U.S. patent application number 15/441920 was filed with the patent office on 2017-06-15 for system and method for neuro-stimulation.
The applicant listed for this patent is TRUSTEES OF BOSTON UNIVERSITY. Invention is credited to Susan D'Andrea, Jason D. Harry, Scott Kellogg, James B. Niemi.
Application Number | 20170165486 15/441920 |
Document ID | / |
Family ID | 39636620 |
Filed Date | 2017-06-15 |
United States Patent
Application |
20170165486 |
Kind Code |
A1 |
Harry; Jason D. ; et
al. |
June 15, 2017 |
SYSTEM AND METHOD FOR NEURO-STIMULATION
Abstract
A neuro-stimulation system employs a includes a stimulator which
may include electrode devices and/or vibration elements. A
controller may be employed to drive the stimulating elements with
an electrical signal. In response to the electrical signal, the
stimulating elements deliver electrical and/or mechanical
stimulation to the body part. The stimulation may be an aperiodic
stimulation and/or may be a subthreshold stimulation. In one
embodiment, the stimulator is disposable and the processor
determines usage of the stimulator and ensures that the stimulator
is limited to a certain amount of use. Neuro-stimulation systems
may be applied to sensory cells of body parts during movement of
the body parts to induce neuroplastic changes. Such movement may
involve a variety of therapeutic applications, e.g. in stroke
patient therapy.
Inventors: |
Harry; Jason D.; (Rumford,
RI) ; Niemi; James B.; (Chepachet, RI) ;
Kellogg; Scott; (Mattapoisett, MA) ; D'Andrea;
Susan; (Barrington, RI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TRUSTEES OF BOSTON UNIVERSITY |
Boston |
MA |
US |
|
|
Family ID: |
39636620 |
Appl. No.: |
15/441920 |
Filed: |
February 24, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14249856 |
Apr 10, 2014 |
9616234 |
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15441920 |
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11927597 |
Oct 29, 2007 |
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14249856 |
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10429252 |
May 5, 2003 |
7349739 |
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11927597 |
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60377202 |
May 3, 2002 |
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60880026 |
Jan 12, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36021 20130101;
A61N 1/36007 20130101; A61N 1/3601 20130101; A61H 2201/5043
20130101; A61N 1/0476 20130101; A61H 2201/5023 20130101; A61H
2201/165 20130101; A61N 1/321 20130101; A61N 1/36071 20130101; A61H
23/0263 20130101; A61F 5/0026 20130101; A61N 1/0556 20130101; A61N
1/36017 20130101; A61N 1/36164 20130101; A61N 1/0452 20130101; A61N
1/3627 20130101; A61N 1/0456 20130101; A61N 1/0472 20130101; A61H
23/02 20130101; A61H 2201/5007 20130101; A61H 2201/1207 20130101;
A61N 1/36003 20130101; A61N 1/36034 20170801; A61N 1/0484 20130101;
A61N 1/37247 20130101; A61H 23/004 20130101; A61N 1/0492 20130101;
A61N 2/006 20130101; A61N 1/0464 20130101; A61H 2201/5058
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/04 20060101 A61N001/04; A61H 23/00 20060101
A61H023/00; A61N 2/00 20060101 A61N002/00; A61H 23/02 20060101
A61H023/02; A61N 1/372 20060101 A61N001/372; A61N 1/05 20060101
A61N001/05 |
Claims
1-80. (canceled)
81. A method, comprising: generating at least one bias signal using
a system for providing sub-threshold stimulation, the system
comprising an application body with a stimulating element
generating the at least one bias signal; inputting the at least one
bias signal to at least one sensory cell area of a muscle of a
subject, wherein the muscle changes position; and inducing a
neuroplastic response in the nervous system of the subject by
inputting the at least one bias signal for at least a period of
time whereby the subject's sensation of the position of the muscle
is improved.
82. The method according to claim 81, wherein the at least one bias
signal is continuously applied to the at least one sensory cell
area of the muscle.
83. The method according to claim 81, wherein the at least one bias
signal is non-continuously applied to the at least one sensory cell
area of the muscle.
84. The method according to claim 81, wherein the at least one bias
signal is a modulated bias signal applied to the at least one
sensory cell area of the muscle.
85. The method according to claim 81, wherein the at least one bias
signal is a modulated bias signal that is continuously applied to
the at least one sensory cell area of the muscle.
86. The method according to claim 81, wherein the at least one bias
signal is a modulated bias signal that is non-continuously applied
to the at least one sensory cell area of the muscle.
87. A method, comprising: generating at least one bias signal using
a system for providing sub-threshold stimulation, the system
comprising an application body with a stimulating element
generating the at least one bias signal; inputting the at least one
bias signal to at least one sensory cell area of a body part of a
subject, wherein the subject is experiencing pain at the body part;
and inducing a neuroplastic response in the nervous system of the
subject by inputting the at least one bias signal for at least a
period of time whereby the subject's management of the pain at the
body part is improved.
88. The method according to claim 87, wherein the pain is caused by
musculoskeletal hyperextension or excursion resulting from
proprioceptive deficit in the body part.
89. The method according to claim 87, wherein the body part is a
back of the subject.
90. The method according to claim 87, wherein the at least one bias
signal is continuously applied to the body part of the subject.
91. The method according to claim 87, wherein the at least one bias
signal is non-continuously applied to the body part of the
subject.
92. The method according to claim 87, wherein the at least one bias
signal is a modulated bias signal applied to the body part of the
subject.
93. The method according to claim 87, wherein the at least one bias
signal is a modulated bias signal that is continuously applied to
the body part of the subject.
94. The method according to claim 87, wherein the at least one bias
signal is a modulated bias signal that is non-continuously applied
to the body part of the subject.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S.
application Ser. No. 10/429,252 filed May 5, 2003, the contents of
which are incorporated herein by reference. U.S. application Ser.
No. 10/429,252 claims the benefit of U.S. Provisional Patent
Application No. 60/377,202 filed May 3, 2002, the contents of which
are incorporated herein by reference. This application also claims
the benefit of U.S. Provisional Patent Application No. 60/880,026
filed Jan. 12, 2007, the contents of which are incorporated herein
by reference.
BACKGROUND OF INVENTION
[0002] Field of Invention
[0003] The present invention is generally directed to a system for
providing neuro-stimulation, and more particularly, to a system
that employs electrical current and/or mechanical vibration to
deliver subthreshold and/or aperiodic stimulation to enhance
detection and communication of sensory information.
[0004] Description of the Related Art
[0005] The nervous system of mammals is a complex set of
interrelated and interacting sub-systems. The sub-systems are
categorized and named both by their anatomic positions and by their
function. At the highest level, the nervous system is divided into
central and peripheral nervous systems. The central nervous system
(CNS) is comprised of the brain and spinal cord; the peripheral
nervous system (PNS) subsumes all the remaining neural structures
found outside the CNS. The PNS is further divided functionally into
the somatic (voluntary) and autonomic (involuntary) nervous
systems. The PNS can also be described structurally as being
comprised of afferent (sensory) nerves, which carry information
toward the CNS, and efferent (motor) nerves, which carry commands
away from the CNS.
[0006] Interconnections between afferent and efferent nerves are
found in the spinal cord and brain. Taken together, certain
groupings of afferent and efferent nerves constitute sensorimotor
"loops" that are required to achieve coordinated movements in the
face of perturbations from the environment and changes in
volitional intent. In the periphery (trunk, upper extremities, and
lower extremities), afferent nerves carry sensory information
arising from special neurons that are sensitive to pain,
temperature, and mechanical stimuli such as touch and vibration at
the skin surface, and position, force, and stretch of deeper
structures such as muscles, tendons, ligaments, and joint capsule.
The term "proprioception" generally applies to sensory information
directly relevant to limb position sense and muscle contraction.
Combined with tactile (touch) sensation, mechanical sensory
information is collectively known as "somatosensation."
[0007] Specialized "mechanoreceptor" neurons transduce mechanical
stimuli from the body's interaction with the environment into
electrical signals that can be transmitted and interpreted by the
nervous system. Pacinian corpuscles in the skin fire in response to
touch pressure. Muscle spindles, found interspersed in skeletal
muscle tissue, report on the state of stretch of the surrounding
muscle. Golgi tendon organs sense the level of force in the tendon.
Free nerve endings in structures surrounding joints (ligaments,
meniscus, etc.) provide additional information about joint
position. Some of these mechanoreceptor systems are thought to
interact directly via excitatory and inhibitory synapses and
descending pathways to modulate the performance or interpretation
of signals from other mechanoreceptor systems.
[0008] Sensory cells of all types are typically threshold-based
units. That is, if the stimulus to a sensory cell is of
insufficient magnitude, the cell will not activate and begin
signaling. Such a stimulus is called "subthreshold." A stimulus
that is above the threshold is called "suprathreshold."
[0009] Connections within the nervous system-brain, spinal cord,
and peripheral nerves are highly changeable in the face of demands
placed on the body. New forms of activity, pathologies, and
injuries all can lead to durable changes, both beneficial and
deleterious, in the nervous system. In healthy individuals, these
neurological changes allow for the acquisition of new physical
skills, a process termed "motor learning." Following certain types
of soft tissue injury (e.g. rupture of the anterior cruciate
ligament of the knee, a structure known to be rich in
mechanoreceptors), and subsequent medical efforts such as surgery
used to repair the damage, the nervous system can undergo
compensatory changes to accommodate for loss of the natural sensory
neurons. Similar PNS and CNS nervous system changes account for
some individuals' ability to regain lost motor function following
spinal or brain injuries. Taken together, these structural changes
in the nervous systems--the creation of new useful interconnections
or the pruning away of unused pathways--are termed
"neuroplasticity" or "neuroplastic changes."
[0010] Recent research has established that afferent (sensory)
activity from the periphery is one of the key drivers of
neuroplastic changes in the nervous system, both in the PNS and
CNS.
[0011] Stimulation below perception levels (i.e. subthreshold
stimulation) used to enhance the function of sensory cells is
described in U.S. Pat. Nos. 5,782,873 and 6,032,074 to Collins, the
entire contents of which are incorporated by reference. Collins
discloses a method and apparatus for improving the function of
sensory cells by effectively lowering their threshold of firing.
Briefly, a subthreshold stimulation, or subsensory stimulation or
"bias signal," is input to the sensory neuron thereby predisposing
the neuron to firing, without actually causing it to fire. In some
embodiments, the stimulation may have an aperiodic waveform. In one
particular embodiment, the bias signal is a broadband signal
containing many frequencies, often termed "white noise." Since
sensory cells are typically threshold-based units, lowering the
sensory cell threshold decreases the level of outside stimulus
needed to cause the sensory cell to respond (i.e. fire). Thus, the
sensory cell, in the presence of the bias signal, is expected to
respond to stimulus intensities that would normally be considered
subthreshold to the neuron in the absence of noise. Both electrical
and mechanical modalities of bias signal, used individually or in
combination, may be used to effect the lowering of sensory neuron
detection threshold. In other words, the stimulation essentially
energizes sensory neurons based on a principle termed "stochastic
resonance" (SR), so that they are predisposed to fire in response
to stimuli from the environment. By increasing the sensitivity of
mechanoreceptors, it is possible effectively to boost the flow of
sensory information traveling from muscles, joints, and skin to the
body's control centers in a fashion that is concordant with normal
function.
[0012] One exemplary clinical use of increased sensory information
is in the rehabilitation of individuals who suffer loss of
sensorimotor function following stroke. According to the American
Stroke Association, stroke is the leading cause of serious,
long-term disability in the U.S., with the annual cost of
stroke-related care expected to exceed $58 billion in 2006.
Approximately 700,000 cases of stroke occur each year in the U.S.
As a result, over 460,000 patients a year are left with motor
impairments, the most common of which is hemiparesis, a weakness or
partial paralysis of the body. In addition, a majority of the 5.5
million stroke survivors in the U.S. have some degree of
impairment. While many patients improve with current physical
rehabilitation therapy, most are left with significant motor
deficits. Full recovery from stroke is uncommon. Thus, additional
techniques for reversing the motor deficits caused by stroke are
necessary. Boosting sensory traffic using the present invention is
one such technique. A similar exemplary clinical use is physical
rehabilitation for individuals who have suffered traumatic brain
injury. Further exemplary clinical uses arise in treatment of
individuals who have a temporary or permanent loss of sensory
function resulting from aging, disease, or physical injury. For
such individuals, the therapy is directed less toward driving
neuroplastic changes and more toward providing an ongoing sensory
boost as a palliative treatment for a chronic sensory
condition.
SUMMARY OF THE INVENTION
[0013] Embodiments of the present invention provide
neuro-stimulation systems that deliver stimulation to enhance the
function of sensory cells. In view of the foregoing, an exemplary
application applies a neuro-stimulation system to reverse the
sensorimotor deficits caused by stroke. Focusing on mechanical
sensory neurons in the periphery, embodiments of the present
invention take advantage of the interplay between mechanoreceptors
and neuromuscular performance. These sensory neurons provide touch,
motion, and force feedback that is contributes to coordinated
movement, acquisition of motor skills, and reestablishing
sensorimotor function following injury. As such, embodiments of the
present invention apply stimulation to mechanoreceptors to increase
their ability to transmit sensory information. The mechanoreceptors
receiving stimulation may include, for instance, subcutaneous
mechanoreceptors as well as receptors in deeper structures. This
stimulation enhances mechanical sensory information provided to the
spinal cord and brain.
[0014] A neuro-stimulation system according to an exemplary
embodiment may employ a controller which includes a user interface,
a power supply, at least one electrical connector, and a processor
with software. According to values entered into the user interface,
the controller determines an electrical signal directed from the
power supply to the electrical connector. The neuro-stimulation
system also includes a stimulator detachably coupled to the
controller via the electrical connector. The stimulator has a
plurality of stimulating elements, including, optionally, at least
one electrode device and/or at least one vibration element. The
stimulator also includes an attachment element to attach the
stimulator to a body part. The controller is operable, via the user
interface, to drive at least one of the stimulating elements with
an electrical signal, which in turn deliver electrical and/or
mechanical stimulation to the body part. The vibration elements
and/or electrodes may be driven to deliver stimulation that is
subthreshold and/or stimulation that has an aperiodic waveform. In
one particular embodiment, the stimulator is disposable and the
processor determines usage of the stimulator and ensures that the
stimulator is limited to a certain amount of use.
[0015] In an exemplary application, the neuro-stimulation system
above is employed adjunctive to movement of a body part. For
example, such movement may be employed as a part of post-stroke
rehabilitative therapy. By applying stimulation from the
neuro-stimulation system in proximity to the region of the body
affected by stroke, the neuroplastic process (the creation of new
sensorimotor pathways that allow healthy areas of the brain to
assume the functions of the damaged portion) is enhanced. This
therapy is particularly effective when used in conjunction with
physical rehabilitation procedures. As such, preferred embodiments
of the neuro-stimulation system may have small, lightweight
components which facilitate the application of stimulation during
physical therapy and do not interfere with the therapy with wires,
connection cables, etc.
