U.S. patent application number 13/613995 was filed with the patent office on 2013-01-03 for orthopedic device having anteroposterior articulation.
Invention is credited to Arni Thor INGIMUNDARSON, Ashley KIMES.
Application Number | 20130006156 13/613995 |
Document ID | / |
Family ID | 40204630 |
Filed Date | 2013-01-03 |
United States Patent
Application |
20130006156 |
Kind Code |
A1 |
INGIMUNDARSON; Arni Thor ;
et al. |
January 3, 2013 |
ORTHOPEDIC DEVICE HAVING ANTEROPOSTERIOR ARTICULATION
Abstract
An orthopedic device in the form of an unloading osteoarthritic
knee brace has proximal and distal frame members with a
flexion-extension hinge positioned between the proximal and distal
frame members. At least one articulating free hinge is positioned
in an upright between the flexion-extension hinge and one of the
proximal and distal frame members. The free hinge provides free
rotation of the proximal or distal frame member about the
anteroposterior axis with respect to the flexion-extension
hinge.
Inventors: |
INGIMUNDARSON; Arni Thor;
(Gardabaer, IS) ; KIMES; Ashley; (Irvine,
CA) |
Family ID: |
40204630 |
Appl. No.: |
13/613995 |
Filed: |
September 13, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12264020 |
Nov 3, 2008 |
8292838 |
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13613995 |
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Current U.S.
Class: |
602/16 |
Current CPC
Class: |
A61F 2005/0165 20130101;
A61F 2005/0139 20130101; A61F 2005/0134 20130101; A61F 5/0123
20130101; B33Y 80/00 20141201 |
Class at
Publication: |
602/16 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1. An orthopedic device having opposed first and second sides along
an anterior-posterior plane, the device comprising: first and
second frame members arranged to secure about anatomical portions
of a wearer; first and second uprights connecting respectively to
the first and second frame members; and a hinge connecting the
first and second uprights, the hinge permitting movement of the
first and second frame members relative to one another into
extension and flexion; wherein at least one of the first and second
uprights includes a single articulating portion permitting the at
least one of the first and second uprights and the respective first
or second frame member connected thereto to freely rotate at least
within a range of 90 degrees generally about an anteroposterior
axis with respect to the hinge; at least one stability strap
connecting to at least one of the first and second frame members,
and selectively adjustable to rotate at least one of the first and
second frame member about the articulating portion and arranged to
exert a force directed toward the first side of the brace by
passing through the first articulating portion that is offset by an
opposed force created within the hinge when the device is in use by
a wearer;.
2. The orthopedic device according to claim 1, wherein the first
and second frame members are first and second shell portions.
3. The orthopedic device according to claim 1, wherein at least one
of the first and second uprights comprises: a hinge support portion
connecting to the hinge; a frame member support portion connecting
to a respective one of the first and second frame members; and the
articulating portion located between the hinge support portion and
the frame member support portion and connecting the hinge and frame
member support portions.
4. The orthopedic device according to claim 3, wherein the
articulating portion is an overmolded portion encompassing at least
a portion of each of the hinge support portion and the frame member
support portion.
5. The orthopedic device according to claim 3, wherein the
articulating portion comprises: a first connection member
connecting to the hinge support portion; a second connection member
connecting to the frame member support portion; and a pivot pin
connecting the first and second connection members in a freely
pivotable manner.
6. The orthopedic device according to claim 1, wherein a clearance
is formed between the first and second frame members along the
second side of the brace.
7. The orthopedic device according to claim 1, wherein the first
and second uprights are located only on the first side of the
device.
8. The orthopedic device according to claim 1, wherein the first
and second uprights are located on first and second sides of the
device.
9. An orthopedic device having opposed first and second sides along
an anterior-posterior plane, the device comprising: first and
second shells arranged to secure about anatomical portions of a
wearer; first and second uprights connecting respectively to the
first and second shells; and a hinge connecting to the first and
second uprights, the hinge permitting movement of the first and
second shells relative to one another into flexion and extension;
wherein at least one of the first and second uprights includes a
first articulating portion permitting the at least one of the first
and second uprights and the respective first or second shell
connected thereto to freely rotate generally about an
anteroposterior axis with respect to the hinge; and wherein a first
stability strap connecting to at least one of the first and second
shells is selectively adjustable to rotate the at least one of the
first and second uprights and the respective first or second shell
connected thereto a predetermined amount about the first
articulating portion and the first stability strap is further
arranged to exert a first force passing through the first
articulating portion that is offset by an opposed force created
within the hinge, and a second stability strap connecting to at
least one of the first and second shells is selectively adjustable
to rotate the other of the at least one of the first and second
uprights and the respective first or second shell connected thereto
about the second articulating portion and the second stability
strap is further arranged to exert a second force passing through
the second articulating portion that is offset by an opposed force
created within the hinge when the device is in use by a wearer;
wherein the first and second stability straps exert the first and
second forces from the second side of the brace.
10. The orthopedic device according to claim 9, further comprising:
wherein at the other of the least one of the first and second
uprights includes a second articulating portion permitting the
other of the at least one of the first and second uprights and the
respective first or second shell connected thereto to freely rotate
generally about an anteroposterior axis with respect to the
hinge.
