U.S. patent application number 15/995872 was filed with the patent office on 2019-12-05 for interferential electrical stimulation device with targeting capabilities.
The applicant listed for this patent is Feinstein Patents, LLC. Invention is credited to Peter A. Feinstein.
Application Number | 20190366087 15/995872 |
Document ID | / |
Family ID | 68693709 |
Filed Date | 2019-12-05 |
United States Patent
Application |
20190366087 |
Kind Code |
A1 |
Feinstein; Peter A. |
December 5, 2019 |
Interferential Electrical Stimulation Device With Targeting
Capabilities
Abstract
An interferential current system for performing a therapeutic
procedure includes a controller, a stimulation power supply and at
least one sensor providing patient derived sensor feedback to the
controller. The system also includes at least two electrodes
disposed on an epidermis of the patient and arranged to supply
transcutaneous electrical impulses to a therapeutic target area
when supplied power by the stimulation power supply. The electrodes
supply impulses at two different frequencies, giving rise to at
least one beat impulse having an interference frequency. The
controller generates a patient specific model based at least in
part on the sensor feedback, the patient specific model indicative
of at least one of: electrode placement appropriate for the
transcutaneous electrical impulses to reach the therapeutic target
area, appropriate magnitudes of the at least two different
frequencies, appropriate magnitude of the interference frequency,
and appropriate sweep frequencies.
Inventors: |
Feinstein; Peter A.; (Palm
Beach Gardens, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Feinstein Patents, LLC |
Wilkes-Brarre |
PA |
US |
|
|
Family ID: |
68693709 |
Appl. No.: |
15/995872 |
Filed: |
June 1, 2018 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36014 20130101;
A61N 1/323 20130101; A61N 1/36132 20130101; A61N 1/0408 20130101;
A61N 1/36021 20130101; A61N 1/36034 20170801; A61N 1/36146
20130101 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61N 1/32 20060101 A61N001/32 |
Claims
1. An interferential current system for performing a therapeutic
procedure on a patient, said device comprising: a controller; a
stimulation power supply in communication with said controller; at
least one sensor providing sensor feedback to said controller, said
sensor feedback indicative of a patient parameter derived from the
patient; a plurality of electrodes in electrical communication with
said stimulation power supply, said plurality of electrodes
configured to be disposed on an epidermis of the patient and
arranged to supply transcutaneous electrical impulses to a
therapeutic target area when supplied power by said stimulation
power supply, wherein said plurality of electrodes comprises at
least two electrodes supplying transcutaneous electrical impulses
at two different frequencies, the transcutaneous electrical
impulses provided at two different frequencies giving rise to at
least one beat impulse having an interference frequency; and
wherein said controller generates a patient specific model based at
least in part on said sensor feedback, the patient specific model
indicative of at least: electrode placement appropriate for the
transcutaneous electrical impulses to reach the therapeutic target
area, appropriate magnitudes of the at least two different
frequencies and an appropriate magnitude of the interference
frequency.
2. The interferential current system of claim 1 wherein said at
least one sensor provides sensor feedback to said controller in
real time during the therapeutic procedure.
3. The interferential current system of claim 2 wherein said
controller updates the patient specific model during the
therapeutic procedure based at least in part upon the sensor
feedback.
4. The interferential current system of claim 2 wherein the
transcutaneous electrical impulses are adjusted during the
therapeutic procedure based at least in part upon the sensor
feedback.
5. The interferential current system of claim 4 wherein the
transcutaneous electrical impulses are adjusted automatically and
in real time by the controller during the therapeutic procedure
based at least in part upon the sensor feedback.
6. The interferential current system of claim 1 wherein the
controller generates a computer assisted plan at least in part
based on the patient specific model, and wherein the controller
activates said stimulation power supply based at least in part upon
the computer assisted plan.
7. The interferential current system of claim 6 wherein said
controller updates the computer assisted plan during the
therapeutic procedure based at least in part upon the sensor
feedback.
8. The interferential current system of claim 1, wherein said at
least one sensor comprises an imaging sensor, and wherein the
sensor feedback comprises image data indicative of patient
anatomy.
9. The interferential current system of claim 8, wherein said at
least one sensor comprises an imaging sensor employing at least one
of the following modalities: ultrasound, Level II ultrasound, 3D
ultrasound, 4D ultrasound, trans esophageal echogram (TEE), x-rays,
computed tomography (CT) scanning, magnetic resonance imaging (MRI)
scanning, 3D magnetic resonance imaging (MRI) scanning, positron
emission tomography (PET), radiography, elastography,
plethsmethography, thermography, bone scanning and image
intensification.
10. The interferential current system of claim 9, wherein said at
least one sensor comprises at least two of any combination of
imaging sensors employing at least two of the following modalities:
ultrasound, Level II ultrasound, 3D ultrasound, 4D ultrasound,
trans esophageal echogram (TEE), x-rays, computed tomography (CT)
scanning, magnetic resonance imaging (MRI) scanning, 3D magnetic
resonance imaging (MRI) scanning, positron emission tomography
(PET), radiography, elastography, plethsmethography, thermography,
bone scanning and image intensification.
11. The interferential current system of claim 1, wherein said at
least one sensor comprises an electrical sensor, and wherein the
sensor feedback comprises electrical signal data.