[0016] Other embodiments of the present invention may have other
configurations and shapes for delivering controlled stimulation to
any sensory cells of any body part according to a variety of
therapeutic applications. Some embodiments may include only
electrodes while others include only vibrating elements for
delivering stimulation. For some applications, it may be preferable
to include all components of a neuro-stimulation system in a single
housing that is applied to the targeted body part. On the other
hand, for other applications, it may be preferable to include the
stimulator in an application body, i.e., a housing applied to the
body part, while the controller has a separate housing which may be
placed at a distance from the application body. Moreover, in other
embodiments, a neuro-stimulation system may be incorporated within
the structure of another distinct device, e.g., a wearable garment,
where the application of stimulation improves an operator's ability
to use the device or to enhance the effectiveness of the device. In
yet other embodiments, stimulator elements (whether strictly
electrical, mechanical, or both) may be implanted under the skin of
the subject. The controller that is attached to the implanted
stimulator elements may itself also be implanted, with connecting
means traversing under the skin to the stimulator elements. In
addition, the controller may remain extracorporeal with connecting
means passing through the skin to the implanted stimulator
elements.
[0017] Still other aspects, features, and advantages of the present
invention are readily apparent from the following detailed
description, by illustrating a number of exemplary embodiments and
implementations, including the best mode contemplated for carrying
out the present invention. The present invention is also capable of
other and different embodiments, and its several details can be
modified in various respects, all without departing from the spirit
and scope of the present invention. Accordingly, the drawings and
descriptions are to be regarded as illustrative in nature, and not
as restrictive.
BRIEF DESCRIPTION OF THE FIGURES
[0018] FIG. 1 is a flow chart of a method for enhancing the
function of a sensory cell.
[0019] FIG. 2 is a flow chart of a method of locating an input
area.
[0020] FIG. 3 is a flow chart of a method of generating a bias
signal.
[0021] FIG. 4 is a schematic depiction of a system for enhancing
the function of a sensory cell.
[0022] FIGS. 5A-5B illustrates an system for enhancing sensorimotor
performance.
[0023] FIG. 6 is illustrates a signal generator of the present
invention.
[0024] FIG. 7 illustrates wearable device, as one embodiment of the
present invention.
[0025] FIG. 8A-8B illustrate wearable device, as another embodiment
of the present invention.
[0026] FIG. 9 illustrates a signal input device of the present
invention.
[0027] FIG. 10A illustrates an exemplary embodiment of a
neuro-stimulation system, including a stimulator for delivering
electrical and/or mechanical stimulation and a controller for
driving the stimulator.
[0028] FIG. 10B illustrates the exemplary neuro-stimulation system
of FIG. 10A coupled to an attachment element for securing the
neuro-stimulation system to a body part.
[0029] FIG. 11 illustrates a graph of success in executing a motor
task versus time for six study groups in a stroke rehabilitation
study examining the effects of sensory enhancement stimulation when
applied during post-stroke rehabilitative therapy.
[0030] FIG. 12 illustrates yet another graph of success in
executing a motor task versus time for the six study groups in the
stroke rehabilitation study of FIG. 11.
[0031] FIG. 13A illustrates the exemplary neuro-stimulation system
of FIG. 10A secured to a subject's arm for use during post-stroke
rehabilitative therapy.
[0032] FIG. 13B further illustrates the exemplary neuro-stimulation
system of FIG. 10A secured to a subject's arm for use during
post-stroke rehabilitative therapy.
[0033] FIG. 14A illustrates the stimulator of the exemplary
neuro-stimulation system of FIG. 10A.
[0034] FIG. 14B further illustrates the stimulator of the exemplary
neuro-stimulation system of FIG. 10A.
[0035] FIG. 15A illustrates the controller of the exemplary
neuro-stimulation system of FIG. 10A.
[0036] FIG. 15B further illustrates the controller of the exemplary
neuro-stimulation system of FIG. 10A.
[0037] FIG. 16 illustrates the circuit of the exemplary
neuro-stimulation system of FIG. 10A.
[0038] FIG. 17 illustrates an exemplary method for operating the
exemplary neuro-stimulation system of FIG. 10A.
[0039] FIG. 18 illustrates an exemplary method for employing a
read-write storage device for limiting use of a disposable
stimulator for an exemplary embodiment of a neuro-stimulation
system.
[0040] FIG. 19 illustrates a recharging base for the exemplary
neuro-stimulation system of FIG. 10A.
[0041] FIG. 20A illustrates a chart of the spectral content of
exemplary mechanical stimulation for an exemplary embodiment of a
neuro-stimulation system.
[0042] FIG. 20B illustrates a chart of the spectral content of
exemplary electrical stimulation for an exemplary embodiment of a
neuro-stimulation system.
[0043] FIG. 20C illustrates a chart of exemplary random noise
signal corresponding to stimulation by an exemplary embodiment of a
neuro-stimulation system.
[0044] FIG. 21A illustrates an exemplary configuration for a
neuro-stimulation system which may be employed to direct
stimulation to any sensory cells of any body part to enhance
detection of a sensory signal by a subject.
[0045] FIG. 21B illustrates another exemplary configuration for a
neuro-stimulation system which may be employed to direct
stimulation to any sensory cells of any body part to enhance
detection of a sensory signal by a subject.
[0046] FIG. 21C illustrates yet another exemplary configuration for
a neuro-stimulation system which may be employed to direct
stimulation to any sensory cells of any body part to enhance
detection of a sensory signal by a subject.
[0047] FIG. 22A illustrates an exemplary neuro-stimulation system
for application to an internal organ.
[0048] FIG. 22B illustrates an exemplary neuro-stimulation system
having a catheter-like configuration with a plurality of
electrodes, each of which may be selectively driven.
DETAILED DESCRIPTION
[0049] Throughout this specification and the drawing figures
associated with this specification, numerical labels of previously
shown or discussed features may be reused in another drawing figure
to indicate similar features.
[0050] The preferred embodiments of the present invention provide a
method and system for improving sensorimotor performance of humans,
non-human mammals, and non-mammalian animals, hereinafter termed
"subjects." Improvements in sensorimotor performance are meant to
include immediate, i.e., acute, effects, such as improved dynamic
joint stability, and more durable effects as would result from
neuroplastic changes in the PNS or CNS. The method comprises
inputting a bias signal to sensory cells of the subject, so as to
improve the function of those sensory cells by effectively lowering
their threshold of firing, while the subject engages in physical
activity. Such physical activity may or may not be specifically
pre-defined depending upon the desired outcome. Acting in
conjunction with this preferred method is a preferred apparatus
that comprises a wearable device and other electromechanical
components that provide a convenient and secure means of delivering
the bias signal to the subject. As used herein, the term "bias
signal" will be taken to mean a subthreshold form of stimulation to
a sensory neuron, whether electrical or mechanical in nature, whose
waveform may be periodic, aperiodic, deterministic, or
non-deterministic and may contain one or many frequencies.
[0051] The method and system according to the preferred embodiments
of the present invention are useful, for example, to enhance
sensorimotor function in healthy individuals as well as in
individuals with disorders, diseases and/or injuries. For example,
the method and system could be used by healthy individuals striving
to learn a new motor skill, such as might be required for athletic
activity. In another example, the method and system could be
applied to individuals with elevated sensory thresholds or other
neurological dysfunction, such as might arise from aging,
peripheral neuropathies, or strokes.
[0052] FIG. 1 is a flow chart of a method for enhancing the
function of a sensory neuron according to one embodiment of the
present invention. In step 102, an area associated with the sensory
cell whose function is to be enhanced and to which a bias signal is
to be input is located. The located area is hereinafter referred to
as the input area. Once the input area has been located, the bias
signal is generated in step 104. Then in step 106, the bias signal
is input to the input area so as to effectively lower the threshold
of sensory cells with which the input area is associated.
[0053] FIG. 2 is a flow chart showing one embodiment of locating an
input area according to step 102. Locating the input area depends,
inter alia, on the sensory system whose function is to be improved
and the method by which a bias signal may be input to sensory cells
associated with the sensory system. Step 202 is a preliminary step
in which an identification scheme is undertaken to identify a
particular sensory system whose function is to be enhanced. The
identification scheme, to some extent, depends on the cooperation
of the individual. That is, this step is similar to a diagnosis,
however, the individual need not be suffering from any disease or
disorder to be subject to the enhancement process contemplated
herein. In one embodiment, the sensory system whose function is to
be enhanced is one whose function has been degraded by disease.
[0054] In an alternative embodiment, the sensory system to be
enhanced is one that functions normally. In step 204, the most
appropriate way of inputting a bias signal to the target sensory
system is determined. The most appropriate input means depends on a
number of factors including, the target sensory system, the nature
of the transduction system for the target sensory system, the
present state of the target sensory system (i.e., whether it is
impaired or in any way dysfunctional), and the nature of the signal
which is to be determined (e.g., the amplitude and frequency
content of the signal). Input means that are appropriate in certain
circumstances include, but are by no means limited to, nerve cuffs,
implanted electrodes, surface electrodes, muscle stimulators,
tendon stimulators and magnetic field stimulators.
[0055] Once the most appropriate input means is determined in step
204, the input area is determined in step 206. The location of an
input area depends on the same factors as the determination of the
most appropriate input means. The location of the input area,
however, varies for a particular input means depending on, among
other factors, whether the target sensory system is in any way
dysfunctional, the cause and location of any such dysfunctionality,
and the nature of the stimulator to be used. More specifically, if
a dysfunctionality caused by some physical damage to sensory cells
is present in the sensory system, it may be necessary to locate the
input area such that the bias signal will bypass the physical
damage causing the dysfunctionality. Further, the fact that some
stimulators, e.g. implanted electrodes or vibratory elements, may
require invasive procedures while others, e.g., surface electrodes
or vibratory elements, require only noninvasive procedures is also
a factor to consider.
[0056] Once the input area is determined and the input means
installed, the bias signal to be input is generated. FIG. 3 shows
one embodiment of a method of generating a bias signal. In an
initial step 302, the bias signal is calibrated. That is, an
optimal level for the bias signal is determined. Depending on the
determinations of steps 204 and 206, there exists a particular form
of bias signal for which the signal detection ability of a given
neuron in the target sensory system is optimally enhanced. For
example, a bias signal having parameters with certain predetermined
values will give rise to optimal enhancement. Calibration helps to
ensure that certain parameters of the bias signals generated will
be adjusted to achieve optimal enhancement. Examples of signal
parameters of the bias signal that may be calibrated are amplitude
(whether measured as peak-to-peak, RMS, or some other method),
frequency or frequency content (as determined perhaps by signal
spectrum analysis), offset (D.C. bias), intensity, and variance
(e.g. the computed time-based standard deviation in signal
amplitude). Calibration is typically accomplished prior to
installation of the enhancement system and may be accomplished
intermittently while the enhancement system is installed. If
calibration is to take place while the enhancement system is
installed, then it is desirable to install the enhancement system
so it is accessible from the outside of the body so that
calibration may be accomplished noninvasively.
[0057] In one embodiment, the calibration is accomplished by
inputting an input signal of interest to a sensory cell coupled
with a bias signal produced by the enhancement system. The response
of the sensory cell to the combined input is recorded as a function
of a parameter of interest in the bias signal. That is, the
response of the sensory cell is recorded as a parameter of interest
in the bias signal is modulated. Using the recorded results, the
coherence between the combined input and the response of the
sensory cell is then characterized by computing some measure such
as the cross-correlation coefficient described below. The response
of the sensory cell is maximally enhanced when the coherence
measure is maximized. This maximally enhanced response corresponds
to some value or range of values of the bias signal parameter of
interest that can be determined by, for example, examining a record
of the bias signal. Thus, an optimal value or range of values for
the parameter of interest of the bias signal is determined. The
process can be repeated using other input signals and parameters of
interest thereby determining a bias signal with optimal parameters
for input signals with varying parameters.
[0058] According to one embodiment of the present invention, the
bias signal is optimized by examining the cross-correlation
coefficient, C.sub.1:
C 1 = C 0 S 2 ( t ) _ ( R ( t ) - R ( t ) _ ) 2 _ ##EQU00001##
where ##EQU00001.2## C 0 = S ( t ) R ( t ) _ ##EQU00001.3##
where S(t) is the input signal, R(t) is the output of the sensory
neuron or sensory system (e.g., the neural mean firing rate signal
or the neural spike train), and the overbar denotes an average over
time. S(t) and R(t) can be measured with any appropriate
transducers, for example, a needle electrode may be used to measure
the output of a neuron. Maximizing C.sub.1 corresponds to
maximizing the coherence between the input signal S(t) and the
neuron's output R(t). The value of C.sub.1 for a given input signal
will depend upon the parameter of interest of the bias signal.
Thus, a bias signal having parameters which will produce the
desired output R(t) may be determined.
[0059] The results of the calibration process may be utilized, for
example, by modulating the bias signal in response to an input
signal or by determining a set of parameter values which, on
average, will achieve optimal enhancement for any input signal. In
the first instance, parameter values for the bias signal are, for
example, tabulated against parameters of the input signal. Upon
occurrence of an input signal, certain parameters of the input
signal are measured, and a bias signal having corresponding
parameter values is generated by, for example, referencing the
tabulated results. In this way, the bias signal is modulated or
optimized for each particular input signal. In the second instance,
a single set of parameter values which will achieve optimal
enhancement for most signals is calculated and used to generate a
bias signal which is for use in response to every input.
[0060] After the input device has been calibrated and installed, in
one embodiment, an input signal to the neuron is detected. As will
be explained in conjunction with FIG. 4, one embodiment of a system
for enhancing the function of a sensory neuron includes signal
detection capabilities, for example, a transducer and signal
processor. Thus, in step 304, input signals to the neuron are
detected using the signal detection capabilities.
[0061] Once an input signal is detected in step 304, a bias signal
is generated in step 306. As explained above with respect to the
calibration process, the bias signal has either parameters which
are modulated depending on certain parameters of each input signal
or a constant, non-modulated, set of parameters which are designed
to optimally enhance the function of a sensory cell in response to
most input signals. If a bias signal having a non-modulated set of
parameters is used, then a somewhat simpler input system is used.
In general, the nature of the bias signal to be used, that is,
modulated or non-modulated, depends on the nature of the sensory
system to be enhanced. Once the bias signal is generated, it is
input to the neuron in step 106.
[0062] In the embodiments described above, a bias signal is
produced only in response to the detection of an input signal to
the neuron. In an alternative embodiment, after the input device
has been calibrated and installed, a bias signal is continuously
generated and input to the neuron. That is, an input signal does
not need to be detected. In a method according to this embodiment,
the bias signal is either modulated or non-modulated. If the bias
signal is modulated, then the continuously generated bias signal is
modulated as described above, when an input signal is detected. If
a non-modulated bias signal is used in this embodiment, then a
simplified input system may be used. As discussed above, whether a
modulated or non-modulated bias signal is used depends upon, inter
alia, the nature of the system to be enhanced.
[0063] In another embodiment, a distributed enhancement process is
used. In this embodiment, the enhancement process described above
is modified such that a bias signal is generated and input to
neurons at a plurality of locations to stimulate an array of
sensory cells and thereby provide a distributed enhancement effect.
