Note: Descriptions are shown in the official language in which they were submitted.
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RANGE OF MOTION DEVICE
FIELD OF TIIT INVENTION
The present invention relates to an adjustable orthosis for stretching tissuc
in the human
body. In particular, the present invention relates to an adjustable orthosis
which can be used for
stretching tissue such as liga2-nents, tendons or muscles around a joint
during flexion or extension
of the joint.
BACKGROUND OF THE INVENTION
In a joint, the range of motion depends upon the anatomy of that joint and on
the
particular genetics of each individual. Typically, joints move in two
directions, flexion and
extension. Flexion is to bend the joint and extension is to straighten the
joint; however, in the
orthopedic convention some joints only flex. For example, the ankle has
dorsiflexion and
p[antarflexion. Other joints not only flex and extend, they rotate. For
exarnple, the elbow joint
has supination and pronation, which is rotation of the hand about the
longitudinal axis of the
forearm placing the palm up or the palm down,
When a joint is injured either by trauma or by surgery, scar tissue can form,
olten
resulting in flexion or extension contractures. Such conditions can limit the
range of motion of
the joint, limiting flexion (in the case of an extension contracture) or
extension (in the case of a
flexion contracture) of the injured joint. It is often possible to correct
this condition by use of a
range-of-motion (ROM) orthosis.
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ROM orthoses are devices commonly used during physical z-ehabilitative therapy
to
increase the range-of-motion over Nvhich the patient can flex or extend the
joint. Commercially
available ROM orthoses are typically attached on opposite members of the joint
and apply a
torque to rotate the joint in opposition to the contraction, "1'he for-ce is
gradually increased to
increase the working range or angle of joint motion. Exemplary orthoses
include U.S. Patent
Nos.: 6,599,263, entitled "Shou.lder Orthosis;" 6,113,562, entitled "Shou.lder
Orthosis;"
5,848,979, entitled "Orthosis;" 5,685,830, entitled "Adjustable Orthosis
Having One-Piece
Connector Section for Flexing;" 5, 611, 764, entitled "Method of Increasii-ig
Range of Motion;"
5,503,619, entitled "Orthosis for Bending Wrists;" 5,456,268, entitled
"Adjustable Orthosis;"
5,453,075, entitled "Orthosis with. Distraction through Range of Motion;"
5,395,303, entitled
"Orthosis with Distraction throubh Range of Motion;" 5,365,947, entitled
"Adjustable Orthosis;"
5,285,773, entitled "Orthosis with Distraction through Range of Motion;"
5,213,095, entitled
"Orthosis with Joint Distraction;" and 5,167,612, entitled "Adjustable
Orthosis," all to Bonutti
and herein are expressly incorporated by rel:erence in their entirety.
SUMMARY OF THE INVENTION
The present invention provides an orthosis for stretching tissue around
a.joint of a patient
between first and second relatively pivotable body portions. The joint and the
first and. second
body portions defining on one side of the joint an inner sector which
decreases in angle as the
joint is flexed and defining on the opposite side of the joint an outer sector
which decreases in
angle as the joint is extended.
The orthosis includes a first arm niember affixable to the first body portion.
'1'he iirst arm
meniber has a first extension member extend.ing at an angle a. therefrom. A
second arm member
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affixable to the second body portion is also included. The second arni member
has a second
extension member having an arcuate shape extending therefrom. The second and
first extension
members are operatively connected, such that the second extension member
travels through the
fi.rst extension member along an arcuate path when the second arm member is
moved from a first
position to a second position relative to the first arm member.
The orthosis further includes a drive assenibly for selectively moving the
second
extension member relative to the first extension member. The drive assembly is
mounted onto
the first extension member, engaging the second extension member. "I'he drive
assembly can be
manually or automatically actuated to selectively move the second extension
member relative to
the first extension member.
BRIEF DESCRIPTION OF THE DRAWINGS
A more complete und.erstanding of the present invention, and the attendant
advantages
and features thereof, will be more readily understood by reference to the
following detailed
description when considered in conjunction with the accompanying drawings
wherein:
FIG. 1 is a schematic diagram of the orthosis of the present invention in a
flexcd position;
FIG. 2 is a schematic diagram of the orthosis of the present invention in an
extended
position;
FIG. 3 is a second schcmatic diagrani of the orthosis of the present
inven.tion in a flexed
position;
FIG. 4 shows an adjustable first extension member of the ortllosis of the
present
invention;
FIG. 5 shows the adjustable first extension member of FIG. 4 in a second
position;
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FIG. 6 shows a segmented first extension member of the present invention;
FIG. 7 shows an arcuate first extension member of the present invention;
FIG. 8 shows an orthosis of the present invention;
FIG. 9 shows an orthosis of the present invention for flexing and extending a
wrist joint
in a patient;
FIG. 10 shows a non-circular arcuate shaped second extension member of the
present
invention;
FIG. 11 shows an alternative arcuate shaped second extension member of the
present
invention;
FIG. 12 shows a linear shaped second extension member of the present
invention;
FIGS. 13A and B show exemplary drive assemblies of the present invention;
FIG. 14 is a top plan view of portions of an articulating hand pad support of
the present
invention;
FIG. 15 is a schematic sectional view of the articulating hand pad support of
FIG. 14;
FIG. 16 depicts a side view of another articulating hand pad support of the
present
invention;
FIG. 17A depicts a top view of the articulating hand pad support of'FIG. 16;
FIG. 17B depicts a top view of the articulating hand pad support of FIG. 16
with the
pivotijig plate removed;
FIG. 18 shows an orthosis of the present invention
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FIG. 19 shows a hand pad for the orthosis of FIG. 18;
FIG. 20 shows another hand pad for the orthosis of FIG. 18;
FIG. 21 is a schematic diagratil of an orthosis of the present invention;
FIG. 22 is a schematic diagram of the orthosis of FIG. 21 in an extended.
position;
FIG. 23 is a scheniatic diagram of the orthosis of FIG. 21 in a flexed
position;
FIG. 24 is an isometric view of an orthosis of the present invention;
FIG. 25 is a front view of the orthosis of FIG. 24;
FIG. 26 is a side view of the orthosis of FIG. 24;
FIG. 27 is a sectional view of a drive assembly of the orthosis of FIG. 24;
FIG. 28 is a scction view of an adjustable second cuff for the orthosis of
FIG. 24;
FIG. 29 is an expanded view of the drive assembly connection to the first
member of the
orthosis o f' FIG. 24;
FIG. 30 is a top view of the drive assembly of the orthosis of FIG. 24;
FIG. 31 is an expanded view of.' another drive assembly connection to the
first member of
the orthosis of FIG. 24;
FIG. 32 depicts a bottom view ofthe orthosis of FIG. 24.
FIG. 33 depicts a bottom vicw of a first cuff of the orthosis of FIG. 24;
FIG. 34 is a schematic diagram of an embodiment of an orthosis ofthe present
invention;
FIG. 35 illustrates another embodiment of the invention utilizing a cushion or
spring;
FIG. 36 is an embodiment of the invention illustrating the use of a cam
surface;
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FIG. 37 is an embodiment of the invention utilizing a slideable arcuate
surface;
FIG. 38 illustrates features of an orthosis of the invention where the
relative positions of
component parts of the orthosis are adjustable;
FIG. 39 is an illustration of the use of gears with an arcuate or canl surface
of an orthosis
of the invention;
FIG. 40 is a schematic diagram of an einbodiment of the invention using an
arcuate path
and gear or cam follower;
FIG. 41 illustrates the use of a multi-slotted component to control inovement
of the
orthosis; and
FIG. 42 illustrates an embodiment of the invention where linear movement of a
component is translated into rotational and translational movement of another
component of the
orthosis.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to an orthosis for moving a joint between tirst
and second
relatively pivotable body portions. The joint and the first and second body
portions define on
one side (the flexor side) of the joint an inner sector which decreases in
angle as the joint is
flexed (bent) atid on the opposite side (the extensor side) of the joint an
outer sector which
decreases in angle as the joint is extended (straightened). The orthosis of
the present invention is
affixable to either the flexor or extensor side of the joint for treatment of
flexion or extension
contractures.
Referring now to the drawing figures in which like reference designators refer
to like
elements, there is shown in FIG. 1, a schematic of the orthosis 10 of the
present invention. `fhe
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orthosis 10 includes a first arm member 12 attachable to the first body
portion and a second arm
member 14 attachable to the second body portion, wherein a joint axis of
rotation 16 is
interposed between and offset from the first and second arm members 12 and 14.
"I'he first and
second arm tnembers 12 and 14 arc operatively connected to each other offset
from the joint axis
16.
The first arrn member 12 of the orthosis 10 includes a first extension member
18, which
extends at angle a from the first arm member 12. The second arm member 14 of
the orthosis 10
includes a second extension member 20 extending therefrom and 1laving an
arcuate shape. The
first and second extension members 18 and 20 are operatively connected at
poilit "P," such that
in operation the second extension member 20 travels along an arcuate path
about and
substantially through point "P." TThe arcuate shape of the second extension
member 20 results in
the second body portion rotating about the joint axis 16, when the second arm
member 14 is
moved from a first position to a second position relative to the first arm
member 12. The angle a.
between the first extension member 18 and the first arm member 12 and the
radius of curvature
of the second extension member 20 are a function of the joint to be treated
and the degree of
flexion or extension contractures.
The orthosis further includes a drive assembly 22 at point "P." 'rhe drive
assembly
connects the first and second extension members 18 and 20 for applying force
to the first and
second arm members 12 and 14 to pivot the first and second body portions
relative to each other
about the joint.
The orthosis 10 of the present invention is shown having an angle a such that
the
operative comlection, at point "P," of the first and second extensions 18 and
20 is located in a
plane "A" passing through the joint axis 16, wherein plane "A" is
substantially orthogonal to a
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longitudinal axis of the farst arm member 12. This position o:l'point "P"
provides an angle Ri
between the second arm member 14 and the joint axis 16, wherein J31 is the
maximum angle of
flexion. As shown in FIG. 2, the second extension member includes a stop 24.
