U.S. patent application number 14/563320 was filed with the patent office on 2015-07-02 for motorized functional electrical stimulation step and stand trainer.
The applicant listed for this patent is RESTORATIVE THERAPIES, INC.. Invention is credited to Andrew Barriskill, Scott Simcox.
Application Number | 20150182784 14/563320 |
Document ID | / |
Family ID | 47744683 |
Filed Date | 2015-07-02 |
United States Patent
Application |
20150182784 |
Kind Code |
A1 |
Barriskill; Andrew ; et
al. |
July 2, 2015 |
Motorized Functional Electrical Stimulation Step and Stand
Trainer
Abstract
A functional electrical stimulation step and stand system
comprising two footplates (left and right) connected to a primary
drive motor that cause the footplates to move in a reciprocal
motion. The footplates are further connected to corresponding
servos, which allow for control of the movement of the footplate
with respect to an axis. System comprises an electrical stimulation
control unit. The stimulation step and stand system further
comprises a control unit that has electrical stimulation leads
connected to electrode that deliver an electrical impulse to a
patient's muscles. In a further embodiment, the control unit has
one or more wireless stimulators.
Inventors: |
Barriskill; Andrew;
(Baltimore, MD) ; Simcox; Scott; (Baltimore,
MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RESTORATIVE THERAPIES, INC. |
Baltimore |
MD |
US |
|
|
Family ID: |
47744683 |
Appl. No.: |
14/563320 |
Filed: |
December 8, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13219610 |
Aug 27, 2011 |
8905951 |
|
|
14563320 |
|
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Current U.S.
Class: |
607/3 |
Current CPC
Class: |
A63B 2071/0081 20130101;
A61N 1/36003 20130101; A63B 21/00178 20130101; A61H 2230/805
20130101; A63B 22/0664 20130101; A63B 21/0058 20130101; A61H
23/0254 20130101; A61N 1/0452 20130101; A61H 2201/1621 20130101;
A61H 2201/164 20130101; A61N 1/3603 20170801; A63B 2022/067
20130101; A61H 1/0262 20130101; A63B 2213/004 20130101; A63B
2230/015 20130101; A61H 2203/0406 20130101; A63B 22/0605 20130101;
A63B 69/0064 20130101; A61H 1/0229 20130101 |
International
Class: |
A63B 22/06 20060101
A63B022/06; A61N 1/36 20060101 A61N001/36 |
Claims
1. A functional electrical stimulation step and stand system,
comprising: a left footplate and a right footplate, wherein both
left and right footplates are connected to a primary drive motor
that causes the footplates to move in a reciprocal motion; said
left footplate further connected to a left servo motor and said
right footplate connected to a right servo motor, wherein each of
said right and left servo motors causes its respective footplate to
rotate about an axis; a control unit connected to the left and
right servo motors and which controls the actuation of the left and
right servo motors, wherein the control unit further comprises
functional electrical stimulation leads attached to skin adhesive
electrodes and wherein said adhesive electrodes deliver electrical
stimulation to a patient's muscles; and a hoist capable of
connecting to a harness and holding a patient in an upright
position when in use, wherein said hoist is configured to provide
weight control measurements to the control unit.
2. The functional electrical stimulation step and stand system
recited in claim 1, further comprising two drive arms connecting
said primary drive motor to each of said left and right footplates,
wherein said drive arms comprise various attachment points for
connecting to corresponding right and left cranks at different
attachment points.
3. The functional electrical stimulation step and stand system
recited in claim 2, wherein the footplates are attached to the
drive arms by the corresponding left and a right cranks.
4. The functional electrical stimulation step and stand system
recited in claim 2, wherein attachment of said drive arms at one of
said attachment positions results in a step length based on the
attachment point.
5. The functional electrical stimulation step and stand system
recited in claim 4, wherein one of the attachment positions results
in the footplates being parallel to each other facilitating the
patient's standing position.
6. The functional electrical stimulation step and stand system
recited in claim 1 wherein the footplate servo motors are
configured to cause their respective footplate to vibrate.
7. The functional electrical stimulation step and stand system
recited in claim 1, wherein the control unit is configured to
assists foot movement being evoked volitionally or
electrically.
8. The functional electrical stimulation step and stand system
recited in claim 1, wherein the control unit is configured to
resist foot movement.
9. The functional electrical stimulation step and stand system
recited in claim 1, wherein said control unit further comprises an
additional one or more wired or wireless multi or single channel
stimulators.
