Note: Descriptions are shown in the official language in which they were submitted.
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IMPROVED MODIFIED ORTHOTIC DEVICE
BaCRGRO~D OF TÆ I~VENTION
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- This invention relates to an improved orthotic
de~ice for use in a new assembly of knee stabilizer and
modified cast brace. More particularly, this invention
relates to a new and improved double hinged single side
brace for use in support and alignment of the joints,
security of limb position, prevention of change in
position attributed to rotatory forces on the fxacture
~ite, prevention of swelling complications, and economy
o~ physician's time. Support and protection is to the
medial collateral ligament of lateral collatera~
ligament of the knee.
The knee-joint is made up of two condyloid
~oints and a third joint, partly arthrodial, but not
completely so, since the articular surfaces are not
mutually adapted to each other, so that the mo~ement
is not a simple gliding one. The principal moYemen~s
that take place at the knee-joint are flexion and
extension. The movements of flexion and extension
at this joint aiffer from those in a typical hinge joint,
such as the elbow, in that the axis around which motion
takes place is not a fixed one but shifts forward during
extension, as a gliding movement is superposed on the
rolling, and shifts backward during flexion. ~$~
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Although the knee-joint has been described as
a hinge joint, it is reall~ of a much more complicated
character. It must be regarded as consisting of three
articulations, of two different kinds. The first
kind is a condyloid articulation; in this form of joint,
an o~oid articular surface, or condyle, is received into
an elliptical cavity in such a manner as to permit
flexion, extension, abduction, adduction, and
circumduction, but no axial rotation. The second kind
of articulation involved is arthrodial; this is a joint
which permits only gliding movement. It is formed by
the apposition of plane surfaces, or one slightly
concavei-~he-ether-slightly convex, the amount of
motion between hem being limited by the ligaments or
osseous processes surrounding the articulation.
Persons who have sustained knee injuries, who
have had operations to remove cartilage, or who have
weak knee-joints from causes, such as arthritis or
~theletes who have sustained an injury to the medial
collateral ligament or lateral collateral ligament
of the knee, need protection principally against lateral
motion of the knee, that is, motion may be the result,
for example, of a blow to the side of the knee. At
the same time, a suitable knee brace should not
interfere with the normal flexion and extension of the
leg. The brace should protect the knee against sidewise
motions during both flexion and extension, this means
that the bracing structure should continue to lie parallel
to-the parts--of the=le~ above and below the kne~-joint
in all-position~ of the brace structure and should remain
substantially at the knee and provide protection to the
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The knee-joint has four principal ligaments r one
on either side and two on the inside. There ligaments
may be strained or torn in sports and accidents.
Injuries to these ligaments can be serious and must be
properly treated if disability is to be avoided~ Above
all, repeated injury or strains before healing must
be avoided. All degrees of ligament injuries will lead
to some atrophy of the quadriceps and hamstring muscle
groups.
Many previous orthotic devices for use as
knee braces and protection devices have been simple
hinged structures pivotable about a fixed point, which
cannot move parallel to the complex motion of the knee
joint. Some knee braces for support and protection of
the knee-joint comprises both an inner and outer bracing
structure each a rigid planar and elongated arm and
pivoted about a fixed point. The fixed point lies on
and parallel to the knee and leg. During motion and
a sideways blow, the rigid planar arms may cause further
injury or discomfort to the already injured ligaments
of the knee-;oint.
Some of the previous knee braces fail to provide
~rotection to the injured knee ligaments. ~hile other
braces may lie parallel to the leg and knee-joint while
it i5 extended when the leg is flexed, the bracing
structure fails to follow the motion accurately.
The instant improved orthotic device may be used
in cast bracing for derotational or knee bracing; also
used to distribute the load of functional below-the-knee
fracture bracing. Cast bracing stresses proper alignment
of the joints, security of limb position, prevention of
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swelling complications and economy of physician's time.