12. The interferential current system of claim 11, wherein said at
least one sensor comprises an electrical sensor employing at least
one of the following modalities: electroencephalography (EEG),
electrocardiogram (EKG), nerve conduction tests and electromyograms
(NCT and NCV) and somatosensory evoked potentials (SSEP).
13. The interferential current system of claim 1, wherein said at
least one sensor is integrated with a further element selected from
the group consisting of a robotics device, a robotics machine, a
robotics algorithm, a mobile device and combinations thereof.
14. The interferential current system of claim 1, wherein said
plurality of electrodes comprises: a first electrode supplying
transcutaneous electrical impulses at a first frequency and a
second electrode supplying transcutaneous electrical impulses at a
second frequency different than the first frequency, the
transcutaneous electrical impulses provided at the first and second
frequencies giving rise to a first beat impulse having a first
interference frequency; and a third electrode supplying
transcutaneous electrical impulses at a third frequency and a
fourth electrode supplying transcutaneous electrical impulses at a
fourth frequency different than the third frequency, the
transcutaneous electrical impulses provided at the third and fourth
frequencies giving rise to a second beat impulse having a second
interference frequency.
15. The interferential current system of claim 1 wherein said
controller transmits data via the Internet or other mechanism to
remote or off site locations.
16. An interferential current system for performing a therapeutic
procedure on a patient, said device comprising: a controller; a
stimulation power supply in communication with said controller; at
least one sensor providing sensor feedback to said controller, said
sensor feedback indicative of a patient parameter derived from the
patient wherein said at least one sensor provides sensor feedback
to said controller in real time during the therapeutic procedure; a
plurality of electrodes in electrical communication with said
stimulation power supply, said plurality of electrodes disposed on
an epidermis of the patient and arranged to supply transcutaneous
electrical impulses to a therapeutic target area when supplied
power by said stimulation power supply, wherein said plurality of
electrodes comprises at least two electrodes supplying
transcutaneous electrical impulses at two different frequencies,
the transcutaneous electrical impulses provided at two different
frequencies giving rise to at least one beat impulse having an
interference frequency, wherein the transcutaneous electrical
impulses are adjusted automatically and in real time by the
controller during the therapeutic procedure based at least in part
upon the sensor feedback; and wherein said controller generates a
patient specific model based at least in part on said sensor
feedback, the patient specific model indicative of at least one of:
electrode placement appropriate for the transcutaneous electrical
impulses to reach the therapeutic target area, appropriate
magnitudes of the at least two different frequencies and an
appropriate magnitude of the interference frequency, and wherein
said controller updates the patient specific model during the
therapeutic procedure based at least in part upon the sensor
feedback.
17. The interferential current system of claim 16 wherein the
controller generates a computer assisted plan at least in part
based on the patient specific model, and wherein the controller
activates said stimulation power supply based at least in part upon
the computer assisted plan.
18. The interferential current system of claim 17 wherein said
controller updates the computer assisted plan during the
therapeutic procedure based at least in part upon the sensor
feedback.
19. The interferential current system of claim 16, wherein said at
least one sensor comprises an imaging sensor, and wherein the
sensor feedback comprises image data indicative of patient
anatomy.
20. The interferential current system of claim 19, wherein said at
least one sensor comprises an imaging sensor employing at least one
of the following modalities: ultrasound, Level II ultrasound, 3D
ultrasound, 4D ultrasound, trans esophageal echogram (TEE), x-rays,
computed tomography (CT) scanning, magnetic resonance imaging (MRI)
scanning, 3D magnetic resonance imaging (MRI) scanning, positron
emission tomography (PET), radiography, elastography,
plethsmethography, thermography, bone scanning and image
intensification.
21. The interferential current system of claim 20, wherein said at
least one sensor comprises at least two of any combination of
imaging sensors employing at least two of the following modalities:
ultrasound, Level II ultrasound, 3D ultrasound, 4D ultrasound,
trans esophageal echogram (TEE), x-rays, computed tomography (CT)
scanning, magnetic resonance imaging (MRI) scanning, 3D magnetic
resonance imaging (MRI) scanning, positron emission tomography
(PET), radiography, elastography, plethsmethography, thermography,
bone scanning and image intensification.
22. The interferential current system of claim 16, wherein said at
least one sensor comprises an electrical sensor, and wherein the
sensor feedback comprises electrical signal data.
23. The interferential current system of claim 22, wherein said at
least one sensor comprises an electrical sensor employing at least
one of the following modalities: electroencephalography (EEG),
echocardiography (EKG), nerve conduction tests and electromyograms
(NCT and NCV) and somatosensory evoked potentials (SSEP).
24. The interferential current system of claim 16, wherein said at
least one sensor is integrated with a robotics device, machine, or
algorithm and/or with a mobile device.
25. The interferential current system of claim 16 wherein said
controller transmits data via the Internet or other mechanism to
remote or off site locations for consultation or expert input,
interpretation, and monitoring of the data garnered during or after
the procedure, or for incorporation into electronic medical records
(EMRs), or for telehealth applications.