10. The functional electrical stimulation step and stand system
recited in claim 1, wherein said control unit further comprises up
to ten single channel stimulation channels.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 13/219,641, filed Aug. 27, 2011, the
specification of which is incorporated herein by reference in its
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a training device for
rehabilitation of individuals suffering from neurological injuries.
More particularly, the present invention relates to a device that
utilizes both mechanical and electrical stimulation of individual's
muscles.
[0004] 2. Description of the Background
[0005] The recovery of walking is one of the main goals of patients
after a neurological impairment (including stroke, multiple
sclerosis, cerebral palsy and spinal cord injury (SCI)) as
limitations in mobility can adversely affect most activities of
daily living. Following a neurological injury, there is often
impaired control of balance, paralysis, or weakness of lower
extremity muscles including commonly those that activate the ankle
This often has a substantial adverse impact on walking.
Specifically, individuals may suffer difficulties supporting their
body weight during the stance phase, or shifting weight during the
transition to swing, or lifting their foot for toe clearance during
the swing phase due to the weakness associated with the injury.
Gait training can be done [0006] i. with therapist-assisted over
ground ambulation (with or without assistive device) [0007] ii. in
a Body Weight Supported Treadmill Training (BWSTT) environment,
where assistance for the movement of legs and the pelvis is
provided manually by a therapist or [0008] iii. by a robotic device
(Lokomat, Auto-Ambulator or Gait Trainer), or in water (weight
supported environment, with or without a treadmill). Over ground
gait training (with or without a Functional Electrical Stimulation
(FES) orthosis) can only be used for individuals with already able
to support body weight in an upright position.
[0009] BWSTT, robotic device gait training and aquatherapy gait
training (training in water) can potentially be used to enhance
loco-motor abilities in neurologically impaired individuals, as
lack of trunk balance and ability to bear weight in an upright
position are replaced by the supporting abilities of the device or
environment used (harness, exoskeleton or water). But they are not
typically used in clinical practice to aid in locomotor training in
individuals with motor complete impairments as this training would
need specialized, center based, expensive environment (i.e.
therapeutic pool, robotic exoskeleton) or is very labor intensive
(sometimes requiring 2-3 therapists' sustained effort over long
periods of time).
[0010] BWSTT with manual or robotic assistance of the legs and the
pelvis has been used as a promising rehabilitation method designed
to improve motor function and ambulation in people with SCI
(Behrman and Harkema 2000; Dietz et al. 1995;Wernig and Muller
1992; Wirz et al. 2005; Dobkin et al. 2006; Field-Fote et al.
2005). However, while BWSTT has been shown to provide improvements
in locomotor ability, motor function, and balance for some
patients, the current technology used to assist with the training
is typically very expensive, requires trained therapists for
utilization and can only be used in a rehabilitation center.
Several robotic BWSTT systems have been developed for automating
locomotor training, including the Lokomat (Colomboet al. 2000) and
Gait Trainer (GT) (Hesse and Uhlenbrock 2000).
[0011] The Lokomat is a motorized exoskeleton that drives hip and
knee motion with fixed trajectory using four DC motors (Colombo et
al. 2000). One limitation is that it is difficult to back drive the
Lokomat because it uses high advantage, ball screw actuator. The GT
rigidly drives the patient's feet through a stepping motion using a
crank-and-rocker mechanism attached to foot platforms (Hesse and
Uhlenbrock 2000). These robotic systems have their basic design
goal to assist patients in producing correctly shaped and timed
locomotor movements. This approach is effective in reducing
therapist labor in locomotor training and increasing the total
duration of training, but shows relatively limited functional gains
for some patients (Wirz et al. 2005; Field-Fote et al. 2005). For
instance, only 0.11 m/s gait speed improvement is obtained
following prolonged training using the Lokomat (Wirz et al.
2005).
[0012] FES has been previously used to enhance the quality of gait
training whether as an assistive device (FES orthosis for foot
drop) or to enhance muscle strength and improve cardiovascular
resistance (FES ergometer), thus decreasing gait induced fatigue.
FES has also been used extensively in the rehabilitation of
individuals with SCI to: [0013] i. improve muscle mass and strength
(Frotzler A, Coupaud S, Perret C, Kakebeeke T H, Hunt K J, Eser P.