In this distributed enhancement system, as above, either a
continuous or non-continuous, and modulated or non-modulated bias
signals may be used. As one example, if the sensory function of the
urinary tract is to be enhanced, a bias signal may be input to a
number of distributed points around the bladder so that improved
fullness sensation is obtained.
[0064] One embodiment of an enhancement system 400 for implementing
the method for enhancing the function of a sensory neuron is shown
in FIG. 4. Enhancement system 400 comprises a transducer 402, a
signal processor 404, an input device 408 and a controller 410.
Enhancement system 400 operates on electrical signals. An input
signal to a sensory cell is typically initiated by contact with the
outside world which contact is generally not in the form of an
electrical signal. An input signal might be initiated by, for
example, a touch, a movement of a body segment, a sound wave or
light. One function of transducer 402 is to detect input signal
initiating contacts and convey the contact to enhancement system
400 generally and signal processor 404 specifically. Another
function of transducer 402 is to convert an input signal initiating
contact into a signal in a form that is usable by enhancement
system 400. The mechanism used for transducer 402 depends on the
sensory system targeted. As an example, if the auditory system is
being targeted for enhancement, transducer 402 may take the form of
a stimulating electrode or an array of stimulating electrodes
arranged in the vicinity of the ear. As another example, if the
proprioceptive system is being targeted for enhancement, transducer
402 is a tendon stimulator, implemented by way of a piezoelectric
transducer, installed or attached via elastic straps to a tendon or
parent muscle associated with the sensory cells whose function is
to be enhanced. As still another example, if the vibration or
touch-pressure sensation system is being targeted for enhancement,
transducer 402 is a surface electrode installed or applied over the
skin of the area of the body containing the cells to be stimulated.
Such an electrode is attached using flexible electrode/skin
interfaces.
[0065] Signal processor 404 produces a bias signal to be input to
the sensory system targeted for enhancement through input device
408. Signal processor 404 is electrically connected to transducer
402, input device 408 and controller 410. As discussed above, a
bias signal may be either continuous or non-continuous and
modulated or non-modulated. The form of signal processor 404
depends upon the desired form of the bias signal to be produced. In
one embodiment, where a non-continuous, modulated bias signal is
desired, signal processor 404 preferably includes both signal
detection capabilities and look-up table capabilities to store
parameter values for the bias signal. In another embodiment, where
a constant, non-modulated bias signal is desired, signal processor
404 does not necessarily require signal detection capabilities and
look-up table capabilities. In one embodiment, signal processor 404
is either a special function IC or a general micro-processor and is
preferably small, lightweight and portable. Further, signal
processor 404 preferably includes signal conditioning and data
acquisition abilities. In one embodiment, a PCMCIA chip or card is
used as signal processor 404.
[0066] Signal processor 404 also includes calibration module 406.
Calibration module 406 enables adjustment of the bias signal
produced by signal processor 404. For example, for optimal
enhancement, signal processor 404 produces a bias signal having
predetermined parameters (for example, a predetermined amplitude
and frequency) in response to a particular signal received from
transducer 402. If these predetermined parameters of bias signal
are not properly adjusted, the bias signal will not optimally
enhance the function of the targeted sensory system. Calibration
module 406 enables these predetermined parameters to be adjusted so
that an optimal bias signal is produced. Calibration is typically
accomplished prior to installation of enhancement system 400 and
may be accomplished intermittently while enhancement system 400 is
installed. If calibration is to take place while enhancement system
400 is installed, then it is desirable to install signal processor
404 so it is accessible from the outside of the body so that
calibration may be accomplished noninvasively. In an alternative
embodiment, signal processor 404 is provided with remote access
capability enabling calibration to take place noninvasively whether
or not signal processor is accessible from outside of the body.
[0067] Input device 408 conveys the bias signal produced by signal
processor 404 to the targeted sensory system. Depending on what the
targeted sensory system is, input device 408 might take a number of
different forms as discussed above. Input devices that are
appropriate in certain circumstances include, nerve cuffs,
implanted electrodes, surface electrodes, muscle stimulators,
tendon stimulators, and magnetic field stimulators. The manner in
which input device 408 conveys the bias signal to the targeted
sensory system depends on the form of input device 408 and the
targeted sensory system. For example, a nerve cuff or implanted
electrode is suitable for use when the urinary tract is the
targeted sensory system and is typically implanted surgically and
conveys the bias signal to the sensory components of the system. A
muscle or tendon stimulator, on the other hand, is more suited to
mechanically stimulate the proprioceptive system. Such a stimulator
mechanically stimulates the proprioceptive system by vibrating a
muscle or tendon associated with that system, for example a muscle
in the vicinity of a joint. Muscle or tendon stimulators can be
applied noninvasively using, for example, an elastic band. In one
embodiment, where the targeted sensory system is the vibration or
touch-pressure sensation system, a surface electrode-based system
is used as input device 408. Specifically, the glove electrode, the
sock electrode, and the sleeve electrode, sold under the name
ELECTRO-MESH.TM. may be used as input device 408. The surface
electrode system is placed over the body part of interest, e.g.,
the hand or foot. Still further, input device 408 may be a magnetic
field stimulator used either noninvasively or invasively. For
example, a magnetic field stimulator may be used to stimulate
cutaneous sensory neurons by positioning the stimulator on the
exterior of the body in the vicinity of the sensory cells to be
stimulated using elastic bands. A magnetic field stimulator may be
used invasively, for example, by surgically implanting the
stimulator to stimulate sensory neurons in the area of the
bladder.
[0068] Controller 410 controls interaction between transducer 402,
signal processor 404 and input device 408. The implementation for
controller 410 depends upon, among other things, the form of bias
signal desired. That is, where a non-continuous, modulated bias
signal is desired, controller 410 may be implemented using a
microprocessor. In a simpler embodiment, where a continuous,
non-modulated bias signal is desired, controller 410 may be
implemented using a switch that simply activates the enhancement
signal. Alternatively, signal processor 404 may be adequate, so
that controller 410 is unnecessary for such an embodiment. By way
of example only, controller 410 comprises a microprocessor with
suitable programming, or any digital controller. In one embodiment,
controller 410 is implemented with the aforementioned PCMCIA chip
or card.
[0069] The nature and amplitude of the bias signal is controlled in
accordance with the type of sensory cell to which the bias signals
are applied. Repetitive waveform, pulse or DC signals of the type
typically used for other types of injury treatment (e.g. pain
suppression, bone healing) are often be avoided in the practice of
the present invention, as sensory cells can adapt to simple
deterministic signals thereby reducing or eliminating over time the
effect of such signals on the sensory cells. Instead, in accordance
with the invention, non-deterministic noise signals, such as
random, aperiodic noise signals, or recorded repetitions of noise
signals are preferably used, so that the sensory cells do not adapt
to the noise signals over the extended period of noise signal
application that occurs during a physical training regimen. These
signals can be continuously generated signals such as those created
by known instruments, including a computer random number generator,
a noise diode, or thermal noise from a resistor or other electrical
component. Sampled signals, such as signals stored in a storage
device (RAM, ROM, etc.), or periodically recorded noisy signals,
may also be employed.
[0070] The sensory cell areas containing neurons to be affected by
bias signals may be found at different depths in the human body,
causing different signal transmission filtering characteristics to
exist between certain of the sensory cells and the signal input
device. In a preferred embodiment, the bias signal can be combined
with other signal types to overcome this problem. For example, a
chirped signal can be formed by overlaying a noise signal with a
swept frequency signal that regularly sweeps through a signal
frequency range. This combined signal may be tailored to permit the
amplification of frequency ranges that are normally attenuated by
transmission in the body. Thus, the signal is compensated at the
skin-surface level for expected attenuations that would occur prior
to it reaching the target sensory cell. This technique might also
be used to reduce the effort required to determine an efficacious
signal since it might contain all desired frequency ranges.
[0071] Another method of the present invention involves enhancing
various neurophysiologic functions by applying an externally
produced bias signal to a sensory cell area, as described above,
while the subject is performing a pre-defined physical activity.
Neurophysiologic functions enhanced by this method of the present
invention include, for example, limb position sense enhancement,
increase release of growth hormones, enhanced peripheral
neuroplastic changes, and enhanced central, including cortical,
neuroplastic changes.
[0072] Most physical training regimens are undertaken to induce,
among other things, motor learning, i.e. the acquisition of new
motor skills or the regaining of motor skills that have been lost
due to injury or disease. To achieve the aforementioned
sensorimotor performance enhancements, while a subject performs a
specified physical activity bias signals are applied to sensory
cells involved in the specific physical activity to lower the
threshold at which such cells are triggered by the external stimuli
resulting from the activity. By making the sensory cells more
responsive, the number of action potentials produced for any given
amount of external stimuli is increased, thereby improving the rate
and/or quality of motor learning resulting from the activity.
[0073] Coordinated motion of the extremities, for example, requires
precise interplay between descending volitional signals from the
brain, muscle contraction, limb movement, and interaction with the
environment. This tight control is reliant, in part, on sensory
feedback of a mechanical nature from the extremities involved in
the motion. Somatosensory information, e.g. tactile information
from foot sole and proprioceptive information from knee joint, is
clearly important both to normal gait and to more vigorous
activities such as jumping and landing. The method of the present
invention is effective to boost coordinated sensory information
from the mechanoreceptors involved in limb position sense during
movement of the extremities. This added information content during
movement provides a means for improved sensorimotor control. Such
improvements result in enhanced balance, corrected gait patterns,
and prevention of injuries by avoiding, for example, hyperextension
of joints.
[0074] In one embodiment of the invention, a bias signal is
provided during a training regimen to a plurality of structures
that participate in stability of a joint in a subject, to thereby
promote joint sensation and feedback to enhance stability in the
subject. For example, at least one input device, e.g. an electrode,
can be placed at or near the articular space such that sensory
cells in or adjacent to the ligaments, the joint capsule and
meniscus, are stimulated. The bias signal is provided at a level
below the perception threshold of the sensory cells associated with
the structures as well as below the cutaneous pain threshold.
[0075] In another preferred embodiment, the bias signal can be
provided to at least two structures that maintain joint stability
and are on opposite sides of the joint such that the performance of
the sensory cells contained in these structures are enhanced.
Preferably, a bias signal is provided at or adjacent to the joint
and at least two different antagonist muscles on opposite sides of
a joint where the action of these muscles determines the relative
flexion and extension of the joint.
[0076] The bias signal can be provided simultaneously to each of
the structures or it can occur sporadically at each of the
structures. Preferably, the bias signal is repeatedly provided to
each of the structures, e.g., the bias signal is repeated such that
the bias signal is simultaneously provided to each of the
structures or the bias signal is repeated such that the bias signal
is sporadically provided to each of the structures a plurality of
times.
[0077] Specific bias signal ranges are applicable to specific types
of bias signals used in accordance with this invention. For
example, electrical signals are preferably applied within a current
density range of about 1 .mu.A/in.sup.2 to about 1000
.mu.A/in.sup.2 and a frequency range of about 0 Hz to about 10,000
Hz the skin surface of a recipient. Mechanical signals preferably
have a displacement at the skin surface within the range of about 1
.mu.m to about 10 mm and frequencies within the range of about 0 Hz
to about 1000 Hz. Mechanical signals can be remotely controlled by
providing mechanical actuators on the skin surface that receive
remotely generated waveform signals from a remote transmitter and
convert these signals to mechanical signals. In wireless systems,
electrical signals can also be transmitted from a remote
transmitter to electrodes that apply electrical signals to a
subject. All bias signals are preferably designed to allow for
complex constructive and/or destructive patterns.
[0078] Naturally-occurring growth hormones, as another example, are
released in humans by the pituitary gland. These hormones are part
of the body's system of changing the architecture of muscle and
bone in response to changes in activity. For example, increases in
muscle bulk in response to exercise are partly caused by increased
amounts of circulating growth hormone in the body. Recent research
has established that afferent signals from the periphery,
specifically those arising from muscle, spur release of specific
types of growth hormone from the pituitary (McCall, et al., 2000).
In accordance with the present invention, sensory feedback neurons
are made more active by applying bias signals to lower the sensory
cell threshold during a physical training regimen. For example,
sensory information from muscle spindles that boost release of
growth hormone in response to activity is increased. This is
especially beneficial to individuals, e.g. strength trainers,
working to regain muscle bulk and bone integrity following trauma
or prolonged periods of inactivity. In some cases, the increase in
growth hormone release may be sufficient to eliminate the need for
growth hormone replacement therapies and the need for growth
hormone supplements.
[0079] Interconnections and efficiency of sensorimotor pathways in
the periphery are a manifestation of the acquisition of new motor
skills. That is, a key result of training and practice is the
creation of these new pathways. Indeed, even increases in strength
are due as much to neurologic changes as to increases in muscle
mass, especially early in strength building regimens. Recent
research has shown that afferent activity spurs the creation of new
synapses ("synaptogenesis"), one of the underlying neurophysiologic
processes of peripheral neuroplasticity (Wong, et al., 2000).
Applying bias signals to an input area in accordance with the
method of the present invention increases information-rich sensory
traffic from the periphery drives neuroplastic changes in the
periphery. A common perception of strength training is that it
involves only muscularity, and that neurology is not a
consideration. In actuality, neurological factors are central to
the development and maintenance of muscular strength. In the
initial stages of a strength training regimen, muscle mass does not
increase significantly but strength does as a result of the
neuromuscular learning process. By applying bias signals to an
input area in accordance with the method of the present invention,
the time for completing this process is significantly reduced by
lowering the threshold for the sensory cells involved during this
stage of the strength training. As a result, information-rich
traffic from the periphery drives neuroplastic changes in the
periphery that, among other things, increases the rate by which
muscle mass formed.
[0080] Strength training performed in accordance with the present
invention is also effective in enhancing crossover strength changes
in human appendages such as the arms or the legs. Strength training
research has shown that when only one appendage is subjected to a
strength training regimen, the strength of the untrained appendage
increases to some degree. Thus, if one appendage is immobilized by
a cast or brace, the strength of the immobilized appendage can be
enhanced by using the method of the present invention to lower the
sensory cell thresholds in the opposite appendage during a strength
training regimen for the opposite appendage.
[0081] Many athletic training programs are directed to the
improvement of balance that is required when weight is rapidly
transferred from side to side. Balance enhancement training
regimens have included prolonged repetitive side-to-side motion to
promote motor learning that results in enhanced balance. Again, in
combination with this side-to-side training regimen, the present
invention involves lowering affected sensory cell thresholds during
the training to achieve with greater rapidity enhanced balance.
[0082] Moreover, both normal acquisition of new motor skills, and
the process of regaining motor skills following injuries such as
stroke, rely on the elimination and creation of new connections
throughout the sensory and motor cortices. Recent research has
established that sensory activity from the periphery is one of the
underlying drivers of these beneficial neuroplastic changes in the
brain (McKay, et al., 2002). Applying a bias signal to an input
area in accordance with the method of the present invention also
increases afferent traffic thereby accelerating the improvement of
motor skills.