A special feature is a double hinged single side brace
utilized in paired configuration on each side of the
knee-joint. Within the features of the improved
modified cast brace of this invention is a modified
double hinged double axis joint that restricts the arc
of the leg motion to safe limits, generally 20 to 90
degrees. Functionally, the use of the modified cast
brace joint compares favorably with previous treatments.
Early motion was extremely well tolerated, the
stability of operated knees was well supported and
aided in management of serious knee ligament injuries.
Clinical and laboratory evidence has proven
that prolonged immobilization is detrimental to synovial
joints. Traditional treatment of knee-joint and leg
in~uries commonly involves immobilization for six to
eight weeks. Periods of immobilization of this length
produce alterations in the biochemistry of connective
tis8ue, the micro- and ultra-structure of synovial
membrane, cartilage, tendon, and in the biomechanical
properties of the ligament-bone unit. Muscle atrophy
and vascular thrombi are common extra-articular
complications of prolonged immobilization.
Means for minimizing these undesirable effects
are desirable. Therefore, early protected motion will
re8ult in minimizing the undesirable effects. The
instant invention is a specific modified cast brace
which allows limited knee motion yet protects healing
structures from disruptive stresses.
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SUMMARY OF THE INVENTION
Objects of the present invention are to provide
for an improved modified orthotic-cast brace assembly
w~ich permits and provides freedom of movement of the
knee during flexion and extension of the leg in a cast
S without restriction or physical discomfort during
movement.
Another object of the present invention is to
provide an improved modified orthotic-cast brace assembly
which permits and provides freedom of movement of the
knee during flexion and extension of the leg in a cast
without restriction or physical discomfort during
movement.
Another object of the present invention is to
provlde an improved modified orthotic-cast brace
a~embly which permits and provides for use on an
already injured knee and provides prevention of further
ln~ury or strain.
Another object o$ the present invention is to
provide a paired configuration of rigid double hinged
single side orthotic-knee brace pivotally hinged to
upper and lower flanges and attachment wings for easy
~ecuring and removal to the cast material on the
wearer's leg.
It i~ another object to provide such a modified
orthotic-cast brace and stabilizer that does not
interfere with normal extension and flexion of the
wearer's leg while in the cast, while preventing
sidewise motion of the knee-joint whether the leg is
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flexed or extended giving added ~upport and comfort
thereto and providing rotational stability.
The cast brace assembly of the present invention
includes a bracing structure comprising a rigid support
bar substantially having an optional concave off-set
through its center portion, and at one end pivotally
hinged to an upper flange and at the other end pivotally
hinged to a lower flange. The center portion having the
optional concave off-set of the rigid support is placed
along side the knee-joint.
In preferred embodiments, the present invention
encompasses at least one improved orthotic device as a
knee stabilizer and derotational for support and
protection of a knee joint and leg said device described
as a double hinged ~ingle side brace comprising a
rigid support structure having an optional off-set or
involuted design through its center portion. Butt-joint
hlnge~ provide a less cumbersome hinge arrangement. Said
off-Qet is optionally formed by raising the center bar
or rod by bushings or spacers, or by bending of the
center rod or bar, or by bending the upper and lower
flanges and connecting there between on the raised portion
of the flange a flat straight support bar or rod. The
upper flange to which the upper end of the rigid support
structure is pivotally hinged to the wearer's upper leg
embedded in the cast material above the knee-joint for
movement with the upper leg,and limited motion paraliel
to the upper leg, and lower flange to which the lower end
of the rigid support structure is pivotally hinged to
the wearer's lower leg embedded in the cast material
below the~nee-joint for movement with the lower leg
and limited motion parallel to the lower leg. The
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support and stabilizing structure has a single rigid
Qupport bar or rod optionally having an off-set through
its center portion and doubly hinged each at the upper
and lower end of the rigid support bar. If the off-set
is accomplished by bending the upper and lower flanges,
or if the bushings are used to achieve the of~-set
configuration, then the rigid support bar or rod is flat
and straight between the flanges. The movement of the
leg by normal flexion and extension of the wearer's knee
is freely permitted by the double hinged arrangement.
