U.S. patent application number 10/997737 was filed with the patent office on 2005-05-26 for remote psychological evaluation.
This patent application is currently assigned to IZEX Technologies, Inc.. Invention is credited to Mowery, Blair P., Oyen, Duane, Stark, John G..
Application Number | 20050113652 10/997737 |
Document ID | / |
Family ID | 23327360 |
Filed Date | 2005-05-26 |
United States Patent
Application |
20050113652 |
Kind Code |
A1 |
Stark, John G. ; et
al. |
May 26, 2005 |
Remote psychological evaluation
Abstract
Instrumented orthoses with more sophisticated structures provide
for coordinated support and rehabilitation of complex joints and
multiple injured joints. Improved instrumented orthoses can include
hinges that can rotate in multiple different planes. Particularly
preferred embodiments include a shoulder brace with a hand hold and
a lower extremities brace. Preferably, a control unit monitors the
output of transducers used to instrument the brace. A patient can
be prompted by the control unit for the performance of a variety of
different monitored exercises.
Inventors: |
Stark, John G.; (Deephaven,
MN) ; Oyen, Duane; (Maple Grove, MN) ; Mowery,
Blair P.; (Bloomington, MN) |
Correspondence
Address: |
Patterson, Thuente, Skaar & Christensen, P.A.
4800 IDS Center
80 South 8th Street
Minneapolis
MN
55402-2100
US
|
Assignee: |
IZEX Technologies, Inc.
|
Family ID: |
23327360 |
Appl. No.: |
10/997737 |
Filed: |
November 24, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10997737 |
Nov 24, 2004 |
|
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09339071 |
Jun 23, 1999 |
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Current U.S.
Class: |
600/300 ;
128/920; 600/500; 600/595 |
Current CPC
Class: |
Y10S 482/90 20130101;
A61B 2505/09 20130101; A61F 2005/0167 20130101; A63B 24/0006
20130101; A61B 5/11 20130101; A61F 2005/0134 20130101; A61B 5/165
20130101; A61B 5/4528 20130101; G16H 20/70 20180101; G16H 10/20
20180101; A61F 5/0125 20130101; Y10S 128/92 20130101; A61B 5/1071
20130101; G16H 40/63 20180101; G16H 40/67 20180101; A61B 5/0531
20130101; A61B 5/6812 20130101; A61B 5/225 20130101; A61F 2005/016
20130101 |
Class at
Publication: |
600/300 ;
128/920; 600/595; 600/500 |
International
Class: |
A61B 005/00; A61B
005/103; A61B 005/117 |
Claims
What is claimed is:
1. An ambulatory medical device comprising a display, an input
device, a microprocessor, memory, a download channel with an output
portal and software wherein the software executes on the
microprocessor to present questions on the psychological state of
the patient with answers being input through the input device for
storage for subsequent downloading from the output portal.
2. The ambulatory medical device of claim 1 wherein the display
comprises an LCD display.
3. The ambulatory medical device of claim 1 wherein the input
device comprises a keypad.
4. The ambulatory medical device of claim 1 wherein the
microprocessor has a deep sleep mode.
5. The ambulatory medical device of claim 1 wherein the
microprocessor has analog to digital multiplexing capability.
6. The ambulatory medical device of claim 1 wherein the memory is
non-volatile memory.
7. The ambulatory medical device of claim 1 wherein the output
comprises an RS-232 port.
8. The ambulatory medical device of claim 1 wherein the output
comprises an internal modem.
9. The ambulatory medical device of claim 1 wherein the output
comprises a radio transmitter.
10. The ambulatory medical device of claim 1 wherein the questions
relate to pain levels.
11. The ambulatory medical device of claim 1 wherein the questions
relate to the formation of a pain diagram.
12. The ambulatory medical device of claim 1 wherein the questions
relate to depression.
13. The ambulatory medical device of claim 12 wherein a statistical
analysis is performed on the depression questions to obtain an
objective quantitative measure of depression.
14. The ambulatory medical device of claim 1 wherein the device is
further connected to an orthosis.
15. The ambulatory medical device of claim 1 wherein the device is
further connected to a pulse rate sensor, galvanic skin response or
a blood pressure sensor.
16. A method for remote evaluation of the psychological state of a
patient, the method comprises posing questions to a patient using
an ambulatory device comprising a display, an input device, a
microprocessor, memory, an output portal and software wherein the
software executes on the microprocessor to present questions on the
psychological state of the patient with answers being input through
the input device for storage for subsequent downloading from the
output portal.
17. The method of claim 16 wherein the questions relate to pain
levels.
18. The method of claim 16 wherein the questions relate to the
formation of a pain diagram.
19. The method of claim 16 wherein the questions relate to
depression.
20. The method of claim 19 wherein a statistical analysis is
performed on the depression questions to obtain an objective
quantitative measure of depression.
21. The method of claim 16 wherein the psychological evaluation is
coupled with a physiological evaluation.
22. The method of claim 21 wherein the physiological evaluation
comprises evaluation of the performance of target exercises.
23. The method of claim 21 wherein the physiological evaluation
comprises pulse measurements.
24. The method of claim 21 wherein the physiological evaluation
comprises blood pressure measurements.
25. The method of claim 21 wherein the physiological evaluation
comprises galvanic skin response measurements.
26. The method of claim 16 further comprising modifying a treatment
program in response to the psychological evaluation.
27. The method of claim 16 wherein the downloading of important
information is performed in a timely way.
28. The method of claim 16 further comprising characterizing the
patient's answers prior to review by a health care
professional.
29. The method of claim 28 wherein the characterization is
performed on the ambulatory medical device.
30. The method of claim 28 wherein the characterization is
performed on a central processor.
31. The method of claim 16 wherein detection of specific responses
from the patient prompts an instruction to the patient to
immediately contact a treatment professional.
32. A method of evaluating a patient's mental condition comprising:
collecting answers to a set of questions regarding the patient's
mental condition using a remote controller programmed to pose the
questions and receive the answers; and evaluation of the answers by
a health care professional.
33. The method of claim 32 further comprising performing initial
analysis of the answers using a computer processor.
34. The method of claim 32 wherein the remote controller is
operably connected to transducers associated with an orthosis.
35. The method of claim 34 wherein the transducers are selected
from the group consisting of strain gauges, position sensors, and
combinations thereof.
36. The method of claim 34 wherein the orthosis comprises a hinge
that can rotate in several different planes and a position sensor
operably connected to the hinge such that motion can be measured
with respect to different rotational motions around the joint, the
controller being operably connected to the position sensor to
receive signals related to the position of the hinge.
37. The method of claim 34 wherein the orthosis comprises a
plurality of hinges such that motions about separate hinges
correspond to motions about different joints.
38. The method of claim 32 wherein the controller further processes
a signal related to a physiological condition in the patient
correlated with stress.
39. The method of claim 38 wherein the physiological condition is
pulse rate.
40. The method of claim 38 wherein the physiological condition is
the galvanic skin response.
Description
[0001] CROSS REFERNECE TO RELATED APPLICATIONS
[0002] This application is a continuation of copending U.S. patent
application Ser. No. 09/339,071 to Stark et al., entitled
"Rehabilitative Orthoses," incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0003] The invention relates to orthoses useful for the
rehabilitation of patients with injured joints, weakened joints,
and/or neurological deficits degrading motor control or operation
of joints. More particularly, the invention relates to instrumented
orthoses for the performance of monitored rehabilitative
exercises.
[0004] Both muscles and bones should be exercised to maintain
strength. Also, bone fractures that are exposed to permissible
weight bearing stress often heal more predictably and more rapidly
than fractures that are not stressed at all. Improved healing based
on application of appropriate stress is also believed to be true
for connective tissue, such as ligaments and cartilage.
[0005] In the case of neurological injury or degradation, the nerve
impulse pathways that control skeletal motor functions and joints
are interrupted due to loss of brain cells or nerve conducting
structures. Such neurological injuries can result from
cerebrovascular accidents such as ischemic or hemorrhagic strokes
or certain types of head trauma. Recovery mechanisms involve
creation of new neurological pathways by retraining the motor
functions with different surviving brain cells as receptors. This
requires physical therapy and joint exercise very similar to
exercise that is advantageous for rehabilitation of joints
following orthopedic injury. Additionally, joint disuse following
such neurological injury similarly requires orthopedic
rehabilitation and stress to effect useful recovery, given the
secondary orthopedic damage resulting from the disuse.
[0006] Suitable stress can be applied to the tissue by the
performance of selected exercises. For example, isometric exercises
generally involves the exertion of force against a relatively
immovable object. To perform isometric exercises, a restraining
device can be used that has a substantially unchanging position for
the duration of a particular exercise routine. Isotonic exercises
involve exertion against the same weight or resistance through a
range of motion. Isokinetic exercise is designed to mimic exertions
that take place on a playing field or the like. When performing
isokinetic exercises in a simulated environment, a machine is used
to provide resistance in direct proportion to the exertion of the
exerciser.
[0007] Isometric exercises are particularly usefull with painful
injuries to lower the risk of further injury. If performed in a
controlled manner, isometric exercises can be performed earlier in
the recuperation period to speed recovery. As the patient's
recovery progresses, isotonic exercises or other exercises can be
used to reestablish a desired range of motion about a joint. With
continuing recovery, eventually the patient is able to perform a
full range of exercises.
[0008] A difficulty with the application of stress to an injured
joint is that the application of excessive stress can further
injure the joint rather than assist with the healing. Thus, the
exercises need to be carefully planned to provide appropriate
amounts of stress. Also, the performance of the exercises should be
monitored closely by a physician, physical therapist or other
appropriate health care professional to optimize the treatment and
to reduce the risk of injury. The need to carefully plan and
closely monitor the exercises provides a cost and motivation
barrier to accessing desirable amounts of exercise.
SUMMARY OF THE INVENTION
[0009] In a first aspect, the invention pertains to an instrumented
orthosis comprising:
[0010] a support that fits around the joint of a patient, the
support comprising a hinge that can rotate in different planes;
[0011] a position sensor operably connected to the hinge such that
motion can be measured with respect to different rotational motions
about the joint; and
[0012] a control unit operably connected to the position sensor to
receive signals related to the position of the hinge.
[0013] In another aspect, the invention pertains to method of
rehabilitating a joint that has a range of motion in a plurality of
planes. The method involves exercising with an orthosis having a
hinge that can rotate in different planes. The hinge preferably
includes a position sensor that can provide measurement of the
orientation of the hinge in the different planes. The orthosis
includes a control unit connected to one or more position
sensors.
[0014] In a further aspect, the invention pertains to an orthosis
comprising:
[0015] a support that fits around a plurality of joints of a
patient, the support comprising a plurality of hinges such that
motions about separate hinges correspond to motions about different
joints;
[0016] position sensors operably connected with the hinges such
that motion can be measured about different joints; and
[0017] a control unit operably connected to the position sensors to
receive signals related to the position of the hinges.
[0018] Moreover, the invention pertains to a method of upper body
rehabilitation comprising exercising two or more adjacent joints
using an ambulatory orthosis supporting the two or more adjacent
joints. The orthosis preferably is connected to a control unit that
provides a target exercise routine and immediate feedback on
patient performance relative to the target exercise routine with
respect to motion about either of the adjacent joints.
[0019] In additional aspects, the invention pertains to a leg
orthosis including:
[0020] an ambulatory support structure including:
[0021] a waist support;
[0022] an upper leg support;
[0023] a lower leg support;
[0024] a hinge connecting the waist support with the upper leg
support;
[0025] a hinge connecting the upper leg support and the lower leg
support;
[0026] sensors operably connected to the support structure to
measure forces applied to the support structure; and
[0027] a control unit connected to the sensors to receive
measurements related to the applied forces.