[0083] FIGS. 5A-5C, illustrate one preferred system for applying
input signals in accordance with the method of the present
invention as applied during a physical training regimen. The system
comprises a lower extremity garment 500 that extends from the waist
of a user down both legs. A belt 502 secures the garment at the
waist while foot straps 504 which extend beneath the user's feet
hold the garment snugly against the body during lower body motion.
Foot straps are preferably composed of neoprene or other known
elastic material. Garment 500 preferably includes a plurality of
belt straps 506 positioned circumferentially around the waist
section of the garment 500. The loose ends of straps 506 fold over
belt 502 and attach to garment 500 via Velcro or other known
fastening means to, in effect, form a belt-loop that securely
retains belt 502 at waist level.
[0084] Garment 500 is designed for the application of input signals
at and below the knee. Consequently, the legs of the garment have
closures 508 that permit input device 510 to be positioned at
selected positions relative to the knee, calf and/or lower leg
muscles while also being maintained in place to garment 500.
External caps 511 clip through the garment and onto input device
510, so as to securely hold input device 510 in place. Signal input
devices 510, therefore, can be placed at virtually any position on
the garment as necessary for various applications and to
accommodate the anatomy of the subject. To fit garment 500 to a
user, input devices 510 are first placed on the skin of a user
relative to specific muscles, joints, etc. Garment 500 is then
carefully donned over input devices 510 and external caps 511 are
clipped through garment 500 to hold input devices 510 in place.
Garment 500 is preferably formed of neoprene or any known
stretchable material that enables the garment to closely conform to
the subject and securely hold the input devices 510 securely
against the subject's skin to prevent displacement of the input
devices 510 during the prolonged motion involved in an exercise
regimen.
[0085] Cables 512 electrically connect the input devices 510 to a
signal generator 514. Signal generator 514 provides power to input
device 510 on the inner surface of the garment so that changes in
the position of the electrodes can be adjusted within the area of
input devices 510. Cables 512 are preferably secured to garment 500
such that there are no loose cables to impede body movement. In a
preferred embodiment, cables 512 extending from signal generator
514 are secured within side pockets 516 of garment 500. Cables 512
extend through pockets 516 into a conduit 520 that extends downward
along the leg portions of garment 500. Conduit 520 branches into
multiple conduits at knee level, so as to accommodate input devices
510 positioned at various positions on and about the lower leg.
Input devices 510 can be attached at any position along the length
of cables 512. A cable guide 522 made of plastic or similar
material surround conduit 520 so as to maintain the opening of
conduit 520 into pocket 516. The conduit opening maintained by
cable guide 522 allows cable 512 to be fed into and out of the
length of conduit 520 with considerable ease.
[0086] Cable 512 is preferably of sufficient length to permit
controller 514 to slide from the side of belt 502 to the back of
the belt 502. Thus, signal generator 514 can be repositioned at
various positions along belt 502, so as not to restrict movement
required by specific exercises. Signal generator 514 can also be
worn at other locations or hand held. Generally, the placement of
signal generator 514 is determined based upon location of the joint
to be stabilized, the comfort of the subject and/or the ease of
motion by the subject. To eliminate cables 512, signal generator
514 may include one or more wireless transmitters operative to
transmit signals to signal generator 514 and/or input devices
510.
[0087] Signal generator 514, as shown in FIG. 6, includes a signal
processor 404, a controller 410, control dials 606, a display 608,
a test button 610, and an infrared port 612. Display 608 shows
graphic information that is of interest to the user or clinician
such as current stimulation program, remaining battery life,
stimulation levels, active channels, errors etc. Infrared port 612
(or wireless or cabled, etc.) provides a link to a computer station
that permits the downloading of custom stimulation patterns and
waveforms. Test button 610 permits the confirmation of appropriate
controller function. Controls dials 606 are operative to vary the
amplitude of the noise signals provided to the signal input devices
510 so as to maintain the signals below the threshold level of the
sensory cells targeted, as well as below the subcutaneous threshold
level. The electrical current density at each signal input device
510 is determined by the current amplitude and the size of the
electrode. The current density must be maintained within an
acceptable range. In the case of electrical stimulation, channels
may be electrically isolated from one another or may share a common
ground.
[0088] Input devices 510 can apply, through the skin, input signals
to the structure associated with joint orientation. As earlier
noted, the input devices 510 in the garment can be surface
electrodes, muscle stimulators, tendon stimulators, and magnetic
field stimulators, vibratory stimulators, e.g. small
electromagnetic rotary motors or flat motors (i.e. pancake motors),
piezoelectric actuators, ferrofluid magnetic actuators, or
electrorheologic actuators, or other known signal input device The
signal input devices are appropriately sized and arranged to
localize stimulation to a desired structure. For example, knee
electrodes and actuators are sized as to not impede or restrict
motion and to limit (target) the stimulation to the sensory neurons
of interest. Signal generator 514 can be programmed to vary the
intensity and timing of the signals. For example, when more than
one input device 510 is used, the location and polarity of the
signals can be varied. Similarly, the stimulation can
simultaneously occur at each of input devices 510, or the
stimulation can occur sporadically between each of input devices
510. The power and frequency of stimulation can also be controlled.
The signal is at a level below the perception threshold of sensory
cells associated with the various structures that play a role in
the joint's stability. Thus, the signal is at a level below that
required to trigger the sensory cells in those structures.
[0089] The level of the signal supplied by signal generator 514 may
also be enough to stimulate other cells that are located in
structures not directly involved in joint stability. For example,
sensory cells within the skin may perceive a signal supplied
through an input device 510 placed upon the skin, but the level is
still below the threshold required to stimulate the sensory cells
of the structure, e.g., such as the hamstring below the skin, which
is associated with the stability of the knee joint. Such low level
signals are described in Collins et al., U.S. Pat. No.
5,782,873.
[0090] In another preferred embodiment, provided is a structure 700
for placing signal input devices 510 in contact with the subject's
skin, as shown in FIG. 7. A plurality of arms 704 extend from
central hubs 708 which, when structure 700 is properly worn, are
positioned on opposite sides of the joint of interest. The portion
of arms 704 immediately adjacent to the central hubs 708 is
composed of an expandable material, e.g. rubber. Arms 704 are
preferably biased inwards inward to a degree, such as to securely
engage the leg when structure 700 is positioned on the extremity.
Arms 704 also include a plurality of input devices 510 positioned
such that when structure 700 is properly positioned on the
extremity, input devices 510 are positioned on those areas of the
leg where the bias signal is to be applied in accordance with the
method of the present invention.
[0091] At least one of the arms 704 includes a cable outlet 706
that is electrically wired to each of input devices 510. Outlet 706
accommodates electrical connector 702 of cable 512 such that when
the other end of cable 512 is connected to signal generator 514, an
electrical connection is established between signal generator 514
and input devices 510. Cable 512 is preferably composed of a
stretchable and strain resistant material to reduce the likelihood
of cable 512 becoming detached from outlet 706 or signal generator
514 during use.
[0092] In another aspect of the invention, provided is a joint
covering structure 800, as shown in FIGS. 8A-8B on a knee joint,
having a plurality of input devices 510, and preferably a signal
generator 514, incorporated into or positioned thereon. Input
devices 510 are positioned so as to engage the appropriate
combination of muscles and joints to which the bias signal is to be
applied in accordance with the method of the present invention.
Joint structure 800 is preferably designed to wrap around the joint
and fasten upon itself by Velcro or other known fastening means.
Alternatively, joint structure 800 can be configured to slide onto
and off of the joint. Joint structure 800 is preferably made of
fabric, but can also be made of plastic, rubber, or other material,
as long as at least a portion of the structure is made of a
flexible material which allows the input devices 510 to remain in
place during the flexing and extending of the joint. As
illustrated, the ridged portion 802 of structure 800 is comprised
of thicker material capable of assistively bracing the joint. A
thinner portion 804 of structure 800 is positioned over the joint
so as to allow bending of the joint without displacing the input
devices 510.
[0093] In another aspect of the invention, provided is an electrode
applicator 900, as shown in FIG. 9, which provides a means to
customize the position of, or distance between, signal input
devices 510 (e.g. skin surface electrodes) for a subject receiving
treatment in accordance with the method of present invention. Areas
of flexible, electrically conductive layer 902, such as conductive
rubber, provide an electrically conductive means between wires 908
and signal input devices 510. Covering and surrounding the
conductive layer 902 on the outer surface of the structure is a
nonconductive material 904. These two layers of conductive 902 and
non-conductive materials 904 are permanently affixed to one
another. Also covering conductive layer 902 on its inner, or skin
surface, side is a non-conductive film 906 which is removably
affixed to the conductive layer 902. By removing non-conductive
film 906, the inner surface of conductive layer 902 is exposed,
allowing a signal input device 510 to be affixed to the conductive
layer 902. Non-conductive film 906 is scored or otherwise segmented
in a pattern which allows for portions of the non-conductive film
906, rather than the entire film, to be removed. In this way, the
majority of the conductive layer 902 remains covered by the
non-conductive film 906 during use. Signal input devices 510 are
composed of a thin, electrically conductive material, such as
hydrogel, that provides the electrical interface between the
conductive layer 902 and the subject's skin.
[0094] The apparatus used for performing the method of the present
invention is unique relative to known units used for improving
sensorimotor performance (e.g. motor learning) or the treatment of
injuries and rehabilitation from the effect of an injury. In such
known units, electrodes are mounted on braces or wraps and include
free, untethered electrical conductors, all of which will inhibit
the motion required for the performance of an effective physical
training regimen.
[0095] While the above illustrated embodiments are directed to
pants, a joint stabilizer, and a brace, the term wearable device as
used herein, refers to any structure capable of holding input
devices 510 in place at a desired location.
[0096] The embodiments described herein have been shown as a lower
body wearable device for illustrative purposes only. Similar
embodiments capable of holding signal input devices in place that
are designed to the upper body including the arms and torso of an
individual, are within the spirit and scope of present invention.
The upper body wearable device may be combined with the lower body
wearable device to permit input devices to be positioned and
operated simultaneously along both the upper and lower body in
accordance with the method of the invention.
[0097] Referring now to FIGS. 10A and 10B, a noninvasive, surface
neuro-stimulation system 2000 is illustrated. The neuro-stimulation
system 2000 may be applied to a patient non-sterilely and in an
in-patient/out-patient setting. As shown, the neuro-stimulation
system 2000 employs a stimulator 2100 and a controller 2200, which
may be detachably coupled to each other. The stimulator 2100 is
placed into contact with a body part of a subject, or patient, to
deliver electrical current and/or mechanical vibration. The
controller 2200 is operated to control the delivery of the
electrical current and/or mechanical vibration through the
stimulator 2100 according to the neuro-stimulation therapies
described herein.
[0098] Advantageously, embodiments, such as the neuro-stimulation
system 2000, enable the simultaneous use of electrical current and
mechanical vibration to provide neuro-stimulation. In particular,
the application of both electrical and mechanical stimulation
provides broader targeting of mechanoreceptors. Electrical
stimulation and mechanical stimulation reach different
mechanoreceptors. For example, electrical stimulation may reach
structures that lie deeper below a body part surface, while
mechanical stimulation may reach structures that lie closer to the
surface. A further unexpected benefit of applying both types of
stimulation over the exclusive application of either electrical
stimulation or mechanical stimulation is that all receptors are
consistently activated during stimulation, and the body does not
become confused by the activation of some receptors over other
receptors in a particular sensory cell area.
[0099] Scientists and clinicians working in the field of stroke
rehabilitation have established the critical link between
mechanical sensory information (touch, pressure, and joint angle
sense) produced during rehabilitation activities and the
restoration of brain function. As such, in a preferred application,
the neuro-stimulation system 2000 may be applied to rehabilitate
stroke patients. Demonstrating the utility of such an application,
a study in stroke rehabilitation was performed in an established
animal model (developed by Dr. Jeffrey Kleim at the University of
Florida).
[0100] The animal model used in the study reliably reproduces
strokes in the motor cortex, so that post-stroke recovery of
function may be quantified during a rehabilitation period. This
model generally provides an excellent test-bed for comparing
putative therapeutic interventions, which may include techniques,
devices, or drugs. In this animal model, during a pre-stroke period
which typically spans about 10 days, rats are trained to perform a
task and they are graded according to their ability to perform the
task. For example, the task may require the rats to reach around an
obstacle to obtain food, and the rats are graded according to their
proficiency, or accuracy, in reaching for food. At the end of the
specified pre-stroke period, the rats are given a stroke in the
motor cortex, and their task proficiency is measured over a period
of several days after the stroke. According to clinicians, this
animal model produces behaviors that are similar to those that the
clinicians typically observe in stroke patients undergoing
rehabilitation.
[0101] In this study, sensory enhancement stimulation was employed
during rehabilitation to demonstrate that sensory enhancement
stimulation improves neuroplasticity, or the formation of lasting
functional changes in the brain. Using sixty animals in six
treatment groups (including controls), the study tested whether
sensory stimulation used in conjunction with physical
rehabilitation would improve the reacquisition of skill versus
rehabilitation without such stimulation. Stimulation below the
sensory or motor threshold was delivered during rehabilitation
sessions through implanted electrodes. Furthermore, three different
stimulation amplitudes (RMS) were tested.
[0102] The charts of FIGS. 11 and 12 present the resulting data for
the six study groups in the study: a control group (no stroke), a
group receiving no rehabilitation, a group receiving rehabilitation
without stimulation, and three groups S1, S2, S3 receiving
rehabilitation with three different amplitudes of stimulation,
respectively. The charts indicate that the application of sensory
enhancement stimulation in the study significantly accelerated and
improved the endpoint in the reacquisition of skill when compared
to rehabilitation without stimulation.
[0103] Accordingly, the neuro-stimulation system 2000 provides a
tool for delivering sensory enhancement stimulation for improved
stroke rehabilitation. For example, FIGS. 13A and 13B illustrate
the application of the neuro-stimulation system 2000 to two
respective location on a subject's arm for use during
rehabilitative therapy. The neuro-stimulation system 2000 may be
fitted with an attachment element 2500, such as the arm band also
shown in FIG. 10B, that enables the neuro-stimulation system 2000
to be secured to the subject's arm as illustrated in FIG. 13. Of
course, the neuro-stimulation system 2000 may employ other
attachment elements and may be applied to other parts of the
subject's body which may require rehabilitation.
[0104] FIGS. 14A and 14B show an embodiment of a stimulator 2100.
The stimulator 2100 has one or more contact areas 2102A and 2102B
which are placed into contact with selected sites on the subject's
body, and electrical and/or mechanical stimulation is delivered to
the selected sites. As illustrated in FIG. 14A, the stimulator 2100
may be formed from laminated layers 2104, such as bonded layers of
polycarbonate or the like, which can conform to a body part and
enable sufficient contact with the selected stimulation sites.
[0105] In the particular embodiment shown in FIGS. 14A and 14B, the
stimulator 2100 has a generally elongate shape with two contact
areas 2102A and 2102B at opposing ends. As illustrated in detail in
FIG. 14B, the contact area 2102A is positioned at the end of an arm
2104A that is approximately 7.5 inches long, while the contact area
2104B is positioned at the end of an arm 2104B that angles from the
arm 2104A by approximately 15 degrees and is approximately 5.5
inches long. Moreover, the contact areas 2102A and 2102B are
substantially circular with diameters of approximately 1.5 inches.
