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|United States Patent Application
Stark, John G.
;   et al.
September 6, 2001
Instrumented accelerometers for patient monitoring
Exercise orthoses are described that include a frame, a fluid bladder held
by the frame, a pressure sensor attached to the fluid bladder and a
microprocessor receiving the pressure measurements. The microprocessor
monitors variations in pressure and determines differences between the
measured pressures and predetermined target values. The frame can be
designed to support a hinge joint or at least one vertebra. Furthermore,
corrective back orthoses are described that include a frame, force
applicators connected to the frame to apply force to the patient's spine,
a sensor that measures forces associated with the force Applicators and a
control unit that monitors forces measured by the sensor. The corrective
back orthosis can include fluid bladders as force applicators. The
control unit can include a microprocessor.
Stark, John G.; (Deephaven, MN)
; Oyen, Duane P.; (Maple Grove, MN)
Peter S. Dardi, Ph.D.
WESTMAN CHAMPLIN & KELLY
International Centre, Suite 1600
900 South Second Avenue
April 10, 2001|
|Current U.S. Class:
||602/13; 602/19; 602/26 |
|Class at Publication:
||602/13; 602/26; 602/19 |
What is claimed is:
1. An orthopedic device comprising: (a) a frame that can restrain a first
flexibly connected body portion of an individual relative to a second
flexibly connected body portion; (b) a bladder held by said frame, where
said bladder contacts at least one of said flexibly connected body
portions when said frame is restraining said flexibly connected body
portions; (c) a pressure sensor attached to said bladder such that
pressure within said bladder is measured; and (d) a microprocessor
receiving said pressure measurements, where said microprocessor monitors
variations in pressure.
2. The orthopedic restraining device of claim 1, wherein said frame
comprises a hinge.
3. The orthopedic restraining device of claim 1, wherein said bladder is
positionable relative to said frame to adjust the rest pressure within
4. The orthopedic restraining device of claim 1, wherein said first
flexibly connected body portion of said individual and said second
flexibly connected body portion are connected by a hinge joint or ball
and socket joint.
5. The orthopedic restraining device of claim 1, wherein said first
flexibly connected body portion of said individual and said second
flexibly connected body portion are connected by at least one vertebra.
6. The orthopedic restraining device of claim 1, wherein said bladder
7. The orthopedic restraining device of claim 1, further comprising an
accelerometer to measure acceleration associated with said flexibly
connected body portions.
8. A corrective back orthosis comprising: (a) a frame that fits around at
least a portion of a patient's torso to surround a portion of said
patient's spine; (b) a bladder supported by said frame, where said
bladder is positioned to provide corrective forces to said spine of said
patient; and (c) a pressure sensor attached to said bladder such that
pressure within said bladder is measured.
9. The corrective back orthosis of claim 8, further comprising a
microprocessor that monitors pressures measured by said sensor.
10. The corrective back orthosis of claim 9, further comprising a graphic
display interfaced to said microprocessor, where said graphic display
depicts the forces along spinal orientations of said patient.
11. The corrective back orthosis of claim 8, further comprising a valve
providing for the release of fluid from said bladder.
12. The corrective back orthosis of claim 8, wherein said corrective back
orthotic comprises a plurality of bladders.
13. A corrective back orthosis comprising: (a) a frame that fits around at
least a portion of a patient's torso to surround a portion of said
patient's spine; (b) a force applicator connected to said frame to apply
force to said patient's spine; (c) a sensor that measures forces
associated with said force applicators; and (d) a control unit connected
to said force sensor for displaying values related to said measured
14. The corrective back orthosis of claim 13, wherein said control unit
comprises a microprocessor that monitors forces measured by said sensor.
15. The corrective back orthosis of claim 14, further comprising a graphic
display interfaced to said microprocessor, where said graphic display
depicts forces along spinal orientations of said patient.
16. A method of correcting spinal misalignment of a patient comprising the
step of applying appropriate corrective forces to said spine using a back
orthosis comprising a bladder and a pressure sensor positioned to measure
pressure associated with said bladder, where said bladder is positioned
to provide a contribution to said corrective forces and is adjusted to a
17. The method of claim 16, wherein said appropriate corrective forces are
oriented along a plurality of vectors.
18. The method of claim 16, wherein said back orthosis further comprises a
microprocessor, which monitors pressures measured by said sensor and
determines variation in said measured pressure and predetermined desired
19. The method of claim 18, wherein said microprocessor is interfaced to a
graphic display to provide a graphic analysis of spinal position and of
the vectors of corrective forces used to correct said position.
20. A method of correcting spinal misalignment comprising the step of
applying appropriate corrective forces to said spine using a back
orthosis comprising: a) force applicators connected to a frame that fits
around at least a portion of a patient's torso to surround a portion of
said patient's spine, b) a sensor that measures forces associated with
said force applicators and c) a control unit that displays values related
to said measured forces.
FIELD OF THE INVENTION
 The invention relates to orthotic devices and associated methods
that assist with healing or correction of musculoskeletal defects or
BACKGROUND OF THE INVENTION
 The musculoskeletal system involves a network of ligaments,
cartilage, muscle, bone and the like, which are generally controlled by
the nervous system. The musculoskeletal system is subject to a variety of
stresses, trauma and congenital defects. Surgery may be required to
address certain problems, and physical therapy may solve other problems.
In addition, a physician can use a variety of orthotic devices such as
braces to stabilize an injured or diseased body part. The orthotic device
may form an integral component of the treatment process.