Effect of detraining on bone and muscle tissue in subjects with
chronic spinal cord injury after a period of
electrically-stimulated cycling: a small cohort study. Swiss
Paraplegic Research, Nottwil, Switzerland; Thomas Mohr, Jesper L
Andersen, Fin Biering-S rensen, Henrik Galbo, Jens Bangsbo, Aase
Wagner and Michael Kjaer. Long term adaptation to electrically
induced cycle training in severe spinal cord injured individuals.
Spinal Cord (1997) 35, 1.+-.16) [0014] ii. control spasticity
(Maria Knikou, PhD, and Bernard A. Conway, PhD. Reflex Effects Of
Induced Muscle Contraction In Normal And Spinal Cord Injured
Subjects. Muscle Nerve 26: 374-382, 2002; Daly J., et al.
Therapeutic neural effects of electrical stimulation. IEEE Trans
Rehabil Eng 4:218-230, 1996; Robinson C. J., et al. Spasticity in
Spinal-Cord Injured Patients .1. Short-Term Effects of Surface
Electrical-Stimulation. Arch Phys Med Rehab 69:598-604, 1988)
[0015] iii. improve cardiovascular endurance and respiratory
function (Puran D Faghri, Roger M Glaser, Stephen F Figoni.
Functional Electrical Stimulation Leg Cycle Ergometer Exercise:
Training Effects on Carriorespiratory Responses of Spinal Cord
Injured Subjects at Rest and During Submaximal Exercise. Arch Phys
Med Rehabil 73:1085-1093) [0016] iv improve bone mass (Belanger M,
Stein RB, Wheeler GD, Gordon T, Leduc B. Electrical stimulation:
can it increase muscle strength and reverse osteopenia in spinal
cord injured individuals? Arch Phys Med Rehabil 2000;
81(8):1090-1098; McDonald J W, Becker D, Sadowsky C L, Jane J A,
Sr., Conturo T E, Schultz L M. Late recovery following spinal cord
injury. Case report and review of the literature. J Neurosurg 2002;
97(2 Suppl):252-265) and [0017] v. improve body composition (L.
Griffin, M. J. Decker, J. Y. Hwang, B. Wang, K. Kitchen, Z. Ding,
J. L. Ivy. Functional electrical stimulation cycling improves body
composition, metabolic and neural factors in persons with spinal
cord injury. J Electromyography and Kinesiol 2008: 1-8).
[0018] FES has been postulated to even alter neuronal control,
altering central nervous system plasticity and improving functional
tasks performance (Richard K. Shields and Shauna Dudley-Javoroski.
Musculoskeletal Plasticity After Acute Spinal Cord Injury: Effects
of Long-Term Neuromuscular Electrical Stimulation Training J
Neurophysiol 95: 2380-2390, 2006).
[0019] Combining gait training with FES activation of selected
muscles involved in stepping has been already achieved and there
are several commercially available FES driven orthosis for
utilization in individuals with SCI, mainly to correct foot drop
(Bioness L300, Walk Aid). In addition, in clinical practice,
therapists are frequently utilizing hand held triggered
neuromuscular electrically stimulated (NMES) devices to aid in
foot/toe clearing during the swing phase of the gait when working
with individuals with neurologic lower limb weakness.
SUMMARY OF THE INVENTION
[0020] One object of the present invention is to provide a
functional electrical stimulation step and stand system comprising
two footplates (left and right) connected to a primary drive motor
that cause the footplates to move in a reciprocal motion. The
footplates are further connected to corresponding servos, which
allow for control of the movement of the footplate with respect to
an axis. The ability to control the movement of the footplate is
defined as the firmness of the footplate.
[0021] In a further object of the present invention, the system
comprises an control unit that manages a computer and a six channel
stimulator. The control unit has electrical stimulation leads that
connect to electrodes that deliver an electrical impulse to a
patient's muscles. In a further embodiment, the control unit has
one or more wireless stimulators.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The above and other features, aspects, and advantages of the
present invention are considered in more detail, in relation to the
following description of embodiments thereof shown in the
accompanying drawings, in which:
[0023] FIG. 1 is a picture of a device in accordance with one
embodiment of the invention.
[0024] FIG. 2 is a graphical representation of a stepper assembly
in accordance with one embodiment of the present invention.
[0025] FIG. 3 is a graphical representation of the stepper assembly
in the standing position.
[0026] FIG. 4 is a perspective view of the stepper assembly.
[0027] FIG. 5 is a detailed view of the foot plate.
[0028] FIG. 6 is a detailed view of the foot plate with the servo
plate removed.
[0029] FIG. 7 is a detailed view of the foot plate showing the
servo drive belt.