As such, the shape shown in FIG. 14B accommodates application of
the stimulator 2100 to a subject's arm as shown in FIG. 13. In
general, however, a stimulator 2100 in other embodiments may have a
shape that best accommodates its application to a particular body
part, and thus the shape is not limited to the examples described
herein.
[0106] Preferably, the stimulator 2100 employs at least one
electrode device 2110 and at least one vibration element 2120 for
delivering electrical and mechanical stimulation, respectively. As
such, in the embodiment of FIGS. 14A and 14B, each of the contact
areas 2102A and 2102B has electrode pair 2110 and a vibration
element 2120. The electrode device 2110 refers to a source
electrode and return electrode for electrical stimulation, although
the source electrode and return electrode may be a part of an
integral structure, or, alternatively, parts of separately
applicable structures.
[0107] The electrodes 2110 may be screen-printed carbon and may be
electrically connected to the stimulation site via a medical grade
conductive hydrogel, such as a polyarylacetylene (PAA) hydrogel or
similar material with biocompatibility data for skin contact.
Preferably, electrical signals from the electrodes 2110 are only
conducted through the contact areas 2102A and 2102B in contact with
the stimulation areas. In the embodiment of FIGS. 14A and 14B, the
electrodes at each contact area 2102A and 2102B may have a diameter
of approximately 1.25 inches.
[0108] Additionally, adhesive may be employed on portions of the
stimulator 2100 to secure the stimulator 2100 to the subject's body
and position the contact areas 2102 at the selected stimulation
sites. For example, a thin adhesive ring surrounding the gel at the
contact areas 2102 may be employed to aid in securing the contact
areas 2102 to the stimulation sites. A medical grade double sided
adhesive with biocompatibility data for skin contact may be
employed. In general, the adhesive properties of the stimulator
2100 as well as the supporting connection to the controller 2200 is
adequate to support the stimulator 2100. Advantageously, the
neuro-stimulation system 2000 also stays attached to the patient
during therapy. In some cases, medical tape may be employed to aid
in support. However, it is noted that the use of adhesive required
to support the controller 2200 entirely may be too aggressive
especially for the fragile skin of elderly patients. Thus, the use
of an attachment element 2500, such as an arm band, may be
preferred. A release liner (not shown) may be employed on the
contact side of the stimulator 2100 to cover the hydrogel and
adhesive and to ensure clean contact surfaces before application of
the stimulator 2100 to the subject.
[0109] The vibration elements 2120 may be piezoelectric elements
and may be mechanically coupled to the subject via the gel and
surrounding adhesive. In the embodiment of FIGS. 14A and 14B, the
vibration elements 2120 at each contact area 2102A and 2102B may
have a diameter of approximately 1.25 inches and a maximum
thickness of approximately 0.03 inches. The vibration elements 2120
may include two piezoelectric elements mounted side-by-side, and
may be formed from lead zirconium titanate (PZT) mounted on a
nickel plate.
[0110] Operation of the electrodes 2110 and the vibration elements
2120 is achieved through a circuit 2130. As shown in FIGS. 14A and
14B, a flex circuit 2130 is routed throughout the stimulator 2100
to connect the electrodes 2110 and the vibration elements 2120 to
the controller 2200. For example, the flex circuit 2130 may employ
low resistance silver (Ag) or silver/silver chloride (Ag/AgCl).
[0111] Additionally, the stimulator 2100 may employ an internal
electrically-erasable read-write memory device 2140, such as an
EEPROM, which is connected to the flex circuit 2130. The flex
circuit 2130 provides power, ground, and signals to the memory
device 2140. The memory device 2140 records and stores data on the
operation of the stimulator 2100. As described further below, the
controller 2200 may write data to the memory device 2140 when the
stimulator 2100 is coupled to the controller 2200.
[0112] In some cases, to ensure the proper functioning of each
stimulator 2100, the stimulator 2100 may have a specified shelf
life, e.g. one year. In addition, the stimulator 2100 may be
limited to a single use, after which it must be discarded.
Furthermore, to prevent overuse during a single application, each
stimulator 2100 may have a specified stimulator life, e.g. three
hours, which sets the maximum amount of time the stimulator 2100
may be used during the single use. In one embodiment, the
controller 2200 may be employed to prevent repeated use of the
stimulator 2100 and to track the stimulator's total amount of use
against the specified stimulator life. In particular, as described
further below, the controller 2200 may store usage data regarding
the use of a stimulator in the memory device 2140.
[0113] While the stimulator 2100 may be limited to a single use and
a maximum usage time on the order of a few hours, the controller
2200 may have a significantly longer life. For example, the design
life for the controller 2200 may be approximately four years, with
annual battery replacement. As such, the controller 2200 is
generally reusable. On the other hand, due to the limits on its
use, a single stimulator 2100 is disposable and not reusable.
Therefore, a single controller 2200 is typically used with a
plurality of stimulators 2100.
[0114] The stimulator 2100 has a connector 2150 that enables the
stimulator 2100 to be detachably coupled to the controller 2200.
Electrical signals may be sent and/or received via the connector
2150. As such, the connector 2150 connects the flex circuit 2130 to
the controller 2200. In the embodiment of FIGS. 14A and 14B, the
connector 2150 may be an n-pin connector, e.g. 9-pin connector,
approximately 1 inch long.
[0115] As shown in FIG. 15B, the controller 2200 has a connection
port 2250 which correspondingly receives, or engages, the connector
2150 of the stimulator 2100. For example, the connection port 22
may receive the nine pins for the connector 2150 shown in FIG. 15B.
Through this connection with the stimulator 2100, the controller
2200 may control the delivery of electrical and/or mechanical
stimulation by the stimulator 2100.
[0116] FIGS. 15A and 15B show that the controller 2200 has a
housing 2202 which is defined by the assembly of a front housing
section 2204 and a back housing section 2206. The housing sections
2204 and 2206 may be molded from a material such as acrylonitrile
butadiene styrene (ABS) or the like. In the embodiment of FIGS. 15A
and 15B, the controller 2200 may have overall dimensions of
approximately 3.5''.times.2.5''.times.1.25'' and may have an
overall weight of approximately 100 g. As such, the controller 2200
is sufficiently lightweight and compact for easy application, as
particularly shown in FIG. 13.
[0117] FIG. 15A illustrates a user interface 2210 positioned on a
side of the front housing section 2204. The user interface 2210 may
include a graphic display 2212 for presenting operational
information to a user and input controls, such as a light-touch
membrane keypad 2214, for receiving operational instructions from a
user.
[0118] In particular, the graphic display 2212 may provide the user
with information regarding the status of the stimulator life,
battery life, stimulation time, and the electrical and stimulation
output levels. For example, in the embodiment of FIGS. 15A and 15B,
the graphic display 2212 may be a monochrome graphic display with
128 (W).times.64 (H) pixels, which provide yellow, blue, green, or
similarly colored graphic elements on a black background. As such,
the graphic display 2212 may employ an organic light emitting diode
(OLED). The overall dimensions of the graphic display may be
approximately 1.9''.times.1.3''.
[0119] Meanwhile, as shown in FIG. 15A, the keypad 2214 may have a
power key 2215 to allow the user to turn the controller on and off.
In addition, the keypad 2214 may have adjustment keys 2216 and 2217
to adjust the stimulation levels up and down, respectively. As
discussed further below, the keys 2215, 2216, and 2217 may be
employed in a variety of sequences or combinations to provide input
for the operation of the controller 2100. The keypad 2214 may be a
membrane keypad formed, for example, from polycarbonate or the
like. In the embodiment of FIGS. 15A and 15B, the overall
dimensions of the keypad may be approximately
1.5''.times.0.75''.
[0120] FIG. 15B also shows that a clip 2208, or other similar
structure, may be positioned on a side of the back housing section
2206 to work with an attachment element 2500 for securing the
controller 2200 to the subject. For example, the clip 2208 may be
employed to attach the controller 2200 to the arm band 2500
described previously with reference to FIG. 10B.
[0121] The diagram of FIG. 16 illustrates electrical components and
connections that may be employed for the neuro-stimulation system
2000. It is understood, however, that FIG. 16 merely presents an
example embodiment, and in no way limits the electrical components
and connections that may be employed in other embodiments.
[0122] As shown in FIG. 16, the controller 2200 houses a power
supply 2220 and an embedded processor 2230, which are connected to
each other. The processor 2230 is also connected to the graphic
display 2212 and the keypad 2214. In the embodiment of FIG. 16, the
flying leads of power supply 2220 may be directly soldered for
connection to the processor 2230. The graphic display may be
connected via 0.5 mm SMT ZIF (18 conductor), and the keypad 2214
may be connected via 1 mm SMT ZIF (4 conductor).
[0123] The power supply 2220 generates the required voltage and
current for operating the processor 2230 as well as the electrodes
2110, the vibration elements 2120, and the graphic display 2212.
For example, the power supply may be a lightweight rechargeable
lithium ion battery pack. However, in other embodiments, the
neuro-stimulation system 2000 may employ disposable
non-rechargeable batteries or other types of power sources.
Generally, a lightweight portable power supply 2220 is preferred
over sources such as an electrical outlet to make the controller
2200 also lightweight and portable. In the embodiment of FIG. 16,
the battery 2220 may have a nominal voltage of 3.6 VDC. With a
minimum capacity of approximately 1,600 mAh, the battery 2220 may
provide approximately 3 hours of run time between charges. With a
charge voltage of 4.2 VDC, the charge time for the rechargeable
battery 2220 may be approximately 4 hours. As known, the battery
2220 may include an internal power control module to minimize over
charge/discharge. For repeated use of the rechargeable battery
2220, the battery 2220 is chargeable to preferably at least 75% of
original capacity after 500 cycles.
[0124] The display, keypad, mechanical stimulation, and electrical
stimulation are controlled by the processor 2230. The processor
2230 may, for example, be a central printed circuit board (PCB)
formed from G-10 which serves as the central point of connectivity
and contains all the hardware and software required to generate and
control the stimulation applied through the stimulator 2100. In the
embodiment of FIG. 16, the processor 2230 includes: a field-effect
transistor switch (FET SW) 2231; a microcontroller (.mu.C) 2232
with non-volatile random access memory (nov-RAM) 2233; a DC supply
2234; DC-to-DC converters 2235 and 2236; a mechanical stimulation
drive 2237; an electrical stimulation drive 2238; and a sound
device 2239.
[0125] In the embodiment of FIG. 16, the keypad 2214 may employ
four circuits corresponding with the power key 2215, up and down
adjustment keys 2216 and 2217, as well as ground. The keypad 2214
may employ TTL level signals, as well as single pole single throw
(SPST) switches which are normally open.
[0126] When the power key 2215 on the keypad 2214 is pressed, the
FET switch 2231 is correspondingly turned on and power from the
power supply 2220 is provided via the FET switch 2231 to the rest
of the controller 2200. Once the microcontroller 2232 receives
power and is activated, it holds the FET switch 2231 on. When the
microcontroller 2232 determines a shut down, it turns the FET
switch 2231 off. In the embodiment of FIG. 16, the FET switch 2231
may employ signal level controls and may have a rating of 4.2 V at
500 mA (min).
[0127] The microcontroller 2232 with the non-volatile memory 2233
hosts the firmware and provides overall control for the
neuro-stimulation system 2000. The microcontroller 2232 may be a
single chip microcontroller, which has a speed that is sufficient
to support the input/output and the random signal generation
described herein. The features of the microcontroller 2232 may
include: integrated power on reset circuitry, integrated clock
oscillator, integrated RAM and program memory, internal RTC with
external xtl, integrated 12-bit analog-to-digital converter, two
integrated 12-bit digital-to-analog converters, integrated voltage
reference, and sufficient digital signal processing (DSP)
capability to support white noise generation and filtering (10
Hz-100 Hz).
[0128] In addition, the microcontroller 2132 has sufficient
input/output (I/O) capacity to support: input from a battery
voltage monitor, input from power key 2115, input from up and down
adjustment keys 2116 and 2117, input from the stimulator 2100 for
StimEnable and SatDetect signals described herein, input and output
from the non-volatile RAM 2233, input and output from the EEPROM
2140 of the stimulator 2100, input and output from the graphic
display 2112, ISP input, output for the sound device 2239, output
for the mechanical stimulation drive 2237, and output for the
electrical stimulation drive 2238.
[0129] In the embodiment of FIG. 16, the microcontroller 2232 may
have an output current of approximately 100 mA (min) and may have a
regulation of +/-1% ripple. Moreover, the programming of the
microprocessor 2232 may employ ISP. Meanwhile, non-volatile RAM
2233 provides a minimum of four kilobytes with a memory address of
0xA0 and a serial memory interface.
[0130] The processor 2230 includes the DC supply 2234, which
receives input voltage (V.sub.bat) from the power supply 2220 and
produces regulated and filtered voltage for the control circuitry.
In the embodiment of FIG. 16, the DC supply 2234 receives a nominal
input battery voltage from the power supply 2220 of approximately
3.6 VDC, and may produce an output voltage of approximately 3.0 VDC
and output current of 100 mA (min). Furthermore, the DC supply 2234
may have a regulation of +/-1% ripple.
[0131] The processor 2230 may also employ a sound device 2139, such
as a signal level audio transducer, that sounds or beeps when the
keypad is pressed or during an alert or alarm condition. In the
embodiment of FIG. 16, the sound device 2135 may have an audio
output level of at least 60 dB at 30 cm.
[0132] In addition, the processor 2230 also includes the DC-to-DC
converter 2235, which receives input voltage from the power supply
2220 and generates the higher voltage rails required to drive the
electrical and mechanical stimulation circuitry, described further
below. In the embodiment of FIG. 16, the DC-to-DC converter 2235
may receive an input voltage (V.sub.bat) of approximately 3 VDC and
produce an output voltage of approximately 30 VDC and an output
current of approximately 30 mA (typ) for the delivery of electrical
and mechanical stimulation.
[0133] Furthermore, the processor 2230 also includes the DC-to-DC
converter 2236, which receives input voltage from the power supply
2220 and generates the voltage for operation of the graphic display
2112. In the embodiment of FIG. 16, the DC-to-DC converter 2236 may
receive an input voltage (V.sub.bat) of approximately 3 VDC and
produce an output voltage of approximately 12 VDC and an output
current of approximately of +/-500 mA (typ) for the graphic display
2112. The data transfer to the graphic display 2112 may be serial.
The logic voltage may be approximately 2.4 VDC to 3.5 VDC and the
supply voltage may be approximately 12 VDC (typ).
[0134] Receiving the voltage from the DC-to-DC converter 2235, the
mechanical stimulation drive 2237 and the electrical stimulation
drive 2238 provide the output to drive the vibration elements 2120
and the electrodes 2110 of the stimulator 2100. In particular, the
microcontroller 2232 generates, sets amplitude, filters, and
delivers the aperiodic signal that drives the vibration elements
2120 and the electrodes 2110.