11. The orthopedic device according to claim 10, wherein the first
or second articulating portion comprises: a hinge support portion
connecting to the hinge; and a shell support portion connecting to
a respective one of the first or second shells; wherein the first
or second articulating portion connects the hinge and shell support
portions.
12. The orthopedic device according to claim 9, wherein at least
one of the first and second articulating portions is an overmolded
portion encompassing at least a portion of each of the hinge and
shell support portions.
13. The orthopedic device according to claim 9, wherein the first
or second articulating portion comprises: a hinge support portion
connecting to the hinge; a shell support portion connecting to a
respective one of the first or second shells; and a pivoting
portion connecting the hinge and shell support portions.
14. The orthopedic device according to claim 13, wherein the
pivoting portion comprises: a first connection member connecting to
the hinge support portion; a second connection member connecting to
the shell support portion; and a pivot pin connecting the first and
second connection members in a freely pivotable manner.
15. An orthopedic device having opposed first and second sides
along an anterior-posterior plane, the device comprising: first and
second shells arranged to secure about anatomical portions of a
wearer; first and second uprights connecting respectively to the
first and second shells; and a hinge connecting to the first and
second uprights, the hinge permitting movement of the first and
second shells relative to one another into flexion and extension;
wherein at least one of the first and second uprights includes a
first articulating portion permitting the at least one of the first
and second uprights and the respective first or second shell
connected thereto to freely rotate generally about an
anteroposterior axis with respect to the hinge; wherein the first
articulating portion is an overmolded portion defined by a flexible
or resilient material and encompassing at least a portion of each
of the hinge support portion and the frame member support portion.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of
orthopedic and prosthetic devices, and more particularly to an
orthopedic device that provides stability, protection, support,
rehabilitation, and/or unloading to a portion of the human
anatomy.
BACKGROUND
[0002] Knee braces are widely used to treat a variety of knee
infirmities. Such braces may be configured to impart forces or
leverage on the limbs surrounding the knee joint in order to
relieve compressive forces within a portion of the knee joint, or
to reduce the load on that portion of the knee. Moreover, in the
event that knee ligaments are weak and infirm, a knee brace may
stabilize, protect, support, unload, and/or rehabilitate the
knee.
[0003] The knee is acknowledged as one of the weakest joints in the
body, and serves as the articulating joint between the thigh and
calf muscle groups. The knee is held together primarily by small
but powerful ligaments. Knee instability arising out of cartilage
damage, ligament strain and other causes is relatively commonplace
since the knee joint is subjected to significant loads during the
course of almost any kind of physical activity requiring the use of
the legs.
[0004] A healthy knee has an even distribution of pressure in both
the medial and lateral compartments of the knee. It is normal for a
person with a healthy knee to place a varus moment on the knee when
standing so that the pressure between the medial and lateral
compartments is uneven but still natural.
[0005] One type of knee infirmity that many individuals are prone
to having is compartmental osteoarthritis. Compartmental
osteoarthritis may arise when there is a persistent uneven
distribution of pressure in one of the medial and lateral
compartments of the knee. Compartmental osteoarthritis can be
caused by injury, obesity, misalignment of the knee, or simply due
to aging of the knee.
[0006] A major problem resulting from osteoarthritis of the knee is
that the smooth cartilage lining the inside of the knee wears away.
This leads to a narrowing of the joint space with the development
of cysts and erosions in the bone ends. Because of the narrowing of
the joint, bone comes directly in contact with bone, and an uneven
distribution of pressure develops across the knee which may result
in the formation of bone spurs around the joint. All of these
changes ultimately lead to increasing pain and stiffness of the
joint.
[0007] While there are no cures to osteoarthritis, there are many
treatments. Individuals who have a diagnosis of isolated medial or
lateral compartmental osteoarthritis of the knee are confronted
with a variety of treatment options such as medications, surgery,
and nonsurgical interventions. Nonsurgical interventions include
the use of canes, lateral shoe wedges, and knee bracing.
[0008] Knee bracing is useful to provide compartmental pain relief
by reducing the load on the affected compartment through the
application of an opposing external valgus or varus moment about
the knee joint. Unloading knee braces have been shown to
significantly reduce osteoarthritis knee pain while improving knee
function. Typically, however, the amount of varus and/or valgus
rotation that a brace may provide is limited by the use of rigid or
substantially rigid supporting struts or frames. While some brace
designs do allow for selective, fixed adjustment of the amount of
varus and/or valgus rotation provided by the brace, the disclosed
embodiments provide an unexpected result of freely adjusting varus
and/or valgus rotation for a brace while utilizing the geometry of
the leg and the straps of the brace to selectively adjust the varus
and/or valgus rotation of the leg for a desired effect.
[0009] While known knee braces are successful at reducing pain or
at stabilizing a knee joint, many users find these braces to be
bulky, difficult to don, complicated to configure, and
uncomfortable to wear. For these reasons, the embodiments described
herein have streamlined features capable of providing relief for
medial or lateral compartmental osteoarthritis, or functional
stability of the knee while providing a configuration that has a
low profile and unexpectedly provides a more conforming and
supportive fit for the orthopedic device.
