U.S. patent application number 17/301037 was filed with the patent office on 2021-10-14 for devices, systems, and methods for stimulation therapy.
The applicant listed for this patent is NeuSpera Medical Inc.. Invention is credited to Randolph Kerry Armstrong, Timothy A. Fayram, Brad Holinski, Elia Junco, Milton M. Morris, Gary Shaw, Alexander Yeh.
Application Number | 20210316142 17/301037 |
Document ID | / |
Family ID | 1000005678789 |
Filed Date | 2021-10-14 |
United States Patent
Application |
20210316142 |
Kind Code |
A1 |
Fayram; Timothy A. ; et
al. |
October 14, 2021 |
DEVICES, SYSTEMS, AND METHODS FOR STIMULATION THERAPY
Abstract
Generally discussed herein are systems, devices, and methods for
providing a therapy (e.g., stimulation) and/or data signal using an
implantable device. Systems, devices and methods for interacting
with (e.g., communicating with, receiving power from) an external
device are also provided.
Inventors: |
Fayram; Timothy A.; (Gilroy,
CA) ; Yeh; Alexander; (Los Altos Hills, CA) ;
Shaw; Gary; (Santa Clara, CA) ; Armstrong; Randolph
Kerry; (Katy, TX) ; Morris; Milton M.;
(Houston, TX) ; Junco; Elia; (Palo Alto, CA)
; Holinski; Brad; (Newark, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NeuSpera Medical Inc. |
San Jose |
CA |
US |
|
|
Family ID: |
1000005678789 |
Appl. No.: |
17/301037 |
Filed: |
March 23, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15830862 |
Dec 4, 2017 |
10994139 |
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17301037 |
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PCT/US2016/057952 |
Oct 20, 2016 |
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15830862 |
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62244495 |
Oct 21, 2015 |
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62264239 |
Dec 7, 2015 |
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62291379 |
Feb 4, 2016 |
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62350674 |
Jun 15, 2016 |
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62350676 |
Jun 15, 2016 |
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62350681 |
Jun 15, 2016 |
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62350684 |
Jun 15, 2016 |
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62367995 |
Jul 28, 2016 |
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62368005 |
Jul 28, 2016 |
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62373569 |
Aug 11, 2016 |
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62396478 |
Sep 19, 2016 |
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62397620 |
Sep 21, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/37229 20130101;
A61B 5/00 20130101; H02J 50/20 20160201; A61N 1/36185 20130101;
A61N 1/0558 20130101; A61N 1/3787 20130101; A61N 1/37518 20170801;
A61N 1/36062 20170801; A61N 1/3756 20130101; A61N 1/37223 20130101;
H02J 50/40 20160201; A61N 1/37247 20130101; H02J 50/80 20160201;
H02J 50/90 20160201; A61N 1/37252 20130101; A61N 1/0551 20130101;
H02J 50/10 20160201; H02J 7/025 20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; H02J 50/20 20060101 H02J050/20; H02J 50/80 20060101
H02J050/80; A61N 1/375 20060101 A61N001/375; A61N 1/378 20060101
A61N001/378; A61N 1/05 20060101 A61N001/05; H02J 50/10 20060101
H02J050/10; H02J 50/40 20060101 H02J050/40; H02J 50/90 20060101
H02J050/90; A61N 1/372 20060101 A61N001/372 |
Claims
1. (canceled)
2. An external power system comprising: a user interface;
processing circuitry coupled to the user interface; a memory
including instructions that, when executed by the processing
circuitry, cause the processing circuitry to perform operations
comprising: receiving data indicating an amount of stimulation
therapy provided by an implanted stimulation device; comparing the
amount of stimulation therapy provided to a maximum prescribed
limit of stimulation; and causing the user interface to provide an
indication that the maximum prescribed limit of stimulation was
reached or will be reached.
3. The system of claim 2, wherein the indication includes haptic
feedback, a communication to a mobile device, or audio through a
speaker.
4. The system of claim 2, wherein the operations further comprise:
receiving, via the user interface, information about a schedule for
stimulation therapy to be provided by the implanted stimulation
device; and prior to receiving the data indicating the amount of
stimulation therapy provided, providing a signal to the implanted
stimulation device that causes the implanted stimulation device to
provide the stimulation therapy in accordance with the
schedule.
5. The system of claim 2, wherein the operations further comprise:
receiving, by the user interface, a user request for stimulation
therapy; determining the user request does not violate the maximum
prescribed limit of stimulation; and responsive to determining the
user request does not violate the maximum prescribed limit of
stimulation, providing a signal to the implanted stimulation device
that causes the implanted stimulation device to provide the
requested stimulation therapy.
6. The system of claim 5, wherein the operations further comprise:
receiving, by the user interface, data indicating a schedule for
the stimulation therapy to be provided by the implanted stimulation
device; and determining that the requested stimulation therapy and
the schedule for the stimulation therapy in combination do not
violate the maximum prescribed limit of stimulation; wherein
providing the signal to the implanted stimulation device that
causes the implanted stimulation device to provide the requested
stimulation therapy occurs further in response to determining that
the requested stimulation therapy and the schedule for the
stimulation therapy in combination do not violate the maximum
prescribed limit of stimulation.
7. The system of claim 5, wherein: the user request includes data
indicating one or more of a duration, intensity, or time for the
stimulation therapy; and determining the requested stimulation
therapy does not violate the maximum prescribed limit of
stimulation occurs based on the data indicating one or more of a
duration, intensity, or time of the requested stimulation
therapy.
8. The system of claim 2, wherein the operations further comprise:
determining the received data indicating the amount of stimulation
therapy provided by the implanted stimulation device is at the
maximum prescribed limit of stimulation; and responsive to
determining the requested stimulation is at the maximum prescribed
limit of stimulation, refraining from providing power to the
implanted stimulation device for a specified amount of time.
9. The system of claim 8, wherein refraining from providing power
to the implanted device includes powering off a portion of an
external power device that wirelessly provides electrical power to
the implanted stimulation device.
10. The system of claim 2, further comprising a mobile device of a
user receiving information about the stimulation therapy, and
wherein the operations further comprise receiving, at the
processing circuitry, a communication from the mobile device, the
communication indicating one or more of a stimulation schedule, a
reminder sound or vibration, power on time, power off time, or
information about an implanted device power setting.
11. The system of claim 2, wherein the operations further comprise:
quantifying an amount of stimulation provided by the implanted
stimulation device over a specified period of time; and providing a
notification, by the user interface, indicating the quantified
amount of stimulation provided, the notification including a haptic
vibration, a communication using a mobile device, or audio from a
speaker.
12. The system of claim 11, wherein the operations further comprise
inhibiting further stimulation for a specified amount of time in
response to the quantified amount of stimulation provided exceeding
a specified threshold stimulation amount.
13. An electrical stimulation system comprising: an implanted
stimulation device; an external power source in communication with
the implanted stimulation device, the external power source
comprising: a user interface; processing circuitry coupled to the
user interface; and a memory including instructions that, when
executed by the processing circuitry, cause the processing
circuitry to perform operations comprising: receiving data
indicating an amount of stimulation therapy provided by the
implanted stimulation device; comparing the amount of stimulation
therapy provided to a maximum prescribed limit of stimulation; and
causing the user interface to provide an indication that the
maximum prescribed limit of stimulation has been, or is about to,
be reached.
14. The system of claim 13, wherein the indication includes haptic
feedback from the external power source, and the system further
includes a mobile device, and the indication further includes a
user notification provided using the mobile device, or audio
provided using a speaker of the external power source.
15. The system of claim 13, wherein the operations further
comprise: receiving, by the user interface, a schedule of
stimulation therapy to be provided by the implanted stimulation
device; and prior to receiving the data indicating the amount of
stimulation therapy provided, providing a signal to the implanted
stimulation device that causes the implanted stimulation device to
provide the stimulation therapy in accordance with the
schedule.
16. The system of claim 13, wherein the operations further
comprise: receiving, by the user interface, a user instruction for
stimulation therapy; determining the user instruction does not
violate the maximum prescribed limit of stimulation; and responsive
to determining the user instruction does not violate the maximum
prescribed limit of stimulation, providing a signal to the
implanted stimulation device that causes the implanted stimulation
device to provide the stimulation therapy according to the user
instruction.
17. The system of claim 16, wherein the operations further
comprise: receiving, by the user interface, data indicating a
schedule for the stimulation therapy; and determining that the user
instruction and stimulation therapy according to the schedule for
the stimulation therapy, in combination, do not violate the maximum
prescribed limit of stimulation; wherein providing the signal to
the implanted stimulation device that causes the implanted
stimulation device to provide the stimulation therapy occurs
further in response to determining that the user instruction and
the stimulation therapy according to the schedule for the
stimulation therapy, in combination, do not violate the maximum
prescribed limit of stimulation.
18. The system of claim 16, wherein: the user instruction includes
data indicating one or more of a duration, intensity, or time of a
requested stimulation; and determining the user instruction does
not violate the maximum prescribed limit of stimulation includes
using the data indicating the one or more of the duration,
intensity, or time of the requested stimulation.
19. The system of claim 13, wherein the operations further
comprise: determining the received data indicating the amount of
stimulation therapy provided by the implanted stimulation device is
at the maximum prescribed limit of stimulation; and responsive to
determining the indicated amount of stimulation is at the maximum
prescribed limit of stimulation, refraining from providing power
from the external power source to the implanted stimulation device
for a specified amount of time.
20. The system of claim 19, wherein refraining from providing power
to the implanted device includes powering off the external power
source that wirelessly provides electrical power to the implanted
stimulation device.
21. The system of claim 13, further comprising a mobile device of a
user receiving the stimulation therapy, and wherein the operations
further comprise receiving, at the processing circuitry, a
communication from the mobile device, the communication indicating
one or more of a stimulation schedule, a reminder sound or
vibration, power-on time, power-off time, or power setting for the
implanted stimulation device.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/830,862 filed on Dec. 4, 2017, titled
"DEVICE, SYSTEMS, AND METHODS FOR STIMULATION THERAPY, which is a
continuation-in-part of and claims priority benefit to Patent
Cooperation Treaty application PCT/US2016/057952, published with
publication number WO 2017/070372, titled "DEVICE, SYSTEMS, AND
METHODS FOR STIMULATION THERAPY", and filed on Oct. 20, 2016 (the
"PCT Application"). The PCT Application claims priority benefit to
the following U.S. provisional applications: U.S. Provisional
Application No. 62/244,495 filed Oct. 21, 2015 and titled "COMPACT
INTEGRATION OF ELECTRONIC CONTROL HARDWARE WITH ELECTROMAGNETIC
TRANSMITTING ELEMENT"; U.S. Provisional Application No. 62/264,239
filed Dec. 7, 2015 and titled "DISCREET EXTERNAL DEVICE COUPLING TO
IMPLANTED DEVICE"; U.S. Provisional Application No. 62/291,379
filed Feb. 4, 2016 and titled "IMPLANTABLE STIMULATION DEVICES AND
STEERING AND AFFIXING MECHANISMS THEREFORE"; U.S. Provisional
Application No. 62/350,674 filed Jun. 15, 2016 and titled "WIRELESS
NEURAL THERAPY DELIVERY SYSTEMS AND METHODS USING A SERIES OF
ELECTROSTIMULATION SIGNALS"; U.S. Provisional Application No.
62/350,676 filed Jun. 15, 2016 and titled "IMPLANTABLE STIMULATION
DEVICES AND STEERING MECHANISMS THEREFORE"; U.S. Provisional
Application No. 62/350,681 filed Jun. 15, 2016 and titled
"IMPLANTABLE STIMULATION DEVICES, SYSTEMS, AND METHODS"; U.S.
Provisional Application No. 62/350,684 filed Jun. 15, 2016 and
titled "DUAL-FREQUENCY ELECTROSTIMULATION FOR NEURAL THERAPY"; U.S.
Provisional Application No. 62/367,995 filed Jul. 28, 2016 and
titled "IMPLANTABLE STIMULATION DEVICES INCLUDING HOLLOW LUMEN";
U.S. Provisional Application No. 62/368,005 filed Jul. 28, 2016 and
titled "SURFACE ACOUSTIC WAVE BASED COMMUNICATION DEVICE"; U.S.
Provisional Application No. 62/373,569 filed Aug. 11, 2016 and
titled "ACTIVE POWER MANAGEMENT TECHNIQUES FOR WIRELESS IMPLANTABLE
DEVICES"; U.S. Provisional Application No. 62/396,478 filed Sep.
19, 2016 and titled "SYSTEMS AND METHODS FOR EMBEDDING
COMMUNICATION SIGNALS WITH ELECTROSTIMULATION THERAPY"; and U.S.
Provisional Application No. 62/397,620 filed Sep. 21, 2016 and
titled "BACKSCATTER COMMUNICATION TECHNIQUES." The entire content
of each of the above identified applications is hereby incorporated
by reference herein.
TECHNICAL FIELD
[0002] One or more embodiments discussed herein regard devices,
systems, and methods for providing signals (e.g., wireless midfield
powering signals) to an implantable device (e.g., stimulation
device) using an external device (e.g., external midfield coupler
or midfield power source). One or more embodiments discussed herein
regard devices, systems, and methods for providing therapy (e.g.,
stimulation or other modulation) or diagnostics from an implantable
device. One or more embodiments discussed herein regard
configurations for the implantable device and the external device.
One or more embodiments discussed herein regard communicating data
from the implantable device to the external device. One or more
embodiments discussed herein regard devices, systems, and methods
for positioning the implantable device at or near a specific
location and/or shaping the implantable device.
TECHNICAL BACKGROUND
[0003] Most of the known wireless powering methods for implantable
electronics are based on the nearfield coupling method, and these
and other suggested methods suffer from a number of disadvantages.
The power harvesting structure in the implanted device is typically
large (typically on the order of a centimeter or larger). The coils
external to the body in near-field coupling methods are also
typically bulky and inflexible. This presents difficulties with
regard to the incorporation of the external device into daily life.
The intrinsic exponential decay of the near field limits
miniaturization of the implanted device beyond superficial depths
(greater than 1 cm). On the other hand, the radiative nature of the
far field severely limits the energy transfer efficiency.
SUMMARY
[0004] In one or more embodiments, a method is provided for
providing intermittent stimulation by a stimulation system. The
method can include providing intermittent stimulation by a
stimulation system, such as by providing, by an external device of
the stimulation system, radio frequency first signals to an
implantable device of the stimulation system, the implantable
device including an electrode and the first signals causing the
implantable device to provide electrical stimulation through the
electrode for a first time duration. The method can further include
determining, at the external device, that the implantable device is
out of range of a transmission from the external device. The method
can further include after determining the implantable device is out
of range, determining, at the external device, that the implantable
device is within range of the transmission from the external
device. The method can further include providing, by an external
device of the stimulation system, radio frequency second signals to
the implantable device of the stimulation system, the second
signals causing the implantable device to provide electrical
stimulation through the electrode for a third time period.
[0005] The method can further include, before providing the first
signals, generating a sound by a speaker of the external device to
alert a user of the stimulation system that a subsequent electrical
stimulation is to be administered. The method can further include,
after providing the first signals, generating a sound by a speaker
of the external device to alert a user of the stimulation system
that the electrical stimulation has been administered. The method
can further include monitoring an amount of the electrical
stimulation provided by the implantable device and a decay of a
therapeutic effect of the dosage, and in response to determining
the therapeutic effect of the dosage has decayed below a threshold
amount, providing the second signals.
[0006] The method can further include indicating, using a speaker,
motor, or display, to a user of the stimulation system an amount of
time the implantable device has been actively stimulating. The
method can further include indicating, using a speaker or motor of
the external device, to a user of the stimulation system that the
external device is outside of a transmission range of the
implantable device. The method can further include continuing the
indication until location circuitry of the external device
determines the external device is within transmission range of the
implantable device.
[0007] The method can further include indicating, using a speaker
or motor of the external device, to a user of the stimulation
system that the user is to remove the external device from within
transmission range of the implantable device. The method can
further include providing, by the external device, a communication
to a mobile device that causes the mobile device to indicate that
stimulation is about to begin, stimulation has ended, or a location
of the external device is sufficient or insufficient for powering
the implantable device.
[0008] The method can further include receiving, at the external
device, one or more signals indicating that the external device is
to produce a communication, after a specified third time duration
elapses, reminding the user that stimulation is needed. The method
can further include, wherein the communication includes at least
one of an electronic mail, text message, or notification on a
display of the mobile device. The method can further include
providing, by the external device, stimulation data to a mobile
device, the stimulation data including one or more of date, time,
duration, and power of stimulation provided by the implantable
device.
[0009] The method can further include receiving, at the external
device, a communication from a mobile device of a user, the
communication indicating one or more of a stimulation schedule, a
reminder sound or vibration, power on time, power off time, and
implantable device power setting. The method can further include
receiving, from a mobile device and at the external device, one or
more signals that cause the external device to provide the first
signals to the implantable device. The method can further include
receiving, from a user interface of the stimulation system and at
the external device, data indicating a schedule of dates and times
at which to provide stimulation. The method can further include
providing the first and second signals consistent with the
schedule. The method can further include, wherein the schedule
further includes data indicating an intensity of stimulation at a
specified date and time.
[0010] The method can further include determining, by the
implantable device, whether a charge imbalance is present around
the implantable device. The method can further include, in response
to determining that a charge imbalance is present, inhibiting
stimulation. The method can further include, quantifying an amount
of stimulation provided over a specified period of time. The method
can further include inhibiting further stimulation in response to a
quantified amount of electrical stimulation provided exceeding a
specified threshold amount.
[0011] The method can further include, determining, based on a
timer or schedule data, that stimulation is to be provided to a
target. The method can further include, determining whether energy
is being received from the external device. The method can further
include, in response to determining that energy is not being
received from the external device, providing, by the implantable,
stimulation to the target using energy stored in one or more
capacitors of the implantable device. The method can further
include, receiving, at the external device and from a request
stimulation control of a user interface, one or more signals
indicating a user request for stimulation. The method can further
include, comparing, at the external device, an amount of
stimulation provided in a specified period of time to a specified
stimulation threshold. The method can further include, in response
to determining that the amount of stimulation provided in the
specified period of time is less than the threshold, producing
radio frequency third signals to provide electrical energy to the
implantable device. An external device, implantable device, a
mobile device, or a combination thereof including components
configured to implement the method.
[0012] A device or system of devices can be configured to implement
the method. For example, an external device can facilitate
provision of intermittent stimulation by an implantable device. The
external device can include at least one hardware processor, a
memory coupled to the at least one hardware processor, the memory
including data indicating a stimulation schedule stored thereon,
the stimulation schedule indicating a time, frequency, duty cycle,
and duration of stimulation to be provided by the implantable
device, a timer to keep track of time between stimulation sessions
and the duration of current stimulation, and a transmitter coupled
to the at least one hardware processor. The at least one hardware
processor can cause the transmitter to provide radio frequency (RF)
first signals to the implantable device, the implantable device
including an electrode and the first signals causing the
implantable device to provide electrical stimulation through the
electrode for a first time duration specified in the stimulation
schedule. The hardware processor can determine that an implantable
device is out of transmission range of the external device. The
hardware processor can subsequently determine that the implantable
device is within transmission range of the external device. The
external device can wait a second time duration, consistent with
the schedule, after the first time duration has elapsed according
to the timer. The hardware processor can cause the transmitter to
provide, consistent with the schedule, RF second signals to the
implantable device of the stimulation system, the second signals
causing the implantable device to provide electrical stimulation
through the electrode for a third time period consistent with the
schedule.
[0013] The external device can further include a speaker coupled to
the at least one hardware processor. The at least one hardware
processor can further, before providing the first signals, cause
the speaker to generate a sound to alert a user of the stimulation
system that a subsequent electrical stimulation is to be
administered. The at least one hardware processor can further,
after providing the first signals, cause the speaker to generate a
sound to alert a user of the stimulation system that the electrical
stimulation has been administered.
[0014] The at least one processor can further monitor an amount of
the electrical stimulation provided by the implantable device and a
decay of a therapeutic effect of the dosage. The at least one
processor can further, in response to a determination that the
therapeutic effect of the dosage has decayed below a threshold
amount, provide the second signals.
[0015] The external device can include a speaker, motor, or
display. The at least one hardware processor can further cause the
speaker, motor, or display to indicate to a user an amount of time
the implantable device has been actively stimulating. The at least
one hardware processor can further cause the speaker, motor, or
display to indicate to a user that the external device is outside
of a transmission range of the implantable device. The at least one
hardware processor can further cause the speaker, motor, or display
to indicate to a user that the user is to remove the external
device from within transmission range of the implantable
device.
[0016] The external device can further include location circuitry.
The at least one processor can further cause the speaker, motor, or
display to continue the indication until the location circuitry of
the external device determines the external device is within
transmission range of the implantable device. The at least one
processor can further to cause the transmitter to provide a
communication to a mobile device that causes the mobile device to
indicate that stimulation is about to begin, stimulation has ended,
or a location of the external device is sufficient or insufficient
for powering the implantable device. The at least one processor can
further cause the transmitter to produce a communication, after a
specified third time duration elapses, reminding the user that
stimulation is needed. The communication can include at least one
of an electronic mail, text message, or notification on a display
of the mobile device. The at least one processor can further cause
the transmitter to provide stimulation data to a mobile device, the
stimulation data including one or more of date, time, duration, and
power of stimulation provided by the implantable device.
[0017] The external device can further include a receiver coupled
to that at least one hardware processor. The receiver can receive a
communication from a mobile device of a user, the communication
indicating one or more of the stimulation schedule, a reminder
sound or vibration, power on time, power off time, and implantable
device power setting. The receiver can receive one or more signals
from a mobile device that cause the external device to provide the
first signals to the implantable device. The receiver can receive,
from a user interface of the stimulation system and at the external
device, data indicating a schedule of dates and times at which to
provide stimulation. The at least one hardware processor can cause
the transmitter to provide the first and second signals consistent
with the schedule.
[0018] The receiver can receive from a request stimulation control
of a user interface, one or more signals indicating a user request
for stimulation. The at least one hardware processor can further
compare an amount of stimulation provided in a specified period of
time to a specified stimulation threshold. The at least one
hardware processor can, in response to a determination that the
amount of stimulation provided in the specified period of time is
less than the threshold, cause the transmitter to produce radio
frequency third signals to provide electrical energy to the
implantable device. The schedule can further include data
indicating an intensity of stimulation at a specified date and
time.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0020] FIG. 1 illustrates, by way of example, a schematic of an
embodiment of a system using wireless communication paths.
[0021] FIG. 2A illustrates, by way of example, a block diagram of
an embodiment of a midfield source device.
[0022] FIG. 2B illustrates, by way of example, a block diagram of
an embodiment of a portion of a system configured to receive a
signal.
[0023] FIG. 3 illustrates, by way of example, a schematic view of
an embodiment of a midfield antenna with multiple subwavelength
structures.
[0024] FIG. 4 illustrates, by way of example, a diagram of an
embodiment of a phase-matching and/or amplitude-matching network
for a midfield source device.
[0025] FIG. 5 illustrates, by way of example, a diagram of an
embodiment of circuitry of an implantable device.
[0026] FIG. 6 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device.
[0027] FIG. 7 illustrates, by way of example, a perspective view
diagram of another embodiment of an implantable device that shows
internal circuitry and an antenna internal to the device.
[0028] FIG. 8A illustrates, by way of example, a perspective view
diagram of an embodiment of circuitry housing.
[0029] FIG. 8B illustrates, by way of example, a perspective view
diagram of another embodiment of the circuitry housing.
[0030] FIG. 9 illustrates, by way of example, a perspective view
diagram of an embodiment of the circuitry housing that shows the
circuitry internal to the circuitry housing of FIG. 8A.
[0031] FIG. 10 illustrates, by way of example, a signal power vs
time graph for a stimulation pulse from an implantable device.
[0032] FIG. 11A illustrates, by way of example, a perspective view
diagram of a proximal portion of an embodiment of an implantable
device.
[0033] FIG. 11B illustrates, by way of example, a perspective view
diagram of a proximal portion of another embodiment of an
implantable device.
[0034] FIG. 11C illustrates, by way of example, a perspective view
diagram of a proximal portion of yet another embodiment of an
implantable device.
[0035] FIG. 12A illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device with an external
housing invisible to show the internal circuitry of the implantable
device.
[0036] FIG. 12B illustrates, by way of example, an exploded view
diagram of a portion of the implantable device in the dashed box
labelled "12B" in FIG. 12A.
[0037] FIG. 13A illustrates, by way of example, a perspective view
diagram of an embodiment of a proximal portion of an implantable
device and attachable tines.
[0038] FIG. 13B illustrates, by way of example, a perspective view
diagram of an embodiment of the proximal portion of the implantable
device and attachable tines.
[0039] FIG. 13C illustrates, by way of example, a perspective view
diagram of an embodiment of the implantable device with attached
tines.
[0040] FIG. 14A illustrates, by way of example, a perspective view
diagram of an embodiment of a system for attaching tines to an
implantable device.
[0041] FIG. 14B illustrates, by way of example, a perspective view
diagram of an embodiment of the system of FIG. 14A with the tines
being pushed closer to the implantable device.
[0042] FIG. 14C illustrates, by way of example, a perspective view
diagram of an embodiment of the system of FIG. 14B with the tines
attached to the implantable device.
[0043] FIG. 15A illustrates, by way of example, a perspective view
diagram of an embodiment of a system for securing tines to an
implantable device.
[0044] FIG. 15B illustrates, by way of example, an exploded view
diagram of an embodiment of a system for securing tines to an
implantable device as depicted in the dashed box labelled "15B" in
FIG. 15A.
[0045] FIG. 15C illustrates, by way of example, a perspective view
diagram of an embodiment of a system for steering an implantable
device.
[0046] FIG. 15D illustrates, by way of example, an exploded view
diagram of an embodiment of a portion of the system which is a
portion of the system of FIG. 15C.
[0047] FIG. 15E illustrates, by way of example, an exploded view
diagram of an embodiment of a system that includes the pushrod over
the suture.
[0048] FIG. 15F illustrates, by way of example, a perspective view
diagram of a system for detaching the push rod from the implantable
device.
[0049] FIG. 16A illustrates, by way of example, a perspective view
diagram of an embodiment of a suture securing system.
[0050] FIG. 16B illustrates, by way of example, a perspective view
diagram of an embodiment of the suture securing system of FIG. 16A
with the suture secured to a pushrod.
[0051] FIGS. 17A, 17B, and 17C illustrate, by way of example,
perspective view diagrams of an embodiment of a system for
deploying tines of an implantable device.
[0052] FIG. 18 illustrates, by way of example, a perspective view
diagram of an embodiment of a suture and tine deployment mechanism
attached to a proximal portion of an implantable device.
[0053] FIG. 19 illustrates, by way of example, a perspective view
diagram of an embodiment of the suture and tine deployment
mechanism of FIG. 18 with radiopaque markers on the tine deployment
mechanism.
[0054] FIG. 20 illustrates, by way of example, a perspective view
diagram of an embodiment of a suture attached to a proximal portion
of an implantable device.
[0055] FIG. 21 illustrates, by way of example, a perspective view
diagram of an embodiment of a plurality of sutures attached to a
proximal portion of an implantable device.
[0056] FIG. 22A illustrates, by way of example, a perspective view
diagram of an embodiment of a suture and a proximal portion of an
implantable device.
[0057] FIG. 22B illustrates, by way of example, a perspective view
diagram of an embodiment of the suture attached to the implantable
device of FIG. 22A.
[0058] FIG. 22C illustrates, by way of example, a perspective view
diagram of an embodiment of a suture and a proximal portion of an
implantable device in which the suture is attached to a circuitry
housing.
[0059] FIG. 22D illustrates, by way of example, a perspective view
diagram of an embodiment of a suture and tine deployment mechanism
with the tines deployed.
[0060] FIG. 23A illustrates, by way of example, a perspective view
diagram of an embodiment of a suture attached to a grasping
mechanism.
[0061] FIG. 23B illustrates, by way of example, a perspective view
diagram of an embodiment of the grasping mechanism in an open
position.
[0062] FIG. 23C illustrates, by way of example, a perspective view
diagram of an embodiment of the grasping mechanism in a closed
position.
[0063] FIG. 24A illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device and a memory
metal.
[0064] FIG. 24B illustrates, by way of example, a perspective view
diagram of an embodiment of the memory metal in a conduit of the
implantable device.
[0065] FIG. 25A illustrates, by way of example, a perspective view
diagram of an embodiment of a stylet in a conduit of the
implantable device.
[0066] FIG. 25B illustrates, by way of example, a perspective view
diagram of another embodiment of a stylet in a conduit of the
implantable device.
[0067] FIG. 26A illustrates, by way of example, a perspective view
diagram of an embodiment of a system for guiding the implantable
device.
[0068] FIG. 26B illustrates, by way of example, a perspective view
diagram of an embodiment of FIG. 26A with some portions removed to
show the stylet within the implantable device.
[0069] FIG. 26C illustrates, by way of example, an exploded view
diagram of an embodiment of a steering mechanism of the system of
FIGS. 26A and 26B.
[0070] FIG. 27A illustrates, by way of example, an exploded view
diagram of an embodiment of a distal portion of an implantable
device and a guiding mechanism to provide curvature to the
implantable device.
[0071] FIG. 27B illustrates, by way of example, an exploded view
diagram of an embodiment of a distal portion of a catheter with the
guiding mechanism of FIG. 27A situated within the catheter.
[0072] FIG. 28 illustrates, by way of example, a perspective view
diagram of an embodiment of a system for situating an implantable
device within a body.
[0073] FIG. 29 illustrates, by way of example, a perspective view
diagram of an embodiment of a catheter and dilator for creating a
path for or to an implantable device within a body.
[0074] FIG. 30 illustrates, by way of example, a perspective view
diagram of an embodiment of another system for situating a pushrod
and sheath within a body.
[0075] FIG. 31A illustrates, by way of example, a perspective view
diagram of an embodiment of a pushrod and a suture attached to a
proximal end of the implant.
[0076] FIG. 31B illustrates, by way of example, a perspective view
diagram of an embodiment of the pushrod over the suture and
attached to an attachment structure on the proximal end of the
implantable device and the catheter.
[0077] FIG. 31C illustrates, by way of example, a perspective view
diagram of an embodiment of the implantable device within the
catheter.
[0078] FIG. 31D illustrates, by way of example, a perspective view
diagram of an embodiment of the implantable device partially out of
the catheter.
[0079] FIG. 32A illustrates, by way of example, a perspective view
diagram of an embodiment of a system that includes the system of
FIG. 31A positioned at a target anatomy (e.g., an S3 foramen in
this example).
[0080] FIG. 32B illustrates, by way of example, a perspective view
diagram of an embodiment of a system that includes the system of
FIG. 32A positioned at a target anatomy with the catheter and the
pushrod removed.
[0081] FIG. 32C illustrates, by way of example, an exploded view
diagram of an embodiment of a proximal portion of the dashed box
labelled "32C" in FIG. 32B.
[0082] FIG. 33A illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device extraction
system.
[0083] FIG. 33B illustrates, by way of example, an exploded view
diagram of an embodiment of interlaced sutures to assist in
implantable device extraction.
[0084] FIG. 33C illustrates, by way of example, an exploded view
diagram of an embodiment of the system of FIG. 33B with a needle
situated over the interlaced sutures.
[0085] FIGS. 34A, 34B, 34C, and 34D illustrate, by way of example,
perspective view diagrams of an embodiment of an implantable device
extraction system.
[0086] FIGS. 35A and 35B illustrate, by way of example, exploded
view diagrams of an embodiment of another implantable device
extraction system.
[0087] FIG. 36 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device.
[0088] FIG. 37 illustrates, by way of example, a perspective view
diagram of another embodiment of an implantable device.
[0089] FIG. 38 illustrates, by way of example, a perspective view
diagram of an embodiment of a distal feedthrough plate.
[0090] FIG. 39 illustrates, by way of example, a perspective view
diagram of an embodiment of a proximal feedthrough plate.
[0091] FIG. 40 illustrates, by way of example, a perspective view
diagram of an embodiment of an end plate.
[0092] FIGS. 41A and 41B illustrate, by way of example, a diagram
of an embodiment of a technique for assembling an implantable
stimulation device.
[0093] FIG. 42 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable stimulation device.
[0094] FIG. 43 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation
device.
[0095] FIG. 44 illustrates, by way of example, a perspective view
diagram of an embodiment of the device of FIG. 43 from the
perspective of the arrow labelled "44" in FIG. 43.
[0096] FIG. 45 illustrates, by way of example, a perspective view
diagram of an embodiment of an implant/explant system.
[0097] FIG. 46 illustrates, by way of example, a perspective view
diagram of an embodiment of an implant/explant system.
[0098] FIG. 47 illustrates, by way of example, a perspective view
diagram of an embodiment of another implant/explant system.
[0099] FIG. 48 illustrates, by way of example, a perspective view
diagram of an embodiment of a communication and/or stimulation
system.
[0100] FIG. 49 illustrates, by way of example, a waveform diagram
of an embodiment of signals in a communication and/or stimulation
system.
[0101] FIG. 50 illustrates, by way of example, a schematic diagram
of an embodiment of circuitry of an implantable device.
[0102] FIG. 51 illustrates, by way of example, a schematic diagram
of another embodiment of circuitry of an implantable device.
[0103] FIG. 52 illustrates, by way of example, a schematic diagram
of yet another embodiment of circuitry of an implantable
device.
[0104] FIG. 53 illustrates, by way of example, a schematic diagram
of yet another embodiment of circuitry of an implantable
device.
[0105] FIG. 54 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable stimulation device.
[0106] FIG. 55A illustrates, by way of example, a cross-section
diagram of an embodiment of the implantable stimulation device of
FIG. 54 in the direction of the arrows labelled "55A/55B".
[0107] FIG. 55B illustrates, by way of example, another
cross-section diagram of an embodiment of the implantable
stimulation device of FIG. 54 in the direction of the arrows
labelled "55A/55B".
[0108] FIG. 56 illustrates, by way of example, a perspective view
diagram of an embodiment of the stimulation device of FIG. 54
implanted in a body with an external midfield powering device
external to the body.
[0109] FIG. 57 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation
device.
[0110] FIG. 58A illustrates, by way of example, a perspective view
diagram of an embodiment of a plurality of stimulation devices of
FIG. 57 implanted in a body with an external midfield powering
device external to the body.
[0111] FIG. 58B illustrates, by way of example, a perspective view
diagram of another embodiment of a plurality of stimulation devices
of FIG. 57 implanted in a body with an external midfield powering
device external to the body.
[0112] FIG. 59 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation
device.
[0113] FIG. 60 illustrates, by way of example, a perspective view
diagram of an embodiment of a plurality of stimulation devices of
FIG. 59 implanted in a body with an external midfield powering
device external to the body.
[0114] FIG. 61 illustrates, by way of example, a logical circuitry
diagram of an embodiment of a plurality of stimulation devices of
FIG. 59 within range of respective electric fields generated
therebetween.
[0115] FIG. 62 illustrates, by way of example, a diagram of an
embodiment of a system including control hardware and an
electromagnetic transmission element (e.g., the antenna).
[0116] FIG. 63 illustrates, by way of example, a perspective view
diagram of an embodiment of a system that includes the control
hardware and the electromagnetic transmission element on separate
boards.
[0117] FIG. 64 illustrates, by way of example, a diagram of an
embodiment of a system that includes the control hardware and the
electromagnetic transmission element on a single board (e.g.,
substrate).
[0118] FIG. 65 illustrates, by way of example, a perspective view
diagram of an embodiment of a system that includes the control
hardware and the electromagnetic transmission element on a single
board.
[0119] FIG. 66 illustrates, by way of example, a perspective view
diagram of an embodiment of a system that includes a faraday cage
cover over components of control circuitry.
[0120] FIG. 67A illustrates, by way of example, a perspective view
diagram of an embodiment a faraday cage.
[0121] FIG. 67B illustrates, by way of example, a perspective view
diagram of an embodiment of a cover of the faraday cage of FIG.
67A.
[0122] FIG. 67C illustrates, by way of example, a perspective view
diagram of an embodiment of a base of the faraday cage of FIG.
67A.
[0123] FIG. 68 illustrates, by way of example, a perspective view
diagram of an embodiment of the system of FIG. 66 from a back side
of the board.
[0124] FIG. 69 illustrates, by way of example, a perspective view
diagram of an embodiment of a top layer of the board of FIG.
66.
[0125] FIG. 70 illustrates, by way of example, a perspective view
diagram of an embodiment of the top layer of the board with the
faraday cage situated thereon.
[0126] FIG. 71 illustrates, by way of example, a perspective view
diagram of an embodiment of the system of FIG. 66 that includes the
faraday cage cover removed so as to illustrate the discrete
components under the faraday cage.
[0127] FIG. 72 illustrates, by way of example, a block diagram of
an embodiment of a system for providing power to or stimulating an
implanted device.
[0128] FIG. 73 illustrates, by way of example, a perspective view
diagram of a portion of a human body with a view of a low back
portion of the skeletal system.
[0129] FIG. 74 illustrates, by way of example, a perspective view
diagram similar to that of FIG. 73 with an embodiment of clothing
including a pocket positioned over potential implant sites of a
neurostimulator.
[0130] FIG. 75 illustrates, by way of example, a block diagram of
an embodiment of layers of the pocket, such as the pocket shown in
FIG. 74.
[0131] FIG. 76 illustrates, by way of example, a perspective view
diagram of an embodiment of bottom layers of the pocket.
[0132] FIG. 77 illustrates, by way of example, a perspective view
diagram of another embodiment of bottom layers of the pocket.
[0133] FIG. 78 illustrates, by way of example, a perspective view
diagram of the embodiment of bottom layers of FIG. 77 with an
external device situated by the layers.
[0134] FIG. 79 illustrates, by way of example, a perspective view
diagram of an embodiment of the bottom layers of FIG. 77 with an
external device and a top layer.
[0135] FIG. 80 illustrates, by way of example, a perspective view
diagram of an embodiment of the bottom layers of FIG. 77 with an
external device, a top layer, and an elastic band over the top
layer.
[0136] FIG. 81 illustrates, by way of example, a perspective view
diagram of an embodiment of the layers of FIG. 80 with an external
device, and including an attachment mechanism on both the external
device and a top layer of the pocket.
[0137] FIG. 82 illustrates, by way of example, a perspective view
diagram of an embodiment of the system of FIG. 81 with the
attachment mechanisms of the pocket and external device mated so as
to secure the external device in the pocket.
[0138] FIG. 83 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device situated in a
sleeve that includes the top and bottom layers and an attachment
mechanism on a top layer of the sleeve.
[0139] FIG. 84A illustrates, by way of example, a perspective view
diagram of an embodiment of the external device situated in a
sleeve that includes a cushion material on a bottom layer of the
sleeve.
[0140] FIG. 84B illustrates, by way of example, a perspective view
diagram of an embodiment of the external device situated in a
sleeve that includes a cushion material on the external device and
in the sleeve.
[0141] FIG. 85 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device situated in a
sleeve that is situated between layers of clothing or in a pocket
of the clothing.
[0142] FIG. 86 illustrates, by way of example, a perspective view
diagram of an embodiment of an undergarment that includes a
fastening mechanism that allows a user to open a bottom portion of
the undergarment while wearing the undergarment.
[0143] FIG. 87 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device in a closed
position.
[0144] FIG. 88 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device in an open position
so as to show internal circuitry, a top cover, and a bottom
cover.
[0145] FIG. 89 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device in a closed
position.
[0146] FIG. 90 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device in an open position
so as to show internal circuitry, a top cover, and a bottom
cover.
[0147] FIG. 91 illustrates, by way of example, a perspective view
diagram of an embodiment of a cover (e.g., a top or bottom cover)
of the external device that include two air vents.
[0148] FIG. 92 illustrates, by way of example, a perspective view
diagram of an embodiment of a cover (e.g., a top or bottom cover)
of the external device that include four air vents.
[0149] FIG. 93 illustrates, by way of example, a perspective view
diagram of an embodiment of a cover (e.g., a top or bottom cover)
of the external device that includes fins for heat conduction.
[0150] FIG. 94 illustrates, by way of example, another perspective
view diagram of an embodiment of a cover (e.g., a top or bottom
cover) of the external device that includes fins for heat
conduction.
[0151] FIG. 95 illustrates, by way of example, a perspective view
diagram of another embodiment of the external device in an open
position so as to show internal circuitry, a top cover, and a
bottom cover.
[0152] FIG. 96 illustrates, by way of example, a perspective view
diagram of another embodiment of the external device in an open
position so as to show internal circuitry, a top cover, and a
bottom cover.
[0153] FIG. 97 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device in a closed
position with a fastening mechanism attached to a cover of the
external device.
[0154] FIG. 98 illustrates, by way of example, a block diagram of
an embodiment of a system for communicating with an implanted
device.
[0155] FIG. 99 illustrates, by way of example, a block diagram of
an embodiment of another system for communicating with an implanted
device.
[0156] FIG. 100 illustrates, by way of example, a block diagram of
an embodiment of another system for communicating with an implanted
device.
[0157] FIG. 101A illustrates, by way of example, a diagram of
embodiments of various cross-structure leakage paths of a midfield
antenna.
[0158] FIG. 101B illustrates, by way of example, a chart that shows
embodiments of frequency-dependent leakage paths between various
subwavelength structures in an antenna.
[0159] FIG. 102 illustrates, by way of example, a schematic of an
embodiment of a backscatter communication system.
[0160] FIG. 103 illustrates, by way of example, a diagram of an
embodiment of a method that includes updating a broadcast signal
based on information about an implanted device.
[0161] FIG. 104 illustrates, by way of example, a diagram of an
embodiment of a method that includes modulating an antenna signal
receive path for a wireless signal.
[0162] FIG. 105 illustrates, by way of example, a schematic diagram
of an embodiment of a system configured to excite a midfield
antenna and receive a backscatter signal.
[0163] FIGS. 106A-106D illustrate, by way of example, a diagram of
an embodiment of signal frequencies corresponding to different
portions of the system of FIG. 105.
[0164] FIG. 107 illustrates, by way of example, a diagram of an
embodiment of a method that includes adjusting an amplitude and/or
phase characteristic of a cancellation signal.
[0165] FIG. 108 illustrates, by way of example, a diagram of an
embodiment of a system for selectively providing power and/or data
communication to multiple target devices.
[0166] FIG. 109 illustrates, by way of example, a diagram of an
embodiment of a method that includes using different signal
characteristics to communicate power and/or data signals to
different target devices at different times.
[0167] FIG. 110 illustrates, by way of example, a diagram of an
embodiment of a method that includes receiving power transfer
efficiency information from multiple target devices.
[0168] FIG. 111 illustrates, by way of example, a diagram of an
embodiment of a method that includes updating a characteristic of
at least one signal in a set of RF signals based on a data signal
received from a target device.
[0169] FIG. 112 illustrates, by way of example, a diagram of an
embodiment of a method that includes updating a characteristic of
at least one signal in a set of RF signals based on a backscatter
signal.
[0170] FIG. 113 illustrates, by way of example, a diagram of an
embodiment of a method that includes updating a characteristic of
at least one signal in a set of RF signals based on a data signal
received from a target device.
[0171] FIG. 114 illustrates, by way of example, a diagram of an
embodiment of a system for selectively providing power and/or data
to multiple target devices using a remote RF source and a midfield
coupler.
[0172] FIG. 115 illustrates, by way of example, a diagram of an
embodiment of a midfield coupler with multiple tunable devices.
[0173] FIG. 116 illustrates, by way of example, a diagram of an
embodiment of a method that includes using different signal
characteristics to communicate power and/or data signals to
different target devices at different times.
[0174] FIG. 117 illustrates, by way of example, a diagram of an
embodiment of a method that includes updating a modulation
characteristic using an external device.
[0175] FIG. 118 illustrates, by way of example, a diagram of an
embodiment of a method that includes conditionally updating a
modulation characteristic using an external device.
[0176] FIG. 119 illustrates, by way of example, a diagram of an
embodiment of a system that includes multiple external midfield
transceivers.
[0177] FIG. 120 illustrates, by way of example, a diagram of an
embodiment of a communication system.
[0178] FIG. 121 illustrates, by way of examples, a diagram of an
embodiment of a receiver device implanted in tissue.
[0179] FIG. 122 illustrates, by way of example, a diagram of an
embodiment of a multi-polar therapy delivery device.
[0180] FIG. 123 illustrates, by way of example, a diagram of an
embodiment of available electrostimulation vectors in a four-pole
electrostimulation system.
[0181] FIG. 124A illustrates, by way of example, a diagram of an
embodiment of a neural stimulation therapy delivery sequence.
[0182] FIG. 124B illustrates, by way of example, a diagram of an
embodiment of receiving therapy delivery instructions at a
stimulation device.
[0183] FIG. 125 illustrates, by way of example, a diagram of an
embodiment of a method that includes providing a neural stimulation
therapy.
[0184] FIG. 126 illustrates, by way of example, a diagram of an
embodiment of a method that includes identifying or selecting
electrostimulation vectors for use in providing a neural
stimulation therapy.
[0185] FIG. 127 illustrates, by way of example, a diagram of an
embodiment of a method that includes randomly selecting an order
for delivering a neural stimulation therapy via multiple
vectors.
[0186] FIG. 128 illustrates, by way of example, a diagram of an
embodiment of phase-amplitude coupled signals.
[0187] FIG. 129 illustrates, by way of example, a diagram of an
embodiment of a method for concurrently providing a neural
electrostimulation therapy.
[0188] FIG. 130 illustrates, by way of example, a diagram of an
embodiment of a method that includes providing multiple
phase-amplitude coupled therapy signals.
[0189] FIG. 131 illustrates, by way of example, a diagram of an
embodiment of a method that includes selecting one or more signal
component characteristics for use in a PAC signal.
[0190] FIG. 132 illustrates, by way of example, a diagram of an
embodiment of therapy signals with data signal components.
[0191] FIG. 133 illustrates, by way of example, a diagram of an
embodiment of a method that includes retrieving an information
signal from a farfield signal.
[0192] FIG. 134 illustrates, by way of example, a diagram of an
embodiment of a method that includes encoding information in a
therapy signal.
[0193] FIG. 135 illustrates, by way of example, a diagram of an
embodiment of a method that includes determining whether a therapy
was properly provided.
[0194] FIG. 136 illustrates, by way of example, a timing diagram of
an embodiment of intermittent stimulation.
[0195] FIG. 137 illustrates, by way of example, a diagram of an
embodiment of a system, such as can be used for intermittent
stimulation.
[0196] FIG. 138 illustrates, by way of example, a diagram of an
embodiment of a user interface.
[0197] FIG. 139 illustrates, by way of example, a diagram of an
embodiment of a method.
[0198] FIG. 140 illustrates, by way of example, a system with which
one or more methods discussed herein can be performed.
DESCRIPTION OF EMBODIMENTS
[0199] Midfield powering technology can provide power to a deeply
implanted electrostimulation device from an external power source
located on or near a tissue surface, such as at an external surface
of a user's skin. The user can be a clinical patient or other user.
The midfield powering technology can have one or more advantages
over implantable pulse generators. For example, a pulse generator
can have one or more relatively large, implanted batteries and/or
one or more lead systems. Midfield devices, in contrast, can
include relatively small battery cells that can be configured to
receive and store relatively small amounts of power. A midfield
device can include one or more electrodes integrated in a unitary
implantable package. Thus, in some examples, a midfield-powered
device can provide a simpler implant procedure over other
conventional devices, which can lead to a lower cost and a lower
risk of infection or other implant complications. One or more of
the advantages can be from an amount of power transferred to the
implanted device. The ability to focus the energy from the midfield
device can allow for an increase in the amount of power transferred
to the implanted device.
[0200] An advantage of using midfield powering technology can
include a main battery or power source being provided externally to
the patient, and thus low power consumption and high efficiency
circuitry requirements of conventional battery-powered implantable
devices can be relaxed. Another advantage of using midfield
powering technology can include an implanted device that can be
physically smaller than a battery-powered device. Midfield powering
technology can thus help enable better patient tolerance and
comfort along with potentially lower costs to manufacture and/or to
implant in patient tissue.
[0201] There is a current unmet need that includes communicating
power and/or data using midfield transmitters and receivers, such
as to communicate power and/or data from an external midfield
coupler or source device to one or more implanted neural
stimulation devices and/or one or more implanted sensor devices.
The unmet need can further include communicating data from the one
or more implanted neural stimulation devices and implanted sensor
devices to the external midfield coupler or source device.
[0202] In one or more embodiments, multiple devices can be
implanted in patient tissue and can be configured to deliver a
therapy and/or sense physiologic information about a patient and/or
about the therapy. The multiple implanted devices can be configured
to communicate with one or more external devices. In one or more
embodiments, the one or more external devices are configured to
provide power and/or data signals to the multiple implanted
devices, such as concurrently or in a time-multiplexed (e.g.,
"round-robin") fashion. The provided power and/or data signals can
be steered or directed by an external device to transfer the
signals to an implant efficiently. Although the present disclosure
may refer to a power signal or data signal specifically, such
references are to be generally understood as optionally including
one or both of power and data signals.
[0203] Several embodiments described herein can be advantageous
because they include one, several, or all of the following
benefits: (i) a system configured to (a) communicate power and/or
data signals from a midfield coupler device to an implantable
device via midfield radiofrequency (RF) signals, (b) generate and
provide a therapy signal via one or more electrodes coupled to the
implantable device, the therapy signal including an information
component, and producing a signal incident to providing the therapy
signal, (c) receive a signal, based on the therapy signal, using
electrodes coupled to the midfield coupler device, and (d) at the
midfield coupler device or another device, decode and react to the
information component from the received signal; (ii) a dynamically
configurable, active midfield transceiver that is configured to
provide RF signals to modulate an evanescent field at a tissue
surface and thereby generate a propagating field within tissue,
such as to transmit power and/or data signals to an implanted
target device; (iii) an implantable device including an antenna
configured to receive a midfield power signal from the midfield
transceiver and including a therapy delivery circuitry configured
to provide signal pulses to electrostimulation electrodes using a
portion of the received midfield power signal, wherein the signal
pulses include therapy pulses and data pulses, and the data pulses
can be interleaved with or embedded in the therapy pulses; (iv) an
implantable device configured to encode information, in a therapy
signal, about the device itself, such as including information
about the device's operating status, or about a
previously-provided, concurrent, or planned future therapy provided
by the device; (v) a midfield transceiver including electrodes that
are configured to sense electrical signals at a tissue surface;
and/or (vi) adjustable wireless signal sources and receivers that
are configured together to enable a communication loop or feedback
loop.
[0204] In one or more embodiments, one or more of these benefits
and others can be realized using a system for manipulating an
evanescent field at or near an external tissue surface to transmit
power and/or data wirelessly to one or more target devices
implanted in the tissue. In one or more embodiments, one or more of
these benefits can be realized using a device or devices implanted
in a body or capable of being implanted in a body and as described
herein. In one or more embodiments, one or more of these benefits
can be realized using a midfield powering and/or communication
device (e.g., a transmitter device and/or a receiver device or a
transceiver device).
[0205] A system can include a signal generator system adapted to
provide multiple different sets of signals (e.g., RF signals). Each
set can include two or more separate signals in some embodiments.
The system can also include a midfield transmitter including
multiple excitation ports, the midfield transmitter coupled to the
RF signal generator system, and the midfield transmitter being
adapted to transmit the multiple different sets of RF signals at
respective different times via the excitation ports. The excitation
ports can be adapted to receive respective ones of the separate
signals from each set of RF signals. Each of the transmitted sets
of RF signals can include a non-negligible magnetic field (H-field)
component that is substantially parallel to the external tissue
surface. In one or more embodiments, each set of transmitted RF
signals is adapted or selected to differently manipulate an
evanescent field at or near the tissue surface to transmit a power
and/or data signal to one or more target devices implanted in the
tissue via a midfield signal instead of via inductive near-field
coupling or radiative far-field transmission.
[0206] In one or more embodiments, one or more of the
above-mentioned benefits, among others, can be realized, at least
in part, using an implantable therapy delivery device (e.g., that
is adapted to provide neural stimulation) that includes receiver
circuitry including an antenna (e.g., an electric-field or magnetic
field based antenna) configured to receive a midfield power signal
from an external source device, such as when the receiver circuitry
is implanted within tissue. The implantable therapy delivery device
can include therapy delivery circuitry. The therapy delivery
circuitry can be coupled to the receiver circuitry. The therapy
delivery circuitry can be configured to provide signal pulses to
one or more energy delivery members (e.g., electrostimulation
electrodes), which may be integrally coupled to a body of the
therapy delivery device or positioned separately from (e.g., not
located on) the body of the therapy delivery device), such as by
using a portion of the received midfield power signal from the
external source device (e.g., sometimes referred to herein as an
external device, an external source, an external midfield device, a
midfield transmitter device, a midfield coupler, a midfield
powering device, a powering device, or the like, depending on the
configuration and/or usage context of the device). The signal
pulses can include one or more electrostimulation therapy pulses
and/or data pulses. In one or more embodiments, one or more of the
above-mentioned benefits, among others, can be realized, at least
in part, using an external transmitter and/or receiver (e.g.,
transceiver) device that includes an electrode pair configured to
be disposed at an external tissue surface, and the electrode pair
is configured to receive an electrical signal via the tissue. The
electrical signal can correspond to an electrostimulation therapy
delivered to the tissue by the therapy delivery device. A
demodulator circuitry can be coupled to the electrode pair and can
be configured to demodulate a portion of the received electrical
signal, such as to recover a data signal originated by the therapy
delivery device.
[0207] In one or more embodiments that include using a midfield
wireless coupler, tissue can act as a dielectric to tunnel energy.
Coherent interference of propagating modes can confine a field at a
focal plane to less than a corresponding vacuum wavelength, for
example, with a spot size subject to a diffraction limit in a
high-index material. In one or more embodiments, a receiver (e.g.,
implanted in tissue) positioned at such a high energy density
region, can be one or more orders of magnitude smaller than a
conventional near-field implantable receiver, or can be implanted
more deeply in tissue (e.g., greater than 1 cm in depth). In one or
more embodiments, a transmitter source described herein can be
configured to provide electromagnetic energy to various target
locations, including for example to one or more deeply implanted
devices. In an example, the energy can be provided to a location
with greater than about a few millimeters of positioning accuracy.