 The treatment process can involve a variety of stages that will
strongly depend on the specific problem involved and on access to
effective treatment methods. Exercise is a part of many treatment
programs. It is known that properly designed exercise can increase the
speed and improve the quality of the healing of many musculoskeletal
injuries. But it is also recognized that inappropriate exercise can cause
additional injury or slow healing.
 Relatively sophisticated braces with built in transducers can be
used to monitor an exercise program. The transducers measure the forces
being exerted during an exercise routine. These braces serve a variety of
purposes. An important purpose is to assist patients in monitoring their
exercise while minimizing the risk of additional injury. Furthermore,
these braces can assist the responsible physician to monitor efficiently
the progress of the patient and to adjust the exercise program according
to the progress or lack of progress by the patient.
 Back problems are examples of musculoskeletal injury and are
ubiquitous in our society. The spine has 24 motion segments. Forces and
injury are concentrated at areas of transition between the spine's most
rigid and most flexible segments. This results in a tendency towards
degenerative problems at the lower levels of the flexible elements of the
lumbar and cervical spine. The spine involves an interrelationship of
static soft tissue (e.g., ligaments and cartilage), muscle, flexible
connective tissue (e.g., facet joints and disc spaces), bone, and nerve
elements (including spinal cord, autonomic and radicular structure). This
complex structure creates an enormously complex problem for the clinician
attempting to assist a patient through a period of symptomatology.
 Exercise is important for achieving and maintaining a healthy
spine. Studies suggest that back muscles maintain the erect posture of
the spine throughout the day. This requires a certain level of back
muscle strength and endurance. This endurance is also necessary for
lifting and load carrying. Therefore, specific and properly controlled
exercises for back muscle strength and endurance may be useful in
preventing or improving some lower back trouble.
 In addition to problems of degeneration and weakness, misalignment
of the spine can result in a variety of problems and can result in
progressive degeneration. For example, adolescent idiopathic scoliosis
affects approximately 1 to 3 percent of the juvenile population. The
deformity appears during early adolescence as lateral curvature of the
spine in either single curve or double curve patterns.
 The most frequent locations of scoliosis are in the thoracic (chest
area) and lumber (lower back region). A common pattern is the double
"thoracolumbar curve" in which the spine resembles an "S" as the spine
curves first one way in the chest area, then back the other way in the
lower back. As the spine curves, it also rotates, producing either
thoracic or lumbar prominences. Adolescent idiopathic scoliosis is a
progressive disease, which often grows worse with the passage of time.
The progression rate is significantly higher in young girls than in boys.
Bracing can be successful in reducing or arresting progression.
 Besides producing an undesirable appearance, spinal curvature can
result in nerve compression as a result of impingement on nerve roots
passing out from the spine to the limbs. In addition, spinal curvature
can also result in reduced thoracic capacity including reduced cardiac
and pulmonary function. These difficulties result from the size and shape
of the chest. In extreme cases, premature death follows a lifetime of
discomfort and deformity.
 In certain circumstances, direct intervention to correct the
curvature of the spine is indicated. Ultimately, about one youth in one
thousand out of the general population is treated with bracing. Back
braces, such as the Jewett brace, can be used to apply corrective forces
to the spine.
 The commitment to place an adolescent in a restricting device that
encompasses the main trunk for long periods of time is a serious one due
to the physical discomfort factors and the direct expense of fitting the
brace and monitoring the disease through the treatment period. In spite
of these deterrents, bracing is the most frequent treatment for
adolescent idiopathic scoliosis because of the seriousness of the
 Surgery to fuse vertebrae in better positions is an alternative to
bracing. Often in this surgery, rods are inserted along the side of the
spine and tied to the vertebrae to hold the vertebrae in a better
position. This surgery is a major and costly procedure and typically
leads to lessened flexibility. Therefore, every effort is made to
minimize the impact of the pathology and to avoid surgery, if possible.
Alternatives to surgery include bracing for passive correction of the
spinal deformity, and exercise for improved strength and control. Managed
care providers often require bracing before surgery is attempted to
correct or to stabilize spinal curvature.
SUMMARY OF THE INVENTION
 The present invention involves a portable orthopedic restraining
device for the passive correction of biological deformity and/or the
exercising of muscles and other tissues associated with a joint or joints
of a patient. In preferred embodiments the orthopedic restraining device
includes bladders with pressure sensors. The bladders absorb some of the
forces, and fluctuations in the bladder pressure provide for measurements
of the forces applied by the patient. Bladders spread the forces over the
patient's skin and provide a direct measure of the forces on the skin to
provide a warning if the pressures reach a level that would cause injury
to the skin.
 The invention includes corrective back orthoses. The corrective
back orthoses provide for monitoring of the forces applied by the
orthoses to permit more optimal use of the orthoses. In certain
embodiments, bladders are used advantageously in the force applicators.
The corrective back orthoses can include microprocessors for more
sophisticated monitoring of compliance, variations in applied force and
estimates of changes in the patient's condition.
 Specifically, in a first aspect, the invention involves an
orthopedic restraining device including:
 (a) a frame, which can restrain a first flexibly connected body
portion of an individual relative to a second flexibly connected body
 (b) at least one bladder held by the frame, where the bladder
contacts at least one of the flexibly connected body portions when the
frame is restraining the flexibly connected body portions;
 (c) a pressure sensor attached to the bladder such that pressure
within the bladder is measured; and
 (d) a microprocessor receiving the pressure measurements, where the
microprocessor monitors variations in pressure and determines differences
between the measured pressures and predetermined target values.
 The frame can include a hinge or an articulating section. The
bladder preferably is positionable relative to the frame to adjust the
rest pressure within the bladder. The bladder preferably holds air. The
first flexibly connected body portion of the individual and the second
flexibly connected body portion can be connected by many types of joints
such as hinge, ball and socket, intervertebral disc or synchondrosis. The
orthopedic restraining device can further include a display for
displaying a quantity related to the pressure.