SUMMARY
[0010] The orthopedic device disclosed herein may be of an
unloading type knee brace, in accordance with the principles
described in U.S. Pat. No. 7,198,610, granted Apr. 3, 2007, and
U.S. Pat. No. 5,277,698, granted Jan. 11, 1994, both incorporated
herein in their entirety by reference.
[0011] A knee brace in accordance with the present disclosure
utilizes articulating portions in the form of free hinges in the
uprights or struts of the knee brace to provide free varus/valgus
rotation of the proximal and distal (also referred to as first and
second) frame members (or shells) with respect to the
flexion-extension hinge of the knee brace. The articulating
portions allow the upright components and the frame members
connected thereto to freely rotate about an anteroposterior axis
with respect to the flexion-extension hinge. In other words, the
articulating portion is not lockable or fixable, but instead allows
the components to freely rotate within a predetermined range of
motion.
[0012] This configuration provides the unexpected results that when
the knee brace is positioned on the leg and the one or more
stability straps are tightened, the varus/valgus angle of the knee
may be adjusted independently of the flexion-extension hinge
element without compressing and binding the hinge element. Further,
the desired angle of varus/valgus rotation of the knee joint may be
altered by adjustment of the one or more stability straps, in
combination with the use of the free hinges. The desired angle of
varus/valgus rotation can be altered by adjusting the one or more
stability straps. There may also be some variation in the
varus/valgus angle due to the change in the alignment of the leg
through the gait cycle, in so far as the free hinges allow the
proximal and distal frame members to move with the leg when the
alignment of the leg changes.
[0013] These relationships are contrary to what a skilled artisan
in the field of orthopedic braces, and in particular knee braces,
would anticipate. In particular, a skilled artisan would expect
such a configuration to cause the proximal and distal frame members
to compress together, the flexion-extension hinge to bind-up, or
the components of the brace to otherwise obtain an ineffectual
orientation. The anticipated ineffectual orientation would appear
to arise due to the diagonal forces of the one or more stability
straps acting to bring the proximal and distal shells closer
together, thus reducing the function and stability of the knee
brace or undesirably altering the amount of varus/valgus
rotation.
[0014] These particular effects do not in fact occur, but rather,
unexpectedly, the utilization of the articulating free hinges
provides great flexibility in adjusting varus/valgus angles of the
knee, while maintaining the structural support and functionality
required of a knee brace, and further enhancing the conformity and
fit of the brace to the leg. This is due to the fact that there is
a single free point above and a single free point below the
flexion-extension hinge element. The use of a single free point
above and below the hinge element does not allow the proximal and
distal frame members to compress together, but instead allows them
to move only with varus/valgus movement. Thus, the
flexion-extension hinge element acts to maintain the proximal and
distal frame members spaced from each other, even when the one or
more stability straps are adjusted to alter the varus/valgus angle.
The flexion-extension hinge element would not function in this
manner if two free points were provided above and below the hinge.
In such a case, the frame members or the hinge element would
collapse, and thus would not provide suitable structural
support.
[0015] As just mentioned, the varus/valgus angle is substantially
set by the use of one or more stability straps. The articulating
free hinges allow the proximal and distal frame members to freely
rotate without locking within a predetermined range of motion about
an anteroposterior axis in order to alter the varus/valgus angle
when the tension of the one or more stability straps of the knee
brace is adjusted. In other words, once the straps have been
tightened, the varus/valgus angle may only change with the changes
in the alignment of the leg. As mentioned above, the varus/valgus
angle may be adjusted by altering the tension in the stability
straps.
[0016] Meanwhile, since the flexion-extension hinge does not
participate in providing the varus/valgus angle for the knee brace,
the articulating free hinges allow the hinge element to closely
conform to the leg/knee joint throughout the entire gait cycle. In
other words, the upright defined by or including the
flexion-extension hinge member maintains its conformity to the knee
throughout the gait cycle since the articulating free hinges
constantly adjust and flex with the patient during the gait cycle.
In other words, the flexion-extension hinge is allowed to float in
conformance with the leg during the gait cycle due to the single
free point positioned above and the single free point positioned
below the flexion-extension hinge, while the knee brace maintains
sufficient structural support and/or unloading of the knee
joint.
[0017] Accordingly, an orthopedic device in the form of a knee
brace for stabilizing, protecting, supporting, unloading, and/or
rehabilitating the knee is provided. The knee brace is a low
profile brace utilizing articulating free hinges to allow the
varus/valgus angle of the knee to be adjusted.
[0018] In a particular exemplary embodiment, the knee brace has
proximal and distal shells. In the exemplary embodiment, each of
the proximal and distal shells includes an extending portion along
a first side thereof, which may be a lateral or medial side. A
hinge member connects to the proximal and distal shells, and in the
exemplary embodiment to the extending portions. The hinge member
may be a monocentric or polycentric flexion-extension hinge. A
first articulating portion in the form of a free hinge connects
between the flexion-extension hinge member and the proximal shell
to allow the proximal shell to freely rotate into varus/valgus
within a predetermined range of motion about an anteroposterior
axis with respect to the hinge member. A second articulating
portion in the form of a free hinge connects between the
flexion-extension hinge member and the distal shell to allow the
distal shell to freely rotate into varus/valgus within a
predetermined range of motion about an anteroposterior axis with
respect to the hinge member. In this manner, the varus/valgus angle
of the knee brace may be freely adjusted.