The stop 24 acts
to Iimit the angle of maximum extension y between the second arm member 14 and
the joint axis
16. An increase in the length of the stop 24 will decrease the angle of
maximum extension y. A
decrease in the length of the stop 24 will increase the angle of maximum
extension y.
Referring to FIG. 3, the maximum flexion angle can be increased by increasing
the angle
a. An increase in the angle a will move the point "P" to a location "in front
of' the plane "A."
This position of point "P" provides an angle j32 between the second arm member
14 and the joint
axis 16 in maximutn 1lexion, wherein Pz is greater than (3i. The greater the
angle a, the greater
the angle of maximum flexion.
Alternatively, (not shown) a decrease in the angle a will move the point "P"
to a location
"behind" the plane "A." This position of point "P" provides an angle 133
between the second arm
member 14 and the joint axis 1.6 i.n. nl.axi.muzn flexion, wherein (33 is less
than (3l. The smal.Ier the
angle a, the smaller the angle P of maximum t7exion.
Referring to FIG. 4, the first extension member 18 is selectively, pivotally
connected at
location 26 to the first arm member 12. The pivotal connection 26 of the first
extension member
18 permits the angle a between the first extension member 18 and the first arm
member 12 to be
selectively increased and decreased, increasing and decreasing the range of
motion. In a first
position 28, the first extension member 18 is positioned at an angle aI,
wberein the operative
connection, at point "P," of the first and second extension members 18 and 20
is located in a
plane "A" passing through the joint axis 16, wherein plane "A" is
substantially orthogonal to a
longitudinal axis of the first arm member 12. The first position 28 of point
"P" provides a
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maximum angle of flexion of 01. The second extension member stop 24 acts to
limit the anglc of
maximum extension yi between the second arm member 14 and the joint axis 16.
Referring to FIG. 5, in a second position 30 the angle a is increased to an
angle az,
positioning the point "P" to a location "in front of" the plane "A." The
second position 30 of
point "P" provides a maximum angle of flexion of P2, wherein P2 is greatcr
than (3 i. The second
extension inember stop 24 acts to limit the angle of maximum extension 72
between the second
arm member 14 and the joint axis, wherein yZ is less the yl.
The selective pivotal connection 26 of the first extension member 18 to the
first arm
member 12 can have a plurality of selectable positions. The angle a between
the first arm
inember 12 and the first extension 18 can be selectively increased to move the
point "P", on, "in
front of' or "behind" the plane "A." It is also envisioned that a positioned
can be selected to
increase the angle a between the first arm member 1.2 and the first extension
18 sufficiently to
move the point "P" "in front of' plane "A" and "above" the longitudinal axis
of the first arm
member 12, maximizing the maximum angle of flexion P.
The orthosis 10 of the present invention can be connected to the flexor side
of t.he first
and second body portions of the joint, which results in a decrease in angle as
the joint is flexed
(bent) and an increase in angle and the joint is extended (straightened).
Alternatively, orthosis
10 of the present invention can be connected to the extensor side of the
joint, which results in a
decrease in angle as the joint is extended straightened and an increase in
angle as the joint is
flexed (bent).
The previous description of the first arm member 12 depicts a first extension
18 having a
substantially linear shape, extending at an angle a from the first arm
m.exnber 12. However, it is
within the scope of the present invention that the first extension member 18
can be any shape
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extending trom the first arm member 12 which positioia s the point "P" in the
desired relationship
to the plane "A." Referring to FIG. 6, a segmented fist extension member is
shown, including a
first extension nieniber segment 18a and a second extension member segment
18b. The lirst aEld
second extension member segments 18a and 18b extend from the first arm member
1.2,
positioning the point '`P" at an angle a from the first arm member 12.
Referring to FIG. 7, an
arcuate first extension member 18c is shown. The arcuate extension member 18c
extends from
the first arm member 12, positioning the point "P" at an angle a from the
first arm member 12.
Referring to FIG. 8, the orthosis 10 of the present invention includes a first
arm member
12 attachable to the first body portion and a second arm member 14 attachable
to the second
body portion, wherein the joint axis 16 is interposed between and offset from
the first and second
arm members 12 and 14. The first and second arm members 12 and 14 are
connected with each
other offset from the joint axis 16.
The first arm member 12 of the orthosis 10 includes a first extension member
18, which
extends at angle a from the first arm member 12. The second arm member 14 of
the ort.llosis 10
includes a second extension member 20, having an arcuate shape. 1'hc first and
second extension
members 18 and 20 are operatively connected a point "P," such that in
operation the second
extension member 20 travels along an arcuate path about and substantially
through point "P."
The arcuate shape of the second extension member 20 results in the second body
portion rotating
about the joint axis 16, when the second arm member 14 is moved I:rom a first
position to a
second position relative to the first arm member 12. The angle a between the
first extension
rnember 18 and the first arm mcmber 12 and. the radius of cLirvature of the
second extension
member 20 are a function of the joint to be treated and the degree of flexion
or extension
contractures.
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A first cuff 32 is attached to the first arm member 12, wherein the first cuff
32 is
positionable about the first body portion. The first cuff 32 is attached to
the first body portion by
cuff straps. The first cuff 32 secures the first body portion to the first arm
member 12. A second
cuff 34 is attached to the second arm member 14, wherein the second cuff 34 is
positionable
about the second body portion. The second cuff 34 is attached to the second
body portion by
cuff straps. The second cuff 34 secures the second body portion to the second
arm member 14.
(The term "cuff' as used herein means any suitable structure for transmitting
the force of the
orthosis 10 to the limb portion it engages.)
In an exemplary use, the orthosis 10 is operated to extend a joint in the
following manner.
The first cuff 32 is fastened about the first body portion tightly enough that
the first arm member
12 may apply torque to the first body portion without having the C1rst cuff 32
slide along the first
body portion. Similarly, the second cuff 34 is fastened securely around the
second body portion
so that the second arm member 14 may apply torque to the second body portion
without the
second cuff 34 sliding along the second body portion. The orthosis 10 is
attached to the first and
second body portions in a first position. The second arm member 14 is rotated
from the first
position to a second position, relative to the first arm member 12, rotating
the second body
portion about the joint axis 16 stretching the joint. As the second arm member
14 is rotated to
the second position, the second extension member 20 travels along an arcuate
path about and
substantially through point "P." The orthosis 10 is maintained in the second
position for a
predetermined treatment time providing a constant stretch to the joint. After
the expiration of the
treatment time, the second arm member 14 is moved back to the first position,
relieving the joint.
Optionally, the second arm member 14 can be rotated to a third position,
increasing the stretch
on the joint. The second arm member 14 can be rotated at discrete time
intervals to
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incrementally increase the stretch of the joint through the treatment cycle.
After completion of
the treatment cycle, the second arm member is returned to the first position
for removal of the
orthosis 10.
The first and second arm members 12 and 14 are rigid members made of, for
example,
aluminum, stainless steel, polymeric, or composite materials. The arms are
rigid so as to be able
to transmit the necessary forces. It should be understood that any material of
sufficient rigidity
can be used.
In an embodiment, the components of the orthosis 10 of the present invention
are made
by injection molding. Generally for injection molding, tool and die metal
molds of the orthosis
10 components are prepared. Hot, melted plastic material is injected into the
molds. The plastic
is allowed. to cool, forming components. The components are removed from the
molds and
assembled. '1'he cuff portions 32 or 34 can be individual molded and attached
to the arm
members 12 or 14. Alternatively, the cuff'portions can be molded as an
integrated part of'the
arm members 12 or 14.
In use, the orthosis 10 can be connected to the flexor side of the first and
second body
portions of the joint, which results in a d.ecrease in angle as the joint is
flexed (bent) and an
increase in angle as the joint is extended (straightened). Alternatively,
orthosis 10 of the present
invention can be connected to the extensor side of the joint, which results in
a decrease in angle
as the joint is extended straightened and an increase in angle as the joint is
flexed (bent).
In an embodiment, the orthosis 10 includes a first cuff 32 for attachtnent to
a first body
portion, and a second cuff 34 for attachment to a second body portion. The
first body portion is
joined to the second body portion at a joint, around which is located, as is
well known., soi:t
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tissue. Each of the first and second cuffs 32 and 34 includes loop connectors
for receiving straps
extending around the body portions to clainp the cuffs 32 and 34 to the body
portions.
The first cuff 32 is mounted for slidiiig movement on the first arm member 12
and is
slidable along the first arm member 12 in a manner as described below. The
second cuff 34 is
mounted for sliding movement on a second arm member 14 and is slidable along
the second arm
member 12 in a manner as described below.
Bending a Joint in Extension:
In operation of the orthosis 10 to extend the joint, the orthosis 10 starts at
a more flexed
position. '1'he first and second cuffs 32 and 34 are clamped onto the first
and second body
portions, respectively, by straps, tightly enough so that the cuffs 32 and 34
can apply torque to
the body portions to extend the joint. The second arm member 14 is rotated
from the first
position to a second position, relative to the first arm member 12, rotating
the second body
portion about the joint axis 16 stretching the joint. As the second arm membcr
14 is rotated to
the second position the second extension member 20 travels along an arcuate
path about and
substantially through point "P." The orthosis 10 is maintained in the second
position for a
predetermined treatment time providing a constant stretch to the joint.
As the orthosis 10 is rotated from the first position to the second position,
extending the
joint, the first and second cuffs 32 and 34 move along the first and second
arm members 12 and
14. The first cuff 32 moves inwardly along the first arm member 12. Similarly,
the second cuf['
34 moves inwardly along the second arm member 14. Because the cuffs 32 and 34
are clamped
onto the first and second body portions as described above, the outward
pivoting movement of
the first and second arm members 12 and 14 and the cuffs 32 and 34 causes the
joint to be
extended as desired. However, this extension of the joint can place strong
distractive forces on
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the soft tissues around the joint. The sliding movement of the cuffs 32 and
34, inwardly along
the first and second arm members 12 and 14, helps to limit these distractive
forces by
counteracting the outward movement of the first and second arm members 12 and
14. The cuffs
32 and 34 slidc inwardly along the first and second arm members 12 and 14 a
distance far
enough so that the joint is only slightly distracted during extension. Thus,
the detrimental effects
of strong distractive forces normally generated in forced extension of a joint
are avoided, being
replaced with the beneficial effects of limited and controlled distraction.