 In another aspect, the invention involves a corrective back
 (a) a frame that fits around at least a portion of a patient's
torso to surround a portion of the patient's spine;
 (b) a bladder supported by the frame, where the bladder is
positioned to provide corrective forces to the spine of the patient; and
 (c) at least one pressure sensor attached to the bladder such that
pressure within the bladder is measured.
 The corrective back orthosis can further include a microprocessor,
which monitors pressures measured by the sensor. The corrective back
orthosis also can further include a graphic display interfaced to the
microprocessor, where the graphic display depicts the forces along spinal
orientations of the patient in order to permit adjustment of the forces
through changes in pressure in the bladder. In addition, the corrective
back orthosis can include a valve providing for the release of fluid from
the bladder. The corrective back orthosis can include a plurality of
 The corrective back orthosis preferably further includes a manual
pump attached to the bladder such that activation of the manual pump
adjusts pressure in the bladder by varying the amount of fluid within the
bladder. The valve can be controlled by a microprocessor. The corrective
forces applied by the corrective back orthosis preferably are oriented
along a plurality of vectors. The corrective back orthosis can include a
plurality of bladders with independently adjustable pressures.
 In another aspect, the invention involves a corrective back
 (a) a frame that fits around at least a portion of a patient's
torso to surround a portion of the patient's spine;
 (b) force applicators connected to the frame to apply force to the
 (c) a sensor that measures forces associated with the force
 (d) a control unit connected to the force sensor for displaying
values related to the measured forces.
 The control unit can include a microprocessor that monitors forces
measured by the sensor. The corrective back orthosis can further include
a graphic display interfaced to the microprocessor, where the graphic
display depicts the forces along spinal orientations of the patient in
order to permit adjustment of the forces. The corrective back orthosis
also can further include strain gauges operably connected to the frame.
 In another aspect, the invention involves a method of correcting
spinal misalignment of a patient including the step of applying
appropriate corrective forces to the spine using a back orthosis
comprising at least one bladder and a pressure sensor positioned to
measure pressure associated with the bladder, where the bladder is
positioned to provide a contribution to the corrective forces and is
adjusted to a desired inflation. The appropriate corrective forces
preferably are oriented along a plurality of vectors. The back orthosis
used in practicing the method can further include a microprocessor, which
monitors pressures measured by the sensor and determines variation in the
measured pressure and predetermined desired values. The microprocessor
preferably is interfaced to a graphic display to provide a graphic
analysis of the spinal deterioration and the vectors of the corrective
forces used to correct the deterioration. The microprocessor can control
a release valve to adjust pressure within the bladder. The method can
further include the step of estimating using the microprocessor evolving
force vectors based on estimated evolving conditions of the patient.
 In another aspect the invention involves a method of correcting
spinal misalignment including the step of applying appropriate corrective
forces to the spine using a back orthosis comprising: a) force
applicators connected to a frame that fits around at least a portion of a
patient's torso to surround a portion of the patient's spine, b) a sensor
that measures forces associated with the force applicators and c) a
control unit that displays values related to the measured forces.
BRIEF DESCRIPTION OF THE DRAWINGS
 FIG. 1 is a perspective view of an exercise orthosis of the
invention on the leg of a patient, where the orthosis involves a bladder.
 FIG. 2 is a top view of the bladder of FIG. 1 removed from the
 FIG. 3 is a perspective view of an alternative embodiment of a
fluid bladder positioned by the knee of a patient without the remaining
portions of the orthosis being present.
 FIG. 4 is a side view of another alternative embodiment of the
bladder positioned by the knee of a patient without the remaining
portions of the orthosis being present.
 FIG. 5 is a perspective view of an exercise orthosis depicted
around the lower back of a patient with fluid bladders under the surface
outlined with dashed lines.
 FIG. 6 is a perspective view of the exercise orthosis of FIG. 5
shown separately from the patient.
 FIG. 7 is a perspective view of a corrective back orthosis of the
 FIG. 8 is a schematic view of the forces applied to the spine at
three points by the corrective back orthosis shown in FIG. 7.
 FIG. 9 is a schematic view of lateral forces applied by a
corrective back orthosis.
 FIG. 10 is a perspective view of a corrective back orthosis of the
invention that applies lateral forces to the spine of a patient.
 FIG. 11 is a perspective view of an alternative embodiment of a
corrective back orthosis.
 FIG. 12 is a front view of the corrective back orthosis of FIG. 11,
where the orthosis is opened to display the structure within.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
 The present invention involves the incorporation of innovative
technology to a variety of orthopedic braces. In a first type of
orthosis, an improved orthopedic restraining device, such as a brace,
involves the incorporation of a bladder into a device that supports two
flexibly connected body portions. Such a bladder preferably is filled
with a fluid, e.g., a liquid or gas. This device is designed for exercise
of the portion of the patient's body within the device. The pressure
within the bladder is monitored for a variety of purposes.
 In addition, a back orthotic applies corrective forces to a
patient's spine to assist with correcting improper curvature. The
orthotic includes force applicators for applying the corrective forces.
The force applicators can be bladders, which can be filled with a liquid
or gas. In any case, sensors are included for measuring the corrective
forces. In preferred embodiments, a microprocessor monitors the
application of the corrective forces to provide the responsible physician
with valuable information.
 Exercise Orthosis
 Bracing is used to support and align in many areas of orthopaedics.