That is, a transmitted power or energy signal can be directed or
focused to a target location that is within about one wavelength of
the signal in tissue. Such energy focusing is substantially more
accurate than the focusing available via traditional inductive
means and is sufficient to provide adequate power to a receiver on
a millimeter scale. In other wireless powering approaches using
near-field coupling (inductive coupling and its resonant enhanced
derivatives), evanescent components outside tissue (e.g., near the
source) remain evanescent inside tissue, which does not allow for
effective depth penetration. Unlike near-field coupling, energy
from a midfield source is primarily carried in propagating modes
and, as a result, an energy transport depth is limited by
environmental losses rather than by intrinsic decay of the
near-field. Energy transfer implemented with these characteristics
can be at least two to three orders of magnitude more efficient
than near-field systems.
[0208] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat fecal or urinary
incontinence (e.g., overactive bladder), such as by stimulating the
tibial nerve or any branch of the tibial nerve, such as but not
limited to the posterior tibial nerve, one or more nerves or nerve
branches originating from the sacral plexus, including but not
limited to S1-S4, the tibial nerve, and/or the pudendal nerve.
Urinary incontinence may be treated by stimulating one or more of
muscles of the pelvic floor, nerves innervating the muscles of the
pelvic floor, internal urethral sphincter, external urethral
sphincter, and the pudendal nerve or branches of the pudendal
nerve.
[0209] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat sleep apnea and/or
snoring by stimulating one or more of a nerve or nerve branches of
the hypoglossal nerve, the base of the tongue (muscle), phrenic
nerve(s), intercostal nerve(s), accessory nerve(s), and cervical
nerves C3-C6. Treating sleep apnea and/or snoring can include
providing energy to an implant to sense a decrease, impairment, or
cessation of breathing (such as by measuring oxygen
saturation).
[0210] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat vaginal dryness, such as
by stimulating one or more of Bartholin gland(s), Skene's gland(s),
and inner wall of vagina. One or more of the systems, apparatuses,
and methods discussed herein can be used to help treat migraines or
other headaches, such as by stimulating one or more of the
occipital nerve, supraorbital nerve, C2 cervical nerve, or branches
thereof, and the frontal nerve, or branches thereof. One or more of
the systems, apparatuses, and methods discussed herein can be used
to help treat post-traumatic stress disorder, hot flashes, and/or
complex regional pain syndrome such as by stimulating one or more
of the stellate ganglion and the C4-C7 of the sympathetic
chain.
[0211] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat neuralgia (e.g.,
trigeminal neuralgia), such as by stimulating one or more of the
sphenopalatine ganglion nerve block, the trigeminal nerve, or
branches of the trigeminal nerve. One or more of the systems,
apparatuses, and methods discussed herein can be used to help treat
dry mouth (e.g., caused by side effects from medications,
chemotherapy or radiation therapy cancer treatments, Sjogren's
disease, or by other cause of dry mouth), such as by stimulating
one or more of Parotid glands, submandibular glands, sublingual
glands, submucosa of the oral mucosa in the oral cavity within the
tissue of the buccal, labial, and/or lingual mucosa, the soft
palate, the lateral parts of the hard palate, and/or the floor of
the mouth and/or between muscle fibers of the tongue, Von Ebner
glands, glossopharyngeal nerve (CN IX), including branches of CN
IX, including otic ganglion, a facial nerve (CN VII), including
branches of CN VII, such as the submandibular ganglion, and
branches of T1-T3, such as the superior cervical ganglion.
[0212] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat a transected nerve, such
as by sensing electrical output from the proximal portion of a
transected nerve and delivering electrical input into the distal
portion of a transected nerve, and/or sensing electrical output
from the distal portion of a transected nerve and delivering
electrical input into the proximal portion of a transected nerve.
One or more of the systems, apparatuses, and methods discussed
herein can be used to help treat cerebral palsy, such as by
stimulating one or more muscles or one or more nerves innervation
one or more muscles affected in a patient with cerebral palsy. One
or more of the systems, apparatuses, and methods discussed herein
can be used to help treat erectile dysfunction, such as by
stimulating one or more of pelvic splanchnic nerves (S2-S4) or any
branches thereof, the pudendal nerve, cavernous nerve(s), and
inferior hypogastric plexus.
[0213] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat menstrual pain, such as
by stimulating one or more of the uterus and the vagina. One or
more of the systems, apparatuses, and methods discussed herein can
be used as an intrauterine device, such as by sensing one or more
PH and blood flow or delivering current or drugs to aid in
contraception, fertility, bleeding, or pain. One or more of the
systems, apparatuses, and methods discussed herein can be used to
incite human arousal, such as by stimulating female genitalia,
including external and internal, including clitoris or other
sensory active parts of the female, or by stimulating male
genitalia.
[0214] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat hypertension, such as by
stimulating one or more of a carotid sinus, left or right cervical
vagus nerve, or a branch of the vagus nerve. One or more of the
systems, apparatuses, and methods discussed herein can be used to
help treat paroxysmal supraventricular tachycardia, such as by
stimulating one or more of trigeminal nerve or branches thereof,
anterior ethmoidal nerve, and the vagus nerve. One or more of the
systems, apparatuses, and methods discussed herein can be used to
help treat vocal cord dysfunction, such as by sensing the activity
of a vocal cord and the opposite vocal cord or just stimulating one
or more of the vocal cords by stimulating nerves innervating the
vocal cord, the left and/or Right recurrent laryngeal nerve, and
the vagus nerve.
[0215] One or more of the systems, apparatuses, and methods
discussed herein can be used to help repair tissue, such as by
stimulating tissue to do one or more of enhancing microcirculation
and protein synthesis to heal wounds and restoring integrity of
connective and/or dermal tissues. One or more of the systems,
apparatuses, and methods discussed herein can be used to help
asthma or chronic obstructive pulmonary disease, such as by one or
more of stimulating the vagus nerve or a branch thereof, blocking
the release of norepinephrine and/or acetylcholine and/or
interfering with receptors for norepinephrine and/or
acetylcholine.
[0216] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat cancer, such as by
stimulating, to modulate one or more nerves near or in a tumor,
such as to decrease the sympathetic innervation, such as
epinephrine/NE release, and/or parasympathetic innervation, such as
Ach. One or more of the systems, apparatuses, and methods discussed
herein can be used to help treat diabetes, such as by powering a
sensor inside the human body that detects parameters of diabetes,
such as a glucose level or ketone level and using such sensor data
to adjust delivery of exogenous insulin from an insulin pump. One
or more of the systems, apparatuses, and methods discussed herein
can be used to help treat diabetes, such as by powering a sensor
inside the human body that detects parameters of diabetes, such as
a glucose level or ketone level, and using a midfield coupler to
stimulate the release of insulin from islet beta cells.
[0217] One or more of the systems, apparatuses, and methods
discussed herein can be used to help treat neurological conditions,
disorders or diseases (such as Parkinson's disease (e.g., by
stimulating an internus or nucleus of the brain), Alzheimer's
disease, Huntington's disease, dementia, Creutzfeldt-Jakob disease,
epilepsy (e.g., by stimulating a left cervical vagus nerve or a
trigeminal nerve), post-traumatic stress disorder (PTSD) (e.g., by
stimulating a left cervical vagus nerve), or essential tremor, such
as by stimulating a thalamus), neuralgia, depression, dystonia
(e.g., by stimulating an internus or nucleus of the brain), phantom
limb (e.g., by stimulating an amputated nerve, such an ending of an
amputated nerve), dry eyes (e.g., by stimulating a lacrimal gland),
arrhythmia (e.g., by stimulating the heart), a gastrointestinal
disorder, such as obesity, gastroesophageal reflux, and/or
gastroparesis, such as by stimulating a C1-C2 occipital nerve or
deep brain stimulation (DBS) of the hypothalamus, an esophagus, a
muscle near sphincter leading to the stomach, and/or a lower
stomach, and/or stroke (e.g., by subdural stimulation of a motor
cortex). Using one or more embodiments discussed herein,
stimulation can be provided continuously, on demand (e.g., as
demanded by a physician, patient, or other user), or
periodically.
[0218] In providing the stimulation, an implantable device can be
situated up to five centimeters or more below the surface of the
skin. A midfield powering device is capable of delivering power to
those depths in tissue. In one or more embodiments, an implantable
device can be situated between about 2 centimeters and 4
centimeters, about 3 centimeters, between about 1 centimeter and
five centimeters, less than 1 centimeter, about two centimeters, or
other distance below the surface of the skin. The depth of
implantation can depend on the use of the implanted device. For
example, to treat depression, hypertension, epilepsy, and/or PTSD
the implantable device can situated between about 2 centimeters and
about four centimeters below the surface of the skin. In another
example, to treat sleep apnea, arrhythmia (e.g., bradycardia),
obesity, gastroesophageal reflux, and/or gastroparesis the
implantable device can be situated at greater than about 3
centimeters below the surface of the skin. In yet another example,
to treat Parkinson's, essential tremors, and/or dystonia the
implantable device can be situated between about 1 centimeter and
about 5 centimeters below the surface of the skin. Yet other
examples include situating the implantable device between about 1
centimeter and about 2 centimeters below the surface of the skin,
such as to treat fibromyalgia, stroke, and/or migraine, at about 2
centimeters to treat asthma, and at about one centimeter or less to
treat dry eyes.
[0219] Although many embodiments included herein describe devices
or methods for providing stimulation (e.g., electrostimulation),
the embodiments may be adapted to provide other forms of modulation
(e.g., denervation) in addition to or instead of stimulation. In
addition, although many embodiments included herein refer to the
use of electrodes to deliver therapy, other energy delivery members
(e.g., ultrasound transducers or other ultrasound energy delivery
members) or other therapeutic members or substances (e.g., fluid
delivery devices or members to deliver chemicals, drugs, cryogenic
fluid, hot fluid or steam, or other fluids) may be used or
delivered in other embodiments.
[0220] FIG. 1 illustrates, by way of example, a schematic of an
embodiment of a system 100 using wireless communication paths. The
system 100 includes an example of an external source 102, such as a
midfield transmitter source, sometimes referred to as a midfield
coupler, located at or above an interface 105 between air 104 and a
higher-index material 106, such as body tissue. The external source
102 can produce a source current (e.g., an in-plane source
current). The source current (e.g., in-plane source current) can
generate an electric field and a magnetic field. The magnetic field
can include a non-negligible component that is parallel to the
surface of the source 102 and/or to a surface of the higher-index
material 106 (e.g., a surface of the higher-index material 106 that
faces the external source 102). In accordance with several
embodiments, the external source 102 may comprise structural
features and functions described in connection with the midfield
couplers and external sources included in WIPO Publication No.
WO/2015/179225 published on Nov. 26, 2015 and titled "MIDFIELD
COUPLER", which is incorporated herein by reference in its
entirety.
[0221] The external source 102 can include at least a pair of
outwardly facing electrodes 121 and 122. The electrodes 121 and 122
can be configured to contact a tissue surface, for example, at the
interface 105. In one or more embodiments, the external source 102
is configured for use with a sleeve, pocket, or other garment or
accessory that maintains the external source 102 adjacent to the
higher-index material 106 (see, e.g., the subsection herein titled
"DISCREET EXTERNAL DEVICE COUPLING TO IMPLANTED DEVICE", for
example), and that optionally maintains the electrodes 121 and 122
in physical contact with a tissue surface. In one or more
embodiments, the sleeve, pocket, or other garment or accessory can
include or use a conductive fiber or fabric, and the electrodes 121
and 122 can be in physical contact with the tissue surface via the
conductive fiber or fabric. Sleeves, pockets, or other garments or
accessories suitable for use with the external source 102 are
described in further detail, for example, in at least the
subsection herein titled "DISCREET EXTERNAL DEVICE COUPLING TO
IMPLANTED DEVICE."
[0222] In one or more embodiments, more than two outwardly facing
electrodes can be used and processor circuitry on-board or
auxiliary to the source 102 can be configured to select an optimal
pair or group of electrodes to use to sense farfield signal
information (e.g., signal information corresponding to a delivered
therapy signal or to a nearfield signal). In such embodiments, the
electrodes can operate as antennas. In one or more embodiments, the
source 102 includes three outwardly facing electrodes arranged as a
triangle, or four outwardly facing electrodes arranged as a
rectangle, and any two or more of the electrodes can be selected
for sensing and/or can be electrically grouped or coupled together
for sensing or diagnostics. In one or more embodiments, the
processor circuitry can be configured to test multiple different
electrode combination selections to identify an optimal
configuration for sensing a farfield signal (an example of the
processor circuitry is presented in FIG. 2A, among others).
[0223] FIG. 1 illustrates an embodiment of an implantable device
110, such as can include a multi-polar therapy delivery device
configured to be implanted in the higher-index material 106. In one
or more embodiments, the implantable device 110 includes all or a
portion of the circuitry 500 from FIG. 5, discussed in further
detail below. In one or more embodiments, the implantable device
110 is implanted in tissue below the tissue-air interface 105. In
FIG. 1, the implantable device 110 includes an elongate body and
multiple electrodes E0, E1, E2, and E3 that are axially spaced
apart along a portion of the elongate body. The implantable device
110 includes receiver and/or transmitter circuitry (not shown in
FIG. 1, see e.g., FIGS. 2A, 2B, and 4, among others) that can
enable communication between the implantable device 110 and the
external source 102.
[0224] The various electrodes E0-E3 can be configured to deliver
electrostimulation therapy to patient tissue, such as at or near a
neural or muscle target. In one or more embodiments, at least one
electrode can be selected for use as an anode and at least one
other electrode can be selected for use as a cathode to define an
electrostimulation vector. In one or more embodiments, electrode E1
is selected for use as an anode and electrode E2 is selected for
use as a cathode. Together, the E1-E2 combination defines an
electrostimulation vector V12. Various vectors can be configured
independently to provide a neural electrostimulation therapy to the
same or different tissue target, such as concurrently or at
different times.
[0225] In one or more embodiments, the source 102 includes an
antenna (see, e.g., FIG. 3) and the implantable device 110 includes
an antenna 108 (e.g., and electric field-based or magnetic
field-based antenna). The antennas can be configured (e.g., in
length, width, shape, material, etc.) to transmit and receive
signals at substantially the same frequency. The implantable device
110 can be configured to transmit power and/or data signals through
the antenna 108 to the external source 102 and can receive power
and/or data signals transmitted by the external source 102. The
external source 102 and implantable device 110 can be used for
transmission and/or reception of RF signals. A transmit/receive
(T/R) switch can be used to switch each RF port of the external
source 102 from a transmit (transmit data or power) mode to a
receive (receive data) mode. A T/R switch can similarly be used to
switch the implantable device 110 between transmit and receive
modes. See FIG. 4, among others, for examples of T/R switches.
[0226] In one or more embodiments, a receive terminal on the
external source 102 can be connected to one or more components that
detect a phase and/or amplitude of a received signal from the
implantable device 110. The phase and amplitude information can be
used to program a phase of the transmit signal, such as to be
substantially the same relative phase as a signal received from the
implantable device 110. To help achieve this, the external source
102 can include or use a phase-matching and/or amplitude-matching
network, such as shown in the embodiment of FIG. 4. The
phase-matching and/or amplitude matching network can be configured
for use with a midfield antenna that includes multiple ports, such
as shown in the embodiment of FIG. 3.
[0227] Referring again to FIG. 1, in one or more embodiments, the
implantable device 110 can be configured to receive a midfield
signal 131 from the external source 102. The midfield signal 131
can include power and/or data signal components. In some
embodiments, a power signal component can include one or more data
components embedded therein. In one or more embodiments, the
midfield signal 131 includes configuration data for use by the
implantable device 110. The configuration data can define, among
other things, therapy signal parameters, such as a therapy signal
frequency, pulse width, amplitude, or other signal waveform
parameters. In one or more embodiments, the implantable device 110
can be configured to deliver an electrostimulation therapy to a
therapy target 190, such as can include a neural target (e.g., a
nerve), a muscle target, or other tissue target. An
electrostimulation therapy delivered to the therapy target 190 can
be provided using a portion of a power signal received from the
external source 102. Examples of the therapy target 190 can include
nerve tissue or neural targets, for example including nerve tissue
or neural targets at or near cervical, thoracic, lumbar, or sacral
regions of the spine, brain tissue, muscle tissue, abnormal tissue
(e.g., tumor or cancerous tissue), targets corresponding to
sympathetic or parasympathetic nerve systems, targets at or near
peripheral nerve bundles or fibers, at or near other targets
selected to treat incontinence, urinary urge, overactive bladder,
fecal incontinence, constipation, pain, neuralgia, pelvic pain,
movement disorders or other diseases or disorders, deep brain
stimulation (DBS) therapy targets or any other condition, disease
or disorder (such as those other conditions, diseases, or disorders
identified herein).
[0228] Delivering the electrostimulation therapy can include using
a portion of a power signal received via the midfield signal 131,
and providing a current signal to an electrode or an electrode pair
(e.g., two or more of E0-E3), coupled to the implantable device
110, to stimulate the therapy target 190. As a result of the
current signal provided to the electrode(s), a nearfield signal 132
can be generated. An electric potential difference resulting from
the nearfield signal 132 can be detected remotely from the therapy
delivery location. Various factors can influence where and whether
the potential difference can be detected, including, among other
things, characteristics of the therapy signal, a type or
arrangement of the therapy delivery electrodes, and characteristics
of any surrounding biologic tissue. Such a remotely detected
electric potential difference can be considered a farfield signal
133. The farfield signal 133 can represent an attenuated portion of
the nearfield signal 132. That is, the nearfield signal 132 and the
farfield signal 133 can originate from the same signal or field,
such as with the nearfield signal 132 considered to be associated
with a region at or near the implantable device 110 and the therapy
target 190, and with the farfield signal 133 considered to be
associated with other regions more distal from the implantable
device 110 and the therapy target 190. In one or more embodiments,
information about the implantable device 110, or about a
previously-provided or future planned therapy provided by the
implantable device 110, can be encoded in a therapy signal and
detected and decoded by the external source 102 by way of the
farfield signal 133.
[0229] In one or more embodiments, the device 110 can be configured
to provide a series of electrostimulation pulses to a tissue target
(e.g., neural target). For example, the device 110 can provide
multiple electrostimulation pulses separated in time, such as using
the same or different electrostimulation vectors, to provide a
therapy. In one or more embodiments, a therapy comprising multiple
signals can be provided to multiple different vectors in parallel,
or can be provided in sequence such as to provide a series or
sequence of electrostimulation pulses to the same neural target.
Thus, even if one vector is more optimal than the others for
eliciting a patient response, the therapy as a whole can be more
effective than stimulating only the known-optimal vector because
(1) the target may experience a rest period during periods of
non-stimulation, and/or (2) stimulating the areas nearby and/or
adjacent to the optimal target can elicit some patient benefit.
[0230] The system 100 can include a sensor 107 at or near the
interface 105 between air 104 and the higher-index material 106.
The sensor 107 can include, among other things, one or more
electrodes, an optical sensor, an accelerometer, a temperature
sensor, a force sensor, a pressure sensor, or a surface
electromyography (EMG) device. The sensor 107 may comprise multiple
sensors (e.g., two, three, four or more than four sensors).
Depending on the type of sensor(s) used, the sensor 107 can be
configured to monitor electrical, muscle, or other activity near
the device 110 and/or near the source 102. For example, the sensor
107 can be configured to monitor muscle activity at a tissue
surface. If muscle activity greater than a specified threshold
activity level is detected, then a power level of the source 102
and/or of the device 110 can be adjusted. In one or more
embodiments, the sensor 107 can be coupled to or integrated with
the source 102, and in other examples, the sensor 107 can be
separate from, and in data communication with (e.g., using a wired
or wireless electrical coupling or connection), the source 102
and/or the device 110.
[0231] The system 100 can include a farfield sensor device 130 that
can be separate from, or communicatively coupled with, one or more
of the source 102 and the sensor 107. The farfield sensor device
130 can include two or more electrodes and can be configured to
sense a farfield signal, such as the farfield signal 133
corresponding to a therapy delivered by the device 110. The
farfield sensor device 130 can include at least one pair of
outwardly facing electrodes 123 and 124 configured to contact a
tissue surface, for example, at the interface 105. In one or more
embodiments, three or more electrodes can be used, and processor
circuitry on-board or auxiliary to the farfield sensor device 130
can select various combinations of two or more of the electrodes
for use in sensing the farfield signal 133. In one or more
embodiments, the farfield sensor device 130 can be configured for
use with a sleeve, pocket, or other garment or accessory that
maintains the farfield sensor device 130 adjacent to the
higher-index material 106, and that optionally maintains the
electrodes 123 and 124 in physical contact with a tissue surface.
In one or more embodiments, the sleeve, pocket, or other garment or
accessory can include or use a conductive fiber or fabric, and the
electrodes 123 and 124 can be in physical contact with the tissue
surface via the conductive fiber or fabric. Sleeves, pockets, or
other garments or accessories suitable for use with the farfield
sensor device 130 are described in the subsection herein titled
"DISCREET EXTERNAL DEVICE COUPLING TO IMPLANTED DEVICE." An example
of at least a portion of a farfield sensor device 130 is further
described herein in connection with FIG. 2B.
[0232] In one or more embodiments, the external source 102 provides
a midfield signal 131 including power and/or data signals to the
implantable device 110. The midfield signal 131 includes a signal
(e.g., an RF signal) having various or adjustable amplitude,
frequency, phase, and/or other signal characteristics. The
implantable device 110 can include an antenna, such as described
below, that can receive the midfield signal 131 and, based on
characteristics of receiver circuitry in the implantable device
110, can modulate the received signal at the antenna to thereby
generate a backscatter signal. In one or more embodiments, the
implantable device 110 can encode information in the backscatter
signal 112, such as information about a characteristic of the
implantable device 110 itself, about a received portion of the
midfield signal 131, about a therapy provided by the implantable
device 110, and/or other information. The backscatter signal 112
can be received by an antenna at the external source 102 and/or the
farfield sensor device 130, or can be received by another device.
In one or more embodiments, a biological signal can be sensed by a
sensor of the implantable device 110, such as a glucose sensor, an
electropotential (e.g., an electromyography sensor,
electrocardiograph (ECG) sensor, resistance, or other electrical
sensor), a light sensor, a temperature, a pressure sensor, an
oxygen sensor, a motion sensor, or the like. A signal
representative of the detected biological signal can be modulated
onto the backscatter 112. Other sensors are discussed elsewhere
herein, such as with regard to FIG. 136, among others. In such
embodiments, the sensor 107 can include a corresponding monitor
device, such as a glucose, temperature, ECG, EMG, oxygen, or other
monitor, such as to receive, demodulate, interpret, and/or store
data modulated onto the backscatter signal.
[0233] In one or more embodiments, the external source 102 and/or
the implantable device 110 can include an optical transceiver
configured to facilitate communication between the external source
102 and the implantable device 110. The external source 102 can
include a light source, such as a photo laser diode or LED, or can
include a photo detector, or can include both of a light source and
a photo detector. The implantable device 110 can include a light
source, such as a photo laser diode or LED, or can include a photo
detector, or can include both of a light source and a photo
detector. In an embodiment, the external source 102 and/or
implantable device 110 can include a window, such as made of
quartz, glass, or other translucent material, adjacent to its light
source or photo detector.
[0234] In an embodiment, optical communications can be separate
from or supplemental to an electromagnetic coupling between the
external source 102 and the implantable device 110. Optical
communication can be provided using light pulses modulated
according to various protocols, such as using pulse position
modulation (PPM). In an embodiment, a light source and/or photo
detector on-board the implantable device 110 can be powered by a
power signal received at least in part via midfield coupling with
the external source 102.
[0235] In an embodiment, a light source at the external source 102
can send a communication signal through skin, into subcutaneous
tissue, and through an optical window (e.g., quartz window) in the
implantable device 110. The communication signal can be received at
a photo detector on-board the implantable device 110. Various
measurement information, therapy information, or other information
from or about the implantable device can be encoded and transmitted
from the implantable device 110 using a light source provided at
the implantable device 110. The light signal emitted from the
implantable device 110 can travel through the same optical window,
subcutaneous tissue, and skin tissue, and can be received at photo
detector on-board the external source 102. In an example, the light
sources and/or photo detectors can be configured to emit and/or
receive, respectively, electromagnetic waves in the visible or
infrared ranges, such as in a range of about 670-910 nm wavelength
(e.g., 670 nm-800 nm, 700 nm-760 nm, 670 nm-870 nm, 740 nm-850 nm,
800 nm-910 nm, overlapping ranges thereof, or any value within the
recited ranges).
[0236] FIG. 2A illustrates, by way of example, a block diagram of
and embodiment of a midfield source device, such as the external
source 102. The external source 102 can include various components,
circuitry, or functional elements that are in data communication
with one another. In the example of FIG. 2A, the external source
102 includes components, such as processor circuitry 210, one or
more sensing electrodes 220 (e.g., including the electrodes 121 and
122), a demodulator circuitry 230, a phase-matching or
amplitude-matching network 400, a midfield antenna 300, and/or one
or more feedback devices, such as can include or use an audio
speaker 251, a display interface 252, and/or a haptic feedback
device 253. The midfield antenna 300 is further described below in
the embodiment of FIG. 3, and the network 400 is further described
below in the embodiment of FIG. 4. The processor circuitry 210 can
be configured to coordinate the various functions and activities of
the components, circuitry, and/or functional elements of the
external source 102.
[0237] The midfield antenna 300 can be configured to provide a
midfield excitation signal, such as can include RF signals having a
non-negligible H-field component that is substantially parallel to
an external tissue surface. In one or more embodiments, the RF
signals can be adapted or selected to manipulate an evanescent
field at or near a tissue surface, such as to transmit a power
and/or data signal to respective different target devices (e.g.,
the implantable device 110) implanted in tissue. The midfield
antenna 300 can be further configured to receive backscatter or
other wireless signal information that can be demodulated by the
demodulator circuitry 230. The demodulated signals can be
interpreted by the processor circuitry 210. The midfield antenna
300 can include a dipole antenna, a loop antenna, a coil antenna, a
slot or strip antenna, or other antenna. The antenna 300 can be
shaped and sized to receive signals in a range of between about 400
MHz and about 4 GHz (e.g., between 400 MHz and 1 GHz, between 400
MHz and 3 GHz, between 500 MHz and 2 GHz, between 1 GHz and 3 GHz,
between 500 MHz and 1.5 GHz, between 1 GHz and 2 GHz, between 2 GHz
and 3 GHz, overlapping ranges thereof, or any value within the
recited ranges). For embodiments incorporating a dipole antenna,
the midfield antenna 300 may comprise a straight dipole with two
substantially straight conductors, a folded dipole, a short dipole,
a cage dipole, a bow-tie dipole or batwing dipole.
[0238] The demodulator circuitry 230 can be coupled to the sensing
electrodes 220. In one or more embodiments, the sensing electrodes
220 can be configured to receive the farfield signal 133, such as
based on a therapy provided by the implantable device 110, such as
can be delivered to the therapy target 190. The therapy can include
an embedded or intermittent data signal component that can be
extracted from the farfield signal 133 by the demodulator circuitry
230. For example, the data signal component can include an
amplitude-modulated or phase-modulated signal component that can be
discerned from background noise or other signals and processed by
the demodulator circuitry 230 to yield an information signal that
can be interpreted by the processor circuitry 210. Based on the
content of the information signal, the processor circuitry 210 can
instruct one of the feedback devices to alert a patient, caregiver,
or other system or individual. For example, in response to the
information signal indicating successful delivery of a specified
therapy, the processor circuitry 210 can instruct the audio speaker
251 to provide audible feedback to a patient, can instruct the
display interface 252 to provide visual or graphical information to
a patient, and/or can instruct the haptic feedback device 253 to
provide a haptic stimulus to a patient. In one or more embodiments,
the haptic feedback device 253 includes a transducer configured to
vibrate or to provide another mechanical signal.
[0239] FIG. 2B illustrates generally a block diagram of a portion
of a system configured to receive a farfield signal. The system can
include the sensing electrodes 220, such as can include the
electrodes 121 and 122 of the source 102, or the electrodes 123 and
124 of the farfield sensor device 130. In the example of FIG. 2B,
there are at least four sensing electrodes represented collectively
as the sensing electrodes 220, and individually as SE0, SE1, SE2,
and SE3; however, other numbers of sensing electrodes 220 may also
be used. The sensing electrodes can be communicatively coupled to a
multiplexer circuitry 261. The multiplexer circuitry 261 can select
pairs of the electrodes, or electrode groups, for use in sensing
farfield signal information. In one or more embodiments, the
multiplexer circuitry 261 selects an electrode pair or grouping
based on a detected highest signal to noise ratio of a received
signal, or based on another relative indicator of signal quality,
such as amplitude, frequency content, and/or other signal
characteristic.
[0240] Sensed electrical signals from the multiplexer circuitry 261
can undergo various processing to extract information from the
signals. For example, analog signals from the multiplexer circuitry
261 can be filtered by a band pass filter 262. The band pass filter
262 can be centered on a known or expected modulation frequency of
a sensed signal of interest. A band pass filtered signal can then
be amplified by a low-noise amplifier 263. The amplified signal can
be converted to a digital signal by an analog-to-digital converter
circuitry (ADC) 264. The digital signal can be further processed by
various digital signal processors 265, as further described herein,
such as to retrieve or extract an information signal communicated
by the implantable device 110.
[0241] FIG. 3 illustrates, by way of example, a schematic view of
an embodiment of a midfield antenna 300 with multiple subwavelength
structures 301, 302, 303, and 304. The midfield antenna 300 can
include a midfield plate structure with a planar surface. The one
or more subwavelength structures 301-304 can be formed in the plate
structure. In the example of FIG. 3, the antenna 300 includes a
first subwavelength structure 301, a second subwavelength structure
302, a third subwavelength structure 303, and a fourth
subwavelength structure 304. Fewer or additional subwavelength
structures can be used. The subwavelength structures can be excited
individually or selectively by one or more RF ports (e.g., first
through fourth RF ports 311, 312, 313, and 314) respectively
coupled thereto. A "subwavelength structure" can include a hardware
structure with dimensions defined relative to a wavelength of a
field that is rendered and/or received by the external source 102.
For example, for a given .lamda..sub.0 corresponding to a signal
wavelength in air, a source structure that includes one or more
dimensions less than .lamda..sub.0 can be considered to be a
subwavelength structure. Various designs or configurations of
subwavelength structures can be used. Some examples of a
subwavelength structure can include a slot in a planar structure,
or a strip or patch of a conductive sheet of substantially planar
material. Examples of subwavelength structures are provided in at
least the subsection herein titled "COMPACT INTEGRATION OF
ELECTRONIC CONTROL HARDWARE WITH ELECTROMAGNETIC TRANSMITTING
ELEMENT."
[0242] FIG. 4 illustrates generally the phase-matching or
amplitude-matching network 400. In an embodiment, the network 400
can include the antenna 300, and the antenna 300 can be
electrically coupled to a plurality of switches 404A, 404B, 404C,
and 404D, for example, via the first through fourth RF ports 311,
312, 313, and 314 illustrated in FIG. 3. The switches 404A-D are
each electrically coupled to a respective phase and/or amplitude
detector 406A, 406B, 406C, and 406D, and a respective variable gain
amplifier 408A, 408B, 408C, and 408D. Each amplifier 408A-D is
electrically coupled to a respective phase shifter 410A, 410B,
410C, and 410D, and each phase shifter 410A-D is electrically
coupled to a common power divider 412 that receives an RF input
signal 414 to be transmitted using the external source 102.
[0243] In one or more embodiments, the switches 404A-D can be
configured to select either a receive line ("R") or a transmit line
("T"). A number of switches 404A-D of the network 400 can be equal
to a number of ports of the midfield source 402. In the example of
the network 400, the midfield source 402 includes four ports (e.g.,
corresponding to the four subwavelength structures in the antenna
300 of the example of FIG. 3), however any number of ports (and
switches), such as one, two, three, four, five, six, seven, eight
or more, can be used.
[0244] The phase and/or amplitude detectors 406A-D are configured
to detect a phase .PHI.1, .PHI.2, .PHI.3, .PHI.4) and/or power (P1,
P2, P3, P4) of a signal received at each respective port of the
midfield source 402. In one or more embodiments, the phase and/or
amplitude detectors 406A-D can be implemented in one or more
modules (hardware modules that can include electric or electronic
components arranged to perform an operation, such as determining a
phase or amplitude of a signal), such as including a phase detector
module and/or an amplitude detector module. The detectors 406A-D
can include analog and/or digital components arranged to produce
one or more signals representative of a phase and/or amplitude of a
signal received at the external source 102.
[0245] The amplifiers 408A-D can receive respective inputs from the
phase shifters 410A-D (e.g., Pk phase shifted by .PHI.k,
.PHI.1+.PHI.k, .PHI.2+.PHI.k, .PHI.3+.PHI.k, or .PHI.4+.PHI.k). The
output of the amplifier, O, is generally the output of the power
divider, M when the RF signal 414 has an amplitude of 4*M (in the
embodiment of FIG. 4), multiplied by the gain of the amplifier
Pi*Pk. Pk can be set dynamically as the values for P1, P2, P3,
and/or P4 change. .PHI.k can be a constant. In one or more
embodiments, the phase shifters 410A-D can dynamically or
responsively configure the relative phases of the ports based on
phase information received from the detectors 406A-D.
[0246] In one or more embodiments, a transmit power requirement
from the midfield source 402 is Ptt. The RF signal provided to the
power divider 412 has a power of 4*M. The output of the amplifier
408A is about M*P1*Pk. Thus, the power transmitted from the
midfield coupler is M*(P1*Pk+P2*Pk+P3*Pk+P4*Pk)=Ptt. Solving for Pk
yields Pk=Ptt/(M*(P1+P2+P3+P4)).
[0247] The amplitude of a signal at each RF port can be transmitted
with the same relative (scaled) amplitude as the signal received at
the respective port of the midfield coupler coupled thereto. The
gain of the amplifiers 408A-D can be further refined to account for
any losses between the transmission and reception of the signal
from the midfield coupler. Consider a reception efficiency of
.eta.=Pir/Ptt, where Pir is the power received at the implanted
receiver. An efficiency (e.g., a maximum efficiency), given a
specified phase and amplitude tuning, can be estimated from an
amplitude received at the external midfield source from the
implantable source. This estimation can be given as
.eta..apprxeq.(P1+P2+P3+P4)/Pit, where Pit is an original power of
a signal from the implanted source. Information about a magnitude
of the power transmitted from the implantable device 110 can be
communicated as a data signal to the external source 102. In one or
more embodiments, an amplitude of a signal received at an amplifier
408A-D can be scaled according to the determined efficiency, such
as to ensure that the implantable device receives power to perform
one or more programmed operation(s). Given the estimated link
efficiency, .eta., and an implant power (e.g., amplitude)
requirement of Pir', Pk can be scaled as
Pk=Pir'/[.eta.(P1+P2+P3+P4)], such as to help ensure that the
implant receives adequate power to perform the programmed
functions.
[0248] Control signals for the phase shifters 410A-D and the
amplifiers 408A-D, such as the phase input and gain input,
respectively, can be provided by processing circuitry that is not
shown in FIG. 4. The circuitry is omitted to not overly complicate
or obscure the view provided in FIG. 4. The same or different
processing circuitry can be used to update a status of one or more
of the switches 404A-D between receive and transmit configurations.
See the processor circuitry 210 of FIG. 2A and its associated
description for an example of processing circuitry.
[0249] FIG. 5 illustrates, by way of example, a diagram of an
embodiment of circuitry 500 of the implantable device 110, or
target device. The circuitry 500 includes one or more pad(s) 536,
such as can be electrically connected to the antenna 108. The
circuitry 500 can include a tunable matching network 538 to set an
impedance of the antenna 108 based on an input impedance of the
circuitry 500. The impedance of the antenna 108 can change, for
example, due to environmental changes. The tunable matching network
538 can adjust the input impedance of the circuitry 500 based on
the varying impedance of the antenna 108. In one or more
embodiments, the impedance of the tunable matching network 538 can
be matched to the impedance of the antenna 108. In one or more
embodiments, the impedance of the tunable matching network 538 can
be set to cause a portion of a signal incident on the antenna 108
reflect back from the antenna 108, thus creating a backscatter
signal.
[0250] A transmit-receive (T/R) switch 541 can be used to switch
the circuitry 500 from a receive mode (e.g., in which power and/or
data signals can be received) to a transmit mode (e.g., in which
signals can be transmitted to another device, implanted or
external). An active transmitter can operate at an Industrial,
Scientific, and Medical (ISM) band of 2.45 GHZ or 915 MHz, or the
402 MHz Medical Implant Communication Service (MICS) band for
transferring data from the implant. Alternatively, data can be
transmitted using a Surface Acoustic Wave (SAW) device that
backscatters incident radio frequency (RF) energy to the external
device. See at least the subsection herein titled "SURFACE ACOUSTIC
WAVE BASED COMMUNICATION DEVICE" for further discussion on a SAW
based backscatter approach.
[0251] The circuitry 500 can include a power meter 542 for
detecting an amount of received power at the implanted device. A
signal that indicates power from the power meter 542 can be used by
a digital controller 548 to determine whether received power is
adequate (e.g., above a specified threshold) for the circuitry to
perform some specified function. A relative value of a signal
produced by the power meter 542 can be used to indicate to a user
or machine whether an external device (e.g., the source 102) used
to power the circuitry 500 is in a suitable location for
transferring power and/or data to the target device.
[0252] In one or more embodiments, the circuitry 500 can include a
demodulator 544 for demodulating received data signals.
Demodulation can include extracting an original information-bearing
signal from a modulated carrier signal. In one or more embodiments,
the circuitry 500 can include a rectifier 546 for rectifying a
received AC power signal.
[0253] Circuitry (e.g., state logic, Boolean logic, or the like)
can be integrated into the digital controller 548. The digital
controller 548 can be configured to control various functions of
the receiver device, such as based on the input(s) from one or more
of the power meter 542, demodulator 544, and/or the clock 550. In
one or more embodiments, the digital controller 548 can control
which electrode(s) (e.g., E0-E3) are configured as a current sink
(anode) and which electrode(s) are configured as a current source
(cathode). In one or more embodiments, the digital controller 548
can control a magnitude of a stimulation pulse produced through the
electrode(s).
[0254] A charge pump 552 can be used to increase the rectified
voltage to a higher voltage level, such as can be suitable for
stimulation of the nervous system. The charge pump 552 can use one
or more discrete components to store charge for increasing the
rectified voltage. In one or more embodiments, the discrete
components include one or more capacitors, such as can be coupled
to pad(s) 554. In one or more embodiments, these capacitors can be
used for charge balancing during stimulation, such as to help avoid
tissue damage.
[0255] A stimulation driver circuitry 556 can provide programmable
stimulation through various outputs 534, such as to an electrode
array. The stimulation driver circuitry 556 can include an
impedance measurement circuitry, such as can be used to test for
correct positioning of the electrode(s) of the array. The
stimulation driver circuitry 556 can be programmed by the digital
controller to make an electrode a current source, a current sink,
or a shorted signal path. The stimulation driver circuitry 556 can
be a voltage or a current driver. The stimulation driver circuitry
556 can include or use a therapy delivery circuitry that is
configured to provide electrostimulation signal pulses to one or
more electrodes, such as using at least a portion of a received
midfield power signal from the external source 102. In one or more
embodiments, the stimulation driver circuitry 556 can provide
pulses at frequencies up to about 100 kHz. Pulses at frequencies
around 100 kHz can be useful for nerve blocking.
[0256] The circuitry 500 can further include a memory circuitry
558, such as can include a non-volatile memory circuitry. The
memory circuitry 558 can include storage of a device
identification, neural recordings, and/or programming parameters,
among other implant related data.
[0257] The circuitry 500 can include an amplifier 555 and analog
digital converter (ADC) 557 to receive signals from the
electrode(s). The electrode(s) can sense electricity from nerve
signals within the body. The nerve signals can be amplified by the
amplifier 555. These amplified signals can be converted to digital
signals by the ADC 557. These digital signals can be communicated
to an external device. The amplifier 555, in one or more
embodiments, can be a trans-impedance amplifier.
[0258] The digital controller 548 can provide data to a
modulator/power amplifier 562. The modulator/power amplifier 562
modulates the data onto a carrier wave. The power amplifier 562
increases the magnitude of the modulated waveform to be
transmitted.
[0259] The modulator/power amplifier 562 can be driven by an
oscillator/phase locked loop (PLL) 560. The PLL disciplines the
oscillator so that it remains more precise. The oscillator can
optionally use a different clock from the clock 550. The oscillator
can be configured to generate an RF signal used to transmit data to
an external device. A typical frequency range for the oscillator is
about 10 kHz to about 2600 MHz (e.g., from 10 kHz to 1000 MHz, from
500 kHz to 1500 kHz, from 10 kHz to 100 kHz, from 50 kHz to 200
kHz, from 100 kHz to 500 kHz, from 100 kHz to 1000 kHz, from 500
kHz to 2 MHz, from 1 MHz to 2 MHz, from 1 MHz to 10 MHz, from 100
MHz to 1000 MHz, from 500 MHz to 2500 MHz, overlapping ranges
thereof, or any value within the recited ranges). Other frequencies
can be used, such as can be dependent on the application. The clock
550 is used for timing of the digital controller 548. A typical
frequency of the clock 550 is between about one kilohertz and about
one megahertz (e.g., between 1 kHz and 100 kHz, between 10 kHz and
150 kHz, between 100 kHz and 500 kHz, between 400 kHz and 800 kHz,
between 500 kHz and 1 MHz, between 750 kHz and 1 MHz, overlapping
ranges thereof, or any value within the recited ranges). Other
frequencies can be used depending on the application. A faster
clock generally uses more power than a slower clock.
[0260] A return path for a signal sensed from a nerve is optional.
Such a path can include the amplifier 555, the ADC 557, the
oscillator/PLL 560, and the modulator/power amplifier 562. Each of
these items and connections thereto can optionally be removed.
[0261] In one or more embodiments, the digital controller 548, the
amplifier 555, and/or the stimulation driver circuitry 556, among
other components of the circuitry 500, can comprise portions of a
state machine device. The state machine device can be configured to
wirelessly receive power and data signals via the pad(s) 536 and,
in response, release or provide an electrostimulation signal via
one or more of the outputs 534. In one or more embodiments, such a
state machine device needs not retain information about available
electrostimulation settings or vectors, and instead the state
machine device can carry out or provide electrostimulation events
after, and/or in response to, receipt of instructions from the
source 102.
[0262] For example, the state machine device can be configured to
receive an instruction to deliver a neural electrostimulation
therapy signal, such as at a specified time or having some
specified signal characteristic (e.g., amplitude, duration, etc.),
and the state machine device can respond by initiating or
delivering the therapy signal at the specified time and/or with the
specified signal characteristic(s). At a subsequent time, the
device can receive a subsequent instruction to terminate the
therapy, to change a signal characteristic, or to perform some
other task. Thus, the device can optionally be configured to be
substantially passive, or can be configured to be responsive to
received instructions (e.g., contemporaneously received
instructions).
[0263] Electrical signals from the electrodes 534 can be digitized
by the analog to digital converter 557 and/or modulated by the
modulator 562 and provided to the digital controller 548. The
electrical signals can be analyzed by the digital controller 548,
such as to determine if a charge imbalance exists. In response to
determining a charge imbalance exists, the digital controller 548
can pause or halt the circuitry 500 from providing further
stimulation. In one or more embodiments, the electrical signals can
be analyzed by the digital controller 548 to determine a response
from the target. The digital controller 548 can modify the
stimulation to adjust the stimulation and thereby evoke a desired
response from the target.
[0264] To help prevent tissue damage and electrode degradation,
chemical reactions at the electrode interface can be reversed.
Reversible reactions occur within a voltage range called a water
window. During successive stimulation pulses, a slight imbalance
between each phase can cause charge to build up on an electrode.
This charge will increase the electrical potential and eventually
push the charge accumulation outside of the water window. Charge
balancing becomes more nuanced due to time-variant non-linearities
in a system. For example, when a charge is injected in a first
phase of stimulation, some of the charge will dissipate into the
media (e.g., the body). If a recovery phase extracts a same amount
of charge as that injected into the media, then the overall
potential of the media will drift negative. To help this potential
imbalance, a system can be configured to extract only about 90% of
the injected charge, such as to help compensate for these effects.
It is generally expected that a body will buffer an imbalance,
given adequate time and minimal magnitude. However, with high
frequency stimulation, there are too many pulses in a short time
window that the body does not have time to buffer. Any slight
imbalance in charge can cause charge to build up quickly,
potentially causing bodily harm.
[0265] There are two methods of stimulation, namely current
controlled stimulation and voltage controlled stimulation. In both
techniques, charge balancing can be referred to as charge
metering.
[0266] For current controlled stimulation, the charge can be
integrated on a capacitor and used directly for the return phase.
This is called a passive system. Another option is to use active
charge balancing whereby the current is measured either using a
timer or other counter in combination with the amplitude. The
charge can be calculated as a product of time and amplitude. A
current driver can output a value corresponding to the amount of
accumulated charge (e.g., the calculated value). These systems can
be tuned to output some percentage of the determined charge (e.g.,
90% or other percent), such as to make up for dissipation or
non-linearities.
[0267] In voltage stimulation, a sense resistor may be used to
monitor a stimulation current and measure the accumulated charge.
The sense resistor can have a known resistance value. By measuring
the voltage, the current can be calculated and integrated. The
signal produced by charge metering (e.g., calculating accumulated
charge) can be provided to a comparator that can indicate that
stimulation is to be disable, such as in response to the comparator
determining the accumulated charge is greater than (or equal to) a
threshold value.
I. Implantable Device Configurations
[0268] Section headings herein, like the one above ("IMPLANTABLE
DEVICE CONFIGURATIONS"), are provided to guide a reader generally
to material corresponding to the topic indicated by the heading.
However, discussions under a particular heading are not to be
construed as applying only to configurations of a single type;
instead, the various features discussed in the various sections or
subsections herein can be combined in various ways and
permutations. For example, some discussion of features and benefits
of external devices may be found in the text and corresponding
figures under the present section heading "IMPLANTABLE DEVICE
CONFIGURATIONS".
A. Implantable Stimulation Devices and Steering and Affixing
Mechanisms Therefore
[0269] This section describes embodiments and/or features of
therapy devices, guiding mechanisms for situating an implantable
device (e.g., the therapy device) within tissue, and/or affixing
mechanisms for helping ensure the implantable device does not
appreciably move when situated within the tissue. One or more
embodiments regard therapy devices for treatment of incontinence
(e.g., urinary incontinence, fecal incontinence), overactive
bladder, pain or other conditions or symptoms, such as those
described elsewhere herein.
[0270] An advantage of an implantable device discussed in this
section (and others) can include one or more of: (i) a configurable
implantable device that can be altered in shape and/or electrode
configuration to help target a site for electrostimulation within a
body; (ii) an implantable device that can be implanted and then
affixed at a target location (such as an S3 foramen); (iii) an
implantable device with improved signal reception efficiency (e.g.,
using (1) a dielectric material surrounding an antenna, the
dielectric material including a dielectric constant that is between
a dielectric constant of human tissue and that of air, or (2)
multiple antennas in the implantable device, such as to include a
primary antenna inductively coupled to a secondary antenna), (iv) a
thinner, discreet implantable device that can be implanted in areas
of thinner tissue, such as between skin and bone; (v) an
implantable device that can provide an electrostimulation pattern
that an elongated tubular implantable device is not able to provide
(due to the location of the electrodes and shape of the implantable
device; and (vi) a network of implantable devices that can provide
a local or wide area stimulation individually or in combination,
among others.
[0271] In accordance with several embodiments, a system includes an
implantable device comprising an elongated member having a distal
portion and a proximal portion. The device includes a plurality of
electrodes, a circuitry housing, circuitry within the circuitry
housing adapted to provide electrical energy to the plurality of
electrodes, an antenna housing, and an antenna (e.g., a helical
antenna) in the antenna housing. The plurality of electrodes is
situated or located along the distal portion of the elongated
member. The circuitry housing is attached to the proximal portion
of the elongated member. The circuitry is hermetically sealed or
encased within the circuitry housing. The antenna housing is
attached to the circuitry housing at a proximal end of the
circuitry housing opposite to an end of the circuitry housing
attached to the elongated member.
[0272] The system may optionally comprise an external midfield
power source adapted to provide a power or electrical signal or
energy to the implantable device. The implantable device may be
adapted to communicate information (e.g., data signals) to an
antenna of the external source via the antenna. One, more than one
or all of the electrodes may optionally be located at a proximal
portion or central portion of the elongated member instead of the
distal portion. The circuitry housing may optionally be attached to
a distal portion or central portion of the elongated member. The
antenna housing may not be attached to the circuitry housing or may
not be attached to the proximal end of the circuitry housing. The
antenna housing may optionally include a dielectric material with a
dielectric constant between that of human tissue and air, such as a
ceramic material. The ceramic material may optionally cover the
antenna. The elongated member may optionally be flexible and/or
cylindrical. The electrodes may optionally be cylindrically-shaped
and positioned around a circumference of the elongated member.
[0273] The elongated member may optionally include a channel
extending through the elongated member from a proximal end of the
member to the distal portion of the elongated member and a memory
metal wire situated in the channel, the memory metal wire
pre-shaped in an orientation to provide curvature to the elongated
member. The memory metal may optionally be shaped to conform to a
shape of an S3 foramen and generally match a curve of a sacral
nerve. The antenna may be a primary antenna and the device may
further include a secondary antenna in a housing attached to the
antenna housing, the secondary antenna shaped and positioned to
provide a near field coupling with the primary antenna. The device
may optionally include one or more sutures attached at one or more
of: (1) a proximal portion of the antenna housing; (2) a proximal
portion of the circuitry housing; and (3) an attachment structure
attached to a proximal end of the antenna housing. The antenna may
optionally be coupled to a conductive loop of the circuitry
situated in a proximal portion of the circuitry housing. There may
be a ceramic material between the antenna and the conductive
loop.
[0274] FIG. 6 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device 600. The
implantable device 110 can include one or more features of the
implantable devices discussed in this section. The implantable
device 600, as illustrated, includes an elongated, distal body
portion 602. The body portion 602 includes a plurality of
electrodes 604 embedded at least partially therein and/or affixed
thereto. The body portion 602 includes a distal end 606 and a
proximal end 608. The proximal end 608 is affixed to a circuitry
housing 610. The circuitry housing 610 is affixed to an antenna
housing 612. The antenna housing 612, as illustrated, includes a
plurality of tines 614 affixed thereto.
[0275] The body portion 602, electrodes 604, circuitry housing 610,
and antenna housing 612 are illustrated as being generally
cylindrical. The implantable device 600 is configured to be powered
wirelessly (e.g., through electromagnetic waves incident on the
implantable device 600 and external to the body in which the
implantable device 600 is implanted). The implantable device 600 is
configured to provide stimulation (e.g., neurostimulation, muscle
stimulation, other electrostimulation) or other forms of modulation
(e.g., denervation) to a therapy site within a patient (e.g., a
human or other animal patient). The implantable device 600 can be
situated within a patient using a catheter (discussed with regard
to FIGS. 26A-35B, and elsewhere herein).
[0276] The body portion 602 can include a flexible material. In one
or more embodiments, the flexible material can include
polyurethane, silicone, epoxy and/or any other flexible material.
In one or more embodiments, the body portion 602 can include a
shape memory polymer. The flexible material can provide the ability
to shape the body portion 602, such as while the body portion 602
is internal to the patient.
[0277] The electrodes 604 illustrated include an electrode array of
four stimulation electrodes 604 along the body portion 602. The
electrodes 604, in one or more embodiments, include platinum,
iridium, stainless steel, titanium, titanium nitride, or other
conductive material. In one or more embodiments, the electrodes
include a platinum and iridium alloy, such as a combination that is
90% platinum and 10% iridium. Other combinations are possible
(e.g., 85% platinum and 15% iridium, 95% platinum and 5% iridium,
80% platinum and 20% iridium). In one or more embodiments, the
electrodes can include a coating, such as with a material that can
improve electrical performance in a specified medium, such as a
body. In one or more embodiments, the electrodes 604 are
electrically separated from one another, such as by one or more
electrical switches. In one or more embodiments, the electrodes 604
are about one to ten millimeters (e.g., one to three, two to five,
two to eight, three to six, four to nine, five to seven, six to
ten, two to four, overlapping ranges thereof, or any value within
the recited ranges, such as three millimeters) in width (along the
elongated dimension of the body portion 602). In one or more
embodiments, the electrodes 604 are separated by about one to ten
millimeters (e.g., one to three, two to five, two to eight, three
to six, four to nine, five to seven, six to ten, two to four,
overlapping ranges thereof, or any value within the recited ranges,
such as three mm). In one or more embodiments, the diameter of the
electrodes is about one to five millimeters (e.g., one to two, one
to three, two to four, three to five, overlapping ranges thereof,
or any value within the recited ranges, such as 1.1 mm. 1.2 mm, 1.3
mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm). The
electrodes 604 are, respectively, electrically connected to
circuitry 716 (see FIG. 7) and hermetically enclosed in the
circuitry housing 610.
[0278] The circuitry housing 610 can provide a hermetic enclosure
for the circuitry 716. The circuitry housing 610 can include
titanium (e.g., commercially pure, 6Al/4V or another alloy),
platinum, stainless steel, or a ceramic material (such as zirconia
or alumina, for example), or other hermetic, biocompatible
material. The circuitry housing 610 provides an airtight space for
the circuitry 716. If a metallic material is used for the circuitry
housing 610, the circuitry housing 610 can be used as part of the
electrode array, such as can effectively increase the number of
selectable electrodes 604 for stimulation or other modulation.
[0279] An antenna housing 612 can be located at a proximal end 611
of the circuitry housing 610. An antenna 718 (see FIGS. 12A-12C,
for example) within the antenna housing 612 can be used for
powering and communication to and/or from the implantable device
600, such as from a device external to the patient or subject.
[0280] Rather than being hermetic, the circuitry housing 610 can be
backfilled to prevent ingress of moisture therein. The backfill
material can include a non-conductive, waterproof material, such as
an epoxy, parylene, Tecothane.RTM. material, a copy thereof, or
another material.
[0281] In one or more embodiments, tines 614 can be attached at a
proximal portion of the antenna housing 612 (see FIGS. 14A, 14B,
14C, 15A, 15B, 15C, 16A, and 16B, among others, for a view of a
proximal portion of the antenna housing 612). The tines 614 can
provide the ability to affix (e.g., attach or couple) the
implantable device 600 at a specific location within the patient.
The tines 614 can be configured to affix the implantable device 600
to a specific anatomical structure. The tines 614 can be made of a
polymer or other flexible or semi-flexible material, such as can
include silicone, polyurethane, epoxy, or like materials. The tines
614 can flare away from a central axis of the antenna housing 612
such that a distal portion of a given tine 614 is closer to the
central axis than a more proximal portion of the given tine 614,
such as is shown in FIG. 6, among other FIGS.
