supply 212 connected to
another functional neurosurgical implant in the form of a
functional neurological treatment device such as an electrical
stimulation device to provide treatment, with the treatment device
implanted directly into the brain or in a separate intercranial
implant.
[0070] It is also contemplated that the universal power supply 212
could be configured to deliver power to more than one functional
neurosurgical device 216, 216' (see FIG. 9). Under such
circumstances, implanting the universal power supply 212 and each
functional neurosurgical device 216, 216' independent of each other
provides flexibility in the location of each and the access and
replacement of one device independent of the others.
[0071] In the foregoing embodiments it is also contemplated that
the intercranial implant with universal power supply could be
configured as an "off the shelf" item. That is, the implant need
not be a custom cranial implant configured to conform to the
particular shape and contour of the patient's skull. For example,
the intercranial implant with universal power supply may be
pre-configured to occupy a defined shape and space with the
universal power supply contained within the implant. In this
manner, a sterile universal power supply implant may be stocked
ready for use in surgery with a functional neurosurgical device
implant.
[0072] While the preferred embodiments have been shown and
described, it will be understood that there is no intent to limit
the invention by such disclosure, but rather, is intended to cover
all modifications and alternate constructions falling within the
spirit and scope of the invention.
* * * * *