[0028] In another aspect, the invention pertains to a method of
rehabilitating a stroke victim including performing a set of
exercises using an ambulatory orthosis supporting the hip and knee.
The orthosis preferably is connected to a control unit that
provides a target exercise routine directing the application of
forces by the patient at the hip and knee and provides immediate
feedback on patient performance relative to the target routine.
[0029] In a further aspect, the invention pertains to a shoulder
orthosis including:
[0030] an ambulatory shoulder support;
[0031] a hand hold extending from the shoulder support;
[0032] a transducer operably connected to the hand hold such that
forces applied to the hand hold result in an altered signal from
the transducer; and
[0033] a control unit connected to the transducer to receive
measurements of forces applied to the hand hold.
[0034] The ambulatory shoulder support preferably includes a trunk
support and an under arm support directly or indirectly connected
to the trunk support by a hinge, preferably a multi-dimensional
hinge.
[0035] In addition, the invention pertains to a method of
evaluating a patient's mental condition comprising:
[0036] collecting answers to a set of questions regarding the
patient's mental condition using a remote controller programmed to
pose the questions and receive the answers; and
[0037] evaluation of the answers by a health care professional.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] FIG. 1 is a schematic perspective view of an orthosis for
supporting two joints.
[0039] FIG. 2 is a schematic perspective view of an orthosis with a
hinge capable of rotating in multiple planes.
[0040] FIG. 3 is a schematic perspective view of an embodiment of a
support portion.
[0041] FIG. 4 is a schematic perspective view of an alternative
embodiment of a support portion.
[0042] FIG. 5 is a sectional top view of a hinge with a mechanical
locking feature and a position sensor, where the section is taken
through the central axis of the hinge.
[0043] FIG. 6 is a side view of a portion of the hinge of FIG. 5
with another portion removed.
[0044] FIG. 7 is a top view of an electromechanical hinge, where a
portion of the casing and other structures are removed to expose
internal structure.
[0045] FIG. 8 is a sectional, side view of the electromechanical
hinge of FIG. 7 taken along line 8-8.
[0046] FIG. 9 is an exploded, perspective view of an embodiment of
a mechanical hinge with an easy to use locking mechanism.
[0047] FIG. 10 is a sectional front view of a manual resistance
unit that can be used with the mechanical hinge of FIG. 9.
[0048] FIG. 11 is a side view of an orthosis with an articulating
hinge connecting two support portions.
[0049] FIG. 12 is a side view of a mechanical, biaxial hinge.
[0050] FIG. 13 is a fragmentary, perspective view of one embodiment
of a hinge that provides for motion in two planes.
[0051] FIG. 14 is an exploded, perspective view of the principle
components of the hinge of FIG. 13.
[0052] FIG. 15 is a fragmentary, perspective view of an alternative
embodiment of a hinge that provides for rotation in two planes.
[0053] FIG. 16 is a fragmentary, perspective view of an orthosis
with a squeeze ball for the patient's hand.
[0054] FIG. 17 is a fragmentary, perspective view of an orthosis
with a squeeze ball of FIG. 16 and a wrist hinge.
[0055] FIG. 18 is a fragmentary, perspective view of an orthosis
with a hand grip.
[0056] FIG. 19 is a front view of a shoulder orthosis.
[0057] FIG. 20 is a perspective, front view of a lower extremity
orthosis.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0058] Sophisticated instrumented orthoses/braces provide for more
complex and coordinated rehabilitation exercises than previously
possible. In particular, certain embodiments are suitable for the
rehabilitation of complex joints that enable motion in multiple,
different planes. These complex joints can be rehabilitated much
more efficiently and appropriately using the more sophisticated
orthoses described herein. Furthermore, other embodiments of the
improved orthoses are particularly suitable for the rehabilitation
of stroke victims. These stroke braces provide suitable
rehabilitation for patients that have lost motor function on one
side or both sides of their body. Thus, the rehabilitation can
involve muscle building as well as neuro-reflex retraining. Using
these sophisticated orthoses, many serious injuries/illnesses can
be treated more effectively than was possible previously and,
potentially, at a lower cost.
[0059] Certain embodiments of the improved orthoses are suitable
for the rehabilitation of joints that move in multiple planes of
motion. Joints that move in multiple planes of motion include, for
example, shoulder, spine, hip, wrist and ankle/foot. These orthoses
include a support structure that fits around the joint and supports
the body portions connecting at the joint. The support structure
includes one or more hinges that provide for motion of the joint in
multiple planes of motion. Position sensors preferably provide for
measurements of the position of the hinge in the multiple planes of
motion. The hinge or hinges preferably provide for the measurement
of the motion about two or more planes of motion. The orthoses can
include additional types of transducers, such as strain gauges.
Preferred embodiments include instrumented shoulder braces that
provide for the multiple planes of motion of the shoulder.
Preferred shoulder braces can further include instrumented supports
for the arm, elbow and/or hand.
[0060] Certain embodiments of the improved orthoses are
particularly suitable for use as a stroke brace. Stroke victims can
lose a significant portion of their motor control on one or both
sides of their body. These victims need a particularly high level
of support and can benefit tremendously from appropriate type of
rehabilitative exercises. Because stroke victims generally have
injuries that involve multiple joints, a stroke brace includes a
support structure that provides support for multiple joints.
Preferred stroke orthoses include an upper extremity brace along
with a long leg brace, although other embodiments can be used. In
preferred embodiments, the support structures include hinges
providing for motion of multiple joints.
[0061] The hinges preferably include position sensors for measuring
the motion about the hinge. The orthoses can include additional
types of transducers, such as strain gauges. The orthosis can
provide for multiple planes motion about one or more of the joints.
The instrumentation of the orthosis generally involves a control
unit that is operably connected to transducers on the orthosis. The
control unit can be used to provide feedback and instructions to
the patient to assist with the retraining of neurological pathways.
Instrumentation of the orthosis reduces the need for professional
intervention.
[0062] Hand injuries may not be adequately treated by standard
types of orthoses with hinges. Furthermore, hand muscles can
atrophy due to inactivity following an arm injury. An improved hand
orthosis includes an instrumented squeeze device, such as an
air-bulb or a foam grip. Generally, the instrumented squeeze ball
is supported by a support that extends, at least, to the patient's
wrist. In certain embodiments, the instrumentation measures the
total force exerted by the hand onto the squeeze ball. In other
embodiment, the instrumentation provides for measurements of forces
applied by individual fingers. The capability to measure the force
exerted by individual fingers is particularly suitable for a stroke
brace where redevelopment of neuromuscular control of the movement
of individual fingers is a significant consideration.
[0063] As noted above, preferred embodiments of the improved
orthoses include a control unit operably connected to transducers
placed on the orthosis for position, strain or other measurements.
The control unit preferably includes a microprocessor to assist
with the monitoring of the rehabilitative exercises. Information
regarding the compliance and performance of the patient can be
downloaded from the control unit for evaluation by a health care
professional. Microprocessor based control units can provide
instruction to and prompting of the patient for the performance of
the selected exercises. The selection of suitable exercises
preferably is performed by a health care professional following an
examination of the condition of the patient. The control unit is
programmed accordingly.
[0064] 1. Orthosis Structure
[0065] Previous instrumented orthoses are designed for placement
around a single joint. Support portions support the respective body
portions that meet at the joint. A selectively flexible
connection/hinge connects the support portions at or near the joint
such that rotation of the hinge provides for motion around the
joint. Hinges used in these orthoses provide for rotation in a
single plane. Transducers can provide for measurements of strain
within the support and/or the position of the hinge. A
microprocessor based control unit provides for monitoring of the
measurements of the transducers. To the extent that previous
instrumented orthoses have extended to multiple joints such as a
knee brace extending to the foot, the measurements at the second
joint have not involved rotation of the second joint. In other
words, a force detector at the foot measures the force applied
against the leg as a whole and not the force due to torque at the
ankle. Further description of previous instrumented orthoses is
found in U.S. Pat. No. 5,484,389 to Stark et al, entitled
"Instrumented Orthopedic Restraining Device and Method of Use,"
incorporated herein by reference.
[0066] Various features of instrumented rehabilitation orthoses
have been refined generally to provide for improved performance of
the orthosis. Many of these features can be adapted for use in the
improved orthoses described herein. These features are described in
detail in copending and commonly assigned U.S. Provisional
Application Ser. No. 60/098,779 to Stark et al., entitled "ORTHOSES
FOR JOINT REHABILITATION," incorporated herein by reference,
hereinafter "application 60/098,779". Certain of these features are
described with particularity below, as appropriate. While
application 60/098,779 is incorporated herein in its entirety, it
is referred to for particular features in additional citations
below.
[0067] Improved orthoses described herein provide for more
sophisticated rehabilitation procedures than previous instrumented
orthoses. Referring to FIG. 1, certain embodiments of an improved
orthosis 100 include a first support portion 102, a second support
portion 104, and a third support portion 106 such that multiple
joints can be supported by orthosis 100. First support portion 102
preferably is connected to second support portion 104 by flexible
connection/hinge 108. Similarly, second support portion 104
preferably is connected to third support portion 106 by flexible
connection/hinge 110. Control unit/controller 112 can be connected
to position sensors, described further below within hinges 108 and
110 and to strain gauges 114, 116. Alternative embodiments can
include only one hinge or more than two hinges, with a
correspondingly appropriate number of support portions.
[0068] Support portions 102, 104, 106 can be connected directly to
hinges 108, 110 or by way of linkers 118, 120, 122, 124. In
particular, linker 118 links support portion 102 with hinge 108,
linker 120 links support portion 104 with hinge 108, linker 122
links support portion 104 with hinge 110 and linker 124 links
support portion 106 with hinge 110. Linkers 118, 120, 122, 124 can
have any desired rigid structure that is suitable given the
structure of the support portion and the hinge.
[0069] Other embodiments 130 of the improved orthoses include
hinges that provide for the motion of a joint in multiple planes.
Referring to FIG. 2, first support portion 132 and second support
portion 134 are connected to multidimensional hinge 136. As
described further below, multidimensional hinge 136 can include a
plurality of single plane hinges or more complex structures.
Support portions 132, 134 can be directly attached to
multidimensional hinge 136 or by way of linkers 138, 140,
respectively. Orthosis 130 preferably includes, at least, one
strain gauge 142 to measure forces applied at hinge 136.
[0070] A variety of constructions can be used for the support
portions 102, 104, 106, 132, 134 (FIGS. 1 and 2) such that a
support portion properly supports the respective body portion.
Referring to FIG. 3, a first embodiment 150 of a support portion
has frame members 152 and 154 that extend on either side of a body
portion. Straps 156 extend from one frame member 152, 154 to the
other to hold support portion 150 in place around the corresponding
body portion. Straps 156 can be replaced with fabric sheets or
other flexible or rigid connectors. Straps 156 can be secured to
frame members 152, 154 with any of a variety of fasteners, such as
snaps, buckles, clamps and hook and loop fasteners. The length of
straps 156 can be adjusted using conventional designs. A rope and
pulley system can be used for tightening and loosening support
structure 150, as described further in application 60/098,779.
Frame members 152, 154 connect directly to hinge elements 158, 160,
although linkers can be used, if desired.
[0071] Referring to FIG. 4, an alternative embodiment 166 of a
support structure that surrounds the corresponding body portion.