[0282] FIG. 7 illustrates, by way of example, a perspective view
diagram of another embodiment of an implantable device 700 that
shows internal circuitry 716 and an antenna 718. The circuitry
housing 610 and the antenna housing 612 are shown as transparent so
as to not obscure the view of the items internal thereto.
[0283] The circuitry 716 is configured to provide a programmable
control for each electrode 604 in the electrode array. Any of the
electrodes along the array can be programmed, using or based on
signals from the source 102 received at the circuitry 716, as a
current source or sink. Each of the electrodes 604 can be
independently addressed for current or voltage amplitude in
generally the same manner. For example, to reach further into the
patient, the electrode labelled "0" can be programmed as a current
source. Any one or more of the other electrodes, in this example,
can be programmed as a current sink.
[0284] The circuitry 716 is shown housed within the circuitry
housing 610. The circuitry 716 is electrically connected to the
electrode array, such as at the distal portion of the circuitry
housing 610 by respective electrical connections 720. The circuitry
716 is electrically coupled to the antenna 718, such as through an
inductive coupling or a wired connection. The antenna 718 and/or
electrodes 604 can be encapsulated in a non-hermetic material and
connected to the circuitry 716, such as by using one or more
feedthrough connections, such as discussed with regard to FIGS. 8A
and 8B.
[0285] FIG. 8A illustrates, by way of example, a perspective view
diagram of an embodiment of a circuitry housing 610A. The circuitry
housing 610A as illustrated includes a wall 820 (e.g., a casing),
proximal feedthroughs 822, and distal feedthroughs 824. In an
embodiment, a wall thickness 821 can be between about 25
micrometers and about 400 micrometers (e.g., less than 400
micrometers, less than 350 micrometers, less than 300 micrometers,
less than 250 micrometers, less than 200 micrometers, less than 150
micrometers, less than 130 micrometers, less than 125 micrometers,
less than 120 micrometers, less than 115 micrometers, less than 110
micrometers, less than 100 micrometers, less than 50 micrometers,
between 25 micrometers and 100 micrometers, between 40 micrometers
and 60 micrometers, between 50 micrometers and 100 micrometers,
between 100 micrometers and 200 micrometers, between 150
micrometers and 400 micrometers, between 200 micrometers and 350
micrometers, overlapping ranges thereof, or any value within the
recited ranges, such as 50 micrometers), and can depend on the
material(s) used to create the circuitry housing 610A. In an
embodiment, an outer diameter 823 of the circuitry housing 610A can
be about 1 mm to 3 mm (e.g., 1 mm to 2 mm, 1.5 mm to 2.5 mm, 1.50
mm to 1.75 mm, 2 mm to 3 mm, overlapping ranges thereof, or any
value within the recited ranges, such as 1.66 mm, 1.70 mm, 1.60 mm,
1.55 mm, 1.72 mm). The circuitry housing 610A can be created using
a machining process or can be drawn, cast, molded, or otherwise
provided. The circuitry housing 610A can be made of a metal, metal
alloy, ceramic, or similar material, such as can include a
combination of platinum and iridium. The circuitry housing 610A can
include a dielectric film, such as polyimide, lining an inner
surface thereof, such as to provide more electrical insulation for
circuitry housed within the circuitry housing 610A.
[0286] The proximal feedthroughs 822 and the distal feedthroughs
824 provide a space through which a wire (a conductive wire or
non-conductive wire) can be passed from inside the circuitry
housing 610A to outside the circuitry housing 610A. The
feedthroughs 822 pass through a proximal portion 825 of the
circuitry housing 610A, such as to provide a wire to an antenna 718
in the antenna housing 612 or other proximal destination, such as
external to the patient's body. The feedthroughs 824 pass through a
distal portion 827 of the circuitry housing 610A, such as to
provide a wire to a respective electrode 604 or a distal portion of
the body portion 602, such as the distal end 606.
[0287] FIG. 8A illustrates the circuitry housing 610A as including
a bipolar proximal feedthrough 822 (e.g., two feedthroughs through
the proximal portion 825) and a quadripolar distal feedthrough 824
(e.g., four feedthroughs through the distal portion 827). The
circuitry housing 610A can be used in embodiments that include a
wired connection between the antenna 718 and the circuitry 716.
[0288] FIG. 8B illustrates, by way of example, a perspective view
diagram of another embodiment of a circuitry housing 610B. The
circuitry housing 610B includes distal feedthroughs 824 and no
proximal feedthroughs 822. Note that while the number of distal
feedthroughs 824 is illustrated as four, the number of distal
feedthroughs 824 can be any number two or greater in various
embodiments. The number of distal feedthroughs 824 and proximal
feedthroughs 822 can be limited by the outer diameter 823 of the
circuitry housing 610B and a diameter of the feedthroughs
824/822.
[0289] The circuitry housing 610B can be used in an embodiment in
which there is an inductive (e.g., near field) coupling between the
circuitry 716 and the antenna 718. The feedthroughs 824 can be used
for electrical connections to the electrodes 604, or a mechanical
connection to a distal portion of the body portion 602, such as the
distal end 606.
[0290] FIG. 9 illustrates, by way of example, a perspective view
diagram of the embodiment of the circuitry housing 610A that shows
the circuitry 716 internal thereto. The circuitry 716, as
illustrated, includes an Application Specific Integrated Circuitry
(ASIC) 928, a board 930, and discrete components (e.g., one or more
inductors, capacitors, resistors, diodes, transistors, switches,
oscillators, or the like). The ASIC 928 can be designed as a
System-on-Chip (SoC) package. In one or more embodiments, the
substrate for the SoC can be thinned to 625 micrometers or less
(e.g., between about 50 micrometers and 250 micrometers, about 100
micrometers, between about 75 micrometers and about 125
micrometers, between about 100 micrometers and 300 micrometers,
between about 50 micrometers and 625 micrometers, or other
thickness within a range provided). The ASIC 928 can be attached to
the board 930 (e.g., a printed circuit board (PCB)), such as by
using a flip-chip attachment. The material for the board 930 can be
a glass-reinforced epoxy laminate comprising a composite material
composed of woven fiberglass cloth with an epoxy resin binder that
is flame resistant (e.g., FR4 material), aluminum nitride,
polyimide, or the like. The thickness of the board 930 can be less
than 125 microns (e.g., between 50 and 100 microns, greater than 75
and less than 125 microns, greater than 100 and less than 125
microns, between 75 and 100 microns, between 100 and 120 microns,
overlapping ranges thereof, or any value within the recited
ranges), in one or more embodiments. The discrete components 932
can be surface mount or other components.
[0291] Pads 934 can be used for electrical connections to wires
that are fed through the feedthroughs 824. Pads 936 can be used for
electrical connections to wires that are fed through the
feedthroughs 822. The connections to the pads 934/936 can include
wire bonds, magnet wire, extension of the feedthrough wires, flat
ribbon wires, and/or soldered connections to a flexible board
substrate, among others.
[0292] FIG. 5 illustrates, by way of example, a diagram of an
embodiment of circuitry 500 that can be housed by the circuitry
housing 610, such as can include the ASIC 928, the board 930, or
other components of FIG. 9. The ASIC 928 can be an SoC integrating
functions for wireless RF power harvesting, RF communications,
digital control, and therapy delivery. The ASIC 928 can be
manufactured using (complementary metal-oxide semiconductor) CMOS
technology, such as can use a 0.18 micron or other process.
[0293] FIG. 10 illustrates, by way of example, a graph showing an
example 1100 of signal power vs. time for a stimulation pulse from
the implantable device 600, such as created by the circuitry 1000,
such as can include one or more of the components of the circuitry
716. The stimulation waveform can be controlled using stimulation
driver circuitry 556. The stimulation can be wirelessly programmed
from an external powering unit for varying amplitudes (e.g., 0-10V
in voltage controlled case or 0-10 mA in current controlled case)
in discrete levels. Control of stimulation waveforms can include
the use of a digital to analog converter (DAC) of the stimulation
driver circuitry 556.
[0294] The stimulation can be digitally programmed for varying
pulse frequencies (e.g., between about 0.1 Hz to 100,000 Hz,
between 1 Hz and 1 kHz, between 0.1 Hz and 100 Hz, between 100 Hz
and 1 kHz, between 500 Hz and 2 kHz, between 1 Hz and 10 kHz,
between 5 kHz and 15 kHz, between 10 kHz and 20 kHz, between 1 kHz
and 10 kHz, between 1 kHz and 15 kHz, between 50 kHz and 100 kHz,
overlapping ranges thereof, or any value within the recited ranges)
and pulse widths (e.g., between about 10-1000 microseconds, between
10 and 500 microseconds, between 10 and 100 microseconds, between
50 and 200 microseconds, between 100 and 500 microseconds, between
250 and 750 microseconds, between 400 and 1000 microseconds,
between 500 and 1000 microseconds, between 750 and 1000
microseconds, between 400 and 800 microseconds, overlapping ranges
thereof, or any value within the recited ranges). The stimulation
can be monophasic or biphasic. Monophasic means the stimulation
current flows in only one direction. A biphasic signal flows in
both directions (e.g., positive and negative pulses, such as can be
provided in a non-overlapping, partially-overlapping, or
substantially concurrent manner). In an embodiment, a biphasic
signal can be "charge balanced" such that there is effectively zero
net charge movement (i.e., an amount of signal that is positive is
about the same as an amount of signal is negative). The stimulation
shape can be generally rectangular, exponential, or other shape.
The stimulation waveform can be programmed to emit a burst of
pulses (e.g., between 1 and 1000 pulses, between 1 and 100 pulses,
between 50 and 200 pulses, between 10 and 500 pulses, between 100
and 400 pulses, between 250 and 750 pulses, between 500 and 1000
pulses, between 300 and 800 pulses, between 750 and 1000 pulses,
overlapping ranges thereof, or any value within the recited
ranges). A burst of pulses can be followed by a period without
pulses, another series of pulses, and so on, such as shown in FIG.
10. In some embodiments, the period of time between pulses ranges
between 1 ms and 1000 ms (e.g., between 1 ms and 100 ms, between 10
ms and 150 ms, between 50 ms and 500 ms, between 100 ms and 800 ms,
between 150 ms and 450 ms, between 200 ms and 600 ms, between 250
ms and 1000 ms, between 400 ms and 800 ms, between 500 ms and 1000
ms, between 750 ms and 1000 ms, overlapping ranges thereof or any
value within the recited ranges). Of course, values outside of
these ranges could also be used. In some embodiments, each burst of
pulses may have a duration between 0.1 ms and 100 ms (e.g., between
0.1 ms and 1 ms, between 0.2 and 20 ms, between 0.1 ms and 10 ms,
between 1 ms and 10 ms, between 5 ms and 50 ms, between 10 ms and
100 ms, between 10 ms and 50 ms, between 20 ms and 80 ms, between
30 ms and 60 ms, between 60 ms and 100 ms, overlapping ranges
thereof, or any value within the recited ranges. Of course, values
outside of these ranges could also be used. In some embodiments,
each pulse has a duration of between 20 microseconds and 2000
microseconds (e.g., between 20 microseconds and 50 microseconds,
between 20 microseconds and 200 microseconds, between 50
microseconds and 500 microseconds, between 100 microseconds and
1000 microseconds, between 500 microseconds and 2000 microseconds,
between 1000 microseconds and 2000 microseconds, between 100
microseconds and 500 microseconds, overlapping ranges thereof, or
any value within the recited ranges). Of course, values outside of
these ranges could also be used. The stimulation driver circuitry
556 can be programmed to ramp a stimulation pulse upwards (e.g.,
pulses with increasing amplitude), such as in response to
activation to a programmed amplitude. Upon deactivation of
stimulation, the stimulation driver circuitry 556 amplitude can be
programmed to ramp the stimulation pulse downwards (e.g., using
pulses with decreasing amplitude) to zero. The stimulation pulses
can be synchronized in time with various parameters, such as with
features of various stimulation waveforms from other wireless
implants at other anatomical locations.
[0295] The stimulation driver circuitry 556 can be programmed to
ramp a stimulation pulse upwards (e.g., pulses with increasing
amplitude), such as in response to activation to a programmed
amplitude. Upon deactivation of stimulation, the stimulation driver
circuitry 556 amplitude can be programmed to ramp the stimulation
pulse downwards (e.g., using pulses with decreasing amplitude) to
zero. The stimulation pulses can be synchronized in time with
various parameters, such as with features of various stimulation
waveforms from other wireless implants at other anatomical
locations.
[0296] FIG. 11A illustrates, by way of example, a perspective view
diagram of a proximal portion of an embodiment of an implantable
device 1200A. The device 1200A can be powered through signals
received at an antenna 718A housed in the antenna housing 612. The
antenna housing 612 can be in a proximal portion of the device
1200A. The antenna 718A can be connected to the circuitry 716
through one or more of the feedthroughs 822. In one or more
embodiments, the antenna 718A can be a dielectric rod antenna,
helically shaped, a coil, or other shape. The device 1200A includes
the circuitry housing 610A. In one or more embodiments, the antenna
718A can be an asymmetric dipole antenna, such as with the
circuitry housing 610A serving as part of the dipole. In one or
more embodiments, the antenna can be a dielectric rod antenna.
[0297] FIG. 11B illustrates, by way of example, a perspective view
diagram of a proximal portion of another embodiment of an
implantable device 1200B. The device 1200B is similar to the device
1200A with the device 1200B including a helically-shaped antenna
718B and the circuitry housing 610B. A normal vector of the antenna
718B can be generally parallel to a magnetic field induced by the
antenna 718B. The antenna 718B can include a helical traveling wave
antenna with its normal vector generally parallel with a pointing
vector of an incident wave. The antenna can also be an asymmetric
dipole antenna with the hermetic package serving as part of the
dipole. As previously discussed, the antenna can be a dielectric
rod antenna.
[0298] In one or more embodiments, the antenna housing 612 can be
gold brazed to the circuitry housing 610A-B. In one or more
embodiments, the antenna housing 612 can include an epoxy,
tecothane, or other RF transparent and protective material. The
antenna 718B can be coupled in the near field to the circuitry
housing 610B, such as to help increase the amount of
electromagnetic energy captured by antenna 718C.
[0299] In one or more embodiments, the antenna housing 612 can
include a ceramic material, such as zirconia or alumina. Because
the dielectric constant of zirconia is closer to that of muscle,
embodiments including zirconia or other ceramic materials can help
stabilize the impedance of the antenna 718 and decrease the change
in impedance when the antenna 718 is surrounded by different tissue
types. The power transfer efficiency, while the antenna 718 is
surrounded by a lower permittivity tissue, is increased when using
a ceramic housing. In this case, the antenna 718 can be composed as
a single ceramic structure with the feedthrough.
[0300] Rather than using a feedthrough to connect the antenna 718,
the power can be transferred from an antenna outside the circuitry
housing 610 to a structure (e.g., another antenna) within the
circuitry housing 610. The energy transfer can occur or be effected
inductively through a ceramic cap 1264. The ceramic cap 1264 can be
used to seal one end of the circuitry housing 610B. In one or more
embodiments, a loop or helix structure can be encapsulated in the
antenna housing 612 outside the circuitry housing 610B.
Electromagnetic energy from outside the body is transferred to the
antenna 718B, which in turn transfers the energy to the antenna
718C within the circuitry housing 610B. In effect, the antenna 718B
acts as a relay to the antenna 718C within the circuitry housing
610B. The antenna 718C within the package can be connected to the
circuitry 716 (e.g., through the pad 936).
[0301] FIG. 11C illustrates, by way of example, a perspective view
diagram of a proximal portion of yet another embodiment of an
implantable device 1200C. An alternative antenna structure includes
the use of multiple antennas that are not physically connected with
a conductor. For example, a loop 718E can serve as a primary
antenna. The loop 718E can be connected (through the feedthrough
832) to the circuitry 716. One or more surrounding loops 718D can
capture energy and transfer it to the primary antenna (the loop
718E) through near field coupling. In contrast to a single, larger
loop with the same additive cross-sectional area as multiple,
smaller loops, each of the smaller loops can be operated below
their self-resonant frequency while within tissue.
[0302] FIG. 12A illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device 1300A with an
external housing invisible to show the internal circuitry of the
implantable device. FIG. 12B illustrates, by way of example, an
exploded view diagram of a portion of the implantable device 1300A
in the dashed box labelled "12B" in FIG. 12A. In one or more
embodiments, an antenna 718F can be placed within a circuitry
housing 610C. In such embodiments, the material of the circuitry
housing 610C is made of an RF transparent material such as
zirconia, alumina, or glass, or other ceramic material, rather than
a metal. The antenna 718F can be a helical antenna that is wrapped
around the circuitry 716. Such a configuration can provide a more
compact package as compared to other embodiments.
[0303] In the embodiment shown in FIGS. 12A and 12B, quadripolar
feedthroughs are situated in both sides of the circuitry housing
610C. Such a configuration can help allow for an increased number
of electrodes (8 in this case but other numbers of electrodes
(e.g., 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, more than 12), as
compared to other embodiments previously discussed.
[0304] FIG. 13A illustrates, by way of example, a perspective view
diagram of an embodiment of a proximal portion of an implantable
device and attachable tine system 1400A. FIG. 13B illustrates, by
way of example, a perspective view diagram of an embodiment of the
proximal portion of the implantable device and attachable tine
system 1400B of FIG. 13A. FIG. 13C illustrates, by way of example,
a perspective view diagram of an embodiment of an implantable
device 1400C with tines attached thereto. The tines 614 can be used
for fixation of the implantable device, such as by grappling
tissue. A growth of a fibrous tissue aid can provide additional
long term fixation, such as to help prevent migration of the
implant. However, in some cases, fixation with tines 614 is not
useful, such as for a temporary implant that is used for a trialing
period. The trialing period can be to determine if a patient has a
proper therapeutic response. In one or more embodiments, the tines
614 cannot be affixed to the implant during the trialing period,
such as to allow the device to be more easily removed from the
patient. After a trial period is complete that shows a proper
therapeutic response to the therapy, the tines 614 can be added to
the device, such as shown in FIGS. 13A-13C.
[0305] The system 1400A-B can include an attachment structure 1468
affixed to or integrally formed with the antenna housing 612. The
attachment structure 1468 can be situated at a proximal end of the
antenna housing 612. The tines 614 can be a part of a structure
that includes a cap 1470 that fits over the attachment structure
1468 and/or the antenna housing 612. The cap 1470 can fit over the
structure 1468 and the tine structure can be slid onto the
implantable device, such as is shown in FIGS. 13B and 13C.
[0306] A non-circular structure 1466 at a proximal end of the tine
structure can help lock the tines 614 into place on the implantable
device. The structure 1468 allows for tines to be attached to the
implantable device, such as while the device is placed at the
target anatomy. The mating of the structure 1468 and the cap 1470
can help make it more difficult for the tines 614 to rotate (e.g.,
about a longitudinal axis of the implantable device 600). This
limited motion advantageously helps keeps the tines 614 in place,
in accordance with several embodiments.
[0307] FIG. 14A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 1500A for attaching tines 614
to an implantable device. FIG. 14B illustrates, by way of example,
a perspective view diagram of the system of FIG. 14A with the tines
614 being pushed closer to the circuitry housing 610. FIG. 14C
illustrates, by way of example, a perspective view diagram of the
system of FIG. 14B with the tines 614 attached to the circuitry
housing 610.
[0308] The tines 614 can be guided to a proximal portion of the
implantable device 600, such as by using a suture 1476 that extends
at least to a surface of the anatomical structure (e.g., such as
can extend external to the patient's body). The cap 1470 can have
an opening therethrough that allows the tines 614 to fit around the
suture 1476. Using a hollow pushrod 1472 that has the suture 1476
therethrough, the tines 614 can be pushed into place through tissue
and attached to the implant, such as shown in FIGS. 14A-14C. The
suture 1476 can be held taut. The tines 614 and pushrod 1472 can be
inserted while the suture 1476 is held taut. The suture 1476
provides a guide to the implantable device 600 while also providing
a tension against which the tines 614 can be attached.
[0309] FIG. 15A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 1600B for securing tines 614
to an implantable device. FIG. 15B illustrates, by way of example,
an exploded view diagram of an embodiment of the area corresponding
to the dashed box labelled "15B" in FIG. 15A. The attachment
structure 1466 can include a non-circular, symmetric shape (a cube
or hexagon, or other polygon) or non-symmetric shape. The
attachment structure 1466 can be molded at the proximal end of the
implantable device 600. A pushrod 1478 (such as can include a
mating socket device) can be used to turn the structure that
includes the tines 614. Turning the pushrod 1478 while attached to
the structure 1466 can lock the tines 614 into place, such as to
help ensure that the implantable device 600 does not move after
implantation. The pushrod 1478 can include a hole 1484
therethrough. A suture 1476 (e.g., a suture attached to the
implanted device) can be threaded through the hole 1484 to guide
the pushrod 1478 to the attachment structure 1466. Such embodiments
can help control the depth, angle, rotation, and/or curvature
direction of the electrode array of the implant during
placement.
[0310] FIG. 15C illustrates, by way of example, a perspective view
diagram of an embodiment of a system 1600C for steering an
implantable device 600. The implantable device 600 includes the
suture 1476 attached thereto. The suture 1476 can be threaded
through the hole 1484. The suture 1476 can guide the pushrod 1478
to the implantable device 600, such as to situate a polygon
attachment mechanism on an end of the push rod with the attachment
structure 1466.
[0311] FIG. 15D illustrates, by way of example, an exploded view
diagram of an embodiment of a portion of the system 1600D which is
a portion of the system 1600C. An attachment structure 1485 is
configured to mate with the attachment structure 1466. FIG. 15E
illustrates, by way of example, an exploded view diagram of a
system 1600E that includes the pushrod 1478 over the suture
1476.
[0312] The pushrod 1478 can provide an ability to steer the implant
(e.g., the implantable device 600) by applying a moment in the
desired direction. For example, this allows personnel to pull the
implant away from the body (e.g., out of a catheter or patient) out
of a catheter if the implant or the catheter are not in the correct
location. When the implant is in the correct position, a mechanism
can be used to release the implant, such as can include a button
coupled to a bearing that, when pressed, releases the bearing and
allows the pushrod 1478 to be released from the implant, such as is
similar to a socket driver. In one or more embodiments, the pushrod
1478 can be used as a microwave waveguide to transmit energy to the
implant, such as can be used to test the positioning of the implant
by activating it.
[0313] The implantable device can be situated in a catheter. The
pushrod 1478 can be attached to the attachment structure 1466. This
pushrod 1478 can include bore holes 1482 that extend laterally
through a distal portion thereof. The pushrod 1478 can then be
pressed into the catheter (into the patient's body) and when the
implantable device has been driven to a desired depth, an insertion
handle 1480 can be placed through a laterally extending bore hole
1482 and the pushrod 1478 can be rotated to point the implantable
device in the desired direction.
[0314] FIG. 15F illustrates, by way of example, a perspective view
diagram of an embodiment of a system 1600F for detaching the
pushrod 1478 from the implantable device 600. A second pushrod 1467
can be inserted into the hole 1484 (e.g., alongside the suture
1476). The second pushrod 1467 can contact the implantable device
600, such as at the attachment structure 1466. In one or more
embodiments, the second pushrod 1467 can be held in place while the
first pushrod 1478 is retracted to separate the pushrod 1478 from
the implantable device 600. In one or more embodiments, the second
pushrod 1467 can be made of a metal, such as a memory metal
material (e.g., nitinol) or other metal or metal alloy.
[0315] FIG. 16A illustrates, by way of example, a diagram of an
embodiment of a suture securing system 1000A. The system 1000A as
illustrated includes a pushrod that includes a hollow rod portion
1479, a handle 1481, detents 1483, and a female mating structure
1485, a male mating structure 1487, and a suture 1476. The pushrod
can be used as described with regard to the pushrod 1478. The male
mating structure 1487 can be a male luer cap, in one or more
embodiments. The female mating structure 1485 can include a female
luer thread, in one or more embodiments. As the structure 1487 is
coupled with the structure 1485 (e.g., screwed onto the structure
1485) a tapered opening 1493 of the structure 1487 puts pressure on
a mating tapered structure 1495, such as to squeeze the tapered
structure 1495 and put mechanical pressure on the suture, thus
mechanically securing the suture 1476 to the pushrod, such as to
secure the pushrod at a specific location.
[0316] FIG. 16B illustrates, by way of example, a diagram of an
embodiment of a system 1000B that includes the male mating
structure 1487 attached to the female mating structure 1485 (most
of the female mating structure 1485 is occluded in FIG. 16B). The
suture 1476 is secured to the pushrod in FIG. 16B.
[0317] FIGS. 17A, 17B, and 17C illustrate, by way of example,
perspective view diagrams of an embodiment of a system 1700A,
1700B, and 1700C for deploying tines 614 of an implantable device.
During a trialing period, a cap 1486 can surround the tines 614 to
keep them in an un-deployed position. The cap 1486 can include an
RF transparent material, such as to help prevent interference with
powering of the implant or other signals to an antenna of the
implantable device. The cap 1486 can be connected to a suture 1476,
such as to allow for easy deployment of the tines 614 by pulling on
the suture 1476. The cap 1486 can be retrieved through the tissue,
such as by using the suture 1476 as a guide. Alternatively, the cap
1486 can be composed of a bio-absorbable material such that the cap
1486 can be left in the body and will degrade overtime and
eventually expose the tines 614.
[0318] FIG. 18 illustrates, by way of example, a perspective view
diagram of an embodiment of a tine deployment system 1800 attached
to a proximal portion of an implantable device. The implantable
device can be connected to multiple sutures 1488 and 1490. One
suture 1490 can be used to extract the implantable device, and one
suture 1488 can be used to deploy the tines 614. The sutures 1488
and 1490 can be concentric or side by side. In one or more
embodiments, only one suture 1488 or 1490 is used. An embodiment
can include only the suture 1488 if it is known that a patient will
not need device removal. An embodiment can include only the suture
1490 if the tines do not need to be deployed or are already
deployed. The suture 1490 can be pulled to remove the implantable
device 600 from the body.
[0319] FIG. 19 illustrates, by way of example, a perspective view
diagram of an embodiment of the suture and tine deployment system
1800 of FIG. 18 with radiopaque markers 1492 on the suture 1488.
The suture 1488 can also include radio-opaque markers 1492. This
allows for the suture 1488 to be visible under fluoroscopy so that
the suture 1488 can be located below the skin surface after
implantation. A tool can be used to hook onto the subcutaneous
suture 1488, such as can be accomplished with imaging guidance. In
case that the suture 1488 has broken, the radio-opaque marker 1492
can help aid a physician in guiding an extraction tool to grasp the
proximal end of the implant and/or indicate to the physician a
location of the broken suture and that the suture 1488 is
broken.
[0320] FIG. 20 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2000 including a suture
attached to a proximal portion of an implantable device. The suture
1490 can be attached to the implant at one or more positions, such
as can include a proximal end of the implantable device 600, the
circuitry housing 610, the antenna housing 612, or another location
of the implantable device 600. Multiple connection points can help
strengthen the connection. Multiple connection points can help aid
in steering a proximal portion of the implant during
extraction.
[0321] FIG. 21 illustrates, by way of example, a perspective view
diagram of an embodiment of a plurality of sutures 1490 attached to
a proximal portion of an implantable device. Multiple sutures 1490
can be attached, such as around the circumference of the proximal
end of the implantable device. Such multiple sutures can be used to
help steer the implantable device during extraction.
[0322] FIG. 22A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2200A including a suture 2292
and a proximal portion of an implantable device. FIG. 22B
illustrates, by way of example, a perspective view diagram of an
embodiment of the suture 2292 attached to the implantable device of
FIG. 22A. FIG. 22C illustrates, by way of example, a perspective
view diagram of an embodiment of a system 2200C including the
suture 2292 and a proximal portion of an implantable device in
which the suture is attached to the implantable device. FIG. 22D
illustrates, by way of example, a perspective view diagram of an
embodiment of the suture 2292 and tine deployment mechanism with
the tines 614 deployed. The suture 2292 can be attached to the
implantable device at multiple positions such as for strengthening
the connection and to aid in steering the proximal end of the
implantable device during extraction. For extraction, the suture
2292 can be connected, such as at or near the skin surface, to a
rod which can be drawn through a distal end of a dilator. By
pulling on the rod while pushing the dilator, a channel can be
created to the implantable device. This channel can be used for
extraction of the implantable device.
[0323] FIG. 23A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2300A including a rod 2396
attached to a grasping mechanism. FIG. 23B illustrates, by way of
example, a perspective view diagram of an embodiment of the
grasping mechanism 2394 in an open position. FIG. 23C illustrates,
by way of example, a perspective view diagram of an embodiment of
the grasping mechanism 2394 in a closed position.
[0324] If the proximal end of the suture 1488 is subcutaneous, a
grasping mechanism 2394 can be used to grab onto the proximal end
of the suture 1488, effectively extending the suture 1488 to be
transcutaneous. This extension can then be fed through a dilator,
such as to position the dilator relative to the implantable device.
In cases where pulling a suture is inadequate to remove the
implantable device, or in a chronic implantation cases in which the
suture may no longer be viable, a mechanical instrument can be used
for retrieval of the implantable device. A mechanical rod 2396
shaped grasping instrument (see FIG. 23A) can be inserted within a
catheter. At the distal tip of an instrument, a grasping mechanism
2394 can extend from the rod 2396 and clamp the proximal end of the
implantable device or the suture 1488. The grasping mechanism 2394
can be spring loaded, such as with high leverage, to provide
adequate friction between claws 2398 of the grasping mechanism 2394
and the implantable device or suture, such that the physician can
apply sufficient pull force to remove the implantable device.
Alternatively, the grasping mechanism 2394 can include a ratchet
based retention mechanism, such as can be similar to that of a
mechanical pencil.
[0325] FIG. 24A illustrates, by way of example, a perspective view
diagram of an embodiment of a shaping system 2400A for shaping an
implantable device 2402. FIG. 24B illustrates, by way of example, a
perspective view diagram of an embodiment of a system 2400B that
includes the system 2400A in operation. Consider the implantable
device 600. The electrodes 604 can be curved relative to one
another to extend along a target nerve or other anatomical
structure. In one or more embodiments, this curving of the
implantable device 600 can be done using a curved stylet that is
tunneled through a lead in a body of the implantable device 600.
The curved stylet can allow the physician to orient the tip of the
electrode array to the correct location and/or orientation.
[0326] For a wireless, leadless implantable device 2402, an
alternate technique is shown here. A preformed, curved memory wire
2404 (e.g., nitinol or other memory metal) can be integrated into
the implantable device 2402, such as is shown in FIG. 24B. The
curvature of the wire 2404 can be predetermined to be ideal for a
specific anatomical target. Although the implantable device 2402 is
curved, it can be easily straightened to fit through a straight
catheter for implantation. As the implantable device exits the
catheter or other delivery device at the target anatomical site,
the natural bias of the implantable device 2402, as provided by the
memory wire 2404, causes the implantable device to curve. A pushrod
(e.g., the pushrod 1478) that is temporarily connected to the
implantable device can help allow a physician to guide the
implantable device 2402 to the correct location with the correct
curvature orientation. In one or more embodiments, a bend or
curvature in an implantable device can be created by molding (e.g.,
reflowing) the implantable device to a specific shape.
[0327] FIG. 25A illustrates, by way of example, a perspective view
diagram of an embodiment of a stylet 2506 in an internal conduit of
the implantable device, or implant 2500A. Rather than using memory
wire 2404 within a channel inside the implantable device to provide
a suitable bend for the target anatomy, such as is discussed with
regard to FIGS. 24A-24B, a stylet 2506 can be inserted into a
continuous channel that travels through the implantable device to
the distal end 606. Alternatively, the stylet 2506 can be curved
around the circuitry housing 610, such as shown in FIG. 25B or a
channel can be included in the implantable device 600 which allows
the stylet 2506 to curve around the circuitry 716 in the circuitry
housing 610. Alternatively, the hermetic package can include a
channel such that the stylet 2506 is able to pass through a channel
that passes through or around the circuitry 716. The physician can
then control the electrode array in a manner similar to a lead-type
electrode array. The stylet 2506 can be situated in a proper
location using a pushrod and catheter or by situating the stylet
2506 in the implantable device prior to implantation. Rather than
using the memory wire 2404, the implantable device 600 can be
shaped by molding (e.g., reflowing) the implantable device 600,
such as by using a mold.
[0328] FIG. 26A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2600A for guiding an
implantable device. FIG. 26B illustrates, by way of example, a
perspective view diagram of an embodiment of a system 2600B that
includes the system 2600A of FIG. 26A with some portions
transparent to show a stylet within the implantable device. FIG.
26C illustrates, by way of example, an exploded view diagram of an
embodiment of a steering mechanism 2600C of the system of FIGS. 26A
and 26B. FIG. 26A illustrates a steerable electrode 604 on a
wireless implantable device that includes two stylets 2508 and 2510
on opposing sides of the electrodes 604. The stylets 2508 and 2510
can be, at least partially, inserted into respective channels 2514.
The channels 2514 can either partially or fully enclose the stylets
2510 and 2508 therein, such as to at least partially enclose the
stylets 2510 and 2508 within the structure of the electrodes 604.
The channel 2514 can extend to about the tip of the implantable
device (the distal end 606). Applying force on one of the stylets
2508 and 2510 and less force on the other stylet 2508 and 2510
steers the distal end 606 of the implantable device. For example,
applying force on the left stylet 2508 in the direction of the
distal end causes the electrode array tip to bend to the right due
to the increased length of the stylet 2508 in the associated
channel 2514.
[0329] The stylets 2508 and 2510 can be temporarily attached to
distal tip 2512. By applying enough force to the stylet 2508/2510,
the stylet 2508/2510 can be removed from the temporary attachment
and removed from the body. In another case, the steering mechanism
2600C can be used as a test electrode or an array of test
electrodes. If the electrode array is left in the patient, then
trimmers could be used to cut a length of the dual stylets that do
not touch the electrodes 604. In one or more embodiments, the
steering mechanism 2600C can be made of biodegradable material,
such that the patient's body decomposes the steering mechanism
while the steering mechanism 2600C is in the patient. In one or
more embodiments, the electrode 604 and the dual stylets 2508 and
2510 are inserted into the patient through a catheter. The catheter
in this case can be made of two concentric materials. An inner
concentric material can be twisted or maneuvered in such a way to
cut the extensions of the dual stylets without the need of
inserting another tool.
[0330] FIG. 27A illustrates, by way of example, an exploded view
diagram of an embodiment of a distal portion of a system 2700A
including an implantable device 600 and a guiding mechanism 2716 to
provide curvature to the implantable device 600. FIG. 27B
illustrates, by way of example, an exploded view diagram of an
embodiment of a distal portion of a system 2700B including a
catheter 2718 with the guiding mechanism 2716 of FIG. 27A situated
within the catheter 2718. A guiding mechanism 2716 that includes a
redirecting wedge can be used to guide the direction of the
implantable device 600. The guiding mechanism 2716 can include a
curvature that matches a contour of the implantable device 600. A
pushrod can be used to advance the implantable device along the
guiding mechanism 2716. When the implantable device 600 is pushed
to the end of the guiding mechanism, the curve (e.g., wedge) of the
guiding mechanism 2716 redirects the implantable device 600 to a
curved orientation. The curve of the guiding mechanism 2716 can be
configured such that when the implantable device 600 is pushed
across the curve, the resulting curve of the implantable device
matches a curve of target anatomy.
[0331] The curve at the tip of the guiding mechanism 2716 forces
the implantable device 600 to bend at the same curvature as that of
the guiding mechanism 2716 as the implantable device 600 is
advanced along the curved tip. The guiding mechanism 2716 can be
positioned using a catheter 2718 near a target anatomy which can
benefit from a curvature in providing better stimulation to a
target anatomy or improved electrode impedance, for example. The
guiding mechanism 2716 can be configured to fit within the catheter
2718 along with the implantable device 600. The guiding mechanism
2716 can include a marking (e.g., a radiopaque marking or other
marking) to indicate a location of the curved tip of the guiding
mechanism 2716. The marking can be used to determine if the curved
tip is deployed beyond the tip of the catheter 2718 and/or whether
the guiding mechanism 2716 is properly located within the catheter
2718 or the target anatomy.
[0332] FIG. 28 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2800 for situating the
implantable device 110 within a target anatomy. The target anatomy
illustrated in FIG. 28 is an S3 foramen 2820. The implantable
device 600 can be injected to the target anatomy 2820 using the
catheter 2718. The implantable device 600 can be sized to be
delivered through the catheter 2718. The catheter 2718, in one or
more embodiments, can range in size from 4 F to 10 F (e.g., from 4
F to 7 F, from 5 F to 9 F, from 6 F to 10 F, from 4 F to 6 F, from
8 F to 10 F, overlapping ranges thereof, or any value within the
recited ranges). In the example of FIG. 28, the implantable device
600 can be injected through the third sacral foramen (i.e. the S3
foramen) to a location near the sacral nerve, such as to help treat
incontinence, urinary urge, fecal incontinence, constipation,
and/or pelvic pain. Alternatively, the implantable device 600 can
be injected through soft tissue surrounding the spinal cord to the
dorsal root ganglion or to peripheral nerves to treat pain or can
be injected through a bore in the skull for deep brain stimulation,
for example.
[0333] FIG. 29 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 2900 including a catheter 2718
and dilator 2922 for situating the implantable device 600 within a
body. In one or more embodiments, access to the target nerve can be
initially performed using a hollow needle (not shown in the FIGS.),
such as under imaging guidance (e.g., fluoroscopy, ultrasound, or
the like). The needle can include radio-opaque markers thereon to
aid in positioning. The physician my send electrical current
through the needle to test for a proper physiologic response and
help ensure that the needle is in a proper location. After
sufficient placement of the needle is established, a guidewire can
be inserted through the needle to a distal tip of the needle. The
needle can then be retracted while the guidewire is held in place.
Next, the hollow dilator 2922 is placed inside of a catheter 2718.
The catheter 2718 and dilator 2922 combination can then be placed
over the guidewire and used to create a dilated channel to the
target anatomy. The dilator 2922 and guidewire can then be removed.
The remaining catheter 2718 creates a tunnel to access the target
anatomy through which the implantable device 600 can be situated,
oriented, or other placed at the proper location.
[0334] FIG. 30 illustrates, by way of example, a perspective view
diagram of an embodiment of another system 3000 for situating an
implantable device 600 within a body. A pushrod 3024 can be used to
push the implantable device 600 through the catheter 2718 to the
target anatomy. The pushrod 3024 can be hollow, such as to allow a
suture connected to the implantable device to pass through the
pushrod 3024. The proximal end of the suture can remain above the
skin surface of the patient. The implantable device 600 is placed
into the catheter 2718 and can have its proximal end connected to
the pushrod 3024. The pushrod 3024, in one or more embodiments,
includes a socket driving mechanism as previously discussed. Force
is applied to the proximal end of the pushrod 3024 to guide the
implantable device 600 to an anatomical location. The pushrod 3024
can then be used to hold the implantable device 600 at a set
location while the physician pulls on the catheter 2718 to remove
it. This action, in one or more embodiments, deploys the tines 614
which expand when exposed. The pushrod 3024 can be removed, leaving
the implantable device 600 in place. The resistance to movement
provided by the tines 614 can be adequate to separate the
implantable device from the pushrod, or a release mechanism, such
as a button and bearing or a button and connector device, can be
used to release the pushrod 3024 from the implantable device 600.
In some embodiments, a second pushrod can be inserted into the
pushrod 3024, such as to separate the implantable device 600 from
the pushrod 3024 (see FIG. 15F, for example).
[0335] Portions of this process are illustrated in FIGS. 31A, 31B,
31C, and 31D. The system 3100A of FIG. 31A illustrates a pushrod
1478 and a suture 1488 attached to a proximal end of the
implantable device 600. The system 3100B of FIG. 31B illustrates
the pushrod 1478 over the suture 1488 and attached to an attachment
structure 1466 on the proximal end of the implantable device 600
and the catheter 2718. The system 3100C of FIG. 31C illustrates the
implantable device within the catheter 2718. The system 3100D of
FIG. 31D illustrates the implantable device 600 exiting a distal
end of the catheter 2718. The distal end of the catheter 2718 can
press the tines towards a center of the implantable device 600 and
can be released to a full extending position after exiting the
catheter 2718. The suture 1488 can include radiopaque markers 1492
thereon. The implantable device 600 is illustrated as being in a
pre-curved position, such as can include using a memory wire.
[0336] FIG. 32A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 3200A that includes the system
3100A positioned at a target anatomy (e.g., an S3 foramen 2820 in
this example). The system 3200A includes the implantable device 600
partially external to the catheter 2718 and partially through the
S3 foramen 2820. The pushrod 1478 is at least partially within the
catheter 2718 and the suture 1488 extends out of the patient's
body. The system 3200A includes the implantable device 600
partially external to the catheter 2718 and partially through the
S3 foramen 2820. The pushrod 1478 is at least partially within the
catheter 2718 and the suture 1488 extends out of the patient's
body. FIG. 32B illustrates, by way of example, a perspective view
diagram of an embodiment of a system 3200B that includes the system
3200A positioned at a target anatomy with the catheter 2718 and the
pushrod 1478 removed. The suture 1488 is illustrated as extending
beyond a surface of the patient's skin 3226.
[0337] FIG. 32C illustrates, by way of example, an exploded view
diagram of a proximal portion of items in the dashed box labelled
"32C" in FIG. 32B. The proximal portion 3200C includes a retaining
device 3228 through a loop on the suture 1488. The retaining device
3228 can help ensure that the suture 1488 remains at least
partially external to the patient's body. Such a configuration
helps ensure easy access to the suture 1488 in case the implantable
device 600 is to be removed from the patient.
[0338] Implantable devices discussed herein can be powered using
mid-field power technology such as discussed with respect to the
source 102 and elsewhere herein. Mid-field powering technology
discussed herein can provide for efficient power transfer to an
implantable device, such as can be at a visceral depth. The
mid-field powering technology can provide an ability to steer, or
focus, a power signal.
[0339] FIG. 33A illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device extraction system
3300A. The system 3300A as illustrated includes a needle 3332 with
an extension suture 3330 running there through. At the distal end
of the needle 3332, the extension suture 3330 can be sticking out,
and can be connected to the suture 1488 attached to the implantable
device 600.
[0340] The extension suture 3330 can be tied or otherwise connected
to the suture 1488 that is attached to the implantable device 600.
Such a system can help in extracting the implantable device 600
from a patient's body if the retaining device 3228 is missing, or
the suture 1488 is otherwise fully internal to the patient's body.
FIG. 33B illustrates, by way of example, an exploded view diagram
of an embodiment of interlaced sutures to assist in implantable
device extraction. This figure illustrates the sutures 3330 and
1488 interlaced or otherwise connected. FIG. 33C illustrates, by
way of example, an exploded view diagram of an embodiment of the
system of FIG. 33B with the needle 3332 situated over the
interlaced sutures. The needle 3332 can be guided by the suture
1488 to the implantable device 600.
[0341] FIGS. 34A, 34B, 34C, and 34D illustrate, by way of example,
perspective view diagrams of an embodiment of an implantable device
extraction system 3400A, 3400B, 3400C, and 3400D, respectively. The
system 3400A is similar to the system 3300C with the needle 3332
inserted through the skin to the implantable device 600. The
proximal end the suture 1488 is attached to the extension suture
3330. In the embodiments of FIGS. 33A-33C, the extension suture
3330 is pre-tunneled through needle 3332. However, the needle 3332
can be extended over the extension suture 3330 after the extension
suture 3330 is coupled to the suture 1488.
[0342] After the sutures 3330 and 1488 are securely connected, the
physician (or other operating personnel) can pull the connected
sutures until they are taut. The needle 3332 can then be inserted
while maintaining the suture 1488 taut. The suture 1488 is used as
a guide to the implantable device 600. FIG. 34A illustrates an
embodiment after this procedure has been accomplished.
[0343] The needle 3332 can be removed and replaced with a dilator
3334, such as is shown in FIG. 34B. The dilator 3334 can be placed
over the needle 3332 and then the needle 3332 can be removed and
the dilator 3334 placed through skin, such as while keeping the
suture 1488 taut (e.g., using one or more structures discussed with
regard to FIGS. 16A-16B, manual pressure, or the like). The needle
3332 includes an outer diameter that is less than an inner diameter
of the dilator 3334.
[0344] Tissue can be dilated using larger dilators until a catheter
2718 with an inner diameter larger than a largest diameter of the
implantable device 600 can be inserted into the patient. In some
embodiments that include the tines 614, the tines 614 are the
portion of the implantable device 600 with the largest diameter. In
such embodiments, the inner diameter of the catheter 2718 and/or
dilator 3334 should be larger than the effective diameter of the
tines 614. FIG. 34C illustrates the catheter 2718 and/or dilator
3334 over a portion of the implantable device 600 and the suture
1488.
[0345] The catheter 2718 can be held in place, such as to help make
sure the catheter 2718 does not retract. Pulling force can be
applied to the suture 3330 and/or 1488 in order to allow the
implantable device 600 to be extracted from the body through the
catheter 2718. FIG. 34D illustrates the implantable device 600
within the catheter 2718 as it is being extracted from the body.
The catheter 2718 can then be removed from the body.
[0346] FIGS. 35A and 35B illustrate, by way of example, exploded
view diagrams of an embodiment of another implantable device
extraction system 3500A and 3500B, respectively. Again, if the
retaining device 3228 has been removed and/or string has been
retracted into body, fluoroscopic guidance (using radiopaque
markers on the suture 1488) can be used to find the suture 1488.
These radio-opaque markings can help allow personnel to locate the
suture 1488 within the body. As shown in FIG. 35A, the needle 3332
can be used (e.g., under fluoroscopic guidance) to burrow an
opening to the suture 1488. The opening is indicated by dashed
lines 3538 in FIG. 35B. A mechanical grasper 3536 can be deployed
into the hole created by the needle 3332. The grasper 3536 can
mechanically grab the suture 1488 and be used to pull the suture
1488 out of the body. A process, such as one similar to that
discussed with regard to FIGS. 33A-33C and 34A-34D, can be used to
extract the implantable device 600 (with or without the extension
suture 3330).
B. Implantable Stimulation Devices Including Hollow Lumen
[0347] In accordance with several embodiments, an implantable
stimulation device includes a lumen (e.g., a tubular element that
is hollow, such as to include a channel therethrough) in which a
stylet or other guiding device can be inserted. In one or more
embodiments, the lumen can be used to help situate the device at a
specified or desired location and/or can aid in assembling a
portion of the device.
[0348] One or more embodiments can include a hollow lumen that
traverses substantially an entire length of the implantable device,
such as to extend from a proximal end of the device to at or near a
distal end of the device. The hollow lumen can aid in manufacturing
the implantable device. Additionally, or alternatively, the hollow
lumen can help in positioning the implantable device into a
particular location near tissue or otherwise internal to a patient.
The hollow lumen can include an opening therein that is
sufficiently large to allow a stylet to be situated therein.
[0349] Implantable devices can be difficult to properly place. It
can be difficult to steer the implantable device to a desired
location within a body.
[0350] An addition of a central lumen that goes nearly all or all
of the way through the device, such as to an internal surface of an
outer casing at the distal end thereof can help alleviate concerns
with pushing a device into place and can also provide placement of
devices that do not include any leads.
[0351] Such an implantable device configuration can allow for the
insertion of a stylet into the device to the distal tip and allows
for a non-lead implantable device to be accurately placed. Using
such a hollow lumen, a sheath that is used to help guide the device
and/or a pushrod can be unnecessary.
[0352] Also, the hollow lumen can help provide an aid in
manufacturing the device. With a hollow lumen, a distal feedthrough
conductor can be attached to the circuitry assembly with the hollow
lumen already brazed into place. With a hollow lumen, a circuitry
housing and/or antenna housing can be placed into position over a
distal feedthrough flange and/or a proximal flange of the hollow
lumen. A proximal feedthrough conductor can be attached to
circuitry of the device with excess conductor length. The excess
conductor length can serve as a service loop in device assembly.
The hollow lumen can serve as a fixture that can help position the
circuitry housing and/or the antenna housing into a final position
for brazing and/or welding.
[0353] FIG. 36 illustrates, by way of example, an embodiment of an
at least partially implantable, biocompatible device 3600. The
device 3600 as illustrated includes an outer casing 3602,
electrodes 3604A, 3604B, 3604C, and 3604D, a hollow lumen
comprising lumen portions 3606A and 3606B (and lumen hole 3832A in
some embodiments (see FIG. 38)), circuitry 3608, a circuitry
housing 3616, distal feedthroughs 3612A and 3612B, proximal
feedthroughs 3614A and 3614B, an antenna housing 3618, an antenna
3610, feedthrough plates 3620 and 3624, and an end plate 3622.
[0354] The distal feedthroughs 3612A-B can be similar to the
feedthroughs 824. The proximal feedthroughs 3614A-B can be similar
to the feedthroughs 822. The circuitry 3608 can include components,
such as one or more of those illustrated in FIG. 5. The circuitry
3608 can be similar to components in the circuitry housing 610A,
such as shown in FIG. 9. The antenna 3610 can be similar to the
antenna 718A-E or other antenna discussed with regard to the
implantable device 110, such as the antenna 108. The outer casing
3602 can be similar to the body portion 602. The electrodes 3604A-D
can be similar to the electrodes E0-E3. The circuitry housing 3616
can be similar to the circuitry housing 610A-B. The antenna housing
3630 can be similar to the antenna housing 612.
[0355] The plurality of electrodes 3604A, 3604B, 3604C, and 3604D
(e.g., ring electrodes) are exposed on the outer casing 3602.
Conductors connecting the electrodes 3604A-D to the circuitry 3608
and some distal feedthroughs are not shown in FIG. 36 so as to help
in not obscuring the view. The outer casing 3602 can include a
dielectric material, such as can include a silicone or
thermoplastic elastomer.
[0356] The hollow lumen portion 3606B extends from a proximal end
3626 of the device 3600 to a proximal side of the feedthrough plate
3624. The hollow lumen portion 3606A extends from a distal side of
the feedthrough plate 3624 to a distal end 3628 of the device 3600.
In one or more embodiments, the hollow lumen portions 3606A-B
combine to form a hollow lumen that extends from the proximal end
of the device 3600 to the distal end 3628 of the device 3600.
[0357] In one or more embodiments, the hollow lumen portion 3606A
can be affixed to an electrode assembly of the device (e.g., the
outer casing 3602, the electrodes 3604A-D thereon, and the
conductors attached to the electrodes). In one or more other
embodiments, the hollow lumen portion 3606A can be situated in and
not affixed to the outer casing 3602. In such embodiments, the
hollow lumen portion 3606A can be affixed to the feedthrough plate
3624. In one or more embodiments, the hollow lumen portion 3606A
can be made of a flexible material, such as a memory metal, such as
MP35N, nitinol, or other memory metal. In one or more other
embodiments, the hollow lumen portion 3606A can be made of a
thermoplastic, such as Tecothane.RTM. material. Using a flexible
material for the hollow lumen portion 3606A allows the outer casing
3602 to remain flexible in embodiments in which the outer casing
3602 is made of a flexible material. Such flexibility can help
provide mobility in positioning and shaping of the implantable
device 3600.
[0358] The hollow lumen portion 3606B can be affixed to one or more
of the feedthrough plates 3620 and/or 3624 and/or the end plate
3622. In one or more embodiments, the hollow lumen portion 3606B
can be made of a hermetic material, such as a metallized ceramic,
glass, quartz, sapphire, platinum, platinum-iridium, a memory
metal, a combination thereof or the like. In one or more
embodiments, the hollow lumen portion 3606B is made of a rigid
(non-flexible) material.
[0359] The circuitry 3608 as illustrated includes a flex circuitry,
however the circuitry 3608 can include a rigid circuitry, such as
can be similar to that shown in FIG. 9. The circuitry 3608 provides
energy harvesting, power management, and/or stimulation signal
capabilities, such as to provide stimulation to tissue through the
electrodes 3604A-D. The circuitry 3608 is electrically connected to
the antenna 3610, such as through conductors in the proximal
feedthroughs 3614A-B. The antenna 3610 can include a dipole
antenna, a loop antenna, a coil antenna, a slot or strip antenna,
or other antenna. The antenna 3610 can be shaped and sized to
receive signals in a range of between about 400 MHz and about 3 GHz
(e.g., between 400 MHz and 1 GHz, between 500 MHz and 2 GHz,
between 1 GHz and 3 GHz, between 500 MHz and 1.5 GHz, between 1 GHz
and 2 GHz, between 2 GHz and 3 GHz, overlapping ranges thereof, or
any value within the recited ranges).
[0360] The circuitry 3608 is electrically connected to the
electrodes 3604A-D through conductors in the distal feedthroughs
3612A-B. The circuitry 3608 is encased in a circuitry housing 3616.
The circuitry housing 3616, in one or more embodiments, is separate
from the outer casing 3602. In such embodiments, the circuitry
housing 3616 and the outer casing 3602 can each be affixed to the
feedthrough plate 3624. In one or more embodiments, the circuitry
housing 3616 can be affixed directly to the outer casing 3602, such
as without the feedthrough plate 3624. In such embodiments, the
distal feedthroughs 3612A-B can be part of the outer casing 3602
and/or the circuitry housing 3616, such as in embodiments in which
the outer casing 3602 or the circuitry housing 3616 include the
feedthrough plate 3624 as an integral part thereof. The circuitry
housing 3616 can be made of titanium, ceramic, or other
biocompatible and/or hermetic material.
[0361] The antenna 3610 is encased in the antenna housing 3618. The
antenna housing 3618, in one or more embodiments, is separate from
the circuitry housing 3616 and the outer casing 3602. In such
embodiments, the antenna housing 3618 can be affixed to the
circuitry housing 3616 by affixing the antenna housing 3618 and the
circuitry housing 3616 to the feedthrough plate 3620, such as by
welding and/or brazing the antenna housing 3618 and/or the
circuitry housing 3616 to the feedthrough plate 3620. The antenna
housing 3618 as illustrated is located more proximal than the
circuitry housing 3616, such as to situate the antenna 3610 more
proximal than the circuitry 3608. The plate 3622 can hermetically
seal the antenna housing 3618 from the external environment.
[0362] FIG. 37 illustrates, by way of example, a perspective view
diagram of another embodiment of an implantable device 3700. The
implantable device 3700 is similar to the device 3600 with the
device 3700 including an encapsulant 3730 encapsulating the antenna
3610 and not including the antenna housing 3618 and also not
including the plate 3622. The hollow lumen portion 3606B as
illustrated in FIG. 37 extends beyond the proximal end 3626 of the
device 3700. As illustrated in FIG. 36 the hollow lumen portion
3606B extends to the proximal end 3626 of the device 3600. In one
or more other embodiments, the hollow lumen portion 3606B can
extend from at or near the distal end 3628 (internal to the outer
casing 3602) to near, but not to, the proximal end 3626. In such
embodiments, the end plate 3622 or the encapsulant 3730 can include
an opening therein that provides access to the hollow lumen.