The fundamental principles of bracing include mechanical alignment,
removal of abnormal stresses by providing support, as with a splint or
cast, and restoration of normal physiology. While bracing is fundamental,
it has limitations even when involving a hinge joint such as the knee or
elbow. The limitations involve the fit of the orthosis to the soft
tissue, contact interface, e.g. skin care, and translation of the device
through physiologic or more limited range of motion.
 With respect to the present exercise orthosis, the bladder provides
for cushioning of the forces within the brace generated by the patient's
exercising. Also, the bladder may spread the forces over a significant
surface area of the skin. The spreading of the forces may vary according
to the amount of fluid within the bladder. Nevertheless, the forces on
the skin can be sufficient to injure the patient due to damage of or
interference with neural or circulatory functions. Measuring the pressure
is a direct way to determine if excessive forces are being applied to the
 In addition, the pressure is a measure of the forces being exerted
by the patient. In this way, the exercise can be monitored to determine
if the patient is following a predetermined exercise routine. Orthoses
for supporting a portion of the body and for exercise, especially
isometric exercise, have used strain gauges within the structure of the
device to measure the forces applied during exercise. See, U.S. Pat. No.
5,052,375, incorporated herein by reference. While the pressure in the
bladder may not provide directly the forces applied by the exercising
patient, the pressure can be used to monitor the exercise routine in a
meaningful way if the bladder is positioned and inflated properly.
 Generally, the exercise orthosis will contain one or more bladders
attached to a frame. The frame can take any form that provides a
relatively rigid support. For example, the frame can include molded
polymer portions that fit around a body portion, or metal supports that
connect around a body portion using straps.
 The positioning of the bladder will depend on the design of the
orthosis and the part of the body to be supported by the orthosis. The
bladder should be placed around the joint to be exercised, such that the
bladder, when inflated, will contact either the muscle or connective
tissue surrounding the joint. In this way, the bladder or bladders can
absorb one or more of the significant forces applied by the patient
against the brace.
 Absorption of these forces by the bladder will result in a change
in the pressure in the bladder. The pressure in the bladder is monitored
to measure this change. An empirical determination can be made by
correlating the variation in pressure measurements with corresponding
forces applied by the patient. Such empirical determinations are
evaluated for a particular brace design and bladder inflation. Then, an
appropriate exercise routine can be designed based on desired pressure
changes. The exercise routine can be reevaluated as treatment progresses.
 The preferred fluid for placement in the bladder is air, since air
can be pumped easily into the bladder and released. A variety of other
fluids can be used such as inert gases and liquids. Furthermore, a
deformable gelatinous material can be used in the bladder as long as a
reasonable pressure can be measured with the material. Also, materials
can be used that change phase such as liquids that form a gel once inside
 Preferably, the amount of fluid in the bladder is variable for
adjustment of the bladder within the orthosis. The apparatus used to
change the fluid amounts generally will depend on the fluid. Unless air
is used, a supply of the fluid will be needed. The valves can be manually
adjustable, or they can be controlled electronically through a
controller. A valve can be used for filling the bladder, and a separate
valve can be used for emptying the bladder, although a single valve can
be used. Unless the fluid source is at high pressure, a pump will be
needed to pump the fluid into the bladder. An electrical pump can be
used, but a manual pump is preferred for cost considerations and for ease
 The bladder can be used in a sealed form such that the amount of
material within the bladder remains constant. Having a constant amount of
material within the bladder may not be optimal since the orthosis
generally can be reconfigured for different orientations of the joint.
The brace then would have to be adjustable to accommodate the bladder
with a constant amount of material in the different positions. Whether
the amount of fluid within the bladder is variable or not, it may be
desirable to have adjustments, such as straps or hook and loop fasteners,
to permit repositioning of the bladders and/or to alter the resting
pressure on the bladder.
 Referring to FIG. 1, an exercise brace 100 is depicted supporting
the knee 102 of a patient 104 in a frame 105. In this embodiment, the two
flexibly connected body portions supported by frame 105 are the thigh 106
and the lower leg 108. Frame 105 can include adjustable hinges 110 to
permit variation in the angle of brace 100. The angle typically is fixed
at a selected position for performing the exercises, which can be
isometric, isotonic or other exercises. Hinge 110 can be an
electromechanical hinge or a mechanical hinge. A standard hinge can be
replaced by an articulating section of the frame that functions as a
hinge. Various alternative structures for the hinge and the frame
generally are described in U.S. Pat. No. 5,052,375 and WO 96/36278,
incorporated herein by reference.
 The brace 100 further includes a controller 112 for monitoring and
analyzing performance of exercise routines by the patient 104. Controller
112 generally includes a display, which can involve a series of lights or
preferably a digital display. Controller 112 preferably includes a
 The microprocessor can be interfaced to provide information to a
physician. The interface can be provided by a port for connection to
another computer or to a modem. Alternatively, the interface can be
accomplished by transmission of electromagnetic radiation such as radio
waves to a nearby or more distant base station. In some embodiments, the
controller can be reprogrammed remotely to adjust the exercise routine
according to the evolving status of the patient's condition.
 In a preferred embodiment of controller 112, a microprocessor based
system has several subsystems. Preferred subsystems include: power supply
such as a 9 volt battery, transducer bias circuit, transducer signal
conditioning circuit, analog to digital converters, a microprocessor such
as a Motorola 68HC11, real time clock, RAM and non-volatile storage such
as SRAM or EEPROM, graphic display such as a 64.times.128 pixel LCD
display with corresponding driver, keypad, audible or tactile feedback
device, data link to transducer, and RS232 standard output for serial
connection or modem access. The total device can be integrated into a
single package or physically partitioned between portions mounted
directly on frame 105 and portions mounted in a small case, which
optionally can be attached to frame 105.