Bending a Joint Flexion:
In operation of the orthosis 10 to flex the joint, the orthosis 10 starts at a
more extended
position. The first and second cuffs 32 and 34 are clamped onto the iirst and
second body
portions, respectively, by straps, tightly enough so that the cuffs 32 and 34
can apply torque to
the body portions to extend the joint. The second arm member 14 is rotated
from the i:irst
position to a second position, relative to the first arm member 12, rotating
the seconcl body
portion about the joint axis 16 stretching the joint. As the second arm member
14 is rotated. to
] 5 the second position the second extension member 20 travels about and
substantially though point
"P," along an arcuate path. The orthosis 10 is maintained in the second
position for a
predetermined treatment time providing a constant stretch to the joint.
As the orthosis 10 is rotated from the first position to the second position,
flexing the
joint, the first and second cuffs 32 and 34 move along the l7irst and second
arm members 12 and
14. T'he first cuff 32 moves outwardly along the first arm member 12.
Similarly, the second cul:f
34 i-iloves outwardly along the second arm member 14. Because the cuffs 32 and
34 are clamped
onto the first and second body portions the inward pivoting movement of the
first and second
arm members 12 and 14 and the cuffs 32 and 34 causes the joint to be flexed as
desired.
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IIowever, this flexion of the joint can place strong compressive forces on the
soft tissues around
the joint. The sliding movement of the cuffs 32 and 34, outwardly along the
first and second arm
members 12 and 14, helps to limit these compressive forces by counteracting
the inward
movement of the first and second arm members 12 and 14. The cuffs 32 and 34
slide outwardly
along the first and second arm members 12 and 14 a distance far enough so that
the joint is only
slightly compressed during flexion. Thus, the detrimental effects of strong
compressive forces
normally generated in forced flexion of a joint are avoided, being replaced
with the beneficial
effects of limited and controlled compression.
Referring now to FIG. 9, the orthosis 10 can be used to bend a wrist in
flexion or
extension. The orthosis 10 includes a first arm member 12 attachable to the
forearm of a patient.
T'he first cuff 32 is clamped onto the forearm by straps. A second arm member
14, operatively
connected to the airst arm niember 12, is attachable to the hand of the
patient, wherein the axis of
the wrist joint is interposed between and offset from the first and second arm
members 12 and
14. The second arm member 14 includes a base member 36 attach thereto. A hand
pad 38 is
attached to the base member 36. The hand pad 38 is clamped onto the hand by
straps, tightly
enough so that the second arm member 14 can apply torque to the joint. The
hand pad 38 can be
shaped to conform to the palm or the back surface of the hand.
Bending Wrist in Flcxion:
When a vvrist is to be bent in flexion, the first cuff 32 is connected with
the forearm and
the hand pad 38 is connected with the palm of the hand. The first cuff 32 and
hand pad 38 are
clannped onto the forearm and hand, respectively, by straps, tightly enough so
that they can apply
torque to t7ex the joint. The second arm member 14 is rotated from the first
position to a second
position, relative to the first arm member 12, rotating the hand about the
wrist joint axis 16
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stretching the joint. As the second arm member 14 is rotated to the second
positioEl the second
extension member 20 travels along an arcuate path about and substantially
through point "P."
The orthosis 10 is maintained in the second position for a predetermined
treatment time
providing a constant stretch to the wrist joint.
Bending Wrist in Extension:
When a wrist is to be bent in extension, the first cuff 32 is connected with
the forearm
and the hand pad 38 is connected with the back surface of the hand. The first
cuff 32 and hand
pad 38 are clamped onto the forearm and back surface of the hand,
respectively, by straps, tightly
enough so that they can apply torque to flex the joint. The second arm member
14 is rotated
from the first position to a second position, relative to the first arm member
12, rotating the hand
about the wrist joint axis 16 stretching the joint. As the second arm member
14 is rotated to the
second position the second extension member 20 travels along an arcuate path
about and
substantially through point "P." The orthosis 10 is maintained in the second
position for a
predetermined treatment time providing a constant stretch to the wrist joint.
In an embodiment, the hand pad 38 is removable attached to the base menlber
36. The
hand pad 38 includes a first surface, which has a substantially convex shape,
to conform to the
palm. of the hand. A second surface, opposite the first surface, is also
included, having a
substantially concave shape, to conform to the back surface of the hand. '1'he
hand pad 38 can be
removable attached to the base member 36 su.ch that the first or second
surfaces engages the
hand of the patient.
For example, the hand pad 38 is removably secured to base member 36 by detent
pin 40.
"I`he ret-novable securing of the hand pad 38 allows the orthosis 10 to be
used for both flexion and
extension of the wrist. In flexion, the hand pad 38 is connected to the base
member 36 with the
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first surface facing "up" to conform to the palm of the hand. In extensioci,
the hand pad 38 is
connected to the base niember 36 with the second surface facing "up" to
conform to the back
surface of the hand.
The base member 38 can be mounted for sliding movcment on the second arm
member
14 and is slidable along the second arm member 14 in a manner as described
below.
Bending Wrist in Extension:
In operation of the orthosis 10 to extend the wrist joint, the orthosis 10
stai-ts at a more
flexed position. The first cuff 32 is connected with the forearm and the hand
pad 38 is connected
with the palm of the hand. The first cuff 32 and hand pad 38 are clamped onto
the forearm and
palm of the hand so as to apply torque to extend the wrist joint. The second
arm member 14 is
rotated from the first position to a second position, relative to the first
arm member 12, rotating
the hand about the wrist joint axis 16 stretching the wrist joint. As the
second arm member 14 is
rotated to the second position the second extension member 20 travels along an
arcuate path
about a.nd substantially through point "P." The orthosis 10 is maintained in
the second position
for a predetermined treatment time providing a constant stretch to the joint.
As the orthosis 10 is rotated from the first position to the second position,
extending the
joint, the base member 36 and hand pad 38 move along the second arm member 14.
'fhe base
member 36 and hand pad 38 move inwardly along the second arm member 14.
Because the cuff
32 and hand pad 38 are clamped onto the forearm and hand the outward pivoting
movement of
the first and second arm members 12 and 14 causes the joint to be extended as
desired.
Ilowever, this extension of the joint can place strong distractive forces on
the sofl: tissues aroiuld
the joint. The sliding movement of the base m.ember 36 and hand pad 38,
inwardly along the
second arm member 14, helps to limit these distractive forces by counteracting
the outward
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movement of the second arm members 12 and 14. The base member 36 and hand pad
38 slide
inwardly along the second arm member 14 a distance far enough so that the
joint is only slightly
distracted during extension. Thus, the detrimental effects of strong
distractive forces normally
generated in forced extension of a joint are avoided, being replaced with the
beneficial effects of
limited and controlled distraction.
Bending Wrist in Flexion:
In operation of the orthosis 10 to flex the wrist joint, the orthosis 10
starts at a more
extended position. The first cuff 32 is connected with the forearm and the
hand pad 38 is
connected with the back surface of the hand. The first cuff 32 and hand pad 38
are clamped onto
the forearm and back surface of the hand so as to apply torque to flex the
wrist joint. The second
arm member 14 is rotated from the first position to a second position,
relative to the first arm
member 12, rotating the hand about the wrist joint axis 16 stretching the
wrist joint. As the
second arnl member 14 is rotated to the second position the second extension
member 20 travels
along an arcuate path about and substantially through point "P." The orthosis
10 is maintained in
the second position for a predefined treatment time providing a constant
stretch to the joinfi.
As the orthosis 10 is rotated from the first position to the second position,
flexing the
joint, the base member 36 and hand pad 38 move along the second arm member 14.
The base
member 36 and hand pad 38 move outwardly along the second arm member 14.
Because the
cuff 32 and hand pad. 38 are clamped onto the forearm and hand the inward
pivoting movement
of the first and second arm members 12 and 14 causes the joint to be flexed as
desired.
1-low-ever, this flexing of the joint can place strong compressive forces on
the soft tissues around
the joint. The sliding movement of the base inember 36 and hand pad 38,
outwardly along the
second arm member 14, helps to limit these compressive forces by counteracting
the inward
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movement of the first and second arm members 12 and 14. The base member 36 and
hand pad
38 slide outwardly along the second arm member 14 a distance far enough so
that the joint is
only slightly compressed during extension. Thus, the detrimental effects of
strong conlpressive
forces normally generated in forced flexion. of a joint are avoided, being
replaced with the
beneficial effects of limited and controlled compression.
In the above description, the hand pad 38 is shown sliding inwardly and
outwardly along
the second arm member 14. However, it is contemplated that the hand pad 38 can
slide in other
directions. For example, the hand pad 38 can slide substantially orthogonal to
the second arm
member 14, wherein the substantially orthogonal directions can have an arcuate
path. Similarly,
as discussed in more detail below, it is contemplated within the scope of the
present invention
that hand pad 38 can be connected to the second arm member 14 such that hand
pad 38 can
cxhibit both longitudinal and orthogonal motion (and combinations thereof)
with respect to the
second arm member 14.
In the above description, the second extension member 20 is shown and
described as
having a substantially circular arcuate shape, positioning the axis of
rotation at the joint axis 16.
However, it is contemplated that the second extension member 20 can have
alternative shapes.
Referring to FIG. 10, the second arm member 14 is shown having a non-circular
arcuate shaped
second extension member 44. The non-circular arcuate shaped second extension
member 44
provide an axis of rotation which changes as the second arm member 14 is moved
from the first
position to the second portion. As such, as the second arm member 14 is moved
from the first
position to the second. portion the second body portion will exhibit both a
rotational motion,
about the joint axis 16, and a translational motion, distracting or
compressing the joint.