[0363] FIG. 38 illustrates, by way of example, a perspective view
diagram of an embodiment of the feedthrough plate 3620. The
feedthrough plate 3620 as illustrated includes a plurality of
distal feedthroughs 3612A-D. The feedthroughs 3612A-D provide a
path for a conductor to travel through the feedthrough plate 3620,
such as while providing a hermetic seal or otherwise protecting the
conductors therein. The conductors in the distal feedthroughs
3612A-D are each respectively coupled to an electrode 3604A-D and
to the circuitry 3608, such as to a pad of the pads 934. While
there are four distal feedthroughs 3612A-D illustrated in the
feedthrough plate 3620, there can be any number of distal
feedthroughs, such as can include a single distal feedthrough for
each of the electrodes on the implantable device. The feedthrough
plate 3620 as illustrated includes a lumen hole 3832A on/to which
the hollow lumen portion 3606A can be situated or affixed. A
periphery of the lumen hole 3832A is thus about the same as a
periphery of the hollow lumen portion 3606A. In one or more
embodiments, the hollow lumen portion 3606A can be welded or brazed
to the feedthrough plate 3620. The reverse side (e.g., proximal
side) of the feedthrough plate 3620 can look the same as the side
depicted (e.g., the distal side). The hollow lumen portion 3606B
can be connected to the lumen hole 3832A on the reverse side of the
feedthrough plate 3620.
[0364] FIG. 39 illustrates, by way of example, a perspective view
diagram of an embodiment of the feedthrough plate 3624. The
feedthrough plate 3624 as illustrated includes a plurality of
proximal feedthroughs 3614A-B. The feedthroughs 3614A-B provide a
path for a conductor to travel through the feedthrough plate 3624
while providing a hermetic seal. The conductors in the proximal
feedthroughs 3614A-B are each respectively coupled to the antenna
3610 and to the circuitry 3608, such as a pad of the pads 936. The
feedthrough plate 3624 as illustrated includes a lumen hole 3832B
in which the hollow lumen portion 3606B can be situated. An outer
perimeter of the lumen hole 3832B is thus larger than an outer
perimeter of the hollow lumen portion 3606B. In one or more
embodiments, the hollow lumen portion 3606B can be welded or brazed
to the feedthrough plate 3624 around the lumen hole 3832A, such as
to affix the feedthrough plate 3624 to the hollow lumen portion
3606B.
[0365] FIG. 40 illustrates, by way of example, a perspective view
diagram of an embodiment of the end plate 3622. The end plate 3622
as illustrated includes a lumen hole 3832C in which the hollow
lumen 3606 can be situated. An outer perimeter of the lumen hole
3832C can thus be larger than an outer perimeter of the hollow
lumen portion 3606B. In one or more embodiments, the hollow lumen
portion 3606B can be welded or brazed to the feedthrough plate 3624
around the lumen hole 3832A, such as to affix the feedthrough plate
3624 to the hollow lumen 3606.
[0366] FIGS. 41A and 41B illustrate, by way of example, a diagram
of a technique 4100 (e.g., a method) for assembling an implantable
device that includes a hollow lumen, such as the device 3600 or
3700. The technique 4100, as illustrated, includes situating the
feedthrough plate 3620 over the hollow lumen portion 3606A (and, in
one or more embodiments, on a proximal end of the outer casing
3602), at operation 4102; electrically connecting conductors (at a
proximal side of the feedthrough plate 3620) to the circuitry 3608,
at operation 4108; positioning circuitry 3608 within the circuitry
housing 3616, at operation 4110; positioning circuitry housing 3616
(on the outer casing 3602 or feedthrough plate 3620), at operation
4112; affixing distal side of circuitry housing 3616 to feedthrough
plate 3620 or outer casing 3602, at operation 4114; electrically
connecting conductors from the proximal feedthrough 3614A-B to the
circuitry 3608, at operation 4116; positioning feedthrough plate
3624 (on the circuitry housing 3616 and/or over the hollow lumen
portion 3606B), at operation 4118; affixing the feedthrough plate
3624 to the circuitry housing 3616, at operation 4120; positioning
the antenna housing 3618 (over the hollow lumen portion 3606B
and/or on the feedthrough plate 3624), at operation 4122; affixing
the antenna housing 3618 to the feedthrough plate 3624 and/or the
circuitry housing 3616, at operation 4124; positioning end plate
3622 (over the hollow lumen portion 3606A and/or on the antenna
housing 3618), at operation 4126; affixing the end plate 3622 to
the antenna housing 3618, at operation 4128; hermetically sealing
area around the hollow lumen portion 3606B (e.g., an area between
the lumen hole 3832C), such as by welding (in the case of a metal),
brazing (in the case of a ceramic) or melting glass (in the case of
glass), at operation 4130; connecting electrodes (through a
conductor) to respective distal feedthroughs 3612A-D in the
feedthrough plate 3620, at operation 4132; and affixing the hollow
lumen portion(s) 3606A-B and/or the outer casing 3602 to the
feedthrough plate 3620, at operation 4134.
[0367] The operations 4122, 4124, 4126, and 4128 are optional, as
the antenna housing 3618 and the end plate 3622 are not used in
some embodiments. In such embodiments, the technique 4100 can
alternatively include encapsulating the antenna 3610 in an
encapsulant 3730 (e.g., a dielectric material), such as by
situating the encapsulant (and curing the encapsulant in some
embodiments). The encapsulant 3730 can be situated on the
feedthrough plate 3620, such as to cover the feedthroughs 3614A-B
on the proximal side of the feedthrough plate 3620. The encapsulant
3730 can be situated around the hollow lumen portion 3606B and the
antenna 3610, such as to fully encapsulate the antenna 3610. As
operation 4118 is performed, the conductors on the distal side of
the feedthrough plate 3620 will generally form respective service
loops.
C. Rigid Implantable Devices
[0368] FIG. 42 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable device 5600, such as can
be used for nerve stimulation. In several embodiments, an
implantable device comprises a rigid configuration. Such
implantable devices, in one or more embodiments, can include an
oblong shape. The implantable device 5600 as illustrated includes a
disc shaped body portion 5602, a plurality of electrodes 5604, and
a circuitry housing 5606.
[0369] The body portion 5602 can be made of a rigid biocompatible
material, such as can include platinum, iridium, titanium, ceramic,
zirconia, alumina, glass, and/or a combination thereof among
others. The body portion 5602 can be longer (length indicated by
arrow 5608) than it is wide (width indicated by arrow 5610). A
thickness (indicated by arrows 5614) can be less than the width. An
example range of lengths of the body portion 5602 includes about
six millimeters to about four centimeters (e.g., six millimeters to
one centimeter, eight millimeters to two centimeters, one
centimeter to four centimeters, two centimeters to four
centimeters, once centimeter to three centimeters, overlapping
ranges thereof, or any value within the recited ranges). An example
range of widths of the body portion 5602 includes about six
millimeters to about four centimeters (e.g., six millimeters to one
centimeter, eight millimeters to two centimeters, one centimeter to
four centimeters, two centimeters to four centimeters, once
centimeter to three centimeters, overlapping ranges thereof, or any
value within the recited ranges). An example range of thicknesses
of the body portion 5602 includes about a half a millimeter to
about five millimeters (e.g., half a millimeter to one millimeter,
one millimeter to two millimeters, one millimeter to four
millimeters, two millimeters to four millimeters, three millimeters
to five millimeters, half a millimeter to 2.5 millimeters, once
centimeter to three centimeters, overlapping ranges thereof, or any
value within the recited ranges).
[0370] The body portion 5602 includes electrodes 5604 located along
a periphery thereof. The electrodes 5604, as illustrated, are
located on the periphery. The electrodes 5604 are illustrated as
about evenly distributed on the periphery, such that a distance
between directly adjacent electrodes (directly adjacent as the
periphery is traversed clockwise or anti-clockwise) is generally
uniform (e.g., within ten percent of being uniform). The electrodes
5604, as illustrated, are located at respective intersections of a
bisector of the length or width and the periphery. A length
bisector is indicated by dotted line 5618 and a width bisector is
indicated by dotted line 5616. In an embodiment in which the body
portion has an elliptical footprint, the length bisector (dotted
line 5618) is the minor axis and the width bisector (dotted line
5616) is the major axis of the footprint. While the device 5600 is
illustrated as including four electrodes 5604, the device 5600 can
include one or more electrodes. For example, the device can include
two, three, four, five, six, seven, eight or more electrodes
located on the periphery of the device 5600.
[0371] The body portion 5602 includes a circuitry housing 5606 at
least partially therein. In one or more embodiments, the circuitry
housing 5606 can be flush with a surface 5620 of the body portion
5602. The circuitry housing 5606 can provide a hermetic seal for
electric or electronic components and interconnects housed therein,
or can otherwise provide protection for the circuitry housed
therein, such as without being hermetic. The electric or electronic
components can include one or more transistors, resistors,
capacitors, inductors, diodes, central processing units (CPUs),
field programmable gate arrays (FPGAs), Boolean logic gates,
multiplexers, switches, regulators, amplifiers, power sources,
charge pumps, oscillators, phase locked loops (PLLs), modulators,
demodulators, radios (receive and/or transmit radios), buffers,
circulators, amplifiers, and/or antennas (e.g., a helical shaped
antenna or a patch antenna, among others), or the like, such as
other circuitry of the implantable device discussed elsewhere
herein. The components in the circuitry housing 5606 can be
arranged to form stimulation therapy generation circuitry to
provide stimulation therapy signals to the electrodes 5604, a
receiver (to receive power and/or data signals from a midfield
device), a transmitter (to provide data signals to the midfield
device), and/or an electrode selection circuitry (to select which
electrode(s) are anode(s) and which are cathode(s)). The electrodes
5604 can be respectively electrically connected to circuitry in the
circuitry housing 5606, such as by using a unipolar feedthrough and
an insulated conductor 5622.
[0372] In one or more embodiments, a side 5624 of the device 5600
can be flat, such as to form an edge. In one or more embodiments,
the side 5624 can be rounded. The surface 5620 and an opposing
surface (view of opposing surface occluded in FIG. 42) of the
device 5600 can be substantially flat (e.g., have a flattening
ratio of about 0.9 or greater) or can be rounded at least in a
portion thereof. Each of the electrodes 5604 and the circuitry
housing 5606 can be flush with the surface 5620 (and the same or
different on the opposite surface, which can be generally the same
as the view in FIG. 42).
[0373] FIG. 43 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation device
5700. The implantable stimulation device 5700 is similar to the
stimulation device 5600 with the device 5700 including an
implant/explant structure 5730. The implant/explant structure 5730
is located on a proximal portion 5726 of the device 5700. The
device 5700 includes a distal portion 5728 opposite the proximal
portion 5726. The distal and proximal portions are defined relative
to the direction the device 5700 will be implanted and do not
necessarily connote orientation after implantation. The device 5700
is arranged to be implanted distal portion 5728 first and proximal
portion 5726 thereafter, even though, after implantation, the
distal portion 5728 may be closer to a surface of the skin than the
proximal portion 5726.
[0374] The implant/explant structure 5730 as illustrated includes
three bars 5732A, 5732B, and 5734. The bars 5732A-B as illustrated
are generally parallel to the major axis (the dotted line 5616).
The bar 5734 is generally perpendicular to the bars 5732A-B. A
suture (not shown in FIG. 43) can be attached to the
implant/explant structure 5730. The suture, in one or more
embodiments can be attached to the bar 5734. The bar 5734 can
include a male or female connector (e.g., a clip, screw hole, hole,
or other connection or interface mechanism) to which a pushrod may
be attached, such as for implantation of the device 5700. Note
that, while the bars of the implant/explant structure 5730 are
illustrated as being straight, they can be curved, or some other
shape.
[0375] FIG. 44 illustrates, by way of example, a perspective view
diagram of the device 5700 from the perspective of the arrow
labelled "44" in FIG. 43. The device 5700 as illustrated includes a
connector 5836 to which a push rod and/or a suture may be attached.
The connector 5836 can be a screw hole, a hole, a clip, detent, or
other male or female interface or coupling means for attaching the
push rod and/or suture to the device 5700.
[0376] FIG. 45 illustrates, by way of example, a perspective view
diagram of an embodiment of an implant/explant system 5900. The
implant/explant system 5900, as illustrated, includes a suture 5938
and a pushrod 5940. The pushrod 5940 as illustrated includes screw
threads 5942. The screw threads 5942 can be screwed into the
connector 5836 in embodiments in which the connector includes a
screw hole. The connector 5836 and the mating connector on the
pushrod 5940 (e.g., the screw threads 5942 in the example of FIG.
45) can be attachable and detachable. Thus, the pushrod 5940 can be
used to implant the device 5700 and the pushrod 5940 can be
removed, leaving the device 5700 implanted.
[0377] FIG. 46 illustrates, by way of example, a perspective view
diagram of an embodiment of an implant/explant system 6000. The
system 6000 as illustrated includes the pushrod 5940 attached to
the implant/explant structure 5730. The device 5700 is in a
catheter 6046 that pierced skin 6044 of a user. The catheter 6046
can have angled sidewalls, such as to help guide the device 5700
into the proper orientation and/or to help the catheter pierce the
skin 6044. The pushrod 5940 can be used to force the device 5700
under the skin 6044 and into a proper location in the body.
[0378] In one or more embodiments, the device 5600/5700 can be
implanted into the body without using a catheter. In such
embodiments, an incision can be made through the skin and tissue
under the skin to create a tunnel to a desired location. The device
5600/5700 can then be inserted into the tissue through the tunnel,
such as by using a pushrod or a flatter, more flexible obstacle
stick or obturator (flatter and more flexible than the
pushrod).
[0379] FIG. 47 illustrates, by way of example, a perspective view
diagram of an embodiment of an implant system 6100. The implant
system 6100, as illustrated, includes a plurality of implantable
devices 5700A, 5700B, and 5700C and a midfield powering device
6148. The stimulation devices 5700A-C are specific embodiments of
the device 5700. The midfield device 6148 produces directed and
focused electromagnetic fields. The midfield device 6148 can be
similar to or the same as the midfield device 5028 or the source
102. The midfield powering device 6148 provides electromagnetic
signals to each of the stimulation devices 5700A-C that can be
used, by the circuitry in the circuitry housing 5606, such as to
power the stimulation device 5700A-C and produce stimulation
therapy.
[0380] The focus and direction of the electromagnetic field
produced by the midfield powering device 6148 can be altered by
adjusting a phase of a signal produced by one or more antennas of
the midfield powering device 6148.
[0381] When using a time domain multiplexing communication system
between an external transmitter and an implanted receiver, the
phase and amplitude can be dynamically adjusted to help focus
energy (e.g., more efficiently focus energy) at the implanted
receiver, such as with using a power detector at the stimulation
device for feedback. The midfield device 6148 can provide power
and/or data signals to the implantable devices 5700A-C in a time
domain multiplexed manner, such as to provide signals to one of the
devices 5700A-C at one time and to another of the devices 5700A-C
at another time.
[0382] One or more features of the implantable devices discussed
herein can include: (1) a generally flattened (e.g., planar) and
rigid (non-flexible and non-stretchable) body; (2) electrodes
spaced radially (e.g., spaced apart with about 90 degrees between
adjacent electrodes in the example of four electrodes), such as to
enable spatial stimulation patterns; (3) the body can be shortened
along one axis (width as discussed herein) to allow the stimulation
device to pass through a smaller incision and dilated entry path
than if both axes are the same length; (4) it can accommodate a
screw type implant and explant tool, such as by using an
implant/explant structure; (5) the stimulation devices do not
require lead tunneling or a pocket for a self-contained implantable
pulse generator, such as is required for many self-contained
stimulation devices; and/or (6) the stimulation devices can be
sized and implanted so as to be cosmetically unnoticeable without
the presence of the external stimulator.
[0383] One or more embodiments of stimulation devices discussed
herein include a generally flattened, rigid configuration. These
devices can be used to stimulate one or more peripheral nerves,
such as an occipital or super orbital nerve structure. Such
implants can provide stimulation to the motor cortex. The devices
discussed herein can be implanted into muscular tissue, such as to
help affix the implant in location. Such an implant can help
alleviate concerns associated with Twiddler's syndrome, for
example.
[0384] The stimulation devices can be used to help alleviate
symptoms related to migraines, other headaches, or fibromyalgia,
such as by stimulating an occipital or trigeminal nerve. The
stimulation devices can provide functionality of an occipital
stimulator implant. Implanting multiple stimulation devices near
the target nerve can allow for more or varied spatial stimulation
patterns.
[0385] The stimulation devices can be used to provide epidural
stimulation in the spine. The stimulation devices can be used to
provide cortical stimulation, such as for a stroke patient, such as
to help alleviate movement and/or other neurological disorders
associated with the stroke.
D. Surface Acoustic Wave Based Communication Devices and
Methods
[0386] In accordance with several embodiments, an implantable
stimulation device comprises a surface acoustic wave (SAW) device,
such as to provide one or more backscatter signals. In one or more
embodiments, the SAW device provides a time delay (e.g., a buffer)
for a portion of a signal to be transmitted back to a powering
and/or communication device (e.g., any of the external devices or
sources described herein, such as source 102).
[0387] Midfield powering technology can help enable the powering of
a deeply implanted stimulation device from an external source
located on or near the surface of a patient's skin. While power
delivery is important to activate a device, two-way communication
can help allow the outside world to know that the implant is
in-fact powered and/or to provide feedback signals for manipulating
fields (e.g., one or more evanescent fields), such as to better
focus a power signal on the implanted device. Further, two-way
communication can help allow for transmission of data from an
implanted sensor integrated with (on or near) the implanted
device.
[0388] Some communication schemes can have one or more
disadvantages when used for communicating with an implanted device
(e.g., a deeply implanted device), such as a device with strict
power limitation in the microwatt range. Active transmission
schemes integrating an on-chip oscillator in the implanted device
have limited oscillator accuracy without an integrated phase lock
loop, micro electromechanical system (MEMS), and/or crystal
oscillator. Using a phase lock loop increases the start-up time and
power consumption, sometimes beyond the power buffering capability
of a small off-chip capacitor even when duty cycled. The limited
oscillator accuracy can make detection of the signal difficult due
to the increased noise bandwidth and center frequency tracking.
[0389] Passive communication schemes, such as load modulation, deal
with a strong interferer, which is the powering signal (often times
>50 dB greater in signal strength than the communication
signal). Unlike in inductive coupling approaches of power transfer,
with midfield powering, a signal is loaded more by the tissue
itself than the receive antenna of the implanted device. In accord
with some embodiments, using schemes such as backscatter can be
difficult because of the limited time delay between the implanted
device and external device.
[0390] Discussed in this subsection are implantable devices that
can include a SAW device and systems and methods for using the
same. Described is one or more communication schemes between an
external device and an implantable device. The implantable device
can include a SAW device as a time delay (e.g., signal buffer)
element. The SAW device can be used to store (e.g., temporarily
store) an electromagnetic wave as a propagating mechanical wave,
such as in a piezoelectric substrate. An implantable device can
temporarily store the wave energy in the SAW device. When the
implantable device is in transmit mode, the time delayed radio
frequency (RF) energy from the SAW device can be used (e.g., as a
carrier wave or on its own) for data transmission back to the
external device. During this time, the external device may refrain
from transmitting an energizing signal, such as when the external
device is in receive mode. In such embodiments, there may not be a
strong interfering signal from the external device that can cause
interference in a signal transmitted from the implantable device.
Such embodiments can help provide communications from the
implantable device to the external device using less power. Such
embodiments can help provide communications to the external device
that are more easily detected at the transmitter, at least because
a portion of the signal from the implantable device to the external
device may not include an interfering signal from the
transmitter.
[0391] Direct Current (DC) energy can be stored on the implantable
device so as to power the implantable device while it is
transmitting (e.g., stimulation energy from the external device
4202 (e.g., the source 102) and/or a signal to the external
device). This energy can be, at least partially, used to modulate
the carrier signal transmitted from the implant. In one or more
embodiments, the SAW device can be used simultaneously as a
bandpass filter for the implant transmission downlink, such as to
help reject out of band sources, such as for increased immunity to
noise or other signal interference.
[0392] FIG. 48 illustrates, by way of example, a logical block
diagram of an embodiment of a system 4200. The system 4200 as
illustrated includes an external device 4202 and an implantable
device 4201. The external device 4202 can provide power and/or
communication signals to the implantable device 4201. In one or
more embodiments, the external device 4202 can include a midfield
source that provides a midfield signal to the implantable device
4201. Midfield signals and sources are discussed elsewhere herein.
The circuitry 500 can include one or more of the components of the
implantable device 4201, the circuitry 4400 (see FIG. 50), the
circuitry 4500 (see FIG. 51), the circuitry 4600 (see FIG. 52),
and/or the circuitry 4700 (see FIG. 53).
[0393] The implantable device 4201 receives signals from the
external device 4202 and provides signals to the external device
4202. These signals are represented by the line 4203. The
implantable device 4201 can provide modulation (e.g., stimulation
therapy, denervation, or other therapy to a location in a body,
such as to modulate (e.g., stimulate) a nerve, muscle, or other
tissue. The implantable device 4201 can provide data signals to the
external device 4202.
[0394] The implantable device 4201 as illustrated includes a first
switch 4204, a SAW device 4206, a second switch 4208, circuitry
4210, synchronization circuitry 4218, and electrodes 4224. The
switches 4204 and/or 4208 can include one or more transistors or
mechanical switches arranged to provide alternate electrical paths
for electrical signals from the external device 4202 (a receive
path) and to the external device 4202 (a transmit path). The
transmit path includes the "T" of the respective switches 4204 and
4208 and the receive path includes the "R" of the respective
switches 4204 and 4208.
[0395] The SAW device 4206 includes a material that has an
elasticity that provides a medium to convert an electric signal
incident thereon into a mechanical wave in the SAW device 4206. The
SAW device 4206 then converts the mechanical wave back into an
electric signal. Since the propagation of the mechanical wave
occurs slower than the propagation of an electric signal in a
normal conductor, the SAW device 4206 advantageously acts as a time
delay element for the electric signal, in accordance with several
embodiments. A piezoelectric material can be used as a transducer
that converts between mechanical and electrical waves in SAW
devices.
[0396] The circuitry 4210 as illustrated includes energy harvesting
circuitry 4212, power management circuitry 4214, stimulation
circuitry 4216, demodulator receive circuitry 4220, system control
circuitry 4222, and capacitors 4226.
[0397] The energy harvesting circuitry 4212 can include a rectifier
and one or more capacitors to help store a rectified signal. The
energy harvesting circuitry 4212 can power the implantable device
4201, such as when a stimulation signal is being received from the
external device 4202 and in some embodiments after a stimulation is
received is received from the external device 4202.
[0398] The stimulation circuitry 4216 provides electrical signals
to electrodes 4224. The stimulation circuitry 4216 can include one
or more switches to choose which electrode(s) are anodes and which
are cathodes.
[0399] The synchronization circuitry 4218 can include circuitry to
determine when the implantable device 4201 is to be in a transmit
mode and when the implantable device 4201 is to be in a receive
mode. The synchronization circuitry 4218 can determine an amplitude
of an envelope of a signal from the external device 4202. Based on
the amplitude of the envelope, the synchronization circuitry 4218
can determine the proper mode. When the envelope is sufficiently
large (e.g., above a threshold), the implantable device 4201 can be
in or switched to receive mode and the external device 4202 can be
in transmit mode. When the envelope is sufficiently small (e.g.,
below a second, sometimes different, threshold) the implantable
device 4201 can be switched to or in transmit mode and the external
device 4202 can be in or switched to receive mode. An amplitude of
the envelope is a difference between consecutive maximum and
minimum voltages of the signal.
[0400] FIG. 49 illustrates, by way of example, a wave diagram of an
embodiment of electric signals 4300 in a system that includes a SAW
device. The signals 4300 as illustrated include a signal 4302 from
an external device, a signal 4304 representative of received power
at the implantable device 4201, a signal 4306 as delayed by the SAW
device 4206, a signal 4308 that is to be used as (1) a carrier wave
in modulating a signal transmission to the external device 4202 or
(2) as a signal to be transmitted back to the external device 4202
without modulation, an energizing cycle 4310, and a transmission
cycle 4312.
[0401] The signal 4302 is from the external device 4202 and
provides electric power and a base signal from which to provide
data from the implantable device 4201 to the external device 4202.
The signal 4304 represents the signal received at an antenna of the
implantable device 4201. The delay between the start of the signal
4302 and the signal 4304 is a propagation delay from the signal
4302 travelling to an antenna of the implantable device 4201. The
signal 4306 is at least a portion of the signal 4304 after being
processed through the SAW device 4206. The SAW device 4206 provides
a time delay 4314 to the propagation of the signal 4302 (e.g., the
portion of the signal 4302 that is incident on the SAW device
4206).
[0402] The signal 4308 represents the signal that can be used to
transmit data to the external device 4202. The signal 4308 is the
signal that remains after an energizing cycle 4310 is complete and
during a communication cycle 4312. The energizing cycle 4310
indicates a time frame during which the external device 4202 is
transmitting. The energizing cycle 4310 indicates a general time
frame in which the signal 4304 can be used for energy harvesting,
such as by the harvesting circuitry 4212. While the energizing
cycle 4310 is illustrated as ending at the time the signal 4302 is
done being transmitted, the energizing cycle 4310 can last past the
time the signal 4302 is done being transmitted.
[0403] While the external device 4202 is in transmit mode and the
implantable device 4201 is in receive mode, the implantable device
4201 can operate to harvest power from the signal 4304 and/or
decode data from the signal, such as is indicated by the energizing
cycle 4310. After the power harvest period ends, the external
device 4202 can be switched to receive mode and the implantable
device 4201 can be switched to transmit mode. After the switching
of the implantable device is complete, the remaining signal from
the SAW device 4206 can be used (1) as a carrier wave that can be
used to modulate one or more signals to be transmitted to the
external device 4202 or (2) as a stimulating signal that is
provided to the antenna to provide data to the external device
4202. In the first case, the external device 4202 can decode the
data encoded on the carrier wave. In the second case, the external
device 4202 can interpret a signal received as a binary "1" and no
signal received as a binary "0" (or vice versa). The second case is
simpler as far as circuitry on the implantable device 4201, but
provides only a single bit every transmission, while the first case
includes more circuitry on the implantable device (e.g., to
modulate the signal) but can transmit more than one bit at a
time.
[0404] FIG. 49 illustrates a minimum 4303 and a consecutive maximum
4301. The amplitude of the envelope at that point is the voltage
difference between the maximum 4301 and the minimum 4303 (taking
into consideration the signs of the respective voltages). The
synchronization circuitry 4218 can compare a determined envelope
amplitude to a specified threshold. If the envelope amplitude is
below the specified threshold, the synchronization circuitry 4218
can provide a signal indicating that the implantable device 4201 is
to switch to a transmit mode, such as to provide data to the
external device 4202.
[0405] The demodulator receive circuitry 4220 can include a
demodulator to separate information present on a modulated signal
from a carrier wave. The system control circuitry 4222 can include
a digital controller or processing circuitry, such as is discussed
elsewhere herein. The capacitors 4226 can include one or more
buffer and/or bypass capacitors.
[0406] In general, an external energizer (e.g., a powering and/or
communication device that operates external to tissue in which an
implantable device is situated and operates) can be used to focus
energy to the implantable device 4201. With both switches 4204 and
4208 in receive mode, the signal from the external device 4202 can
be used to power/communicate to/with the implantable device 4201. A
downward edge of the powering signal envelope can be detected, such
as by the synchronization circuitry 4218 to indicate when a power
cycle is ended. In response to detecting or determining the power
cycle has ended, the T/R switches 4204 and 4208 can be changed to
transmit mode. In transmit mode, the implantable device 4201 can
transmit the buffered RF signal. The amount of RF signal buffered
in the SAW device 4206 can be between 20-500 nanoseconds (e.g.,
between 20 and 200 nanoseconds, between 50 and 250 nanoseconds,
between 100 and 400 nanoseconds, between 200 and 500 nanoseconds,
between 300 and 450 nanoseconds, between 200 and 400 nanoseconds,
overlapping ranges thereof, or any value within the recited
ranges), or approximately 100-300 nanoseconds (e.g., 100 to 200
nanoseconds, 150 to 250 nanoseconds, 200 to 300 nanoseconds, 150 to
300 nanoseconds, 100 to 250 nanoseconds, overlapping ranges
thereof, or any value within the recited ranges) per millimeter of
signal propagation length of the SAW device 4206 with a tradeoff
being buffer time versus size of SAW device. The RF signal can be
modulated with a load, either trying to match or matching the
impedance to the transmit antenna or shorting to ground. In one or
more embodiments, the presence or absence of an "echoed" RF signal
determines bit "0" or "1". In such scheme, one or more bits can be
transmitted every power cycle.
[0407] FIG. 50 illustrates, by way of example, a wiring diagram of
an embodiment of circuitry 4400 that can be included in the
implantable device 4201. The circuitry 4400 as illustrated includes
an antenna 4402, the SAW device 4206, the circuitry 4210, and a
buffer capacitor 4414.
[0408] The antenna 4402 receives electromagnetic waves and converts
the electromagnetic waves to electric signals. The antenna 4402 can
include a dipole, coil, helix-shaped, patch, or other antenna. In
one or more embodiments, the antenna 4402 can be sized and shaped
to receive signals in a subset of frequencies between about 420
Megahertz and about 4 Gigahertz (e.g., between 400 MHz and 1 GHz,
between 400 MHz and 3 GHz, between 500 MHz and 2 GHz, between 1 GHz
and 3 GHz, between 500 MHz and 1.5 GHz, between 1 GHz and 2 GHz,
between 2 GHz and 3 GHz, overlapping ranges thereof, or any value
within the recited ranges). The antenna 4402 can be similar to
other antennas discussed herein. The signal from the antenna 4402
can be provided to a circulator 4404.
[0409] A circulator is a passive component. The circulator 4404 is
a multiple port device that transfers a signal entering any port to
the next port in rotation (as indicated by the arrow on the
circulator 4404). The circulator 4404 provides multiple paths for
electrical signals incident thereon, depending on which port of the
circulator 4404 the signals are incident. Signals from the antenna
4402 are provided to a power divider 4406A.
[0410] A power divider is a passive component. The power divider
4406A divides the signal incident thereon into two signals and
provides them onto two respective signal paths (e.g., the path 4407
and the path 4409 in the example of the power divider 4406A). The
power divider 4406A provides a portion of the signal received to a
rectifier 4410 and another portion of the signal received to the
SAW device 4206.
[0411] A rectifier converts an alternating current (AC) signal into
a direct current (DC) signal by allowing a current to flow
therethrough in only one direction. The rectifier 4410 converts the
AC signal received from the power divider 4406A into a DC signal
that is provided to a power regulator 4412.
[0412] A power regulator receives an electrical signal at a first
power and produces a signal at a generally constant second power.
The power regulator 4412 generally provides a ceiling to an amount
of power provided at the output thereof. The power regulator 4412
provides regulated power to a stimulator interface 4430. A buffer
capacitor 4414 can store energy for later usage. The stimulator
interface 4430 can include the stimulation circuitry 4216,
capacitors 4226, and/or the electrodes 4224.
[0413] The SAW device 4206 receives another portion of the signal
from the power divider 4406A. The SAW device 4206 provides a time
delay to a signal incident thereon. The signal from the SAW device
4206 is provided to another power divider 4406B. The power divider
4406B provides a portion of the signal from the SAW device 4206 to
a modulator 4426 and another portion of the signal to a demodulator
4418.
[0414] A demodulator separates information modulated onto a carrier
signal from the carrier signal itself. The demodulator 4418 is an
analogue part to the modulator 4426. The output (e.g., information)
from the demodulator 4418 is provided to the digital controller
4420.
[0415] The digital controller 4420 receives a signal from an
oscillator 4422 and information from the demodulator 4418 and the
sensor interface 4428. The digital controller 4420 can use the
oscillator 4422 as a clock. The digital controller 4420 can alter
operations of the implantable device based on the information from
the demodulator 4418 and/or the sensor interface 4428. The
operations can include which electrode(s) 4224 are operating as
cathode(s) and/or anode(s), a duty cycle of a stimulation wave, an
amplitude or frequency of the stimulation wave, or other operation
of the sensor interface 4428 or stimulator interface 4430.
[0416] The digital controller 4420 can provide a data signal to a
buffer 4424. A buffer electrically isolates an output from an
input. The buffer 4424 generally allows an impedance of the output
to be unaffected by the impedance of the input. The buffer 4424
provides information signals from the digital controller 4420 to
the modulator 4426.
[0417] A modulator modulates information (in the form of electrical
signals) onto a baseband signal. The modulator 4426 modulates
information from the digital controller 4420 onto a baseband signal
provided by the power divider 4406B. The modulated signal from the
modulator 4426 is provided to the circulator 4404. The modulated
signal from the circulator 4404 is provided to the antenna 4402.
The antenna 4402 transmits the modulated signal to the external
device 4202.
[0418] In one or more embodiments, a sensor of the sensor interface
4428 can include a temperature sensor. The temperature sensor can
provide data to the digital controller 4420. The data can be
monitored to determine whether the stimulation from the implantable
device 110 has caused a temperature of a target area to increase by
more than a specified threshold amount (e.g., one, two, or three
degrees Fahrenheit or Celsius) or to be greater than a specified
threshold temperature (e.g., 102, 103, 104, 105, and so on degrees
Fahrenheit). In response to determining the temperature has changed
by greater than the threshold amount or is greater than the
threshold temperature, the digital controller 4420 can pause or
halt stimulation.
[0419] In one or more embodiments, the digital controller 4420 or
548 of the implantable device 110 or the digital controller 6412 of
the external source 102 can determine a power of stimulation to be
provided to a target area. In response to determining the power is
greater than, or equal to a specified power threshold, the
stimulation can be provided as intermittent stimulation (discussed
elsewhere, such as with regard to FIGS. 135-138, among others).
[0420] FIG. 51 illustrates, by way of example, a wiring diagram of
another embodiment of circuitry 4500 that can be included in the
implantable device 4201. The circuitry 4500 can perform the same
operations as the circuitry 4400, with the circuitry 4500 including
only a single circulator 4404, no power dividers, and including a
T/R switch 4532, such as is similar to the switches 4204 and
4208.
[0421] In the circuitry 4500, a signal is received at the antenna
4402. The signal from the antenna 4402 is provided to the switch
4532. In receive mode, the switch 4532 provides signals to the
electrical path 4513 and in transmit mode, the switch 4532 receives
signals along the electrical path 4511 and provides signals to the
SAW device 4206. Along the receive path, the signal from the switch
4532 is provided to a demodulator 4418 and a rectifier 4410.
[0422] Signals from the rectifier 4410 are provided to the power
regulator 4412. Signals from the power regulator 4412 are provided
to the many components of the circuitry 4500 to receive power
(e.g., the stimulator interface 4430, sensor interface 4428,
digital controller 4420, or other components that require power to
operate).
[0423] Signals from the demodulator 4418 are provided to the
digital controller 4420. Signals from the digital controller 4420
are buffered by the buffer 4424 and provided as an input to the
modulator 4426.
[0424] Signals incident on the circulator 4404 from the switch 4532
are provided to the SAW device 4206. The SAW device 4206 buffers
the signal and provides the signal as an input to the modulator
4426. The modulator 4426 modulates the signal from the buffer 4424
onto the signal received from the SAW device 4206 (e.g., using the
signal from the SAW device 4206 as a carrier wave). The modulated
signal is provided to the circulator 4404 which provides the
modulated signal to the switch 4532. The switch 4532 provides the
modulated signal to the antenna 4402. The antenna 4402 transmits
the modulated signal to the external device 4202.
[0425] FIG. 52 illustrates, by way of example, a wiring diagram of
another embodiment of circuitry 4600 that can be included in the
implantable device 4201. The circuitry 4600 can perform
substantially the same operations as the circuitry 4400 and 4500,
with the circuitry 4600 including only a single circulator 4404,
single power divider 4406A, and no switches.
[0426] In the circuitry 4600, a signal is received at the antenna
4402. The signal from the antenna 4402 is provided to the
circulator 4404. The circulator 4404 provides signals from the
antenna 4402 to the power divider 4406A. The power divider 4406A
divides the signals incident thereon into two signals, one signal
for the electrical path 4615 and another signal for the electrical
path 4617.
[0427] Signals from the rectifier 4410 are provided to the power
regulator 4412. Signals from the power regulator 4412 are provided
to components of the circuitry to receive power (e.g., the
stimulator interface 4430, sensor interface 4428, digital
controller 4420, or other components that require power to operate
(e.g., active components)).
[0428] Signals from the demodulator 4418 are provided to the
digital controller 4420. Signals from the digital controller 4420
are buffered by the buffer 4424 and provided as an input to the
modulator 4426.
[0429] Signals from the power divider 4406A and on the electrical
path 4617 are provided to the SAW device 4206. The SAW device 4206
buffers the signal and provides the signal as an input to the
modulator 4426. The modulator 4426 modulates or adjusts the signal
from the buffer 4424 onto the signal received from the SAW device
4206 (e.g., using the signal from the SAW device 4206 as a carrier
wave). The modulated signal is provided to the circulator 4404. The
circulator 4404 provides the signal from the modulator 4426 to the
antenna 4402. The antenna 4402 transmits the modulated signal to
the external device 4202.
[0430] Note that FIGS. 50, 51, and 52 each include a modulator
4426. The modulator 4426 is optional. In one or more embodiments, a
signal from the SAW device 4206 can be provided to the antenna 4402
in cases where a first bit of binary information is to be provided
to the external device 4202 and the signal from the SAW device 4206
can be grounded in cases where a second bit of binary information
is to be provided to the external device 4202. FIG. 53 illustrates
a wiring diagram of such circuitry.
[0431] FIG. 53 illustrates, by way of example, a wiring diagram of
another embodiment of circuitry 4700 that can be included in the
implantable device 4201. The circuitry 4700 is similar to the
circuitry 4600, with the circuitry 4700 including a switch 4208 in
place of the modulator 4426. A first input of the switch 4208 can
be coupled to a reference voltage (e.g., ground), such as a DC
reference voltage. A second input of the switch 4208 can be coupled
to the output of the SAW device 4206. The digital controller 4420
provides a signal to the switch 4208 (on the connection 4719) that
determines if the switch 4208 outputs the zero line or the one
line.
[0432] Similar circuitries can be realized by replacing the
modulator 4426 of the circuitry 4400 and 4500 with a switch 4208.
Note that the buffer 4424 can be removed in such embodiments.
E. Combined Localized and Wide Area Therapy Stimulation
[0433] In accordance with several embodiments, therapy devices are
adapted to provide one or more of a localized therapy stimulation
and a wide area therapy stimulation. In one or more embodiments,
both the localized therapy and the wide area stimulation can be
provided simultaneously. In some embodiments, the localized therapy
and the wide area stimulation is provided separately, or
non-simultaneously.
[0434] An advantage of one or more embodiments discussed in this
subsection can include one or more of: (i) increased area of
stimulation, such as by producing an electric field between a
proximal electrode and a distal electrode, that can reduce
constraints on positioning of the implantable device; (ii)
increased flexibility in type of stimulation provided, such as by
allowing for a wide area stimulation (less intense stimulation over
a wider area) and/or a local area stimulation (more intense
stimulation over a smaller region), or both; (iii) increased
flexibility in type of stimulation provided, such as by including
two implantable devices that can provide therapy individually or
therebetween (such as to provide a signal that originates at one
implantable device and travels to another implantable device,
stimulating tissue therebetween), among others.
[0435] FIG. 54 illustrates, by way of example, a perspective view
diagram of an embodiment of an implantable stimulation device 4800.
The stimulation device 4800 as illustrated includes a plurality of
first electrodes 4802A and 4802B separated by a dielectric material
4804. The stimulation device 4800 as illustrated further includes a
circuitry housing 4806. The circuitry housing 4806, first
electrodes 4802A-B, and the dielectric material 4804 are
illustrated as being in a distal portion 4812 of the stimulation
device 4800. The stimulation device 4800 as illustrated further
includes a second electrode 4802C and an attachment device 4808.
The second electrode 4802C and the attachment device 4808 are
illustrated as being in a proximal portion 4814 of the stimulation
device 4800. The circuitry housing 4806 can be in the proximal
portion 4814 of the stimulation device. In one or more embodiments,
the number of first electrodes can be greater than two (e.g.,
three, four, five, six, seven, eight, or more). In one or more
embodiments, the number of second electrodes can be greater than
one (e.g., two, three, four, five, six, seven, eight, or more).
[0436] A distance (indicated by the arrow 4813) between a most
proximal electrode of the first electrodes (electrode 4802B in the
example of FIG. 54) and a most distal electrode of the at least one
second electrode (electrode 4802C in the example of FIG. 48) can be
greater than one and a half centimeters and less than ten
centimeters. A distance (indicated by the arrow 4811) between two
directly adjacent electrodes of the first electrodes (electrodes
4802A and 4802B in the example of FIG. 54) can be less than one and
a half centimeters, in one or more embodiments. In one or more
embodiments, the distance between two directly adjacent electrodes
of the first electrodes can be less than ten millimeters.
[0437] The circuitry housing 4806 can be made of similar or same
materials and/or configured similar to other circuitry housings
discussed herein, such as the circuitry housing 610A-C, 3616, or
other circuitry housing. The electrodes 4802A-C can be made of
similar or same materials and/or configured similar to other
electrodes discussed herein, such as the electrodes 604, E0-E4, or
other electrodes.
[0438] FIG. 55A illustrates, by way of example, a cross-section
diagram of the implantable stimulation device of FIG. 54 in the
direction of the arrows labelled "55A/55B". The stimulation device
4900A as illustrated includes a casing 4916 around two insulated
electrical conductors 4920 and 4922. The electrical conductor 4920
can act as an antenna and can be electrically coupled to circuitry
in the circuitry housing 4806. The electrical conductor 4922 can
electrically connect the electrode 4802C to the circuitry in the
circuitry housing 4806. A dielectric material 4924 can surround the
electrical conductors 4920 and 4922. The dielectric material 4924
can help reduce cross-talk between the conductors 4920 and 4922,
such as to help electrically isolate signals on the conductors 4920
and 4922 from one another.
[0439] FIG. 55B illustrates, by way of example, another
cross-section diagram of the implantable stimulation device of FIG.
54 in the direction of the arrows labelled "55A/55B". The
implantable stimulation device 4900B is similar to the stimulation
device 4900A, but only includes a single conductor 4926 instead of
two conductors 4920 and 4922 (as in the device 4900A). The single
conductor 4926 can electrically connect the electrode 4802C to the
circuitry in the circuitry housing 4806, such as is similar to the
electrical conductor 4922. In addition, the electrical conductor
4926 can act as an antenna for the stimulation device 4900B. The
electrical conductor 4926 can provide electrical signals to the
electrode 4802C at one time and relay electrical signals incident
thereon to the circuitry in the circuitry housing at another time.
The electrical conductor 4926 can be time domain multiplexed to act
as an electrical wire and an antenna (at differing times). The
circuitry in the circuitry housing 4806 can switch the function of
the electrical conductor 4926 by activating and/or deactivating one
or more switches in the electrical path of the electrical conductor
4926 (see circuitry discussed elsewhere herein, such as the
circuitry 500, 4400, 4500, 4600, and 4700, for examples of switches
and circuitry configurations).
[0440] FIG. 56 illustrates, by way of example, a perspective view
diagram of an embodiment of the stimulation device of FIG. 54
implanted in a body with an external midfield device 5028 external
to the body. The midfield device 5028 can communicate signals to
the implantable stimulation device 4800 and/or receive signals from
the implantable stimulation device 4800. The midfield device 5028
can be similar to the source 102 or other external transmitter
devices, powering devices, or couplers discussed herein. The
midfield device 5028 can be proximate a surface of skin 5030 of a
user, such as directly on the skin or with some fabric, adhesive,
dielectric material (e.g., silicone), among others between the skin
5030 and the midfield device 5028.
[0441] The midfield device 5028 provides electrical power to the
stimulation device 4800 from outside the body. The power from the
midfield device 5028 can at least partially be used by therapy
generation circuitry in the circuitry housing 4806 to provide
stimulation therapy to a nerve 5032 and/or 5034 of the body.
Stimulation therapy can be provided to the nerve 5032 and 5034 at
different times or simultaneously. For example, the electrodes
4802A and 4802B can be configured (by activating and/or
deactivating switches of the circuitry in the circuitry housing) as
anode and cathode (or vice versa), respectively, and the electrode
4802C can be open (part of an incomplete circuitry so as to be
non-conductive). Such a configuration can provide a localized
stimulation therapy, such as through an electric field that is
produced between the two electrodes 4802A-B, such as to provide
stimulation therapy to the nerve 5032. In another example, either
one of the electrodes 4802A-B can be configured as an anode or
cathode and the electrode 4802C can be configured as a
corresponding cathode or anode. Such a configuration can provide a
wide area stimulation therapy, such as through an electric field
that is produced between the electrode 4802A or 4802B and the
electrode 4802C. In this configuration, therapy may be delivered to
the nerve 5034 and, in some cases, the nerve 5032. In yet another
example, the electrodes 4802A and 4802B can be configured as anode
and cathode (or vice versa), respectively, and the electrode 4802C
can be configured as either an anode or a cathode. Such a
configuration can provide both a wide area stimulation therapy and
a localized stimulation therapy, simultaneously.
[0442] An advantage, from a clinical perspective, can include the
wide area stimulation field allowing for less precise electrode
position placement relative to the target nerve(s). From the
clinician's perspective, this stimulation system allows room for
electrode placement error. After implantation, the stimulation
system can be reprogrammed rather than surgically revised as
well.
[0443] FIG. 57 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation device
5100. The stimulation device 5100 as illustrated includes only the
two electrodes 4802A-B. The stimulation device 5100 as illustrated
includes the dielectric material 4804 between the two electrodes
4802A-B. The stimulation device 5100 as illustrated further
includes a circuitry housing 4806 and an antenna housing 5136. The
antenna housing 5136 can be include the same or similar materials
and/or be configured similar to or the same as other antenna
housings discussed herein, such as the antenna housings 612, 3618,
3630, or other antenna housing discussed herein.
[0444] FIG. 58A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 5200A including a plurality of
stimulation devices 5100A and 5100B (respective specific
embodiments of the stimulation device 5100 of FIG. 57) implanted in
a body with an external midfield device 5028 external to the body.
The multiple implanted stimulation devices 5100 can provide
localized stimulation therapy or simultaneously provide both
localized stimulation therapy and wide area stimulation therapy.
The localized stimulation therapy can be provided by configuring
the electrode 4802A and 4802C both anodes or cathodes and the
electrode 4802B and 4802D both cathodes or anodes. The wide area
stimulation therapy and localized therapy can be provided by
configuring the electrodes 4802A-B as anode and cathode (or vice
versa), respectively, and configuring the electrodes 4802C-D as
cathode and anode (or vice versa), respectively.
[0445] The midfield device 5028 can be configured to alter a
direction of a signal provided therefrom, such as by adjusting a
phase of a signal provided by one or more antennas (e.g., coupler
elements, sometimes referred to as subwavelength structures) on the
midfield device 5028. See FIGS. 5, 62, 63, and/or 105 for a
discussion of a phase altering network configured to adjust the
phase provided by one or more antennas). The direction of the
signal can be configured such that an electromagnetic field from
the midfield powering device 5028 is focused on the stimulation
device 5100A at a first time, such as to provide electrical power
to the stimulation device 5100A. The phase(s) of signal(s) provided
by one or more of the antennas of the midfield device 5028 can then
be altered such that an electric field from the midfield device
5028 is focused on the stimulation device 5100B, such as to provide
electrical power to the stimulation device 5100B.
[0446] In one or more embodiments, the circuitry in the circuitry
housing 4806 can include one or more capacitors that can be charged
using the electric field from the midfield powering device 5028
(see, e.g., FIGS. 5 and 48, among others, for examples of a
capacitor(s) that can be included in the circuitry in the circuitry
housing 4806). A capacitor can be discharged to provide power to
the stimulation device, such as at times when the midfield powering
device 5028 is not providing power to the stimulation device
5100A-B or when the therapy generation circuitry is to provide
therapy. Using the capacitor, both of the stimulation devices
5100A-B can provide therapy simultaneously, such as to provide a
wide area stimulation therapy between electrodes of the two
stimulation devices 5100A-B, such as to a nerve 5238. In one or
more embodiments, one of the stimulation devices 5100A can be
powered directly by the midfield powering device 5028 and the other
of the stimulation devices 5100B can be powered by the capacitor
(after charging using the electric field provided by the midfield
powering device 5028).
[0447] In one or more embodiments, stimulation therapy from each
device can be synchronized, such as to provide a wide area
stimulation. The synchronization can be controlled by a
communication signal from the midfield device or from
synchronization circuitry (see FIG. 48) that synchronizes the
timing of therapy production and/or therapy initialization.
[0448] FIG. 58B illustrates, by way of example, a perspective view
diagram of an embodiment of a system 5200B including the plurality
of stimulation devices 5100A and 5100B implanted in a body with an
external midfield powering device 5028 external to the body. The
system 5200B is similar to the system 5200A, with the system 5200B
including an insulated conductor 5240 electrically connected to
both the stimulation devices 5100A-B. Such an insulated conductor
5240 helps the system 5200A to provide only a wide area stimulation
therapy, only a localized stimulation therapy, or to provide both a
localized and wide area stimulation therapy (simultaneously or
non-simultaneously). The system 5200B can provide only a wide area
stimulation therapy by configuring one or more of the electrodes
4802A and 4802B as an anode and configuring one or more of the
electrodes 4802C and 4802D as a cathode (or vice versa). The system
5200B can provide only a localized stimulation therapy by
configuring the electrodes 4802A and 4802C as anodes and the
electrodes 4802B and 4802D as cathodes (or vice versa). The system
5200B can provide both localized and wide area stimulation therapy
simultaneously by configuring the electrodes 4802A and 4802D as
anodes and the electrodes 4802B and 4802C as cathodes (or vice
versa). This is in contrast to the system 5200A, which can only
provide either only localized stimulation therapy or simultaneously
provide localized stimulation therapy and wide area stimulation
therapy. The distance between the devices 5100A and 5100B can be
the same as or similar to the distance indicated by the arrows 4813
as discussed elsewhere herein.
[0449] FIG. 59 illustrates, by way of example, a perspective view
diagram of an embodiment of another implantable stimulation device
5300. The stimulation device 5300 is similar to the stimulation
device 5100, with the stimulation device 5300 including the
electrodes 4802A-B spaced further apart, such as to provide a wide
area stimulation therapy therebetween. A distance between the
electrodes 4802A-B (indicated by arrow 5342) can be increased
(relative to that shown in FIG. 57) by situating the circuitry
housing 4806 and the antenna housing 4808 between the electrodes
4802A-B (such as shown in FIG. 59) or lengthening the dielectric
material 4804 (in the direction of the arrows). The distance
between the electrodes 4802A-B can be greater than 1.5 cm (to
provide a wide area stimulation therapy) or less than 1.5 cm (to
provide a localized stimulation therapy). Other distances may also
be used as desired and/or required to effect the different types of
stimulation.
[0450] FIG. 60 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 5400 including a plurality of
stimulation devices 5300A and 5300B (respective specific
embodiments of the stimulation device 5300 of FIG. 59) implanted in
a body with an external midfield device 5028 external to the body.
The system 5400 is similar to the system 5200A, with the system
5400 configured to provide a wide area stimulation therapy using
electrodes of the same stimulation device. A distance (indicated by
arrow 5444) between the stimulation devices 5300A and 5300B can be
greater than one and a half centimeters, such as to provide a wide
area stimulation therapy between electrodes of the devices 5300A-B,
or can be less than 1.5 cm, such as to provide a localized
stimulation therapy between electrodes of the devices 5300A-B. The
stimulation therapy provided by the devices 5300A-B can be incident
on a nerve 5446 or a branch 5448 and/or 5450 of the nerve 5446.
[0451] FIG. 61 illustrates, by way of example, a logical circuitry
diagram of an embodiment of a plurality of stimulation devices of
FIG. 59 within range of respective electric fields generated
therebetween. Resistors 5452A, 5452B, 5452C, 5452D, 5452E, and
5452F represent impedances between the electrodes on each end of
the resistor 5452A-F. The resistor 5452A represents an impedance
between the electrodes 4802A and 4802D. The resistor 5452B
represent an impedance between the electrodes 4802B and 4802C. The
resistor 5452C represents an impedance between the electrodes 4802B
and 4802D. The resistor 5452D represent an impedance between the
electrodes 4802A and 4802C. The resistor 5452E represents an
impedance between the electrodes 4802A and 4802B. The resistor
5452F represent an impedance between the electrodes 4802D and
4802C. Generally speaking, the impedance of the resistors 5452E and
5452F is less than the impedance of the resistors 5452A and 5452B,
which are less than the impedance of the resistors 5452C and 5452D.
The strength of the electric field generated between two electrodes
is generally inversely proportional to the value of the impedance
of the resistor between the electrodes. The wide area stimulation
therapy generally has a weaker electric field, but provides therapy
to wider volume than the localized therapy stimulation.
II. External Device Configurations
[0452] A. Compact Integration of Electronic Control Hardware with
Electromagnetic Transmitting Element
[0453] This subsection is generally related to packaging of an
electromagnetic transmission element (e.g., the source 102,
midfield device 6148 or 5028, among other external transmission
elements), with electronic control hardware. More specifically, one
or more embodiments in this subsection regard devices, systems, and
methods that include the electromagnetic transmission element
mounted to the same board as the control hardware.
[0454] Control hardware can include electronics components (passive
components (e.g., diodes, transistors, resistors, capacitors,
inductors, or the like), discrete integrated circuits, logic
components (e.g., logic gates, multiplexers, or the like),
application specific integrated circuits (ASICs)) as well as
metallic traces which connect signal and power pads for each of the
components. During a design process, the coupling between the
electronic control hardware and an electromagnetic transmission
element (e.g., an antenna) is carefully managed, and almost
inevitably results in a loss of efficiency for the electromagnetic
transmission element and/or a loss of signal integrity for the
electronic components. This loss of efficiency and/or signal
integrity becomes more impactful in packages with compact designs.
Embodiments discussed in this subsection can help overcome the loss
of efficiency in the transmission element and/or the loss of signal
integrity in the electronic components.