 A preferred controller 112 stores a software program that manages
the use of the device for patient rehabilitation. The software preferably
provides for alerting the patient when exercises are to be done using
audible or vibrator signals. The controller 112 under software control
preferably provides instructions on the exercises as well as feedback and
reinforcement messages to the patient.
 A preferred controller 112 counts and tracks exercises in both
content and quality, stores the results in non-volatile memory, and puts
itself to sleep when inactive to conserve power. The software program can
wake up between exercise sessions to confirm periodically the continued
use of the orthopedic restraining device 100 and to monitor the forces
during a non-exercise mode. The controller 112 preferably accepts
software program changes by way of an RS232 serial cable direct computer
link or via a telephone modem.
 Brace 100 preferably includes a bladder 114, which can be
configured in a variety of ways based on the criteria described above. In
FIG. 1 the bladder 114 is approximately toroidal in shape. The toroidal
bladder 114 is placed with its center positioned roughly over the knee
102. The toroidal bladder 114 can be attached to the brace 100 in a
variety of ways including reversible attachment with straps having hook
and loop fasteners and permanent attachment by fastening sewing cuffs
around another portion of the brace 100.
 Bladder 114 can be made from a variety of materials. The material
should be puncture resistant and comfortable against the patient's skin.
Preferred materials for bladder 114 include, for example, natural rubber,
synthetic rubber, thermo plastic elastomers and combinations thereof FIG.
2 displays toroidal bladder 114 separately from the rest of brace 100.
Toroidal bladder 114 has an outlet valve 116 and a removable manual
inflator 118 attached to the bladder 114 by way of a one way valve 120. A
variety of designs can be used for the manual inflator 118. The outlet
valve 116 is actuated by squeezing the valve. The manual inflator 118 can
be replaced with a variety of motorized pumps, where the pumps are
optionally operated by controller 112. Similarly, the outlet valve can be
replaced by an electrically controlled valve. Alternatively, a single
valve can be used for inflation and deflation. Any of a variety of
commercially available valves can be used.
 The bladder 114 preferably includes a pressure sensor 122 connected
using wire 124 to controller 112. The pressure sensor 122 can be any
reasonable type. A variety of suitable pressure sensors are commercially
available. Preferred pressure sensors include the MPX series of pressure
sensors manufactured by Motorola because of their linear output and small
size. Other suitable pressure sensors use silver oxide ink surfaces
separated by a dielectric material. If excessive pressures are measured,
an alarm can be designed to warn the user in order to avoid skin damage.
Furthermore, the pressure readings can be used to monitor the exercise
routine, as described further below.
 Alternative embodiments of the bladders can be used. Also, a
plurality of bladders can be used. These bladders may or may not be
positioned in the immediate vicinity of the joint to be exercised since
forces will be exerted against contact points within the orthosis away
from the joint. Some bladders may only serve to cushion the brace while
others are designed for monitoring the exercise routine. Some or all of
the bladders will be equipped with a pressure sensor, and some of all of
the bladders may be monitored by the controller.
 An alternative embodiment 130 of the bladder is depicted in FIG. 3
in position around a knee 132 without the rest of the brace present. The
horse-shoe bladder 130 is similar to the toroidal bladder 114 except that
a section of the toroid is removed. The horse-shoe bladder 130 can be
positioned with the open portion oriented near the lower portion of the
leg 134 or near the top portion of the leg 136. Horse-shoe bladder 130 is
equipped with an outlet valve 138, a manual inflator 140 connected by way
of a one-way valve 142 and a pressure sensor 144.
 Another alternative embodiment 150 of the bladder is depicted in
FIG. 4. This roughly ellipsoidal bladder 150 is designed to be placed at
the underside of the knee 152. It is also equipped with an outlet valve
154, a manual inflator 156 attached by way of a one-way valve 158 and a
pressure sensor 160.
 Referring to FIG. 5, an exercise orthosis 200 can be designed to
fit the torso 202 of patient 204 in order to assist with back exercises.
Back orthosis 200 can include one or more bladders 206. Preferably, a
plurality of bladders 206 are included within back orthosis 200 to avoid
putting pressure on the spine.
 Back orthosis 200 should be positioned to support a portion of the
back for exercise. A different orthosis may be needed to exercise each
different portion of the back depending on the design of the orthoses.
The brace can be used for isometric exercises or other exercises, such as
scoliosis exercises where the patient moves counter to the forces being
exerted on the back to decrease the forces.
 Referring to FIG. 6, at least one of bladders 206 includes a
pressure sensor 208 to measure the pressure within the bladder 206.
Pressure sensor 208 is attached to controller 210 by wire 212. Controller
210 functions similarly to controller 112 described with respect to FIG.
1. Bladders 206 can be filled and emptied in a variety of ways depending
on the fluid used. In one preferred embodiment where air is the fluid,
valve 214 is used to inflate or deflate both bladders 206 depicted.
Detachable ball 216 can be used to inflate bladders 206 by manual
pumping. Pressure generally is affected by the physical conditions such
as temperature and positioning on the brace.
 Referring to FIGS. 5 and 6, orthosis 200 preferably has a
relatively rigid frame 218. Preferred materials for the frame include a
variety of polymer materials, possibly combined with natural or synthetic
fabric and/or metal. Ventilation holes 220 can be put in the frame 218.
Padding can be included, if desired. A large variety of approaches can be
used to secure the orthosis to the patient. FIG. 6 depicts a design using
straps 222 having mated plastic clips 224, 226 attached to the ends of
the straps 222. The exact number of straps and types of clips can be
varied, as desired.