Support portion 166 generally is somewhat rigid and can be
constructed from a variety of materials. Preferred materials for
the construction of support portion 166 include, for example,
molded plastic shells, plaster, water-activated fiberglass, heat
moldable thermoplastics, heat shrink plastic, and other cast
forming materials. Support portion 166 can be premolded in various
sizes such that a particular size is selected "off-the-shelf'based
on measurements of the patient. Alternatively, support portion 166
can be constructed to provide a custom fit for a particular
patient. These custom molded support portions are molded to fit the
body portions of the particular patient by a trained physician or
technician.
[0072] Whether or not a linker is used to connect a particular
support portion and a hinge, a hinge can involve just one or a
plurality of distinct hinge elements, as appropriate. As used
herein, a hinge element is a physically distinct structure that has
two or more lever arms that rotate relative to each other. A hinge
includes one hinge element if a support portion has a single lever
arm connecting it by way of the hinge to the other support portion
and more than one hinge element if a support portion has multiple
lever arms at distinct locations of attachment to the support
portion.
[0073] For example, as shown in FIG. 2, hinge 136 has a single
hinge element, which corresponds to the hinge itself. In contrast,
in FIG. 3 the hinge includes two hinge elements 158, 160.
Similarly, in FIG. 1 each hinge 108, 110 is depicted with two hinge
elements. More than two hinge elements can be included in a single
hinge, although it is preferably to use one or two hinge elements
per hinge. Support structure 166 in FIG. 4 can be attached to one
hinge element or two hinge elements by direct attachment or using
appropriate linkers. The hinge elements are placed such that the
joint can rotate when the orthosis is properly placed around the
joint and the hinge elements are not in a locked position.
[0074] When forces are applied by the patient against the orthosis,
the orthosis tends to change position relative to the patient's
joint. This shifting reduces the effectiveness of any exercises
being performed with the orthosis and may necessitate realignment
of the orthosis for proper fit. The orthosis can be designed to
reduce or eliminate this shifting.
[0075] A first approach to prevent a knee orthosis from slipping
during exercise is to construct the orthosis with indentations in
the femur supracondylar area just above the knee. An alternative
solution involves the use of additional securing cuffs. Securing
cuffs are designed to be tightened more during exercise routines to
help secure the orthosis relative to the joint. Securing cuffs
include a gripping element and, for example, can be placed against
the leg above the knee such that when tightened, the gripping
element applies pressure above the kneecap and pushes on the knee
without pushing on the vasculature and lymphatic drainage
posteriorly. In other embodiments, the securing cuff can be
appropriately placed. Cuffs 270, 272 can be tightened with a
variety of fasteners including hook and loop fasteners.
[0076] Another approach to securing the orthosis involves securing
the orthosis to a belt by way of one or more straps. Still another
approach involves reducing the friction of the surface contacting
the orthosis or part of the orthosis, for example, using a high
friction, polymer sleeve. Still another approach to securing the
orthosis involves the placement of crossed straps behind the joint.
The straps apply forces that tend to maintain the straps in the
fold of the joint. Furthermore, for a knee orthosis, the orthosis
can end with a heel cup or other support placed along the bottom of
the foot. Such a foot support preferably includes a strap or the
like around the foot to hold the bottom of the orthosis at the
bottom of the foot and, thus, to fix the hinge roughly at the
knee.
[0077] With any of these approaches for inhibiting orthosis motion
during use, the method preferably distributes the restraining
forces sufficiently such that no portion of the skin is subject to
excessive pressures that could bruise the skin as well as damage or
interfere with neural or circulatory functions. Most of these
approaches for preventing movement of the support portions are
described further in the 60/098,779 application.
[0078] Hinges 108, 110, 136 (FIGS. 1 and 2) are intended to be
interpreted broadly as any flexible connection that provides for
angular motion of one support portion relative to another support
portion. Hinges 108, 110, 136 preferably can be locked at a
selected angle to protect the joint from undesired motion and/or to
provide for isometric exercises. Hinges 108, 110 can be mechanical,
electromechanical or a combination thereof, as described further
below. In preferred embodiments, the hinge/flexible connection
includes a position sensor such that the relative orientation of
the hinge can be measured and monitored by the controller 112. For
example, U.S. Pat. No. 5,052,375, to Stark et al. entitled
"Instrumented Orthopedic Restraining Device and Method of Use,"
incorporated herein by reference, discloses the use of a
potentiometer-like mechanism used as a position sensor. Other
suitable position sensors can be used, such as magnetic or optical
sensors that are either digital or analog devices. Position sensing
is useful for the evaluation of range-of-motion exercises and a
variety of other exercises, as described further in the 60/098,779
application.
[0079] An embodiment of a suitable mechanical hinge capable of
locking and unlocking is shown in FIG. 5. Hinge 180 includes a
first engaging member 182 and a second engaging member 184. Members
182, 184 have teeth 186, 188, respectively, that engage when hinge
180 is in a locked position. Knob 190 is used to rotate bolt 192.
Second engaging member 184 includes a threaded screw hole 194 that
is mated with bolt 192 such that rotation of knob 190 moves knob
190 relative to member 184. Spring 196 tends to separate members
182, 184 from each other to the extent allowed by the relative
position of bolt 192 within threaded hole 194. Clip 198 within
recess 200 prevents separation of bolt 192 from member 184.
Referring to FIG. 6, strain gauges 202 are located on frame 204.
Frame 204 can be a linker between hinge 180 and a support portion
or a component of a support portion.
[0080] Referring to FIGS. 5 and 6, hinge 180 includes a position
sensing device in the form of a variable resister. In particular,
member 184 includes two flexible wiper arms 210, 212. Wiper arms
210, 212 are in electrical contact with each other such that
current can flow between them. Flexible wiper arm 210 contacts
resistance element 214, while flexible wiper arm 212 contacts
conducting element 216. Resistance element 214 and conducting
element 216 have an electrical potential difference between them.
Resistance element 214 has an electrical connection 218 at one end
such that the electrical resistance resulting from current flow
through resistance element 214 depends on the position of wiper arm
212 as determined by the relative angular orientation of member 184
relative to member 182. Wires 220 provide for electrical connection
of resistance element 214 and conducting element 216 directly or
indirectly to controller 112.
[0081] Referring to FIG. 7, an electromechanical hinge 240 is
shown. Hinge 240 includes a first element 242, which connects to a
first support portion 244, and a second element 246, which connect
to a second support portion 248. Second element 246 connects with
axle 250, which rotates within shaft 252 such that second element
246 can rotate relative to first element 242. Axle 250 is secured
with nut 254. Shaft 252 passes through armature 256. Armature 256
is held within case 258. Case 258 is secured to first element
242.
[0082] Lead 270 electrically connects stator coil 272 within stator
housing 274 with a current source. Stator coil 272 is designed to
attract armature 256 when sufficient magnetic field is generated by
electric current flowing through stator coil 272. The current can
be supplied from controller 112. When armature 256 is attracted to
stator coil 272, a pair of free riding discs 276, 278 are gripped
between armature 256 and stator housing 274. Outer disc 276 is made
preferably from a suitable metal, and inner disc 278 is made
preferably from a suitable polymeric material to provide for a
smooth grip between the surfaces and to prevent wear between the
surfaces. A spring 280 biases armature 256 away from stator housing
274 when the magnetic attraction between coil 272 and armature 256
is insufficient to overcome the forces of spring 280. Sufficient
attraction between coil 272 and armature 256 locks first element
242 relative to second element 246.
[0083] In preferred embodiments, a hinge provides selectable
resistance to rotation for the performance of isotonic exercises.
For example in the embodiment of FIG. 7, lesser amounts of
attraction between coil 272 and armature 256 can result in
selectable amounts of resistance/friction in the rotation of first
element 242 relative to second element 246. The selectable
resistance can be adjusted with controller 102 by varying the
current supplied by controller 102 to stator coil 272.
[0084] Referring to FIGS. 7 and 8, a position sensor/variable
resistor includes a resistance element 290 and wirer arm 292.
Resistance element 290 is connected to case 258. Wiper arm 292 is
keyed to rotate with axle 250 such that rotation of second element
246 relative to first element 242 rotates wiper arm 292 to
different angular positions along resistance element 290. Conductor
arm 294 provides current to wiper arm 292. Conductor arm is
electrically insulated relative to case 258 while providing
electrical connection by way of connection 296. Resistance element
290 is connected to electrical connection 298. Resistance
measurements can be made by way of connectors 296, 298. Resistance
measurements are a function of the angular position of support
portion 244 relative to second support portion 248.
[0085] Mechanical and electromechanical hinges are described
further in U.S. Pat. No. 5,484,389 to Stark et al., incorporated
herein by reference. In particular, a suitable electromechanical
hinge with variable resistance controllable by way of controller
112 is described further in published PCT application WO 96/36278,
entitled "An Orthopedic Device Supporting Two or More Treatment
Systems and Associated Methods," incorporated herein by
reference.
[0086] A preferred embodiment of a left, mechanical hinge 300 is
shown in FIG. 9. This hinge has a construction that provides for
particularly easy release of the lock by a patient with one hand.
The orientation of the hinge is measured by a position sensor to
assist the patient in resetting the lock at a desired orientation.
A right hinge would be the mirror image of the hinge in FIG. 9.
[0087] Hinge 300 includes a outer plate 302, washer 304, locking
unit 306, ring lever 308, electrical resistance disc 310 and inner
plate 312. Outer plate 302 is connected to a frame member 318.
Strain gauge 319 can be attached to frame member 318. Outer plate
302 and inner plate 312 include concentric stop holes 320, bolt
holes 322, connection holes 324 and slot 326. The corresponding
holes are aligned between left outer plate 302 and inner plate
312.
[0088] One or two stop pins can be placed through two aligned stop
holes 320 in outer plate 302 and inner plate 312 to define limits
of hinge rotation. Bolts or other fasteners are secured through
bolt holes 322 to hold hinge 300 together. Electrical resistance
disc 310 rests within a hollow 338 within inner plate 312.
Electrical resistance disc 310 makes electrical contact with wire
340.
[0089] Locking unit 306 includes control disc 346, slider 348,
slider spring 350 and lock-out latch 352. Control disc 346 includes
bolt holes 322 and a slit 354 in which slider 348 slides. Slider
348 has a groove 356 and an indentation 358 with a catch 360.
Lock-out latch 352 has a knob 362 and a bar 364. Bar 364 slides
within slots 326 and can fit within groove 356 to hold slider 348
in a depressed, unlocked, position.
[0090] Ring lever 308 is connected with a frame member 370. Ring
lever 308 has an opening 372 with a diameter slightly larger than
the diameter of control disc 346 such that control disc 346 can fit
within opening 372. Control disc 346 preferably has a thickness
slightly larger than ring lever 308. A set of concentric, notches
374 are located around the edge of opening 372 of ring lever 308.
Catch 360 of slider 348 fits within the notches 374 to lock the
hinge at a particular orientation when slider 348 is in an extended
position. Depressing slider 348 against the force of spring 350
disengages catch 360 from one of the notches 374 such that hinge
300 is free to rotate within the bounds establishes by any stop
pins. Ring lever 308 includes an electrical contact 376 set within
a hole 378 that contacts electrical resistance disc 310. Electrical
contact 476 is connected by wire 380 to controller 112 or
alternative resistance meter.
[0091] Outer plate 302, inner plate 312, ring lever 308, control
ring 346, lock-out latch 352 and slider 348 preferably are made
from rigid, durable materials. In particular, outer plate 302 and
inner plate 312 are preferably made from an aluminum alloy, and
ring lever 308, control ring 346, lock-out slide 352 and slider 348
preferably are made from stainless steel. Spring 350 generally
would be made from resilient steel or the like. Washer 304 and stop
pin 330 generally are made from polytetrafluoroethylene or the
like. Electrical resistance disc 310 can be made from circuit board
material with a resistance element screen-printed on its
surface.