[0455] Embodiments in this subsection include devices, systems, and
methods for integrating control hardware into a planar
electromagnetic transmission element in an electronic device
package (e.g., on a printed circuitry board (PCB), a flexible
substrate, or other medium on which an electronic device can
reside).
[0456] There are many types of planar electromagnetic transmission
elements including a microstrip or patch antenna, a slot antenna,
or a combination thereof. These antennas can be made in a variety
of shapes and sizes and configured to interact (efficiently) with a
wide variety of electromagnetic signal frequencies. Another type of
planar electromagnetic transmission element includes a mid-field
antenna, such as a midfield antenna described in WIPO Publication
No. WO/2015/179225 published on Nov. 26, 2015 and titled "MIDFIELD
COUPLER", which is incorporated herein by reference in its
entirety.
[0457] Decreasing a form factor of a package that includes such a
planar electromagnetic transmission element is difficult due, at
least in part, to efficiency and signal losses from electromagnetic
radiation communicating between components near the electromagnetic
transmission element. Thus, integrating control hardware into a
planar antenna or electromagnetic element on a printed computer
board (PCB) can cause undesirable losses in the signal integrity
and performance of the electromagnetic control element. These
effects can be even more of a concern when package size must be
reduced and the electromagnetic transmission element covers a
majority of a footprint of the package.
[0458] In the case of a mid-field powering coupler (electromagnetic
transmission element), the planar metal pattern which provides
efficient energy transfer to an implanted device (e.g., an
implanted medical device) may be several centimeters in length in
both dimensions (length and width). Control hardware (e.g.,
electronic hardware components) can be used to provide Radio
Frequency (RF) power to ports of the mid-field coupler, modulate
the RF signal for communication with the implanted device, receive
communications from the implanted device, and/or provide a user
interface for the patent/clinician to set one or more parameters of
the circuitry or receive data from the implanted device. The
control hardware can be designed on a separate PCB from the
mid-field powering coupler, but at the cost of size (form
factor).
[0459] For attaching the circuitry (the electromagnetic
transmission device and the control hardware) to the body, it can
be beneficial to have dimensions of the integrated device
(electromagnetic transmission element and control hardware) be near
the same size as the electromagnetic transmission element, which
can be the largest part of the transmission element, so as to
reduce the form factor of the integrated circuitry. To reduce the
form factor further, the electronic components can be integrated on
the same substrate as the mid-field powering coupler. For example,
in a two board integrated circuitry where the RF signal is sourced
from a board separate from the midfield coupler (e.g., the control
hardware is on a board separate from the electromagnetic
transmission element) the circuitry may have an overall thickness
of 15 mm or more. In contrast, a single board solution (e.g., a
device that includes the control hardware on the same board as the
electromagnetic transmission element) can have an overall thickness
of about 3 mm (e.g., 1 mm to 5 mm, 2 mm to 4 mm). The volume saved
from the integration can be used for additional battery capacity or
allowing the device to be housed in a thinner package that is less
obtrusive or visible, such as when the device is worn.
[0460] However, due to the limited area of outer layers of a
circuitry substrate (e.g., a PCB or flexible substrate), it can be
difficult to integrate the components and traces with the
electromagnetic transmission element. In one or more embodiments,
the hardware control components can be placed on the same layers as
the patterned electromagnetic transmission element and microstrip
feed lines for excitation of the electromagnetic transmission
element. The placement of these components and traces along these
layers can cause undesired coupling that can cause communication
between the control hardware and the electromagnetic transmission
element, resulting is loss of signal integrity and/or power
transfer efficiency.
[0461] An advantage of one or more embodiments discussed in this
subsection can include one or more of: (i) circuitry operating with
reduced noise from the environment; and (ii) a mid-field powering
device with a reduced form factor, such as compared to one with
control circuitry and a transmission element on separate boards;
among others.
[0462] FIG. 62 illustrates, by way of example, a diagram of an
embodiment of a system 6400 including control hardware and an
electromagnetic transmission element (e.g., the antenna 6406). The
system 6400 includes the control hardware on a first board 6402 and
the antenna 6406 on a second board 6404. Such a system includes a
form factor that is large compared to a system that includes the
control hardware and the transmission element on a single board,
such as shown in FIGS. 64 and 65, for example.
[0463] The control hardware, in the embodiment illustrated in FIG.
62, includes power management circuitry 6408, a transceiver 6410, a
controller 6412, a power divider 6413, a plurality of gain
amplifiers 6414, a plurality of phase shifters 6416, and a
plurality of power amplifiers 6418. The power management circuitry
6408 can include one or more voltage regulators, current
regulators, rectifiers, capacitors, or other power circuitry. The
power management circuitry 6408 can provide power signals to other
components of the control hardware, such as to power the control
hardware.
[0464] The transceiver 6410 in one or more embodiments can be
replaced with just a transmitter. The transceiver 6410 can provide
RF signals to the power divider 6413, such as with or without data
modulated onto the RF signals. The controller 6412 can provide
functionality and/or include components similar to or the same as
that of the processor circuitry 210, or other similar circuitry
discussed herein. The power divider 6413 can provide functionality
and/or include components similar to or the same as that of the
power divider 412, or other power dividers discussed herein. The
gain amplifiers 6414 increase an amplitude of a signal at an input
port thereof. The phase shifters 6416 can provide functionality
and/or include components similar to or same as that of the phase
shifter 410, or other phase shifters discussed herein. The power
amplifiers 6418 can provide functionality and/or include components
similar to or same as that of the power amplifiers 408, or other
power amplifiers discussed herein. The antenna 6406 can be a
multi-port antenna with a plurality of subwavelength structures,
such as is discussed with regard to the antenna of the source 102
and illustrated in FIG. 3, for example.
[0465] FIG. 63 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 6500 that includes the control
hardware and the electromagnetic transmission element on separate
boards. The system as illustrated includes a midfield coupler on a
first board 6502, control hardware on a second board 6504 and RF
connectors 6506A and 6506B electrically and mechanically coupling
the first and second boards. The system 6500 is an implementation
of the system 6400.
[0466] FIG. 64 illustrates, by way of example, a diagram of an
embodiment of a system 6600 that includes the control hardware and
the electromagnetic transmission element on a single board (e.g.,
substrate). Such a system can include a form factor that is smaller
as compared to the system 6400.
[0467] FIG. 65 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 6700 that includes the control
hardware and the electromagnetic transmission element on a single
board 6722. The system 6700 as illustrated includes the control
hardware and the transmission element on a top layer of the
substrate (not illustrated in the view provided by FIG. 65. See
FIGS. 66-71 for views of the transmission element and/or control
hardware). The transmission element is separated from the control
hardware by a faraday cage 6720 or other element that excludes
electrostatic or electromagnetic influences, such as to shield the
control hardware from electromagnetic radiation of the transmission
element and vice versa.
[0468] The faraday cage 6720 can be a part of the electromagnetic
transmission element that radiates. The control components are
fully integrated within a conductive surface of the transmission
element using the faraday cage 6720. In such embodiments, the
faraday cage 6720 is acting both as a shield (for the control
components) and as a radiating element of the transmission element.
Due to the skin depth of the material used for the faraday cage
6720, the electromagnetic currents at the outer surface of the
faraday cage that induce radiation do not penetrate more than
several microns at gigahertz frequencies. Thus, the internal
components can advantageously be shielded from the electromagnetic
fields induced by the faraday cage 6720 radiating as part of the
transmission element, in accordance with one or more
embodiments.
[0469] In one or more embodiments, the board 6722 can include
multiple layers, such as a first layer 6724, a second layer 6726,
and a third layer 6728. The third layer 6728 can be thicker than
the first layer 6724 and the second layer 6726. In one or more
embodiments, the board 6722 can be made of an FR4 substrate (e.g.,
a glass-reinforced epoxy laminate comprising a composite material
composed of woven fiberglass cloth with an epoxy resin binder that
is flame resistant), a silicon substrate, ajinomoto buildup film
(ABF), a dielectric, or other material. The control hardware can be
situated on a top surface of the first layer 6724 along with
routing (e.g., traces) between components of the control hardware.
The components of the control hardware (e.g., high power
components) may have thermally conductive material applied to
conduct heat to the faraday cage 6720.
[0470] A ground plane can be situated on the second layer 6726. The
faraday cage 6720 can be shorted to the ground plane by one or more
vias 6730. One or more vias 6732 can provide a signal to a port of
a slot 6734 (e.g., a resonating element) on the third layer 6728.
The signal to the port can be from one of the power amplifiers
6418. The faraday cage 6720 and the ground plane can be configured
with corresponding slots (a slot pattern) that match the slots 6734
(see FIGS. 66-71 for a view of the matching slots).
[0471] The first layer 6724 and the second layer 6726 may have the
same thickness or different thicknesses. The thickness of each of
the first layer 6724 and the second layer 6726 may range from 1 mil
to 20 mil (e.g., from 1 mil to 10 mil, from 2 mil to 8 mil, from 3
mil to 6 mil, from 5 mil to 15 mil, from 10 mil to 20 mil,
overlapping ranges thereof, or any value within the recited ranges,
such as 5 mil). The third layer 6728 may have a thickness in the
range of 50 mil to 150 mil (e.g., 50 mil to 100 mil, 60 mil to 120
mil, 70 mil to 100 mil, 80 mil to 90 mil, 60 mil to 80 mil, 80 mil
to 110 mil, 90 mil to 150 mil, 70 mil to 120 mil, 100 mil to 150
mil, overlapping ranges thereof, or any value within the recited
ranges, such as eighty-five mil. The dimensions provided and the
number of layers of the board described are merely non-limiting
examples and many variations are possible.
[0472] In one or more embodiments, the control hardware components
are placed on a surface layer of the board 6722 with a majority of
the routing provided on the same surface layer. In the embodiment
of FIG. 65, the control hardware and most of the routing are on a
top surface of the first layer 6724 (e.g., the surface on which the
faraday cage 6720 is mounted).
[0473] In one or more embodiments, the slot mid-field pattern
(e.g., ground plane) can be printed on, or at least partially in,
the second layer 6726 (e.g., the layer immediately below the first
layer 6724). In one or more embodiments, the second layer 6726 can
also serve as a ground plane. One or more vias 6730 can be included
that connect the first layer 6724 with the second layer 6726, such
as to short the faraday cage 6720 at the top layer to ground. In
one or more embodiments, the vias 6730 can be at or near the edges
of the mid-field pattern and/or the edges of the slots which form
the midfield element. Layers between the ground plane and
excitation ports along a bottom surface of the third layer 6728 may
be used for limited traces. In some embodiments, microstrip
excitation slots or feeds are positioned along or adjacent a bottom
surface of the third layer 6728.
[0474] FIG. 66 illustrates, by way of example, a perspective view
diagram of an embodiment of the system 6700 of FIG. 65. The
perspective of FIG. 66 provides a view of a cover 6740 and a base
6742 of the faraday cage 6720. FIG. 67A illustrates, by way of
example, a perspective view diagram of an embodiment of the faraday
cage 6720. FIG. 67B illustrates, by way of example, a perspective
view diagram of an embodiment of the faraday cage cover 6740. FIG.
67C illustrates, by way of example, a perspective view diagram of
an embodiment of the faraday cage base 6742.
[0475] The geometry of the faraday cage cover 6740, in one or more
embodiments, can accommodate and not interfere with (e.g., can be
complementary to, such as to be configured for) the slot pattern of
the electromagnetic transmission element (see FIGS. 69 and 70). The
faraday cage cover 6740 can be implemented with a stamped or
machined metal plate. Possible materials include copper, steel, or
aluminum. The faraday cage cover 6740 can be implemented with a
solid material, a wire mesh, or a combination thereof.
[0476] The faraday cage 6720 can be formed by the faraday cage
cover 6740 which forms a conductive shield above the components
while a ground plane 6750 (see FIG. 69) forms the base of the
faraday cage 6720, below the components. Vias 6730 at the edges of
the slots in the faraday cage 6720 and on edges of the cage base
6742 can help form sides of the faraday cage 6720. A fully enclosed
cage can effectively be formed between the cover above the
components and the layer below the components, such as in the shape
of the midfield transmitter pattern.
[0477] The faraday cage cover 6740 with the ground plane 6750
effectively serve as a thick patterned conductor, such as the
faraday cage 6720 and the transmission element. As long as the
metal sheets above and below the components/traces are greater than
several skin-depths in thickness, then effectively from the
perspective on the electromagnetic transmission element, the
faraday cage with the ground plane is a metallic plate.
[0478] In the embodiments of FIGS. 65 and 66, the faraday cage 6720
is over components of control circuitry. In the embodiments shown,
the faraday cage 6720 is attached to the board 6722 using a
conductive adhesive, such as solder, conductive paste, electrically
conductive tape, or other conductive adhesion mechanism. The board
6722 is illustrated as a four-layer board manufactured using a
four-layer process, but other board designs can be used, such as
can include fewer or more layers. The faraday cage cover 6740 is
illustrated as being a solid material, but in other embodiments can
be mesh or otherwise include one or more holes, perforations, slots
or slits therethrough.
[0479] FIG. 68 illustrates, by way of example, a perspective view
diagram of the system 6700 from an opposite side as that shown in
FIG. 66. One or more microstrip RF slots 6734 can excite the
transmission element (e.g., the combination of the slots 6752 in
the ground plane 6750 and the faraday cage 6720), such as can be
used if the pattern were formed with a thicker metal layer. From
the RF circuitry perspective, the effective thick slot element
allows for wideband enhancement of the electromagnetic transmission
element. Electromagnetic energy is transferred to the transmission
element, which the faraday cage 6720 is a part of, from components
(e.g., oscillator, power amplifier, phase compensation circuitry,
and so forth) inside the faraday cage 6720. A via one or more vias
6732 connects the output of power amplifier from within the faraday
cage 6720 to the slots 6734 of the electromagnetic element outside
of the cage, thus transferring electromagnetic energy internal to
the faraday cage 6720 to the external environment through a via
6732. The slots 6734 can be open circles or open ellipse shapes,
such as shown in FIG. 68.
[0480] In addition, from the perspective of thermal management, the
patterned metal plate (faraday cage cover, patterned ground plane,
and/or vias) can be used for dissipation of heat. Thermally
conductive material such as thermal grease, thermal tape, or
thermal epoxy can be used as a thermal conductor between the
components inside the faraday cage 6720 and the faraday cage base
6742 and/or the faraday cage cover 6740. The thermal conductor can
help radiate heat away from the components inside the cage 6720 to
the external environment.
[0481] FIG. 69 illustrates, by way of example, a perspective view
diagram of an embodiment of the second layer 6726. The second layer
6726 as illustrated includes the ground plane 6750 and slots 6752
in the ground plane 6750. The faraday cage base 6742 can include
slots 6751 therein so as to not interfere with the slots 6752. FIG.
70 illustrates, by way of example, a perspective view diagram of an
embodiment of the system 6700 with the top layer 6724 of the board
6722 removed so as to show the alignment of the slots 6752 and the
slots 6751. As can be seen, the slots 6751 in the faraday cage base
6742 correspond to locations where the slots 6752 are present in
the second layer 6726 (e.g., slot pattern of the electromagnetic
transmission element). Thus, the footprint of the faraday cage base
6742 does not overlap or is not coincident with any portion of the
slots 6752 in the embodiments shown. The patterned midfield plate
pattern is at the second layer 6726 (first internal layer) and is
shorted to the faraday cage 6720 with one or more vias between the
pattern of the electromagnetic transmission element (e.g., midfield
coupler) and the faraday cage 6720.
[0482] FIG. 71 illustrates, by way of example, a perspective view
diagram of an embodiment of the system 6700 that includes the
faraday cage 6720 removed so as to illustrate the discrete
components 7360 under the faraday cage cover, in the faraday cage
6720, and on the first layer 6724. While the components are
illustrated as chips, the components can include one or more
resistors, capacitors, inductors, integrated circuits, transistors,
logic gates, oscillators, state logic components, multiplexers,
switches, connectors, or other electrical or electronic components,
such as one or more of those in the circuitry of the external
device (e.g., the circuitry of the system 6400, 400, or other
external device circuitry discussed herein). The discrete
components 7360 can be electrically connected by one or more traces
7362 on the first layer 6724. A thermal paste, grease, or other
substance, material, or coating can be situated on and/or around
one or more of the discrete components 7360 and/or between the
discrete components 7360 and the faraday cage 6720, such as to
conduct heat away from the components 7360 to the faraday cage
cover 6740 or faraday cage base 6742.The thermal paste or grease
can transfer heat from the electrical or electronic components and
other elements in contact with or sufficiently near the thermal
paste or grease to the faraday cage 6720 and subsequently the
surrounding environment.
B. Discreet External Device Coupling to Implanted Device
[0483] This subsection generally relates to positioning and/or
retention of an external device near a therapy site. More
specifically, described in this subsection are devices, systems,
and methods for discrete positioning and/or verification of the
positioning of the external device external to the therapy site.
This subsection relates to positioning and/or retention of an
external device near a therapy site. More specifically, described
in this section are devices, systems, and methods for discrete
positioning and/or verification of the positioning of a device
external to the therapy site.
[0484] Although considerable progress has been made in the realm of
medical device therapy, there still exists a need for comfortable,
wearable medical devices that interact with an implanted medical
therapy device. The device should be comfortable and relatively
unnoticeable to the eye for a better user experience. The current
form factor for such devices is prohibitively large, such that an
individual wearing such a therapy device is uncomfortable and/or
embarrassed because the device is noticeable.
[0485] Discussed in this subsection are wearable elements which
allow for a comfortable and/or efficient way of carrying an
external device that can provide energy to an implanted therapy
device. In one or more embodiments, a system includes an
implantable sacral neuromodulation device, such as can be implanted
in a patient, and can include an implantable communicating element
configured to send and/or receive a wireless signal to/from an
external device (a wearable device). The external device can
include, for example, an antenna, battery, and/or electronics
(e.g., control circuitry, such as circuitry of the source 102,
antenna 300, or other external device discussed herein). The system
can further include a wearable element (e.g., clothing, a band, or
other wearable garb) configured to be worn by a user (e.g., a
patient) and the external device coupled to or in the wearable
element. The external device can be configured to send and/or
receive a wireless signal to communicate with the implantable
device. In one or more embodiments, the external device can be
placed in multiple locations relative to the wearable element.
[0486] The external device can have a variety of configurations. In
one or more embodiments, the external device can include an antenna
(e.g., a power and/or data transmitter, such as a midfield
transmitter) positioned above an S3 foramen and configured to power
an implantable device (e.g., an implantable neurostimulator). In
one or more embodiments, the implantable device can include an
internal inductive coil and the external device can include an
external inductive coil. The coils can be configured to resonate at
substantially the same frequency, such as to maximize power
coupling. The wearable element (e.g., the external device) can
include a location mechanism configured to indicate proper
alignment between the external device and the implantable device.
The location mechanism may be included in the circuitry of the
external device.
[0487] In one or more embodiments, the system can include a first
external device and a second external device that are coupled to
one another and are positionable above the S3 foramen. The second
external device can be electrically coupled to the first external
device. In one or more embodiments, the first external device can
be configured to receive data from the implantable device and the
second external device can be configured to provide power to the
first external device.
[0488] The external device can have a variety of configurations. In
one or more embodiments, the external device can include a flexible
battery adapted to flex in response to motion of a user wearing the
flexible battery. In one or more embodiments, the wearable element
can be formed from a plurality of elastic straps. The wearable
element can be adjustable to a variety of patient sizes and shapes.
In still other embodiments, the wearable element can be a belt,
pants, shorts, a vest, a sash, an undergarment, or an adhesive
patch. In some embodiments, the wearable element can include at
least one pocket formed therein. The pocket can be movable relative
to the wearable element. In one or more embodiments, the pocket
includes at least one battery disposed therein which is configured
to provide power to the external device.
[0489] Methods are provided for communicating with and powering an
implantable/implanted device. The external device can be activated
to wirelessly transfer a signal through tissue to the implantable
device. For example, the external device can deliver energy to the
implantable device and/or receive data from the implantable device.
The external device can include an external inductive coil or
midfield device. The implantable device can include an internal
inductive coil or other electromagnetic signal receiving element.
One or more of these elements may be used to transfer a
communication signal or to generate power at the implantable
device.
[0490] Wireless communication can be used to position an external
device on/in the wearable element worn by a patient at one of a
plurality of locations, such as to align the external device with a
communicating element on an implanted device. While the external
device can be positioned at a variety of locations, in one or more
embodiments the external device may be ideally positioned on or
over a skin surface in proximity to the implanted device. The
implanted device may send a wireless signal to the external device,
such as can include signals indicating information regarding the
amount of energy being transferred, acknowledgement of programming
signals for the external device, and/or malfunction or error
warnings. The external device can be configured to communicate to
the patient through audio tones, visual displays, or vibration.
This can be used to help guide the patient to place and/or secure
the external device at a location that is sufficient or even ideal
for wireless power transfer. The external device may communicate
battery level of the external device in addition to other statuses
to the user. This may help a patient understand when to change or
charge a battery of the external device.
[0491] The external device can be positioned on/in the wearable
element or at a distance apart from the wearable element. For
example, the wearable element can include a plurality of flexible
straps, and the external device can be removably mated to the
flexible straps, such as in proximity to the implantable device.
Additionally, or alternatively, the external device can be disposed
within a pocket affixed to the wearable element. In one or more
embodiments, the wearable element can be a flexible battery. The
external device can be coupled to the flexible battery and can
deliver energy to the implantable device, such as energy that
originated at the flexible battery.
[0492] FIG. 72 illustrates, by way of example, an embodiment of a
system 8800 for communication of one or more signals between an
implanted device 8804 and an external device 8802. The implanted
device 8804 can be similar to or the same as any of the implantable
devices discussed herein, such as the implantable device 110, 600,
700, or other implantable device. The external device 8802 can be
similar to or the same as any of the external devices discussed
herein, such as the source 102, the antenna 300, or the like. The
external device 8802 can be situated in and/or affixed at a
position within a pocket 8806. The pocket 8806 can be internal to a
wearable element 8808, such as an undergarment, pants, shirt, panty
hose, shorts, bodysuit, and so forth. The implanted device 8804 can
be implanted under the surface a user's skin, such as to be
internal to a user's body 8810. The external device 8802 can
transfer power and/or data to the implanted device 8804. In one or
more embodiments, the implanted device 8804 can be implanted deeper
than 40 mm into the body 8810. In one or more embodiments, the
external device 8802 is positioned in a sleeve (see FIGS. 83,
84A-84B, and 85). More details regarding each of the items depicted
in FIG. 72 are provided with regard to the remaining FIGS. and
other discussion herein.
[0493] FIG.73 illustrates, by way of example, a back-view diagram
of a portion of a human body 8900 and potential placements
locations for the external device 8802 and areas which the pocket
8806 can cover. As illustrated, the external device 8802 can be
placed at or near a position of an S3 foramen, such as can be about
9-10 centimeter from the tip of the coccyx or sciatic notch and/or
about two centimeters to the left or the right of a midline of the
human body (indicated by a dashed line 8902).
[0494] FIG. 74 illustrates, by way of example, a perspective view
diagram of a human body 9000. The body 9000 as illustrated includes
the wearable element 8808 with the pocket 8806 for housing the
external device 8802. The pocket 8806 as illustrated spans at least
two potential locations for placement of the eternal device 8802 as
shown in FIG. 73. The pocket 8806, in one or more embodiments, may
be narrower (in terms of its width relative to the width of the
human body), such as to cover only a single potential location of
the external device 8802. However, having the pocket 8806 span two
or more potential locations allows for a single pocket to
accommodate a wider variety of external device locations.
[0495] In one or more embodiments, instead of locating the pocket
8806 on a side of the body nearest the implantable device 110, the
pocket 8806 can be located on an opposite side of the body. The
external source 102, in such embodiments, may provide more powerful
transmissions than when the external source 102 is located nearer
to the implantable device 110. Such an external source 102 can be
less susceptible to a link failure between the external source and
the implantable device 110 and thus easier for a user to situate
properly. Such an external source 102 can allow a user to better
view the location of the external source 102, such as to help the
user verify that the external source 102 is properly located, is
operating properly, or view a user interface of the external source
102 while the external source 102 is located properly.
[0496] FIG. 75 illustrates, by way of example, an exploded view
diagram of a portion of FIG. 72 that includes the pocket 8806 and
the external device 8802. The pocket 8806 is illustrated as
including a top pocket layer 9150 and a bottom pocket layer 9152.
The top pocket layer 9150 is sometimes referred to as the "top
layers". The bottom pocket layer 9152 is sometimes referred to as
the "bottom layers". Note that the illustration of FIG. 75 can
correspond to the layers of a sleeve as well. Each of the top and
bottom pocket layers 9150 and 9152 are illustrated as including
three fabric layers, however, each of the top and bottom pocket
layers 9150 and 9152 may include fewer or more fabric layers. The
pocket 8806 is illustrated as including six layers and the device
8802 is illustrated as being situated between layer 3 and layer 4
of the pocket. Note that the pocket 8806 may include fewer or more
layers, depending on the application to be accommodated. As
illustrated, the bottom pocket layer 9152 includes three layers,
7581 ("Layer 1"), 7583 ("Layer 2"), and 7585 ("Layer 3"). As
illustrated the top pocket layer 9150 includes three layers, 7591
("Layer 4"), 7593 ("Layer 5"), and 7595 ("Layer 6").
[0497] The Layer 1 of the pocket can include a soft, supple, and/or
compliant material. This layer is closest to the user's skin and
can provide comfort. The Layer 2 and/or Layer 3 can be insulating
material(s) (e.g., materials that resist heat passing therethrough)
and/or waterproof or water resistant, respectively. This heat
insulating property of the material can help protect a user's skin
from heat produced by the external device 8802 and deflect heat
towards the top pocket layer 9150. The waterproof/water resistant
property can help prevent moisture from travelling to the user's
skin and help transport any such moisture towards the top layer(s).
In one or more embodiments, one or more of the bottom pocket layer
9152 may be water wicking so as to transport water away from the
user's skin towards the top layer(s).
[0498] One or more of the top layer(s) Layer 4, Layer 5, and/or
Layer 6 may be a heat conductive material, such as to transport
heat away from the user's body. One or more of the top layer(s)
Layer 4, Layer 5, and/or Layer 6 may be compressive, such as to
help ensure that the wearable element does not slip or otherwise
move on the user's body and to help keep the external device
positioned in a location at which it can communicate with the
implantable/implanted device.
[0499] The wearable element can include a pocket or pockets in
undergarments that can include one or more top and one or more
bottom layers. As previously discussed Layer 1 can be a soft
breathable material, such as polyester. This layer can be in direct
contact with the skin. Layer 2 and/or Layer 3 can be made out of an
insulating material. Layer 3 can be neoprene, Gore-Tex, Outlast, or
other material that includes a low thermal conductivity, such as a
material similar to neoprene. Layer 2 and/or 3 may completely
prevent the penetration and/or absorption of liquid water
(waterproof). Layers 2 and 3 can be the same material. Layer 2
and/or Layer 3, (the inside layer to the pocket, closest to the
body) can include a one-way permeable material, such as
GORE-TEX.RTM., GORE WINDSTOPPER.RTM. membrane,
polytetrafluoroethylene (ePTFE), hemp, sheep's wool, cotton, straw,
aerogel, polyurethane, or the like.
[0500] The pocket can be ventilated to allow heat to dissipate,
sometimes referred to as breathable. Layer 4 and/or layer 6 can
include a breathable material that can allow the release of heat
through the top (the side away from the human body). The top of the
pocket can include a breathable material. The sides of the pocket
can include a breathable and/or waterproof material.
[0501] Insulating materials can include, for example, one or more
of: polyurethane foam, PYROGEL.RTM. XT, GORE-TEX.RTM., GORE
WINDSTOPPER.RTM. membrane, polytetrafluoroethylene (ePTFE), hemp,
sheep's wool, cotton, straw, aerogel, polyurethane, a material with
a high R-value, Outlast, or the like.
[0502] FIG. 76 illustrates, by way of example, a perspective view
diagram of an embodiment of bottom layers 9200 of the pocket 8806.
FIG. 77 illustrates, by way of example, a perspective view diagram
of another embodiment of bottom layers 9300 of the pocket 8806. The
bottom layers 9300 are similar to the bottom layers 9200 with the
bottom layers 9300 covering multiple potential implant locations
(one on each side of the spinus tubercles, for example) and the
bottom layers 9200 only covering one such potential location. The
bottom layers 9200 as illustrated include a first bottom layer 9202
and a second bottom layer 9204. The first bottom layer 9202 can be
closer to the user's body than the second bottom layer 9204 when
the layers 9200 are being worn. The layers 9202 and 9204 can be
affixed to each other, such as by thread, adhesive, or other
affixing means. The layers 9302 and 9304 are similar to the layers
9202 and 9204, respectively, with the layers 9302 and 9304 being
wider than the layers 9202 and 9204 as previously discussed.
[0503] FIG. 78 illustrates, by way of example, a perspective view
diagram of the embodiment of bottom layers 9400, such as is similar
to the layers 9300 of FIG. 77, with the external device 8802
attached to the inner most layer (layer 9304 of the bottom layers
9400 of FIG. 94). FIG. 79 illustrates, by way of example, a
perspective view diagram of an embodiment of layers 9500 that
include the bottom layers 9300 of FIG. 77 with an external device
8802 between the bottom layers and a top layer 9506. The top layer
9506 is the inner most top layer and can be in contact with the
external device 8802. The layer 9506 and can be attached, such as
by thread, adhesive, or other affixing means to any of the bottom
layer(s), such as the layers 9302 and/or 9304.
[0504] FIG. 80 illustrates, by way of example, a perspective view
diagram of an embodiment of layers 9600 similar to the layers 9500
with an elastic band 9608 over the top layer 9506. The elastic band
9608 as illustrated includes optional holes 9610 therethrough, such
as to help provide a ventilation area through which heat can escape
and/or air can be brought in, such as to keep the pocket 8806
breathable. The holes 9610 can each include a greater height
dimension than width dimension, such as shown in FIG. 80. The
height can be in generally the same direction as a height of the
person wearing the wearable element. The width is generally
perpendicular to the height. Such a configuration can allow the
elastic band 9608 to stretch such as without compromising integrity
or longevity of the band 9608. The holes 9610 can be positioned
over just a portion of the band 9608, such as a portion over the
layer 9506 or a portion thereof. The holes 9610 can alternatively
be positioned over an entire width and height of the band 9608. The
band 9608 illustrated is just a portion of the band so as to not
obscure the view of the layers 9506, 9304, and 9302 and the
external device 8802. The band 9608 will generally wrap completely
around a human body so as to help apply a compressive force between
the external device 8802 and the human body and help retain the
external device in place.
[0505] FIG. 81 illustrates, by way of example, a perspective view
diagram of an embodiment of a system 9700 including the layers 9600
with mating attachment mechanisms 9710A and 9710B on both the
external device 8802 and the top layer 9506 of the pocket 8806. The
layer 9506 includes the attachment mechanism 9710B on the innermost
layer of the top layers. The attachment mechanism 9710B can be
mated with the mating attachment mechanism 9710A on the external
device 8802 (see also FIG. 97) or a mating attachment mechanism on
a sleeve in which the external device 8802 may be situated (see.
FIGS. 83, 84A, and 84B). Note that the attachment mechanisms
9710A-B are optional and the pocket 8806 can be sufficiently
stretchable and include such dimensions so as to keep the device in
the proper location without the need for such an attachment
mechanism. The attachment mechanisms 9710A-B can include mechanical
based fastening mechanisms, fabric hook and loop fasteners (e.g.,
VELCRO.RTM. fasteners), a magnet, a SCOTCH.RTM. fastener, or other
attachment mechanism. The attachment mechanisms 9710A-B can be
affixed to a layer or the external device 8802 using an adhesive.
FIG. 82 illustrates, by way of example, a cross-section view
diagram of an embodiment of a system 9800, similar to that of FIG.
81, with the attachment mechanisms 9710A-B of the pocket 8806 and
external device 8802 mated so as to secure the external device 8802
in the pocket 8806.
[0506] FIG. 83 illustrates, by way of example, a cross-section view
diagram of an embodiment of a system 9900 that includes the
external device 8802 situated in a sleeve. The sleeve as
illustrated includes the top layers 9506 and 9912, the bottom
layers 9302 and 9304, and an attachment mechanism 9914 on the top
layer 9912. The top layer 9912 can be similar to any of the top
layers described with regard to FIG. 75. The attachment mechanism
9914 is similar to the attachment mechanisms 9710A-B.
[0507] FIG. 84A illustrates, by way of example, a perspective view
diagram of an embodiment of a system 10000A similar to the system
9900, with the system 10000A including a cushion material 10016 on
the bottom surface 9302. The cushion material 10016 helps provide
support and protect the user from forces due to impact on the
external device 8802. FIG. 84B illustrates, by way of example, a
perspective view diagram of an embodiment of a system 10000B
similar to the system 9900, with the system 10000B including the
cushion material 10016 in the sleeve, such as on the bottom layer
9304 as opposed to on the bottom layer 9302.
[0508] FIG. 85 illustrates, by way of example, a cross-section view
diagram of an embodiment of a system 10100 including a sleeve with
the external device 8802 situated therein. The sleeve as
illustrated is situated between layers of the wearable element
8808, such as in the pocket 8806. In the embodiment of FIG. 85, the
sleeve is affixed to the wearable element 8808 through an
attachment mechanism 9710A on the wearable element 8808 mated with
a fastening mechanism 9710A on the top layer 9912. The attachment
mechanisms 9710A-B as illustrated are within the wearable element
8808. Additionally, another pair of fastening mechanisms may help
affix the sleeve to the external device 8802. One fastening
mechanism can be situated on the top layer 9506 and the mating
fastening mechanism can be situated on the external device
8802.
[0509] FIG. 86 illustrates, by way of example, a perspective view
diagram of an embodiment of an undergarment 10200 that includes
mating fastening mechanisms 10220A and 10220B. The fastening
mechanisms 10220A-B allow a user to open a bottom portion of the
undergarment 10200 while wearing the undergarment 10200. Such an
undergarment 10200 can help provide a way for a user to go to the
bathroom without moving the external device 8802 relative to the
implanted device 8804. Consider that the undergarment 10200 can
include the pocket 8806 or other location at which the external
device 8802 can be affixed. Using such an undergarment, a user can
uncouple the fastening mechanisms 10220A-B, do their business,
recouple the fastening mechanisms 10220A-B, and all the while
retain the position of the external device 8802 relative to the
implanted device 8804. In other embodiments, a user may have to
move the undergarment 10200, thus moving the device 8802 relative
to the implanted device 8804. The user may then reposition the
external device 8802 to a communicable position (a position at
which the external device communicates reliably with the implanted
device 8804), such as by performing the operations discussed with
regard to the location circuitry (see FIGS. 98, 99, and 100).
[0510] FIG. 87 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device 8802 in a closed
position. The external device 8802 as illustrated includes a top
cover 10322 (the cover to contact or be more proximate with the top
layer(s) of the pocket or sleeve) and a bottom cover 10324 (the
cover to contact or be more proximate with the bottom layer(s)).
Edges 10326A and 10326B of the top cover 10322 as illustrated
include a greater radius of curvature than edges 10328A and 10328B
of the bottom cover 10324. By including edges 10324A-B with a
greater radius of curvature, the external device 8802 can remain
more discreet when in use. The bulge created by the external device
8802 will be more discreet and less severe than with edges that
include a smaller radius of curvature. The radius of curvature of
the edges 10328A-B can be important for the comfort of the user.
These edges, if too sharp, may cause discomfort for the user.
Increasing the radius of curvature, however, can increase the
overall footprint of the external device 8802.
[0511] Each of the top cover 10322 and the bottom cover 10324 may
be formed of a thermoplastic, other material or layers of
materials. A "thermoplastic" refers to a polymeric material that
can be repeatedly (i.e.; more than once) softened by increases in
temperature, and hardened by decreasing the temperature. The
thermoplastic may be in the form of a solid or a foam.
Thermoplastic polymeric foams may include, but are not limited to:
expanded polystyrene, polyethylene, polypropylene,
polyvinylchloride, and polycarbonate. Non-limiting examples of
crosslinked thermoplastic foams include: polyethylene, polyethylene
copolymers, and polyvinylchloride. Non-limiting examples of solid
thermoplastic materials include: polycarbonates, poly(ethylene
terephthalate), polyethylene (high density and low density),
polyimide, polypropylene, and the like. One suitable thermoplastic
material is a high-density polyethylene.
[0512] The top cover 10322 of the external device 8802 faces away
from the body. The top cover 10322 can include a high thermal
conductivity, such as CoolPoly.RTM. Thermal Conductive plastic. The
top cover 10322 can have a high specific heat, be a good heat sink,
be "bump", and/or include fins 10938.
[0513] The bottom cover 10324 faces toward the skin when in proper
use. The bottom cover 10324 is directly adjacent to the Layer 2
and/or Layer 3. The bottom cover 10324 can include an insulating
material, such as PYROGEL.RTM. XT or OUTLAST.RTM. FR-LHS
Thermoplastic Polyolefin E1astomers. The bottom cover 10324 can
have a low thermal conductivity and/or a high specific heat.
[0514] FIG. 88 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device 8802 in an open
position so as to show internal circuitry 10430 between the top
cover 10322 and the bottom cover 10324. The circuitry 10430 can
include control circuitry (e.g., components of the external device
discussed elsewhere herein), an antenna (e.g., a midfield coupler),
an inductive coil, a faraday cage, a speaker, a transmit and/or
receive radio (see. FIGS. 98, 99, and 100), or the like. The
control circuitry can provide power to the antenna that radiates
electromagnetic energy. The electromagnetic energy can then be
provided to the implanted device 8804 if the external device 8802
is properly situated related to the implanted device 8804.
[0515] FIG. 89 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device 8802 in a closed
position. FIG. 90 illustrates, by way of example, a perspective
view diagram of an embodiment of the external device 8802 in an
open position so as to show internal circuitry 10530 between the
top cover 10322 and the bottom cover 10324 and the inside of the
bottom cover 10324.The inside of the bottom cover 10324 is
illustrated as including a plurality of recesses 10632, such as to
help insulate the bottom cover 10324 from heat.
[0516] FIG. 91 illustrates, by way of example, a perspective view
diagram of an embodiment of a cover 10700, such as can act as a top
cover 10332 or bottom cover 10334 of the external device 8802. The
cover 10700 as illustrated includes two air vents 10734A and
10734B. The two air vents 10734A-B can hold air to be dissipated
away from the user's body. The two air vents 10734A-B as
illustrated are on opposite sides of the cover 10700. FIG. 92
illustrates, by way of example, a perspective view diagram of an
embodiment of a cover 10800, such as can act as the top cover 10332
or the bottom cover 10324 of the external device 8802. The cover
10800 as illustrated includes four air vents 10734A, 10734B,
10734C, and 10734D. One air vent 10734A-D is illustrated as running
along each side of the cover 10800 and generally parallel to the
corresponding side. Note that the embodiments discussed herein are
not mutually exclusive and may be combined where possible. For
example, a cover can include both the recesses 10632 and one or
more air vents 10734A-D. Such an embodiment may help transport air
from the recesses 10632 to the air vent(s) 9734A-D, such as to help
dissipate heat away from the user's body. Note that the air vents
are optional. In one or more embodiments, the recesses that help
form the air vents are filled with a heat conductive or insulating
material depending on if the vents are on the top cover or the
bottom cover. In one or more embodiments, the air vents are not
present.
[0517] FIGS. 93 and 94 illustrate, by way of example, perspective
view diagrams of an embodiment of the top cover 10322 of the
external device 8802 that includes fins 10938. The fins 10938 can
help conduct heat away from the user's body. The fins 10938 can be
touching or near a heat conducting top layer (of the pocket 8806 or
the sleeve). Note that the fins 10938 are optional. The fins 10938
can extend beyond an outer surface of the top cover 10322. One or
more flat or planar heat sinks can additionally, or alternatively,
be included, such as to dissipate heat.
[0518] FIG. 95 illustrates, by way of example, a perspective view
diagram of another embodiment of the external device 8802 in an
open position so as to show internal circuitry 10430, a top cover
10322, a bottom cover 10324, and connection elements 11138. In one
or more embodiments, the connection elements 11138 can be magnetic
and can mate with mating connection elements on the bottom cover
10324 (not shown in the perspective of FIG. 111). The connection
elements 11138 as shown in FIG. 95 are situated along two, opposite
sides of the external device 8802. In other embodiments, the
connection elements 11138 can be situated along all sides of the
external device 8802, can be situated just in the corners of the
external device 8802 (as shown in FIG. 96), or other configuration.
FIG. 96 illustrates, by way of example, a perspective view diagram
of another embodiment of the external device 8802 in an open
position so as to show the internal circuitry 10430, the top cover
10322, the bottom cover 10324, and connection elements 11138. The
top cover 10322 can be reversibly secured to the bottom cover 10324
by including mating elements on each of the top cover 10322 and the
bottom cover 10324, aligning the mating connection elements, and
then making the connection elements contact each other.
[0519] FIG. 97 illustrates, by way of example, a perspective view
diagram of an embodiment of the external device 8802 in a closed
position with the attachment mechanism 9710A attached to a cover of
the external device 8802. The attachment mechanism 9710A is
discussed elsewhere herein.
[0520] FIG. 98 illustrates, by way of example, a block diagram of
an embodiment of a system 11400 that includes multiple discrete
external components (e.g., the external device 8802 and a battery
11442). The battery 11442 is external to the external device 8802
and situated near the external device 8802 in the pocket 8806 (or
in the sleeve). In one or more embodiments, the battery 11442 may
be situated outside the pocket 8806 or sleeve. In one or more
embodiments, the battery 11442 includes one or more of a lithium
polymer battery, a generally flat, flexible battery, a rechargeable
battery (e.g., a wired battery charging capability or a wireless
battery charging capability, such as through an inductive power
link). The battery 11442 can provide electric power to the electric
and electronic components (e.g., the internal circuitry 10430, such
as can include a transceiver 11444 and other components, such as
circuitry of the external device, the source 102, or the like).
[0521] The location circuitry 11446 includes electric or electronic
components (e.g., resistors, transistors, inductors, capacitors,
diodes, sensors, logic gates, oscillators, multiplexers, antennas,
radios, ADCs, DACs, speakers, or the like) that aid the user in
situating the external device 8802 in the proper location. The
location circuitry 11446 can include components to determine a
received signal strength (RSS) of a signal from the implanted
device 8804. The RSS can be used to create a tone, such as through
a speaker of the internal circuitry 10430 or the location circuitry
11446. The tone created can be modulated based on the value of the
RSS so as to indicate to a user the relative value of the RSS. The
user can then situate the external device 8802 at a location
corresponding to a relatively high RSS (a tone that indicates a
relatively high RSS). In one or more embodiments, the location
circuitry 11446 includes a button that a user can press to initiate
a placement operation and detection process. The location circuitry
11446 can provide the user with an indication (e.g., a tone or
mechanical feedback, such as a vibration or pulse). The location
circuitry 11446 can beep in response to the RSS dropping below a
threshold value, such as to indicate to the user that the external
device is not properly located. The location circuitry 11446 can
refrain from beeping in response to determining the RSS is greater
than (or equal to) a threshold value.
[0522] FIG. 99 illustrates, by way of example, a block diagram of
an embodiment of a system 11500 that includes a single external
device (the device 8802) in the pocket 8806. As is illustrated in
FIG. 99, the battery 11442 can be included internal to the external
device 8802, such as to be located between the top cover 10322 and
the bottom cover 10324.
[0523] FIG. 100 illustrates, by way of example, a block diagram of
an embodiment of a system 11600 that includes multiple discrete
external devices (the device 8802 and other circuitry 11650) in the
pocket 8806. The system 11600 is similar to the system 11400, with
the system 11600 including only an antenna 11654 in the external
device 8802, with all the remaining circuitry external to the
external device 8802. The antenna 11654 is a component of the
transceiver 11444 along with other circuitry. The control circuitry
11652 provides signals to the transceiver or antenna to cause the
antenna to radiate electromagnetic energy, such as to the implanted
device 8804. In one or more embodiments, the battery 11442 and/or
the circuitry 11650 can be housed between a top cover and a bottom
cover similar to the top cover 10322 and/or the bottom cover 10324,
such as to help radiate heat away from the body.
[0524] The antenna 11654 and/or the circuitry 11650 can provide an
indication of the location of the external device 8802 relative to
the implanted device 8804. The circuitry 11650 can include a motor
that can cause a vibration to modulate as the external device 8802
gets closer to/farther from the implanted device 8804. The
circuitry 11650 can provide an alert to the patient if the
implanted device 8804 inside the patient shifts relative to the
external device 8802, such as can be detected by monitoring the
RSS. The frequency at which the antenna 11654 radiates
electromagnetic energy can be programmable. The circuitry 11650 can
monitor an amount of energy available from the battery 11442 and
provide a low battery warning (e.g., a sound or vibration) if the
amount of energy available from the battery 11442 drops below a
specified threshold. The circuitry 11650 can provide an indication
to turn on an implanted device 8804 for treatment. The circuitry
11650 can be connected to a network, such as to provide alerts from
a mobile phone or by email.
[0525] Devices that include a power transmitter, such as the
external device 8802, can "overheat" and burn human skin unless
they are carefully designed, especially when the device needs to be
near the human body to operate properly. Data from at least one
study indicates a "safe" heat absorption level of approximately 40
mW/cm.sup.2. Near the overheating point, skin temperature increases
approximately 0.80.degree. C. for each additional 10 mW/cm.sup.2 of
absorbed power. During normal operation, the external device 8802
heats as a side effect of performing its intended function.
Touching a heated device to human skin initiates a thermal
transient transfer followed by a steady state. Using a pocket or
sleeve around a device, or a device including an external housing,
as discussed herein, such as can be used along with a device
configured to transfer heat away from the body, can avoid pain
and/or skin burns.
[0526] Considering steady-state and to verify thermal safety, a
designer can place a finished device in ambient air, heat the
device to steady state, measure a device's surface temperature, and
compares the surface temperature to a "known-safe" temperature,
such as 41.degree. C. If the measured temperature is less than the
"known-safe" or threshold temperature, the designer can conclude
that the device will not cause pain or burning of the skin.
Although checking the thermal safety of a device by comparing the
surface temperature to the "known safe" temperature may be
convenient, the following factors may limit its applicability: 1)
when compared to human skin, the ambient air presumably provides a
higher thermal resistance to heat moving from the tested device;
And 2) the higher thermal resistance forces the device to reach a
higher temperature than it reaches when in direct contact to a
material or skin. Using ambient air, the thermal load likely
produces conservative test results. However, device performance
generally improves with increasing power dissipation, so the test
may be unjustifiably conservative. Knowing skin-temperature
response and the heat output per area of the external device 8802,
the resulting skin temperature can be calculated without
calculating or measuring an actual device temperature.
[0527] A problem solved by one or more embodiments discussed in
this subsection can include an external device with a form factor
that will conveniently and discreetly situate an external power
transmitter over a desired anatomy (at a desired location). Another
problem solved by one or more embodiments discussed in this
subsection can include an external housing for the power
transmitter (e.g., the power transmitter can be part of the
circuitry 10430) that will not burn, heat, and/or generally be felt
by the patient.
[0528] The form factor can include an undergarment with a pocket or
other mechanism in which the device can be situated near the
desired anatomy (e.g., the implanted device) and an external power
transmitter device and/or pocket/sleeve can dissipate the heat
produced by the power transmitter away from the body. The external
form factor can include the wearable element, a battery to power
the external device 8802, an antenna that is part of the internal
circuitry 10430, electronics that are part of the internal
circuitry 10430, the housing of the circuitry (the top cover 10322,
the bottom cover 10324, and the connection elements 11138 and
11140), and/or a sleeve or pocket in which to situate the
housing.
[0529] As previously discussed, human skin can be sensitive to the
heat dissipated through a surface of the device. Accordingly, the
skin or surface temperature of the external device or other
components near the human body can be an important constraint.
Temperatures at one or more surfaces of the external devices may
become too hot to touch, thus leading to uncomfortable user
experience. For example, a high temperature at any one of a housing
surface or back cover surface, may cause a user to stop using the
device altogether. Further, high temperature surfaces can become a
safety hazard due to local skin burning. Thus, reducing a maximum
temperature of the external devices can be an important
consideration. In doing so, however, the internal temperature of
handheld devices may need to be kept at temperature levels that do
not have a detrimental effect on the operation and longevity of
internal components.
[0530] An advantage of one or more embodiments can include an
increased comfort, when wearing, of the external device for the
patient. The systems discussed herein can be actively ventilated
with heat and moisture regulation, such as can include air and
water vapor permeability, rapid moisture absorption and conveyance
capacity, absence of dampness, rapid drying, and/or low water
absorption of the layer of clothing positioned to the skin. The
systems discussed herein can have dimensional stability even when
wet, durability, ease of cleaning and care, lightweight, and/or
soft and pleasant to the touch. The systems can include a high heat
transfer characteristic away from the human body, breathability,
lightweight, and durability.
[0531] In accordance with several embodiments, the external device
8802 can be positioned above the left or right S3 foramen. The S3
foramina are usually located about 11 cm from the anal verge or 9
cm cephalad to the tip of the coccyx. The S3 foramina are usually
located 1.5-2 cm lateral to the midline at the level of the sacral
notches or about 9 cm above the coccygeal drop-off. The external
device 8802 can include the location circuitry 11446 that will help
the patient determine when the external device 8802 is placed over
a proper location. The S3 foramina are located generally one finger
breadth above and below the S4 and S2 foramina, respectively.
[0532] The external device 8802, such as can include the battery
11442 and/or other circuitry 11650, can be placed in the pocket or
in a sleeve that includes layers similar to those discussed with
regard to the pocket. A polymer coating can be used to line the
inside of the sleeve or the pocket, such as to make it waterproof.
In one or more embodiments, Layer 5 can include a type of
compression/elastic band in order to compress the external device
8802 to the desired location. The compression band can be
integrated into the wearable element. The compression band can
include conduits (holes) large enough to allow for heat
dissipation. The compression band can have multiple channels or
channels of different sizes. The compression band can have a
variety of elasticity properties. The compression band can be about
0.5 mm-2 mm thick (e.g., 0.5-1 mm, 1 mm-1.5 mm, 1.5 mm-2 mm, 1 mm-2
mm, 0.5 mm-1.5 mm, overlapping ranges thereof, or any value within
the recited ranges). The compression band can include conduits
(e.g., holes) that are larger in the y direction (parallel to the
height of the user) compared to the x-direction (perpendicular to
the height of the user). Such a configuration can help conserve the
elasticity of the band, while still allowing for ventilation in the
band. In one or more embodiments, a lower portion of the band may
be void of conduits (as shown in FIG. 80), such as to help allow
heat from the device to rise.
[0533] In one or more embodiments, there may be more than one
pocket 8806, such as to provide a means to place an external
device, such as for multiple different implanted device locations
in one garment. In one or more embodiments, there is a single
pocket for the device 8802. The pocket can be configured to be
positioned above the sciatic notch. The pocket can span a width
starting from about 30 mm lateral from the center of the left S3
foramen to about 30 mm right from the center of S3 foramen. In one
or more embodiments, the pocket can be a total of 140 mm (about 70
mm to the right of the midline, and about 70 mm to the left of the
midline). Other dimensions may be used as desired and/or required
(e.g., length of between 60 mm and 200 mm, between 60 mm and 100
mm, between 70 mm and 150 mm, between 90 mm and 180 mm, between 100
mm and 160 mm, between 120 mm and 180 mm, between 130 mm and 150
mm, between 140 mm and 200 mm, overlapping ranges thereof, or any
value within the recited ranges). In one or more embodiments, there
can be a left pocket and a right pocket, each above and on opposite
sides of the sciatic notch, such as can include a back pocket on
the back left side above the left S3 foramen and another back
pocket that sits directly above the S3 foramen. Each pocket can be
about 60 mm in width by 60 mm in height. Other dimensions or shapes
may be used as desired and/or required (e.g., 50 mm .times.50 mm,
70 mm.times.70 mm, 60 mm.times.50 mm, 50 mm.times.60 mm).
[0534] As previously discussed, mechanisms can be used to keep the
external device 8802 at a proper location within the pocket 8806.
Such mechanisms can help intermittent users remove the external
device 8802 and replace the external device 8802, such as without
compromising the functionality of the external device 8802 or the
implantable device 8804. The attachment mechanisms 9710A-B can
include a mechanical based fastener such as a fabric hook and loop
fastener (e.g., a VELCRO.RTM. fastener), a SCOTCH.RTM. fastener, or
magnets on the unit to secure to a corresponding fastener (e.g.,
another VELCRO.RTM. fastener in the pocket. The VELCRO.RTM. or
other fastener can allow the unit to be secured to the location. A
zipper, gussets, bellows, layers with off-set slits, or extra
material that folds over the pocket 8806 can be used to close off
the pocket 8806 from the external environment. A bottom layer of
the pocket or sleeve can be covered with a sticky material, such as
to help hold the device in place. The Layer 2 and/or Layer 3 can be
at least partially covered in a rubber/silicone/sticky type gel or
similar to help hold the external device 8802 in place. The
wearable element can be placed over the external device 8802 with
rubber/gel lining the whole pocket to hold the external device 8802
in place.
[0535] The sleeve for the external device 8802 can include spandex
or some type of SPANX.RTM. material that can cover the external
device 8802. The sleeve for the external device 8802 can include a
flap, such as to help encapsulate the external device 8802.
[0536] In one or more embodiments, a system can include a wearable
element configured to be worn by a patient, and having an external
device coupled thereto and configured to send and/or receive a
wireless signal to communicate with an implanted device. The
wearable element can include an attachment mechanism to situate the
external device near (e.g., directly above, below, or to the side
of) the S3 foramen so the external device will be in proximity to
the implantable element. The external device 8802 can be placed at
multiple locations on the wearable element. The external device
8802 can include an antenna positionable in proximity to the
implanted device and configured to receive data from the implanted
device or send power to the implanted device 8804. The external
device 8802 can include location circuitry that provides an audible
or tactile indication of the proper location of the external device
8802 on the wearable element. The external device 8802 can be a
first external device and the system can include a second external
device, wherein the first and second external devices are coupled
to one another and positionable at multiple locations on the
wearable element at a distance apart from one another. The second
external device can be configured to provide power to the first
external device. The second external device can include a flexible
battery adapted to flex in response to motion of a user wearing the
flexible battery. The wearable element can include one or more
elastic straps. The wearable element can accommodate a variety of
patient sizes and shapes. The wearable element can include one or
more of an under garment, a pouch, a belt, and an adhesive patch.