The movement comprises any manner consistent with the
double hinged action permitted by the rigid support bar
and normal to the plane of the rigid support bar,
thereby preventing sidewise motion of the knee-joint.
Other o~jects, features and advantages will
appear from the following description of a preferred
embodiment of the invention, taken together with the
attached drawings, in which:
The improved orthotic device assembly consists
é~entially of a bracing structure consisting essentially
of a rigid support bar or rod substantially having a
center portion; at each end of said center portion,
there is pivotally hinged thereto extension flanges.
Securely attached to each extension flange there are
optionally attachment wings. The attachment wingæ are
u~ed to assist in positioning and embedding the exten-
~ion flanges into the casting material to secure the
ca~t brace to the casting material. Alternative to the
optional attachment wings, the extension flange itself
may be flared to simulate the attachment wings. The
flanges can be contoured with bending irons to allow
fluQh apposition to the cast.
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FIG. 1 shows the improved orthotic device
adapted in a modified cast brace according to the
present invention in paired configuration in place
with respect to the extended leg of the wearer;
FIG. 2 shows the orthotic device in a modified
cast brace according to the present invention in
relation to the flexed leg of the wearer;
FIG. 3 is a perspective view of the improved
orthotic device according to the present invention;
FIG. 4 is a detailed.view of a stop means for
regulating or restricting movement in the orthotic
device;
FIG. 5 is a perspective view of alternative
arrangements for positioning the center support bar or
rod~ and
FIG. 6 is a perspective view of alternative
flared flanges for attachment.
Referring to the drawings, FIGS. 1-6, the
orthotic device of the present invention includes a
2Q 61ngle rigid support bar or rod 1 having through the
center portion a support bar or rod 5. The support
bar or rod 5 has two end portions which are continuations
of the center support bar or rod. Each end portion
i~ provided with an opening which accommodates a means.
for pivotally fastening 4 and 6 to each end portion of
the ~upport bar or rod to extension flanges 3 and 7.
The flanges 3 and 7 are pivotally fastened at 4.and 6
to each end portion of the rigid support bar or rod 5.
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Such pivotal connection is essential to the function
of the cast brace, as discussed in the following.
Each of the flanges 3 and 7 are terminated
integrally with optional attachment wings 2 and 9.
Each attachment wing is provided perpendicular to the
connecting flange. Alternatively, the flanges may be
flared to simulate the attachment wings as in FIG. 6.
Referring to FIG. 1 and FIG. 2, the orthotic device is
in place on the wearer's leg. The flanges 3 and 7
terminated by attachment wings 2 and 9 or flaring of
the flanges are generally parallel to the upper and
lower parts of the wearer's leg even at flexion or
extension. The flanges and optional attachment wings
which are securely fastened to each other or using
flared flanges, are embedded into the casting material.
Thereby, the orthotic device is used in a modified cast
or fracture brace and becomes an integral part of the
Cast.
The center portion 5 of the orthotic device
can be optionally designed off-set or involuted design
to avoid pressure against the knee-joint of the wearer.
As ~hown in FIG. 5, various alternative configurations
are possible for attachment and positioning of the
center portion 5. The pivotally mounted flanges 3 and 7,
wings 2 and 9 or flared flanges are securely embedded
in the cast material on the wearer's leg, flange and
attachment wing,or flared flanges,in the upper part of
the cast above the knee-joint and flange and attachment
wing, or flared flanges, in the lower part of the cast
below the knee-joint. The three part construction with
the double hinged action allows the stabilizer to
translate the normal leg action of extension and flexion
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into the confoxmed and supported orthotic bracing
structure integral with the cast. The combination of
motions permitted by the three part construction results
in the motion of the attachment wings and flanges with
respect to the rigid support bar or rod that closely
parallels that natural action of the knee-joint. The
rigid support bar or rod l closely and accurately follows
the action of the wearer's knee and at all times
continuing to provide support and stability to the knee
~oint while the leg is in a cast. Especially protection
against sidewise forces and rotational stability is
provided.