[0030] FIG. 8 is a graphical representation of the control
unit.
[0031] FIG. 9 is a front view of the patient hoist.
[0032] FIG. 10 is a front view of the harness.
[0033] FIG. 11 is a graph showing the displacement of the pedals
with and without servo input.
[0034] FIG. 12 is a graph that shows the various positions of the
servo can be commanded.
[0035] FIG. 13 is a graph that shows the result of commanding the
servo to move the foot plate for a normal gait.
DETAILED DESCRIPTION
[0036] The invention summarized above may be better understood by
referring to the following description, the accompanying drawings,
and the claims listed below. This description of an embodiment, set
out below to enable one to practice an implementation of the
invention, is not intended to limit the preferred embodiment, but
to serve as a particular example thereof. Those skilled in the art
should appreciate that they may readily use the conception and
specific embodiments disclosed as a basis for modifying or
designing other methods and systems for carrying out the same
purposes of the present invention. Those skilled in the art should
also realize that such equivalent assemblies do not depart from the
spirit and scope of the invention in its broadest form.
[0037] As shown in FIG. 1, one embodiment of the invention is a
trainer 100 that combines a robotic device that simulates stepping
and standing with FES while the individual 110 is safely supported
in a harness 120. This design has the potential to tap into
neuro-plasticity driven loco-motor patterning while increasing
muscle strength and cardiovascular endurance and be safely applied
in a center or home-based environment.
[0038] The motion of the individual's feet is controlled by a foot
assembly 200 as shown in FIG. 2. The foot assembly 200 (also
referred to as the stepper assembly) incorporates three motors. The
primary drive motor 210 provides for transverse motion of foot
plates 220 while a servo 230 built into both the left and right
footplate 220 allow the software to independently control the
motion of the foot about the ankle in the sagittal plane. This
control can either assist the foot movement being evoked
volitionally or electrically or it can resist such movement.
[0039] In one further embodiment of the present invention, a stand
training mode allows the foot plates to be brought together helping
the individual patient to develop standing skills utilizing a
combination of electrically evoked peripheral muscle contractions
or volitional and or electrically evoked centrally driven muscle
contractions. In this mode the footplate servos 230 can be used to
induce perturbations, which the individual can train to
counteract.
[0040] The motors controlling each footplate 220 can also be
commanded to produce a vibration motion of the footplates in the
sagittal plane either during standing or stepping motions. This
vibration can be used to deliver therapeutic benefits including the
reduction of spasticity. FES driven gait training utilizing the
training device 100 will be safe for both motor complete and
incomplete neurologically impaired individuals. In addition, the
training device 100 can increase the walking abilities of
individuals with many types of neurological impairments. Given this
the training device 100 can be safely used in a home based
environment to perform long term gait training in individuals with
varying degrees of neurological related paralysis.
[0041] As shown in FIG. 1, training device 100 is composed of a
stepper assembly 200, a control unit 130, and a patient hoist 150
and harness 120. The stepper assembly 200, as shown in FIG. 2, has
a drive motor 210 connected to the drive assembly 250. The drive
assembly 250 is connected to the foot plates 220 by cranks 260
(left and right respectively) through a drive arm 280. The cranks
220 are connected to the drive arm 280 at different positions 270
and held in place by a magnet. The positions 270 determine the step
lengths for the foot plates 220. In one particular embodiment, the
drive arm 280 has three positions 270 resulting in 18'', 15'', and
12'' steps. An additional position 290 brings the footplates 220
together proving a standing position to the individual, as shown in
FIG. 3.
[0042] As shown in FIG. 4, the stepper assembly 200 further
comprises an emergency stop 277 that allows a technician to stop
the drive assembly 250 from moving the foot plates 220. FIG. 5
shows a close up view of the right side foot plate 220 and servo
230. In FIG. 6, the servo cover 600 has been removed and the servo
230 is shown. FIG. 7 shows a view of the footplate from the
opposite side than that shown in FIG. 6. The servo 230 motor
connects to a drive belt 700 that controls the foot plate 220. The
servo 230 connects to a pulley 745 through the drive belt 700. When
the servo motor actuates the belt 700, the pulley 745 turns around
the axis 730 causing the footplate to rotate about the axis 730.
Left unpowered, each footplate moves through a range of plantar and
dorsi flexion movement that is a natural product of the transverse
motion.