 When the portion of the back within the orthosis is stressed, the
pressure in bladders 206 will increase due to the forces exerted against
the orthosis. As with the other embodiments of the exercise orthosis, the
pressure fluctuations within the bladder reflect the forces exerted by
the patient. Therefore, these pressure changes can be used to design a
desirable exercise routine and monitor the patient's compliance with the
target exercise routine.
 Any of the exercise braces described above further can include an
accelerometer. For example, in FIG. 1 accelerometer 160 is depicted on
the orthosis 100. Appropriate accelerometers include, for example, single
chip accelerometers described in the 1996 Allied Electronics Catalog. The
accelerometer 160 can be used to monitor motions at other joints
associated with the joint restrained by the brace. For example, an
accelerometer 160 connected to the knee brace 100 can be used to measure
motion at the hip joint. The accelerometer 160 preferably is connected to
controller 112 for monitoring the accelerometer measurements.
Measurements from the accelerometer 160 can be used to measure
performance attributes of the patient, especially for athletically active
or impaired patients.
 The accelerometer can be especially useful with respect to a back
orthosis. There are many ways of bending the back using a variety of
muscles. In addition, there are methods of moving the back as a unit
involving muscles outside of the back, e.g., hip muscles. The forces
exerted by some of these muscles can be measured through the use of a
strain gauge or a pressure gauge combined with the bladder embodiments as
described above. Forces exerted by muscles connected to joints not within
the brace cannot be measured by force measurements within the brace.
Rapid accelerations of the body or spine may imply improper use or
injury-prone behavior. The patient may be overcompensating through the
use of other muscles for moving the back.
 The use of an accelerometer can determine if the back is being
moved generally. The measurements of the accelerometer provide an
indication if these other muscles are being over-exerted by the patient.
If desired, an alarm can be set up to respond if excessive acceleration
 For use, the exercise orthosis is positioned around the intended
portion of the body connecting two flexibly connected body portions. The
orientation of the flexibly connected body portions is adjusted as
necessary, for example, by adjusting hinges within the orthosis. The
pressures within the bladders are adjusted to a appropriate rest pressure
by changing the quantity of material within the bladder and/or by
adjusting the relative position of the frame and bladder using straps or
other adjustments. Once appropriately adjusted the patient exercises
according to instructions provided by a health professional. A particular
exercise routine may involve several orientations of the flexible body
 Preferably, the patient exercises according to an exercise routine
designed by a physician based on the physical attributes of the patient.
The controller provides feedback to the patient with respect to the
actual performance relative to the target routine. In preferred
embodiments, the controller keeps track of the patient's performance for
evaluation by a health professional. The health professional can adjust
the target exercise routine based on the recorded performance. The target
performance can be made easier if the initial routine was too difficult
or more difficult to account for progress in treatment. The exercise
orthosis and the corrective back orthosis described below also can be
used for behavior modification in terms of training an individual to use
proper posture and the like.
 Corrective Back Orthosis
 As described above, bracing generally involves several challenges.
The challenges for orthosis management are especially acute for scoliosis
bracing. Here, with life threatening implications, the situation demands
an optimum brace fit because the application of forces to the treated
joints is indirect. The spine is simply not angled laterally, but it also
may be rotated, many times in areas away from easily accessible contact
points. Spinal curvature is complicated and aggravated by the dynamics of
gravity, contracture and growth.
 After leaving a fitting session, a brace may rapidly become loose,
for example, due to weight loss or other fluctuation such as water-weight
variation. The forces within the brace may deteriorate due to motor or
viscoelastic responses as the brace is worn. In addition, the brace may
be too tight such that compliance by the patient is difficult or
 Furthermore, the efficient application of mechanical forces to
complex curves of the spine, within the limits of soft tissue and bone
anatomy, should be optimized by accurate quantitation of forces and their
changing relationships, amplitudes and requirements over time. Single
static adjustments of the brace are made by a physician or technician
based on point of time information without information on the progression
of events over time.
 With respect to the present corrective orthosis, one or more of the
force applicators that are used to apply desired corrective forces to the
spine have corresponding sensors to measure the force being applied. The
corrective forces are applied based on a determination of the corrective
forces needed to arrest or reverse the misalignment. The applied forces
generally can be applied to control longitudinal and other deformities
such as pure anterior or posterior (kyphosis, lordosis), pure lateral
bends (scoliosis) and combinations thereof (complex scoliosis).
 The force measured by the sensors can be displayed for ease of
adjustment. In alternative embodiments, one or more bladders are used as
force applicators in a corrective back orthosis to provide cushioning of
the forces. Monitoring the pressure in the fluid bladder provides a
quantitative measurement related to the corrective forces.
 The force measurements assist a person fitting the brace to set the
forces at desirable levels. Also, the force measurements permit the
patient to adjust the forces to appropriate values if changes in fit of
the orthosis occur between visits to the attending health professional.
If it is undesirable for patients to adjust the forces themselves, at
least the patients can monitor for changes in the measured forces so that
they can seek appropriate adjustment by professionals.
 Preferably, the force sensors are connected to a microprocessor,
which provides the capability to monitor the variation in applied
corrective force over time. The monitored forces provided by the
microprocessor assist invaluably with the assessment of the progress with
the brace. Minimally, the microprocessor can be used to evaluate
compliance by the patient, which is a major issue with scoliosis bracing.
The brace cannot help if is not being worn. In addition, the force sensor
can attach to an alarm either through the microprocessor or separately to
provide a warning to the patient if the forces become excessive.