The improved orthotic device used in a modified
ca~t brace is attachable to the inner or outer leg.
Preferably the orthotic device in a modified cast brace
is positioned and secured in paired configuration on
both sides of the knee opposite the orthotic center of
the knee to provide rotational stability. The center
portion of the rigid support bar or rod is placed
directly over the medial or lateral ligament.
~, By the double hinge arrangement, the motions
of flexion or extension are easily followed by the
modified cast brace employing the orthotic device
with the accompanying cast support. The principle
upon which the invention is based, as well as the
operation of the three-segment double hinged arrangement,
i~ be~t understood by referring to FIG. l and FIG. 2.
The bracing structure remains generally parallel to the
knee-~oint, but the action of the joint formed by the
stabilizer accurately parallels the action of the
ndividual wearer' 8 knee. At all times, the orthotic
device and knee stabilizer of the modified cast br~ce
; of this invention remains substantially displaced,
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but parallel and adjacent to the knee-joint, continuing
to provide protection and support. Translational
motion of the stabilizer of the modified cast brace is
limited by being secured into the casting material.
By using the present invention, it is thus
possible to have a convenient, effective and comfort~ble
means for stabilizing and supporting the leg and knee-
joint and thereby eliminate discomfort or possible
injury or reinjury to the leg. More importantly, the
improved modified cast brace prevents change in position
which otherwise is attributed to rotating forces on the
fracture site. The double hinge arrangement is a novel
feature among orthotic devices as modified cast braces
and fracture braces. Also, the center portion of the
rigid support bar or rod of the knee stabilizer of the
¢ast brace i8 novel in that it does not place pressure
on the knee-joint. Acting together, the improved bar
or rod and double hinge arrangement with means or
re~tricting movement of the leg form the basis for an
original and useful improvement in the design, function
and operation of the present orthotic device.
Although a direct comp æ ison between the present
construction and other presently known conventional cast
brace structures is difficult, it is the opinion of
person3 who have used the orthotic device in a modifled
cast brace that more than satisfactory results were
obtained. For example, football players, who had each
experienced leg injuries1 wore the described orthotic
device stabilizer and cast brace. By being able to
have some motion to the injured leg, rehabilitation and
full use of the leg was enhanced. ~ach player was then
able to perform his prescri~ed duties witho~ 0x~ended
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recuperation. Joint motion and muscle function are
maintained so that they are at a functional level at the
completion of the treatment.
In use, the orthotic device used in an
improved modified cast brace is used in a cast brace
assembly which protects healing structures from disruptive
stresses on the leg or knee especially rotational forces.
In the use, the modified cast brace assembly with the
orthotic device is employed in a leg cast on patients
with a variety of problems in fractures of the proximal
tibia and distal femur. Among the knee and leg problems
including acute ligamentous injuries, medial and lateral
reconstructions, cruciate ligament prosthesis, total
knee arthroplasties, tibial plateau fractures, and
patello-femoral arthroplasties.
The impr~ved orthotic device with the stop
means for restricting the range of motion of the leg,
~enerally from about 20 to about 90 degrees, the arc and
total range of motion may be varied according to the
individual pathology. The improved modified cast brace
permits isotonic, isometric and progressive resistance
exercises while in the cast brace. The cast is worn from
six to eight weeks or for a time period as required.
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The hinged long leg cast includ~ng t~e dou~le
hinged three-segment-brace support is practical from
the standpoint of cost, t~me and ease of application.