26. An interferential current system for performing a therapeutic
procedure on a patient, said device comprising: a controller; a
stimulation power supply in communication with said controller; at
least two sensors providing sensor feedback to said controller,
said sensor feedback indicative patient parameters derived from the
patient, wherein said at least two sensors employ at least two of
any combination of the following modalities: ultrasound, Level II
ultrasound, 3D ultrasound, 4D ultrasound, trans esophageal echogram
(TEE), x-rays, computed tomography (CT) scanning, magnetic
resonance imaging (MRI) scanning, 3D magnetic resonance imaging
(MRI) scanning, positron emission tomography (PET), radiography,
elastography, plethsmethography, thermography, bone scanning, image
intensification, electroencephalography (EEG), echocardiography
(EKG), nerve conduction tests and electromyograms (NCT and NCV) and
somatosensory evoked potentials (SSEP); a plurality of electrodes
in electrical communication with said stimulation power supply,
said plurality of electrodes disposed on an epidermis of the
patient and arranged to supply transcutaneous electrical impulses
to a therapeutic target area when supplied power by said
stimulation power supply, wherein said plurality of electrodes
comprises at least two electrodes supplying transcutaneous
electrical impulses at two different frequencies, the
transcutaneous electrical impulses provided at two different
frequencies giving rise to at least one beat impulse having an
interference frequency; and wherein said controller generates a
patient specific model based at least in part on said sensor
feedback, the patient specific model indicative of at least one of:
electrode placement appropriate for the transcutaneous electrical
impulses to reach the therapeutic target area, appropriate
magnitudes of the at least two different frequencies and an
appropriate magnitude of the interference frequency.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a system and method which
employs interferential current (IFC) therapy for a variety of
therapeutic purposes, and which also includes targeting
capabilities to ensure that the stimulating currents are directed
to the appropriate areas of the body to achieve the desired
results.
BACKGROUND OF THE INVENTION
[0002] Various types of electrical stimulation have been known to
be used for various therapeutic purposes. For example, one modality
that has gained significant popularity is transcutaneous electrical
nerve stimulation (TENS). TENS stimulates the generation of a
current that flows through leads to electrodes that are placed on
specific locations on a patient's skin in order to elicit reactions
in sensory and motor nerve fibers, typically to block pain messages
along the nerve fibers. As is known, TENS generally employs
low-voltage current that is modulated at low frequency (i.e., 125
Hz) in order to elicit the desired response in the nerve fibers
directly under the electrodes through which the current flows.
[0003] While TENS has proved successful in limited applications
(i.e., involving the stimulation of nerve fibers located just under
the skin), there are problems associated with using TENS and like
modalities in various situations, which has limited the
applications in which such electrical stimulating modalities have
traditionally been used.
[0004] Specifically, it has been found that the lower the
stimulation frequency of an electrical current, the greater the
resistance to the passage of the current through the skin and other
body tissues, leading to potentially significant discomfort being
experienced by the patient. The skin's impedance at 50 Hz is
approximately 3200 ohms, while at 4000 Hz it is reduced to
approximately 40 ohms. The result of applying this latter frequency
is that it will pass more easily through the skin and any other
tissues before hitting the target tissue or organ. However, it has
also been found that medium frequency current (e.g., 4000 Hz)
generally does not have the beneficial therapeutic effects as does
the much lower frequency currents typically employed by traditional
modalities, such as TENS (e.g., 125 Hz).
[0005] Interferential current (IFC therapy) is a unique and
separate form of electrical therapeutic stimulation that expands
the scope and capabilities for medical intervention in situations
not amenable to TENS or any other form of electrical therapy. In
general, IFC therapy utilizes two or more medium frequency currents
which pass through body tissues simultaneously. They are set up so
that their paths cross; and in simple terms they interfere with
each other (hence the name "interferential" current therapy). This
interference gives rise to an interference or beat frequency, which
has the characteristics of low-frequency stimulation. The exact
frequency of the resultant beat frequency can be controlled by the
input frequencies. For example, if one current is at about 4000 Hz
and the other current is at about 3900 Hz, the resultant beat
frequency would be at about 100 Hz.
[0006] Thus, the basic principle of IFC therapy is to utilize the
strong physiological effects of the low frequency electrical
stimulation of muscle and nerve tissues at sufficient depth,
without the associated painful and somewhat unpleasant side effects
of such low frequency stimulation. The medium frequency currents
penetrate the tissues with very little resistance, whereas the
resulting interference current (low frequency) is in the range that
allows effective stimulation of the biological tissues. The
resistance (impedance) of the skin is inversely proportional to the
frequency of the stimulating current. Thus, the therapeutic beat
frequency of IFC results in the desired physiologic response from
the target organ or tissue, while requiring less electrical energy
input to the deeper tissues than would be required if a single low
frequency current was employed, giving rise to less discomfort.
[0007] However, the use of IFC is not without its problems. As
discussed previously, when using TENS or the like low frequency
therapies to treat relatively superficial nerves/tissues, correct
placement of the electrodes immediately over the area to be treated
is a relatively simple matter. However, being that the use of IFC
allows for substantially deeper areas to be treated, and also being
that IFC requires that multiple medium frequency currents intersect
at the precise area to be stimulated (referred to herein as the
"therapeutic target area"), targeting of the anatomic area to be
affected becomes a required component of the use of IFC treatment,
rather than simply putting electrodes on the skin to treat a
localized area of pain and discomfort. Heretofore, there is no
known system employing IFC which also adequately ensures that the
stimulating currents are appropriately targeted such that they
intersect to generate the correct beat frequency precisely at the
therapeutic target area.