[0135] In the embodiment of FIG. 16, an H-Bridge amplifier
configuration is used to push and pull the outputs. The mechanical
stimulation drive 2237 may employ voltage control. The
digital-to-analog conversion may be 10 bit (min), or equivalent
resolution. The voltage-to-voltage conversion may be: 1.3 V in =+30
V out; 650 mV in =0 V out; 0 V in =-30 V out; 0 to 1.3 V. With an
input voltage of 0 to 1.3 V, the output voltage may be: -30 V to
+30 V (max, +/-3 sigma); -20 V to +20 V (+/-2 sigma); -10V to +10V
(typ, +/-1 sigma). The output current may be -30 mA to +30 mA
(max). The waveform produced by the mechanical stimulation drive
2237 is aperiodic with a Gaussian distribution and the frequency
spectrum may be 10 Hz (or lower) to 100 Hz. Filtering may have a
pass band ripple of less than 0.5 dB and equivalent roll off above
100 Hz to a 6-pole Butterworth. Output may also need additional low
pass filtering due to a 1 ms pulse width. Thus, a low pass (LP)
filter 2240 provides additional filtering to "smooth out" the 1 ms
pulse width transitions in the vibration drive. The LP filter 2240
may employ a 3 Pole Chebychev, with a pass band of 10 Hz to 125
Hz.
[0136] In the embodiment of FIG. 16, the electrical stimulation
drive 2238 may employ current control. The digital-to-analog
conversion may be 10 bit (min), or equivalent resolution. The
voltage-to-current conversion may be: 1.3 V in =+150 .mu.A out; 650
mV in =0 .mu.A out; 0 V in =-150 .mu.A out. With an input voltage
of 0 to 1.3 V, the output current may be: -150 .mu.A to +150 .mu.A
(max, +/-3 sigma); -100 .mu.A to +100 .mu.A (+/-2 sigma); -50 .mu.A
to +50 .mu.A (typ, +/-1 sigma). The output voltage may be -30 V to
+30 V (max). The waveform produced by the electrical stimulation
drive 2238 is aperiodic having a Gaussian distribution with a hold
output of 1 ms/level, while the spectrum is defined by the 1 ms
hold time (no additional filtering is required). The hardware
current limit is +/-150 .mu.A. A SatDetect signal 2242 is issued if
the target current cannot be achieved (skin Z is too high) or if
the electrodes are not connected.
[0137] The graphs in FIGS. 20A-C represent aperiodic outputs which
may be produced by the mechanical stimulation drive 2237 and the
electrical stimulation drive 2238. FIGS. 20A and 20B demonstrate
that the spectral content of the mechanical stimulation and the
electrical stimulation, respectively, is within a defined narrow
band, while FIG. 20C shows that output is random over time.
Advantageously, both the randomness and the frequency content
enable targeting of the appropriate receptors. In other words,
different receptors may respond to different stimulation
frequencies, so the aperiodic stimulation helps to promote a
response from receptors which may have such varying response
characteristics. As a further advantage, by randomly and
unpredictably applying a range of frequencies, aperiodic
stimulation avoids the effect of adaptation where the response to
specific frequencies diminishes, or is wiped out, with repeated and
predictable exposure to the same specific frequencies. As shown in
FIG. 20C, the noise is normally distributed about a mean, so the
signal may be electrically expressed as a Gaussian distribution.
The aperiodic sequence preferably does not repeat itself within 20
seconds.
[0138] In the embodiment of FIG. 16, the stimulation output from
the microcontroller 2231 is a current, with maximum value of 0.5
mA. When converted to a voltage signal across a 2.61 k.OMEGA. sense
resistor the input to both the mechanical stimulation drive 2237
and the electrical stimulation drive 2238 is biased to 0.65 VDC.
Therefore, a setting of 100% represents waveforms that span the
entire range, i.e. 0 VDC to 1.3 VDC. A 50% setting in either
electrical or mechanical stimulation spans an output range of 0.325
VDC to 0.975 VDC.
[0139] The output from the mechanical stimulation drive 2237 and/or
the electrical stimulation drive 2238 of the processor 2230 is
transmitted to the stimulator 2100 via the detachable coupling of
the connection port 2250 and the connector 2150. As described
previously, this coupling may employ a 9-pin connection. The
mechanical stimulation drive 2237 drives the vibration elements
2120 of the stimulator 2100, while the electrical stimulation drive
2238 drives the electrodes 2110 of the stimulator 2100.
[0140] With further reference to the embodiment of FIG. 16, the
electrodes 2110 may employ dual carbon electrodes with a resistance
of 500 ohms (max) (measured from each electrode surface to contact
with the flex circuit). The vibration elements 2120 may employ two
parallel piezo elements, with piezoelectric bimorph technology. The
input power to the vibration elements 2120 may be approximately 150
mW (max), and the oscillating range of the vibration elements 2120
may be approximately DC to 20 kHz.
[0141] In the embodiment of FIG. 16, the stimulator 2100 employs an
EEPROM 2140. The EEPROM 2140 may have a size of 1 K (128.times.8)
(min) with a memory address of 0xA1. The power supply to the EEPROM
2140 may be approximately 1.8 to 5.5 VDC. The package for the
EEPROM 2140 may be 8 pin, SOIC SMT. For chip select, the AO address
bit must be decoded.
[0142] When the stimulator 2100 is connected to the controller
2200, the EEPROM 2140 may be serially connected to the processor
2130, so that the processor 2230 may read and write to the EEPROM
2140. In particular, as described previously, the controller 2200
may employ the EEPROM 2140 to track usage data, such as the total
amount of use against a specified stimulator life for the
stimulator 2100.
[0143] Additionally, as further illustrated by FIG. 16, the flex
circuit 2130 provides a way for the controller 2200 to detect the
presence of the stimulator 2100 by shorting pin 3 (V.sub.bat) to
pin 7. As such, when the stimulator 2100 is attached to the
contoller 2200, the StimEnable line 2241 goes high, informing the
microcontroller 2232 to switch on the DC-to-DC converter 2235 (30 V
step up) to power the mechanical stimulation drive 2237 and
electrical stimulation drive 2238.
[0144] FIG. 17 illustrates a controller state diagram and operation
of the example embodiment shown in FIG. 16. As such, the state
diagram of FIG. 17 merely presents a non-limiting example of
operation of the neuro-stimulator 2000.
[0145] Operation of the controller 2200 is governed by the embedded
software of processor 2230. In step 6002, the power key 2215 is
operated, or pressed, to power up the controller 2200. As described
previously, the processor 2230 is able to detect whether a
stimulator 2100 is coupled to the controller 2200. If the
controller 2200 is not connected to a stimulator 2100, the graphic
display 2112 displays the life of battery 2220 in step 6004 and the
controller 2200 shuts down automatically after 2 minutes, as
described further below. Otherwise, when the controller 2200 powers
up, the graphic display (OLED) 2112 displays the life of battery
2220 and life of the stimulator 2100.
[0146] In step 6006, the power key 2115 is pressed again to allow
the electrical stimulation with the stimulator 2100 to be set, in
step 6008. In step 6008A, the up adjustment key 2116 may be pressed
to increase the electrical stimulation up to any value below a
predetermined maximum, e.g. 100%. For example, pressing the up
adjustment key 2116 once increases the electrical stimulation by 5%
of its entire range. On the other hand, in step 6008B, the down
adjustment key 2117 may be pressed to decrease the electrical
stimulation down to any value above a predetermined minimum, e.g.
0%. For example, pressing the down adjustment key 2117 once
decreases the electrical stimulation by 5% of its entire range. In
response to step 6008, the processor 2230, with the electrical
stimulation drive 2238, drives the electrodes 2110 of the
stimulator 2100 with a current that corresponds with the given
setting. When the electrical stimulation level is changed, with the
up and down adjustment keys 2116 and 2117 and even shutdown with
the power key 2115, the change is preferably executed in a ramped
manner. A sudden change may be perceived as uncomfortable to the
patient. As such, a slew rate of approximately 0.2 .mu.A/ms (or 1
.mu.A every 5 ms) may be employed.
[0147] In step 6010, the power key 2115 is pressed again to allow
the mechanical stimulation with the stimulator 2100 to be set, in
step 6012. In step 6012A, the up adjustment key 2116 may be pressed
to increase the mechanical stimulation up to any value below a
predetermined maximum, e.g. 100%. For example, pressing the
adjustment key 2116 once increases the mechanical stimulation by 5%
of its entire range. In step 6012B, the down adjustment key 2117
may be pressed to decrease the mechanical stimulation down to any
value above a predetermined minimum, e.g. 0%. For example, pressing
the adjustment key 2117 once decreases the mechanical stimulation
by 5% of its entire range. In response to step 6012, the processor
2230, with the mechanical stimulation drive 2237, drives the
vibration elements 2120 of the stimulator 2100 with a voltage that
corresponds with the given setting.
[0148] In step 6014, the power key 2115 is pressed again to lock
the stimulation levels set in steps 6008 and 6012. Electrical
and/or mechanical stimulation continues in run mode 6015 with the
set values.
[0149] Step 6016 evaluates conditions for shut down and causes
automatic shut down of the controller 2200 when the conditions are
met. These conditions are indicated by "Cond 1" and "Cond 2" in
FIG. 17.
[0150] Thus, during the run mode 6015, the power key 2115 may be
pressed and held for a specified duration, e.g. two seconds, to
cause the controller to be turned off in step 6016. The controller
2200 does not exit run mode 6015 until the power key 2115 is
pressed for the specified duration.
[0151] In addition, the voltage of the battery 2220 is also
measured during operation. If the remaining charge in battery 2220
falls below 3.2 V, for example, the controller 2200 automatically
shuts down in step 6016.
[0152] As described previously, the processor 2230 holds the FET
switch 2231 on. However, in step 6016, the FET switch 2231, and
thus the controller 2200, may be turned off automatically in the
following time-out situations: [0153] the power key 2115 has not
been pressed for a period of time, e.g. 2 minutes, to advance to
step 6008 after the controller 2200 has been powered up in step
6002. [0154] the power key 2115 has not been pressed for a period
of time, e.g. 5, minutes, to advance to step 6012 after the level
of electrical stimulation has been set in step 6008. [0155] the
power key 2115 has not been pressed for a period of time, e.g. 5
minutes, to advance to run mode 6015 after the level of mechanical
stimulation has been set in step 6012. [0156] no keys are pressed
for a period time, e.g. 2 minutes, after the controller 2200 has
been powered up in step 6002 and no stimulator 2100 is coupled to
the controller 2200. [0157] no keys are pressed for a period of
time, e.g. 2 minutes, after the diagnostic mode has been executed
in step 6003.
[0158] As discussed previously, the processor 2230 determines and
tracks the stimulator life by reading and writing to usage data on
the EEPROM 2140 of the stimulator 2100. FIG. 18 illustrates an
example technique for determining and tracking the stimulator life.
Initially, in step 6105, the processor 2230 reads a code location
on the EEPROM 2140. Step 6110 determines whether a unique code has
already been written to the code location. If the processor 2230
detects a unique code, this indicates that the stimulator 2100 has
already been used, so the processor 2230 proceeds to step 6115
where a message is issued for the operator indicating that the
stimulator 2100 must be replaced. If the processor 2230 does not
detect a unique code, this indicates that the connected stimulator
2100 is new. In this case, in step 6120, the processor 2230 writes
a unique code to the code location to indicate that the stimulator
2100 has been used. Furthermore, in step 6125, the processor 2230
records a value, e.g. "100%," on the EEPROM as the initial value
for the stimulation life. Once the initial value of the stimulator
life has been recorded in step 6125, the process continues to step
6130 where the processor 2230 reads the current value for the
stimulator life. Step 6135 determines whether the processor 2230 is
in run mode 6015. If so, in step 6140, the processor 2230
decrements the value of the stimulator life by a certain value, or
percentage. Step 6145 then determines whether the current value for
the stimulator life has reached zero. If the current value for the
stimulator life has reached zero, in step 6150, the processor 2230
ends the run mode 6015 and issues a message for the operator
indicating that the stimulator 2100 must be replaced. If the
current value for the stimulator life has not reached zero, the
process proceeds to step 6155 where the processor 2230 waits for a
specified period of time, e.g. one minute, before proceeding again
to step 6130.
[0159] As shown in FIG. 17, rather than executing step 6002, the
power key 2115 and up and down adjustment keys 2116 and 2117 may be
operated simultaneously in step 6003 to power up the controller
2200 and to enter a diagnostic mode where software revision, error
message count, and other diagnostic information are be
displayed.
[0160] As discussed previously, the graphic display 2112 may
display symbols, text information, and other graphic elements which
provide the operator information regarding the operation of the
neuro-stimulation system 2000. During the operation of the
embodiment of FIG. 16, the graphic display 2112 may show: [0161] A
battery symbol with a varying number of "bars" that indicate the
approximate remaining charge in the battery 2220. For example:
TABLE-US-00001 [0161] 0 Bar: 3.20 V to 3.29 V (outline of symbol
flashes and alert, e.g. beep, issued by sound device 2239) 1 Bar:
3.30 V to 3.39 V 2 Bar: 3.40 V to 3.49 V 3 Bar: 3.50 V to 3.54 V 4
Bar: 3.55 V to 3.59 V 5 Bar: 3.60 V or Higher
[0162] A stimulator life symbol with a bar graph symbol showing,
e.g. by percentage, the remaining time left in the life of the
stimulator 2100, when the connector 2200 is connected the
stimulator 2100. For example:
TABLE-US-00002 [0162] 0 Bar: less than 5% remaining (outline of
symbol flashes and alert, e.g. beep, issued by sound device 2239) 1
Bar: 6% to 19% 2 Bar: 20% to 39% 3 Bar: 40% to 59% 4 Bar: 60% to
79% 5 Bar: 80% to 100%
[0163] A stimulator time counter showing hour and minute which
tracks the elapsed treatment time during run mode. When the
controller is not in run mode, the hour and minute are not
displayed. [0164] Mechanical and electrical stimulation symbols
which display the output levels, e.g. by percentage, from the
mechanical stimulation drive 2237 and the electrical stimulation
drive 2238. For example, the mechanical stimulation symbol may
indicate a value from 0% to 100%, where 0% represents no
application of mechanical stimulation and 100% represents the
application of +/-30 V to the vibration elements 2120. The
mechanical stimulation symbol may flash when the mechanical
stimulation is set to 100%. Meanwhile, the electrical stimulation
symbol may indicate a value of 0% to 100%, where 0% represents no
application of electrical stimulation and 100% represents the
application of +/-150 .mu.A to the electrodes 2110. The electrical
stimulation symbol may flash when the electrical stimulation is set
to 100%. [0165] A message area which the operator with warning
messages. A corresponding alert, e.g. beep, may be issued by the
sound device 2239. Any single key press turns the alert off. For
example, the messages may include: [0166] "REPLACE STIMULATOR" when
the stimulator life is less than 5% [0167] "CHARGE BATTERY" when
the battery voltage is less than 3.29 V [0168] "SKIN PREP ERROR"
when a SatDetect signal is received [0169] "DISCONNNECT ERROR" when
the StimEnable line indicates that the controller 2200 and the
stimulator 2100 are not coupled.
[0170] During operation, the sound device 2239 may be sounded when
any key on the keypad 2114 is pressed. For example, the sound
device 2239 may issue a single short beep of approximately 200 ms.