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In the previously described embodiments, the arcuate shape of the second
extension
member 20 or 44 as shown have concave radius of'curvature relative to the
joint 16. IIowever,
referring to FIG. 11, it is contemplated that the second extension member 18
or 44 can have a
convex radius of curvature relative to the joint 16. Similar to the concave
radius of curvature,
the convex arcuate shape of the second extension member 18 or 44 results in
the second body
portion rotating about the joint axis 16, when the second arm;nember 14 is
moved froni a first
position to a second position relative to the first arm member 12.
Referring to FIG. 12, the second arm member 14 of the orthosis 10 includes a
second
extension member 48 extending therefrom and having a linear shape. The first
and second
extension members 18 and 48 are operatively connected at point "P," such that
in operation the
second extension member 48 travels along a linear path through point "P." The
linear shape of
the second extension member 48 results in the second body portion being
translated with respect
to the first body portion. The translational movement of the second arm member
14 results is a
distraction or compression of the joint when the second arm member 14 is moved
from a first
position to a second position relative to the first arm member 12.
As discussed further below, the hand pad can be mounted for translational and
rotational
movement on the base member.
Drive Assembly:
Referring to FIGS. 9 and 1.3A, the drive assembly 22 of the orthosis includes
a gear
system. As previously noted, the components of the orthosis, including the
drive assembly 22,
can be made by injection molding a polymer. The drive assembly 22 is supported
in the first
extension member 18, including a gear 50 rotatable about point "P." A shaft
52, attached to the
gear 50, extends from first extension member 18. A knob 54 is coiinected to
the shaft 52,
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opposite the gear 50, for manually rotating the gear 50. The second extension
member 20
includes a series of teeth 56 along an inner surface 58. The second extension
member 20 is
threaded through the first extension member 18, such that the teeth 56 on the
second extension
member 20 engage the gear 50. The rotation of the knob 56 causes the gear 50
to rotate, pushing
or pulling the second extension member 20 through the first extension member
18. The drive
assembly 22 includes a locking or breaking mechanism which prevents the gear
50 from rotating
absent am applied force rotation of the knob 46. Such a lock or breaking
mechanism can include
a compression washer or other known gear locking or breaking mechanisms.
In another embodiment, as shown in FIG. 13B, the shaft 52 is attached to the
gear 50 and
extends from first extension member 18. The knob 54 is connected to the shaft
52 opposite the
gear 50 for manually rotating the gear 50. The second extension member 20
includes a series of
teeth 56 along an inner surface 58. The teeth 56 can extend fi.lIly or
partially along the width of
the inner surface 58. A secondary gear 51 is positioned between the gear 5 0
and the inner
sur:face 58, where the secoiidary gear 51 engages gear 50. `The second
extension member 20 is
threaded through the first extension member 18, such that the teeth 56 on the
second extension
member 20 engage the secondary gear 51. The rotation of the knob 56 causes the
gear 50 to
rotate, thereby rotating the secondary gear 51 and pushing or pulling the
second extension
member 20 through the first extension member 18. The ratio between gear 50
and. secondary
gear 51 is selected to permit an easy rotation of the knob 54, moving of the
second cxtension
member 20 through the first extension memberl8, The drive assembly 22 includes
a locking or
breaking mechanism which prevents the gear 50 from rotating absent am applied
force rotation
of the knob 46. Such a lock or breaking mechanism can include a compression
washer or other
known gear locking or breaking mechanisms.
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The drive assembly 22 is described as utilizing a gear system. However, it is
conteinplated that other known drive systems can be used to move the second
extension member
20 through the first extension member 18, for example a friction type drive
system. Regardless
of the drive system used, the joint orthosis of the present invention can act
as a brace, restricting
the relative movement of the first and second body portions to one degree of
freedom (e.g.
flexion and extension about the joint). Thus, drive assembly 22 can be
configured to allow free
motion in one degree of freedom. This can be achieved in a number of different
ways. For
example, gear 50 can be positioned such that it does not engage teeth 56.
In an alternative embodiment, the drive assembly 22 for an orthosis 10 in
accordance
with the present invention can be actuated by a motor instead of by a manually
actuatable
member, such as the knob 54.
In an embodiment, an electric motor is mounted to the shaft 52 l:or rotation
of the gear 50.
A battery provides electric power to the motor. Alternativcly, the motor can
be supplied with
external power. A nlicroprocessor controls the operation of the motor. 'The
microprocessor and
motor together can be used to cycle the first and second arm members 1.2 and
14 through
extension and flexion; to move the first and second arm members 12 and 14 in
one pivotal
direction a certain amount, hold there while tissue stretches, then move
further in that direction;
or in any other manner. In another manner of use, the orthosis can be set to
cycle to one end of
the joint's range of motion and hold there for a predetermined period of time,
then cycle to the
other end of the joint's range of motion and hold t.here. The programming and
control of the
microprocessor is within the skill oi'the art as it relates to driving the
motor to control the first
and second arm members 12 and t4 to move in known manners. This embodirnent is
ideally
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suited for continuous passive motion exercise, because the orthosis is
portable and because the
motor can be programmed with the desired sequence of movements.
It should be understood that the particular physical arrangement of the motor,
the battery,
and the microprocessor is not the only possible arrangement of those elements.
The invention
contemplates that other arrangements of these or similarly functional elements
are quite suitable,
and thus, the invention is intend.ed to cover any such arrangement.
Additionally, another type of
power source, other than an electric motor, can also be used. For example, the
use of a hydraulic
or pneutnatic motor as the drive mechanism is contemplated.
Referring to FIGS. 14 and 15, another embodiment in which the hand pad 38
articulates
with respect to the second arm member 14 is shown. The second arm member 14
has a circular
base member 40 attached thereto. The circular base member 40 supports a
circular base plate 42,
A circular cover 44 extends upwardly from the circular base member 40 and has
a portion 46
extending radially inwardly toward a vertical axis 48 to define a slide
chamber 50.
A hand pad support slider 52 is received in the slide chamber 50. The support
slider 52
has an upper portion 54 to which the hand pad 38 is attached. "I'he upper
portion 54 is connected
by a neck 56 to a circular planar portion 58. Two annular bearing races 60
extend downwardly
from the planar portion 58 and secure between them a plurality of ball
bearings 62. A washer 64
is disposed above the bearings 62. The ball bearings 62 support the slider 52
and thus the hand.
pad 38 for sliding movement in any direction within the slide chamber 50. The
hand pad 38 can
be made self-centering by springs 66.
Thus, the hand pad 38 is slidable relative to the circular base member 40 in
any direction
for a limited extent. As indicated by the arrow 68, the hand pad 38 is
slidable fore and aft within
the extent of travel allowed by the support slider 52 within the slide chamber
50. As indicated by
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the arrow 70, the hand pad 38 is slidable laterally within the extent of
travel allowed by the
support slider 52 within the slide chamber 50. With these two combined, it can
be seen that the
roller bearing assembly provides a compound of movement of the hand pad 38.
Referring to FIGS. 16, 1 7A and 17B, another embodiment 80 in which the hand
pad 38
articulates with respect to the second arm member 14 is shown. The second arm
member 14 has
a sliding base member 82 slidingly mounted thereto in similar fashion to base
member 36. The
sliding base niernber 82 supports a fixed base plate 84 attached thereto. A
pivotal base plate 86
is pivotally connected to the fixed base plate 84, where the pivotal base 86
plate can arcuately
pivot with respect to the fixed base plate 84 and the second arm member 14.
The pivotal base plate 86 is pivotally secured to the fixed base plate 84 by
threaded
members 88 and 90 extending through an arcuate slot 92 in the pivotal base
plate 86. The
threaded members 88 and 90 are threaded in threaded holes 94 and 96 in the
fixed plate 84. In
this manner the pivotal base plate 86 can travel along the arc-uate slot 92
with respect to the ~rixed
base plate 84. I'he hand pad (not shown) can be removable attached to the
pivotal base plate 86.
1n instances where a joint is misaligned, fixing the position of the joint can
result in
unwanted torsional forces being applied to the joint. The a.E-ticulation of
the hand pad permits the
joint to self align, such that the joint can be rotated about its axis without
the application of
torsional forces on the joint.
Referring now to FIG. 18, an orthosis 100 can be used to bend a wrist in
flexion or
extension.. '1"he orthosis 100 includes a first arm member 102 attachable to
the forearm of a
patient. The first cuff 104 is clamped onto the forearm by straps 106. A
second arm member
108, operatively connected to the l~:zrst arm member 102, is attachable to the
hand of the patient,
wherein the axis of the wrist joint is interposed between and offset from the
first and second arm
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members 102 and 108. The second arm member 108 includes articulating member 80
attached
thereto. A hand pad can be attached to the pivotal base plate 86. rI'he hand
is clamped onto the
hand pad by top member 110 and strap 112, tightly enough so that the second
arm member 108
can apply torque to the joint. The hand pad can be shaped to conforni to the
palm or the back
surface of the hand.
Referring to FIG. 19, a hand pad 114 is provided, where the hand pad 114 can
be
removably attached to the pivotal base plate 86. For example, a hook and loop
tape 116 can be
provided on the hand pad 114 and the pivotal base plate 86. The hand pad 114
is shaped to
conform to the palm of the hand.
Referring to FIG. 20, another hand pad 118 is provided, where the hand pad 118
can be
removably attached to the pivotal base plate 86. Similarly, the hook and loop
tape 116 can be
provided on the hand pad 118 and. the pivotal base plate 86. The hand pad 118
is shaped to
conform to a top surface of the hand. In use, either hand pad 114 or hand pad
118 can be u.sed
with the same orthosis. In this regard, hand pad 114 and hand pad 118 are
preferably sold as a
kit with orthosis 100.
Another embodiment of an orthosis of the present invention is in treatment of
a toe of a
patient's foot. While this embodiment is believed to provide significant
improvements in this
area of treatment, it may likewise be of benefit in treating other joints,
such as ankles, knees,
hips, fingers, wrists, elbows, shoulders, or the spine.