[0008] Therefore, what is desired is a system and method employing
electrical stimulation for therapeutic purposes, which allows for
deep penetration of an appropriate low frequency current but
without causing tissue damage and/or patient discomfort and which
ensures that the therapeutic low frequency currents are accurately
directed to the desired therapeutic target area.
SUMMARY OF THE INVENTION
[0009] In one respect, the present invention is directed to an
interferential current system for performing a therapeutic
procedure on a patient, the device including a controller, a
stimulation power supply in communication with the controller and
at least one sensor providing sensor feedback to the controller,
the sensor feedback indicative of a patient parameter derived from
the patient. The system also includes at least two electrodes in
electrical communication with the stimulation power supply, the
electrodes disposed on an epidermis of the patient and arranged to
supply transcutaneous electrical impulses to a therapeutic target
area when supplied power by the stimulation power supply. The at
least two electrodes supply transcutaneous electrical impulses at
two different frequencies, the transcutaneous electrical impulses
provided at two different frequencies giving rise to at least one
beat impulse having an interference frequency. The controller
generates a patient specific model based at least in part on the
sensor feedback, the patient specific model indicative of at least
one of: electrode placement appropriate for the transcutaneous
electrical impulses to reach the therapeutic target area,
appropriate magnitudes of the at least two different frequencies
and an appropriate magnitude of the interference frequency.
[0010] In some embodiments, the at least one sensor provides sensor
feedback to the controller in real time during the therapeutic
procedure. In certain of these embodiments, the controller updates
the patient specific model during the therapeutic procedure based
at least in part upon the sensor feedback. In certain embodiments,
the transcutaneous electrical impulses are adjusted during the
therapeutic procedure based at least in part upon the sensor
feedback. The certain of these embodiments, the transcutaneous
electrical impulses are adjusted automatically and in real time by
the controller during the therapeutic procedure based at least in
part upon the sensor feedback. The model also incorporates on and
off, either manual or automatic, to address target organ tissue and
neurologic innervation adaptability that can result in escape from
the effects of a particular frequency so that adjusting wave forms
and frequencies at different time periods prevents target organ
escape from response.
[0011] In some embodiments, the controller generates a computer
assisted plan at least in part based on the patient specific model,
and the controller activates the stimulation power supply based at
least in part upon the computer assisted plan. In certain of these
embodiments, the controller updates the computer assisted plan
during the therapeutic procedure based at least in part upon the
sensor feedback.
[0012] In some embodiments, the at least one sensor comprises an
imaging sensor, and the sensor feedback comprises image data
indicative of patient anatomy. In certain of these embodiments, the
at least one sensor comprises an imaging sensor employing at least
one of the following modalities: ultrasound, Level II ultrasound,
3D ultrasound, 4D ultrasound, trans esophageal echogram (TEE),
x-rays, computed tomography (CT) scanning, magnetic resonance
imaging (MRI) scanning, 3D magnetic resonance imaging (MRI)
scanning, positron emission tomography (PET), radiography,
elastography, plethsmethography, thermography, bone scanning and
image intensification. In certain embodiments, the at least one
sensor comprises at least two of any combination of imaging sensors
employing at least two of the following modalities: ultrasound,
Level II ultrasound, 3D ultrasound, 4D ultrasound, trans esophageal
echogram (TEE), x-rays, computed tomography (CT) scanning, magnetic
resonance imaging (MRI) scanning, 3D magnetic resonance imaging
(MRI) scanning, positron emission tomography (PET), radiography,
elastography, plethsmethography, thermography, bone scanning and
image intensification.
[0013] In some embodiments, the at least one sensor comprises an
electrical sensor, and the sensor feedback comprises electrical
signal data. In certain of these embodiments, the at least one
sensor comprises an electrical sensor employing at least one of the
following modalities: electroencephalography (EEG),
echocardiography (EKG), nerve conduction tests and electromyograms
(NCT and NCV) and somatosensory evoked potentials (SSEP). In some
embodiments, the at least one sensor is integrated with a robotics
device, machine, or algorithm and/or with a mobile device.
[0014] In some embodiments, the plurality of electrodes comprises:
a first electrode supplying transcutaneous electrical impulses at a
first frequency and a second electrode supplying transcutaneous
electrical impulses at a second frequency different than the first
frequency, the transcutaneous electrical impulses provided at the
first and second frequencies giving rise to a first beat impulse
having a first interference frequency; and, a third electrode
supplying transcutaneous electrical impulses at a third frequency
and a fourth electrode supplying transcutaneous electrical impulses
at a fourth frequency different than the third frequency, the
transcutaneous electrical impulses provided at the third and fourth
frequencies giving rise to a second beat impulse having a second
interference frequency.