The wearable element can include at least one pocket formed
therein. In one or more embodiments, the at least one pocket can be
movable relative to the wearable element. The external device 8802
can include a top cover 10322 and a bottom cover 10324 as described
herein.
[0537] A method for communicating with an implanted neurostimulator
device, can include positioning an external device on or at least
partially in a wearable element worn by a patient at one of a
plurality of locations, such as to align the external device with
the implanted neurostimulator device and activating the external
device to transfer a wireless signal through tissue to the
implanted neurostimulator device. The external device can be
positioned on a skin surface positioned proximate the implanted
neurostimulator device and surrounded by the wearable element. The
wearable element can include a plurality of flexible straps, and
the external device can be removably mated to the wearable element
and positioned near (e.g., proximate to) the implanted
neurostimulator device. The external device can be disposed within
a pocket in the wearable element.
[0538] In one or more embodiments, the wearable element can include
a form factor reducing garment, such as a SPANX.RTM. garment,
spandex, yoga clothing, or the like. The external device 8802 can
be worn on the wearable element. The wearable element's elasticity
can be low enough to compress the external device to the desired
location, while elastic enough for patient comfort. The wearable
element can include a pocket for the external device. The pocket
8806 can include a one-way permeable material, such as
GORE-TEX.RTM. material. The pocket can be one larger pocket with
attaching mechanisms for variability in placement. The pocket can
include a pocket within a pocket, so the patient can offset the
external device in the x-y plane in order to make the wearable
element universal for either the left or right sacral region. The
wearable element can come in a variety of forms to match the
patient's style. The styles can include shorts, briefs, hipsters,
thongs, bodysuit, pantyhose, tights, or any type of clothes that
would be considered an under garment. A sub-category of the styles
can include the waist band height and the amount of leg and buttock
coverage.
[0539] The elasticity and material of the wearable element can
allow for different slimming levels. To smooth out curves, the
wearable element material can be thinner. For shaping the body, the
elasticity level can be decreased and/or the material thickness can
be increased, or any combination of the two. For even more
compression and sculpting, the material can be thicker and/or less
elastic, or different combinations of the two to provide various
levels of comfort. These combinations of material elasticity and
thickness can allow the patient to choose from a variety of comfort
levels and be an aesthetically pleasing solution, such as
"Tummy-Taming", "Muffin Top-Reducing", or "Waist-Whittling".
[0540] The fabric may convey water vapor from body perspiration out
through the material (be one-way permeable) while the pocket for
the external device can remain impervious to external liquids. The
wearable element may be actively ventilated, may provide heat and
moisture regulation, and/or provide good air and water vapor
permeability. The material can be machine washable and may not
retain odors, in one or more embodiments.
[0541] An external layer of the pocket that can help keep the
external device in the desired position may be dimensionally stable
even when wet. The wearable element may be used as sleep wear or
active wear. For sleepwear, the pants or shorts could be loose,
such as with only the circumferential material that goes around the
waist above the desired location made of the spandex material. The
circumferential elastic part (e.g., the band 9608) of any of the
active wear or sleep wear can be of uniform or non-uniform height
around the waist.
[0542] Examples of different shapes, sizes, and styles of wearable
elements include tight or non-tight shorts, such as mid-thigh
shorts, high-thigh shorts, high-waist shorts, and/or mid-thigh
shorts, briefs, such as high-waist briefs and/or retro briefs,
hipsters, such as hi-hipster panty, panty boy shorts, and/or girl
shorts, thongs, such as high-waisted thong, a bodysuit, such as an
open bust bodysuit, a closed bust bodysuit, and/or a mid-thigh
bodysuit suit, and pantyhose, such as a high waist and/or a no-show
panty hose.
[0543] Some patients may not need or use constant stimulation from
an implanted device, but can use stimulation intermittently from
the external device 8802 to the implanted device 8804. This can be
due, at least in part, to carryover effects of the
electrostimulation. For example, a patient may only need
stimulation one hour every 24 hours for continued efficacy of the
therapy. What follows is some aspects surrounding an external
device with design features specific to intermittent
stimulation.
[0544] Sleepwear can include a pocket as discussed herein, such as
for intermittent or constant treatment. The control circuitry 11652
can include a timer. The control circuitry 11652 can provide an
indication to the user (noise, vibration, pulse, or other
indication) in response to the timer beginning or expiring, such
that the user can know how long to wear the external device 8802.
The control circuitry 11652 can track the amount of dosage the
patient has received. The control circuitry 11652 can calculate the
decay of the therapeutic effect dosage to inform the patient when a
next stimulation dose is to be administered. The therapeutic effect
of the dosage can be determined in clinical studies or the like. A
stimulation dosage can be provided to a target area of a person.
The person can indicate whether the stimulation is effective and
for how long the stimulation is effective after the dosage. This
can be performed on multiple persons. The decay of the therapeutic
effect of the dosage can be derived from this data and stored as
data on a memory of the external device, mobile device, or the
like.
[0545] The external device 8802 can inform the user how long the
device has been stimulating or has been turned on, such as through
the control circuitry 11652. The control circuitry 11652 can
automatically stop providing electrical power to the antenna in
response to determining an appropriate stimulation "dosage" has
been achieved.
[0546] The sleeve can have the fasteners for attachment, and for
intermittent uses, the user can buy the fasteners off the shelf and
stick it on to their clothing themselves, such as in embodiments in
which the external device 8802 includes the location circuitry
11446. The control circuitry 11652 can use the timer to help ensure
that electrostimulation is not provided to the implantable device
8804 for a specific amount of time.
[0547] The control circuitry 11652 can let the user know when the
stimulation will begin and end, such as through noises and/or
vibrations. The control circuitry 11652 can alert the user to
indicate when the user is to remove the external device 8802 and/or
when the user is to place the external device 8802 near the
implanted device 8804. The control circuitry 11652 can annoy or
keep alarming the user to put the external device 8802 near the
implanted device 8804, such as in response to determining the
external device 8802 is not sufficiently close to the implanted
device 8804. In one or more embodiments, the control circuitry
11652 may constantly remind the user until the external device 8802
is correctly placed for stimulation. The reminder can have a
"snooze" feature such as to remind the user after a specific amount
of time has elapsed. The control circuitry 11652 can include a
BlueTooth.RTM., Wi-Fi.RTM., Zigbee.RTM., or other short range
connection circuitry that can interface with a phone, through which
a user can program the control circuitry 11652, such as to
customize the alarm settings.
[0548] There can be a specific setting for the intermittent user
that wears the device all day regardless of whether the stimulation
is on or off. The external device 8802, such as through the control
circuitry 11652, can let the patient know when the stimulation
begins, ends, and/or the duration of stimulation. The external
device 8802 can send an alert (e.g., an email, text, or other
audible, visual or textual reminder) that a user can access via a
mobile device (e.g., smartphone, tablet, computer via a software
application program or a web browser). The alert may be sent by
sending data over a wireless network. There can be a setting to
insert the reminder on the user's calendar, such as through the
control circuitry 11652.
[0549] The external device 8802 can have various sounds to indicate
different alarms. These alarms can be programed through a software
application (app) on a mobile device (e.g., smartphone or computing
device). The external device can be allowed to store a certain
amount of data in its memory before it would have to be connected
to the mobile device (e.g., phone), software application on the
mobile device, or network, such as to upload the data before it is
overwritten. The user can track how long, for how many days, hours,
etc. the user has stimulated the implanted device, such as by using
the software application. The external source 102 can be
pre-programmed with a selection of therapy regimes, such that the
user can select using the software application. The user defined
regimes may also be customized by the user, such as to allow the
user to define their own timing settings, reminders, sounds,
vibrations, power on, power off, settings, stimulation schedule,
etc. The software application can provide the user with the ability
to find the device (in case the user has misplaced the external
device 8802), such as where the external source 102, such as
through the control circuitry 11652 can ping when a feature is
selected on the software application or a command is otherwise
provided to the software application.
[0550] The control circuitry 11652 can include a safety feature
which prevents over-heating of the external device 8802, such as
can include monitoring of a temperature sensor reading and cutting
power to the external device 8802 if a threshold temperature is met
or exceeded.
[0551] A password or other security mechanism can be required by
the control circuitry 11652 or the app in order to adjust
stimulation settings, such as power of stimulation, duration, etc.
of the stimulation. The control circuitry 11652 can include device
can include a Light Emitting Diode (LED) or other light that can be
red or green, or whichever color to indicate the device is on, off,
or searching for the implanted device, for example.
[0552] While FIGS. 75-86 regard pockets and other holding or
attachment features, other holdings, attachments, garbs, or the
like, may be used to retain the external source 102. In one or more
embodiments, the external source 102 can be mechanically coupled to
a belt, such as by using a belt clip. The belt clip can hold the
external source 102 in a manner similar to a smart phone belt clip.
In one or more embodiments, an adhesive can be attached to a cover
(see FIGS. 87-97, among others) of the external source 102. The
external source 102 can be retained in or coupled to a chair,
bed-cover, toilet seat, or the like. A pocket can be included in,
on, or around or an attachment mechanism can be part of the chair,
bed-cover, toilet seat, hat, floor mat, or the like. For example,
the external source 102 can be situated in a lumbar support mat. In
one or more embodiments, a harness or strap with a sleeve or
attachment mechanism can be used to help locate and hold the
external source 102 near the implantable device 110. In one or more
other embodiments, a vest or vest-like clothing can include a
pocket or attachment mechanism to help locate and hold the external
source 102 near the implantable device 110. In one or more
embodiments, a pocket, sleeve, or the like can be included in a
hat. The external source 102 can be situated in the hat and provide
power to an implantable device in, on, or near a brain of the
user.
[0553] To help ensure that the external source 102 is located
sufficiently close to the implantable device 110, an attachment
mechanism 9710A-9710B can be used. The attachment mechanism
9710A-9710B can include one or more magnets, clips, Velcro.RTM., or
the like. Alignment aides such as a temporary or permanent mark
(e.g., tattoo) on the user's body can be used to indicate a
location of an implantable device internal to the user.
[0554] In one or more embodiments, the external source 102 can be
molded to conform to a shape of a user's body at a location near
the implanted device 110. Embodiments of such molding are provided
in at least FIGS. 32-33 of U.S. Pat. No. 9,583,980, titled
"Multi-Element Coupler for Generation of Electromagnetic
Energy".
[0555] FIG. 136 illustrates, by way of example, a waveform diagram
of an embodiment of a waveform 13600 of intermittent stimulation.
The waveform 13602 indicates voltage, current, or power of an
implantable device. The line 13604 indicates time. T.sub.1 and
T.sub.2 represent consecutive stimulation sessions. .DELTA.t.sub.1
13606 represents a time duration of a first stimulation session
T.sub.1, .DELTA.t.sub.2 13608 represents a time duration between
the first stimulation session T.sub.1 and the second stimulation
session T.sub.2, and .DELTA.t.sub.3 13610 represents a time
duration of the second stimulation session T.sub.2. Intermittent
stimulation can, for example, include a time between stimulation
sessions, of a specified duration .DELTA.t.sub.2. In one example,
this duration can be greater than an hour. A duration sufficiently
close to another duration, means within 10% of the stated duration.
For example, a duration sufficiently close to an hour includes all
times in the range 54-66 minutes. In other examples, this duration
can be less than an hour, such as to be on the order of seconds or
minutes, such as to include a half hour, an hour, or a time
therebetween. A stimulation session can last from less than a
second to over an hour.
[0556] The stimulation sessions T.sub.1 and T.sub.2 can be time
multiplexed or spatially multiplexed. In time multiplexing, the
stimulation sessions T.sub.1 and T.sub.2 can include bursts of
stimulation. The stimulation can be produced by the implantable
device, such as under supervision of an external device. The
stimulation can include a variety of magnitudes and frequencies of
electromagnetic radiation from the implantable device. The
stimulation, in one or more embodiments, can include a magnitude of
between about 0.5 volts and about 10 or more volts. The
stimulation, in one or more embodiments, can include a frequency of
between about 1 Hertz and about 20 kilohertz. The stimulation
session Ti or T2 can provide a burst of energizing power to a
location within a body.
[0557] FIG. 137 illustrates, by way of example, a diagram of an
embodiment of a system 13700 for stimulation using an implantable
device. The system 13700 includes a mobile device 13702, the
external source 102, a server 13704, and the implantable device
110. The mobile device 13702 can include a smartphone, laptop
computer, tablet computer, smartwatch, dedicated controller, or the
like. The mobile device 13702 can provide a user with access to
functionality of an application operating thereon through a UI
13800A. The external source 102 can communicate with the mobile
device 13702. The external source 102 and the mobile device 13702
can include a transmit, receive, or transceiver radio to facilitate
such communication. While the mobile device 13702 and the external
source 102 are shown as separated in FIG. 137, in one or more
embodiments, the external source 102 can be built into a case of
the mobile device 13702 or otherwise be integrated into the mobile
device 13702.
[0558] The external source 102 can include a UI 13800B through
which a user can access functionality of the external source 102 or
the implantable device 110. The external source 102 can communicate
with the implantable device 110, such as to provide energy for
stimulation or data to configure the implantable device 110 (e.g.,
an amplitude, frequency, power, electrode selection, or the like
for stimulation). The external source 102 can include one or more
components or configurations of the external devices 4202, 4800,
5028, 6400, 6500, 6700, 7300, 8205, 8802, 31102. The implantable
device 110 can include one or more components or be configured
similar to one or more of the implantable devices 4201, 4800, 4900,
5100, 5300, 5600, 5700, 7611, 7612, 7682, 8804, 31104, or 1210.
[0559] To help facilitate the provision of the stimulation session
T.sub.1 or T.sub.2 the implantable device 110 can include one or
more capacitors, batteries (e.g., chemical based battery, such as a
rechargeable battery), or other energy storage components (e.g.,
capacitor array 13026 se FIG. 122). The energy storage components
can provide power for stimulation faster than the external source
102 can provide power for stimulation. In one or more embodiments,
the implantable device 110 can include circuitry to determine
whether power is being provided from the external source 102, and
in response to determining that power is not being provided from
the external source 102, to electrically connect the energy storage
components (e.g., using a switch) to provide power to electrodes
and other circuitry of the implantable device 110.
[0560] In one or more embodiments, the external source 102 can be
used to charge the energy storage component and the charge storage
component can then provide energy for stimulation. In one or more
other embodiments, the external source 102 can be used to charge
the energy storage component, and then both the charge storage
component and the external source 102 can concurrently provide
energy for stimulation.
[0561] In one or more embodiments, the implantable device 110 or
the external source 102 can determine a signal strength of a signal
from the external source 102 or the implantable device 110,
respectively. In response to determining the signal strength is
greater than, or equal to, a threshold signal strength, the
implantable device 110 can produce stimulation. In response to
determining the signal strength is less than, or equal to, the
threshold signal strength, the implantable device 110 can refrain
from producing stimulation. As long as the implantable device 110
determines that the signal strength is greater than, or equal to,
the threshold signal strength, the implantable device 110 can
continue to produce stimulation.
[0562] A battery 11442 (see FIG. 100) of the external source 102
can be configured to provide only enough power to the external
source 102 so that the external source 102 can provide enough
energy to the implantable device 110 for the stimulation session
T.sub.1 or T.sub.2. For example, the battery 11442 of the external
source 102 can include enough power to provide energy for a single
stimulation session or multiple stimulation sessions. When the
battery 11442 is depleted, the external source 102 may be disposed
of, or the battery 11442 of the external source 102 replaced. In
one or more embodiments, the external source 102 may be provided by
a prescription. In such embodiments, a user can get another
external device with energy sufficient to power the implantable
device 110 for another stimulation session by refilling their
prescription.
[0563] A user can include multiple implanted devices within their
body. The implanted devices can be spatially multiplexed. One or
more of the implanted devices can receive energy from an external
source 102 while one or other of the implanted devices do not
receive energy from the external powering unit. FIGS. 116 and 117
and the corresponding description thereof describes time
multiplexed implants, the discussion of which can be extended to
spatially multiplexed implants.
[0564] In one or more embodiments, the external source 102 or the
mobile device 13702 can be coupled to the server 13704. The
external source 102 or the mobile device 13702 can provide data
regarding stimulation to the server 13704. The server 13704 can
accumulate data from a plurality of external devices or mobile
devices. The server 13704 can store and organize the data, such
that data regarding patients with a similar trait (e.g., issue
being treated, age, gender, or the like) can be mined to determine
a stimulation schedule, maximum allowable stimulation threshold, or
the like.
[0565] FIG. 138 illustrates, by way of example, a diagram of an
embodiment of a user interface (UI) 13800 of an external powering
unit or a mobile device. Note that the UIs 13800A and 13800B or
FIG. 137 are specific instances of the UI 13800. The UI 13800 can
be used, such as by a user with the implanted device 110 and the
external source 102. The UI 13800 can be a part of the mobile
device 13702 coupled to the external source 102, or part of the
external source 102. The UI 13800 includes a display, such as a
touch screen, liquid crystal display, light emitting diode, or
other display. Using the UI 13800, a user can view a stimulation
history, receive a notification, request stimulation, schedule
stimulation, or the like.
[0566] The UI 13800 as illustrated includes a stimulation report
13802, notifications 13804, 13806, 13808, 13810, and 13812, a
request stimulation control 13814, and a schedule stimulation
control 13822. The stimulation report 13802 details, whether
numerically or graphically, a desired stimulation and an actual
stimulation provided. The implantable device 110 can record and
report, to the external source 102, how much stimulation was
actually provided. The data provided from the implantable device
can include a date, time, intensity, duration, frequency, or other
detail regarding the stimulation provided by the implantable
device. The data provided from the implantable device can be
converted, by the external powering unit or the mobile device, to
the actual stimulation data of the stimulation report. The desired
stimulation profile can be determined using a schedule, such as can
be input using the schedule control 13722.
[0567] The notifications 13704, 13706, 13708, 13710, and 13712 are
examples of text, graphics, or a combination thereof, that can be
presented on the UI 13700. The notification 13704 indicates that a
next stimulation in X minutes. The time on the notification 13704
can be configurable, such as by a user of the application, a
physician, other medical personnel, or the like. The time of the
notification 13804 can be in seconds or hours, rather than minutes.
The notification 13806 indicates that the user is to place the
external source 102 near an implantable device 110. The external
source 102 can provide a sound, vibration, light, or the like, to
indicate that the implantable device 110 is sufficiently close
(e.g., close enough that the external source 102 can supply the
implantable device 110 with power) or that the implantable device
110 is not close enough (e.g., not close enough for the external
source 102 to supply the implantable device 110 with power).
[0568] The notification 13808 indicates that stimulation has ceased
because a maximum prescribed limit of stimulation has been reached.
The implantable device 110 can record how much stimulation (e.g.,
in terms of time, intensity, amplitude, frequency, a combination
thereof, or the like) has been provided to the user. The
implantable device 110 can relay the amount of stimulation to the
external source 102. The external source 102 (or the implantable
device 110) can keep a running total of stimulation provided over a
specified period of time (e.g., fraction of an hour, hour, day,
week, month, year, etc.). The external source 102 (or the
implantable device 110) can stop providing energy to the
implantable device 110 (or stimulation to a target area) in
response to determining the running total is greater than (or equal
to) a maximum allowable threshold. In response to determining the
maximum allowable threshold has been reached (or exceeded), the
implantable device 110 can provide a signal to the external source
102 indicating the same. The external device 110 can produce a
signal that causes the UI 13800 to display the notification
13708.
[0569] The notification 13810 indicates that a battery 11442 of the
external source 102 is low in power. The notification 13810 can be
provided in response to the control circuitry 11652 (see FIG. 100)
determining the battery 11442 is low in power. The control
circuitry 11652 can produce a signal that causes the UI 13800 to
display the notification 13810, such as in response to determining
the battery 11442 is low. The notification 13812 indicates that a
next dosage is due and that the user is to position the external
source 102 sufficiently close to the implantable device 110. A
current time can be compared to data of the stimulation schedule,
such as by the control circuitry 11652 or circuitry of the mobile
device 13702. The circuitry can determine that a next dosage is
due. In response to determining the next dosage is due, a signal
can be produced by the circuitry that causes the UI 13800 to
provide a view of the notification 13812.
[0570] Each of the notifications 13804, 13806, 13808, 13810, and
13812 can be accompanied by a respective vibration or sound, such
as to alert a user not currently viewing the UI 13800.
[0571] The request stimulation control 13814 allows a user to
request a stimulation dosage. Circuitry of the external source 102
or the mobile device 13702 can determine, such as by data in a
memory thereof, whether a maximum allowable stimulation has been
produced or whether the schedule allows for less than the maximum
allowable stimulation. In response to determining that the request
would not violate a maximum allowable stimulation (e.g., based on
the threshold, the stimulation provided in a specified time period,
a schedule of future stimulation dosages to be provided in the
specified time period, a combination thereof, or the like) the
stimulation request can be fulfilled. Fulfilling the stimulation
request can include the external source 102 providing energy to the
implantable device 110 and, in response, the implantable device 110
providing electrical energy to a target area.
[0572] The request stimulation control 13814 can be selected by
user who notices or is informed of a return of symptoms being
treated by the stimulation of the implantable device 110. The
request stimulation control 13814 can include a duration control
13816, an intensity control 13818, and an initiate control 13820.
The duration control 13816, in response to selection by a user
(e.g., by clicking and releasing a mouse while a cursor hovers over
the control, touching the control on a touch screen, speaking, or
the like), can provide a menu or input box, through which the user
can control a duration of the requested stimulation. A menu can
include a drop-down menu that include items that can be selected by
the user. Each item of the menu, in response to being selected,
causes the requested stimulation to last a different amount of
time.
[0573] The intensity control 13818, in response to selection by a
user, can provide a menu or input box through which the user can
control an intensity of the requested stimulation. A menu can
include a drop-down menu that include items that can be selected by
the user. Each item of the menu, in response to being selected,
causes the requested stimulation to be of the selected intensity.
The intensities can include high, medium, low, an intensity
therebetween, or the like. Each of the intensities can be mapped to
a specified voltage, current, or frequency. The initiate control
13820, in response to selection by the user, causes the circuitry
of the mobile device 13802 or external source 102 to determine
whether the requested stimulation will cause the stimulation
provided to exceed a maximum allowable stimulation threshold. In
one or more embodiments, the initiate control 13820, when selected,
causes the requested stimulation to be provided regardless of how
much stimulation was previously provided.
[0574] The schedule stimulation control 13822 allows a user,
physician, caretaker, or other personnel to schedule future
stimulation. The schedule stimulation control 13822 as illustrated
includes a time control 13824, a date control 13826, a duration
control 13828, an intensity control 13830, a repeat control 13832,
and a save control 13834. The time control 13824 allows a user to
specify a time at which the stimulation begins. The date control
13826 allows a user to specify a day of the month, week, year, or
the like, the scheduled stimulation is provided. The duration
control 13828 is similar to the duration control 13816. The
intensity control 13832 is similar to the intensity control 13818.
The save control 13834 in response to selection by the user, stores
scheduled stimulation data into a memory. The scheduled stimulation
data reflects the state of the controls 13824, 13826, 13828, 13830,
or 13832 at the time the save control is selected 13834.
[0575] In one or more embodiments, the external source 102 can
include a motion sensor, such as three axis accelerometer, position
detection sensor (e.g., using global positioning system (GPS),
triangulation, or other position detection technique). The sensor
can be a part of the control circuitry 11652 (see FIGS. 98-100).
The data from the sensor can be analyzed to indicate that the user
is going to the bathroom more or less frequently, an amount of time
the user spends in a bathroom, or the like. The data from the
sensor can be interpreted by the external source 102. The external
source 102 can adjust (e.g., automatically) a stimulation schedule
according to data from the sensor. For example, if a user is
determined to be spending more time in the bathroom or going to the
bathroom more frequently, the external powering device can provide
a stimulation dosage, such as to supplement the stimulation
schedule or in place of a next scheduled dosage.
[0576] Using the schedule stimulation control 13822 a user can
indicate an intent to wear the external source 102 (e.g., using a
pocket, clothing, or the like discussed with regard to FIGS. 75-86,
among others), such as in sufficient proximity to the implantable
device 110 to provide power thereto. The external source 102 or the
mobile device 13802 can determine a stimulation schedule based on
data provided through the schedule stimulation control 13822. The
external source 102 or the mobile device 13702 can adjust the
dosage of stimulation so that the user receives their prescribed
amount of dosage and does not receive too much stimulation (e.g.,
more than a maximum allowable stimulation threshold).
[0577] Intermittent stimulation has a wide array of applications.
That is, intermittent stimulation can at least help in treating a
variety of ailments. Intermittent stimulation can help treat, for
example, depression, heart failure, epilepsy, hypertension,
obesity, inflammation, Crohn's disease, arthritis, an autoimmune
disease, or the like, such as through stimulation of the Vagus
nerve. A mechanism of action for depression, heart failure, or
epilepsy is modification of parasympathetic balance, which is a
chemical process. Effects of stimulation can last after the
stimulation, such as can be due, at least in part, to chemical
half-lives.
[0578] Intermittent stimulation of the Phrenic nerve, or one or
more other nerves, can serve as an electric inhaler for asthma.
Stimulation of nerves that control respiration, temporarily or
on-demand, can help increase an amount of air drawn into the lungs.
A user, through the use of the request stimulation control 13714,
can use a stimulator or stimulation system as needed with onset of
symptoms. Similarly, intermittent stimulation can be used to help
treat symptoms of sleep apnea, such as through stimulation of the
hypoglossal nerve. Night time stimulation or intermittent nighttime
stimulation can be used to help open airways. One or more sensors
of the external powering unit can be used to determine an
electrocardiogram (EKG) or electromyography (EMG) or oxygen level
for feedback, such as to determine whether stimulation is needed or
helpful.
[0579] Intermittent stimulation can be used to help treat
inflammation of the spleen. Splenic inflammation can be treated by
intermittent stimulation of a splenic nerve multiple times a day or
once or more times every several days for a specified period of
time (e.g., 1-30 minutes, or other amount of time).
[0580] Intermittent stimulation can be used to help treat
depression, heart failure (HF), epilepsy, hypertension, obesity,
inflammation, asthma, or Parkinson's, such as through deep brain
stimulation. Deep brain stimulation can be used when symptoms
persist, such as can be based on feedback from the external
powering device or one or more sensors monitoring a biological
parameter of the user. The biological parameter can include blood
pressure, heart rate, or the like. The biological parameter can be
monitored using a separate wearable device or one or more sensors
of the external powering device.
[0581] Intermittent stimulation of the cortical or motor cortex can
help increase blood flow, such as to the brain. Consider a patient
who has suffered from a stroke. That patient can have the
implantable device implanted in or near their brain to stimulate
the cortical or motor cortex. The patient can be prescribed
stimulation for a specified intermittent time period (e.g., one or
more minutes every five minutes, ten minutes, fifteen minutes, half
hour, hour, or some time therebetween).
[0582] Intermittent stimulation of peripheral nerves can be used to
treat pain. Such stimulation can be on-demand or scheduled. A
dorsal root ganglion nerve cluster can be stimulated to help treat
a symptom of focused pain. One or more nerve endings can be
stimulated for post amputation pain. Intermittent stimulation of
one or more nerve endings left after an amputation can help relieve
pain from phantom limb syndrome. The stimulation can help
reestablish feedback from the remaining limb to a central nervous
system.
[0583] Severe dry eyes can be treated through intermittent
stimulation of a trigeminal nerve, lacrimal gland, or the like. A
nerve or gland can be stimulated, such as to cause tears to be
produced. The stimulation can be provided on-demand, on a scheduled
time, or the like.
[0584] Intermittent stimulation can be used to help treat headache,
cluster headache, or migraine. To treat headache, cluster headache,
or migraine stimulation can be provided to a sphenopalatine
ganglion, near an occipital bone, supraorbital, or trigeminal
nerve.
[0585] FIG. 139 illustrates, by way of example, a diagram of an
embodiment of a method 15100. The method 15100 can be for providing
intermittent stimulation using a stimulation system that can
include an external device, an implantable device, a mobile device,
or a combination thereof. The method 15100 as illustrated includes
providing (by an external device of the stimulation system) radio
frequency first signals to an implantable device of the stimulation
system, the implantable device including an electrode and the first
signals causing the implantable device to provide electrical
stimulation through the electrode for a first time duration, at
operation 15102; determining, by the external device, that an
implantable device is out of range of a transmission from the
external device, at operation 15104; determining (after a specified
time period has elapsed, such as ten minutes, fifteen minutes,
thirty minutes, forty-five minutes, an hour, greater than an hour,
or a time therebetween), by the external device, that the
implantable device is within range of a transmission from the
external device, at operation 15106; and providing, by an external
device of the stimulation system, radio frequency second signals to
the implantable device of the stimulation system, the second
signals causing the implantable device to provide electrical
stimulation through the electrode for a third time period, at
operation 15108.
[0586] The method 15100 can further include before providing the
first signals, generating a sound by a speaker of the external
device to alert a user of the stimulation system that a subsequent
electrical stimulation is to be administered. The method 15100 can
further include after providing the first signals, generating a
sound by a speaker of the external device to alert a user of the
stimulation system that the electrical stimulation has been
administered. The method 15100 can further include monitoring an
amount of the electrical stimulation provided by the implantable
device and a decay of the therapeutic effect of the dosage. The
method 15100 can further include, in response to determining the
therapeutic effect of the dosage has decayed below a threshold
amount, providing the second signals.
[0587] The method 15100 can further include indicating, using a
speaker, motor, or display, to a user of the stimulation system an
amount of time the implantable device has been actively
stimulating. The method 15100 can further include indicating, using
a speaker or motor of the external device, to a user of the
stimulation system that the external device is outside of a
transmission range of the implantable device. The method 15100 can
further include continuing the indication until location circuitry
of the external device determines the external device is within
transmission range of the implantable device. The method 15100 can
further include indicating, using a speaker or motor of the
external device, to a user of the stimulation system that the user
is to remove the external device from within transmission range of
the implantable device.
[0588] The method 15100 can further include providing, by the
external device, a communication to a mobile device that causes the
mobile device to indicate that stimulation is about to begin,
stimulation has ended, or a location of the external device is
sufficient or insufficient for powering the implantable device. The
method 15100 can further include receiving, at the external device,
one or more signals indicating that the external device is to
produce a communication, after a specified third time duration
elapses, reminding the user that stimulation is needed. The method
15100 can further include, wherein the communication includes at
least one of an electronic mail, text message, or notification on a
display of the mobile device.
[0589] The method 15100 can further include providing, by the
external device, stimulation data to a mobile device, the
stimulation data including one or more of date, time, duration, and
power of stimulation provided by the implantable device. The method
15100 can further include receiving, at the external device, a
communication from a mobile device of a user, the communication
indicating one or more of a stimulation schedule, a reminder sound
or vibration, power on time, power off time, and implantable device
power setting. The method 15100 can further include receiving, from
a mobile device and at the external device, one or more signals
that cause the external device to provide the first signals to the
implantable device.
[0590] The method 15100 can further include receiving, from a user
interface of the stimulation system and at the external device,
data indicating a schedule of dates and times at which to provide
stimulation. The method 15100 can further include providing the
first and second signals consistent with the schedule. The method
15100 can further include, wherein the schedule further includes
data indicating an intensity of stimulation at a specified date and
time. The method 15100 can further include determining, by the
implantable device, whether a charge imbalance is present around
the implantable device. The method 15100 can further include in
response to determining that a charge imbalance is present,
inhibiting stimulation.
[0591] The method 15100 can further include quantifying an amount
of stimulation provided over a specified period of time. The method
15100 can further include inhibiting further stimulation in
response to a quantified amount of electrical stimulation provided
exceeding a specified threshold amount. The method 15100 can
further include determining, based on a timer or schedule data,
that stimulation is to be provided to a target. The method 15100
can further include determining whether energy is being received
from the external device. The method 15100 can further include, in
response to determining that energy is not being received from the
external device, providing, by the implantable, stimulation to the
target using energy stored in one or more capacitors of the
implantable device. The method 15100 can further include receiving,
at the external device and from a request stimulation control of a
user interface, one or more signals indicating a user request for
stimulation. The method 15100 can further include comparing, at the
external device, an amount of stimulation provided in a specified
period of time to a specified stimulation threshold. The method
15100 can further include, in response to determining that the
amount of stimulation provided in the specified period of time is
less than the threshold, producing radio frequency third signals to
provide electrical energy to the implantable device.
III. Therapy and/or Data Signal Configurations
A. Backscatter Communication Techniques
[0592] FIG. 101A illustrates, by way of example, embodiments of
various cross-structure leakage paths of a midfield antenna 300. In
the embodiment of FIG. 101A, any one or more of the first, second,
third, and fourth subwavelength structures 301-304 can be excited
(e.g., using separate or discrete signals via respective RF ports)
and the midfield signal 131 can be transmitted from the antenna
300. As a result of the first subwavelength structure 301 being
excited, one or more leakage signals are received at the other
structures, for example, because the various subwavelength
structures of the antenna 300 can share a common substrate or can
be otherwise electrically coupled. For example, leakage signals
from the first subwavelength structure 301 can be transmitted from
the first subwavelength structure 301 to the second subwavelength
structure 302, transmitted to the third subwavelength structure
303, and transmitted to the fourth subwavelength structure 304.
Similarly, leakage signals from the second subwavelength structure
302 can be transmitted from the second subwavelength structure 302
to the first subwavelength structure 301, transmitted to the third
subwavelength structure 303, and so on.
[0593] In the embodiment of FIG. 101, leakage signals from the
first subwavelength structure 301 are shown being transmitted to
the second, third, and fourth subwavelength structures 302-304, and
leakage signals from each of the second, third, and fourth
subwavelength structures 302-304 are shown being transmitted to the
first subwavelength structure 301. For clarity of the illustration,
only several of the many possible leakage or interference signal
paths are illustrated in FIG. 101A. For example, the only leakage
signal that is illustrated as originating from the second
subwavelength structure 302 is the leakage signal that is
transmitted from the second subwavelength structure 302 to the
first subwavelength structure 301, however, other leakage signals
originating from the second subwavelength structure 302 are
transmitted to the other structures as well.
[0594] The cross-structure leakage can be used constructively or
intentionally in some cases to influence the midfield signal 131
generated and transmitted by the antenna 300. In other examples,
the cross-structure leakage can be undesirable or can lead to
complications in transmitting or receiving RF signals from the
antenna 300. Various factors can contribute to the relative
strength or influence of one or more leakage signals on other
subwavelength structures or on the midfield signal 131 transmitted
from the antenna 300. For example, a physical layout or geometry of
the subwavelength structures can influence a magnitude or frequency
characteristic that can be emphasized or deemphasized in leakage
among the structures. In an example, an antenna with subwavelength
structures arranged asymmetrically will exhibit different
cross-structure leakage effects than an antenna with the
subwavelength structures arranged symmetrically.
[0595] FIG. 101B illustrates, by way of example, a chart that shows
embodiments of frequency-dependent leakage paths between various
subwavelength structures in an antenna. The x-axis shows an
excitation frequency and the y-axis shows a relative signal
response amplitude in decibels (dB). In FIG. 101B, a first trace
331 corresponds to a response of the first subwavelength structure
301 to a test stimulus, for example, when no test stimulus is
applied to other subwavelength structures of the antenna 300. The
first trace 331 represents how much power is reflected from the
first subwavelength structure 301. At 0 dB, all of the excitation
power is reflected from the first subwavelength structure 301 and
no signal is radiated from the antenna 300. At approximately 1.62
GHz, the first trace 311 is about -13 dB, which implies that if 3
dBm of power or test stimulus is delivered to the first
subwavelength structure 301, then -10 dBm is reflected. The
remainder of the power is "accepted" by or delivered to the
antenna, and is radiated or absorbed as a signal loss by the
antenna 300.
[0596] A second trace 332 corresponds to a leakage path between the
first and second subwavelength structures 301 and 302. That is, the
second trace 332 indicates a power level of a signal received at
the second subwavelength structure 302 relative to a power level of
a signal input to the first subwavelength structure 301. For
example, when the second trace 332 is at 0 dB, all of the power of
a test stimulus that is delivered to the first subwavelength
structure 301 is present at the second subwavelength structure 302.
When the second trace 332 at -10 dB (e.g., around 1.55 GHz), then a
1 watt (30 dBm) stimulus applied to the first subwavelength
structure 301 corresponds to 20 dBm (or 0.1 watts) of power
received at the second subwavelength structure 302. Similarly, a
third trace 333 corresponds to a leakage path between the first and
third subwavelength structures 301 and 303, and a fourth trace 334
corresponds to a leakage path between the first and fourth
subwavelength structures 301 and 304.
[0597] In an example, the backscatter signal 134 from the
implantable device 110 can be received using one of the first,
second, third, or fourth subwavelength structures 301-304, as
further described below. Information about one or more of the
different leakage paths between and among the subwavelength
structures can be considered when receiving and processing the
backscatter signal 134.
[0598] FIG. 102 illustrates, by way of example, a diagram of an
embodiment of a system that illustrates how the antenna 108 of the
implantable device 110 can be used to receive, modulate, and
transmit a signal. Generally, current flowing on a transmitting
antenna 12206 (e.g., corresponding to the antenna 300) leads to a
first transmitted signal 12211 and a voltage induced on a receiving
antenna, such as on the antenna 108. If the antenna 108 is
connected to a load 12250, then a current 12221 can be induced at
the antenna 108, on a signal path between the antenna 108 and the
load 12250, in response to the first transmitted signal 12211
arriving at the antenna 108. The induced current 12221 at the
antenna 108 leads to radiation or signal transmission from the
receiving antenna 108. The radiation, or backscatter signal 12234,
from the antenna 108 can be transmitted back to the original
transmitting antenna 12206 and can induce a voltage on the
transmitting antenna 12206. The induced voltage on the transmitting
antenna 12206 can thus provide a signal that can be detected by
circuitry or a load coupled to the transmitting antenna 12206.
[0599] The induced current 12221 can be based on the load 12250
that is coupled to the antenna 108. Changes in the load 12250 can
influence characteristics of the induced current 12221, which in
turn can influence characteristics of the backscatter signal 12234.
In FIG. 102, a modulation device 12230 is coupled to the antenna
108, and the modulation device 12230 can be configured to modulate
the induced current 12221. In one or more embodiments, the
modulation device 12230 includes a switch or transistor configured
to act as a portion of a load for the antenna 108. When the
transistor's gate receives a specified threshold signal, a signal
sufficient to turn the transistor on, a current signal can readily
travel through the modulation device 12230. When the transistor's
gate is off, then no current signal travels through the modulation
device 12230. Since the induced current 12221, and thus the
backscatter signal 12234, depend on a load presented to the
antenna, the embodiment of FIG. 102 can provide a modulated
backscatter signal 12234 according to a modulation signal 12231
provided to the modulation device 12230. In one or more
embodiments, the modulation signal 12231 is a PWM signal. In one or
more embodiments, the backscatter signal 12234 can be provided as a
relatively short burst of (dedicated) high frequency pulses that
occur at separate times, or the backscatter signal 12234 can be
provided as a pulse position modulated or pulse width modulated
signal. Other data or signal modulation schemes can similarly be
used.
[0600] In one or more embodiments, the modulation signal 12231 can
be a relatively low frequency signal relative to the first
transmitted signal 12211. Thus, modulation switching control
circuitry, such as in the implantable device, can operate at
various data communication frequencies that can be less than an RF
carrier frequency of the first transmitted signal 12211. The
modulation switching control circuitry can operate at relatively
low frequencies, corresponding to a power savings for the
implantable device relative to other devices that use an RF
generator circuitry.
[0601] FIG. 103 illustrates, by way of example, a diagram of a
method 12300 that includes updating a broadcast signal based on
information about an implanted device. At operation 12310, the
method 12300 includes transmitting a power and/or data signal to an
implanted device. For example, operation 12310 can include
transmitting the midfield signal 131 from the antenna 300 of the
external source 102. At operation 12320, the signal transmitted by
the external source 102 can be received by the implantable device
110. At operation 12330, one or more characteristics of the
received signal can be measured using the implantable device 110.
For example, a magnitude of a power signal received, or an
efficiency of a power transfer, can be measured or calculated, such
as using processor circuitry (e.g., digital controller of FIG. 5)
on board the implantable device 110.
[0602] At operation 12332, information about one or more of an
operating characteristic of the implantable device 110, a therapy
provided by the implantable device 110, or a physiologic parameter
sensed by the implantable device 110, can be monitored by the
implantable device 110. For example, information about an
electrostimulation parameter, an electrode impedance
characteristic, or other information can be monitored. At operation
12340, the information measured at operation 12330 and/or the
information monitored at operation 12332 can be encoded into a data
signal and used to generate the modulation signal 12231.
[0603] At operation 12350, the encoded information can be
transmitted from the implanted device 110, for example, via the
backscatter signal 12234. At operation 12360, the encoded
information can be received at the external source 102. The
processor circuitry 210 of the external source 102 can be used to
decode the received signal, such as to extract the measured or
monitored information from the implantable device 110. In one or
more embodiments, at operation 12310, the method 12300 can include
using the decoded information to update a power and/or data signal
transmission characteristic. The method 12300 can return to
operation 12310 to transmit a subsequent power and/or data signal,
such as using the updated transmission characteristic.
[0604] FIG. 104 illustrates, by way of example, a diagram of an
embodiment of a method 12400 that includes modulating an antenna
signal receive path for a wireless signal. The method 12400 can
begin with operation 12320, including receiving the signal
transmitted by the external source 102 using the implantable device
110. At operation 12440, the method 12400 includes modulating a
receive path in the implanted device to encode implanted device
information 12430 in a communication signal. Modulating the receive
path can be performed according to the example of FIG. 102, for
example, using the modulation device 12230 to modulate a signal
path between the antenna 108 and a load 12250. At operation 12450,
the method 12400 can include transmitting a signal from the
implantable device 110 by reflecting a portion of the received
signal (e.g., the first transmitted signal 12211 from the antenna
300 of the external source 102) according to the modulation.
[0605] FIG. 105 illustrates, by way of example, a schematic diagram
of an embodiment of a system configured to excite a midfield
antenna and receive a backscatter signal. The example of FIG. 105
includes a source configured to provide the RF input signal 414,
and the power divider 412, or splitter, configured to provide
multiple instances or portions of an RF drive signal, such as to
the antenna 300. The example includes modulation circuitry 12501
for modulating the RF drive signal, and a first preamplifier 12502.
The example includes a signal splitter 12503 that divides the RF
drive signal into multiple different RF signals, such as to provide
multiple signals for respective different ones of the RF ports on
the antenna 300.
[0606] Multiple signal channels can extend from the signal splitter
12503 to the antenna 300. A first signal channel can include first
phase shifter circuitry 12505A and first amplifier circuitry
12506A, a second signal channel can include a different second
phase shifter circuitry 12505B and different second amplifier
circuitry 12506B, and so on. Each of the signal channels extending
from the signal splitter 12503 can thus be separately adjusted or
tuned to have different phase and/or amplitude characteristics for
differently exciting the antenna 300 via respective RF ports.
[0607] In one or more embodiments, a fourth channel extends from
the signal splitter 12503 to the antenna 300 and includes fourth
amplifier circuitry 12507 and a circulator 12510. The circulator
12510 can be configured to enable use of a corresponding RF port,
such as the fourth RF port 314, for both excitation via the RF
input signal 414 and reception of the backscatter signal 12234. A
signal received from the antenna 300, after processing by the
circulator 12510, is illustrated in the example of FIG. 106A.
[0608] The example of FIG. 105 further includes a cancelation
signal path from the power divider 412 to summing circuitry 12520.
The cancelation signal path includes adjustable amplifier circuitry
12512 and adjustable phase shift circuitry 12515. Using the summing
circuitry 12520, signals from the cancelation signal path can be
summed with the backscatter signal 134 received via the antenna 300
(e.g., via an electrical signal received from the fourth RF port
314) to provide a summed signal (see FIG. 106B). In an example, the
cancelation signal path provides, at the summing circuitry 12520, a
signal having substantially equal amplitude and opposite phase to
an expected interference signal portion received via the fourth RF
port 314.
[0609] In one or more embodiments, a cancellation signal provided
(e.g., after the phase shift circuitry 12515) can be defined at
least in part as
-(Lc*[S.sub.41P.sub.1+S.sub.42P.sub.2+S.sub.43P.sub.3]), where Lc
is a leakage from the circulator, and Px corresponds to a transmit
power for a designated port. Thus, in one or more embodiments, an
appropriate cancelation signal can be determined based on prior
knowledge of the behavior or self-interference of the various ports
of the antenna 300. FIG. 107 illustrates an embodiment of selecting
or determining an appropriate canceling signal.
[0610] The example of FIG. 105 further includes an auxiliary signal
path configured to carry an auxiliary signal from the power divider
412 to mixer circuitry 12530. At the mixer circuitry 12530, the
summed signal from the summing circuitry 12520 can be mixed with
the auxiliary signal to provide a data signal (see FIG. 106C).
[0611] The example of FIG. 105 further includes a low-pass filter
12540, a high-pass filter 12550, and a decoder circuitry 12560. The
decoder circuitry 12560 can be used to extract encoded information
from the data signal after the data signal is processed by the
filters 12540 and 12550. The filters 12540 and 12550 help to "clean
up" the data signal to facilitate data extraction by removing noise
(see FIG. 106D). For example, the filters can be used to filter out
and substantially remove various harmonics generated as a result of
mixing the received signal with the RF carrier.
[0612] FIGS. 106A-106D illustrate, by way of example, signal
diagrams of embodiments corresponding to different portions of the
system of FIG. 105. For example, the signal diagram illustrated in
FIG. 106A corresponds to the portion of FIG. 105 labeled "106A",
the signal diagram illustrated in FIG. 126B corresponds to the
portion of FIG. 105 labeled "106B", and so on. In FIGS. 106A-106D,
f.sub.0 corresponds to a center frequency of a self-interference or
leakage signal, such as due to cross-coupling and leakage effects
of the antenna 300, described above. Sidebands of the leakage
signal include components of the backscatter signal 12234. These
sidebands are generally centered around f.sub.0-f.sub.BS and
f.sub.0+f.sub.BS. In one or more embodiments, f.sub.0 is around 915
MHz, however, other center frequencies can be used (e.g., at or
around the range of 860-960 MHz, at or around 2.45 GHz, or at or
around 402 MHz to about 405 MHz, or at other frequencies). The
backscatter signal 12234 can be modulated according to, for
example, 40-320 kHz, however other modulation frequencies can be
used (e.g., between 40 and 100 kHz, between 60 and 200 kHz, between
100 and 300 kHz, between 150 and 250 kHz, between 200 and 300 kHz,
between 150 and 320 kHz, overlapping ranges thereof, or any value
within the recited ranges). In one or more embodiments, the
backscatter signal at f.sub.BS can be about 80-100 dB below the
self-interference signal at f.sub.0. Thus, a problem to be solved
includes suppressing the self-interference signal and extracting
data from the backscatter signal. A solution includes using the
circuitry of FIG. 105 to introduce the cancelation signal and
auxiliary signal to cancel a portion of the backscatter signal
related to the self-interference of the antenna 300 itself. That
is, self-interference due to coupling between ports of the antenna
300 can be significant, and the self-interference can be predicted
and canceled using an opposing signal from the RF source (e.g., 180
degrees out of phase with the self-interference signal).
[0613] In an embodiment, FIG. 106A represents a communication
signal modulated according to a specified modulation scheme (e.g.,
to encode information) that includes sidebands and a carrier
frequency. FIG. 106B can represent a combination of the modulated
communication signal with a cancelation signal that is 180 degrees
out of phase with the communication signal. The cancelation signal
can be selected or tuned based on characteristics of the adjustable
amplifier circuitry 12512 and the adjustable phase shift circuitry
12515 in the cancelation signal path. Thus, the leakage signal at
f.sub.0 can be reduced to a DC signal with sidebands that can be
extracted with a high-pass filter. In one or more embodiments, the
combination of the modulated communication signal with the
cancelation signal can improve a signal-to-noise ratio of the
backscatter signal by about 30 dB or more (e.g., 20 to 40 dB, 25 to
35 dB, 30 to 40 dB, 20 to 30 dB, overlapping ranges thereof, or any
value within the recited ranges).
[0614] In one or more embodiments, FIG. 106C represents the
communication signal after it is mixed with the auxiliary signal
(e.g., a carrier signal) from the auxiliary signal path. The mixed
signal includes various harmonic signal components that can be
filtered out. FIG. 106D can represent the filtered backscatter
signals that can be further analyzed or processed, such as using
the processor circuitry 210, to retrieve information encoded by the
implantable device 110. Further analog and/or digital filtering can
be performed to recover data signal components.
[0615] In one or more embodiments, an initial model can be
generated to describe the coupling characteristics, or
self-interference, of the antenna 300. From that initial model,
slight perturbations in the phase can be injected in the signal to
create layers of cancellation in an algorithm. FIG. 107, for
example, illustrates, by way of example, a diagram of an embodiment
of a method 12700 that includes adjusting an amplitude and/or phase
characteristic of a cancellation signal.
[0616] At 12710, the method of FIG. 107 includes setting a gain
characteristic of the adjustable amplifier circuitry 12512 to an
initial gain level, and/or setting a phase shift characteristic of
the adjustable phase shift circuitry 12515 to an initial phase
shift level, to provide a cancelation signal. At operation 12720, a
DC component of the received signal can be measured when the
external source 102 receives the backscatter signal 12234, such as
to determine an effectiveness of the cancelation signal. At
operation 12725, an amplitude characteristic of the measured DC
signal can be compared with a threshold. If the DC signal is within
a threshold margin, then the initial gain level and/or the initial
phase shift level can be set as a reference and used for further
signal processing. If the DC signal is outside of the threshold
margin, then, at operation 12730, the initial gain level and/or the
initial phase shift level can be changed or perturbed, such as at
the same time or in turn.
[0617] After the gain and/or phase shift characteristics are
perturbed, the method can continue at operation 12740 by measuring
the DC component again. At operation 12745, if the DC signal level
is not decreased, then at operation 12750 the method can revert to
a prior gain and/or phase shift level, and then return to operation
12730 for further adjusting the gain and/or phase shift. If, at
operation 12745, the DC signal level decreased, then the method
continues at operation 12747 to check whether the DC signal level
is within the specified threshold margin. If the signal is not
within the specific margin, then the method returns to operation
12730 for further adjusting the gain and/or phase shift. If the
signal is within the specified margin at operation 12747, then the
method continues to operation 12760. At operation 12760, the
adjusted gain and/or phase shift level(s) can be set as a reference
for use in recovering data from the backscatter signal 12234.
[0618] In one or more embodiments, a self-jamming cancelation
algorithm based on coupling or self-leakage characteristics of the
antenna 300 includes (1) assuming an initial coupling or leakage
characteristic between different ports of the antenna 300 (see,
e.g., the example of FIG. 3), (2) determining an n-order polynomial
equation to fit or model the leakage characteristic, (3) using the
external source 102, sending a command to the implantable device
110 to introduce an expected phase perturbation into a backscatter
signal to be received by the external source 102 (such a low-level
phase modulation, also known as phase jitter modulation, can be in
the form of a regular pattern or a pseudo-random pattern, or the
backscatter circuitry can use OOK modulation of the backscatter
signal (e.g., with full modulation depth) by modulating the
backscatter signal with a switch to detune a receive antenna, such
as including modulating in the 0-1 MHz range), (4) subtracting the
phase jitter from the received backscatter signal at the external
source 102 to obtain a signal of interest (e.g., in the OOK method,
the received signal can be mixed with the transmitter carrier RF
signal and filtered to extract the modulated signal), and (5)
updating the external source 102, e.g. to adapt to a degraded
received signal, by instructing the external source to send a
different phase jitter instruction to the implantable device 110.
In one or more embodiments that includes multiple implantable
devices powered by a single external source 102, each implantable
device 110 can have a unique identification code and the external
source 102 can transmit a unique phase jitter command to each
implantable device 110.
B. Active Power Management Techniques for Wireless Implantable
Devices
[0619] Generally discussed in this subsection are systems, devices,
and methods for providing or delivering a therapy using an
implantable device. In one or more embodiments, the therapy
includes an electrostimulation therapy provided to one or more
neural targets in a body. In one or more embodiments, the
electrostimulation therapy is provided using an implant device that
wirelessly receives power and data signals from a midfield
transmitter (e.g., an external source, such as the source 102).
[0620] There is a current unmet need that includes communicating
power and/or data using midfield transmitters and receivers, such
as to communicate power and/or data from an external midfield
coupler to one or more implanted neural stimulation devices and/or
one or more implanted sensor devices.
[0621] In one or more embodiments, multiple devices can be
implanted in patient tissue and can be configured to deliver a
therapy and/or sense physiologic information about a patient. The
multiple implanted devices can be configured to communicate with
one or more external devices. In one or more embodiments, the one
or more external devices are configured to provide power and/or
data signals to the multiple implanted devices, such as
concurrently or in a time-multiplexed (e.g., "round-robin")
fashion. The provided power and/or data signals can be steered or
directed by an external device to efficiently transfer the signals
to an implantable device. Although the present disclosure may refer
to a power signal or data signal specifically, such references are
to be generally understood as optionally including one or both of
power and data signals.
[0622] Several embodiments described herein are particularly
advantageous because they include one, several, or all of the
following benefits: (i) a dynamically configurable, active midfield
transceiver that is configured to provide RF signals to modulate an
evanescent field at a tissue surface and thereby generate a
propagating field within tissue, such as to transmit power and/or a
data signal to an implanted target device; (ii) a dynamically
configurable, substantially passive midfield transceiver or lens
that is configured to receive remote RF signals and in response
provide RF signals to modulate an evanescent field at a tissue
surface and thereby generate a propagating field within tissue,
such as to transmit power and/or a data signal to an implanted
target device; (iii) a tunable device for changing one or more RF
signal receipt or transmission characteristics; (iv) feedback
circuitry for updating or adjusting one or more signal receipt or
transmission characteristics based on previous or current signal
transmission activity; (v) adjustable midfield and far-field RF
signal sources that can change a power transmit level based on
information from one or more other midfield devices or implanted
devices; (vi) providing power and/or data signals to multiple
target devices using a common source device, such as concurrently
or at different time intervals; (vii) sensing backscatter signal
information to determine a quality of a signal transmission to a
target device implanted in tissue; and/or (viii) providing power
and/or data signals to one target device using multiple different
source devices.