Furthermore, while many examples provided herein may illustrate the invention
used to
treat the metatarsal and proximal phalanx of the toe, these examples are non-
limiting on other
joints of the toe that also may be treated by the present invention. It is
understood by those
skilled in the art that the otlier joints of the toe may be flexed or
extended, without departing
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from the spirit and scope of the invention. Additionally, the present
invention is described in use
on the "big" toe or hallux on the foot. Thus, it should be understood by those
skilled in the art
that the present invention is equally applicable for use oi1 the second,
third, fourth and minimtis
toes of the foot.
Each toe in the foot extends from the metatarsal bone and is formed by the
proximal
phalanx, middle phalanx, and distal phalanx, each of which is respectively
pivotally connected to
form a joint there between. The orthosis ofthe present invention may be
configured to flex or
extend (or both) a toe joint, where the joint defines an inner sector on the
flexor side that
decreases in angle as the joint is flexed (bent) and aii outer sector on the
extensor side that
decreases in angle as the joint is extended (straightened).
Refcrring now to the figures in which like reference designators refer to like
elements,
there is shown in FIG. 21, a schematic of the orthosis 200 of the present
invention. 'The orthosis
200 includes a first member 202 attachable to a first body portion, such as a
user's foot. The
shape and configuration of the first member 202 may be selected to support or
conform generally
] 5 to a patient's foot. For example, the first member 202 may be a platform
that contacts or
supports the underside of a user's foot. Sidewalls or curved edges may be
provided to help
position, cradle, or securely hold the foot in proper position.
Alternatively, the first member 202 may have a profile or shape that generally
conforms
to a user's arch, shoe size, or foot width so that it fits more comfortably,
holds the 1:oot securely
in place, or improves alignment of the device so that the range of motion
imparted by the device
corresponds to a joint's healthy range of motion. This conforming shape or
profile may be
accomplished., for instance, by providing interchangeable platforms
corresponding to different
foot sizes and shapes. '1'he interchangeable platform may be selectively
removed and replaced
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by an interchangeable platform of a different size. Alternatively; the first
member 202 may have
adjustable surfaces that can be resized or repositioned to better support or
correspond to a
patient's foot. For example, the overall length of the first member 202 may be
adjustable, or the
width of the first member 202 near the toes may be adjusted to account for
different foot widths.
In addition, raised walls or edges that support the feet may be selectively
moveable so that they
can be moved to accommodate different foot sizes. Once the foot is in place
and the edges are
moved to their desired position, they may be selectively locked or secured in
place to help hold
the foot in place. Additionally, the first member 202 may be configured with
an arch, which in
some instances also may be adjustable such as by having interchangeable arch
inserts, by
coniiguring the arch to be inflatable, or the like.
'I'he first member 202 is operatively associated with or connected to a second
member
204 so that the first and second members 202 and 204 may move or rotate with
respect to each
other. As shown in FIG. 21, the supporting surface of the first member 202 may
be offset from
the supporting surface of the second member 204. This amount of offset
provided may vary
froni patient to patient or fron-i joint to joint, and in some cases an offset
may not be provided.
Thus, it may be advantageous to allow the offset of the orthosis 200 to be
adjustable so that a
physician or user may change its size as needed to improve comfort, fit, or
operation of the
orthosis 200.
In use, the second rnember 204 may be attachable to a second body portion,
such as at
least one toe on the foot so that the relativc movement of the two members
also causes
movement of the joint. As shown in FIG, 22, the orthosis 200 may have an axis
of rotation 206
that is aligned with the axis of rotation of the joint. In this manner, the
instantaneous axis of
rotation (IAR) of the first and second members 202 and 204 may better match
the TAR of the
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treated joint. As will be discussed in greater detail below, while the axis of
rotation 206 of the
device is illustrated in FIGS. 21-23 as occurring only along a single line,
the axis of rotation 206
may also shift or move depending on the relative positioning of the first and
second members
202 and 204 in a manner that corresponds to changing axis of rotation that a
joint niay
experience through its range of motion. The first and second members 202 and
204 are
operatively connected to each other, offset from the orthosis axis 206.
"I`he first member 202 of the orthosis 200 includes a first extension member
208
extending therefrom. The second member 204 of the orthosis 200 includes a
second extension
member 210 extending therefrom and having an arcuate shape. The lirst and
second extension
members 208 and 210 are operatively connectcd at point "P," such that in
operation the second
extension member 210 travels along an arcuate path about and substantially
through point "P."
The arcuate shape of the second extension member 210 results in the toe
rotating about the
orthosis axis 206, or alternatively about a moving IAR, when the second member
204 is moved
from a first position to a second position relative to the first member 202.
The first extension member 208 can extend substantially vertically from the
f:irst member
12 or extend at an angle a from the first niember 202. In one embodiment of
the invention, the
angle a and the radius of curvature of the second extension member 210 are
configured such that
of the orthosis axis 206 is aligned with the axis of rotation of the joint.
The previous description of the first member 202 depicts a first extension 208
having a
substantially linear shape, extending at an angle a from the first member 202.
I-lowever, it is
within the scope of the present invention that the first extension member 208
can be any shape
extending from the first member 202 which aligns orthosis axis 206 with the
axis of rotation of
the joint. Purthermore, as mentioned previously and again below, in some
instances the axis of
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rotation of the joint may change or move slightly. Therefore, in some
instances it may be
desirable for the orthosis to mimic the IAR of the joint. As will be
illustrated in detail below,
this can be accomplished in several ways. One modification of the embodiment
of the invention
shown in FIG. 21, for instance, may be for the second extension member 210 not
to have a
constant radius of curvature.
The orthosis 200 further includes a drive assembly 212, which is illustrated
in FIG. 21 at
or near point "P." In this embodiment, the drive assembly 212 is operably
connected to the first
and second extension members 208 and 210 for applying force to the first and
second members
202 and 204 to pivot the second body portion about the orthosis axis 206. As
will be shown
below in additional embodiments, the drive assembly 212 may be configured or
disposed to
interact with or operate on one of the first or second members 202 and 204
independently.
Referring to FIG. 22, in order for the orthosis 200 to extend the joint the
first and second
members 202 and 204 may be affixed to the first and second body portions,
respectively, tightly
enough so that the first and second members 202 and 204 can apply torque to
extend the joint.
The second extension member 210 is moved through the drive assenibly 212 from
a first position
to a second position, relative to the first extension member 208, rotating the
second member 204
and the second body portion about the orthosis axis 206 stretching the joint.
As the second
member 204 is rotated to the second position, the second extension member 210
travels at least
partially through point "P" and may travel substantially through this point
for a large range of
motion. Because the first and second members 202 and 204 are affixed to the
first and second
body portions, the outward pivoting movement of the second n-tember 204
cacises the joint to be
extended as desired. The orthosis 200 may then be maintained in the second
position for a
predetermined treatment time providing a constant stretch to the joint. The
orthosis may
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alternatively be configured to impart a constant force or load on the joint or
may utilize the
techniques of Static Progressive Stretch as described in co-pending
application scrial no.
11/203,516, entitled "Range of Motion System and Method", and filed on August
12, 2005, the
entirety of which is incorporated by reference.
Returning to the example where the orthosis is maintained in the second
position, after
the expiration of the treatment time, the second member 204 may then be moved
back to the first
position, relieving the joint. Optionally, the second member 204 can be
rotated to a third
position, increasing the stretch on the joint, or partially reducing it to
allow limited relaxation of
the surrounding tissue. The second member 204 can be rotated at discrete time
intervals to
incrementally increase, reduce, or vary the stretch of the joint through the
treatment cycle. After
completion of the treatment cycle, the second arm 204 is returned to the first
position for
removal of the orthosis 200.
Referring to FIG. 23, in operation of the orthosis 200 to flex the joint. "f
he li._rst and
second members 202 and 204 are affixed to the first and second body portions,
respectively,
tightly enough so that the first and second members 202 and 204 can apply
torque to extend the
,joint. A cuff, strap, laces, or other retaining device may be used to
securely associate respective
body portions of the joint with the first and second members 202, 204. The
second extension
member 210 is moved through the drive assembly 212 from the first position to
a second
position, relative to the first extension inember 208, rotating the second
member 204 and the
second body portion about the orthosis axis 206 stretching the joint. As the
second member 204
is rotated to the second position, the second extension member 210 travels
substantially througli
point "P." Because the first and second members 202 and 204 are affixed to the
first and second
body portions, the inward pivoting movement of the second member 204 causes
the joint to be
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flexed as desired. The orthosis 200 is maintained in the second position for a
predetermined
treatment time providing a constant stretch to the joint.
After the expiration of the treatment time, the second member 204 is moved
back to the
first position, relieving the joint. Optionally, the second member 204 can be
rotated to a third
position, thereby increasing, decreasing, or otherwise varying the stretch on
the joint. The
second member 204 can be rotated at discrete time intervals to incrementally
increase the stretch
of the joint through the treatment cycle. After completion of the treatment
cycle, the second arm
204 is returned to the first position for removal of the orthosis 200.
I'1GS. 24-26 further illustrate several aspects of the invention more
concretely. An
orthosis 220 of the present invention includes a first member 221 having a
first cuff 222
attachable to a user's foot and a second member 223 having a second cuff 224
attachable to a toe
of the user's foot, wherein the second member 223 is rotatable with respect to
the first member
221 about an axis of rotation 226. The first and second members 221 and 223
are attached to the
foot and toe of the user with the first and second cuffs 222 and 224, stich
that as the second
member 223 is rotated about the axis of rotation 226, the toe is rotated about
a joint axis.
A first extension member 228 is affixed to and extends from the first mei:nber
221,
wherein a drive assembly 230 is positioned on an end portion of the first
extension member 228.
A second extension member 232 is similarly affixed to and extends from the
second member
223, wherein the second extension member 232 has an arcuate shape. The second
extension
member 232 engages the drive assembly 230 of the iirst extension. member 228
at a point "P."