[0015] In accordance with another aspect of the present invention,
an interferential current system for performing a therapeutic
procedure on a patient includes a controller, a stimulation power
supply in communication with the controller and at least one sensor
providing sensor feedback to the controller, the sensor feedback
indicative of a patient parameter derived from the patient, wherein
the at least one sensor provides sensor feedback to the controller
in real time during the therapeutic procedure. The system also
includes a plurality of electrodes in electrical communication with
the stimulation power supply, the plurality of electrodes disposed
on an epidermis of the patient and arranged to supply
transcutaneous electrical impulses to a therapeutic target area
when supplied power by the stimulation power supply. The plurality
of electrodes comprises at least two electrodes supplying
transcutaneous electrical impulses at two different frequencies,
the transcutaneous electrical impulses provided at two different
frequencies giving rise to at least one beat impulse having an
interference frequency. The transcutaneous electrical impulses are
adjusted automatically and in real time by the controller during
the therapeutic procedure based at least in part upon the sensor
feedback. The controller generates a patient specific model based
at least in part on the sensor feedback, the patient specific model
indicative of at least one of: electrode placement appropriate for
the transcutaneous electrical impulses to reach the therapeutic
target area, appropriate magnitudes of the at least two different
frequencies and an appropriate magnitude of the interference
frequency. The controller updates the patient specific model during
the therapeutic procedure based at least in part upon the sensor
feedback and such other data accumulated over the course of use in
all patients where the system has been used to optimize targeting
based on "big data" accumulation and analysis.
[0016] In accordance with still another aspect of the present
invention, an interferential current system for performing a
therapeutic procedure on a patient includes a controller, a
stimulation power supply in communication with the controller and
at least two or multiple sensors providing sensor feedback to the
controller, the sensor feedback indicative patient parameters
derived from the patient. The at least two or multiple sensors
employ at least two of the following modalities: ultrasound, Level
II ultrasound, 3D ultrasound, 4D ultrasound, trans esophageal
echogram (TEE), x-rays, computed tomography (CT) scanning, magnetic
resonance imaging (MRI) scanning, 3D magnetic resonance imaging
(MRI) scanning, positron emission tomography (PET), radiography,
elastography, plethsmethography, thermography, bone scanning, image
intensification, electroencephalography (EEG), echocardiography
(EKG), nerve conduction tests and electromyograms (NCT and NCV) and
somatosensory evoked potentials (SSEP). The system also includes a
plurality of electrodes in electrical communication with the
stimulation power supply, the plurality of electrodes disposed on
an epidermis of the patient and arranged to supply transcutaneous
electrical impulses to a therapeutic target area when supplied
power by the stimulation power supply. The plurality of electrodes
comprises at least two electrodes supplying transcutaneous
electrical impulses at two different frequencies, the
transcutaneous electrical impulses provided at two different
frequencies giving rise to at least one beat impulse having an
interference frequency. The controller generates a patient specific
model based at least in part on the sensor feedback, the patient
specific model indicative of at least one of: electrode placement
appropriate for the transcutaneous electrical impulses to reach the
therapeutic target area, appropriate magnitudes of the at least two
different frequencies and an appropriate magnitude of the
interference frequency.
[0017] The embodiments as discussed above are illustrative and are
not intended to exhaust all possible arrangements, modifications,
and variations of features of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a block diagram schematically illustrating a basic
device employing interferential current (IFC) therapy together with
targeting capabilities to ensure that the stimulating currents are
directed to the appropriate areas of the body to achieve the
desired results, according to an exemplary embodiment of the
present invention.
[0019] FIG. 2 is schematic view illustrating rudimentary
operational characteristics of the device shown in FIG. 1.
[0020] FIGS. 3A and 3B are schematic views illustrating basic
exemplary options for the placement on a patient of the electrodes
of the device shown in FIG. 1.
[0021] FIG. 4 is a schematic view illustrating an exemplary
targeting scheme employed by the device shown in FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0022] Referring now to the Figures and first to FIG. 1, there is
shown an exemplary embodiment of a device (10) for performing
various therapeutic treatments on a patient (50). The device (10)
includes a controller (12), a stimulation power supply (14) in
communication with the controller (12) and one or more sensors (16)
providing sensor feedback to the controller (12), The device (10)
also includes a plurality of electrodes (18.sup.1,18.sup.2 . . .
18.sup.n) in electrical communication with the stimulation power
supply (14). As will be explained in more detail below, the
controller (12), the stimulation power supply (14) and the
electrodes (18.sup.1,18.sup.2 . . . 18.sup.n) are particularly
configured to employ interferential current (IFC) therapy, while
the controller (12) and the one or more sensors (16) are configured
to provide targeting capabilities to ensure that the stimulating
currents are directed to the appropriate areas of the patient's
body to achieve the desired results.
[0023] The plurality of electrodes (18.sup.1,18.sup.2 . . .
18.sup.n) are disposed on an epidermis (52) of the patient (50) and
are arranged to supply transcutaneous electrical impulses that
cause a variety of reactions, depending upon the targeted area, as
explained in more detail below. Various options are possible for
electrode (18.sup.1,18.sup.2 . . . 18.sup.n) placement, as well as
types of electrodes used, also as is explained in more detail
below.
[0024] The controller (12) causes the stimulation power supply (14)
to supply power to the plurality of electrodes (18.sup.1,18.sup.2 .
. . 18.sup.n) according to a programmed set of parameters, again
depending on the targeted area and the desired response to be
elicited.
[0025] The device (10) also includes an input mechanism (20) (such
as a keyboard, touchscreen, joystick or the like) as is known in
the art, which allows the user to enter control parameters and the
like. As but one example, input mechanism (20) may include a button
or other type of controller to turn the device on or off manually,
or to trigger the stimulation power supply (14). This may be
particularly desirable, for example, when the device (10) is used
in connection with causing certain desired responses intended to be
performed on-demand by the patient. Another example allowing
greater flexibility and ease of use is based on a mobile device
(such as a cellphone) or mobile device (e.g., cellphone) app. Such
an app might also have the ability to notify a patient or a
healthcare provider that the sensors are accumulating data
indicating that at a specific time the user has to activate the IFC
device as in an alarm for manual use by the user. Similarly, such a
program could automatically turn on the device at a specific time
for a specific reason without any input from the person being
treated.