[0019] First and second stability straps or a single spiraling
strap connect to the proximal and distal shells and are selectively
adjustable to provide desired rotation of the proximal and distal
shells about an anteroposterior axis to the proximal and distal
shells with respect to the flexion-extension hinge member. In this
manner, when the knee brace is positioned on the leg, the stability
straps are adjusted to obtain the desired amount of varus/valgus
rotation of the knee joint. The shells substantially maintain their
configuration once the straps are tightened, although some
variation may occur during the gait cycle due to changes in the
alignment of the leg. The varus/valgus angle of the knee can be
further adjusted by the additional adjustment of the stability
straps, which adjustment allows the shells to rotate about the free
hinges to another configuration and to stabilize in the new
configuration in order to provide a desired varus/valgus rotation
to the knee.
[0020] In an exemplary embodiment, the first and second
articulating free hinges each include a hinge support portion
connecting to the hinge member and a frame or shell support portion
connecting to the respective frame or shell members. In a
variation, the shell support portion may be a portion of the shell
itself or otherwise integrally formed with the shell. A resilient
portion connects the hinge and shell support portions to allow the
hinge and shell support portions to flex with respect to each
other. The flexure occurs about an anteroposterior axis, but as an
alternative, flexure may also occur about both an anteroposterior
axis and the proximal-distal axis. In one embodiment, the resilient
portion is an overmolded portion that encompasses at least a
portion of each of the hinge and shell support portions.
[0021] In a variation, the first and second articulating free
hinges each include a hinge support portion connecting to the hinge
member and a shell support portion connecting to the respective
shell members. A pivoting portion connects the hinge and shell
support portions to allow the hinge and shell support portions to
pivot with respect to each other. In one embodiment, the pivot
portion includes a first connection member connecting to the hinge
support portion and a second connection member connecting to the
shell support portion. A pivot pin connects the first and second
connection members in a freely pivotable manner. In a further
variation, one or both of the free hinges can be locked in a
specific orientation if a patient requires additional
medial-lateral stability.
[0022] While the articulating free hinges allow the proximal and
distal shells to freely rotate about an anteroposterior axis with
respect to the hinge member, once the brace is positioned on the
leg and the stability straps are tightened the shells substantially
obtain a specified configuration for providing varus/valgus
rotation to the knee. Contrary to expectations, the free hinges do
not allow the shells to collapse about the flexion-extension hinge
element or otherwise obtain a different orientation unless the
alignment of the leg changes.
[0023] Thus, the configuration of the knee brace allows the brace
to self align to any leg shape by allowing the flexion-extension
hinge to float and thus closely conform to the leg via the single
pivot point above and the single pivot point below the hinge
element. Once the one or more stability straps are tightened, the
upright including the hinge element, while still allowing flexion
and extension of the knee, forms a substantially rigid and robust
support against or along the leg due to the interaction of the
diagonal forces of the stability straps that are applied to the
shells and the internal support of the leg against the inside of
the brace. Thus, the forces of the stability straps are focused on
providing the varus/valgus angle and the unloading of the knee
joint.
[0024] The support provided by the upright and the hinge element to
the leg is maintained so long as the anatomy or alignment of the
leg doesn't change. Accordingly, once the one or more stability
straps are tightened, a lateral or medial force applied to the
flexion-extension hinge element will not produce movement of the
hinge. The flexion-extension hinge element does move with the leg
when the alignment of the leg changes throughout the gait cycle due
to the single free point provided above and the single free point
provided below the hinge. For each particular point in the gait
cycle, however, if movement of the leg is frozen, the upright
including the hinge element feels substantially rigid against the
leg and is not subject to medial-lateral movement.
[0025] In an alternate configuration of a knee brace, one of the
proximal or distal articulating free hinges may be locked at a
particular varus/valgus angle, or a single free hinge may be
provided either proximally or distally of the flexion-extension
hinge. In this manner, the knee brace still provides adjustability
for the varus/valgus angle of the knee, while incorporating
increased rigidity, thus obtaining benefits of both the free hinge
brace configuration and a rigid strut brace configuration.
[0026] The numerous other advantages, features and functions of
embodiments of an orthopedic device will become readily apparent
and better understood in view of the following description and
accompanying drawings. The following description is not intended to
limit the scope of the orthopedic device, but instead merely
provides exemplary embodiments for ease of understanding.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] These and other features, aspects, and advantages of the
present invention will become better understood with regard to the
following description, appended claims, and accompanying drawings
where:
[0028] FIG. 1 is a front perspective view of an embodiment of a
knee brace according to the present disclosure;
[0029] FIG. 2 is a partial view of the knee brace of FIG. 1 showing
the proximal shell in various lateral and medial rotated positions
with respect to the flexion-extension hinge member;
[0030] FIG. 3 is a front perspective view of the knee brace of FIG.