[0092] Frame members 318 and 370 extend from hinge 300 such that
movement of frame member 318 relative to frame member 370 involves
rotation of hinge 300. When hinge 300 rotates, outer ring 302 and
inner ring 312 rotate relative to ring lever 308. Outer ring 302,
inner ring 312 and control disc 346 are held fixed with respect to
each other by way of bolts passing through bolt holes 322. The
orientation of hinge 300 is locked unless slider 348 is depressed
such that catch 360 is withdrawn from notches 372. Lock-out slide
352 can hold slider 348 in the depressed, unlocked position. The
position of ring lever 308 relative to inner ring 312 can be
measured by way of the position of electrical contact 376 along
electrical resistance disc 310. The relative position of electrical
contact 376 along electrical resistance disc 310 provides a
variable electrical resistance useful for position/orientation
sensing.
[0093] It may be convenient to provide for release of a hinge with
a remote control. The release of an electromechanical hinge using a
command from the controller is described above. It may be desirable
to have a simple mechanical remote release. A simple photographic
shutter release can be adapted for this purpose with the hinge of
FIG. 9. The shutter release can be screwed at its threaded tip into
hinge 300 at threaded hole 394 in control ring 346. Pressing the
plunger of the cable release advances a cable, which in turn
depresses slider 348 thereby unlocking hinge 300. Alternative
designs for mounting of a manual hinge release involve pulling a
plunger that in turn pulls slider 348 such that the lock is
disengaged and such that releasing the plunger reestablishes the
hinge lock.
[0094] While electronic control of the resistance in a flexible
connection/hinge has advantages, cost and design simplicity favors
a purely mechanical hinge. Referring to FIG. 10, With a purely
mechanical hinge, such as shown in FIG. 5, strain gauge readings
can be accurately calibrated to reflect the forces applied to move
the hinge against a setting on a mechanical resistance applicator.
Thus, control unit 112 can be used to monitor the isotonic
exercises even though the resistance is not electronically
controlled. A mechanical resistance applicator can be made integral
with the hinge, but in preferred embodiments the resistance unit
can be separated from the hinge such that no resistance is applied
to the hinge when resistance is not desired. A resistance
applicator can designed to amplify small changes in the resistance
that correlate with easily made changes in the position of a
knob.
[0095] Referring to FIG. 10, a cross section through the center of
an embodiment of resistance applicator 400 is shown. Resistance
applicator 400 includes housing 404, a crank 406, a compression
structure 408, knob 410, bearing unit 412, washer 414 and spacers
416.
[0096] Housing 404 includes lock pins 428. A second lock pin is not
shown in the sectional drawing. Lock pins 328 provide releasable
connection for attachment of resistance applicator 400 to a hinge,
such as hinge 300 of FIG. 9. In particular, lock pins 428 of
resistance applicator 400 can be secured through connection holes
324 to releasably secure resistance applicator 400 in an operable
position with respect to hinge 300. Alternative locking approaches
can be used for the attachment of the friction applicator to the
hinge. Housing 404 includes threaded hole 432 for engaging knob
410. Housing 404 further includes cylindrical protrusion 438 for
engaging compression structure 408.
[0097] Crank 406 includes cylindrical extension 454 for engaging
compression structure 408 and pads 458, which engage a support
portion, such that rotation of the hinge of the orthosis rotates
crank 406 relative to housing 404.
[0098] Compression structure 408 provides for small changes in the
resistance due to changes in the distance between washer 414 and
housing 404 as knob 410 is rotated, thus amplifying resistance
changes by way of the knob. Compression structure 408 generally
produces friction as a result of shear forces within compression
structure 408 due to relative motion of housing 404 and crank 406.
In one embodiment, compression structure 408 includes alternating
crank discs and housing discs to form a multiple clutch plate.
Crank discs engage crank 406, such that the crank discs rotate with
crank 406. Housing discs have a central hole shaped to engage
protrusion 438 in housing 404, such that housing discs rotate with
housing 404.
[0099] Knob 310 includes a threaded shaft 482 with threads and
diameter suitable for engaging the threads of threaded hole 432 in
housing 404. Bearing unit 412 preferably includes a ring of ball
bearings in a bearing case. Bearing unit 412 can be replaced with
other bearing structures or other friction reducing approaches such
as hydro bearings.
[0100] Washer 414 has a suitable inner diameter such that threaded
shaft 482 can pass through the inner diameter but bearing unit 412
cannot pass. Washer 414 has an outer diameter such that washer 414
rests on extension 454 of crank 406 covering the opening to
compression unit 408 between housing 404 and crank 406. Two
optional spacers preferably are located with one on each side of
compression unit 408. The spacers have the shape of a washer but
with a suitably larger inner diameter and smaller outer diameter
than washer 414 such that the spacers fit within the cavity between
crank 406 and housing 404.
[0101] The primary components of the resistance applicator 400
preferably are made from metals and/or alloys. Aluminum alloys and
stainless steel are suitable metals for the construction of housing
and crank components. Rigid polymers can be used in place of metals
for the housing and crank elements. The spacers preferably are made
of brass. The housing disc preferably is made from spring steel,
and the crank disc preferably is made from spring tempered phosphor
bronze. The bearing case can be made from Nylon.RTM..
[0102] Resistance applicator 400 is designed to attach to a hinge
such that housing 404 moves with a frame member attached to one
side of the hinge while crank 406 moves with a frame member
attached to the other side of the hinge. Thus, rotation of the
hinge results in rotation of housing 404 relative to crank 406.
Tightening of knob 410 presses washer 414 down onto compression
unit 408. Housing rings and crank rings rotate relative to each
other when housing 404 moves relative to crank 406. Increasing the
pressure on compression unit 408 results in increased resistance in
the rotation of housing 404 relative to crank 406 because of
friction between housing rings and crank rings. This design
provides for sensitive adjustment rotational resistance by rotation
of knob 410. The improved hinge 300 shown in FIG. 9 combined with
the improved resistance applicator 400 is described further in the
60/098,779 application.
[0103] In alternative embodiments, a hinge takes the form of an
articulating hinge 490, as shown in FIG. 11. Articulating hinge 490
can be made with resilient collapsible materials such as a bendable
straw, sliding sections that can slide past each other to
articulate, or other similar constructions. Sliding sections can be
locked relative to one another by way of clamps 492 attached to
slots 494 defining a range of motion, where the clamps are
tightened manually with wing nuts or the like, or electronically
with solenoids or the like. As shown in FIG. 11, articulating hinge
490 is connected to two support portions 166 that surround the
corresponding body portions. Alternatively, one or both support
portions 166 can be replaced with other types of support portions
or by linkers that connect the support portions to hinge 490.
[0104] Certain joints such as the knee are cams that do not involve
rotation about a single axis. A biaxial hinge can be used to more
closely approximate the motion of the joint cam. A biaxial hinge
500 generalizing on the structure of hinge 300 is shown in FIG. 11.
Biaxial hinge 500 includes a proximal arm 502 and a distal arm 504.
Proximal arm 502 includes teeth, which engage teeth on distal arm
504. Proximal arm 502 further includes lock notches and an
electrical contact for position (orientation) sensing. A control
ring operates similarly to control ring 346 in hinge 300 to control
the locking/unlocking of the hinge. Further details on biaxial
hinge 500 can be found in the 60/098,779 application.
[0105] Orthosis 130 shown in FIG. 2 includes hinge 136 capable of
rotation in multiple planes to provide for multiple ranges of
motion about a single joint. A first embodiment of a hinge capable
of motion in multiple planes is shown in FIG. 13 and an exploded
view in FIG. 14. Hinge 510 includes rod 512 that moves within
sleeve 514. Sleeve 514 has four resilient sections 516 that form a
truncated conical shape. Sleeve 514 further has threads 518. Cap
520 fits over and screws onto sleeve 514. Cap 520 includes worm
gear threads 522. Lever 524 has mated worm gear threads 526 to
complete the worm gear with lever 524 adjacent cap 520.
[0106] Cap 520 can be screwed to varying degrees to increase or
decrease the tension at resilient sections 516. Tension at
resilient sections 516 grips rod 512 to a corresponding degree. The
worm gear comprising threads 522 and 526 can be used to screw cap
520 on to or off from sleeve 514. The worm gear is advanced by the
rotation of lever 524.
[0107] Hinge 510 moves in two degrees of freedom, with one degree
of freedom corresponding to the rod 512 moving into or out from
sleeve 514. The rotation of rod 512 provides motion in the second
degree of freedom. Screwing cap 520 sufficiently locks both degrees
of freedom. Hinge 510 can be incorporated into a shoulder orthosis
such that motion of the rod 512 into and out from sleeve 514
provides for movement of the patient's elbow toward or away from
the torso while rotation of rod 514 provides for movement of the
arm toward the front or toward the rear.
[0108] In preferred embodiments, hinge 510 includes position
sensors such that the orientation in each degree of freedom can be
measured. In one embodiment, rod 512 includes a resistive element
530 that can be used to contact a conductive brush within sleeve
514. Resistive element 530 can be used to measure the position of
rod 512 as it projects to varying degrees within shaft 512.
Slimily, rod 512 can further include a conductive brush 532 that
contacts a resistive element. Brush 512 can be used to measure the
orientation of rod 512 depending on the rotation of rod 512 within
sleeve 514.
[0109] A second multidimensional hinge 540 is displayed in FIG. 15.
Hinge 540 includes a first hinge 542 attached to a first lever arm
544. A second lever arm 546 links first hinge 542 with second hinge
548. Rotation about the first hinge involves relative rotational
motion of first lever arm 544 relative to second lever arm 546 and
second hinge 548. Third lever arm 550 is attached to second hinge
548, such that rotation about second hinge 548 rotates second lever
arm 546 relative to third lever arm 550.
[0110] Preferably, first hinge 542 and second hinge 548 are
separately lockable, and, optionally, have adjustable resistance.
Designs for single plane hinges described above can be used for
first hinge 542 and second hinge 548. These hinges have position
sensors, such that the orientation of each hinge can be measured.
Multidimensional hinge 540 can be used advantageously in orthoses
for joints that move in multiple planes. For example, hinge 540 can
be used in a shoulder brace where one of lever arms 544 and 550
moves with the patient's arm while the other is fixed to their
abdomen.
[0111] Strain gauges 114, 116, 142 can be useful for the
performance of both isometric and isotonic exercises. Strain gauges
can be placed at any suitable location such that the strain in the
underlying material reflects the torque applied between two
respective flexibly connected body portions surrounding the joint
of interest. Suitable locations for the strain gauges involve
placement of the strain gauges on a structure that is attached to
the corresponding hinge. The strain gauges generally are located on
a rigid element near the hinge that is under stress when torque is
applied to the hinge. Since different structures have different
relationships between the support portions and the hinge, the
preferred locations for the strain gauges depend on the particular
construction of the orthosis.
[0112] Whether monitoring isometric exercises or isotonic
exercises, strain measurements obtained by way of a strain gauge
can be correlated with the corresponding forces applied by the
patient. Strain gauges 114, 116 are connected to controller 112,
which evaluates the strain based on the electrical properties of
the strain gauge. Suitable strain gauges are available from Vishay
Micromeasurements Group (Raleigh, N.C.) (e.g., type 125AD, part
number EK-XX-125AD-350 with dual copper pads), or JP Technologies
(San Bernardino, Calif.). Evaluation of the strain is discussed
further below in the context of controller 112.