Also, the comfort to the patient is notable, both in
ease of movement when permitted, in weight and functional
stability and support. Another distinct advantage of
the modified cast brace is the possible reuse of t~e
joint which lessens the cost.
More particularly, a notable advantage to t~e
use of the instant orthotic devi¢e in a modified cast
brace assembly with the three-segment double hinge
brace is the ease of application. Many other cast brace
joints and assemblies require the joints need be
aligned parallel and over the axis of rotation of the
knee. This critical alignment requires an alignment
jlg - a special tool is required~ The instant joint is
unique since it does not require special alignment.
It is sufficient to place one joint on each side of
the knee with the placement reasonably determined over
,the center of rotation for the knee. Orientatio~ of
the joints and extensions contoured to the upper and
lower leg curvature allows ease of placement in the
cast with maximum comfort to the patient.
When applying the orthotic device in a
modified cast brace with the joint in place, plaster
may be used as a general cast material. Some of the
newer synthetic materials may be more durable with
active athletic patients. Also, newer synthetic
materials are lighter in weight than plaster. In use
of any casting material, the joints are then easily
applied to the cast by implanting the extended flanges
and attachment wings thereto. Means for integral
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attachment of the orthotic device to the casting
material is provided.
Within the embodiment of this invention i9 the
means for regulating and restricting the movement of
the cast brace. Because of the ease of movement of
the knee fitted with an improved cast brace, including
the orthotic device, there is a need for a means for
regulating and restricting the movement of the leg.
Confined movement is often recommended at early stages
of healing. Later, freer movement of the knee and
leg can be permitted. Therefore, patients with
operated cases fail to require longer time for recovery
of motion. Repaired knees which n loosen" during
immobilization does not apply to cases employing the
instant device. Therefore, knees treated with early
protected motion show no harm and enhance recovery and
early full use of the knee joint.
A1BO~ included within the invention, ~s the
means for angular positioning of the leg. Also,
cond dered is a stop means for limiting the folding
movement of the mechanical double hinged joint. There
i~ capability for free movement of the knee, restricted
movement and fixed angular positioning of the knee-joint~
Varied capability to control the knee and leg mo~ement
give~ early protected motion, with early lim~ted knee
motion, followed by free motion. Actually, motion can
be initiated at any time, if the patient has a condition
which will permit movement.
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The feature of the orthotic device in the
modified cast brace is the three-segment double hinged
joint, uncommon to other fracture braces. In addition,
the modified cast brace is provided with stop means for
adjusting to limit both flexion and extension of the leg
and knee-joint, pre-set and resettable means for
added freedom in setting a range of knee motions.
Setting can range from a locked position to a limited
motion to a completely adjustable brace to desired
limits.
The modified cast brace can be applied with
conventional casting materials. For example, if a long
leg cast is suitable to the pathology, it can be applied
as over a cast sock and elastic knee cage. These items
are optional. Additionally, felt pads may be placed over
the malleoli, the extensor hallucis longus tendon on
the dorsum of the foot, and the peroneal nerve. An
additional piece of felt may be placed over the patella
to create an identifiable bump for trimming and to turn
the edges away from the shin. The modified cast brace
with the improved orthotic device in paired configuration
is embedded in the casting material on each site of
the knee-joint.
The modified cast brace with the improved
orthotic device of this invention is useful in many
ailments of the leg, knee and knee ligaments. Both
pre- and post-operative utility has been realized.
Chronic and acute knee and knee ligament injuries can
be treated and rehabilitated. In most cases,
rehabilitation time after treatment was shortened.
Quadriceps and hamstring tone rated fair to good on
removal of the modified cast brace. L~osening of
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repaired knees can be prevented since complete
immobilization is not required.
While certain novel features of the invention
have been disc~osed herein, and pointed out in the
annexed claims, it will be understood that, in
accordance with the doctrine of equivalents, various
omissions, substitutions and changes may be made by
those skilled in the art without departing from the
spirit and scope of the invention.