1 showing a different degree of varus rotation of the knee as
applied by the knee brace;
[0031] FIG. 4 is a perspective view of a partially completed hinge
assembly for use with the knee brace of FIG. 1;
[0032] FIG. 5 is a perspective view of the completed hinge assembly
of FIG. 4;
[0033] FIG. 6 is a front view of another partially completed hinge
assembly for use with the knee brace of FIG. 1;
[0034] FIG. 6A is a side perspective view of a variation of the
proximal part of a hinge assembly for use with the knee brace of
FIG. 1 or FIG. 13;
[0035] FIG. 7 is a front view of the completed hinge assembly of
FIG. 6;
[0036] FIG. 8 is a perspective view of yet another hinge assembly
for use with the knee brace of FIG. 1;
[0037] FIG. 9 is a perspective view of a variation of the hinge
assembly of FIG. 8;
[0038] FIG. 10 is an exploded view of the hinge assembly of FIG.
8;
[0039] FIG. 11 is a perspective view of yet another variation of
the hinge assembly of FIG. 8;
[0040] FIG. 12 is an exploded view of the hinge assembly of FIG.
11;
[0041] FIG. 13 is a variation of the knee brace of FIG. 1 that
utilizes a single free hinge assembly.
[0042] It should be noted that the drawing figures are not
necessarily drawn to scale, but instead are drawn to provide a
better understanding of the components thereof, and are not
intended to be limiting in scope, but rather to provide exemplary
illustrations. It should further be noted that the figures
illustrate exemplary embodiments of a knee brace and the components
thereof, and in no way limit the structures or configurations of a
knee brace and components thereof according to the present
disclosure.
DETAILED DESCRIPTION
[0043] A. Environment and Context
[0044] An embodiment of an orthopedic device is provided to reduce
the effect of osteoarthritis in a knee joint, or stabilize a knee
joint that has been weakened by injury or other infirmities.
Although the illustrated embodiment shows the flexion-extension
hinge positioned on the lateral side of the orthopedic device and
the stability straps positioned on the medial side of the
orthopedic device, it will be understood that the orthopedic device
may be configured to reduce or cure both medial and lateral knee
joint infirmities, and thus, the hinge may be positioned on the
medial side of the orthopedic device and the stability straps may
be positioned on the lateral side of the orthopedic device.
Further, flexion-extension hinges may also be positioned on both
the lateral and medial sides of the orthopedic device, however, in
the exemplary embodiment a single flexion-extension hinge and the
associated upright with free hinges surprisingly provides
sufficient stability and support to the knee joint, without the
need for additional rigid supports on the opposing side of the knee
brace.
[0045] The use of the phrases "freely rotatable," "free rotation,"
and variations thereof (including "free hinge") means that there is
the ability for continuous, non-fixable, non-lockable rotation
within a predetermined range of motion. In other words, "freely
rotatable," "free rotation," and variations thereof mean that there
is no hindrance to rotation, such as a fixing or locking mechanism,
and thus, components are free to rotate within a predetermined
range of motion. Exemplary predetermined ranges within which
components can freely rotate are, within nearly 360 degrees, within
generally 270 degrees, within generally 180 degrees, within
generally 90 degrees, within generally 45 degrees, and within
generally 15 degrees. Of course, any suitably desired predetermined
range may be utilized. The usage of the words generally or nearly
in the context of this applications allow for variations due to
tolerances, or other recognized manifestations of inherent
limitations on achieving perfect ranges of rotation.
[0046] The embodiment of the disclosure is particularly adapted for
a human knee joint, and may be dimensioned to accommodate different
types, shapes and sizes of human joints and appendages. In
addition, embodiments may be provided to orient principal forces
exerted by strap systems of the embodiments at any desirable
location to treat knee infirmities.
[0047] For explanatory purposes, the knee brace embodiment
described herein is divided into sections which are denoted by
general anatomical terms for the human body. Each of these terms is
used in reference to a human leg which is divided in similar
sections with a proximal-distal plane generally extending along the
meniscus of the knee between the femur and tibia. Any axis formed
along the proximal-distal plane, or any plane parallel thereto,
from the anterior to the posterior, as defined below, can be
considered to be an "anteroposterior" axis within the context of
this application and which has its ordinary meaning and refers to
an axis extending from the anterior to the posterior.
[0048] The embodiment of the knee brace is also divided into
anterior and posterior sections by an anterior-posterior plane. The
anterior-posterior plane generally corresponds to the coronal or
frontal plane of a human leg. Each of the anterior and posterior
sections is further divided about the center of the knee by a
transverse or proximal-distal plane and median, sagittal or
lateral-medial planes. Thus, the term "lateral" further has its
ordinary meaning and refers to a location lying at or extending
toward the right or left side, away from the median plane of the
knee. Additionally, the term "medial" has its ordinary meaning and
refers to a location lying or extending toward the median plane of
the knee. The anatomical terms described herein are not intended to
detract from the normal understanding of such terms as readily
understood by one of ordinary skill in the art of orthotics.