[0113] As noted above, for a variety of treatments, it is useful to
incorporate an instrumented hand hold. Referring to FIG. 16, a hand
hold 600 is mounted on top of a support 602. Support 602 projects
from a arm rest 604. Support 602 should have a height for
comfortable gripping of hand hold 600. In preferred embodiments,
arm rest 604 forms part of an instrumented orthosis that, at least,
extends past a patient's elbow. Arm rest 604 can be part of a
shoulder brace, as described further below. Hand hold 600 can have
any comfortable shape for gripping, such as spherical or
cylindrical.
[0114] As shown in FIG. 17, arm rest 604 can include a wrist hinge
606. Wrist hinge 606 preferably includes a position sensor, a
position lock and adjustable friction, as described above with
respect to preferred embodiments of various hinge designs. Hand
hold 600 rests on a hand support 608 that connects to arm rest 604
through wrist hinge 606. As shown in FIG. 17, hand hold 600 rests
on hand support 608 without elevation with a support 602.
[0115] Hand hold 600 can be a bladder filled with a fluid, such as
a gas, liquid or a pseudo-liquid formed by a granular material or
the like. Alternatively, hand hold 600 can be formed from a
compressible material, such as a foam or the like. The degree of
compressibility can be selected to obtain a suitable amount of
exercise from hand hold 600. If hand hold 600 is filled with a
fluid, hand hold 600 can include one or more valves 610. Valve 610
can be used to add or remove fluid from hand hold 600 to vary the
nominal pressure in ball 600.
[0116] Hand hold 600 preferably includes a pressure sensor 612 or a
strain gauge. Pressure sensor 612 can be used to measure the amount
of force applied by a patient when squeezing hand hold 600. When
hand hold 600 is squeezed, the pressure increases in hand hold 600,
if hand hold 600 contains a fluid. A strain gauge measures forces
applied to squeeze ball 600 according to the increased strain along
the surface of ball 600. Pressure sensor 612 and/or a strain gauge
generally are connected to controller 112 by wire 614.
[0117] Suitable strain gauges were described above. Pressure sensor
612 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, and NPP 301A from
Lucas Novasensor, Fremont Calif., which are small and inexpensive.
Other suitable pressure sensors use silver oxide ink surfaces
separated by a dielectric material or piezoelectric materials that
produce a voltage when stressed.
[0118] In an alternative embodiment, the orthosis includes a hand
grip 630, as shown in FIG. 18. Hand grip 630 can be mounted in the
same way with respect to an arm support 604 as squeeze ball 600.
Hand grip 630 includes finger rests 632. Finger rests 632 are
indentations that provide a specific location for resting each
finger. In preferred embodiments, hand grip 630 includes pressure
sensors/strain gauges 634 in the vicinity of each finger rest 632.
Pressure sensors/strain gauges 634 can be used to measure the force
approximately corresponding to the force applied by a particular
finger. Pressure sensors/strain gauges 634 are connected to
controller 112 by way of wires 636.
[0119] Hand grip 630 generally includes some compartmentatization
such that forces applied by one finger are approximately segregated
in effect within a corresponding compartment. Thus, if hand grip
630 includes a fluid or fluids, the fluids can be placed within
separate compartments for each finger, preferably separated by a
relatively rigid barrier. Similarly, a compressible material, e.g.,
a foam, supporting each finger can be similarly separated by a
relatively rigid barrier.
[0120] An instrumented orthosis can be configured to delivery one
or more monitored, therapeutic energy treatments along with the
capability of performing monitored exercise. The therapeutic energy
is delivered by way of an energy transducer. Suitable types of
energy transducers include, for example, ultrasonic transducers,
pulsed electromagnetic field transducers, implantable electrical
current transducers, surface electrical current transducers, and
electrical muscle contraction stimulator. The transducers are
located at an appropriate position to provide treatment for the
injured area. The transducers preferably are controlled and
monitored by controller 112. Further discussion of combined
treatment approaches using exercise and/or energy propagating
transducers are described in published PCT application WO 96/36278,
entitled "An Orthopedic Device Supporting Two or More Treatment
Systems and Associated Methods," incorporated herein by
reference.
[0121] In simplified embodiments, controller 112 may just include
analog circuits and a suitable display. In preferred embodiments,
controller 112 includes a digital processor to provide a more
sophisticated interface with the patient and/or with a health care
professional and to perform more involved monitoring functions. The
digital processor preferably is a microprocessor. The digital
processor can be programmed in any of a variety of computer
languages including, for example, basic, assembler, C, C++ and the
like. Preferably, controller 232 is portable, which in this context
means that the controller is small enough to be ambulatory with the
patient. More preferably, controller 112 is small enough to be held
in the hand of a patient, and even more preferably to be placed in
a standard shirt pocket.
[0122] A preferred microprocessor based controller 112 has several
subsystems including a power supply such as a battery, a transducer
bias circuit such as described below, A/D converters, a
microprocessor, real time clock, RAM and non-volatile storage such
as FLASH, SRAM or EEPROM, a graphic display such as a 64.times.128
pixel LCD display with a corresponding driver, keypad, audible or
tactile feedback device, data link to transducer, and an integral
modem or RS232 standard output for serial connection or modem
access.
[0123] In one particular embodiment, the microprocessor is a
Motorola MC68HC11A1FN 8-bit microcontroller with built-in deep
sleep shutdown mode for power conservation between active events, a
programmable serial interface and an 8-channel, 8-bit A/D
converter. In this embodiment, controller 232 can provide analog
multiplexing and A/D conversion for up to 8 analog input signals
over a voltage range from 0.0 to +5.0 volts. For example, three of
the channels can be devoted to provide signal conditioning for up
to three strain gauges, and three of the channels can be devoted to
providing signal conditioning for up to three position (angle)
sensors. The remaining two input channels then can be used for
additional treatment devices. If desired, added sensors can be
handled by multiplexing and duty-cycling.
[0124] In this preferred embodiment, the controller module memory
includes SRAM, FLASH and EEPROM, where each section is
independently addressable. Each section can support, at least, 32K
words with 8-bits (1 byte) per word. The EEPROM supports in-circuit
reprogramming by way of the microcontroller serial channel for code
updates. The FLASH memory provides non-volatile storage of recorded
data. The real time clock is battery powered to allow time keeping
to continue when the microcontroller circuitry is off The real time
clock is capable of generating periodic interrupts at a
programmable rate to power switching circuitry to activate the
microcontroller during an alert mode of operation.
[0125] The RS-232 interface consists of three conductor (T.times.D,
R.times.D and GND) jack type connector with a mechanical switch to
automatically switch power on to all on-board electronics when the
plug is inserted. The baud rate of the interface is programmable
with standard rates such as 9600 and 19200. A suitable display is a
Densitron.TM. LE3328 LCD with Hitachi HD61202 and HD61203 LCD
controller chip sets. The display can be run with a five volt
supply that can be separate or not from the power supply for the
rest of controller 232. In this embodiment, a three key keypad is
interfaced with the microcontroller.
[0126] All of the components of controller 112 can be placed on the
orthosis or in a separate case. The components of controller 112
can be integrated into a single package or physically partitioned
into portions mounted on the orthosis frame and/or portions placed
into one or more small cases.
[0127] Controller 112 preferably stores a software program that
manages the use of the device for patient rehabilitation. The
software can provide for alerting the patient to scheduled times
for the performance of exercises using audible and/or vibratory
signals. Controller 112 preferably provides instructions on the
exercises as well as feedback and reinforcement messages to the
patient. The software preferably is custom programmed for the
patient by a health care professional based on an evaluation of the
patient's condition. Approaches for programming the control unit is
described further in the 60/098,779 application.
[0128] Stored information relating to the patient's performance of
exercises generally is downloaded to the supervising health care
professional at specified intervals. The download of the
information can be performed in a variety of ways. If the patient
goes to the office of the health care professional, controller 112
can be directly connected to the monitor station/computer using the
RS232 port or other port using suitable protocols including
standard protocols. Alternatively, controller 112 can be attached
to a modem by way of the RS232 port or other suitable port. Since
with certain embodiments the file sizes are relatively small, a
single chip, 9 volt supply Rockwell.RTM. 2400 baud or 9600 baud
modem can be used. Controller 112 can be in radio communication
with a monitor station. Controller 112 then would include a radio
transmitter and, optionally, a receiver. Radio communication with a
monitor station is described further and U.S. Pat. No. 5,823,975
entitled "Local Monitoring System For an Instrumented Orthopedic
Restraining Device and Methods Therefore," incorporated herein by
reference. The display or a television set similarly can be in
communication with controller 112 by way of radio transmissions or
infrared communication such that a wire attachment is not
necessary. Additional features of the controller are describe in
the 60/098,779 application.
[0129] In order for the value of electrical resistance associated
with a strain gauge to be useable as a measure of applied stress
during isometric exercises, the values must be referenced to a
"null" valve approximately corresponding to a value when no strain
is applied to the orthosis. The null value can be set by a manual
adjustment performed by the health care professional or by the
patient. The "null" value, however, is preferably established
automatically without the need for calibration by the user.
Furthermore, the variations in the resistance due the strain gauge
preferably are converted into a voltage value that is amplified to
make efficient use of an analog-to-digital (A/D) converter with a
specified number of binary digits. A preferred summing amplifier
circuit for calibrated strain gauge measurement is described in
detail in the 60/098,779 application.
[0130] Further aspects of the improved orthoses are illustrated by
reference to three particular preferred embodiments.
[0131] A. Shoulder Brace
[0132] Referring to FIG. 19, a preferred embodiment of a shoulder
brace 700 includes trunk support 702, under arm support 704,
upright support 706, shoulder hinge 708, arm support 710, elbow
hinge 712, fore arm extension 714 and controller 716. Trunk support
702 includes a padded hip rest 730 contoured to rest comfortably
against a patient's hip and distribute any downward forces over a
reasonable area. Padded hip rest 730 can include a relatively rigid
shell, made from fiber glass, polytetrafluorethylene other suitable
polymers, metal or the like. Padding, such as cloth covered foam
padding, can be placed adjacent the rigid shell. Trunk support 702
generally further includes a strap 732, which can wrap around a
patient's waist to secure trunk support 702. Strap 732 preferably
has an adjustable length, optional padding 734 and a fastener
component 736, such as a portion of a hook-and-loop fastener, a
buckle or any other suitable fastener component. A second fastener
component 738 is attached to a strap or directly to padded hip rest
730, as desired. Second fastener component 738 is the complement to
fastener component 736, such that fastener components 736, 738 can
be secured to each other.
[0133] Under arm support 704 includes a padded support portion 740,
which can include a relatively rigid shell with padding located
along the inner and/or upper surface. Under arm support 704 further
includes a strap 742, which can wrap around a patient's chest to
secure under arm support 704. Strap 742 has an optional pad 744,
and preferably has an adjustable length and a fastener component
746. A second fastener component 748 can be attached to another
strap or directly to padded support portion 748. Fastener
components 746, 748 can be complementary components of a buckle
fastener, a look-and-loop fastener, or any other suitable fastener.
Under arm support 704 further includes a shoulder strap 750.
Shoulder strap 750 can include padding 752, and preferably has an
adjustable length. In this embodiment, shoulder strap 750 extends
from strap 742 to padded support portion 740, although other
configurations are possible. Shoulder strap 750 is designed to
extend over the opposite shoulder of the patient relative to the
shoulder supported by under arm support 704.