As discussed previously, the sound device 2239 may also be sounded
when an alert condition occurs. For example, the sound device 2239
may issue a short beep every 2 seconds. An issued alert may be
acknowledged and ended by pressing any key on the keypad 2114.
[0171] As discussed previously, in the embodiment of FIG. 16, the
controller 2200 may employ a rechargeable lithium ion battery pack
for the power supply 2220. Therefore, in this embodiment, the
neuro-stimulation system 2000 also employs a charging device for
recharging the lithium ion battery pack after its charge has been
depleted. Referring now to FIG. 19, a charging device, or console,
2300 is illustrated. The charging console 2300 may be formed from
ABS, or a similar material. In particular, the charging console
2300 includes two cradles 2310, which may individually receive and
detachably connect a controller 2200 to a separate charging circuit
2330. As shown in FIG. 19, the cradles 2310 correspond in shape
with at least a part of the controllers 2200 and permit the
controllers 2200 to slide into the cradles and be stably
positioned. In addition to sliding the controllers 2200 into the
cradles 2310, the controllers 2200 may snap into the cradles 2310
to further secure the controllers 2200 in place.
[0172] As shown in FIGS. 15B and 16, a controller 2200 may have
electrical contacts 2260, which provide an electrical connection
with the rechargeable battery 2220. Correspondingly, as shown in
FIGS. 16 and 19, the charging console 2300 may have electrical
contacts 2360, which engage the electrical contacts 2260 of the
controller 2200 when the controller 2200 is stably positioned in
the cradle 2310. As shown, the electrical contacts 2260 are
positioned on an end surface of the controller 2200. When the end
of the controller 2200 is received into the cradle 2310, the
electrical contacts 2260 of the controller 2200 are aligned for
conductive contact with the electrical contacts 2360 of the
charging console 2300. In one embodiment, the connection between
the controller 2200 and the charging console 2300 may employ
pogo-pin, or similar spring-biased, contacts.
[0173] The two charging circuits 2330 are illustrated in FIG. 16.
The charging circuits 2330 may be printed circuit boards based on
Micrel, or equivalent, linear charging chip sets. The charging
circuits 2330 may draw power from a conventional universal input
wall module 2400 which is plugged into a conventional electrical
wall outlet. The input voltage into the wall module 2400 may range
from approximately 115 VAC to 230 VAC (min). The line may have a
frequency of approximately 50 Hz to 60 Hz. The output voltage from
the wall module 2400 may be approximately 5 VDC to 16 VDC with an
output current of approximately 2.5 A (min).
[0174] Meanwhile, the charge current in the charging circuits 2330
may be approximately 1.2 Amps with a charge voltage of
approximately 4.2 VDC. As indicated previously, in the embodiment
of FIG. 16, the charge time may be approximately 4 hours. The chip
set may provide for an internal shutdown when the end of the
charging is reached. In addition, an LED indicator 2320 may be
employed to indicate that the battery is fully charged. For
instance, it may switch from an amber color to green when charging
is complete.
[0175] In sum, embodiments of the neuro-stimulation system 2000 may
provide a stimulator 2100 detachably coupled to a wearable
controller 2200, which has a user interface 2210 including a
graphic display 2212 and a keypad 2214. Preferred embodiments of
the neuro-stimulation system 2000 have small, lightweight
components which facilitate the application of stimulation during
therapy and do not interfere with the therapy with wires,
connection cables, etc. Furthermore, through the user interface
2210, embodiments may permit an operator to manually set the
mechanical stimulation level and/or the electrical stimulation
level. Accordingly, the vibration elements 2120 and/or electrodes
2110 may be driven to deliver stimulation that has an aperiodic
waveform and/or stimulation that is subthreshold. Through the
graphic display 2212, embodiments may display data, such as
information on the stimulator life and battery life as well as the
electrical and mechanical stimulation settings. Other embodiments
may also have the ability to detect when the controller 2200 is
attached to the stimulator 2100. Further embodiments have the
ability to track the remaining life in the stimulator 2100.
[0176] While the controller 2200 has been described previously with
respect to the stimulator 2100 as shown for example in FIG. 10A, it
is understood that the controller 2200, or any aspects thereof, may
be employed with other embodiments of a stimulator, or stimulator
system, such as those described herein.
[0177] As described previously, the neuro-stimulation system 2000
may be applied to provide sensory enhancement stimulation during
stroke rehabilitation and improve neuroplasticity, i.e. the
formation of lasting functional changes in the brain. For instance,
the neuro-stimulation system 2000 may be applied to a subject's
arm, as illustrated in FIGS. 13A and 13B, while the arm undergoes
movement associated with post-stroke rehabilitative physical
therapy.
[0178] Research in clinical neuroscience has established that
recovery of CNS or PNS function following injury (e.g. stroke) in
many circumstances depends very strongly on the level of personal
involvement and commitment to progress on the part of the sufferer.
That is, if the subject is not closely involved and directly
participating in the rehabilitation initiative, progress will be
slowed or perhaps blocked. This need for personal motivation and
participation is often cited as explanatory for the failure of
"passive rehabilitation" to generate demonstrable functional
outcomes.
[0179] On this basis, modern rehabilitation regimens rely
increasingly on methods that directly engage the subject in the
process. One example is constraint induced movement therapy (CIMT)
to address hemiparesis. The subject's functioning extremity, e.g.
right arm, is mechanically blocked from use for long periods of
time thereby forcing the subject to use their affected extremity.
Another example is customized physical therapy in which the
regiment is designed specifically around tasks and abilities that
are important to an individual subject. Common to these and other
forms of participatory rehabilitation is that the subject's own
brain is volitionally striving toward movements and capabilities of
personal importance to them.
[0180] More recently, the use of virtual reality (VR) systems has
gained clinical momentum as another form of participatory
rehabilitation. As part of a rehabilitation regimen, subjects
interact with a VR system that reacts in real time to their
attempts to use affected extremities. Often the VR system is
essentially a computer video game system that displays real-time
images on a monitor that react to or are controlled by the subject.
Such a system can be adjusted to the subject's particular
circumstance to motivate certain types of attempted movements. As
such, a further embodiment of the present invention combines
subthreshold neuro-stimulation with VR systems. An example VR
system which may be employed is the Nintendo.RTM. Wii gaming
system. In this embodiment, stimulation devices, such as the
devices described herein, would be placed on the skin, or implanted
under the skin, and would deliver subthreshold neuro-stimulation
during VR-guided activities. As is the case with other forms of
rehabilitation, boosting sensory traffic during VR rehabilitation
sessions improves neuroplastic remodeling outcomes. Like other
embodiments described herein, this embodiment takes advantage of
the interplay between subthreshold stimulation and physical
rehabilitation. The individual receives the heretofore
unanticipated benefit of receiving subthreshold stimulation while
moving the target body segments. Since by definition susbsensory
stimulation does not by itself evoke nerve activity, the embodiment
employs physical activity to ultimately cause the nerve activity.
The subthreshold stimulation effectively and uniquely boosts the
natural sensory signaling in a fashion that is directly useful to
the central nervous system.
[0181] However, it is understood that the application of
subthreshold neuro-stimulation for stroke rehabilitation is merely
exemplary. FIG. 21A illustrates a configuration for a
neuro-stimulation system 3000A which may be broadly employed to
direct stimulation to any sensory cells of any body part to enhance
detection of a sensory signal from the sensory cells. In
particular, as shown in FIG. 21A, the neuro-stimulator system 3000A
includes a stimulator 3100A which delivers stimulation to a body
part 1. To control and drive the stimulator 3200A, the
neuro-stimulation system 3000A includes at least a power supply
3220A and a processor 3230A, which collectively may be referred to
as a controller 3200A (illustrated with a dotted line in FIG. 21A).
The stimulator 3100A and controller 3200A in this embodiment may be
respectively similar to the stimulator 2100 and the controller 2200
of the neuro-stimulator system 2000 described above.
[0182] The processor 3230A receives electrical power from the power
supply 3220A and sends an electrical driving signal to the
stimulator 3100, which is operably coupled to the processor 3230A.
The stimulator 3100A includes a stimulating element 3105A. The
stimulating element 3105A may include one or more electrode devices
for delivering electrical stimulation, one or more vibration
elements for delivering mechanical stimulation, or any combination
thereof. Unlike the stimulator 2100 above, the stimulator 3100A in
some embodiments may be configured to include only electrodes or
only vibrating elements, rather than both forms of stimulating
elements. The processor 3230 is operable to drive either electrode
devices and/or a vibration elements with the electrical driving
signal. The stimulator 3100A has a contact surface 3102A which is
positioned to deliver stimulation from simulating element 3105A to
the targeted body part 1. Accordingly, in response to the
electrical driving signal, the stimulator 3100A provides
stimulation to the body part 1. Preferably, the stimulation is
aperiodic stimulation and/or subthreshold stimulation, providing
the advantages described previously.
[0183] Although a stimulator may be detachably coupled to a
controller as with the neuro-stimulator 2000 above, a stimulator
and a controller may also be integrally or fixedly coupled to each
other. As illustrated with the embodiment of FIG. 21A, the
stimulator 3100A may be included with the processor 3230A and the
power supply 3220A in a single application body, or housing, 3001A.
This single application body 3001A may then be applied to the body
part 1 to deliver the stimulation.
[0184] Of course, different components of a neuro-stimulation
system may be organized and coupled in any number of combinations
and housed in any number of devices or bodies. Thus, referring to
FIG. 21B, a neuro-stimulation system 3000B is illustrated, where a
power supply 3220B is separated from an application body 3001B
housing a stimulator 3100B and a processor 3230B. For example, the
power supply 3220B in FIG. 21B may be a battery pack or a
conventional electrical outlet that is detachably coupled to the
application body 3001B. The application body 3001B is positioned to
deliver stimulation to a body part 1 through a contact surface
3102B.
[0185] Meanwhile, FIG. 21C illustrates a neuro-stimulation system
3000C, where a stimulator 3100C is housed in an application body
3001C while a controller 3200C, i.e. a power supply 3220C and a
processor 3230C, is in a separate controller housing 3002C. The
stimulator 3100 is detachably or fixedly coupled to the controller
3200C via a coupling mechanism 3050C, such as a flexible cable,
that enables the processor 3230C to deliver a driving signal to a
stimulating element 3105C from a distance. The application body
3001C is positioned to deliver stimulation through a contact
surface 3102C. Advantageously, because the application body 3001C
does not house the power supply 3230 and the processor 3230, the
application body 3001C may be sized or configured to enable easy
handling and positioning on a body part 1 for the delivery of
stimulation, while the controller 3200 is placed conveniently at a
distance.
[0186] Attachment elements, such as an elastic strap or, a strap
with snaps, hook-and-loop fasteners, or other fasteners may be
employed to secure the stimulator and/or the controller into
desired positions. In the embodiment of FIG. 22C, an attachment
element may position the application body 3001C over the body part
1 targeted for stimulation, while another attachment element may
secure the controller housing 3002C to another part of the body for
comfort and convenience.
[0187] FIGS. 21A-C illustrate contact surfaces that make direct
contact with the body part 1, for example at a skin surface, to
deliver the desired stimulation. However, the actual stimulating
element, e.g. electrode and/or vibration element, does not have to
contact the body part 1 directly. Rather, as shown in FIG. 21A, the
electrical or mechanical stimulation may be transmitted from the
stimulating element 3105A within the application body 3001A to the
contact surface 3102A. For example, the stimulating element 3105A
may be embedded within the application body 3001A, while the outer
contact surface 3102A actually makes contact with the body part 1.
In this example, the application body 3001A, or some structure
thereof, may be formed from a material that allows an electrical
signal or vibration to travel from the stimulating element 3105A to
the contact surface 3102A.
[0188] Various applications of the neuro-stimulation systems, as
shown in FIGS. 21A-C, may be employed to deliver sensory enhancing
stimulation to any body part 1.
[0189] In one embodiment, the body part 1 includes aspects of the
body that aid in swallowing, including the tongue, pharynx, and
esophagus, and a neuro-stimulation system is applied to improve
swallowing function, especially for patients suffering from
dysphagia. As such, an application body housing a stimulator may be
applied externally across the neck to deliver electrical or
mechanical stimulation to the tongue, pharynx, and/or esophagus.
Alternatively, a small application body may be applied in the
throat, especially for patients with severe or chronic disorders.
The application of stimulation enhances the sensory information
required by the swallowing function and improves control of this
swallowing function. In some embodiments, the swallowing function
to be improved is the sensation of the presence of a solid or
liquid bolus in the throat. In other embodiments, the swallowing
function to be improved is timing of swallowing muscle contraction
relative to movement of solid or liquid bolus in the throat. In
further embodiments, the swallowing function to be improved is the
timing of the closure of the trachea relative to the movement of
solid or liquid bolus in the throat.
[0190] In another embodiment, the body part 1 is the heart and a
neuro-stimulation system is applied to improve cardiac function for
patients who suffer from congestive heart failure. A key function
of healthy heart muscle is the regulation of contractions based on
its internal stretch (from filling), which uses mechanoreceptors
similar to muscle spindles found in striated muscle. Poor cardiac
function results when this mechanism is compromised. As such, an
application body housing a stimulator may be applied outside or
inside the chest cavity to deliver stochastic resonance stimulation
to the heart muscle, making the heart more resistant to
overfilling, which may improve cardiac function in patients
suffering from congestive heart failure.
[0191] In an additional embodiment, the body part 1 includes the
lungs, and a neuro-stimulation system may be applied to improve
lung sensation/function in asthmatic patients. An application body
is noninvasively applied to the surface of the chest where
sub-threshold stimulation may be most effectively transferred to
the intercostals muscle. A stimulator in the application body may
provide electrical and/or mechanical stimulation from any number of
electrodes and/or vibrating elements, which are driven by a
controller. In a particular embodiment, the configuration of FIG.
21C may be employed where the controller 3200C is kept in a
controller housing 3002C separated by a distance from the
application body 3001C. The controller housing 3002C, for example,
may approximately have the size of a pack of cigarettes and may be
secured to an attachment element, such as a wrist band, via a
belt-clip. Thus, the coupling mechanism 3050C may include control
and signal wires which extend run from the controller housing 3002C
to the application body 3001C positioned at the chest. Accordingly,
the stimulation from the stimulator 3100C increases the awareness
of lung state during asthmatic attacks and offers better control of
breathing during these attacks. The expansion and/or contraction of
the lung thus increases with the stimulation of the intercostals
muscle in the chest region.
[0192] In yet another embodiment, a neuro-stimulation system may be
applied as a therapy for patients suffering from Parkinson's
disease. For example, an application body housing a stimulator may
be applied to an affected muscle to deliver a noninvasive,
sub-threshold electrical and/or mechanical stimulation to improve
the patient's ability to sense muscle position and offer better
control of muscle flexion. Thus, unwanted motions or movements in
affected muscles or muscle groups associated with Parkinson's
disease are minimized.