[0049] The terms "rigid," "flexible," and "resilient" may be used
herein to distinguish characteristics of portions of certain
features of the orthopedic device. The term "rigid" is intended to
denote that an element of the device is generally devoid of
flexibility. Within the context of support members, frame members,
or shells that are "rigid," it is intended to indicate that they do
not lose their overall shape when force is applied, and in fact
they may break if bent with sufficient force. On the other hand,
the term "flexible" is intended to denote that features are capable
of repeated bending such that the features may be bent into
retained shapes or the features do not retain a general shape, but
continuously deform when force is applied. The term "resilient" is
used to qualify such flexible features as generally returning to an
initial general shape without permanent deformation. As for the
term "semi-rigid," this term is used to connote properties of
support members, frame members, or shells that provide support and
are free-standing, however such support members, frame members, or
shells may have some degree of flexibility or resiliency.
[0050] B. Detailed Description of a Knee Brace
[0051] As discussed above, the embodiment of the knee brace
disclosed herein may be of an unloading, osteoarthritic knee brace
of a type generally described in U.S. Pat. Nos. 7,198,610 and
5,277,698. Accordingly, the description herein focuses on the
structure, materials, and configuration of a particular embodiment
of an unloading, osteoarthritic knee brace, without belaboring the
particular effects and modalities for treating osteoarthritis in
the knee joint.
[0052] In an exemplary embodiment, as seen in FIG. 1, an unloading,
osteoarthritic knee brace 10 includes first and second (proximal
and distal) frame members 12, 14. The frame members may be formed
of any suitable material and in any suitable geometry such that the
frame members provide sufficient support to the limb, as will be
recognized by a skilled artisan. The frame members may in the form
of shells, struts, lattice work, or any other suitable
configurations that at least partially surround and support a
portion of the wearer's anatomy. The frame members may be formed so
as to be rigid, semi-rigid, flexible, or resilient, or any suitable
combination thereof. Exemplary materials include, but are not
limited to, plastics such as polyethylene and polystyrene, carbon
fiber and epoxy composites, and glass fiber and epoxy composites.
It will be recognized that suitable padding may be provided along
the interior shell surfaces in order to aid with user comfort.
[0053] As will be recognized by the skilled artisan, the frame
members 12, 14 will have or define an open configuration to allow
the thigh region 22 and the shin or calf region 26 of the leg 20 to
be encompassed within the respective shell portions 12, 14. It will
further be recognized that any suitable configuration of retaining
mechanism may be provided to maintain the knee brace 10 in position
on the leg 20. Such retaining mechanisms may include straps
utilizing hook and loop fasteners, buckles, snaps, and other
recognized retaining structures. Exemplary retaining mechanisms are
described in detail in U.S. Pat. No. 7,198,610. Such retaining
mechanisms may adjustably connect to the proximal and distal frame
members 12, 14 at connection points 48 to secure the respective
frame members to the thigh and calf regions 22, 26.
[0054] In the exemplary embodiment, the proximal and distal shell
portions 12, 14 each include an extending portion along a first
side thereof. While this extending portion is shown along the
lateral side of the knee brace 10 in FIG. 1, it will be recognized
that the extending portions may be alternately or also provided
along a medial side thereof. It will also be recognized that the
proximal and distal shell portions 12, 14 may be formed without
such an extending portion.
[0055] A flexion-extension hinge 30 connects between the proximal
and distal frame members 12, 14 in order to provide flexion and
extension to the knee brace 10 and the leg 20 to which the brace is
secured. In the exemplary embodiment, the flexion-extension hinge
30 connects between the extending portions of the proximal and
distal frame members 12, 14. The hinge 30 allows the leg to move in
flexion and extension throughout the gait cycle. The hinge 30 also
provides the counteracting forces to keep the proximal and distal
frame members from collapsing together when the stability straps
described below are tightened.
[0056] The hinge 30 may be a monocentric or polycentric hinge, as
will be recognized by the skilled artisan. Exemplary hinges are
described in U.S. Pat. No. 5,302,169, granted Apr. 12, 1994, and
U.S. Pat. No. 7,201,728, granted Apr. 10, 2007, both incorporated
herein in their entirety by reference. The hinge 30 may also
include flexion-extension stops to limit the amount of flexion or
extension of the brace.
[0057] The hinge 30 includes upright members that provide support
to the knee brace 10 and provide the connection points between the
hinge 30 and the proximal and distal frame members 12, 14. In a
typical knee brace, the upright members are substantially rigid or
slightly resilient in order to provide support to the brace. The
uprights may be in any suitable configurations, such as elongated
struts, frame or lattice work, or any other suitable configuration
for connecting the frame members 12, 14 to a flexion-extension
hinge.
[0058] In the exemplary embodiment shown in FIG. 1, the upright
members are divided into proximal and distal hinge supports 32, 34
and proximal and distal frame supports 36, 38. Each of the supports
32, 34, 36, 38 may be formed in a substantially rigid or slightly
resilient configuration utilizing specific geometries and
materials, including, but not limited to, metals, such as aluminum
or steel alloys, plastics, or carbon or glass fiber and epoxy
composites. In a variation, the frame supports may be integrally
formed with the shell portions.
[0059] As shown in FIGS. 1-3, proximal and distal articulating
portions in the form of free hinges 40, 42 are positioned between
the proximal frame and hinge supports 36, 32 and the distal frame
and hinge supports 38, 34. In a variation, the frame supports may
be the frame member itself, such that the free hinges 40, 42 are
connected directly to the proximal and distal frame members 12, 14.