[0134] Upright support 706 connects padded hip rest 730, padded
support portion 740, and shoulder hinge 708. Upright support can be
constructed from any rigid material such as metal, fiber glass or
other rigid material or materials. Upright support 706 can be
bolted to padded hip rest 730 and padded support portion 740,
molded into a rigid shell of padded hip rest 730 and padded support
portion 740, or secured to padded hip rest 730 and padded support
portion 740 in any other reasonable fashion. Upright support 706
can attach directly to a lever arm of shoulder hinge 708 or through
a linking element connecting upright support 706 to a lever arm of
shoulder hinge 708. Upright support 706 holds padded hip rest 730,
padded support portion 740 and shoulder hinge 708 at constant
relative positions.
[0135] Shoulder hinge 708 preferably is a hinge capable of motion
in multiple planes. Suitable designs for hinges with releasable
motion in multiple planes for use as shoulder hinge 708 are
described above. As noted above, upright support 706 is attached to
one lever arm of shoulder hinge 708. A second lever arm of shoulder
hinge 708 is attached to arm support 710.
[0136] Arm support 710 preferably includes a support brace 760 and
padded arm support 762. Support brace 760 is attached to a lever
arm of should hinge 708 and to a lever arm of elbow hinge 712,
either directly or through a linker. Padded arm support 762 is
connected to support brace 760. Padded arm support helps the
patient hold their arm in a proper position along support brace
760.
[0137] One lever arm of elbow hinge 712 is connected to support
brace 760 and a second lever arm of elbow hinge 712 is connected to
fore arm extension 714. Elbow hinge 712 is oriented such that
rotation at the patient's elbow results in rotation of the hinge,
if hinge 712 is in an unlocked setting and the patient's arm is
properly located along arm support 710 and fore arm extension 714
with their hand gripping hand hold 774. Elbow pad 764 is attached
to elbow hinge 712 or support brace 760. If desired, the lengths of
arm support 710 and/or fore arm extension 714 can be
adjustable.
[0138] Fore arm extension 714 includes extension shaft 770, bend
772 and hand hold 774. Shaft 770 can be made adjustable, such that
the distance from the elbow to the hand can be set to an
appropriate value. Bend 772 connects shaft 770 with hand hold 774.
Hand hold 774 preferably is a padded grip. Bend 772 preferably is
connected to shaft 770 by way of a wrist hinge 776. Fore arm
extension 714 preferably include straps 778 to secure the patient's
arm. The hinge shown in FIG. 9 can be adapted for use as elbow
hinge 712 and wrist hinge 776.
[0139] Shoulder brace 700 preferably includes a plurality of
transducers. As depicted in FIG. 19, strain gauges 780, 782 are
associated with upright support 706 and support brace 760,
respectively. Strain gauges 780, 782 can supply measurements
related to forces applied against a locked hinge or forces applied
for rotation of shoulder hinge 708 and/or elbow hinge 712. Shoulder
hinge 708 preferably includes a multidimensional position sensor
784, as described above. Elbow hinge 712 preferably includes a
position sensor, 786. Furthermore, hand hold 774 can include one or
more pressure/stress transducers 788, to provide measurements
related to forces applied by the patient's hand.
[0140] The transducers are preferably connected to controller 716,
generally by wires, although transmitter based approaches can be
used. Suitable designs for controller 716 were described above with
respect to controller 112 of FIG. 1. Straightforward modifications
can be made to accommodate all of the transducers desired for
shoulder brace 700.
[0141] To use shoulder orthosis 700, a patient can slip shoulder
strap 750 over their arm and head. With the weight of shoulder
brace supported on shoulder strap 750, straps 732 and 742 can be
secured to distribute the weight and balance of shoulder brace 700
over the various support segments. With brace 700 secured to the
patient's torso, the patient can position their arm along arm
support 710 with their appropriate hand gripping hand hold 774.
Shoulder brace 700 can serve as a support for the patient's back,
shoulder, elbow, wrist and/or hand. Furthermore, shoulder brace
provides for a variety of exercises to assist with the recovery of
an upper body injury, and/or to prevent the deterioration from lack
of use of joints near an injury. Potential exercise programs are
described further below.
[0142] B. Lower Extremity Full Leg Brace
[0143] Referring to FIG. 20, a particular embodiment of a full leg
brace 800 includes waist support 802, hip hinge 804, thigh support
806, knee hinge 808, shin support 810, ankle hinge 812, ankle/foot
support 814, foot rest 816 and controller 818. Waist support 802
preferably secures at the patient's waist to support the upper
portion of full leg brace 800. Waist support 802 can have a similar
design as trunk support 702, described above. Waist support 802
generally includes support section 820 and hinge link 822. Support
section 820 can be formed from one or more segments of rigid shell
with inner padding to cushion contact with the patient. Multiple
rigid shell segments can be connected with flexible segments for
easier fastening around the patient's waist. Waist support includes
straps 824 or the like to provide for easy fastening and
unfastening of waist support 802. Hinge link 822 provides for rigid
connection of support section 820 with hip hinge 804.
[0144] Hip hinge 804 preferably is a hinge capable of motion in
multiple planes. Suitable instrumented hinges with motion in
multiple planes were described above. Preferred hip hinges 804
provide for motion of the leg forward-to-back as well as
side-to-side, when the hinge is unlocked.
[0145] Thigh support 806 includes a hinge link 830, a support
segment 832 and frame members 834, 836. Hinge link 830 provides
rigid support between hip hinge 804 and support segment 832.
Support segment 832 preferably encircles the patient's thigh, to
secure thigh support 806. Support segment 832 generally includes
rigid shell segments with padding. In preferred embodiments,
support segment 832 includes flexible segments connecting rigid
shell segments. One or more flexible segments preferably include a
releasable fastener 838, such as a hook-and-loop fastener to
provide for easy fastening and unfastening of support segment 832.
Frame members 834, 836 provide rigid connection between support
segment 832 and knee hinge 808. Frame members 834, 836 can be
designed to have adjustable lengths to provide a proper fit.
[0146] In this embodiment, knee hinge 808 includes hinge elements
840, 842, connected, respectively, to frame members 834, 836.
Several suitable designs for instrumented hinge elements 840, 842
are described above. Hinge elements 840, 842 connect to shin
support 810, such that shin support 810 and thigh support 806
connect to different lever arms of each hinge element 840, 842.
[0147] Shin support 810 includes frame elements 850, 852 and straps
854, 856, 858, 860 connected to frame element 850. Frame elements
850, 852 connect with hinge elements 840, 842, respectively. The
patient's leg rests between frame elements 850, 852. Straps 854,
856 connect over the front of the patient's leg, while straps 858,
860 connect behind the patient's leg. Straps 854, 856, 858, 860 can
include padded portions. Straps 854, 856, 858, 860 generally have
an adjustable length and include fastener element 862, 864, 866,
868. Matched fastener elements 870, 872, 874, 876 are connected to
frame element 852 directly or with straps. Fastener elements 870,
872, 874, 876 can be elements of a clip, a buckle, hook-and-loop
fastener or other suitable fastener. Fastener elements 870, 872 and
874, 876 together can be single sheets of hook or loop material of
a hook-and-loop fastener.
[0148] In this embodiment, ankle hinge 812 includes hinge elements
880, 882, connected respectively to frame elements 850, 852.
Several suitable designs for instrumented hinge elements 880, 882
are described above. Hinge elements 880, 882 connect to ankle/foot
support 814, such that ankle/foot support 814 and shin support 810
connect to different lever arms of each hinge element 880, 882.
[0149] Ankle/foot support 814 includes frame segments 884, 886.
Frame segments 884, 886 connect with hinge elements 880, 882,
respectively. Frame segments 884, 886 further connect with foot
rest 816. Frame segments can be made adjustable such that the
distance from hinge elements 880, 882 to foot rest 816 can be
adjusted to the proper length for the patient.
[0150] Foot rest 816 includes a heel support 890 and foot strap
892. Heel support 890 is contoured to the fit the rear portion of a
patient's foot. Foot strap 892 wraps around the patient's foot to
secure the patient's foot against heel support 890. Strap 892
preferably has an adjustable length to obtain a proper fit. Foot
strap 892 includes a fastener portion 894 that connects with mated
fastener portion 896. Fastener portion 896 generally is connected
to heel support 890 on the opposite side relative to the connecting
point of foot strap 892. Fastener portions 894, 896 can be portions
of any suitable fastener, such as buckles, clasps, hook-and-loop
fasteners and the like.
[0151] Full leg brace 800 preferably includes a plurality of
transducers. As depicted in FIG. 20, strain gauge 900 is associated
with hinge link 822. Strain gauge 902 is associated with frame
member 834. Strain gauge 904 is associated with frame segment 884.
Strain gauges 900, 902 and 904 can supply measurements related to
forces applied against a locked hinge or related to rotation of hip
hinge 804, knee hinge 808, and/or ankle hinge 812. Hip hinge 804
preferably includes a multidimensional position sensor 906, as
described above. Hinge element 840 of knee hinge 808 preferably
includes a position sensor, 908, to measure the orientation of knee
hinge 808. Similarly, hinge element 880 of ankle hinge 812
preferably includes a position sensor, 910. Furthermore, heel
support 890 can include one or more pressure/stress transducers
898, to provide measurements related to forces applied by the
patient on their heel.
[0152] The transducers are preferably connected to controller 818,
generally by wires, although transmitter based approaches can be
used. Suitable designs for controller 818 were described above with
respect to controller 112 of FIG. 1. Straightforward modifications
can be made to accommodate all of the transducers desired for full
leg brace 800.
[0153] The brace shown in FIG. 20 is intended to be worn on the
patient's left leg. A corresponding brace can be constructed for
the patient's right leg based on this design by connecting the leg
portion of the brace to the other side of waste support section
820. The leg portion can be identical in construction to the left
leg version shown in FIG. 20, or the leg portion can involve
reversal of the left and right hand elements on the leg portion,
such that the resulting right leg portion corresponds to the left
leg portion reflected through a symmetry plane going through the
center of the leg portion. Furthermore, a lower extremity brace
that supports both of the patient's legs can be constructed with a
single waste support section 820 connected through two hip hinges
804 to appropriate supports for both legs.
[0154] For use, fill leg brace 800 is placed around the patient's
leg with the foot supported by foot support 816, with waist support
802 secured at the patient's waist, and support segment 832 secured
around the patient's thigh. Straps 854, 856, 858, 860 and 892 are
appropriately fastened to fully support fill leg brace 800. Full
leg brace 800 can be used to provide valuable support for the
patient as well as for the performance of a variety of monitored,
programmed exercises, as described further below.
[0155] C. Stroke Brace
[0156] Preferred embodiments of a stroke brace have upper body and
lower extremity support. For the most common stroke debilitation,
i.e., hemiparesis affecting one whole side of the body, the
shoulder brace and fill leg brace described above can be combined.
Shoulder orthosis 700 of FIG. 19 can be used along with lower
extremities orthosis 800 of FIG. 20. In these embodiments, a common
trunk support is substituted for trunk support 702 and waist
support 802. The common trunk support is straightforward to design
by incorporating the features of trunk support 702 and waist
support 802.
[0157] With respect to instrumentation, transducers from orthoses
700, 800 can be connected to separate controllers 716, 818, or the
transducers preferably can be connected to a single controller
adapted to accommodate all of the transducers of both orthoses.
Shoulder orthosis 700 can be physically connected to lower
extremities orthosis 800 for stability, or orthoses 700, 800 can be
physically disconnected except for possibly connection to a single
controller.
[0158] 2. Rehabilitation Using Orthoses
[0159] The controllers described above preferably are programmed
under the supervision of an appropriate health care professional.