[0043] In one particular embodiment, the trainer 100 has a control
unit 130, as shown in FIG. 8, which includes a computer and a 6
channel stimulator. The stimulator produces the functional
electrical stimulation to evoke muscle contractions. The computer
controls the operation of the stimulator, the drive motor 210 and
the two footplate servos 230. Software controlling the servo motors
which power the left and right footplates can be used to guide a
patient's foot through a normal range of motion in the sagittal
plane during stepping training.
[0044] When in use, the trainer 100 can be utilized to track the
appropriate travel of the individual's feet. FIG. 11 is a graph
that shows how the footplate pedal moves with respect to gravity
when unpowered (pedal trace) compared with how the ankle of an able
bodied individual moves when stepping (target pedal trace) vs.
percentage of phase of the gait cycle.
[0045] Furthermore, in FIG. 12 shows one way in which a footplate
servo motor may be commanded to make the footplate's position
coincident with normal gait. For example, commanding the motor to
move 2452 positions results in a 1 degree movement of the
footplate. Superimposing this motor driven footplate movement with
the unpowered footplate movement that arises from the transverse
motion brings the footplate motion (corrected pedal trace)
coincident with the ankle movement of normal gait (target pedal
trace) vs. percent of the gait cycle as shown in FIG. 13.
[0046] Producing this normal ankle movement on this trainer 100 is
one of the possible uses of the footplate servo motors. In one
exemplary embodiment, the motors are also be used to produce
vibration while standing or an exaggerated ankle motion for motor
skill relearning purposes or a reduced ankle motion to accommodate
patients with reduced range of motion in one or both ankle joints.
In one exemplary embodiment, software varies the current supplied
to each footplate servo which has the effect of varying the
firmness of the footplate. Footplate firmness can be varied during
a therapy session for example to gradually overcome plantar flexion
muscle tone.
[0047] In one embodiment of the present invention, the control unit
130 provides up to 10 channels of electrical. It is contemplated
that any number of channels may be utilized to provide electrical
stimulation. In one alternative embodiment, the control unit 130
further includes a 6 channel electrical stimulator and a BlueTooth
communications link that allows it to control up to four additional
single channel stimulators.
[0048] The muscle groups to be stimulated are selected based upon
how the patient presents. For example a hemiparetic patient may
only require muscles on one side to be electrically stimulated.
[0049] Our invention allows the following muscle groups to be
selected for electrical stimulation each either bilaterally or
unilaterally: [0050] Gluteals [0051] Quadriceps [0052] Hamstrings
[0053] Gastrocnemius [0054] Anterior tibialis [0055] Erector spinae
[0056] Abdominals The electrical stimulation is delivered to each
muscle group via adhesive skin surface electrodes at the
appropriate time in the gait cycle as determined by the position of
drive arms in their circular path.
[0057] A further embodiment of the invention allows the electrical
stimulation angles to be adjusted. The following is a table of
default angles that can be provided in one particular embodiment of
the present invention. The 0 degree position is the left drive arm
at top dead center.
TABLE-US-00001 Muscle group Stimulation on angle Stimulation off
angle Left quadriceps 50 285 Right quadriceps 230 105 Left
hamstring 235 70 Right hamstring 55 250 Left gluteal 90 245 Right
gluteal 270 65 Left gastroc 235 70 Right gastroc 55 250 Left
anterior tibialis 50 285 Right tibialis 230 105 Left abdominal 340
180 Right abdominal 160 359 Left erector spinae 190 290 Right
erector spinae 10 110
[0058] The invention has been described with references to a
preferred embodiment. While specific values, relationships,
materials and steps have been set forth for purposes of describing
concepts of the invention, it will be appreciated by persons
skilled in the art that numerous variations and/or modifications
may be made to the invention as shown in the specific embodiments
without departing from the spirit or scope of the basic concepts
and operating principles of the invention as broadly described. It
should be recognized that, in the light of the above teachings,
those skilled in the art can modify those specifics without
departing from the invention taught herein. Having now fully set
forth the preferred embodiments and certain modifications of the
concept underlying the present invention, various other embodiments
as well as certain variations and modifications of the embodiments
herein shown and described will obviously occur to those skilled in
the art upon becoming familiar with such underlying concept. It is
intended to include all such modifications, alternatives and other
embodiments insofar as they come within the scope of the appended
claims or equivalents thereof. It should be understood, therefore,
that the invention may be practiced otherwise than as specifically
set forth herein. Consequently, the present embodiments are to be
considered in all respects as illustrative and not restrictive.
* * * * *