Any suitable mechanism that allows free rotation within a
predetermined range of motion about an anteroposterior axis between
the proximal frame and hinge supports 36, 32 and the distal frame
and hinge supports 38, 34 may be utilized. Of course, as previously
mentioned, the free hinges may also allow rotation about the
proximal-distal axis, or any other suitable or desired rotation.
Exemplary articulating free hinges are discussed in detail
below.
[0060] As exemplified in FIG. 2, the articulating free hinge 40
allows the proximal frame member 12 to freely rotate within a
predetermined range of motion about an anteroposterior axis AP with
respect to the hinge 30, when the brace 10 is not positioned on the
leg 20. Similarly, the articulating free hinge 42 allows the distal
frame member 14 to freely rotate about an anteroposterior axis with
respect to the hinge 30, when the brace 10 is not positioned on the
leg 20. When the brace 10 is positioned on the leg, the free hinges
40, 42 still allow the proximal and distal frame members 12, 14 to
rotate, however, the leg 20 must also change its alignment to move
with the proximal and distal frame members 12, 14. In this manner,
the varus/valgus angle of the knee may be adjusted.
[0061] Further, as also shown in FIG. 2, and unexpectedly, the
flexion-extension hinge 30 does not compress or bind when the
proximal and distal frame members 12, 14 rotate about an
anteroposterior axis. Instead, the hinge 30 maintains its position
while allowing the proximal and distal frame members 12, 14 to
freely rotate without locking about the hinge 30. Thus, the
varus/valgus angle of the knee can be adjusted, as will be
discussed in detail below.
[0062] Returning to FIG. 1, the knee brace 10 also includes
proximal and distal stability straps 16, 18. The stability straps
16, 18 are connected to the proximal and distal frame members 12,
14 at connection points 28. The stability straps 16, 18 are
selectively adjustable to provide a varus or valgus three point
pressure moment on the leg through the variable stability strap
forces AA and BB along the direction of the stability straps in a
manner that is described in detail in U.S. Pat. No. 7,198,610.
Exemplary adjusting mechanisms include ratchet mechanisms, or
slotted D-ring and straps utilizing hook and loop fasteners, as
will be recognized by a skilled artisan. A single spiraling
stability strap may be utilized to the same effect in place of the
two illustrated stability straps.
[0063] As further shown in FIG. 1, once the stability straps are
tightened to a certain degree, a varus/valgus moment M is applied
to the knee region 24. Further, the proximal and distal frame
members 12, 14 want to collapse together. This tendency to collapse
manifests compressive forces A and B that are transmitted through
the free hinges 40, 42 and offset by force C within the hinge 30.
Since the compressive forces A and B are offset, such the hinge 30
does not compress and bind up or alter its configuration. Thus,
unexpectedly, the hinge 30 maintains its position, such that the
assembly of the hinge 30 and the proximal frame and hinge supports
36, 32 and the distal frame and hinge supports 38, 34 feels
substantially rigid and provides sufficient stability and support
to the leg 20. The hinge 30 of course continues to allow flexion
and extension, even while the assembly provides the necessary
support to the leg.
[0064] The fact that such an assembly, which includes both the
proximal and distal free hinges 40, 42, provides sufficient
rigidity or support and stability to the knee joint is an
unexpected result. Further, the fact that such a single assembly
aligned along a lateral or medial side of the leg only is
sufficient to provide the necessary support to the leg and knee
joint is also an unexpected result. Common sense would seem to
dictate that the inclusion of such free hinges 40, 42, without the
use of an opposed substantially rigid strut or support would
eliminate the necessary support for the leg and joint by allowing
the frame members and flexion-extension hinge to collapse upon each
other or to bind up.
[0065] The varus/valgus moment M discussed above manifests via the
lateral-medial forces 1, 2, 3, 4, which are offset along the leg 20
at the points where the proximal and distal frame members 12, 14
and the proximal and distal stability straps 16, 18 contact the
lateral and medial sides of the leg 20.
[0066] As previously mentioned, the articulating free hinges 40, 42
allow the proximal and distal frame members 12, 14 to freely rotate
within a predetermined range of motion with respect to the hinge
30. Once the brace 10 is positioned on the leg, however, the thigh
and calf regions 22, 26 must move with the proximal and distal
frame members 12, 14 in order for the frame members to move.
Accordingly, if the alignment of the leg does not change, the
proximal and distal frame members 12, 14 cannot move into
varus/valgus and the upright assembly, including the
flexion-extension hinge 30 and the free hinges 40, 42, thus feels
substantially rigid against the leg, while still allowing for
flexion and extension of the leg. Since the thigh and calf regions
22, 26 move with the proximal and distal frame members 12, 14, any
desired amount of varus/valgus rotation of the knee region 24 can
be obtained.
[0067] As shown in FIG. 1, once the stability straps 16, 18 have
been tightened, the proximal and distal frame members 12, 14 become
fixed, along with the leg 20, such that the articulating free
hinges 40, 42 do not allow free movement of the frame members
unless the leg portions also move with the frame members. Thus,
unexpectedly, the upright assembly including the hinge 30 and the
free hinges 40, 42, maintains its position and feels substantially
rigid against the leg, rather than altering its position and
creating instability or binding-up to prevent flexion and
extension. The hinge 30 does move to closely conform to the leg
when the alignment of the leg changes throughout the gait
cycle.