In one preferred embodiment, the controller has four modes of
operation: OFF, STANDBY, ALERT and FULL ON. In the OFF mode,
primary and backup battery power are removed, and no operations are
taking place in the controller. In the STANDBY mode, no primary
battery power is online, and backup battery power is used to
maintain the real time clock and SRAM. Back-up power can be
supplied by a coin cell or the like. STANDBY mode is generally used
while the primary battery is being replaced or recharged.
[0160] In ALERT mode, the real time clock produces a signal at
programmed, periodic intervals to activate all on-board electronic
components. ALERT-ACTIVE submode has all circuits active. Exercises
are generally performed during the ALERT-ACTIVE mode. In
ALERT-SLEEP submode, only the real time clock and SRAM memory
remain active. ALERT-SLEEP mode is the standard mode of operation
between exercise prompts. To allow switching between submodes,
primary and backup battery power should be available during the
ALERT mode. A beeper function can be used to prompt the patient
that an exercise time has been reached.
[0161] FULL-ON mode primarily is used during programming and data
transfer operations. All on-board electronics and the display are
active. FULL-ON mode can be activated automatically when an
interface cable is connected.
[0162] In a preferred embodiment, the controller can prompt and
monitor the performance of isometric exercises, range of motion
exercises, isotonic exercises and/or neurosensory, reflex,
proprioception and neuromotor exercises. When the patient has
suffered a stroke, preferably the exercises involve more than
simple proprioception. The stroke generally destroys neurological
pathways involving brain cells controlling reflexes, movements, and
the like. Thus, the patient must relearn new neurological pathways
connected to different memory locations. A variety of reflex
exercises can be used to relearn these neurological pathways.
[0163] When the health care professional programs the controller,
the desired exercises from this group of possible exercises are
selected along with the associated parameters and timing conditions
for the selected exercises. Also, the controller preferably can
store two or more sets of exercise routine parameters that can be
used in different time intervals relative to the start of
rehabilitation. In other words, after a first set of exercise
routines have been used for a certain period of time, the
controller selects a second, generally more difficult, set of
exercises for the patient to perform. These exercises can be
performed for any selected joint or group of joints.
[0164] Similarly, the control unit can be programmed to prompt the
patient to perform different exercises at different time of the
day. These can be designed in a variety of ways by the health care
professional based on the particular circumstances of the patient.
For example, the control unit can prompt the patent to perform
range-of-motion exercises every three hours, finger squeeze
exercises every hour and longer exercise sessions for neurological
rehabilitation every evening.
[0165] Preferably, the controller prompts the patient at the time
for performance of the selected exercises. In some embodiments, the
patient presses a key when they are ready to proceed. The display
on the monitor can graphically show the patient's motions with
suitable coordinates for the particular exercise and compare them
with a target performance, if suitable. The controller can store
all of the data points or averages over a set of exercises
performed over a period of time.
[0166] To perform the isometric exercises of a particular joint,
the corresponding hinge is adjusted to a particular angle. If a
manual hinge is used, the hinge is manually adjusted. The
controller may instruct the patient if the hinge is set at the
desired angle. At the correct angle, the patient applies stress
against the fixed hinge in one direction or the other. The
controller instructs the patient if the applied stresses are within
tolerance values of a target value. The controller preferably
prompts the patient regarding the timing of the exercises,
including the repetition rate and the amount of time to hold an
applied stress. After the selected number of repetitions are
performed the exercises are terminated or a new angle of the hinge
is selected. The process is repeated until exercises are performed
at all of the desired angles for the particular joint. For hinges
that rotate in multiple planes, the joint can be exercised with
forces applied along any plane of motion appropriate for the joint.
The motion can be in a single plane at a particular time or within
multiple planes simultaneously, such as moving a hand in a circle
with an outstretched arm.
[0167] Improvement in joint function can be advanced with attention
to achieving a desirable range-of-motion (ROM). The ROM can be
monitored using the orthosis with a suitable position sensing hinge
or hinges, as described above. The particular hinge is set to allow
rotation, at least over a portion of the possible rotation range.
For hinges that rotate in multiple planes of motion, the
range-of-motion exercises can be performed in the different
planes.
[0168] Proprioception in this context refers to the patient's sense
of position in space, such as the bend of a particular joint. This
seeming innate knowledge is a learned phenomenon involving a
complex interaction of nerve sensations from sensors that are
processed and combined with feedback and correction. A joint has
dozens of single-celled measurement sensors: Paninian-like
receptors, Ruffini corpuscles and the like. The brain and spinal
cord process the information from these cellular sensors. When a
joint is damaged, dozens of sensors may be permanently lost. For
example, the anterior cruciate ligament of a knee has over 60
sensor/receptor cells some of which may be lost when the ligament
tears. The body makes up for lost receptors by recruiting new
sensor information from adjacent places. A new pathway and analysis
must be relearned by the nervous system. With a properly designed
orthosis this process should be accelerated and enhanced.
[0169] In one embodiment, the controller display prompts an action
through a graphic display, for example, to get a ball back into a
circle, and the patient must react quickly, reflexively with the
rehabilitating joint in the orthosis to move the ball on the
screen. The position of the ball on the screen is correlated with
the position of the joint by way of the position sensor in the
orthosis operably connected to the controller. By changing the
position of the joint, e.g. knee, the patient can move the ball
back into the circle or to another target of some kind. These
exercises improve cooperation and coordination. A similar game
format can be used to perform isometric exercises where the amount
of strain measured by the strain gauge is used to move the cursor.
For hinges/joints that rotate in multiple planes, the full range of
motion can be explored in a proprioception exercise.
[0170] Isotonic exercises are similar to the range-of-motion
exercises except that selected resistance is provided in the
selected hinge. Resistance is provided by a manual unit, such as
resistance unit 400 above, or by an electrical resistance hinge
actuated by a controller, such as electromechanical hinge 240
above. In any case, a desired amount of resistance is set manually
or automatically. The joint is then flexed over a prescribed
range-of-motion. A controller can monitor the degree of flexing of
the joint using a position sensor in the hinge and the amount of
forces applied during the flexing using a strain gauge. The strain
gauge can be calibrated such that a strain reading can be matched
with a corresponding torque applied to the hinge.
[0171] Some preferred embodiments include an additional component
to provide for closed chain exercises when used with the joint
supporting component. Closed chain exercises involve muscular
motion against resistance to mimic natural motions against gravity
or to provide balanced stresses to the joint. Closed chain
exercises can be contrasted with open chain exercises where a limb
or trunk is moved or stressed in space without any resistance
against the motion other than perhaps the weight of the limb
itself. Closed chain exercise may provide more balanced exercise of
the various muscle groups within a patient's limb or trunk. The
closed chain component may or may not be physically connected with
the joint supporting orthosis components.
[0172] For the performance of closed chain exercises, a body
portion pushes against an essentially immovable surface. The
surface can be a floor, a wall, a table top or the like. In order
to monitor the forces being applied, a sensor is used that is
placed between the body part and the surface, for example, the
stress sensor 898 of heel support 890. If closed chain exercises
are to be performed with joints other than the knee, a suitable
force sensor can be used. For example, a elbow can be exercised
pushing with a hand against a pad sensor on a table or against a
wall. These sensors can be connected to the controller. Additional
information on the performance of the exercises described above and
the corresponding programming of the controller is found in the
60/098,779 application.
[0173] As noted above, the controller can be attached to a variety
of additional devices, such as closed chain exercise units, energy
propagating transducers and the like, to assist with treatment.
Generally, the monitoring of the operation of these additional
units can be performed with the controller in a straightforward
manner.
[0174] The controller can be programmed to accept other input from
the patient. In particular, inquiries can be directed to the
patient at the start of an exercise routine, at the end of an
exercise routine or at other times. The answers are stored for
downloading to a health care professional along with suitable
information regarding the performance of programmed exercises.
[0175] As part of the monitoring operation, the controller
preferably, continuously monitors the performance of an exercise to
prevent difficulties. For example, after exercises have been
started, the transducer parameters are evaluated to determine if
the exercises are being performed within specified parameters. If
the exercises are not being performed within tolerance values, a
sound warning can be given. Additional description on the
performance of exercises with an instrumented orthosis are
described in the 60/098,779 application.
[0176] Periodically, the information stored by the processor is
downloaded to a health care professional. Various methods for
downloading the information were described above. In principle, the
controller can store all of the information about the performance
of particular sets of exercise routines and download all of this
information for analysis. Alternatively, the controller can perform
some initial data analysis to reduce the amount of data that must
be stored and transferred. The preliminary analysis, if any,
performed by the controller can include grouping and/or averaging
of groups of exercises over certain periods of time and/or
performed at particular times of the day. Thus, raw or analyzed
data can be transferred. This analysis can involve an evaluation of
variation with the progress of time to assist the health care
professional evaluate whether the patient is making sufficient
improvement and to evaluate whether the exercise routine programmed
into the controller is appropriate.
[0177] To reduce the chance of the patient injuring themselves
using the orthoses described herein, the patient preferably is
examined by a trained health care professional prior to using the
orthosis. Upon evaluating the condition of the patient, the
controller is programmed for suitable exercises. In preferred
embodiments, a monitor station assists the health care professional
with the programming process. Once the controller is connected to
the monitor station by way of an RS 232 connection, a modem
connection, a radio connection, a IR connection or other suitable
connection using an appropriate protocol the program is downloaded
into the controller.
[0178] At prescribed periods of time, information stored in the
controller regarding the performance of the exercises by the
patient can be downloaded into the monitor station. The time
interval can be determined based on the storage capacity of the
controller, the suitable length for evaluation of progress by
health care professional or other similar issues. The download of
information from the controller to the monitor station can be
performed at the health care facility where the monitor station is
located or from a remote location. If performed at the health care
facility, the information can be downloaded by direct hook up of
the controller with the monitor station or through a modem, radio
connection, infrared connection or the like. Remote hook up can be
performed with a modem connection, internet connection, radio
communication or other longer range connection. A combination of
the downloading of performance parameters with telecommunications
capability is described further in copending and commonly assigned
U.S. patent application Ser. No. 09/226,866, entitled "REMOTE
MONITORING OF AN INSTRUMENTED ORTHOSIS," incorporated herein by
reference.
[0179] Suitable analysis is performed of the data for example, the
downloaded data on the exercises can be plotted in raw form or
following some form of data averaging or selection. Based on an
evaluation of the downloaded data, the health care professional can
maintain the exercise program in its initially programmed form or
modify the exercise program to account for unexpected developments.
In preferred embodiments, the health care professional can
reprogram the controller remotely such that any desired changes in
the routine can be made without the patient needing to visit the
health care facility. Further information on performance data
analysis is found in the 60/098,779 application.
[0180] One of several important functions of a microprocessor
controlled orthosis is to monitor compliance with performance of
exercises. A useful adjunct to the compliance monitoring function
can be achieved by performing a psychological evaluation of the
patient. The psychological test can be used to evaluate the
suitability of the programmed exercises as well as indicate other
potential problems with the healing process not directly linked to
the exercises.
[0181] Specifically, patients undergoing treatment for an injury
are under stress. Pain, immobility, lack of understanding, fear
contribute to the stress resulting from the injury. The stress
complicates recovery because the stress interacts with other
emotional or physical complaints. In particular, patients under
stress undergo changes in their psychology. This psychological
change commonly manifests itself as depression, fear, anxiety,
anger or other types of decompensation.
[0182] The stress and associated changes in psychology complicates
the recovery by impairing the patient's ability to understand the
problem and to cooperate filly in their own recovery. For example,
depressed patients experience more pain, as measured by increased
need for pain medication. Also, depressed patients exert less force
during physical testing and, therefore, are measurably weaker.
Thus, stress and associated complications can result in an
objective, measurable decrease in physical ability.