[0026] Also as is well known in the art, the device (10) includes a
display (22) to provide visual and/or auditory output to the
patient and/or another user of the device (10) (e.g., a medical
professional). The display (22) may also present the patient/user
with other helpful information. For example, the device (10) may be
linked to a mapping app on a mobile device (such as Google maps or
Waze) in order to display or otherwise provide information
concerning appropriate healthcare or other public facilities.
[0027] In some embodiments the system further includes the ability
to transmit information and data obtained via the Internet or other
mechanism to remote or off site locations for consultation or
expert input, interpretation, and monitoring of data garnered
during or after the procedure, or for incorporation into electronic
medical records (EMRs), or for telehealth applications.
[0028] The device may further include an antenna (28) or the like
(such as Bluetooth functionality) in order to provide connectivity
to a mobile network or direct connectivity to a mobile phone,
computerized fitness tracker, smart watch, etc. The antenna (28) or
the like may also be used to provide wireless connectivity for the
sensor(s) (16) rather than employing a wired connection.
[0029] The device (10) further includes a memory (24), which allows
the device to store various parameters that may be employed by the
controller (12).
[0030] The controller (12), stimulation power supply (14), input
mechanism (20), display (22), memory (24) and antenna (28) may be
contained in a housing (26), as should be apparent to those skilled
in the art. Various types of connectors may be provided on the
housing to allow for connection of the electrodes
(18.sup.1,18.sup.2 . . . 18.sup.n), the sensor (16), or various
other devices (e.g., mobile phones, tablets, smart watches, etc.)
also as should be apparent to those skilled in the art.
[0031] As discussed above, the present invention is particularly
adapted to employ interferential current (IFC) technology. Also as
discussed above IFC therapy generally utilizes two medium frequency
currents which pass through the tissues simultaneously. They are
set up so that their paths cross; and in simple terms they
interfere with each other. This interference gives rise to an
interference or beat frequency, which has the characteristics of
low-frequency stimulation. The exact frequency of the resultant
beat frequency can be controlled by the input frequencies. For
example, if one current is at about 4000 Hz and the other current
is at about 3900 Hz, the resultant beat frequency would be at about
100 Hz.
[0032] Referring now to FIG. 2, an exemplary arrangement of
electrodes employing IFC therapy is shown applied to the epidermis
(52) of a patient (50). In this example, a first pair of electrodes
(18.sup.1, 18.sup.2) supplies transcutaneous electrical impulses at
a first frequency (represented by solid lines) and a second pair of
electrodes (18.sup.3, 18.sup.4) supplies transcutaneous electrical
impulses at a second frequency (represented by dashed lines)
different than the first frequency. The transcutaneous electrical
impulses provided at the first and second frequencies giving rise
to a beat impulse in a therapeutic target area (located at the
position shown in FIG. 2 where the area defined by solid lines and
the area defined by dashed lines overlap, as highlighted with
vertical cross-hatching) having an interference frequency.
[0033] The beat impulse is controlled depending on the type of
nerve/tissue/organ to be stimulated, as well as on real-time
feedback of the elicited response (as explained in more detail
below). For example, it has been found that beat impulses having a
frequency in the range of from 1-5 Hz may provide desirable
stimulation properties for sympathetic nerves, beat impulses having
a frequency in the range of from 10-150 Hz may provide desirable
stimulation properties for parasympathetic nerves, beat impulses
having a frequency in the range of from 10-50 Hz may provide
desirable stimulation properties for motor nerves, beat impulses
having a frequency in the range of from 90-100 Hz may provide
desirable stimulation properties for sensory nerves, beat impulses
having a frequency in the range of from 90-150 Hz may provide
desirable stimulation properties for nociceptive fibers, and beat
impulses having a frequency in the range of from 1-10 Hz may
provide desirable stimulation properties for smooth muscle. As will
be recognized, other types of nerves/tissues/organs may respond to
other beat impulse frequencies.
[0034] Turning now to FIGS. 3A and 3B, an exemplary positioning of
electrodes (18.sup.1 and 18.sup.2) on the patient (50) is shown. In
this exemplary embodiment, a first electrode (18.sup.1) supplies
transcutaneous electrical impulses at a first frequency and a
second electrode (18.sup.2) supplies transcutaneous electrical
impulses at a second frequency different than the first frequency,
the transcutaneous electrical impulses provided at the first and
second frequencies giving rise to a first beat impulse having a
first interference frequency. The first and second electrodes
(18.sup.1,18.sup.2) are positioned such that the therapeutic target
area thereof is positioned to cause stimulation of a first desired
nerve/tissue/organ with the first beat impulse having the first
interference frequency as is explained in more detail below.