An actuation of the drive assembly 230 operates to move the second extension
member 232
t.hrough the drive assembly 230, such that the second cuff 224 travels along
an arcuate path "A"
with respect to the first member 221. The arcuate shape of the second
extension member 232
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results in the toe rotating about the joint axis, as the second cuff 224 is
moved along the arcuate
path "A." The drive assembly 230 can be actuated to move the second cuff 224
and toe from a
first position to a second position relative to the first cuff 222. Once
again, the term "cuff" as
used herein means any suitable structure for transmitting the force of the
orthosis 220 to the limb
portion it engages.
The first extension member 228 can extend substantially vertically from the
first member
221 or extend at an angle a from the first member 221, where the angle a and
the radius of
curvature of the second extension member 232 (if constant) can be configured
such that of the
axis of rotation 226 is aligned with the joint axis of ration. As previously
discussed, the
curvature of the second extension member 232 need not be constant, and
therefore the axis of
rotation may shift or move in a manner that preferably mimics or approximates
the moving IAR
the joint would normally have. Another potential benefit of the orthosis 220
having the
capability of a moving IAR is when inultiple joints are being treated by the
device. For instance,
the range of motion or the tip of a toe or finger may involve cooperative
motion of two or more
joints, If the combined bending of the multiple joints causes the overall
motion to rotation about
a moving axis, it wou.ld be beneficial for the orthosis to approximate this
moving IAR. Thus. the
curvature of the second extension member 232 may be complex in order to better
approximate a
moving IAR.
Referring to FIG. 27, the drive assembly 230 can include a housing 240 having
a worm
gear 242 therein. A first miter gear 244 is attached to the worm gear 242 such
that a rotation of
the first miter gear 244 rotates the worm gear 242. The drive assembly 230
further includes a
drive shaft 246 have a knob 248 at one end and a second miter gear 250 at an
opposite end. 'I'he
second miter gear 250 is positioned within the housing 240, in engagement with
the first miter
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gear 244. A rotation of the knob 248 rotates the drive shaft 246 and the
second miter gear 250,
which in turn rotates the first miter gear 244 and the worm gear 242.
A gear surface 252 of the second extension member 232 includes a plurality of
teeth 254.
The second cxtension member 232 is positioned throughout the housing 240, such
that the worm
gear 242 engages the teeth 254 of the second extension member 232. A rotation
of the knob 248
rotates the worm gear 242, which in turn moves the second extension member 232
through the
housing 240.
In an alternative embodiment, the drive assembly 230 for orthosis 230 in
accordance with
the present invention can be actuated by a motor instead of by a manually
actuatable member,
such as the knob 248. Likewise, the motor may be configured an adapted with
gearing that
causes the orthosis to cycle through a range of motion in a predetermined
manner, or
alternatively maybe controlled by a programmable logic controller (PLC).
In an embodiment, an electric motor is mounted. to the drive shaft 246 for
rotation of the
second miter gear 250. A battery or other source of energy provides electric
power to the motor,
Alternatively, the motor can be supplied with external power. A microprocessor
controls the
operation of the motor. The microprocessor and motor together can be used to
cycle the second
cuff 34 through a plurality of positions that cause the.joint to undergo a
range of motion, either
by extension, by flexion, or both. For example, the microprocessor may be used
to move the
second cuff 34 in one pivotal direction a certain amount, hold thcrc while
tissue stretches, then
move further in that direction; or in any other manner.
In another manner of use, the orthosis can be set to cycle to one end of the
joint's range of
motion and hold there for a predetermined period of time, then cycle to the
other end of the
joint's range of motion and hold there. The programming and control of the
microprocessor is
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within the skill of the art as it relates to driving the motor to control the
second cuff 34 to move
in known manners. 'hhis embodiment is ideally suited for continuous passive
motion exercise,
because the orthosis is portable and because the motor can be programmed with
the desired
sequence of movements.
It should be understood that the particular physical arrangement of the motor,
the power
source, and the microprocessor is not the only possible arrangement of those
elements. The
invention contemplates that other arrangements of these or similarly
functional elements are
quite suitable, and thus, the invention is intended to cover any such
arrangement. Additionally,
another type of power source, other than an electric motor, can also be
tiised. For example, the
use of a hydraulic or pneumatic motor as the drive mechanism is contemplated.
The present invention can further include a monitor for use with the orthosis
220, which
provides assurances the patient is properly using the orthosis 220 during
his/her exercise period.
For instance, the monitor can have a position sensor, a temperature sensor, a
Force sensor, a clock
or timer, or a device type sensor for monitoring the patien.t's implementation
of a protocol. The
information obtained from these monitoring devices may be stored for later
analysis or
conf rmation of proper use or may be transmitted in real-time during use of
the device. The data
obtained from the monitor can be analyzed by a healthcare professional or
technician and the
protocol can be adjusted accordingly.
rl'his analysis may be conducted remotely, thereby saving the time and expense
of a home
visit by a healthcarc professional or technician. An exemplary monitoring
system is provided in
U.S. Publication No. 20040215111 entitled "Patient Monitoring Apparatus and
Method for
Orthosis and Other Devices," to Bonutti et al., the content of which is herein
expressly
incorporated by reference in its entirety.
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In an exemplary use, the orthosis 220 is operated to rotate a toe about
a,joint axis in the
following manner. The first cuff 222 is 1:astened about the foot with one or
more straps, laces, or
similar retaining device. Similarly, the second cuff 224 is fastened securely
to the toe of the
user, such that the joint and joint axis 226 is interposed between the first
and second cuffs 222
and 224. The orthosis 220 is attached to the foot and toe in a first position.
The drive assembly
230 is actuated to move the second extension member 232, such that the second
cuff 224 travels
along an arcuate path from the first position to a second position, relative
to the first cuff 222,
rotating the toe about the joint axis stretching the joint. The orthosis 220
is maintained in the
second position for a predetermined treatment time providing a constant
stretch to the joint.
After the expiration of the treatment time, the second cuff 224 is moved back
to the first position,
relieving the joint. Optionally, the second cuff 224 can be rotated to a third
position, thereby
increasing or decreasing the stretch on the joint. The second cu.ff 224 can be
rotated at discrete
time intervals to incrementally increase the stretch of the joint through the
treatment cycle. After
completion of the treatment cycle, the second arm member is returned to the
first position for
removal of the orthosis 220.
Referring to FIG. 28, the second member 223 can include an attachment bracket
260 for
adjustably attaching the second cuff 224 to the second extension member 232.
'I"he attachment
bracket 260 can include a toe rod 262 extending therefrom. The second cuff 224
can be
slideably mounted on the toe rod 262 to position second cuff 224 over the toe.
Alternatively, the
toe rod 262 can be of sufficient length such that the second cuff 24 can be
slidingly positioned on
a selected toe on the foot of the user, for example, the big toe, rn.inina.us
toe, or any toe
therebetween.
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The second cuff 224 can be positioned on the toe rod 262 with a first bracket
264, where
the toe rod 262 passes through a passage 266 in the first bracket 264. A set
screw 268 is
provided to secure the first bracket 264 to the toe rod. 262. When the set
screw 268 is loosencd,
the first bracket 264 is free to slide along the toe rod 262. A tightening of
the set screw 268
secures the first bracket 264 in place on the toe rod 272.
The second cuff 224 can further include a second bracket 270, where the second
bracket
270 can be pivotally mounted to the first bracket 264. For example, the second
bracket 270 can
be attached to the first bracket 264 with a pin or screw connector, allowing
the second bracket
270 to rotate with respect to the first bracket 264.
Additionally, when a joint is flexed or extended a compressive force may be
applied to
the connective tissue surrounding the joint. It may be desirable to control
the compressive force,
distracting the joint as the joint is flexed or extended. "Distraction" is
defined by one dictionary
as "Separation of the surfaces of a joint by extension without injury or
dislocation of the parts."
(Taber's Cyclopedic Medical Dictionary, 16th Edition, 1989, page 521), and
involves stretching
1.5 rather than compressing the joint capsule, soft tissue, ligaments, and
tendons.
Additionally, the second bracket 270 can be slideably mounted to the first
bracket 264.
For example the second bracket 270 can be mounted to the first bracket 264
with a dovetail joint
272, allowing the second bracket 270 to slide with respect to the first
bracket 264. The sliding
niovement of the second cuff 224 helps to limit the distractive or compressive
forces which can
be imparfed on the joint by the rotation of the second cuff 224 with respect
to the first cuff 222.
The attachment bracket 260 can be pivotally mounted to the second extension
member 232. For
example, the attachment bracket 260 can be attached to the second extension
member 232 with a
pin or screw connector 274, allowing the attachment bracket 260 to rotate with
respect to the
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second extension member 232. The second extension member 232 further includes
an extension
bracket 276 having a slotted portion 278. A set screw 280 is positionable
through the slotted
portion 278, engaging the attachment bracket 260, such that the set screw 280
can be used to
control the pivotal position of the attachment bracket 260 with respect to the
second extension
member 232.
The adjustable connection of the second cuff 224 to the attachment bracket 260
and the
pivotal connection of the attachment bracket 260 to the second extension
member 232 can be
used to align the second cuff 224 with the toe. The alignment of the second
cuff 224 on the toe
can be used to substantially limit the force applied to the toe to that of a
torque about the joint
axis 226.
Bending a Joint in Extension:
In operation of the orthosis 220 to extend the joint, the orthosis starts at a
more Oexed
position. The first and secot:td cuffs 222 and 224 are clamped onto the foot
and toe portions,
respectively, by straps 234, tightly enough so that the first and second
inembers 221 and 223 can
apply torque to extend the joint. `I'he second. extension member 232 is moved
through the drive
assembly 230 from the first position to a second position, relative to the
first extension rneRnber
228, rotating the second cuff 224 and the toe about the orthosis axis 226
stretching the joint. As
the second cuff 224 is rotated to the second position the second extension
member 232 travels
along an arcuate path "A" about and substantially through point "P." The
orthosis 220 is
niaintained in the second position for a predetermined treatment time
providing a constant stretch
to the j oint.
As the orthosis 220 is rotated frona the first position to the second
position, extending the
joint, the second. cuff 224 moves along the first bracket 64. Because the
first and second
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members 221 and 223 are clamped onto the foot and toe as described above, the
outward
pivoting movement of the second cuff 224 causes the joint to be extended as
desired. flowever,
this extension of the joint can place strong distractive forces on the soft
tissues around the joint.