[0623] In one or more embodiments, the digital controller 548, the
amplifier 555, and/or the stimulation driver circuitry 556, among
other components of the circuitry 500, can comprise portions of a
state machine device. See FIG. 5 for the digital controller 548,
amplifier 555, and/or the stimulation driver circuitry 556. The
state machine device can be configured to wirelessly receive power
and data signals via the pad(s) 536 and, in response, release or
provide an electrostimulation signal via one or more of the outputs
534. In one or more embodiments, such a state machine device needs
not retain information about available electrostimulation settings
or vectors, and instead the state machine device carries out or
provides electrostimulation events substantially immediately after,
and in response to, receipt of instructions from the wireless
transmitter.
[0624] For example, the state machine device can be configured to
receive an instruction to deliver a neural electrostimulation
therapy signal, such as at a specified time or having some
specified signal characteristic (e.g., amplitude, duration, etc.),
and the state machine device can respond by initiating or
delivering the therapy signal. At a subsequent time, the device can
receive a subsequent instruction to terminate the therapy, to
change a signal characteristic, or to perform some other task.
Thus, the device can optionally be configured to be substantially
passive, or responsive to contemporaneously-received
instructions.
[0625] In some embodiments of the midfield source devices described
herein, a target or focal region can be adjusted, such as without
mechanical reconfiguration of the source, using degrees of freedom
provided by the amplitudes and phases of the input port signals.
Such field directing or focusing can be useful in applications in
which a source may be used to power implantable devices configured
to interact with organs in rhythmic motion (e.g., due to breathing
or heartbeat), to power one or more implantable devices, or to
power an implantable device that is movable inside the body.
[0626] To shift a focal region, excitation signal characteristics
for different subwavelength structures (e.g., subwavelength
structures that are part of the same or different source device)
can be configured and reconfigured, such as in real-time, such as
to enable various field patterns to be provided.
[0627] FIG. 108 illustrates, by way of example, a diagram of an
embodiment of a system 7600 for selectively providing power and/or
a data communication signals to (respective) multiple target
devices. The system 7600 includes the antenna 300 (see FIG. 3),
such as can be included or used in the source 102 (see FIG. 1). The
antenna 300 can be configured to communicate power and/or data
signals to one or both of a first target device 7611 and a second
target device 7612. That is, the external midfield device (e.g.,
the antenna 300 or circuitry that can be electrically coupled
thereto, such as illustrated in FIG. 4 among other FIGS.) can be
configured to manipulate an evanescent field at or near an external
tissue surface to direct transmission of wireless power and/or data
signals within the tissue, such as to the first and/or second
target device 7611 and 7612. In FIG. 108, the first and second
target devices 7611 and 7612 are therapy delivery or sensor
devices, and each includes multiple electrodes E0, E1, E2, and E3.
Other target devices can similarly be used and may have different
numbers and/or configurations of electrodes. The first target
device 7611 and the second target device 7612 can be similar to or
the same as the implantable device 110, 600, 700, or other
implantable device discussed herein.
[0628] In one or more embodiments, the external midfield device
communicates signals to the first and second target devices 7611
and 7612 at different, non-overlapping time intervals. For example,
the external midfield device can send signals to and/or receive
signals from the first target device 7611 during a first interval
.DELTA.t1 and a third interval .DELTA.t3, and the external midfield
device can send signals to and/or receive signals from the second
target device 7612 during a second interval .DELTA.t2 and a fourth
interval .DELTA.t4. The external midfield device can communicate
power and/or data in a round-robin manner, with the antenna 300
providing different signals to different targets at different
times. Optionally, the external midfield device provides a blanking
period or delay between the different communication intervals. An
example illustrating communication intervals is presented
graphically in FIG. 109.
[0629] FIG. 109 illustrates, by way of example, a diagram of an
embodiment of a method that includes using different signal
characteristics to communicate power and/or data signals to
different target devices at different times. In the method of FIG.
109, the external midfield device corresponds to the source 102 of
FIG. 1. That is, the external midfield device includes four
subwavelength structures that can be separately excited by
respective RF drive signals. In one or more embodiments, the
amplifiers 408A-D and/or the phase shifters 410A-D from the example
of FIG. 4 can be respectively coupled to the subwavelength
structures of the external midfield device, such as to provide
separate RF drive signals to each of the subwavelength structures.
The subwavelength structures of the external midfield device can be
concurrently excited to transmit a set of RF signals that together
can influence evanescent and propagating waves, such as to direct
power and/or data communication signals to various targets within
tissue.
[0630] FIG. 109 illustrates a series of signals, including first,
second, third, and fourth signals S1, S2, S3, and S4, respectively,
that are sequentially transmitted from the external midfield device
to one or the other of the first and second target devices 7611 and
7612. Each of the signals S1-S4 can be transmitted by the external
midfield device when the transceiver is configured in a specified
manner to influence evanescent fields at the tissue surface and, as
a result, generate a propagating signal directed or focused toward
a specified target. For example, during a first transmission
interval .DELTA.t1 and during a third transmission interval
.DELTA.t3, the external midfield device is configured to transmit
the first and third signals S1 and S3, respectively, to the first
target device 7611.
[0631] In FIG. 109, the external device transmit signal illustrates
generally that an RF signal, or a set of RF signals, is transmitted
over a specified interval. Although the external device transmit
signal is illustrated as a square wave, it can represent other,
time-varying or static signals transmitted during the various
specified intervals. For example, the first signal S1 can
correspond to a first PWM signal having a first duty cycle that is
provided during the first transmission interval .DELTA.t1, and the
second signal S2 can correspond to a different PWM signal having a
second duty cycle that is provided during the second transmission
interval .DELTA.t2. Other signal types can similarly be used.
[0632] During the first transmission interval .DELTA.t1 and the
third transmission interval .DELTA.t3, the external midfield device
is configured to excite a first one of its subwavelength structures
("Structure 1") using a reference RF drive signal, such as can have
a reference phase angle .PHI..sub.Ref and can be provided at an
amplifier power saturation level Psat, to transmit the first signal
S1 or the third signal S3 to the first target device 7611. During
the first transmission interval .DELTA.t1 and the third
transmission interval .DELTA.t3, the external midfield device is
configured to excite second, third, and fourth subwavelength
structures ("Structure 2", "Structure 3", "Structure 4") using
phase-shifted versions of the reference RF drive signal. For
example, the second subwavelength structure can receive an
excitation signal that is phase-shifted from the reference by
.PHI..sub.1-Dev1, the third subwavelength structure can receive an
excitation signal that is phase-shifted from the reference by
.PHI..sub.2-Dev1, and the fourth subwavelength structure can
receive an excitation signal that is phase-shifted from the
reference by .PHI..sub.3-Dev1. In one or more embodiments, any two
or more of .PHI..sub.1-Dev1, .PHI..sub.2-Dev1, and .PHI..sub.3-Dev1
can refer to the same or different phase-shift magnitude.
[0633] In one or more embodiments, each of the subwavelength
structures can receive an RF drive signal having a different power
characteristic. Any one or more of the signals provided to the
first through fourth subwavelength structures can be provided at
its respective amplifier power saturation level, or at some other
power level. In one or more embodiments, each amplifier that is
coupled to a subwavelength structure can have a current supply that
is tuned to change the amplifier's saturation power. As a result,
one or more of the structures can be driven by different power
levels, yet each drive signal can be provided under saturation
conditions.
[0634] In one or more embodiments, the first signal S1 transmitted
during the first transmission interval .DELTA.t1 is the same power
and/or data signal that is transmitted as the third signal S3
during the third transmission interval .DELTA.t3. In one or more
embodiments, the first signal S1 is different than the third signal
S3. That is, the first signal S1 and the third signal S3 can
include different levels of power and/or can include different data
or information transmitted from the external midfield device to the
first target device 7611.
[0635] During the second transmission interval .DELTA.t2 and the
fourth transmission interval .DELTA.t4, the external midfield
device is configured to excite a first one of its subwavelength
structures using a reference RF drive signal, such as can be
provided at an amplifier saturation level Psat, to transmit the
second signal S2 and the fourth signal S4 to the second target
device 7612. The second target device 7612 can be in a location
other than the location of the first target device 7611. During the
second transmission interval .DELTA.t2 and the fourth transmission
interval .DELTA.t4, the external midfield device is configured to
excite second, third, and fourth subwavelength structures using
phase-shifted versions of the reference RF drive signal. For
example, the second subwavelength structure can receive an
excitation signal that is phase-shifted from the reference by
.PHI..sub.1-Dev2, the third subwavelength structure can receive an
excitation signal that is phase-shifted from the reference by
.PHI..sub.2-Dev2, and the fourth subwavelength structure can
receive an excitation signal that is phase-shifted from the
reference by .PHI..sub.3-Dev2. In one or more embodiments, any two
or more of .PHI..sub.1-Dev2, .PHI..sub.2-Dev2, and .PHI..sub.3-Dev2
can refer to the same or different phase-shift magnitude. In one or
more embodiments, at least one of .PHI..sub.1-Dev2,
.PHI..sub.2-Dev2, or .PHI..sub.3-Dev2 is different than its
corresponding .PHI..sub.1-Dev1, .PHI..sub.2-Dev1, and
.PHI..sub.3-Dev1, such that the field transmitted from the external
midfield device differently influences an evanescent field during
transmission of the first and second signals S1 and S2 to
differently direct propagating waves toward the first and second
target devices 7611 and 7612, respectively.
[0636] FIG. 110 illustrates, by way of example, a diagram of an
embodiment of a method 7800 that includes receiving power transfer
efficiency information from multiple target devices. At operation
7810, the method can include generating a first set of RF signals.
In one or more embodiments, and with reference to FIG. 4,
generating a first set of RF signals can include dividing the RF
input signal 414 and providing multiple separate signals, such as
including phase-modulated and/or amplitude-modulated versions of a
reference signal, to one or more output ports or subwavelength
structures in a transmitter or transceiver, such as the external
midfield device. At operation 7820, the method can include
transmitting the first set of RF signals by exciting multiple
different subwavelength structures in the external midfield device
using respective separate RF signals.
[0637] At operation 7830, and in response to the transmitting the
first set of RF signals at operation 7820, the method 7800 can
include receiving a first signal at a target device, such as at the
first target device 7611. The received first signal can include at
least a portion of the transmitted set of RF signals from the
external midfield device. That is, the set of RF signals
transmitted by the external midfield device can create a
propagating wave signal, and at least a portion of that propagating
wave signal can be received by receiver circuitry (e.g., comprising
a portion of the demodulator 544 or the rectifier 546 of the
example of FIG. 5) at the target device (e.g., an implantable
device).
[0638] At operation 7835, the method can include receiving a signal
transfer quality indication at the external midfield device, such
as based on the first signal received at the first target device
7611. In one or more embodiments, the signal transfer quality
indication includes a data signal transmitted from the first target
device 7611 to the external midfield device (e.g., transmitted
using RF, near-field, optical, or other communication channel). The
data signal can include information about a quantity of power
received and/or information about a quality or coherence of data
received at operation 7830.
[0639] In one or more embodiments, the signal transfer quality
indication includes receiving a backscatter signal at the external
midfield device, such as substantially concurrently with the
transmitting the first set of RF signals at operation 7820. At
operation 7835, the received backscatter signal can include
information about a portion of the transmitted first set of RF
signals that is received by the first target device 7611. That is,
based on characteristics of the received backscatter signal, the
external midfield device can be configured to determine how much of
a power signal transmitted was received at the first target device
7611. In one or more embodiments, an amplitude of a backscatter
signal can be proportional to an amount of power received at a
target device. In one or more embodiments, a power transfer
efficiency characteristic can be determined based on the amplitude
of the backscatter signal, or based on a received signal transfer
quality indication.
[0640] At operation 7840, one or more parameters of the external
midfield device can be updated or adjusted, such as to reconfigure
the external midfield device for power and/or data communication
with the second target device 7612. For example, updating the
signal generator parameters at operation 7840 can include updating
a phase-modulation or amplitude-modulation characteristic
associated with one or more of the RF signal channels coupled to
subwavelength structures of the external midfield device. At
operation 7850, the method 7800 includes generating a second set of
RF signals using the updated signal generator parameters. In FIG.
110, the second set of RF signals generated at operation 7850 is
different than the first set of RF signals generated at operation
7810. That is, at least one of the signals in the first set of RF
signals includes a characteristic (e.g., amplitude, frequency,
phase, morphology, etc.) that is different than at least one of the
signals in the second set of RF signals. At operation 7860, the
method 7800 includes transmitting the second set of RF signals,
such as using the same external midfield device. In one or more
embodiments, the same transceiver is used but different excitation
ports and/or subwavelength structures are used to transmit the
first and second sets of RF signals at operations 7810 and
7860.
[0641] At operation 7870, and in response to the transmitting the
second set of RF signals at operation 7860, the method 7800 can
include receiving a second signal at a target device, such as at
the second target device 7612. The received second signal can
include at least a portion of the transmitted second set of RF
signals from the external midfield device. That is, the second set
of RF signals transmitted by the external midfield device can
create a propagating wave signal, and at least a portion of that
propagating wave signal can be received by receiver circuitry
(e.g., comprising a portion of the demodulator 544 or the rectifier
546 of the example of FIG. 5) at the second target device 7612.
[0642] At operation 7875, the method 7800 can include receiving a
signal transfer quality indication at the external midfield device,
such as based on the second signal received at the second target
device 7612. In one or more embodiments, the signal transfer
quality indication includes a data signal transmitted from the
second target device 7612 to the external midfield device (e.g.,
transmitted using RF, near-field, optical, or other communication
channel). The data signal can include information about a quantity
of power received and/or information about a quality or coherence
of data received at operation 7870.
[0643] FIG. 111 illustrates, by way of example, a diagram of an
embodiment of a method 7900 that includes updating a characteristic
of at least one signal in a set of RF signals based on a data
signal received from a target device. At operation 7910, the method
7900 includes transmitting a first set of RF signals using a
midfield transmitter. For example, the transmitting can include
exciting multiple different subwavelength structures in the
external midfield device using respective separate RF signals.
[0644] At operation 7920, such as in response to the transmitting
the first set of RF signals at operation 7910, the method 7900 can
include receiving a first signal at a target device, such as at the
first target device 7611. The received first signal can include at
least a portion of the transmitted set of RF signals from the
external midfield device. That is, the set of RF signals
transmitted by the external midfield device at operation 7910 can
create a propagating wave signal, and at least a portion of that
propagating wave signal can be received by receiver circuitry
(e.g., comprising a portion of the demodulator 544 or the rectifier
546 of the example of FIG. 5) at the first target device 7611.
[0645] At operation 7930, the method 7900 can include delivering a
neural electrostimulation therapy signal using the first target
device 7611, and using at least a portion of the first signal
received at operation 7920. For example, the first signal received
at operation 7920 can include a power signal that can be stored, at
least temporarily, by the first target device 7611, such as by
using one or more capacitors. The power signal can be provided to
the stimulation driver circuitry 556, for example, which can be
coupled to one or more electrodes (e.g., E0-E3) of the first target
device 7611. The stimulation driver circuitry 556 can use the power
signal to provide an electrostimulation signal to provide a
therapy.
[0646] At operation 7940, the method 7900 can include providing a
data signal from the first target device 7611 to the external
midfield device. The data signal can include information about the
therapy signal delivered at operation 7930, or the data signal can
include information about a status of the first target device 7611,
among other things. For example, the data signal can include
information about a remaining or available power, such as can be
used by the first target device 7611 and/or the external midfield
device to determine whether or when to request or provide an
additional power signal transfer from the external midfield device
to the first target device 7611. In one or more embodiments, the
data signal includes information about a quality of the first
signal received at operation 7920. Based on the quality
information, the external midfield device can update or adjust a
device parameter to enhance the quality of subsequent
transmissions.
[0647] For example, at operation 7950, the external midfield device
can update a characteristic of at least one of the RF signals, in
the first set of RF signals, based on the data signal provided by
the first target device 7611 at operation 7940. Updating a
characteristic can include changing one or more of a signal
amplitude, frequency, phase, morphology, or other characteristic of
at least one of the signals in the first set of RF signals. When at
least one of the signals in the set of RF signals is changed, then
the evanescent field at the tissue surface can be differently
manipulated, such as to differently direct a propagating wave
within tissue.
[0648] FIG. 112 illustrates, by way of example, a diagram of an
embodiment of a method 8000 that can include updating a
characteristic of at least one signal in a set of RF signals based
on a backscatter signal. At operation 8010, the method 8000
includes transmitting a first set of RF signals using a midfield
transmitter. For example, the transmitting can include exciting
multiple different subwavelength structures in the external
midfield device using respective separate RF signals to generate a
propagating field in tissue.
[0649] At operation 8020, the method 8000 can include receiving a
first signal at the first target device 7611, such as described
above at operation 7920. Substantially concurrently with operation
8020, and at operation 8025, the external midfield device can
receive a backscatter signal, such as in response to the
transmitted first set of RF signals at operation 8010. The
backscatter signal can include a diffused portion of the
transmitted first set of RF signals. Based on the status of the
first target device 7611 (e.g., the first target device 7611 being
in a transmit mode or a receive mode), the first target device 7611
can influence or modulate the portion of the first set of RF
signals that is reflected or backscattered toward the transmitter
or external midfield device. In one or more embodiments, the
backscatter signal is proportional to the received power at the
first target device 7611.
[0650] At operation 8050, based on the received backscatter signal
at operation 8025, the method 8000 can include updating a
characteristic of at least one of the RF signals in the transmitted
first set of RF signals. For example, if the backscatter signal has
an amplitude other than an expected amplitude, then the external
midfield transceiver can change one or more characteristics of the
RF signals in the first set of RF signals, such as to redirect a
propagating wave toward the first target device 7611.
[0651] FIG. 113 illustrates, by way of example, a diagram of an
embodiment of a method 8100 that includes updating a characteristic
of at least one signal in a set of RF signals based on a data
signal received from a target device. At operation 8110, the method
8100 includes transmitting a first set of RF signals using a
midfield transmitter (e.g., the antenna 300, the source 102, or
other midfield device discussed herein). For example, the
transmitting can include exciting multiple different subwavelength
structures in the external midfield device using respective
separate RF signals to generate a propagating field in tissue.
[0652] At operation 8120, and in response to the transmitting the
first set of RF signals at operation 8110, the method 8100 can
include receiving a first signal at first and second target
devices, such as at the first target device 7611 and at the second
target device 7612. The first signal can be received substantially
concurrently by the first and second target devices 7611 and 7612.
The received first signal can include at least a portion of the
transmitted set of RF signals from the external midfield device.
That is, the set of RF signals transmitted by the external midfield
device can create a propagating wave signal, and at least a portion
of that propagating wave signal can be received by respective
receiver circuitry (e.g., comprising a portion of the demodulator
544 or the rectifier 546 of the circuitry of FIG. 5) at the target
devices.
[0653] At operation 8140, the method 8100 includes providing a data
signal from one or both of the first target device 7611 and the
second target device 7612 to the external midfield device. In one
or more embodiments, the data signals include information about a
status of the target devices, or a therapy delivered from one or
both of the target devices, among other things. For example, the
data signal can include information about a remaining or available
power, such as can be used by the first target device 7611 and/or
the external midfield device to determine whether or when to
request or provide an additional power signal from the external
midfield device to the first target device 7611. In one or more
embodiments, the data signal includes information about a quality
of the first signal received by one or both of the target devices
at operation 8120. Based on the quality information, the external
midfield device can update or adjust a device parameter to enhance
the quality of subsequent transmissions, such as by directing or
steering a subsequent propagating wave signal toward one or the
other of the first and second target devices 7611 and 7612.
[0654] In one or more embodiments, at operation 8150, the external
midfield device can update a characteristic of at least one of the
RF signals, in the first set of RF signals, such as based on one or
both of the data signals provided by the first or second target
devices 7611 and 7612 at operation 8140. Updating a characteristic
can include changing one or more of a signal amplitude, frequency,
phase, morphology, or other characteristic of at least one of the
signals in the first set of RF signals. When at least one of the
signals in the set of RF signals is changed, then the evanescent
field at the tissue surface can be differently manipulated, such as
to differently direct a propagating wave within tissue. For
example, as a result of updating a signal characteristic at
operation 8150, a different second set of RF signals can be
provided by the external midfield device, such as to direct
transmission of a power or data signal to only one of the first and
second target devices 7611 and 7612, or to another device.
[0655] FIG. 114 illustrates, by way of example, a diagram of an
embodiment of a system 8200 for selectively providing power and/or
data communication to multiple target devices using a remote RF
source and a midfield device. The system 8200 includes a remote
field source 8220, an external device 8205, and multiple target
devices. The external device 8205 can be configured to receive a
field or an electromagnetic, remote signal from the remote field
source 8220, modulate the received signal, and in response
communicate power and/or data signals to one or both of the first
target device 7611 and the second target device 7612. That is, the
external device 8205 can be configured to manipulate an evanescent
field at or near an external tissue surface to direct transmission
of wireless power and/or data signals within the tissue, such as to
the first and/or second target device 7611 and 7612. The external
device 8205 can be configured to communicate the power and/or data
signals to a target device concurrently or asynchronously with
receiving the remote signal from the remote field source 8220.
[0656] The remote field source 8220 can be configured to provide an
electromagnetic field or remote RF signal (herein, "remote signal")
that can be received and/or modulated by the external device 8205.
The remote field source 8220 can include an RF generator circuitry
8222 that is configured to generate one or more RF signals based on
instructions from a control circuitry 8221. The control circuitry
8221 can provide signal parameter information to the RF generator
circuitry 8222, such as can include amplitude, frequency, phase,
waveform morphology, or other signal parameter information. The
remote field source 8220 can further include a memory circuitry
8224 or clock circuitry 8225 in data communication with one or more
of the control circuitry 8221 and RF generator circuitry 8222, such
as to store the signal parameter information and/or to trigger
signal generation. In one or more embodiments, the remote field
source 8220 includes a feedback control circuitry 8223 that can use
the control circuitry 8221 to change one or more signal parameters
and thereby change a characteristic of the remote signal that is
provided. In one or more embodiments, the remote field source 8220
includes multiple RF outputs, and the multiple outputs can be
excited independently. The multiple outputs can be excited
concurrently or at separate times. In one or more embodiments, each
output is coupled to a different phase shifter 8226A-8226D that can
be used to change a characteristic of the outputted remote signal.
Other signal-modifying elements can be included at or before the
outputs, such as amplifier or attenuator circuitry.
[0657] The external device 8205 can include various hardware
structures that are configured to receive a portion of the remote
signal from the remote field source 8220 and, in response, transmit
one or more different signals to the target devices. The external
device 8205 can receive far field energy, such as from the remote
field source 8220, and can use at least a portion of the received
energy to manipulate an evanescent field and direct a power and/or
data signal to a target device. In one or more embodiments, the
external device 8205 includes a control circuitry that harvests at
least a portion of the energy received from the remote field source
8220 and controls one or more tunable devices 8206. The tunable
devices 8206 can be used to change a characteristic of an input or
receiver circuitry, such as to facilitate reception of the remote
signal from the remote field source 8220. The tunable devices 8206
can be used to change a characteristic of an output or transmitter
circuitry, such as to change a characteristic of a power and/or
data signal transmitted from the external device 8205 to one of the
first and second target devices 7611 and 7612. In one or more
embodiments, the external device 8205 includes a transceiver
circuitry 8207 configured to relay data communications between the
remote field source 8220 and one or more target devices.
[0658] The remote field source 8220 can provide or broadcast the
remote signal over a field interval .DELTA.t0. In response, the
external device 8205 can communicate power and/or data to the first
and/or second target devices 7611 and 7612 over the first through
fourth intervals .DELTA.t1-.DELTA.t4. The field interval .DELTA.t0
can optionally at least partially overlap in time with one or more
of the first through fourth intervals .DELTA.t1-.DELTA.t4. Other
transmission interval schemes can similarly be used. The discussion
of FIG. 84 includes an example of using the remote field source
8220 and the external device 8205 to communicate multiple signals
to different target devices.
[0659] In one or more embodiments, the external device 8205 and/or
the remote field source 8220 can include or use a sensor, such as
the sensor 107 in the example of FIG. 1. Information from the
sensor can be used by the external device 8205 and/or by the remote
field source 8220 to update a signal characteristic or therapy
parameter.
[0660] FIG. 115 illustrates, by way of example, a schematic of an
embodiment of the external device 8205 (sometimes referred to as a
midfield coupler, external source, or external device) with
multiple tunable devices 8206. The external device 8205 is provided
above an interface between air 8304 and a higher-index material
8306, such as body tissue. In one or more embodiments, the external
device 8205 can be conceptualized as a lens that receives an
electromagnetic signal and focuses or directs the received signal
in a specified and controlled manner.
[0661] The external device 8205 can include one or more
subwavelength structures configured to receive an input RF signal
(e.g., a far-field RF signal), and can include the same or other
subwavelength structures configured to transmit one or more output
RF signals to influence an evanescent wave at a tissue surface and
thereby communicate power and/or data to one or more target
devices.
[0662] The tunable devices 8206 can include various passive or
active devices that can be used to change an electrical signal
characteristic. Some examples of a tunable element include a
capacitor, resistor, inductor, amplifier circuitry, phase
modulation circuitry, or other element, device, or circuitry that
can be configured to receive an electrical signal and, in response,
provide a different or updated electrical signal.
[0663] In one or more embodiments, the external device 8205
includes control circuitry that controls parameters of the tunable
devices 8206. For example, the control circuitry can be configured
to change a capacitance of a capacitor element in the external
device 8205 to change an RF output signal characteristic. In one or
more embodiments, the control circuitry is powered using a portion
of an RF signal received at the external device 8205 from the
remote field source 8220. The control circuitry can include
components similar to, or the same as the processor circuitry 210,
digital controller 548, or other control circuitry discussed
herein.
[0664] In one or more embodiments, the external device 8205
includes memory circuitry (not shown in FIG. 114, see FIG. 140 for
one or more embodiments of memory circuitry) that can be used to
store parameter information for the tunable devices 8206. In one or
more embodiments, the memory circuitry (e.g., nonvolatile,
read-only, and/or flash memory) stores configuration information
for the external device 8205, and the configuration information can
include reference parameter information for the tunable devices
8206, historical parameter value information for the tunable
devices 8206, or other information regarding a configuration or
operating status of the external device 8205, the remote field
source 8220, or one or more remote target devices.
[0665] FIG. 116 illustrates, by way of example, a diagram of an
embodiment of a method that includes using different signal
characteristics to communicate power and/or data signals to
different target devices at different times. The external device
8205 can receive a remote field signal over the field interval
.DELTA.t0. The remote field signal can include power and/or data
for use by the external device 8205 to facilitate communication
from the external device 8205 to the first and second target
devices 7611 and 7612.
[0666] In one or more embodiments, the external device 8205
includes the same or similar features to those described above for
the source 102 of FIG. 1. That is, the external device 8205 can
include multiple (e.g., four) subwavelength structures that can be
separately excited by respective RF drive signals. The
subwavelength structures of the external device 8205 can be
separately or concurrently excited to transmit a set of RF signals
that together can influence evanescent and propagating waves, such
as to direct power and/or data communication signals to various
targets within tissue.
[0667] FIG. 116 illustrates a series of signals, including first,
second, third, and fourth signals S1, S2, S3, and S4, respectively,
that are sequentially transmitted from the external device 8205 to
one or the other of the first and second target devices 7611 and
7612. Each of the signals S1-S4 is transmitted by the external
device 8205 when it is configured in a specified manner to
influence evanescent fields at the tissue surface and, as a result,
generate a propagating signal directed or focused toward a
specified target. For example, during a first transmission interval
.DELTA.t1 and during a third transmission interval .DELTA.t3, the
external device 8205 is configured to transmit the first and third
signals S1 and S3, respectively, to the first target device
7611.
[0668] In FIG. 116, the external device signal illustrates
generally that an RF signal, or a set of RF signals, is transmitted
over specified intervals. Although the external device signal is
illustrated as a square wave, it can represent other, time-varying
or static signals transmitted during the various specified
intervals. For example, the first signal S1 can correspond to a
first PWM signal having a first duty cycle that is provided during
the first transmission interval .DELTA.t1, and the second signal S2
can correspond to a different PWM signal having a second duty cycle
that is provided during the second transmission interval .DELTA.t2.
Other signal types can similarly be used.
[0669] As shown in FIG. 116, the remote field signal is
transmitted, such as from the remote field source 8220 to the
external device 8205, over the field interval .DELTA.t0 that begins
at time t.sub.f0 and ends at time t.sub.f1. In response to receipt
of the remote field signal at the external device 8205, the
external device 8205 can modulate the received signal, and/or
generate a new signal, to provide the first signal S1 to the first
target device 7611. As shown in FIG. 116, the first signal S1 is
transmitted beginning at time ti following time t.sub.fo. The
duration between t.sub.1 and t.sub.f0 can represent a power-up or
charging time for the external device 8205, or the external device
8205 can be instructed to inhibit transmission of the first signal
S1 until the specified time t.sub.1. The remote field can be
provided substantially continuously over at least the first,
second, and third signals S1, S2, and S3. Other transmission
configurations can similarly be used, for example, the remote field
can be intermittently provided or received at the external device
8205, and the external device can include one or more signal
storage circuitry that can be used to store power signals that can
be later used to transmit power and/or data to a target device. For
example, the remote field can terminate at a time t.sub.f1, such as
before transmission of the fourth signal S4 is completed. That is,
at least a portion of the fourth signal S4 can be transmitted from
the external device 8205 when the remote field is absent, for
example by configuring the external device 8205 to use a power
signal stored at the external device 8205.
[0670] FIG. 116 illustrates how various ones of the tunable devices
8206 can be configured during different signal transmission
intervals. For example, Element 1, such as a resistor, can be
configured to influence a remote field reception characteristic at
the external device 8205. At least during the field interval
.DELTA.t0, Element 1 can be configured to have a parameter value
R1, such as can be selected to optimize receipt of the remote field
signal at the external device 8205. If a characteristic of the
remote field changes, then Element 1 can also change to enhance or
maintain a signal reception quality.
[0671] Elements 2, 3, and 4 can correspond to signal transmission
characteristics from the external device 8205. That is, by tuning
or changing the values of Elements 2, 3, or 4, different signals
can be transmitted or modulated by the external device 8205. During
the first transmission interval .DELTA.t1 and the third
transmission interval .DELTA.t3, the external device 8205 can be
configured such that Element 2 (e.g., a capacitor) has a parameter
value C1, Element 3 (e.g., an inductor) has a parameter value L1,
and Element 4 (e.g., a phase shifter) has a parameter value
.PHI..sub.1. Under this configuration, the external device 8205 can
be configured to transmit the first signal S1 or the third signal
S3, such as in response to receiving the remote field signal, to
the first target device 7611.
[0672] At time t3, one or more of the values of Elements 2, 3, and
4 can be changed such that the external device 8205 can be
configured to transmit the different second signal S2 or fourth
signal S4. For example, during the second transmission interval
.DELTA.t2 and the fourth transmission interval .DELTA.t4, the
external device 8205 can be configured such that Element 2 has a
parameter value C2, Element 3 has a parameter value L2, and Element
4 has a parameter value .PHI..sub.2. Under this configuration, the
external device 8205 can be configured to transmit the second
signal S2 or the fourth signal S4, such as in response to receiving
the remote field signal, to the second target device 7612.
[0673] By selecting different parameter values for the Elements
1-4, the external device 8205 can thus be configured to receive
different remote field signals and/or to transmit different signals
to one or more target devices by differently modulating an
evanescent field. For example, during transmission of the first and
second signals S1 and S2, an evanescent field at a tissue surface
can be differently modulated and thereby differently direct
propagating waves toward the first and second target devices 7611
and 7612, respectively.
[0674] FIG. 117 illustrates, by way of example, a diagram of an
embodiment of a method 8500 that includes updating a modulation
characteristic using the external device 8205. At operation 8510,
the method 8500 can include receiving RF energy at the external
device 1205, such as from the remote field source 8220. Receiving
the RF energy can include receiving the remote field from the
example of FIG. 116, such as during a field interval .DELTA.t0. In
one or more embodiments, the external device 8205 is configured by
one or more of the tunable devices 8206 to receive the RF energy
from a specified source.
[0675] At operation 8520, the method 8500 includes modulating the
RF energy, received at operation 8510, using the external device
8205. In response to modulating the RF energy using the external
device 8205 and one or more of the tunable devices 8206, the method
8500 can include providing a first output signal. The first output
signal can be selected to modulate an evanescent field in a
specified manner to transmit a propagating wave to a target device.
For example, at operation 8530, the external device 8205 can be
configured to transmit the first output signal to the first target
device 7611. In one or more embodiments, operation 8530 can
correspond to using the external device 8205 to transmit the first
signal S1, from the example of FIG. 116, to the first target device
7611.
[0676] At operation 8540, the method 8500 can include differently
modulating the RF energy, received at operation 8510, using the
external device 8205. Differently modulating the RF energy can
include configuring one or more of the tunable devices 8206 of the
external device 8205 to be differently valued than during the
operation 8520. Based on the differently configured tunable devices
8206, the external device 8205 can provide a second output signal.
At operation 8550, the external device 8205 can be configured to
transmit the second output signal to the second target device 7612.
In one or more embodiments, operation 8550 can correspond to using
the external device 8205 to transmit the second signal S2, from the
example of FIG. 116, to the second target device 7612.
[0677] At operation 8560, one or more data signals can be provided
from the first and/or second target devices 7611 and 7612 to the
external device 8205. The one or more data signals can include,
among other things, information for use by a control circuitry in
the external device 8205 to determine whether or when to update or
adjust one or more of the tunable devices 8206. For example, the
one or more data signals can include information about a quality of
a power signal received at the first target device 7611 from the
external device 8205. If the information indicates a poor quality
of the power signal received, then at operation 8570 the external
device 8205 can select one or more new or different parameter
values for one or more of the tunable devices 8206, such as to
update an evanescent field modulation characteristic, and thereby
differently direct a subsequent power signal to the first target
device 7611 or to another specified location or device.
[0678] In one or more embodiments, one or more data signals can be
provided from the first and/or second target devices 7611 and 7612
to the remote field source 8220. The data signals can be provided
directly to the remote field source 8220 or can be transmitted to
the remote field source 8220 using an intermediate device such as
the transceiver circuitry 8207 of the external device 8205. In
response to the data signals, the remote field source 8220 can
update a field characteristic of the remote field, for example, to
increase a transmission power or to change a frequency of the
remote field. For example, if insufficient power is received at the
first target device 7611 to carry out a therapy event, then the
external device 8205 and/or the remote field source 8220 can change
one or more parameters to attempt to increase a magnitude of power
that is available to the first target device 7611.
[0679] FIG. 118 illustrates, by way of example, a diagram of an
embodiment of a method 8600 that includes conditionally updating a
modulation characteristic using an external device. The method 8600
can include operations 8510, 8520, and 8530 from the method 8500 of
FIG. 117. At operation 8640, the method 8600 includes receiving a
transmission quality indication at the external device 8205.
Receiving the transmission quality indication can include receiving
a data signal from the first target device 7611, the data signal
including information about a quality of a previous or current
signal transmission from the external device 8205 to the first
target device 7611. In one or more embodiments, receiving the
transmission quality indication at the external device 8205
includes receiving a backscatter signal in response to the
transmitting the output signal at operation 8530. In one or more
embodiments, receiving the transmission quality indication at the
external device 8205 includes receiving information about whether
or how a task was performed by the first target device 7611, and
then inferring a transmission quality between the external device
8205 and the first target device 7611 based on the task
information.
[0680] At operation 8650, the method 8600 can include determining
whether the received transmission quality indication is acceptable,
that is, whether it meets or exceeds a specified threshold quality
level. The threshold quality level can be programmed into the
external device 8205, or can be dynamically set or adjusted by the
external device 8205 based on various factors. For example, the
threshold quality level can be set differently depending on a
criticality of the information in the output signal transmitted at
8530.
[0681] If the transmission quality level is determined, at
operation 8650, to be acceptable, then the method can continue at
operation 8651 with continuing to transmit an output signal from
the external device 8205 without performing a parameter update. If
the transmission quality level is not determined to be acceptable,
then the method 8600 can continue at operation 8652 by updating a
modulation characteristic using the external device 8205. Updating
the modulation characteristic at operation 8652 can include
changing a parameter of one or more of the tunable devices 8206 and
thus configure the external device 8205 to provide or transmit a
different or updated output signal. For example, after updating the
modulation characteristic at operation 8652, the method can
continue by returning to operation 8530 to transmit the output
signal to the first device 7611.
[0682] In one or more embodiments, the feedback loop can include a
"greedy" search algorithm that looks for improvements in the
received transmission quality indication at operations 8640 and
8650. If an incremental improvement in transmission quality is
observed for a given set of signal transmission parameter values at
the external device 8205, then the update at operation 8652 can
include subsequent updates of parameters that are similarly valued
to those parameters under which the incremental improvement was
observed.
[0683] In one or more embodiments, the feedback loop that includes
operations 8530, 8640, 8650, and 8652 can continue for a specified
number of iterations or until an acceptable transmission quality
level is achieved. For example, at startup of the external device
8205 and/or of a target device, the system can perform the
operations of FIG. 118 to iteratively identify an optimal
configuration for sending or receiving power and/or data signals.
In one or more embodiments, operation 8652 includes retrieving
previous, known-good parameter values for one or more of the
tunable devices 8206, such as from a memory circuitry on board the
external device.
[0684] The various examples of FIGS. 117 and 118 are described with
respect to the external device 8205. One of more of the procedures
described in these examples can be similarly performed by the
external midfield device to receive signal transmission quality
information and, in response, update a characteristic of the
external midfield device to enhance or adjust a quality of
subsequent signal transmissions from the external midfield device
to a target device.
[0685] FIG. 119 illustrates, by way of example, a diagram of an
embodiment of a system 8700 that includes multiple external
midfield transceivers. The system 8700 includes a first antenna
300A and a second antenna 300B. The first and second antennas 300A
and 300B can the same or similar features as the external midfield
device described above in connection with FIG. 108.
[0686] Both of the first and second external midfield antennas 300A
and 300B can be configured to transmit power and/or data signals to
the first target device 7611. In one or more embodiments, both of
the first and second antennas 300A and 300B are configured to
transmit a separate power signal to the first target device 7611
concurrently, that is, during a common interval .DELTA.t. In one or
more embodiments, the transmitted power signals from the first and
second antennas 300A and 300B are selected to interfere
constructively and a resulting or combined field is received by the
first target device 7611. In one or more embodiments, the first and
second antennas 300A and 300B comprise two of multiple external
transceivers arranged as a mesh network, wherein each of the
multiple external transceivers is configured to exchange data to
help coordinate power transfers or data transfers to the first
target device 7611 or to other devices.
C. Wireless Neural Therapy Delivery Systems and Methods Using a
Series of Electrostimulation Signals
[0687] Systems, methods and devices described herein advantageously
facilitate placement and programming of implantable therapy
delivery devices (e.g., neural stimulation devices) by providing
for rapid selection of electrode pairs, or vectors, so that several
available anode/cathode stimulation combinations are energized for
a short duration of time through a period of a rotation sequence. A
total period to complete a rotation sequence could be as short as 1
second or less. Off times, such as when an anode/cathode
combination is being switched, can be very short.
[0688] Such an electrode or vector selection procedure can have
several desirable consequences. For example, a clinician can locate
an electrode array in an approximate location near a neural target.
The clinician need not perform intraoperative test stimulations to
ensure that an optimal configuration is programmed. Instead, an
optimal configuration will be used for at least a portion of a
therapy event. As a result, less time is consumed at implant and
programming costs can be minimized.
[0689] In an example, a clinician can program a large number of
different electrode combinations or vectors for use (see, e.g.,
FIG. 131, below) and the clinician can be less concerned that some
of the programmed vectors will result in suboptimal stimulation at
a targeted nerve structure. At least because the implantable
devices discussed herein can wirelessly receive power signals via a
midfield coupling, a clinician is not constrained by the implanted
device's electrode switching times, its discharge circuit that
delivers stimulation to the electrodes, or larger power consumption
rates from a battery that would result in premature depletion in
conventional battery-laden implanted devices. One or more of the
vectors can be configured, such that when selected and power is
provided to the electrodes of the vector, a stimulation signal is
steered to a target. Different vectors can steer the stimulation to
different locations. A phase and/or amplitude shifting network,
similar to that described with regard to the external device, can
be implemented in the implantable device 110 to help steer the
stimulation.
[0690] When using a time domain multiplexing communication system
between an external transmitter and an implanted receiver, the
phase and amplitude can be dynamically adjusted to help focus
energy (e.g., more efficiently focus energy) at an implanted
receiver device, such as with or without using a power detector.
One or more of a power detector and a phase detector can be used at
the implantable device or at the stimulation device, such as to
provide feedback regarding the operation and/or location of the
implantable device.
[0691] FIG. 120 illustrates, by way of examples, a diagram of an
embodiment of a communication system 31100, such as can be
time-domain multiplexed. The system 31100 can include an external
midfield transceiver 31102, such as can be similar to or the same
as the source 102, and an implantable transceiver 31104, such as
can be similar to or the same as the implantable device 110. The
transceiver 31102 includes a communicatively coupled midfield
antenna 31106 and the transceiver 31104 includes a communicatively
coupled electric field or magnetic field based antenna 31108. The
antennas 31106 and 31108 can be configured (e.g., in length, width,
shape, material, etc.) to transmit and receive signals at
substantially the same frequency. The transceiver 31104 can
transmit data signals through the antenna 31108 to the transceiver
31102 and can receive power and data signals transmitted by the
transceiver 31102 through the antenna 31106.
[0692] The external midfield coupler (external transmitter) and
implantable device transceiver (that includes the implantable
device antenna) can be used for both transmission and reception of
RF signals. T/R switches can be used to switch each RF port of the
external transmitter from transmit (transmit data or power) mode to
receive (receive data) mode. A T/R switch can be used to switch the
implantable device between transmit (data transmission mode) and
receive (power or data receive) modes.
[0693] An output of the receive terminal (on the external
transmitter) of the T/R switch can be connected to one or more
components that detect the phase and/or amplitude of the received
signal from the implantable device. This phase and amplitude
information can be used to program the phase of the transmit signal
to be substantially the same relative phase as the received signal.
To help achieve this, the transceiver 31102 can include a
phase-matching or amplitude-matching network. The network can be
used with a midfield coupler that includes multiple ports, such as
the antenna 300.
[0694] FIG. 121 illustrates, by way of example, an embodiment of a
system including a multi-polar therapy delivery device 110
implanted in tissue. In an example, the device 110 is implanted in
tissue below a tissue-air interface 1204. In the example of FIG.
121, the device 110 includes an elongate body and multiple
electrodes E0, E1, E2, E3, and E4 that are axially spaced apart
along a portion of the elongate body. The device 110 includes
receiver and/or transmitter circuits that enable communication
between the device 110 and a source 102. In an example, the source
102 is a midfield source, such as the source 102 discussed above in
the embodiments of FIG. 1 and FIG. 2, respectively.
[0695] The various electrodes E0-E3 can be configured to deliver a
neural electrostimulation therapy to patient tissue, such as at or
near a neural target. In an example, at least one electrode can be
selected for use as an anode and at least one other electrode can
be selected for use as a cathode to define an electrostimulation
vector. In the example of FIG. 1, electrode E1 is selected for use
as an anode and electrode E2 is selected for use as a cathode.
Together, the E1-E2 combination defines an electrostimulation
vector "V10". Similarly, electrode E0 is selected for use as an
anode and electrode E3 is selected for use as a cathode to define
another electrostimulation vector "V11". The vectors can be
configured independently to provide a neural electrostimulation
therapy to the same or different neural target, such as
concurrently or at different times.
[0696] In one or more embodiments, the device 110 can be configured
to provide a series of electrostimulation pulses to a neural
target. For example, the device 110 can provide multiple
electrostimulation pulses separated in time, such as using the same
or different electrostimulation vectors, to provide a therapy. That
is, a single therapy event can include multiple different
electrostimulation signal components, such as provided using
different portions of the same device 110.
[0697] In one or more embodiments, the single therapy event
includes at least two electrostimulation signals or pulses
provided, in turn, to the same or different neural target, using
different electrostimulation vectors, and optionally using
different electrostimulation signal characteristics. In one or more
embodiments, a delay or non-stimulation interval can be provided
between each electrostimulation signal. The delay can be due in
part to a switching time in the device 110 to switch an output
circuit between the at least first and second vectors used for the
therapy event. The delay can be fixed or adjustable, and can
optionally be different between each signal component that
comprises a portion of a therapy event.
[0698] In one or more embodiments, at least one electrostimulation
signal provided to a particular vector, of multiple signals
provided to multiple respective vectors and comprising a portion of
a therapy event, can be more optimal than others for treating a
patient. However, repeatedly stimulating the same neural target via
the same electrostimulation vector can have undesired consequences.
For example, a therapeutic benefit of the stimulation can wane over
time as a target learns or adapts to the stimulation. To address
this problem, the present inventors have recognized that it can be
desirable to give an optimal vector or target a "rest", that is, to
provide a period of non-stimulation.
[0699] In one or more embodiments, a therapy comprising multiple
signals can be provided to multiple different vectors in turn, such
as to provide a series or sequence of electrostimulation pulses to
the same neural target. In this example, even if one vector is more
optimal than the others for eliciting a patient response, then the
therapy as a whole can be more effective than stimulating only the
known-optimal vector because (1) the target will receive a rest
during periods of non-stimulation, and (2) stimulating the areas
nearby or adjacent to the optimal target can elicit some patient
benefit.
[0700] In one or more embodiments, a system configured to deliver a
series of electrostimulation pulses using multiple different
vectors in a sequence can be easier to program than a device that
may require manual evaluation and selection of electrostimulation
vectors from among multiple available vectors. For example, if a
system is configured to provide a therapy by cycling through all
available electrostimulation electrode combinations and vectors,
then at least one of the vectors is likely to be more optimal or
more beneficial to the patient than the others, and that at least
one of the vectors will provide an electrostimulation signal for at
least a portion of a therapy event. Excess or less optimal
therapies or signals can be nonetheless delivered to other
locations, or using non-optimal vectors, for example with less
concern about power consumption because the device 110 receives its
electrostimulation power wirelessly from an external source.
[0701] FIG. 122 illustrates, by way of example, a diagram of an
embodiment of a multi-polar therapy delivery device, such as the
device 110 of FIG. 1. In one or more embodiments, the device 110
includes an antenna 13021, such as a dipole, helically-shaped,
coil, or other antenna, such as can be configured to receive power
or data communication signals from the source 13002. The device 110
can include receiver circuitry 13022, such as coupled to the
antenna 13021. The receiver circuitry 13022 can receive or
interpret one or more signals received via the antenna 13021. In
one or more embodiments, the device 110 includes processor
circuitry 13024 and memory circuitry 13023 (e.g., volatile,
non-volatile, random access, read only, or the other data storage
device). The processor circuitry 13024 can be configured to act in
coordination with the receiver circuitry 13022 to receive power or
data signals from the source 13002 and direct the signals to one or
more of the memory circuitry 13023, a signal generator circuitry
13025, or a capacitor array 13026. In one or more embodiments, the
processor circuitry 13024 can perform operations of the digital
controller 548. The items of the device 110 can be used with one or
more items of the circuitry 500.
[0702] In one or more embodiments, the signal generator circuitry
13025 is configured to use power signals received via the antenna
13021 to generate a therapy signal, such as a neural
electrostimulation or modulation signal. The therapy signal can
include an AC signal having one or more adjustable characteristics.
The one or more adjustable characteristics can include a waveform
morphology shape, amplitude, phase, frequency, pulse width, timing,
or other characteristic. In one or more embodiments, the signal
generator circuitry 13025 is coupled to the capacitor array 13026.
The capacitor array 13026 stores electrostimulation energy from the
signal generator circuitry 13025. One or more of the signal
generator circuitry 13025 and the processor circuitry 13024 can
selectively discharge stored electrostimulation energy, for
example, to provide a therapy via one or more outputs of the device
110.
[0703] The device 110 includes multiple possible outputs, and each
output can include output circuitry or other hardware configured to
provide an electrostimulation signal to a target. In one or more
embodiments, the device 110 includes a first output 13031 that
includes, among other things, an output stage of a therapy signal
amplifier or a hardware coupler for coupling the first output 13031
to a therapy delivery electrode (e.g., one or more of the
electrodes E0-E3 or other electrode(s) of the implantable device
discussed herein). The device 110 in the embodiment of FIG. 122
includes second, third, and fourth outputs 13032, 13033, and 13034,
such as can each be similarly configured to the first output
13031.
[0704] In one or more embodiments, the signal generator circuitry
13025 can time delivery of electrostimulation signals via one or
more of the first, second, third, and fourth outputs 13031-13034.
For example, the signal generator circuitry 13025 can provide
different electrostimulation signals to one or more of the outputs
13031-13034 in a serial or parallel manner. That is, in one or more
embodiments, the signal generator circuitry 13025 can be configured
to provide different, discrete electrostimulation signals from each
of at least two of the first through fourth outputs 13031-13034 in
turn, such as one following another in time. In one or more
embodiments, the signal generator circuitry 13025 can be configured
to provide different, discrete electrostimulation signals from each
of at least two of the first through fourth outputs 13031-13034
concurrently, such as at least partially overlapping in time.
[0705] In one or more embodiments, processor circuitry 13024 and/or
signal generator circuitry 13025 comprise portions of a state
machine device (e.g., similar to other state machine devices
discussed herein). The state machine device can be configured to
wirelessly receive power and data signals via the antenna 13021
and, in response, release or provide an electrostimulation signal
via one or more of the first-fourth outputs 13031-13034. In one or
more embodiments, such a state machine device needs not retain
information about available electrostimulation settings or vectors,
and instead the state machine device carries out or provides
electrostimulation events substantially immediately after, and in
response to, receipt of instructions from the wireless transmitter.
For example, the state machine device can be configured to receive
an instruction to deliver a neural electrostimulation therapy
signal, such as at a specified time or having some specified signal
characteristic (e.g., amplitude, duration, frequency, specified
number of pulses, etc.), and the state machine device can respond
by initiating or delivering the therapy signal. At a subsequent
time, the device can receive a subsequent instruction to terminate
the therapy, to change a signal characteristic, or to perform some
other task. Thus, the device 110 can optionally be configured to be
substantially passive, or responsive to contemporaneously-received
instructions.
[0706] FIG. 123 illustrates, by way of example, of a table 13100
showing an embodiment of available electrostimulation vectors in a
four-pole electrostimulation system. The table 13100 is a partial
list of potential combinations of four discrete electrodes. In the
embodiment shown, table 13100 includes a first column labeled
"Vector" that provides a name or designation for a given
combination of electrodes. The table 13100 includes second, third,
fourth, and fifth columns, labeled E0, E1, E2, and E3,
respectively, such as corresponding to the electrodes of the device
110 in the example of FIG. 1. Entries in the table 13100 include
"A" to indicate that a cell corresponds to an anode of a vector,
and "C" to indicate that a cell corresponds to a cathode of a
vector. The table 13100 merely illustrates examples, and more
examples are possible, some of which can be realized by simply
switching "C" with "A" and "A" with "C" in the table 13100.
[0707] Two or more of the available electrodes can be electrically
coupled to form an anode or cathode. For example, in the table
13100, a first vector V0 includes E0 as an anode and includes E1,
E2, and E3 commonly coupled as a cathode. A second vector V1
includes E1 as an anode and includes E0, E2, and E3 commonly
coupled as a cathode. In one or more embodiments, any two or more
of the available electrodes can be coupled to form an anode or
cathode. In one or more embodiments, or any one or more of the
electrodes can be unused, such as can be designed in the table
13100 by shaded cells. FIG. 124A illustrates, by way of example, a
diagram of an embodiment of a first neural electrostimulation
therapy event 13200. In the example of FIG. 124A, the first therapy
event 13200 includes four discrete electrostimulation signals, each
of which is provided via a different electrostimulation vector and,
optionally, using different signal characteristics. For example,
the electrostimulation signals can be provided via different
electrostimulation vectors that are available to the device 110 of
FIG. 1.
[0708] In the embodiment of FIG. 124A, the device 110 is
illustrated having four different configurations. In a first
configuration 110A, the device 110 is configured to use electrode
E0 as an anode and to use electrodes E1, E2, and E3 commonly
coupled as a cathode (e.g., corresponding to a first vector V0 in
the table 13100). In a second configuration 110B, the device 110 is
configured to use electrode E1 as an anode and to use electrodes
E0, E2, and E3 commonly coupled as a cathode (e.g., corresponding
to a second vector V1 in the table 13100). In a third configuration
110C, the device 110 is configured to use electrode E2 as an anode
and to use electrodes E0, E1, and E3 commonly coupled as a cathode
(e.g., corresponding to a third vector V2 in the table 13100). In a
fourth configuration 110D, the device 110 is configured to use
electrode E3 as an anode and to use electrodes E0, E1, and E2
commonly coupled as a cathode (e.g., corresponding to a fourth
vector V3 in the table 13100).
[0709] In the embodiment of FIG. 124A, the first therapy event
13200 extends from an initial time t0 to a final time tf. A first
delay interval, D1, starts at time t0 and ends at time t1. During
D1, the device 110 can undergo a configuration routine, such as to
place the device 110 in the first configuration 110A with the
electrode E0 as an anode and the other electrodes commonly coupled
as a cathode. At time t1, a first one of the discrete
electrostimulation signals can be provided via the first vector V0.
The first one of the discrete electrostimulation signals can have
first signal characteristics, include a first waveform morphology
shape, amplitude, phase, frequency, pulse width, timing, or other
characteristic. Generally, a frequency characteristic is selected
such that at least one full signal cycle can be delivered, such as
between times t1 and t2. In one or more embodiments, a frequency
characteristic is selected such that multiple signal cycles are
delivered, such as between times t1 and t2. The first one of the
signals can terminate at time t2, at which time a second delay
interval D2 can begin. The second delay interval D2 can be the same
or different than the first delay interval, e.g., in terms of
duration or activity. In one or more embodiments, during the second
delay interval D2, therapy delivery from the device 110 is
inhibited as the device 110 changes from the first configuration
110A to the second configuration 110B.
[0710] At time t3, a second one of the discrete electrostimulation
signals can be provided via the second vector V1. The second one of
the discrete electrostimulation signals can have second signal
characteristics, include a second waveform morphology shape,
amplitude, phase, frequency, pulse width, timing, or other
characteristic. In one or more embodiments, at least one or more of
the second signal characteristics are the same as the first signal
characteristics, or at least one or more of the second signal
characteristics are different than the first signal
characteristics. For example, the first one of the discrete
electrostimulation signals can have a first amplitude
characteristic and a first frequency characteristic, and the second
one of the discrete electrostimulation signals can have the same
first amplitude characteristic and same first frequency
characteristic. In an alternative example, the first one of the
discrete electrostimulation signals can have a first amplitude
characteristic and a first frequency characteristic, and the second
one of the discrete electrostimulation signals can have a different
second amplitude characteristic and a different second frequency
characteristic.