 Furthermore, the microprocessor can assist with fitting the brace
by providing a graphic display of the forces as they are adjusted. In an
active adjustment mode, the microprocessor can alter the forces within
the brace to ensure proper levels of force to correct for unexpected
changes in the forces or to alter the forces as a function of time in
response to expected changes in spinal curvature. For example, if fluid
bladders are used, the amount of fluid within the bladder can be changed
to adjust the force. Alternatively, strap or other adjustments can be
made to alter the pressure without a pump.
 Appropriate braces for these corrective orthoses support at least a
significant portion of the patient's torso. The material used to make the
brace should be relatively rigid, although some parts of the side
portions can be flexible without diminishing the support significantly.
Therefore, the patient's back is well supported and the forces applied by
the orthosis are relatively constant. The brace can optionally include
padding, which helps distribute the weight of the brace and thereby
provides greater comfort.
 Strain gauges can be attached to the frame to measure stresses
within the frame. Changes in the applied forces generally occur along
with changes in the fit of the frame on the patient. Changes in the fit
of the frame results in corresponding changes in the stresses on the
frame. Therefore, changes in stress can be used as another indicator of
changes in corrective forces being applied. The strain gauges should be
positioned at appropriate points along the frame to provide an indication
of changes in orientation of the frame on the patient. These stress
sensors may also provide a measure of the amount of force applied by the
 The stress sensors preferably are monitored by the microprocessor
along with the force sensors. If the applied forces change sufficiently
as measured by the force sensors and/or the strain gauges to indicate
excess, misdirected or inadequate corrective forces, a warning can be
provided that the forces need adjustment. Note that the force sensors and
the strain gauges can both operate on similar or identical principle, but
they are applied to different types of measurements.
 In a preferred orthosis, the force applicators are repositionable
so that they can be placed where desired and moved as treatment
progresses, if appropriate. The locations of the force applicators can be
programmed into the control unit. Based on the force measurements, the
microprocessor preferably determines the force vectors and torques
applied to the spine. These can be graphically displayed on the control
unit to allow for adjustments to the forces. Then, these forces are
monitored by the control unit during use to evaluate forces applied over
time to the spine and to ensure compliance by the patient.
 The microprocessor also can be programmed with the curvature of the
spine. Then, the microprocessor can use a three dimensional polar view to
account for twist in the spine as well as bends. The forces can be
related to the orientation of the spine to assist the physician in
setting the correct forces. The spinal curvature can be updated and
reentered into the microprocessor at subsequent clinic visits.
 Referring to FIG. 7, one embodiment of a corrective back orthosis
300 is displayed. Shoulder straps 302, 304 are connected to frame
supports 306 and 308. Frame support 306 supports frame members 310 and
312. Frame support 308 supports frame members 314 and 316. Strain gauges
318 are located on frame members 310 and 312. Similar strain gauges can
be placed on frame members 314 and 316 and/or frame supports 306 and 308.
 Bars 320 and 322 are attached to frame members 310 and 312 with
pairs of adjustable brackets 324, 326 and 328, 330, respectively. By
loosening a pair of adjustable brackets, either 324 and 326 or 328 and
330, bars 320 and 322 can be moved up or down along frame members 310 and
312. Similarly, bar 332 is attached to frame members 314 and 316 at
adjustable brackets 334 and 336. Loosening of adjustable brackets 334 and
336 permits the repositioning of bar 332 to a desired position where the
adjustable brackets 334 and 336 are retightened.
 Force applicators 350, 352 and 354 are located on bars 320, 322 and
332, respectively. Force applicators 350, 352 and 354 generally have a
padded surface for contacting the patient. Force applicators preferably
include a force sensor, such as pressure sensor 356, located on the
padded surface or just below the padded surface. Pressure sensor 356
measure the forces applied to the patient as well as the pressure on the
patient's skin. The pressure sensors can be of the types described above
with respect to measuring pressure in a bladder. The pressure sensors
preferably are connected to a control unit 358.
 In alternative embodiments, the force applicators include fluid
bladders with pressure sensors. The fluid bladders can be sealed with a
fixed amount of fluid, or they can be designed for inflation and
 The corrective back orthosis can include straps 360 and 362
attached to frame members 314 and 316. Straps 360 and 362 include buckles
364 and 366. Buckles 364 and 366 can be attached to knobs 368 and 370 to
secure the orthosis on the patient. Alternatively, the straps can be
attached to frame members 310 and 312. A variety of other fastening
devices can be used to secure the orthosis.
 The orthosis 300 is positioned on a patient to produce one, two,
three or more points of force, as depicted in FIG. 8 with two points of
force applied from the back and one point of force applied from the
front. The bars are positioned to apply the forces at the desired height.
The orthosis can be altered to include more than three force applicators
such that forces are applied at more than three points. Similarly, the
relative numbers of forces applied from the front and back can be
 The forces applied by corrective back orthosis 300 are directed in
a front-to-back and back-to-front direction (collectively referred to as
front-to-back forces below). Alternatively, forces can be applied with
forces in a lateral direction as depicted in FIG. 9. Corrective back
orthosis 400 in FIG. 10 provides for lateral components to the forces.
 FIG. 10 depicts an alternative embodiment 400 of the corrective
back orthosis. Corrective back orthosis 400 has a pelvic girdle 402 and
throat molds 404 connected by two upright supports 406 and 408. Upright
support 406 is located along the front of the patient during use, and
upright support 408 is located along the person's back. Corrective back
orthosis 400 includes three side straps 410, 412 and 414. A different
number of side straps can be used as desired.