[0035] With respect specifically to FIG. 3B, a third electrode
(18.sup.3) supplies transcutaneous electrical impulses at a third
frequency and a fourth electrode (18.sup.4) supplies transcutaneous
electrical impulses at a fourth frequency different than the third
frequency, the transcutaneous electrical impulses provided at the
third and fourth frequencies giving rise to a second beat impulse
having a second interference frequency. The third and fourth
electrodes (18.sup.3,18.sup.4) are positioned such the therapeutic
target area thereof is positioned to cause stimulation of a second
desired nerve/tissue/organ with the second beat impulse having the
second interference frequency as is explained in more detail
below.
[0036] As will be understood by those skilled in the art,
additional pairs of electrodes may be employed to produce
additional beat impulses at the same or different beat frequencies
as those described above, depending on the particular application
of the device (10).
[0037] Each of the first pair of electrodes (18.sup.1, 18.sup.2)
may be formed as a separate pad, or as illustrated in FIG. 3A, both
electrodes (18.sup.1, 18.sup.2) may be disposed on a common pad
(30) for ease of placement on the patient (50). In the example of
FIG. 3A, the sensor (16) is also disposed on the same pad (30) for
further ease of placement.
[0038] In the exemplary embodiment of FIG. 3B, both of the first
pair of electrodes (18.sup.1, 18.sup.2) are disposed on a common
pad (30') and both of the second pair of electrodes (18.sup.3,
18.sup.4) are disposed on another common pad (30') for ease of
placement on the patient (50). In the example of FIG. 3B, however,
the sensor (16) is disposed separately from the electrode carrying
pads (30').
[0039] The pads (30,30'') and/or the electrodes (18) may take any
of numerous forms. In some cases, the pads/electrodes may be formed
with an adhesive on one side, such that the pads/electrodes can be
affixed to the patient's skin. If desired, the pads/electrodes can
be incorporated into or onto to an article of clothing (e.g., a
glove or a sock), a surgical drape or the like, a medical device,
such as a splint, cast or other immobilization device, a
wheelchair, a hospital bed, etc. The pads/electrodes can also take
the form of a thin, flexible electrical circuit, such as in the
nature of a temporary tattoo formed of an electrically conductive
material.
[0040] Referring now to FIG. 4, a targeting aspect of the present
invention is schematically shown. In general, medical procedures
are highly interactive processes, and many critical decisions are
made during the procedure and executed immediately. The goal of the
targeting aspect of the present invention is to provide
intelligent, versatile tools that augment the medical
professional's ability to treat patients, both prior to and during
the procedure.
[0041] As can be seen, the targeting system (100) shown in FIG. 4
can be broken down into three main stages: pre-procedure (102),
intra-procedure (104) and post-procedure (106). A key aspect of all
three stages is imaging/sensor data (110) collected from the
patient (50), for example using the one or more sensors (16).
[0042] The types of imaging/sensor data (110) can vary greatly,
depending on the particular nerves/tissues/organs to be stimulated,
and the manner in which they are intended to be stimulated. In this
regard, it is contemplated that the device (10) of the present
invention can be used in connection with numerous applications
involving various biological systems.
[0043] For example, device (10) can be used for the purposes of
assisting a patient suffering from a condition that inhibits the
patient from achieving spontaneous and controlled micturition, as
described in more detail in copending U.S. patent application Ser.
No. 15/951,318, filed by applicant of the present application.
Other examples of contemplated applications for the device (10)
according to the present invention include: erectile dysfunction;
various cardiac issues (e.g., cardiac arrhythmias, congestive heart
failure, cardiomyopathies); various neurological issues (e.g.,
traumatic brain injury, deep brain stimulation, Parkinson's
disease, Alzheimer's disease, concussion, multiple sclerosis,
failed back syndrome/arachnoiditis); various OB/GYN issues,
including better control of menstrual pain, bleeding and cramps,
and inducing and controlling labor; control of bleeding and/or
reducing edema, for example during surgery or after a trauma;
various gastrointestinal issues (e.g., ileus--post op or having
other causes, stimulating a sense of satiety as an alternative to
bariatric surgery and gastric banding, bile duct and/or pancreatic
duct sphincter control, gall bladder contraction); various
orthopedic and musculoskeletal issues (e.g., muscle stimulation for
post-op joint replacement rehab, fracture care, sports
medicine-athletic injuries, traumatic injury, robotic control
utilizing feedback from muscle stimulation, activation and
deactivation for mechanical parts such as amputation prostheses and
mechanical devices to aide in mobilization of paralysis or spinal
cord injuries); and various other conditions that may benefit from
IFC therapy.
[0044] As will be recognized by those skilled in the art, different
types of imaging/sensor data (110) will be relevant for different
of the above examples, depending on the particular application in
question, with there being many known and yet to be developed
diagnostic modalities that may be appropriate.
[0045] For example, many imaging modalities are known that would be
appropriate to collect imaging sensor data (110), including
ultrasound (including Level II ultrasound, 3D ultrasound, 4D
ultrasound, etc.), trans esophageal echogram (TEE), x-rays,
computed tomography (CT) scanning, magnetic resonance imaging MRI
scanning (3D or otherwise), positron emission tomography (PET),
radiography, elastography, thermography, bone scanning, etc. More
advanced imaging techniques involving combinations of various
modalities may also be used, such as MRI-TRUS (magnetic resonance
imaging/transrectal ultrasound) fusion, which has been used to
perform targeted prostate biopsies.