The sliding nlovement of the second cuff 224 helps to limit these distractive
forces by
counteracting the outward movement. Thus, the detrimental effects of strong
distractive forces
normally generated in forced extension of a joint are avoided, being replaced
with the benelicial
effects of limited and controlled d.istraction.
Bending a Joint Flexion:
In operation of the orthosis 220 to flex the joint, the orthosis 220 starts at
a more
extended position. The first and second cuffs 222 and 224 are clamped onto the
foot and toe
portions, respectively, by straps 234, tightly enough so that the first and
second members 221
and 223 can apply torque to extend the joint. The second extension member 232
is moved
through the drive assembly 230 from the first position to a second position,
relative to the first
extension member 228, rotating the second cuff 224 and the toe about the
orthosis axis 26
stretching the joint. As the second cuff 224 is rotated to the second position
the second extension
mernber 232 travels along an arcuate path "A" about and substantially through
point "P." The
orthosis 220 is maintained in the second position for a predetermined treati-
nent time providing a
constant stretch to the j oint.
As the orthosis 220 is rotated froni the first position to the second
position, flexing the
joint, the second cuff 224 moves along the first bracket 264. I3ecause the
first and second
members 221 and 223 are clamped onto the foot and toe as described above, the
inward pivoting
movement of the second cuff 224 causes the joint to be flexed as desired.
However, this flexion
of the joint can place strong compressive forces on the soft tissues around
the joint. The sliding
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movement of the second cuff 224 helps to limit these compressive forces by
counteracting the
inward movement. Thus, the detrimental effects of strong compressive forces
normally
generated in forced flexion of a joint are avoided, being replaced with the
beneficial effects of
limited and controlled compressio.n.
Referring to Fig. 29, the drive assembly 230 can be adjustable mounted to the
lirst
extension member 228. The first extension member 228 includes a longitudinal
slotted section
282. A threaded member 284 is positioned through the longitudinal slotted
section 282, where
the threaded member 284 is threaded into a threaded hole 286 in the drive
assembly 230. The
position of the drive assembly 230 is secured on the first extension member
228 by tightening the
threaded member 284, compressing the first extension member 228 between the
threaded
member 284 and the drive assembly 230. The position of the drive assembly 230
can be adjusted
by loosening the threaded member 284 and sliding the drive assembly 230 along
the longitudinal
slot 282. In this manner the position of the drive assembly 230 can be
adjusted to align the axis
of rotatiortz 226 with the joint axis.
The drive assembly 220 caal further includes an indented portion 288. The
indented
portion 288 in sized to receive the first extension member 228 therein, such
that the first
extension member 228 slides through the indented portion 288 as the drive
assembly 230 is
moved along the first extension member 230. 'I'he indented portion 288 is
configured to align
the drive assembly 230 with respect to the first extension member 228. The
indented portion 288
provides the further benefit of resisting a rotation of the drive assea-nbly
230 with respect to the
first extension member 228 when the orthosis 220 is in use.
Referring to FIG. 30, the drive assembly 230 can include a pair of indented
portions 288
and 290, positioned on opposite sides on the drive assembly 230. As shown in
FIG. 29, the first
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indented section 288 can be used to position the drive assembly 230 in an
outer position on the
orthosis 220, where the drive assenibly 230 is positioned on an outside
surface 292 of the first
extension member 228.
Alternatively, as shown in F1G. 31, the second Endented section 290 can be
used to
position the drive assembly 230 in an inner position on the orthosis 220,
whcre the drive
assembly 230 is positioned on an inner surface 294 of the first extension
member 228. The
threaded member 284 is positioned throubh the longitudinal slotted section
282, where the
threaded member 284 is tlireaded into a second threaded hole 296 in the drive
assembly 230.
In an embodiment, the first member 221 can be adjustable mounted to the first
cuff 222,
such that the position of the second cuff 224 can be adjusted to align the
second cuff 224 with a
toe of interest and the joint axis of the toe. In instaiices were the joint of
a toe is misaligned, for
example for toe deformations such as hammer toe, bunion, etc, the linear and
angular position of
the second cuff 224 can be adjusted with respect to the first cuff 222
aligning the second cuff 224
with the misaligned toe such that the axis of rotation 226 of the orthosis 220
is aligned with the
axis of rotation of the toe joint. In the manner, the orthosis 220 can be
adjusted to prevent the
unwanted application of torsional forces to the toe joint.
Referring to FIG. 32, the first member 221 is adjustably attached to a bottom
surface of
the first cuff 222. The first member 221 can included a longitudinal slot 300,
through which a
pair of tltreaded members 302 and 304 are positioned, attaching the first
member 221 to the first
cuff 222. The first member 221 can be moved along the longitudinal slot 300 to
laterally adjust
the position of the first member 221 with respect to the first cuff 222. The
first member 221 is
secured in position by tightening the threaded member 302 and 304, compressing
the first
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member 221 between the threaded members 302 and 304 and the bottom surl'ace
298 of the first
cuff 222.
The first member 221 can further iiiclude a second longitudinal slot 306,
parallel and
offset from the first longitudinal slot 300. The first member 221 can be
attached to the first cuff
222, using the second longitudinal slot 306 to longitudinally adjust the
position of the first
member 221 with respect to the first cuff 222. Similarly, the first member 221
can be moved
along the second longitudinal slot 306 to laterally adjust the position of the
first member 221
with respect to the first cuff 222.
It is also contemplated that the angular position of the first member 221 cail
be adjusted
with respect to the first cuff 222. In an embodiment, as shown in FIG. 33, the
bottom surface
298 of the first cuff 222 includes a center threaded hole 308 and an arcuate
slot 310. An
internally threaded fastener 312 is slidingly positioned in the arcuate slot
310, opposite the
bottom surface 298. The first member 221 is attached to the first cuff 222 by
positioning the
threaded members 302 and 304 through a longitudinal slot 300 or 306 of the
first member 221
and engaging the threaded hole 308 and the internally threaded fastener 312 in
the arcuate slot
310. The angular position of the first member 221 can be adjusted with respect
to the first cuf[~
222 by pivoting the first member 221 about threaded member 302 in the center
threaded hole
308, such that the internally threaded fastener 312 and the second threaded
member 302 travel
along the arcuate slot 310. The first member 221 is secured in position by
tightening the
threaded members 302 and 304, compressing the first meniber 221. between the
threaded
members 302 and the bottom surface 298 of the first cuff 222, and compressing
the first member
221 and first cuff 222 between threaded member 304 and internally threaded
fastener 312.
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The bottom surface 298 of the first cuff 222 can further include a second
arcuate slot 314,
where an internally threaded fastener 316 is slidingly positioned in the
second arcuate slot 314,
opposite the bottom surface 298 of the first cuff 222. Similar to arcuate slot
310, second arcuate
slot 314 can be used to angularly adjust the position of the first member 221
with respect to the
first cuff 222.
Specifically, the first member 221 is attached to the first cuff 222 by
positioning the
threaded members 302 and 304 through a longitudinal slot 300 or 306 of the
first member 221
and engaging the threaded hole 308 and the internally threaded fastener 316 in
arcuate slot 314.
The angular position of the first mei-nber 221 can be adjusted with respect to
the first cuf'f 222 by
pivoting the first member 221 about threaded member 302 in the center threaded
hole 308, such
that the internally threaded fastener 316 and the second threaded member 304
travel along the
arcuate slot 314. The first member 221 is secured in position by tightening
the threaded member
302 and 304, compressing the first member 221 between the threaded members 302
and the
bottom surlace 298 of the first cuff 222, and compressing the first member 221
and first cuff 222
between the threaded menlber 304 and internally threaded fastener 316.
It is also contemplated that the first member 221 can be attached to the first
cuff 221
using the arcuate slots 310 and 314 and the respected internally threaded
members 312 and 316.
Specifically, the first member 221 is attached to the first cuff 222 by
positioning the threaded
members 302 and 304 through a longitudinal slot 300 or 306 orthe :i':xrst
member 221 and
engaging the internally threaded fastener 312 in the arcuate slot 3 10 and the
internally threaded
fastener 316 in arcuate slot 314. The angular position of the first member 221
can be adjusted
with respect to the first cuff 222 by pivoting the first member 221 such that
the internally
threaded fasteners 312 and 316 travel along the arcuate slots 310 and 314. The
first member 221
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is secured in position by tightening the threaded member 302 and 304, the
first member 221 and
first cuff 222 between the treaded members 302 and 304 and internally threaded
fastener 312 and
316.
While the embodiment discussed above utilize a second extension member having
an
arcuate shape to control movement of the second member relative to the first,
ii should be
understood that skilled artisans having the benefit of this disclosure will
appreciate that other
configurations may likewise provide similar relative movement.
FIG. 34, for example, schematically illustrates an embodiment of an orthosis
330 of the
invention having a first member 332 and a second member 334, both of which
preferably having
sufficient structure or component parts to hold body members near the treated
joint or joints. ln
the embodiment illustrated in FIG. 34 the second member has a first pivoting
contact point 336
about which the geared body member may rotate. In this embodiment, the first
pivoting contact
336 does not move in relation to the first body member 330, birt as indicated
in FIG. 32 one
alternative embodiment may allow relative movement that can he resisted. by a
flexible device
338 such as a spring, compressed gas, foamed material, elastomer or the like.
Returning once again to FIG. 34, the second meniber may have an additional
pivot
contact 340, preferably disposed at a location at or near the opposite end of
the second member
334 from where the first pivoting contact 336 is located. The second pivoting
contact 340 may
be configured with a drive assembly 344 that causes the second member 334 to
follow a
predetermined path. Thus, the second pivoting contact 340 in the embodiment of
FIG. 34 is
configured to move relative to the first member 332 in order to cause the
joint to move from a
Cirst position to second one.