[0193] In a further embodiment, a neuro-stimulation system may be
applied to manage pain. Contrary to Transcutaneous Electrical Nerve
Stimulation (TENS) which manages pain by overloading a sensory
channel, the neuro-stimulation system in this embodiment applies
subthreshold stimulation in a less invasive technique to ground the
sensory channel instead of overloading it. In some cases, the pain
is caused by musculoskeletal hyperextension or excursion resulting
from proprioceptive deficit in the body part. For example, back
pain may be caused by a proprioceptive deficit in a person's trunk
and in one embodiment, neuro-stimulation may be applied to increase
stability and strength to manage this back pain.
[0194] In yet a further embodiment, the body part 1 is the forehead
and, a neuro-stimulation system may be applied to reduce
chronic/tension headaches. For instance, an application body
housing a stimulator may be applied noninvasively to affected
muscles or muscle groups in the forehead area where sub-threshold
stimulation may be applied to control tension and relieve chronic
pain due to uncontrollable muscle spasms. The stimulator in the
application body may provide electrical and/or mechanical
stimulation from any number of electrodes and/or vibrating
elements, which are driven by a controller.
[0195] In another embodiment, the body part 1 employs a prosthetic
device, and a neuro-stimulation system may be applied to improve
function with the prosthetic device. Generally, sensors on
prostheses (proprioception, pressure, etc.) are introduced to
pectoral sensory pathways and successfully decoded by the brain.
The brain forms new neural connections to process and use the
information from the sensors on the prosthesis. This embodiment
applies stochastic resonance stimulation in conjunction with the
signals from the sensors to promote neural development and to
increase the sensitivity of the pectoral nerves to these signals.
For example, a stimulator may be incorporated with the prosthetic
device to deliver electrical and/or mechanical stimulation during
use of the prosthetic device.
[0196] In yet another embodiment, a neuro-stimulation system may be
applied to reduce phantom limb sensations by those who have lost a
limb. In particular, an application body housing a stimulator may
be applied to deliver stochastic resonance stimulation to severed
nerves associated with the missing limb or to surrounding intact
nerves. Such stimulation encourages the brain to dissociate the
neural connections causing phantom limb or phantom pain sensations.
Applying the stimulation to severed nerves provides the brain with
greater information about the current state of the body, alerting
the brain of the loss of the limb. Applying the stimulation to
surrounding intact nerves encourages the brain to focus on the
neural connections that are not associated with the damage.
[0197] In a further embodiment, a neuro-stimulation system may be
employed for strength training in patients with a sensory deficit.
Recent studies have shown that people who actually did certain
physical exercises, e.g. finger exercises, gained no more strength
than people who did no physical exercise but simply thought about
doing the exercise for the same amount of time. Thus, a stimulator
may deliver stochastic resonance stimulation to the joints of a
patient with a sensory deficit. Such stimulation may result in a
faster increase strength by making the brain more aware of body
movement.
[0198] In yet a further embodiment, a neuro-stimulation system may
be employed as a therapy for arousal dysfunction. An application
body housing a stimulator may be applied to appropriate areas to
deliver stimulation and improve sexual sensory function in these
areas.
[0199] In another embodiment, the body part 1 may be a finger tip
that is used to read Braille, and a neuro-stimulation system may be
employed to improve sensory function corresponding to Braille
reading ability. The contact surface for delivery of stimulation is
a surface with Braille which is then coupled to a stimulator.
Stochastic resonance stimulation applied to finger tips has been
shown to improve detection of small stimuli. The use of the Braille
system for vision impaired reading of text requires precision on
the part of the reader to identify small raised dots on paper. This
effort can be difficult when the reader is new to Braille, the
print is small, or the pages are worn. Therefore, the stimulator
3100 of the neuro-stimulator system 3000 may provide stochastic
resonance stimulation to the finger tip to improve a person's
ability to detect the raised dots of Braille text. This embodiment
is an example of an external device, e.g. the Braille surface, that
is provided with a stimulation source and when a body part, e.g.
the finger tip, contacts or interacts with the external device, the
stimulation source applies the stimulation to sensory cells of the
body part to enhance sensory function associated with the body
part. Other examples of such external devices are provided
herein.
[0200] In yet another embodiment, the body part 1 may be the nasal
septum while the contact surface may be sized and configured to
accommodate stable positioning on the nasal septum. As such, the
neuro-stimulation system may be applied to improve the olfactory
function of a human. The application of a sub-threshold electrical
and/or mechanical signal to the nasal septum increases sensation
and provides an improvement in the sense of smell. Therefore, one
or more stimulators are positioned to apply a sub-threshold signal
to the nasal septum. Preferably, to promote comfort and ease of
use, only a small stimulator is positioned on the nasal septum
while the controller is positioned elsewhere. Thus, referring to
FIG. 21C, the stimulator 3100C may be housed in an application body
3001C and the controller 3200C may have a separate housing 3002C.
In particular, the housing 3002C for the controller 3200C may be
shaped like a cigarette pack, which can conveniently placed in a
shirt pocket or worn on the waist via a belt clip.
[0201] Similarly, yet another embodiment of the neuro-stimulator
may be employed to improve the olfactory function of a canine.
Canines are often used in tasks requiring the use of smell as a way
of locating an object or person. These tasks include searching for
missing persons, detecting explosives, and locating contraband such
as drugs. Thus, in this application, referring to FIG. 21C, the
body part 1 is a canine's nose, and the application body 3001C
housing the stimulator 3100C is configured to fit across the nose
with a first attachment element while the controller 3200C in a
housing 3002C may be separately mounted on another part of the
canine with a second attachment element, such as a dog collar.
[0202] Further embodiments of the neuro-stimulator system may be
employed to improve auditory sensory function and detection of
audio signals. In some embodiments, the neuro-stimulation system
provides an electrical or audio noise signal with hearing assistive
devices, e.g. hearing aids, cochlear implants, etc., to improve the
auditory function of their users and the effectiveness of these
devices. With such embodiments, the hearing assistive device may
act as the application body 3001A which houses the complete
neuro-stimulation system 3000A, as depicted in FIG. 21A. When
employed to improve auditory function, the body part 1 includes
aspects of the auditory system which affect the auditory nerves,
while the stimulator sends a signal that may be received by the
auditory system. Although FIGS. 21A-C illustrate a contact surface
positioned in direct contact with the body part 1, it is understood
that other embodiments may deliver stimulation to the body part 1
without direct contact. For example, a stimulation in the form of
sound may be delivered across a space between the stimulator 3100
and the body part 1. As such, to improve a subject's ability to
hear particular sounds, the neuro-stimulation system 3000 may
combine a noise signal with the particular sounds that are
transmitted over a space to the subject. For example, audio
recordings that require transcription may be combined with a noise
signal to improve the transcriber's ability to detect the audio. In
another example, audio signals from a sonar system may be combined
with a noise signal to improve the monitor's ability to detect
faint sonar signals.
[0203] Another embodiment of the neuro-stimulation system is
employed to improve visual function, where the body part 1 is the
eye. In this embodiment, the neuro-stimulation system may add noise
to the visual signal, or light, from the object being viewed. For
example, vision is used extensively in the scrutiny of images
(x-ray, etc.) for medical diagnosis or in the screening of packages
and contents for security purposes. The neuro-stimulation system
may generate noise in a band of visual wavelengths, and the noise
may be transmitted along with the images, such as those from a
security screening monitor. The stimulation from the transmitted
noise may improve the ability to detect weak information being
received by the eye. Similar to the improvement of auditory
function described previously, stimulation in the form of visual
signals may be delivered across a space between the stimulator and
the body part 1.
[0204] Yet another embodiment of the neuro-stimulation system is
employed to improve tasting function, where the body part 1 is a
tongue. A discriminating palate is key to the process of taste
testing used in the culinary arts, brewing, etc. As such, the
contact surface of a stimulator may be placed into contact with
areas of the tongue surface to deliver electrical or mechanical
stimulation from the simulating element 3105 to the gustatory
(taste nerve) cells. Such stimulation improves the ability of the
subject to taste. Due to relatively limited access to the tongue
inside the mouth, referring to FIG. 21C the stimulator 3100C may
employ an application body 3001C that is separate from the housing
3002C of the controller 3200C. Thus, components of the
neuro-stimulation system 3000C, i.e. the controller 3200C, do not
have to be positioned on the tongue, and the application body 3001C
may be conveniently sized and configured to be easily and
comfortably positioned on the tongue inside the mouth.
[0205] While FIGS. 21A-C illustrate general configurations for a
neuro-stimulation system, FIGS. 22A-B illustrate specific example
embodiments of neuro-stimulation systems that may be applied to
address particular medical conditions. As illustrated in FIG. 22A,
a neuro-stimulation system 4000 is employed to deliver electrical
stimulation, stochastic resonance or otherwise, to an internal
organ. Use of this embodiment may include applying stimulation to:
the bladder and colon as therapy for incontinence; the stomach as
therapy for disorders involving the feeling of fullness; the gall
bladder as therapy for bile secretion; or the esophagus,
intestines, urethra, and bile duct for peristaltic encouragement or
improvement. As shown in FIG. 22A, the application body 4001 of the
stimulator 4100 is an expandable material, such as a mesh, which is
positioned over an organ, or body part, 1. The application body
4001 accommodates expansion and contraction of the organ during
normal function, e.g. during filling of the bladder, etc. The
stimulating elements 4105 may be electrodes which are distributed
over the stimulation application body 4001 to provide diffuse
application of electrical stimulation over targeted surfaces of the
organ 1. During application, the expandable material 4001 is
trimmed to accommodate the size of the targeted organ 1 and may be
sutured at selected points to the surface of the organ 1. In
addition to serving as attachment elements 4500, the suture points
help keep the application body 4001 in tension across the organ 1.
The stimulator 4100 may be composed of one or more resorbable
materials, including resorbable conducting metals or polymers for
the electrodes 4105. As such, additional procedures to remove the
stimulator 4100 are unnecessary. As further illustrated in FIG.
22A, the stimulator 4100 is coupled to a remote controller 4200,
which includes a power source 4220 and processor 4230 to drive the
electrodes and deliver electrical stimulation to the organ 1.
[0206] FIG. 22B illustrates yet another embodiment of the
neuro-stimulator 5000 which may deliver stimulation to multiple
points of a body part 1. In particular, FIG. 21E shows a
stimulation application body 5001 which has a catheter-like
structure having a proximal end 5001A and a distal end 5001B. The
stimulator 5100 may be applied subcutaneously. The stimulating
elements 5105 include a plurality of electrodes which are spaced
longitudinally along the stimulation application body 5001 to
provide electrical stimulation to multiple parts of a body part 1.
Each stimulating element 5105 receives an electrical signal via a
conductor, such as a wire, that extends longitudinally to the
proximal end 5001A which is operably coupled to a controller 5200.
The controller 5200 has a processor 5230 which delivers electrical
signals from a power source 5220 to selected electrodes along the
application body 5001. As such, the processor 5230 can define any
combination and sequence of electrical stimulation sources and
sinks along the application body 5001. Thus, the neuro-stimulation
system 5100 in FIG. 22B provides a customizable configuration which
facilitates application of stimulation to different regions of the
body and which may suit the varying needs of patients.
[0207] Although an application body in a neuro-stimulation system
may be specially shaped or configured to accommodate a particular
body part to deliver stimulation, other neuro-stimulation systems
may incorporate a stimulator into the structure of another device,
such as a consumer product, which is initially intended to provide
other functions outside of stimulation delivery. As such, the
device, or a part thereof, becomes an application body for
stimulation delivery. Combining a neuro-stimulation system with
another device may improve an operator's ability to use the device
or may enhance the effectiveness of the device. The prosthetic
device combined one or more simulators or the hearing assistive
device combined with one or more stimulators, described previously,
provide examples of neuro-stimulation systems that incorporate a
stimulator within another device.
[0208] In another example, a stimulator may be incorporated into a
gun or rifle to deliver stimulation that improves a person's
ability to shoot a gun. Accurate gun shooting is required
especially in long range targeting, such as sniping. One aspect of
accurate gun shooting is the ability of the shooter to control the
precise action of a hair trigger and maintain gun stock position
relative to the shooter's body as the projectile is fired from the
gun. An embodiment of a neuro-stimulation system may incorporate a
stimulator with a vibrating stimulating element into the trigger
and/or the gun stock. As such, the gun may provide stochastic
resonance stimulation to a trigger finger through the gun trigger
and/or to a region of the body between the arm and torso through
the gun stock. In this example, parts of the gun act as application
bodies for the delivery of sensory enhancement stimulation.
[0209] In yet another example, an embodiment of a neuro-stimulation
system may incorporate stimulators into a waterproof shower mat to
deliver stochastic resonance stimulation to a person's feet and
reduce the likelihood that the person will fall in the shower. In a
particular embodiment, the shower mat may be battery powered and
may employ force sensors in the mat to determine where the foot is
making contact and allow focused delivery of stimulation to areas
of the mat where the person is standing. As discussed previously,
the delivery of such stimulation to the feet enhances human
balance, reducing the likelihood of falling.
[0210] In a further example, an embodiment of a neuro-stimulation
system may incorporate a stimulator into a sock, which delivers
stochastic resonance stimulation to a foot. The stimulating element
may be formed from a flexible polymer which vibrates from an
electrical signal received from a controller coupled to the
stimulator. The sock conforms to the shape of the foot and remains
in contact with areas of the bottom of the foot without requiring
any load on the bottom of the sock. Advantageously, the sock may be
used by diabetics and other similar individuals who are not
physically active and do not spend a significant amount of time on
their feet to place a load on the sock. Even while seated or lying
down, the sock maintains contact with the soles of the foot, so
that the foot receives the effect of stimulation delivered by the
stimulator. The benefits of applying such a stimulation to the
bottom of the foot were described previously. In a particular
embodiment, the controller may deliver different driving signals to
the stimulating element depending on the load on the sock, i.e.
load differences between standing and sitting. As such, a sensor
may be employed to indicate the loading state of the sock to the
controller, so that the driving signal may be correspondingly
adjusted.
[0211] Therefore, embodiments of the present invention provide a
variety of configurations and shapes for delivering controlled
stimulation to any sensory cells of any body part according to a
variety of therapeutic applications. In some preferred embodiments,
subthreshold and/or aperiodic stimulation is applied to enhance
transmission and detection of sensory information. In some
applications, this results in improved neuromuscular
performance.
[0212] It is understood that while the embodiments described herein
may provide subthreshold and/or a periodic stimulation, the
embodiments may also be capable of providing supra-threshold
stimulation. In particular, supra-threshold stimulation may be
applied as technique to determine, e.g. iteratively, a person's
sensory threshold during initial system setup and before the
subthreshold and/or a periodic stimulation is applied.
[0213] However, the foregoing specific embodiments of the present
invention as set forth in the specification herein are for
illustrative purposes only. Various deviations and modifications
can be made within the spirit and scope of this invention, without
departing from the main theme thereof. It will be appreciated by
persons skilled in the art that the present invention is not
limited by what has been particularly shown and described herein
above. While the present invention has been described in connection
with a number of exemplary embodiments, and implementations, the
present inventions are not so limited, but rather cover various
modifications, and equivalent arrangements, which fall within the
purview of prospective claims. All dimensions, and the like,
provided herein are exemplary.
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