[0046] The imaging modalities used may be static, or dynamic. In
addition, various functional modalities may be employed, such as
Doppler ultrasound to evaluate blood flow or other forms of
plethsmethography (which is measurement of blood flow dynamics) or
various functional neuroimaging techniques to evaluate brain
activity. Image intensification is another diagnostic modality that
can be used, which affords x-ray assessment in real time with
motion as in some of the ultrasound options. This can be important
during procedures such as cardiac catheterizations.
[0047] Additionally, various other types of electrical sensor data
may be used to assist with targeting of the IFC currents. For
example, electroencephalography (EEG) may be employed for
applications involving the brain, while echocardiography (EKG) may
be employed for applications involving the heart. Nerve conduction
tests and electromyograms (NCT and NCV) and somatosensory evoked
potentials (SSEP) may also be employed.
[0048] The sensor(s) may be integrated with a robotics device,
machine, or algorithm. Examples of this would be surgical robotics
machines made by MAKO Surgical, Intuitive Surgical, and Restoration
Robotics which respectively are used for surgically-assisted
operations in terms of joint replacements, robotic abdominal
surgery, robotic placement of hair transplant follicles, and
robotic assisted prostate surgery. Rather than using robotics to
aid surgeons, the robotics technology can be combined with IFC to
give extremely accurate microscopic and larger field targeting
through the IFC.
[0049] In fact, the robotics could be combined with IFC such that
an individual could do essentially "IFC robotic surgery" in which
the robotic assisted mechanism not only targets the area through
robotic anatomic analysis, but also then the robotic arms
controlled by the surgeon would place the appropriate
interferential electrodes on the skin and, through the connecting
robotic arm also supply the appropriate electric current with
feedback through the robotic surgery targeting technology and
device.
[0050] Instead or in addition, the sensor(s) may be integrated with
a cellphone or other mobile device as the coordinating interface.
This is envisioned as incorporating current cellphone apps that
actually provide handheld diagnostic ultrasounds using either the
cellphone camera mechanism or a program using the cellphone's
screen. For example, there are cellphone apps currently being used
by women to view their fetus at any time during pregnancy as
opposed to having an actual formal ultrasound. This type of mobile
targeting device could, in the clinical setting, be easier to use
than the currently employed bladder scanner ultrasound machine.
Using such a cellphone app would include wireless transmission of
the electrical impulses to the electrodes, or could even include a
transducer connected to wires, which then plug into a port in
either a computer or the cellphone, similar to the way music
earplugs now transmit music from a cellphone either through wires,
or wireless headphones.
[0051] It should also be recognized that a combination of two or
more of the above described, and/or other, techniques may be
employed to collect the imaging/sensor data (110) employed by the
targeting system (100).
[0052] Turning again to FIG. 4, imaging/sensor data (110) is used
in the pre-procedure stage (102) to generate a patient specific
model (at 120), such as a three-dimensional model of the patent's
anatomy. Of particular importance is locating on the model the one
or more therapeutic target areas of the patient to be targeted with
the IFC. This model is then used with other data in the memory (24)
of device (10) to generate a computer assisted plan (at 122),
including the location for initial placement of the electrodes
(18), as well as data indicative of the frequencies of the
interferential currents to be generated to create the beat
impulse(s) having the interference frequency/frequencies desired
for the particular application.
[0053] The electrodes (18) are positioned according to the computer
assisted plan (122), and the IFC therapy procedure may be
commenced. During the intra-procedure stage (104), additional
imaging/sensor data (110) may continue to be collected from the
patient (50), which data (110) may be used to update the patient
specific model (at 130), for example, if changes to the patient's
anatomy occur, and to update the computer assisted plan (at 132).
For example, it may be determined that one or more of the
electrodes (18) should be repositioned and/or that the frequencies
of the interferential currents require adjustment so that the
frequencies of the resulting beat impulse(s) are correspondingly
adjusted.
[0054] Also, during the intra-procedure stage (104), computer
assisted execution of the plan may be performed (at 134), for
example, by the controller (12). Such execution may be performed
automatically, manually in response to user input or automatically
in part and manually in part. For example, the controller (12) may
increase and/or decrease the frequencies of the resulting beat
impulses automatically in real time in response to sensed
conditions. It may also control the robotics previously mentioned,
and it would be in communication with those targeting
algorithms.
[0055] After the procedure is completed, in a post-procedure stage
(106), imaging/sensor data (110) may continue to be collected, and
then a computer assisted assessment may be performed (at 140) in
order to generate data concerning the impact of the procedure on
the patient (50). This data, which may be stored in a database
(142) may be used in order to help with planning future procedures
for the same patient (50) or with other patients, for example who
will undergo similar procedures. For example, the data may be
helpful in generating the computer assisted plan (122).
[0056] The data can be connected to and used with telehealth,
electronic medical record (EMR), and offsite doctor transmission
and analysis programs as part of the integration with advanced
computer algorithms and trends in medical care.
[0057] Although the invention has been described with reference to
particular arrangement of parts, features, and the like, these are
not intended to exhaust all possible arrangements or features, and
indeed many modifications and variations will be ascertainable to
those of skill in the art.
[0058] For example, the present invention is designed so that any
imaging/sensor modalities that are available but have not been
incorporated into the description of the invention, or that become
available as technology advances, are considered part of the
invention and incorporated by modifying the electrical and
mechanical parts and protocols associated with them to achieve the
aims of the present invention.
* * * * *