[0183] In the past, such factors generally have been accommodated
or accepted as unavoidable because there has been no way to follow
easily or to evaluate reasonably the changes in the patient's
mental state. The ability to monitor the patient's mental emotional
state can lead to important advances in the treatment of orthopedic
injuries. To make effective use of the information on the patient's
emotional state, the information preferably is coordinated with
other aspects of the orthopedic and neurological recovery.
[0184] As a result of their injury, patients likely will undergo a
predictable series of changes as they first adapt to the pain of
their injury, the inconvenience, the expense and the change in
their function. The patient's emotional changes likely will include
aspects of denial anger, bargaining, acceptance, etc., which have
also been associated with death and dying, as described by
Elisabeth Kubler-Ross. For a more complete description of these
emotional changes see "On Death and Dying," Elisabeth Kubler-Ross,
Simon & Schuster (1969), incorporated herein by reference.
These changes can be correlated with predictable or identifiable
factors, such as age, gender, mechanism and socio-economic
status.
[0185] The emotional changes are a form of psychological pain.
Since it is known that patients will undergo these emotional
changes, a more complete treatment of the patient includes the
management of the emotional changes accompanying the physical
trauma. Effective management and/or treatment of the emotional
changes preferably would involve 1) education, 2) monitoring, 3)
accurate characterization, 4) cooperation-based contingent
intervention, and 5) communication.
[0186] In analogy with Kubler-Ross models, patients can benefit
from the simple knowledge that emotional changes are common and
predictable. Reassuring information can be passed along to the
patient at regular intervals, consistent with identifiable patient
demographic parameters. Patient suffering is reduced by mental
preparation. The educational data can only be presented with
optimum timing if the patient's ability to absorb the information
is known. Thus, individual specific and time specific psychological
quantification can be used to considerable advantage. Psychological
quantification can be accomplished efficiently through portable
psychological testing coordinated with the patient's physical
therapy or exercise prescription. In particular, appropriate
educational information can be presented by the controller.
[0187] As part of the monitoring function, the treating
professional preferably knows what the patient is experiencing and
when they are experiencing it. These experiences will be based on
the patient's specific stresses, demands, events and individual
psychology. The experiences also will parallel progress or relapse
in the orthopedic treatment regime. While qualitative features of
the patient's emotional responses may be predictable, it is
difficult to know when the psychological treatment can be
effectively provided. By analogy, with physical discomfort the
specific timing of effective administration of pain medication,
assistance with physical activities and nursing assistance is
highly variable and patient specific. The treatment is more
effective when the patient is able to say when they require pain
medication or other forms of help.
[0188] Monitoring is an important component to effective treatment.
Effective monitoring is not possible without ongoing, systematic
and injury appropriate querying of the patient. To perform this in
a cost effective way, the monitoring function must be portable with
the patient. This portable monitoring can be accomplished by
incorporating psychological monitoring on an orthopedic management
system, such as those described herein. In particular, the
monitoring function can be coordinated by the controller, which is
programmed to pose questions and to receive answers from the
patient. The psychological monitoring can be used to modify
parameters in the orthopedic management, such as device comfort,
exertion levels and pain control, when the monitoring function
detects deviations from an expected emotional or psychological
condition.
[0189] To obtain an accurate characterization of the patient's
emotional state, the treating professional and the patient need to
work together to determine the stage of the patient's emotional
recovery, the depth and type of the patient's distress, and changes
in the patient's emotional condition as the problem either resolves
or worsens. There are a number of literature based instruments
available that have been used to characterize patients on a
one-time basis to quantify an emotional state. These instruments
can be adapted to an ongoing monitoring of a constantly evolving
medical-surgical state, such as associated with an orthopedic or
neurological injury.
[0190] A first instrument for emotional evaluation involves the
formation of a pain diagram. The patient is asked if the pain
occurs at the expected location. Pain away from the expected
location may indicate a complication or missed injury. See the
discussion in Mayer et al., "A Prospective Short-Term Study of
Chronic Low Back Pain Patients Utilizing Novel Objective Functional
Measurement, Pain 25:53-68 (1986), incorporated herein by
reference.
[0191] An alternative approach is known as the Million analog
scale. The patient is asked to characterize their discomfort based
on a range of possible limitations. For example, they may be asked
to state on an arbitrary scale their perceived functional
restriction from "no pain" to "worst possible pain." In addition,
they may be asked whether they are easily able to work, unable to
work or some gradation between these limits. The responses
generally change based on the patient's recovery process and their
perception of their recovery process. Thus, this is a
straightforward tool to regularly administer during high risk
periods as a significant tool to report changes in the patient's
condition. For further discussion of this approach see, for
example, R. Million et al., "Assessment of the Progress of the
Back-Pain Patient," Spine, 7(3):204-212 (1982), incorporated herein
by reference.
[0192] Patient's often find it difficult to describe their
symptoms. In addition, patients in a certain high risk category for
back injury are likely to have a range of educational limitations.
This is a paradox that the patients who are most likely to sustain
a certain type of injury are also least likely to be able to
adequately characterize it as needing and deserving treatment. The
McGill Pain Questionnaire provides a tool to overcome these
difficulties. The McGill Pain Questionnaire uses words that the
patient can understand and appropriately choose, but words that the
patient would not likely use without suggestion. The words are
provided in a format and grouping that tells more about the
patient's situation and emotional state than just their pain level.
A further description of the McGill Pain Questionnaire is described
in R. Melzack, "The McGill Pain Questionnaire: Major Properties and
Scoring Methods," Pain 1:277-299 (1975), incorporated herein by
reference. The questionnaire can be updated and modified as
appropriate.
[0193] Another potential instrument is the Beck Depression
Inventory (BDI). Depression often follows injury and states of
pain. A method of polling the patient for signs of depression would
be another usefull method of controlling and improving the recovery
process, as the patient progresses through their disease
process.
[0194] The BDI is a series of questions whose answers reflect the
patient's mental state with respect to indications of depression.
The BDI provides a standardized, objective measure that
approximates clinical judgments of the intensity of depression
without variability due to an evaluator's idiosyncrasies or
theoretical orientation. The BDI's ease of administration and low
cost provide for its economical use, for example, with a patient
suffering from an orthopedic injury. Furthermore, statistical
analysis can be performed with the quantitative data generated by
the BDI.
[0195] In its standard form, the BDI consists of 21 items that are
scored to assess the patient's state of depression. Each of the 21
items can be rated on a scale of 0-3 such that the total score
ranges from 0-63. The patient selects the number next to a
statement that reflects the way that he/she has felt over a
selected time period. The degree of depression is evaluated by the
sum of the individual numbers with totals indicating as follows:
0-9 no depression, 10-16 mild depression, 17-29 moderate depression
and 30-63 severe depression. In the standard test, the 21 items
are: 1) sadness, 2) pessimism, 3) failure, 4) dissatisfaction, 5)
guilt, 6) punishment, 7) self-dislike, 8) self-accusations, 9)
suicidal thought, 10) crying, 11) irritability, 12) withdrawal, 13)
indecision, 14) self-image, 15) work inhibition, 16) insomnia, 17)
fatigue, 18) anorexia, 19) weight loss, 20) hypochondria, 21)
libido loss.
[0196] In summary, these instruments can be used 1) to demonstrate
the location of pain as typical or atypical (the pain diagram), 2)
to evaluate the patient's own perceived level of disability (the
million analog scale), 3) to describe the specific nature of the
pain as stinging, burning, torturing, or the like (the McGill Pain
Questionnaire), or to reflect the effect of the difficulties on the
patient's mental state (Beck Depression Inventory). Suitable tests
are described further in the 60/098,779 application. Thus,
standardized instruments for emotional evaluation can be integrated
into an orthopedic treatments regime organized around an
instrumented orthosis.
[0197] In particular, the questions can be posed and the answers
received through the controller. These questions can be posed at
regular intervals. The questions can be interspersed throughout the
day and coordinated with the timing of exercise routines. In
particular, different subset of questions can be asked at different
times. For example, a subset of questions on pain levels can be
asked in the morning while a subset of questions on depression can
be asked in the afternoon. To assist with these tests, the
controller can be attached to a television set to provide a larger
display, if desired. If administered in an appropriate and timely
manner, the subjective aspects of the patient's suffering can be
identified and quantified for appropriate intervention.
[0198] The psychological test can be integrated with the physical
evaluation of the patient to form a more complete overall
evaluation. Using this evaluation, the exercise routine can be
modified in response partly to the to mental attitude of the
patient to help assure further compliance with the exercises and to
increase the comfort level of the patient. The balance of all of
these factors can lead to faster rehabilitation of the patient.
[0199] The patient's ability to cooperate with their treatment is
determined by their emotional state. Like physical pain, the
patient's emotional state changes in a highly individualized
manner. If the patient's emotional state can be more scientifically
evaluated, characterized and bracketed with identifiable ranges and
types, the modification to a more effective or more pleasurable
reinforcement scheme can be assisted through cooperation-based
contingent intervention. In particular, the information received
from the patient is used to improve the cooperation of the patient
in their own recovery. Thus, the relationship between the patient
and the treating professional is augmented in a way that
strengthens the relationship without adding unreasonable cost to
treatment.
[0200] With respect to implementing the cooperation-based
contingent intervention, the controller first evaluates the
immediacy of the patient's state. If there are serious concerns,
such as if the patient indicates that the pain is unbearable or
tortuous or if the patient is seriously depressed, the controller
can either instruct the patient to immediately call the doctor or
directly interface with the health professional's computer to down
load the information, with the patient's help, if needed.
Alternatively, the controller can modify the exercise level by
decreasing the exertion if the pain is higher than desired or
increase the level if the pain is low and the patient is frustrated
by the slow pace.
[0201] Thus, the patient's physical and mental condition, as
communicated in the psychological evaluation, can provide useful
information regarding the modifications to the treatment program in
response to the patient's evolving physical condition and the
mental state of the patient. Cooperation-based contingent
intervention involves integrating the result of the psychological
evaluation to the patient's evolving physical abilities to provide
for improved adjustment of the treatment program. For example, a
variety of different formats for presenting a particular exercise
can be tried to evaluate whether the patient is more receptive to
the particular formats. The formats can be put in the form of a
game or in the form of detailed instructions with continuous
positive reinforcement.
[0202] Communication with the health care professional is an
important aspect of the process. The controller can be used to
intervene in the communication process to ensure that important
information is communicated in a timely way. Regardless of any
immediate concerns, the outcome of the patient's responses are
reported to the treating professional for confirmation, data
analysis and other types of support. Prior to evaluation by the
health care professional, the patient's responses are characterized
and identified. This can be done by the controller or by a remote
processor. A scientific and quantifiable method of evaluating
emotional change is an important component of the evaluation
process.
[0203] As a supplement to or as an alternative to, the questioning
of the patient regarding their emotional state, physiological
measurements can be made regarding conditions correlated with
stress. For example, pulse rate can be measured with, for example,
a laser Doppler sensor or a pulse oximeter. A pulse oximeter is an
apparatus that the patient inserts their finger into to measure
pulse rate and blood oxygenation. Similarly, galvanic skin response
can be measured using electrodes placed on the skin. The electric
resistance of skin is measured with the electrodes. In addition,
blood pressure can be measured with a blood pressure cuff. These
physiological measurements can be controlled and monitored with the
controller. The physiological measurements can then be downloaded
to the health care provider.
[0204] The embodiments described above are intended to be
illustrative and not limiting. Additional embodiments are within
the claims. Although the present invention has been described with
reference to preferred embodiments, workers skilled in the art will
recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
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