 Side straps 410, 412 and 414 are attached to the front upright
support 406 at brackets 416, 418 and 420. Side straps 410, 412 and 414
are attached to the back upright support 408 at brackets 422, 424 and
426. Brackets 416-426 preferably are adjustable such that the position
along the upright supports 406 and 408 can be set as desired. Brackets
416-426 preferably include strain gauges 428. Side straps 410, 412 and
414 can be detached in a variety of ways so that the orthosis 400 can be
put on and taken off.
 Side straps 410, 412 and 414 include force applicators 430, 432 and
434. Force applicators 430, 432 and 434 preferably include pressure
sensors 436, 438 and 440. Pressure sensors 436, 438 and 440 can be
connected to a control unit 442. Strain gauges 428 preferably are
attached to control unit 442. Control unit 442 preferably includes a
microprocessor as in other control units described above.
 In alternative embodiments, the forces are supplied by one or more
bladders, either alone or in combination with other types of force
applicators. One or more of the bladders can include a pressure sensor.
The pressure sensor can be used to monitor the forces against the skin as
well as to monitor the corrective forces applied by the bladder.
Appropriate pressure transducers have been described above with respect
to exercise orthoses.
 Corrective back orthoses 300 and 400 depicted in FIGS. 7 and 10,
respectively, have a similar overall design. In preferred embodiments,
the features can be combined to include force applicators positioned
along the front and back as well as the sides. Other basic designs can be
used to construct corrective back orthoses of the invention. One
alternative design is depicted in FIGS. 11 and 12.
 Referring to FIGS. 11 and 12, corrective back orthosis 500 includes
a front support 502 and a back support 504. Front support 502 is
connected to back support 504 by a series of straps 506 that can be
disengaged to permit the patient to remove the orthosis 500. Force
applicators 508 can be placed in appropriate positions within supports
502 and 504 such that desired levels of corrective forces are applied
when the orthosis 500 is in place. Alternatively, the supports can be
oriented along the patient's sides.
 Removable bulbs 510 are used to pump air into bladders 508. Valves
512 control air flow into and out of bladders 508. Alternatively,
electrical valves and pumps can be used to control the fluid in the
bladders 508. Also, force applicators 508 can be pads or fluid bladders
using fluids other than air. Fluid bladders are preferred such that the
amount of force can be adjusted with the orthosis 500 in place by varying
the amount of fluid within the bladder.
 Force applicators 508 can be made repositionable, for example, by
using hook and loop fasteners. A large fraction of the inner surfaces of
supports 502 and 504 can be covered with loop fabric, and the backs of
force applicators can include hook type fasteners. If the force
applicators 508 are repositionable, the force applicators can be
positioned as desired for a particular patient at a particular point in
time. The force applicators 508 can be positioned to apply front-to-back
forces or a combination of front-to-back forces and lateral forces. In
alternative orientations of the supports, the force applicators can be
positioned to apply lateral forces alone. The number of force applicators
508 can be varied as desired.
 Force applicators 508 preferably include force sensors 514.
Preferred force sensors are pressure sensors. Force sensors are connected
to control unit 516. Strain gauges 517 are attached to supports 502 and
504. Strain gauges 517 preferably are connected to control unit 516.
 Additional cushions 518 can be included for comfort. Additional
cushions 518 can be pads or fluid bladders. If additional cushions 518
are air bladders, a valve 520 and bulb 522 can be included to fill and
empty additional cushions 518.
 For use, an initial examination of the patient generally takes
place at a medical facility. Measurements are made of deformity
parameters as well as normative data on progression of curve shape and
resolution patterns needed to design treatment. Information on the spinal
curvature is reproduced from measurements taken from x-rays. This
information can be directly input into the control unit for the brace.
More preferably, this information is first input into a base station, a
microprocessor used by a health professional to track patient's condition
and progress. A corrective vector prescription is determined based on the
 The information can then be downloaded from the base station to the
control unit by a variety of protocols. The base station processor and
control unit processor can be connected by RS 232 connection, by
telephone modem or other similar connections. Alternatively, the
processors can transfer information through radio frequencies using
transmitters and receivers.
 A representation of the deformed spine and the corrective force
vectors can be graphically displayed by the base station and/or the
control unit. The force applicators are positioned to correspond to the
locations of the force vectors. The pressures can then be set to
correspond to the magnitudes of the corrective force vectors. The control
unit preferably monitors the pressure measurements to provide a warning
of excess, misdirected and/or inadequate corrective forces. The
corrective forces are established according to desired parameters.
 The patient generally then wears the brace away from the care of
the health care provider. The control unit monitors compliance and any
variation in the forces within the brace. The patient further can perform
exercises within the brace. These scoliosis exercises generally involve
motions directed by the force applicators to further the corrective
activity. To perform these exercises, the patient moves to decrease the
exerted forces of the force applicators. This requires muscular force
directed similarly to the forces exerted by the force applicators. These
exercises can be monitored by the control unit and later downloaded to a
base station for evaluation by a health professional.
 Information monitored by the control unit can be periodically
downloaded to the base station. This information can be transferred by a
hard wire connection, transmission using a modem over phone lines or by
transmission using electromagnetic radiation such as radio waves or
infrared radiation. The downloaded information can be evaluated by a
health care professional. This information can be used to reevaluate the
selected corrective parameters. Also, this information can be used to
evaluate changes in the applied forces.
 In addition, periodic examinations can be made to remeasure the
deformity parameters. The deformity parameters preferably is input into
the base station and/or the control unit. The new deformity parameters
are used to select a new corrective force vector prescription. This
process is then repeated until sufficient progress has been made that the
treatment can be terminated, or if insufficient progress is obtained such
that alternatives to bracing are attempted.
 Other embodiments of exercise orthoses and corrective back orthoses
are within the claims.
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