[0711] The second one of the discrete electrostimulation signals
can terminate at time t3, at which time a third delay interval D3
can begin, and so on. Any one or more of the electrostimulation
signal characteristics can be the same or different for the various
signals delivered using the device configurations 110A, 110B, 110C,
or 110D.
[0712] In one or more embodiments, the delay characteristics D1,
D2, D3, and D4 can have the same duration or can be different.
Similarly, the durations corresponding to each of the discrete
electrostimulation signals (e.g., provided via vectors V0, V1, V2,
and V3, in the example of FIG. 124A) can be the same or
different.
[0713] In one or more embodiments, a therapy event can include
multiple iterations of the first neural electrostimulation therapy
event 13200. For example, at time tf, a therapy can return to time
t0 and repeat the sequence of discrete electrostimulation signals
provided using the multiple vectors as shown. In one or more
embodiments, one or more signal characteristics, vectors, or other
system attributes can be the same or different for each repeated
sequence of signals.
[0714] In the embodiment of FIG. 124A, each of the discrete
electrostimulation signals can be provided for substantially the
same duration, and each of the delay intervals can have
substantially the same duration. For example, each
electrostimulation signal can be provided for about 200 ms, and
each delay interval can be about 50 ms, such that the therapy
comprising the four discrete components illustrated in FIG. 124A is
about 1 second in duration. Other intervals and durations may be
used as desired and/or required. The therapy can be repeated for a
specified duration or for a specified number of iterations.
[0715] FIG. 124B illustrates, by way of example, a diagram of an
embodiment of the first neural electrostimulation therapy event
13200 that includes receiving therapy delivery instructions at a
stimulation device. In one or more embodiments, the stimulation
device includes the device 110 configured at least in part as a
state machine. The state machine can be configured to respond to
received power signals and/or instructions by initiating or
inhibiting therapy signal delivery, such as substantially
contemporaneously with receipt of the instructions. In one or more
embodiments, an instruction can include information about, among
other things, a vector to use, a therapy duration, or a signal
characteristic, such as an amplitude, waveform morphology,
frequency, or other characteristic.
[0716] In the example of FIG. 124B, a first instruction, Stim(V0),
can be received at time t1. In response, the device 110 can be
configured to provide a first electrostimulation signal, such as
using the first vector V0. In one or more embodiments, the first
instruction further includes information about one or more signal
characteristics for the first electrostimulation signal, such as a
first amplitude characteristic and a first frequency
characteristic.
[0717] The device 110 can provide the first electrostimulation
signal substantially continuously, such as until a subsequent
instruction is received from a transmitter device. For example, the
device 110 can provide the first electrostimulation signal using
vector V0 until the device 110 receives a second instruction,
Stop(V0), such as at time t2. The Stop(V0) instruction can be
interpreted by the device 110 as an indication that the first
electrostimulation signal should be terminated or inhibited from
being delivered.
[0718] At time t3, a third instruction, Stim(V1), can be received.
In response, the device 110 can be configured to provide a second
electrostimulation signal, such as using the second vector V1. In
one or more embodiments, the second instruction further includes
information about one or more signal characteristics for the second
electrostimulation signal, such as a second amplitude
characteristic and a second frequency characteristic. The second
amplitude characteristic and/or the second frequency characteristic
can be the same or different than the first amplitude and frequency
characteristics used in response to the Stim(V0) instruction.
[0719] In one or more embodiments, the device 110 can provide the
second electrostimulation signal substantially continuously, such
as until a subsequent instruction is received from the transmitter
device. For example, the device 110 can provide the second
electrostimulation signal using vector V1 until the device 110
receives a fourth instruction, Stop(V1), such as at time t4. The
embodiment of FIG. 124B can continue with additional instructions
Stim(V2) and Stim(V3) to provide respective electrostimulation
signals at subsequent times t5 and t7, respectively, and
instructions Stop(V2) and Stop(V3) to inhibit therapy delivery at
times t6 and tf.
[0720] FIG. 125 illustrates, by way of example, an embodiment of a
method 13300 that includes providing a neural stimulation therapy.
At operation 13310, the method can include receiving a power signal
at or using receiver circuitry. For example, at 13310, the method
13300 can include wirelessly receiving a power signal at the
receiver circuitry 13022 of the device 110, such as from a midfield
transmitter. At operation 13320, the method 13300 can include
generating one or more neural stimulation therapy signals, such as
using the signal generator circuitry 13025. In one or more
embodiments, the operation 13320 includes using a portion of the
power signal received at 13310 to generate all or a portion of the
therapy signals.
[0721] At operation 13330, the method 13300 can include selecting a
first electrostimulation vector for neural electrostimulation
therapy delivery. For example, selecting a first electrostimulation
vector can include selecting a vector from among multiple available
vectors, such as corresponding to entries in the table 13100 in the
embodiment of FIG. 123. Selecting the first electrostimulation
vector at operation 13330 can include selecting one or more
electrostimulation signal characteristics for use with the first
electrostimulation vector. For example, one or more of a signal
waveform morphology shape, amplitude, phase, frequency, pulse
width, timing, or other characteristic can be selected.
[0722] At operation 13340, the method 13300 can include providing a
first neural electrostimulation therapy signal to a first
electrostimulation vector (e.g., corresponding to the duration
between t1 and t2 in the embodiment of FIG. 124A). In one or more
embodiments, providing the first neural electrostimulation therapy
signal at operation 13340 includes providing an electrostimulation
therapy for a specified first duration using the vector that was
selected at operation 13330. At operation 13350, the method 13300
can include inhibiting subsequent delivery of a neural
electrostimulation therapy, such as for a specified second duration
(e.g., corresponding to D1 in the example of FIG. 124A). One or
more additional neural electrostimulation therapy signals can be
provided following the second duration.
[0723] At operation 13360, the method 13300 can include selecting a
second electrostimulation vector for neural electrostimulation
therapy delivery. For example, selecting a second
electrostimulation vector can include selecting a vector from among
multiple available vectors, such as corresponding to entries in the
table 13100 in the embodiment of FIG. 123, including a vector other
than the first vector selected at operation 13330. Selecting the
second electrostimulation vector at operation 13360 can include
selecting one or more electrostimulation signal characteristics for
use with the second electrostimulation vector. For example, one or
more of a signal waveform morphology shape, amplitude, phase,
frequency, pulse width, timing, or other characteristic can be
selected.
[0724] At operation 13370, the method 13300 can include providing a
second neural electrostimulation therapy signal to a second
electrostimulation vector (e.g., corresponding to the duration
between t3 and t4 in the embodiment of FIG. 124A). In one or more
embodiments, providing the second neural electrostimulation therapy
signal at operation 13370 includes providing an electrostimulation
therapy for a specified third duration using the vector that was
selected at operation 13360. The third duration can be the same as
or different than the first or second durations.
[0725] At operation 13375, the method 13300 can include a decision
whether or not to repeat the electrostimulation therapy that
includes at least the first and second signals. If the therapy is
not to be repeated, then the therapy can end at operation 13376. If
the therapy is to be repeated, then the therapy can continue at
operation 13380 with optionally updating a therapy characteristic.
For example, one or more of a signal waveform morphology shape,
amplitude, phase, frequency, pulse width, timing, or other
characteristic of a therapy signal can be updated or changed at
operation 13380.
[0726] At operation 13390, the method 13300 can include inhibiting
subsequent delivery of a neural electrostimulation therapy, such as
for a specified fourth duration. One or more additional neural
electrostimulation therapy signals can be provided following the
fourth duration. For example, following the fourth duration, the
method 13300 can return to operation 13340 to provide the first
neural electrostimulation therapy signal using the first
electrostimulation vector, such as using the same or different
therapy signal characteristics.
[0727] FIG. 126 illustrates, by way of example, a diagram of a
method 13400 that includes identifying or selecting
electrostimulation vectors for use in providing a neural
stimulation therapy. At operation 13410, the method 13400 can
include sensing two or more electrodes that are available for
delivering an electrostimulation therapy. For example, referring to
the device 110 of FIG. 122, the processor circuitry 13024 can be
configured to identify or sense two or more electrodes that are
coupled to the signal generator circuitry 13025, such as via one or
more output circuitry, and are available for use to provide an
electrostimulation therapy.
[0728] At operation 13420, the method 13400 can include identifying
available neural stimulation vectors using the electrodes sensed at
operation 13410. In one or more embodiments, the operation 13410
can include sensing the four electrodes E0, E1, E2, and E3 in the
implantable/implanted device (e.g., the device 110 or other
implantable or implanted device discussed herein). At operation
13420, identifying the available vectors can include populating the
table 13100 of available vectors using different combinations of
the four electrodes. In one or more embodiments, identifying
available neural stimulation vectors at operation 13420 includes
identifying or defining vectors that include two or more electrodes
that are electrically coupled.
[0729] At operation 13430, the method 13400 can include selecting
at least two of the vectors identified at operation 13420 for
therapy delivery. For example, the processor circuitry 13024 can be
configured to select from the table 13100 two or more vectors. In
one or more embodiments, the processor circuitry 13024 selects the
two or more vectors based on prior learned or programmed
information about the available vectors. For example, the processor
circuitry 13024 can select one or more vectors using information
about a measured or assumed efficacy of a therapy delivered using a
particular vector.
[0730] At operation 13440, the method 13400 can include providing a
first portion of a neural electrostimulation therapy using a first
one of the vectors selected at operation 13430. Providing the first
portion of the therapy can include providing a first
electrostimulation signal having a first waveform morphology shape,
amplitude, phase, frequency, pulse width, timing, or other signal
characteristic. In the embodiment of FIG. 124A, providing the first
portion of the neural electrostimulation therapy at operation 13440
can correspond to providing an electrostimulation signal via vector
V0, such as by using the device 110. At operation 13450, the method
13400 can include providing a second portion of a neural
electrostimulation therapy using a second one of the vectors
selected at operation 13430. Providing the second portion of the
therapy can include providing a second electrostimulation signal
having a second waveform morphology shape, amplitude, phase,
frequency, pulse width, timing, or other signal characteristic,
such as can be the same or different than a corresponding
characteristic of the first electrostimulation signal provided at
operation 13440.
[0731] At operation 13460, the method 13400 can include repeatedly
providing the first and second portions of the neural
electrostimulation therapy. That is, at operation 13460, the method
13400 can include providing the first portion of the therapy
followed by the second portion of the therapy, then followed by the
first portion of the therapy, and so on, such as for a specified
number of iterations or for a specified therapy duration.
[0732] In one or more embodiments, electrostimulation vectors
selected for use can be associated with two or more different
implantable devices, wherein each device includes two or more
electrodes configured to provide a neural electrostimulation
therapy. A source, such as the source 102 in the example of FIG. 1,
can be configured to steer power and/or data to the multiple
different implantable devices, and one or more processor circuits
(e.g., the processor circuitry 210 in a first device, and a
separate processor circuitry in a second device) can be configured
to coordinate therapy delivery among the different implantable
devices. For example, the source 1202 can be configured to
wirelessly provide an electrostimulation power signal to a first
implantable device configured to provide a first therapy at a first
time, and another source (e.g., antenna 300A-300B) can be
configured to wirelessly provide a subsequent electrostimulation
power signal to a different second implantable device configured to
provide a different second therapy at a subsequent second time.
[0733] FIG. 127 illustrates, by way of example, a diagram of an
embodiment of a method 13500 that includes randomly selecting an
order for delivering a neural stimulation therapy via multiple
vectors. At operation 13510, the method 13500 can include selecting
three or more different neural stimulation vectors for delivery of
different portions of a neural electrostimulation therapy.
Selecting the vectors can include, among other things, selecting
from a table of available vectors, such as using the table 13130 in
the embodiment of FIG. 123. In one or more embodiments, selecting
the three or more neural stimulation vectors at operation 13510
includes using a programmer or user interface to present
information about one or more available vectors to a user, and then
receiving, from a user, an indication of one or more vectors to use
for therapy delivery.
[0734] At operation 13520, the method 13500 can include randomly
selecting an order for delivering a neural electrostimulation
therapy using each of the selected vectors sequentially. For
example, the processor circuitry 1222 can be configured to receive
information about the selected three or more vectors and then
select an order, at random, for providing different portions of an
electrostimulation therapy to the selected three or more vectors.
At operation 13530, the method 13500 can include providing the
neural electrostimulation therapy using each of the selected
vectors sequentially, such as according to the order selected at
operation 13520.
[0735] In one or more embodiments, the operation 13510 can include
using the processor circuitry 210 to select at least vectors V0,
V1, and V2 for delivering respective portions of a neural
electrostimulation therapy. In this example, at operation 13520,
the processor circuitry 210 can select an order for delivering the
respective portions of the therapy. The order can include, for
example, a vector sequence of V0-V1-V2, or V1-V0-V2, or V2-V0-V1,
and so on, as selected at random using the processor circuitry 210.
The signal generator circuitry 13025 can then coordinate therapy
delivery using the randomly selected vector sequence.
[0736] In one or more embodiments, other benefits of the systems
and methods discussed herein can include simplifying programming of
implanted, multipolar electrostimulation devices, such as by
ensuring that at least one vector more optimal than others for
therapy delivery can be selected for use. In addition, an
automatically-generated programming algorithm can be used, such as
with optimal and/or suboptimal stimulation sequences, which may be
equivalent or superior in efficacy to using only known-optimal
configurations. In an example, an optimal sequence can be one that
elicits a physiologic or therapeutic response. Further, programming
settings (e.g., stimulation signal amplitudes, waveforms, pulse
durations, etc.) that may not be feasible in conventional
implantable devices can be implemented, such as because various
power or battery consumption characteristics of such conventional
devices can be disregarded when an external power device is used to
power an implantable device via a midfield coupling.
D. Dual-Frequency Electrostimulation for Neural Therapy
[0737] FIG. 128 illustrates, by way of example, of an embodiment of
phase-amplitude coupled signals. In one or more embodiments,
electrode pairs or vectors are selected or programmed by a
clinician using a remote programmer or remote control. The
clinician can specify various signal characteristics to be used
when providing electrostimulation signals via the selected vectors.
Such signal characteristics can include, but are not limited to,
frequency or phase angle characteristics. In one or more
embodiments, a dual-frequency stimulation configuration can be
selectively enabled or disabled, that is, switched "on" and "off",
according to instructions from a programmer.
[0738] Various patient behaviors can modulate or influence
phase-amplitude coupling in intrinsic neural signals.
Phase-amplitude coupling can also be involved in sensory
integration, memory process, and attentional selection. Such
coupling can be observed in several brain regions including in the
hippocampus, basal ganglia, and neocortex.
[0739] In the embodiment of FIG. 128, a first phase-amplitude
coupled signal 13701 includes a combination of high and low
frequency signals, wherein a power or amplitude of the high
frequency signal's envelope changes with a phase of the low
frequency signal's oscillation period. A second signal 13702
includes the higher frequency signal component from the first
phase-amplitude coupled signal 13701.
[0740] In one or more embodiments, cross-frequency or
phase-amplitude coupling can be quantified or measured, for
example, by identifying a relationship between an activity that
modulates low frequency oscillations (e.g., a sensory or motor
input), and local cortical activity (e.g., local computations),
such as can be correlated to an amplitude of higher frequency
oscillation.
[0741] In one or more embodiments, a therapeutic phase-amplitude
coupled neural electrostimulation signal (PAC signal) can be
provided using multiple, concurrently delivered signal components.
In one or more embodiments, a patient's symptoms, such as related
to one or more of a body movement disorder, Parkinson's disease,
Alzheimer's disease, Huntington's disease, depression, neuralgia,
dystonia, epilepsy, migraines or headaches, or any other condition,
disease or disorder described herein, among others, can be
alleviated or reduced using a PAC signal-based neuromodulation
therapy. Some patient disorders or physiologies can be associated
with an intrinsic phase-amplitude coupled neural signal. A
therapeutic PAC signal can be provided to cancel, mitigate,
normalize, overcome, or otherwise influence an intrinsic
phase-amplitude coupled neural signal, such as can be associated
with an abnormal or diseased patient state.
[0742] In one or more embodiments, a physiological effect of a PAC
signal-based neuromodulation therapy does not wane over time, or
remains effective for a longer duration than a traditional non-PAC
signal-based therapy. Repeatedly stimulating the same neural target
via the same electrostimulation vector can have undesired
consequences. For example, a therapeutic benefit of the stimulation
can wane over time as a target nerve area learns or adapts to the
stimulation. Stimulating a vector or target with a PAC signal can
help at least partially overcome one or more of the problems
discussed.
[0743] FIG. 129 illustrates, by way of example, a diagram of an
embodiment of a method 13800 of concurrently providing a neural
electrostimulation therapy. At operation 13810, the method 13800
includes providing a first electrostimulation signal at a first
frequency using a first vector. For example, operation 13810 can
include providing a first electrostimulation signal, such as having
first amplitude, phase, and frequency characteristics, using the
first vector V10 of the device 110 in the embodiment of FIG. 1.
[0744] At operation 13820, one or more signal characteristics can
be selected for a second electrostimulation signal. The
characteristics can be selected to modulate an amplitude
characteristic of the first signal provided at operation 13810. For
example, a phase or frequency characteristic can be selected for
the second signal to be different than a phase or frequency
characteristic of the first signal such that, when the signals are
concurrently delivered to a similar target neural area, a
combination of the first and second signals is a phase-amplitude
coupled signal. At operation 13830, the method 13800 can include
providing the second electrostimulation signal at a second
frequency using a second vector. For example, operation 13830 can
include providing a second electrostimulation signal, such as
having second amplitude, phase, and frequency characteristics,
using the second vector V11 of the device 110 in the example of
FIG. 1.
[0745] FIG. 130 illustrates, by way of example, a method 13900 that
includes providing multiple phase-amplitude coupled therapy
signals. At operation 13910, the method 13900 can include providing
a first PAC signal comprising first and different second signal
components. In one or more embodiments, the first signal component
can have an amplitude characteristic that is modulated by a phase
characteristic of the second signal component when the first and
second signal components are provided substantially concurrently to
a similar target.
[0746] At operation 13920, the method 13900 can include providing a
second PAC signal comprising the first signal component in
combination with a different third signal component. That is, at
operation 13920, the first signal component can have an amplitude
characteristic that is modulated by a phase characteristic of the
third signal component when the first and third signal components
are provided substantially concurrently to a similar target.
Alternatively, at operation 13920, the third signal component can
have an amplitude characteristic that is modulated by a phase
characteristic of the first signal component when the first and
third signal components are provided substantially concurrently to
a similar target.
[0747] FIG. 131 illustrates, by way of example, a diagram of an
embodiment of a method 14000 that includes selecting one or more
signal component characteristics for use in a PAC signal. At
operation 14010, the method 14000 can include sensing an intrinsic
neural signal from a subject. One or more sensors disposed on, in,
or near a patient body can be configured to receive the intrinsic
neural signal. At operation 14020, one or more characteristics of
the intrinsic neural signal can be determined. For example, at
operation 14020, an amplitude or timing characteristic of the
sensed intrinsic neural signal can be determined. In one or more
embodiments, a patient pathology can be identified based on one or
more characteristics of the sensed intrinsic signal.
[0748] At operation 14030, one or more signal component
characteristics can be selected for use in a neural
electrostimulation therapy. The neural electrostimulation therapy
can include a PAC signal that includes at least two different
electrostimulation signals delivered via different electrodes
corresponding to different electrostimulation vectors. Based on the
determined characteristics of the intrinsic neural signal at
operation 14020, characteristics of the at least two different
electrostimulation signals in the PAC signal can be selected. For
example, the intrinsic neural signal may be weak or may have an
undesirable waveform morphology. In response, the processor
circuitry 13024 of the device 110 can be configured to select a
high amplitude first signal and a lower amplitude second signal,
such as having different frequency characteristics. When the
selected signals are concurrently delivered via spatially
overlapping electrostimulation vectors, the undesirable waveform
morphology of the intrinsic signal can be masked or overcome by the
combination of the higher amplitude, phase-amplitude modulated,
delivered signals.
E. Systems and Methods for Embedding Communication Signals with
Electrostimulation Therapy
[0749] Generally discussed in this subsection are systems, devices,
and methods for providing or delivering a patient therapy using an
implantable device. In one or more embodiments, the patient therapy
includes a modulation (e.g., an electrostimulation) therapy
provided to one or more neural targets in a patient body. In one or
more embodiments, the modulation (e.g., electrostimulation) therapy
is provided using an implant device that wirelessly receives power
and data signals from a midfield transmitter. Systems, devices, and
methods discussed herein can be used to communicate data between
internal and external devices. In one or more embodiments, a
therapy provided by an implanted or internal device includes an
information signal that can be received and interpreted by an
external device.
[0750] FIG. 132 illustrates, by way of example, a diagram of
embodiments of various therapy signals with data signal components.
A first electrostimulation therapy signal 14101 (e.g., a nearfield
signal) includes multiple therapy signal pulses interleaved with,
or spaced apart in time from, one or more data signal pulses. A
second electrostimulation therapy signal 14102 includes therapy
signal pulses with embedded data signal pulses. The data signal
pulses are provided at a sufficiently high frequency, or over a
sufficiently brief duration, such that substantially no physiologic
response is elicited in response to the data signal pulses being
provided at or near the therapy target 190.
[0751] In one or more embodiments, a maximum data signal frequency
can be limited by an absolute refractory period of a target tissue,
such as a neuron or neural tissue. An absolute refractory period
includes a time during which a subsequent stimulus delivered to a
previously-excited neural target will not lead to a subsequent
action potential, no matter how strong a subsequent stimulus is.
The absolute refractory period, in one or more embodiments, can be
about 1 to 2 milliseconds. In one or more embodiments, the first
and second therapy signals 14101 and 14102 include data signal
pulses provided at a sufficiently high frequency and/or
sufficiently low amplitude and/or at a specified timing interval
such that a neurological response to the pulse signal is
avoided.
[0752] In one or more embodiments, the implantable device 110
provides the first signal 14101, such as using an electrode vector
comprising electrodes E0 and E2. The first signal 14101 begins at
time to and terminates later at time t.sub.f. At t.sub.0, the first
signal 14101 includes a first therapy pulse T.sub.1 having a first
pulse duration, .DELTA.t.sub.i. The first signal 14101 includes a
subsequent second therapy pulse T.sub.2, beginning at time t.sub.2,
and having a second pulse duration .DELTA.t.sub.2. In one or more
embodiments, the first and second pulse durations .DELTA.t.sub.1
and .DELTA.t.sub.2 are substantially the same, however, other
durations can similarly be used.
[0753] Amplitude and frequency characteristics of the therapy
pulses can be selected to elicit a therapeutic or other physiologic
response. For example, the therapy pulses can have a peak amplitude
of about 5 volts or less (in one or more embodiment about 1, 2, 3,
4, or 5 volts peak amplitude can be used) and can have a pulse
frequency of 10 kHz or less (e.g., 4 kHz to 10 kHz, 6 kHz to 10
kHz, 8 kHz to 10 kHz, 2 kHz to 6 kHz, 500 Hz to 2 kHz, 200 Hz to 1
kHz, 10 Hz to 100 Hz, overlapping ranges thereof, 2 kHz or less, or
any value within the recited ranges). In one or more embodiments,
the pulse frequency can be on the order of tens of cycles per
second. In one or more embodiments, the pulse frequency can be
about 50 Hz and the first signal 14101 is configured to provide a
spinal electrostimulation therapy. In one or more embodiments, the
pulse frequency can be about 120 Hz and the first signal 14101 is
configured to provide deep brain stimulation therapy. In one or
more embodiments, the pulse frequency can be 500 Hz to 2000 Hz and
is configured to provide a burst signal-based therapy. Generally, a
therapy pulse frequency of the first signal 14101 is sufficiently
low and a therapy pulse amplitude of the first signal 14101 is
sufficiently high to elicit a therapeutic effect.
[0754] In addition to the therapy pulses T.sub.1, T.sub.2, and
T.sub.3, the first signal 14101 further includes data communication
intervals that include data signal pulses. The communication
intervals can be interleaved with the therapy pulses. That is, the
communication intervals occur during blanking intervals or periods
between therapy pulses when no therapy pulses or therapy-related
signal components are provided by the implantable device 110. In
one or more embodiments, the first signal 14101 includes a first
communication interval C.sub.1 between the first and second therapy
pulses T.sub.1 and T.sub.2, and a second communication interval
C.sub.2 between the second and third therapy pulses T.sub.2 and
T.sub.3.
[0755] During the communication intervals, the same or different
electrodes of the implantable device 110, such as used to provide
the first and second therapy pulses T.sub.1 and T.sub.2, can be
excited to produce the data signal pulses. The data signal pulses
can include pulse-width modulated pulses, frequency modulated
pulses, or amplitude modulated pulses that encode information into
a signal that can be delivered by the implantable device 110. A
farfield signal generated as a result of the delivered modulated
pulse signal can be received and decoded by the external source 102
or by another receiver device. For example, the first communication
interval C.sub.1 can include a first pulse-width modulated (PWM)
data signal. The first PWM data signal can be provided at a
frequency that is sufficiently high, and/or at a signal amplitude
that is sufficiently low, such that a physiologic response to the
signal can be avoided. In one or more embodiments, the first PWM
data signal is provided at a frequency that is at least one and
preferably two or three orders of magnitude higher than a frequency
of the therapy pulse components of the first signal 14101. In one
or more embodiments, the first PWM data signal is provided at an
amplitude that is less than a specified threshold amplitude that
corresponds to a known physiologic capture or response-provoking
amplitude threshold. The second communication interval C.sub.2 can
include a second PWM signal. The second PWM signal can optionally
have different characteristics than the first PWM signal, such as
to encode different information than is encoded in the first PWM
signal. In one or more embodiments, therapy pulses and data signals
can be provided by the implantable device 110 using the same or
different electrodes.
[0756] In one or more embodiments, the implantable device 110
provides the second signal 14102, such as using an electrode vector
comprising electrodes E0 and E2. The second signal 14102 begins at
time to and terminates later at time t.sub.f. At t.sub.0, the
second signal 14102 includes a first composite therapy pulse
CT.sub.1 having a first pulse duration, .DELTA.t.sub.1. The second
signal 14102 includes a subsequent second composite therapy pulse
CT.sub.2, beginning at time t.sub.2, and having a second pulse
duration .DELTA.t.sub.2. In one or more embodiments, the first and
second pulse durations .DELTA.t.sub.1 and .DELTA.t.sub.2 are
substantially the same, however, other durations can similarly be
used. Amplitude and frequency characteristics of the first and
second composite therapy pulses CT.sub.1 and CT.sub.2 are selected
to elicit a therapeutic response.
[0757] Each of the first and second composite therapy pulses
CT.sub.1 and CT.sub.2 includes data signal components. That is,
each composite therapy pulse includes a pulse signal portion that
includes an embedded data signal. The embedded data signal
components can include pulse-width modulated pulses, frequency
modulated pulses, or amplitude modulated pulses that encode
information into a signal that can be received and decoded by the
external source 102 or by another receiver device, such as the
farfield sensor device 130. For example, the first composite
therapy pulse CT.sub.1 can include a first pulse-width modulated
(PWM) pulse portion. The first PWM pulse portion can be provided at
a frequency that is sufficiently high, and/or at a signal amplitude
that is sufficiently high, such that a therapeutic response is
elicited or provoked. That is, the first PWM pulse portion can be
sufficiently high frequency such that the frequency of the signal
exceeds a refractory period of a neural target and therefore an
effect of the first PWM pulse portion is essentially the same as a
constant electrostimulation signal or pulse provided over the same
duration.
[0758] As shown in the embodiment of FIG. 132, the composite
therapy pulses CT.sub.1, CT.sub.2, and CT.sub.3, can include data
signal components that are embedded with therapy pulses at
different time intervals or locations with respect to an overall
pulse duration. For example, the first composite therapy pulse
CT.sub.1 includes a data signal component that begins a short
duration after time t.sub.0, and the data signal component
terminates a short duration before t.sub.1. In one or more
embodiments, the data signal component of CT.sub.1 and other
composite therapy pulses can begin a specified or fixed duration
after a rising edge of a pulse. The second composite therapy pulse
CT.sub.2 includes a data signal component that coincides with the
onset of the second composite therapy pulse CT.sub.2 at t.sub.2,
and the third composite therapy pulse CT.sub.3 includes a data
signal component that begins after t.sub.4 and coincides with a
terminal portion of the third composite therapy pulse CT.sub.3 at
t.sub.5. Thus, a data signal component can be embedded with
essentially any portion of a pulse that includes other pulse
portion(s) that are configured to elicit a physiologic response. In
one or more embodiments, a data signal component can be embedded at
specified intervals, randomly, or substantially continuously with a
therapy signal.
[0759] FIG. 132 includes a third electrostimulation therapy signal
14103 that represents an effect of either one of the first and
second therapy signals 14101 and 14102. For example, since the
embedded data signal components in the second therapy signal 14102
are provided at a sufficiently high frequency and/or amplitude, a
physiologic effect of the second therapy signal 14102 is
essentially or effectively the same as a physiologic effect of the
third therapy signal 14103. Similarly, since the interleaved data
signals in the first therapy signal 14101 are provided at a
sufficiently high frequency and/or low amplitude (e.g., sub-capture
threshold), a physiologic effect of the first therapy signal 14101
is essentially or effectively the same as a physiologic effect of
the third therapy signal 14103.
[0760] FIG. 133 illustrates, by way of example, a diagram of an
embodiment of a method 14200 that includes retrieving an
information signal from a therapy-based signal. The method 14200
includes using a closed-loop system comprising the external source
102 and the implantable device 110. The implantable device 110 is
configured to measure or sense information about one or more of
power levels converted from the external source 102, actual therapy
or electrostimulation parameters used by the implantable device
110, lead or electrode impedance characteristics of the implantable
device 110, or other information. The measured or sensed
information is encoded into a therapy signal at the implantable
device 110 and then the therapy signal is provided by the
implantable device 110 and sensed by the external source 102. Thus,
a feedback or communication loop can be established between the
external source 102 and the implantable device 110.
[0761] At operation 14210, the method 14200 includes transmitting a
midfield power signal from the external source 102. Transmitting
the midfield power signal can include in response to exciting one
or more subwavelength structures on the antenna 300 to cause the
antenna 300 to emit an RF signal having a non-negligible H-field
component. At operation 14220, the method 14200 includes receiving
the midfield power signal at the implantable device 110.
[0762] At operation 14230, the method 14200 includes providing a
nearfield electrostimulation therapy using the implantable device
110. Operation 14230 can include providing the first or second
therapy signals 14101 or 14102 from the embodiment of FIG. 132, or
providing other signals, such as can include a data signal
component. The data signal component can include encoded
information about the implantable device 110, or about a therapy
provided or to-be provided by the implantable device 110. Providing
the nearfield electrostimulation therapy at operation 14230 can
include providing a farfield signal that can be detected remotely
from the implantable device 110. In one or more embodiments,
providing the nearfield electrostimulation therapy includes
providing therapy and data signal pulses from the same electrodes
of the implantable device 110.
[0763] At operation 14240, the method 14200 includes receiving, at
the external source 102, the farfield signal corresponding to the
nearfield electrostimulation therapy. Receiving the farfield signal
can include using the electrodes 121 and 122 that are coupled to
the external source 102. The electrodes 121 and 122 can be coupled
to a tissue surface near the implantable device 110, and can sense
electrical activity resulting from the nearfield electrostimulation
therapy provided at operation 14230.
[0764] At operation 14250, the method 14200 includes retrieving an
information signal from the received farfield signal, such as using
the external source 102. In one or more embodiments, retrieving the
information signal includes using the processor circuitry 210
and/or the demodulator circuitry 230, from the embodiment of FIG.
2A, to receive an electrical signal from the electrodes 121 and 122
and process the electrical signal to extract information or data
components from the electrical signal.
[0765] At operation 14260, the method 14200 includes using the
external source 102 to report the information signal to a user
and/or to a remote device. The information signal can be reported
in various ways including audibly (e.g., using the audio speaker
251), visually or graphically (e.g., using the display interface
252), or using a vibratory or other mechanical signal (e.g., using
the haptic feedback device 253). In one or more embodiments, the
reporting at operation 14260 can indicate, among other things, that
the implantable device 110 is working properly or improperly, that
the implantable device 110 received the midfield power signal at
operation 14220 at an acceptable or unacceptable efficiency level,
that an adjustment is required to a positioning of the external
source 102 and/or of the implantable device 110, or an error
condition at one or more of the external source 102 and the
implantable device 110.
[0766] At operation 14270, the method 14200 includes updating a
midfield power signal characteristic, such as based on the
retrieved information from operation 14250. For example, if the
information signal indicates that an insufficient or unexpected
amount of power was received at the implantable device 110 at
operation 14220, then one or more midfield transmission signal
characteristics can be updated or adjusted to attempt to improve
the efficiency or efficacy of any subsequent transmissions.
[0767] FIG. 134 illustrates, by way of example, a diagram of an
embodiment of a method 14300 that includes encoding information in
a therapy signal. The method 14300 includes operations 14220 and
14230 from the method 14200 of FIG. 133, as described above. After
operation 14220 and before operation 14230, the method 14300
includes at least one of operations 14222 and 14224.
[0768] At operation 14222, the method 14300 includes determining
one or more quantitative or qualitative characteristics of a signal
received by the implantable device 110 from the external source
102. In one or more embodiments, operation 14222 includes
determining a quantity of power received or determining an
efficiency of conversion from a received power signal to a power
signal that is usable or consumable by the implantable device 110,
such as to power the implantable device 110 itself or to provide
energy for an electrostimulation therapy delivered by the
implantable device 110. In one or more embodiments, operation 14222
includes analyzing the received signal to determine whether the
signal includes data or instructions for use by the implantable
device 110.
[0769] At operation 14224, the method 14300 includes encoding
information in a therapy signal about the quantitative or
qualitative characteristics determined at operation 14222, about
the implantable device 110 itself, or about physiologic information
sensed by the implantable device 110. For example, the information
about the implantable device 110 itself can include information
about a power or battery status, a therapy schedule, an implant
date, a therapy history such as including information about which
of multiple electrodes was used to provide a therapy, device
diagnostics, device status, or device operation information, or
device configuration information, such as including information
about available electrodes, available electrostimulation vectors,
or sensors that are integrated with or communicatively coupled to
the implantable device 110. In one or more embodiments, the
implantable device 110 is configured to sense physiologic
information using its electrodes or other sensors (e.g., a part of
the sensor interface 4428), and operation 14224 includes encoding
such physiologic information for transmission in a therapy
signal.
[0770] At operation 14230, the method 14300 includes providing the
nearfield electrostimulation therapy, such as including providing
the encoded information, using the implantable device 110. In one
or more embodiments, operation 14230 includes providing a therapy
signal with interleaved data signals (see, e.g., the first therapy
signal 14101 comprising therapy pulses T.sub.1, T.sub.2, and
T.sub.3, and interleaved data signals at communication intervals
C.sub.1 and C.sub.2). The interleaved data signals can be provided
at a sufficiently high frequency, a sufficiently low amplitude,
and/or for a sufficiently brief duration such that a physiologic
response from tissue near the implantable device 110 is not
provoked. In one or more embodiments, operation 14230 includes
providing a therapy signal with data signals embedded with therapy
pulses (see, e.g., the second therapy signal 14102 comprising
composite therapy pulses CT.sub.1, CT.sub.2, and CT.sub.3). The
embedded data signals can be provided at a sufficient amplitude and
frequency such that the physiologic effect of the signals is about
the same as amplitude or frequency characteristics of a
conventional therapy pulse provided for the same overall
duration.
[0771] FIG. 135 illustrates, by way of example, a diagram of an
embodiment of a method 14400 that includes determining whether a
therapy was properly provided. At operation 14410, the method 14400
includes using an external source 102 to encode instructions into a
power signal to be communicated from the external source 102 to the
implantable device 110. The encoded instructions are for use by an
implantable device 110 to generate and provide a therapy signal
having one or more therapy signal characteristics specified by the
instructions. A therapy signal characteristic can include, among
other things, a specified pulse pattern, frequency, burst
characteristic, amplitude, phase, waveform morphology, or other
characteristic. At operation 14420, the method 14400 includes using
the external source 102 to transmit a midfield power signal that
includes the instructions encoded at operation 14410. Transmitting
the midfield power signal can include in response to exciting one
or more subwavelength structures on the antenna 300 to cause the
antenna 300 to emit an RF signal having a non-negligible H-field
component.
[0772] At operation 14430, the method 14400 can include receiving
the midfield power signal at the implantable device 110, and using
the implantable device 110 to decode the instructions. In one or
more embodiments, the antenna 108 of the implantable device 110
receives the midfield power signal and provides a corresponding
electrical signal to one or more of the demodulator 544, the
digital controller 548, or another processor circuitry for decoding
and processing. For example, the instructions including one or more
specified therapy signal characteristics can be decoded from the
electrical signal.
[0773] At operation 14440, the method 14400 includes providing a
nearfield electrostimulation therapy according to the instructions
decoded at operation 14430. For example, the stimulation driver
circuitry 556 can be configured to implement the instructions,
including the one or more specified therapy signal characteristics,
to provide an electrostimulation signal to one or more of the
outputs 534 to the electrode array of the implantable device 110.
When the nearfield electrostimulation therapy is provided at
operation 14440, a corresponding potential difference (e.g., as a
result of an electric dipole moment) can be remotely detected, such
as using the external source 102 or the farfield sensor device 130.
The external source 102 and/or the farfield sensor device 130 can
be electrically coupled to a skin surface near the implantable
device 110 to receive the potential difference information
resulting from the delivered therapy signal. In a tissue or other
space distal from the electrostimulation electrodes and optionally
distal from the therapy target 190, the electric field can be
considered a farfield signal corresponding to the nearfield signal
that results from the electrostimulation therapy. The nearfield
electrostimulation therapy provided at operation 14440 can
optionally include data signal components (see, e.g., the first and
second therapy signals 14101 and 14102 in the embodiment of FIG.
132).
[0774] At operation 14450, the method 14400 includes receiving, via
the sensing electrodes 220 of the external source 102, the farfield
signal corresponding to the nearfield electrostimulation therapy
provided at operation 14440. Receiving the farfield signal can
include using the electrodes 121 and 122 that are coupled to the
external source 102. The electrodes 121 and 122 can be coupled to a
tissue surface near the implantable device 110, and can sense
electrical activity resulting from the nearfield electrostimulation
therapy provided at operation 14440. In one or more embodiments,
the external source 102 can provide a second electrical signal
corresponding to the farfield signal, such as using the processor
circuitry 210.
[0775] At operation 14460, the method 14400 includes determining,
based on the received farfield signal, whether the
electrostimulation therapy was properly provided at operation
14440. The determining at operation 14460 can be performed using
the external source 102, or using an external device in data
communication with the external source 102. The determining at
operation 14460 includes analyzing the second electrical signal
corresponding to the farfield signal to determine whether
characteristics of the nearfield and/or farfield signals correspond
or conform to the one or more therapy signal characteristics
specified at operation 14410. That is, the second electrical
signal, which is derived from the farfield electrical signal, can
be used to determine whether the nearfield electrostimulation
therapy was properly provided at operation 14440 according to the
instructions issued by the external source 102 at operation 14410.
The external source 102 or the implantable device 110 can take
remedial actions if it is determined that the therapy was
improperly provided. For example, the external source 102 can
transmit new or additional instructions to the implantable device
110, such as to update or modify one or more of the therapy signal
characteristics, or the implantable device 110 can select or use a
different electrostimulation vector to provide the therapy.
IV. Embodiments of Computer Hardware and/or Architecture
[0776] FIG. 140 illustrates, by way of example, a block diagram of
an embodiment of a machine 15000 upon which one or more methods
discussed herein can be performed or in conjunction with one or
more systems or devices described herein may be used. FIG. 140
includes reference to structural components that are discussed and
described in connection with several of the embodiments and figures
above. In one or more embodiments, the implantable device 110, the
source 102, the sensor 107, the processor circuitry 210, the
digital controller 548, circuitry in the circuitry housing 610,
4806, 5606, and/or 3616, system control circuitry 4222, power
management circuitry 4214 and/or 6408, the controller 6412,
stimulation circuitry 4216, energy harvest circuitry 4212,
synchronization circuitry 4218, the external device 4202, 5028,
AND/OR 8802, control circuitry 8221, feedback control circuitry
8223, the implanted device 8804, location circuitry 11446, control
circuitry 11652, other circuitry of the implantable device, and/or
circuitry that is a part of or connected to the external source,
such as the circuitry 10430, can include one or more of the items
of the machine 15000. The machine 15000, according to some example
embodiments, is able to read instructions from a machine-readable
medium (e.g., a machine-readable storage medium) and to perform any
one or more of the methodologies, one or more operations of the
methodologies, or one or more circuitry functions discussed herein,
such as the methods described with regard to FIGS. 41A-41B, 103,
104, 107, 110, 111, 112, 113, 117, 118, 125, 126, 127, 129-131,
133, 134, and/or 135. For example, FIG. 140 shows a diagrammatic
representation of the machine 15000 in the example form of a
computer system, within which instructions 15016 (e.g., software, a
program, an application, an applet, an app, or other executable
code) for causing the machine 15000 to perform any one or more of
the methodologies discussed herein can be executed. The
instructions transform the general, non-programmed machine into a
particular machine programmed to carry out the described and
illustrated functions in the manner described. In alternative
embodiments, the machine 15000 operates as a standalone device or
can be coupled (e.g., networked) to other machines. In a networked
deployment, the machine 15000 can operate in the capacity of a
server machine or a client machine in a server-client network
environment, or as a peer machine in a peer-to-peer (or
distributed) network environment. Various portions of the machine
15000 can be included in, or used with, one or more of the external
source 102 and the implantable device 110. In one or more
embodiments, different instantiations or different physical
hardware portions of the machine 15000 are separately implanted at
the external source 102 and the implantable device 110.
[0777] In one or more embodiments, the machine 15000 can comprise,
but is not limited to, a server computer, a client computer, a
personal computer (PC), a tablet computer, a laptop computer, a
cellular telephone, a smart phone, a mobile device, a wearable
device (e.g., a smart watch), a smart home device (e.g., a smart
appliance), other smart devices, a web appliance, a network router,
a network switch, a network bridge, or any machine capable of
executing the instructions 15016, sequentially or otherwise, that
specify actions to be taken by machine 15000. Further, while only a
single machine 15000 is illustrated, the term "machine" shall also
be taken to include a collection of machines 15000 that
individually or jointly execute the instructions 15016 to perform
any one or more of the methodologies discussed herein.
[0778] The machine 15000 can include processors 15010, memory
15030, or I/O components 15050, which can be configured to
communicate with each other such as via a bus 15002. In one or more
embodiments embodiment, the processors 15010 (e.g., a Central
Processing Unit (CPU), a Reduced Instruction Set Computing (RISC)
processor, a Complex Instruction Set Computing (CISC) processor, a
Graphics Processing Unit (GPU), a Digital Signal Processor (DSP),
an Application Specific Integrated Circuitry (ASIC), a
Radio-Frequency Integrated Circuitry (RFIC), another processor, or
any suitable combination thereof) can include, for example,
processor 15012 and processor 15014 that can execute instructions
15016. The term "processor" is intended to include multi-core
processors that can include two or more independent processors
(sometimes referred to as "cores") that can execute instructions
contemporaneously. Although FIG. 140 shows multiple processors, the
machine 15000 can include a single processor with a single core, a
single processor with multiple cores (e.g., a multi-core process),
multiple processors with a single core, multiple processors with
multiples cores, or any combination thereof.
[0779] The memory/storage 15030 can include a memory 15032, such as
a main memory, or other memory storage, and a storage unit 15036,
both accessible to the processors 15010 such as via the bus 15002.
The storage unit 15036 and memory 15032 store the instructions
15016 embodying any one or more of the methodologies or functions
described herein. The instructions 15016 can also reside,
completely or partially, within the memory 15032, within the
storage unit 15036, within at least one of the processors 15010
(e.g., within the processor's cache memory), or any suitable
combination thereof, during execution thereof by the machine 15000.
Accordingly, the memory 15032, the storage unit 15036, and the
memory of processors 15010 are examples of machine-readable
media.
[0780] As used herein, "machine-readable medium" means a device
able to store instructions and data temporarily or permanently and
can include, but is not be limited to, random-access memory (RAM),
read-only memory (ROM), buffer memory, flash memory, optical media,
magnetic media, cache memory, other types of storage (e.g.,
Erasable Programmable Read-Only Memory (EEPROM)) and/or any
suitable combination thereof. The term "machine-readable medium"
should be taken to include a single medium or multiple media (e.g.,
a centralized or distributed database, or associated caches and
servers) able to store instructions 15016. The term
"machine-readable medium" shall also be taken to include any
medium, or combination of multiple media, that is capable of
storing instructions (e.g., instructions 15016) for execution by a
machine (e.g., machine 15000), such that the instructions, when
executed by one or more processors of the machine 15000 (e.g.,
processors 15010), cause the machine 15000 to perform any one or
more of the methodologies described herein. Accordingly, a
"machine-readable medium" refers to a single storage apparatus or
device, as well as "cloud-based" storage systems or storage
networks that include multiple storage apparatus or devices. The
term "machine-readable medium" excludes signals per se.
[0781] The I/O components 15050 can include a wide variety of
components to receive input, provide output, produce output,
transmit information, exchange information, capture measurements,
and so on. The specific I/O components 15050 that are included in a
particular machine will depend on the type of machine. For example,
portable machines such as mobile phones will likely include a touch
input device or other such input mechanisms, while a headless
server machine will likely not include such a touch input device.
It will be appreciated that the I/O components 15050 can include
many other components that are not shown in FIG. 150. The I/O
components 15050 are grouped according to functionality merely for
simplifying the following discussion and the grouping is in no way
limiting. In various example embodiments, the I/O components 15050
can include output components 15052 and input components 15054. The
output components 15052 can include visual components (e.g., a
display such as a plasma display panel (PDP), a light emitting
diode (LED) display, a liquid crystal display (LCD), a projector,
or a cathode ray tube (CRT)), acoustic components (e.g., speakers),
haptic components (e.g., a vibratory motor, resistance mechanisms),
other signal generators, and so forth. The input components 15054
can include alphanumeric input components (e.g., a keyboard, a
touch screen configured to receive alphanumeric input, a
photo-optical keyboard, or other alphanumeric input components),
point based input components (e.g., a mouse, a touchpad, a
trackball, a joystick, a motion sensor, or other pointing
instrument), tactile input components (e.g., a physical button, a
touch screen that provides location and/or force of touches or
touch gestures, or other tactile input components), audio input
components (e.g., a microphone), and the like.
[0782] In further example embodiments, the I/O components 15050 can
include biometric components 15056, motion components 15058,
environmental components 15060, or position components 15062 among
a wide array of other components. For example, the biometric
components 15056 can include components to detect expressions
(e.g., hand expressions, facial expressions, vocal expressions,
body gestures, or eye tracking), measure physiologic signals (e.g.,
blood pressure, heart rate, body temperature, perspiration, or
brain waves, neural activity, or muscle activity), identify a
person (e.g., voice identification, retinal identification, facial
identification, fingerprint identification, or electroencephalogram
based identification), and the like.
[0783] The motion components 15058 can include acceleration sensor
components (e.g., accelerometer), gravitation sensor components,
rotation sensor components (e.g., gyroscope), and so forth. In one
or more embodiments, one or more of the motion components 15058 can
be incorporated with the external source 102 or the implantable
device 110, and can be configured to detect motion or a physical
activity level of a patient. Information about the patient's motion
can be used in various ways, for example, to adjust a signal
transmission characteristic (e.g., amplitude, frequency, etc.) when
a physical relationship between the external source 102 and the
implantable device 110 changes or shifts.
[0784] The environmental components 15060 can include, for example,
illumination sensor components (e.g., photometer), temperature
sensor components (e.g., one or more thermometer that detect
ambient temperature), humidity sensor components, pressure sensor
components (e.g., barometer), acoustic sensor components (e.g., one
or more microphones that detect background noise), proximity sensor
components (e.g., infrared sensors that detect nearby objects), gas
sensors (e.g., gas detection sensors to detection concentrations of
hazardous gases for safety or to measure pollutants in the
atmosphere), or other components that can provide indications,
measurements, or signals corresponding to a surrounding physical
environment. The position components 15062 can include location
sensor components (e.g., a Global Position System (GPS) receiver
component), altitude sensor components (e.g., altimeters or
barometers that detect air pressure from which altitude can be
derived), orientation sensor components (e.g., magnetometers), and
the like. In one or more embodiments, the I/O component(s) 15050
can be a part of the implantable device 110 and/or the external
source 102.
[0785] Communication can be implemented using a wide variety of
technologies. The I/O components 15050 can include communication
components 15064 operable to couple the machine 15000 to a network
15080 or devices 15070 via coupling 15082 and coupling 15072
respectively. For example, the communication components 15064 can
include a network interface component or another suitable device to
interface with the network 15080. In further examples,
communication components 15064 can include wired communication
components, wireless communication components, cellular
communication components, Near Field (nearfield) Communication
(NFC) components, midfield communication components, farfield
communication components, and other communication components to
provide communication via other modalities. The devices 15070 can
be another machine or any of a wide variety of peripheral
devices.
[0786] Moreover, the communication components 15064 can detect
identifiers or include components operable to detect identifiers.
For example, the communication components 15064 can include Radio
Frequency Identification (RFID) tag reader components, NFC smart
tag detection components, optical reader components (e.g., an
optical sensor to detect one-dimensional bar codes such as
Universal Product Code (UPC) bar code, multi-dimensional bar codes
such as Quick Response (QR) code, Aztec code, Data Matrix,
Dataglyph, MaxiCode, PDF417, Ultra Code, UCC RSS-2D bar code, and
other optical codes), or acoustic detection components (e.g.,
microphones to identify tagged audio signals). In addition, a
variety of information can be derived via the communication
components 15064, such as, location via Internet Protocol (IP)
geo-location, location via Wi-Fi.RTM. signal triangulation,
location via detecting a NFC beacon signal that can indicate a
particular location, and so forth.
[0787] In some embodiments, the systems comprise various features
that are present as single features (as opposed to multiple
features). For example, in one embodiment, the system includes a
single external source and a single implantable device or
stimulation device with a single antenna. Multiple features or
components are provided in alternate embodiments.
[0788] In some embodiments, the system comprises one or more of the
following: means for tissue stimulation (e.g., an implantable
stimulation device), means for powering (e.g., a midfield powering
device or midfield coupler), means for receiving (e.g., a
receiver), means for transmitting (e.g., a transmitter), means for
controlling (e.g., a processor or control unit), etc.
[0789] Although various general and specific embodiments are
described herein, it will be evident that various modifications and
changes can be made to these embodiments without departing from the
broader spirit and scope of the present disclosure. Accordingly,
the specification and drawings are to be regarded in an
illustrative rather than a restrictive sense. The accompanying
drawings that form a part of this application show, by way of
illustration, and not of limitation, specific embodiments in which
the subject matter can be practiced. The embodiments illustrated
are described in sufficient detail to enable those skilled in the
art to practice the teachings disclosed herein. Other embodiments
can be used or derived therefrom, such that structural and logical
substitutions and changes can be made without departing from the
scope of this disclosure. This Detailed Description, therefore, is
not to be taken in a limiting sense, and the scope of various
embodiments is defined only by the appended claims, along with the
full range of equivalents to which such claims are entitled.
Specific embodiments or examples are illustrated and described
herein, however, it should be appreciated that any arrangement
calculated to achieve the same purpose can be substituted for the
specific embodiments shown. This disclosure is intended to cover
any and all adaptations or variations of various embodiments.
Combinations of the above embodiments, and other embodiments not
specifically described herein, will be apparent to those of skill
in the art upon reviewing the above description.
[0790] Each of these non-limiting examples or embodiments can stand
on its own, or can be combined in various permutations or
combinations with one or more of the other examples or
embodiments.
[0791] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which methods, apparatuses, and systems discussed
herein can be practiced. These embodiments are also referred to
herein as "examples." Such examples can include elements in
addition to those shown or described. However, the present
inventors also contemplate examples in which only those elements
shown or described are provided. Moreover, the present inventors
also contemplate examples using any combination or permutation of
those elements shown or described (or one or more aspects thereof),
either with respect to a particular example (or one or more aspects
thereof), or with respect to other examples (or one or more aspects
thereof) shown or described herein.
[0792] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "at least one" or
"one or more." In this document, the term "or" is used to refer to
a nonexclusive or, such that "A or B" includes "A but not B," "B
but not A," and "A and B," unless otherwise indicated. In this
document, the terms "including" and "in which" are used as the
plain-English equivalents of the respective terms "comprising" and
"wherein." Also, in the following claims, the terms "including" and
"comprising" are open-ended, that is, a system, device, article,
composition, formulation, or process that includes elements in
addition to those listed after such a term in a claim are still
deemed to fall within the scope of that claim. Moreover, in the
following claims, the terms "first," "second," and "third," etc.
are used merely as labels, and are not intended to impose numerical
requirements on their objects.
[0793] The ranges disclosed herein also encompass any and all
overlap, sub-ranges, and combinations thereof. Language such as "up
to," "at least," "greater than," "less than," "between," and the
like includes the number recited. Numbers preceded by a term such
as "about" or "approximately" include the recited numbers. For
example, "about 10 kHz" includes "10 kHz." Terms or phrases
preceded by a term such as "substantially" or "generally" include
the recited term or phrase. For example, "substantially parallel"
includes "parallel" and "generally cylindrical" includes
cylindrical.
[0794] The above description is intended to be illustrative, and
not restrictive. For example, the above-described examples (or one
or more aspects thereof) may be used in combination with each
other. Other embodiments can be used, such as by one of ordinary
skill in the art upon reviewing the above description. The Abstract
is provided to allow the reader to quickly ascertain the nature of
the technical disclosure. It is submitted with the understanding
that it will not be used to interpret or limit the scope or meaning
of the claims. Also, in the above Detailed Description, various
features may be grouped together to streamline the disclosure. This
should not be interpreted as intending that an unclaimed disclosed
feature is essential to any claim. Rather, inventive subject matter
may lie in less than all features of a particular disclosed
embodiment. Thus, the following claims are hereby incorporated into
the Detailed Description as examples or embodiments, with each
claim standing on its own as a separate embodiment, and it is
contemplated that such embodiments can be combined with each other
in various combinations or permutations. The scope of the
invention(s) and embodiments should be determined with reference to
the appended claims, along with the full scope of equivalents to
which such claims are entitled.
* * * * *