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'1'hc drive assembly 344 illustrated in FIG. 34 is an arm or linkage 346
connected
between the second pivot connection 340 and a rotating wheel 348. "I'he wheel
348 may be
configured so that the linkage 346 can be selectively connected to it in
different radial distances
from the center of rotation of the wheel. This allows the range of motion to
be adjustable by the
care provider, physician, or patient. As the wheel 348 is rotated, the linkage
346 moves in a
manner that causes the second metnber 334 to move in a particular way.
'I'he second member 334 (or alternatively the first member 332) may also have
a sliding
contact suriace 342. The sliding contact surface 342 allows the joint to
rotate or move according
to its natural instantaneous axis of rotation. Thus, if the second pivot
contact 340 moves in a
1.0 manner that does not always exactly correspond to the axis of rotation of
the joint, the sliding
contact surface 342 may move or adjust accordingly. Another potential
advantage of the sliding
contact surface 342 is that is may help facilitate proper alignment of the
joint in the orthosis
during initial setup.
FIG. 34 illustrates some variations that may also be used in orthosis of the
invention. For
instance, the first and or second pivot contact may be configured with a
cushion or spring 338
that allows one or both ends of the second member to impart some flexibility
in the force
imparted to the joint. As noted above, the cushion or spring 338 may be made
of a variety of
suitable materials and constructions to permit sonie flexibility in the
movement of the pivot
points 336, 340.
'1'he use of a spring or cushion allows the orthosis 330 to be used in
dif'ferent treatment
protocols than just by holding the joint in a prescribed location for a period
of time. Instead, the
orthosis can utilize the principles of static progressive stretch as described
in copending
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application no. 11/203,516, entitled "Range of Motion System and Method", and
filed on August
12, 2005, the entirety of which is incorporated by refcrence.
Thus, an orthosis 330 configured with a spring or cushion 338 can be nloved
from an
initial position to a second positiorj that is determined not by position of
the joint but instead by
the amount of force the orthosis 330 imparts on the joint. The joint may then
be subjected to this
loading, and over time as the surrounding tissue stretches the joint will move
and the imparted
forces will be reduced. It should be noted that while Fig. 35 illustrates the
cushion or spring 338
associated with the first pivot contact 336, it is not required to be
associated with it. Instead, for
example, the cushion or spring 338 may be associated with the second pivot 340
so that it can
flex or move in response to resistive forces of the joint and nearby tissue.
Likewise, there may
be a spring or cushion 338 associated with both pivot contacts 336, 340.
Another notable variation between the embodiments of FIGS. 34 and 35 is that
the
rotating wheel 348 in FIG. 34 has multiple single point connections for
connecting the linkage
346 at different distances from the center of rotation of the wheel. In
contrast, the embodiment
of FIG. 35 illustrates that an elongated slot 350 may be used to connect the
linkage 346. The
advantage of utilizing multiple single point connections may be ease of use
and the ability to
quickly confirm the orthosis 330 is properly configured for a prescribed
treatment protocol,
whereas one potential advantage of utilizing an elongated slot 350 is the
ability to quickly adjust
the settings without disassembling the device.
FIG. 36 illustrates an embodiment of the invention where the rotating wlleel
348 is a cam
surface 352. This embodiment is similar to the use of cams and followers as
describeci in U.S.
Patent No. 5,514,143, which is incorporated herein in its entirety. As shown,
the cam surface
352 may have varying distance from the center or rotation of the wheel 348. If
the wheel 358 is
CA 02664015 2009-03-19
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circular, for example, the center of rotation may be located somewhere
different from the
geometric center of the circle or at the center or rotation of the shape. As
it rotates, the
circumferential outer surface causes the linkage 346 to move to the second
member 340 in a
desired manner. Additionally, the outer edge of the "wheel" 348 need not be
round, but instead
may be a cam surface 352 of varying distance from the center or rotation.
Likewise, the outer
surface may have varying radii of curvature as shown in FIG. 36.
The embodiments of FIGS. 37 and 38 further illustrate that a cam surface 352
may be
used to move the second member 332 in a desired, perhaps complex way. As is
the case for
other embodiments described herein, performance of the cam surface 352 may be
enhanced
because of the ability to better mimic or replicate a moving axis of rotation
of the treated tissue
and joint.
In FIG. 37, the cam surface 352 is associated with the first member 332.
Linkages or
arms 346 of the secotzd member 334 have cam followers 354 that trace the cam
surrace 352 and
cause the second member 334 to niove in a more complex manner than just by
rotation around a
fixed axis.
The cam surface 352 of FIG. 37 also is associated with a slot 356 that allows
the relative
location of the first and second members 332 and 334 to be adjusted or moved
without
decoupling the cam followers 354 from the cam surface 352. As shown, the slot
356 allows for
horizontal adjustment repositioning. Although not shown, vertical slots may
also be provided,
either alone or in combination with a horizontal slot.
FIG. 38 illustrates an example where the linkage 346 is a cam surface 352 that
passes
through two or more points 358, 360 that are stationary or fixed relative to
the first member 332
when the orthosis 330 is in use (i.e. al:ter alignment is completed). Once
again, this embodiment
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may be configured to permit horizontal adjustment, such as by providing slot
368, and likewise
may be configured to be vertically adjustable. In addition, this embodiment
also illustrates that
the f~irst and second members 332 and 334 may be represented by rotation about
a pivot 370.
Thus, the use of horizontal, vertical, and rotational adjustnient of the
relative positions of the iirst
and second members 332 and 334 may allow greater fitting of the orfhosis 330
to the treated
tissue and joint.
FIG. 39 is an exploded view of how the cam surface 352 and cam followers 354
may
utilize a geared surface 372. Utilizing a geared surface 372 may allow for a
drive assembly 344
to automate the movement of the orthosis 330.
FIGS. 40 and 41 schematically illustrate other ways in which potentially
complex
movement of the second member 334 may be controlled. FIG. 40 illustrates that
the cam surface
may not be directly formed from a component part of either the first or second
members, but
instead maybe associated with some other structure. For instance, the orthosis
330 may be
operatively connected to a base unit 374 having a plurality of cam surfaces
376 corresponding to
different ranges of motion for related joints, such as when the orthosis 330
can be used to treat a
plurality of differcnt toes or a patient. Once the orthosis 181 is placed on
the patient, the second
member 334 will be positioned to securely hold one of the toes on the
patient's foot and to
engage with the cam surface 376 corresponding to that toe.
FIG. 41 shows that multiple cana surfaces or slots 378 may be formed in a side
panel 380.
The side panel 380 may have a sliding engagement of the second member 334. As
the second
member 334 moves, the engagement with the side panel 380 controls position and
movement.
Moreover, one or more sides or edges of a slot 316 of the embodiment of p'IG.
41 may be geared
to allow implementation of a drive assembly 344.
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FIG. 42 illustrates an embodiment where movement of at least part of a linkage
346 may
be linear, but when combined with a rotational pivot 382, sliding slot 384,
and possibly other
components or combinations described herein, the net effect on the second
member 334 is once
again a controlled movement in a desired manner.
'I'he components of the present invention are rigid members made of, for
example,
aluminum, stainless steel, polymcric, or composite i:naterials. The member and
extensions are
sufficiently rigid to transmit the necessary forces. It should be understood
that any material of
sufficient rigidity might be used. For example, some components can be made by
injcction
molding. Generally, for injection molding, tool and die metal molds of the
components are
prepared. Hot, melted plastic material is injected into the molds. The plastic
is allowed to cool,
forming components. The components are removed from the molds and assembled.
Furthermore, it is contemplated that the components can be made of polymeric
or
composite materials such that the device can be disposable. For example, at
least some or all of
the components can be made of a biodegradable material such as a biodegradable
polymer.
Among the important properties of these polymers are their tendency to
depolymerize relatively
easily and their ability to form environmentally benign byproducts when
degraded or
depolymerized. One such biodegradable material is poly (hydroxyacids)
("PHA's") such as
polyactic acid ("PLA") and polyglycolic acid ("PGA").
Additionally, the device can be made of a nonmagnetic material. In such
instance, the
device can be used as a positioning device for use in imaging devices, such as
a MRI device. It
is also contemplated that the device can be used as a positioning device for
use during surgical
procedures, where it may be necessary to ad,just and hold the position of the
joint.
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In a method of manufacture, the cuffs can include a base plate having a
plurality a strap
attached thereto, where the straps are position about a body portion of a
patient. The straps are
attached to the base plate using fastener elements, such as screws threaded
into the base plate.
The screws can be removable to allow for easy removal and/or replacement of
the straps.
Alternatively, in an embodiment where the base plate is made of a polymeric
material,
the straps can be welded to the base plate using an energy welding technique
such as, RF
welditlg, ultra-sonic welding, high frequency welding, etc. For example, in
ultra-sonic welding
an acoustic tool in used to transfer vibrational energy into the weld areas of
the straps and the
base plate. The friction of the vibrating molecules generates heat, which
melts the surface
material of the base plate in the welding area, at which point the vibrational
energy is stopped.
Pressure is applied to the strap and the base plate, allowing the melted
material to solidify within
the material of the strap. In this method the strap is secured to the base
plate without the need of'
fasteners.
Similarly, where the cuffs are made of a polymeric rnaterial, the cuff can be
welded to the
orl:bosis using energy welding techniques. For example, the cuffs can be made
of a substantially
rigid, flexible, or fabric polymeric material which can be welded directly
onto the arm members
of the orthosis. It is also contemplated that the straps can be an integral
part of the cuffs. For
exaniple, where the cuffs are made of a polymeric fabric, the straps can be
integrally formed in
the fabric pattern when making the cuffs.
All references cited herein are expressly incorporated by reference in their
entirety.
It will be apprcciated by persons skilled in the art that the present
invention is not liniited
to what has been particularly shown and described herein above. For example,
although the
examples presented identify the toe joint, the present invention can be used
for any joint in the
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body of the patient. In addition, unless mention was made above to the
contrary, it should be
noted that not all of the accompanying drawings are to scale. A variety of
modifications and
variations are possible in light of the above teachings without departing from
the scope and spirit
of the invention, which is limited only by the following claims.