[0068] As exemplified in FIG. 3, the varus/valgus angle of the knee
and leg that is provided by the rotation of the frame members 12,
14 about the free hinges 40, 42 can be altered further by adjusting
the tension in the stability straps 16, 18. Again, once the
stability straps 16, 18 have been tightened, the frame members 12,
14 achieve a stable varus/valgus configuration such that the
upright assembly including the hinge 30 and the free hinges 40, 42,
feels rigid on the leg, while still allowing flexion and extension
of the leg.
[0069] Accordingly, even though there are free articulating pivot
points or flex points 40, 42 in the uprights between the hinge 30
and the frame members 12, 14, once the brace 10 is positioned on
the leg and the stability straps 16, 18 are tightened, the hinge
assembly 30 and uprights form a substantially rigid support for the
leg, while the hinge 30 allows flexion and extension. The
varus/valgus angle of the knee can be adjusted by tightening or
loosening the stability straps 16, 18 in order to allow the leg 20
and frame members 12, 14 to rotate about an anteroposterior axis
via the free hinges 40, 42 with respect to the hinge 30, until a
stabilized configuration is reached such that the hinge assembly 30
and uprights again feel rigid against the leg. This function occurs
due to the use of a single free point above and a single free point
below the hinge 30. If two free points were used above and below
the hinge, the frame members could collapse or compress together
and thus would diminish the function of the brace.
[0070] As previously discussed, such a result is contrary to
expectations, since a skilled artisan would have expected a
flexion-extension hinge using proximal and distal free flex or
pivot points to shift positions or compress and bind-up when the
brace is positioned on the leg. Instead, the exemplary
configuration provides an orthopedic device that allows for great
variation in the amount of varus/valgus angle applied to the leg,
while still providing a stable support and an upright assembly that
feels substantially rigid throughout the gait cycle even though
proximal and distal free flex or pivot points are utilized.
[0071] Exemplary configurations of articulating free hinges are
discussed below.
[0072] C. Various Configurations of Articulating Free Hinges
[0073] A first variation of a hinge assembly utilizing articulating
portions in the form of free hinges is shown in FIGS. 4 and 5. A
flexion-extension hinge 50 includes proximal and distal hinge
struts or supports 52, 54. Proximal and distal frame struts or
supports 56, 58 are also provided. The proximal and distal frame
struts or supports 56, 58 may be integrally formed with the
proximal and distal hinge struts or supports 52, 54 and cut or
milled into separate pieces, or they may be separately formed.
Suitable materials are discussed above with respect to the uprights
of the knee brace 10.
[0074] Proximal and distal articulating free hinges 60, 62, seen in
FIG. 5, are positioned between the proximal and distal frame
supports 56, 58 and the proximal and distal hinge supports 52, 54.
The free hinges 60, 62 may be formed by overmolding a flexible or
resilient material, such as plastic, in the gaps between the
proximal and distal frame supports 56, 58 and the proximal and
distal hinge supports 52, 54. Overmolding techniques and materials,
such as those described in U.S. provisional patent application No.
60/900,719, filed Feb. 12, 2007, and incorporated herein in the
entirety by reference, may be utilized in order to create the free
hinges and uprights.
[0075] The overmolded free hinges 60, 62 will encompass at least a
portion of the proximal and distal shell supports 56, 58 and the
proximal and distal hinge supports 52, 54, as it is necessary to
provide surfaces onto which the free hinges 60, 62 are
overmolded.
[0076] In a variation, as seen in FIGS. 6 and 7, a
flexion-extension hinge 70 includes proximal and distal hinge
struts or supports 72, 74. Proximal and distal frame struts or
supports 76, 78 are also provided. The proximal and distal frame
struts or supports 76, 78 may be integrally formed with the
proximal and distal hinge struts or supports 72, 74 and cut or
milled into separate pieces, or they may be separately formed.
Suitable materials are discussed above with respect to the uprights
of the knee brace 10.
[0077] Similarly to the variation just discussed, as shown in FIG.
7, overmolded free hinges 80, 82 are provided in the gaps between
the proximal and distal shell supports 76, 78 and the proximal and
distal hinge supports 72, 74.
[0078] In order to provide more surface area for the overmolded
material to adhere to, as shown in FIG. 6, holes 84 are bored,
drilled, cast, injection molded, or otherwise formed in the
proximal and distal frame supports 76, 78 and the proximal and
distal hinge supports 72, 74.
[0079] A variation of the free hinge of FIG. 6 is shown in FIG. 6A.
While the free hinge 80 of FIG. 6A is shown incorporated into the
proximal frame support 76 and the proximal hinge support 72, it
will be understood that this configuration of the free hinge 80 can
be utilized in either the proximal or distal free hinge
position.
[0080] As shown in FIG. 6A, the free hinge 80 is formed in an
overmolded manner, as discussed herein. In order to provide
sufficient strength of adhesion between the overmolded free hinge
80 and the supports 76, 72, flange portions 86 extend from the
distal and proximal ends of the supports, respectively. Holes 84
are bored through the flange portions 86 in order to provide
further surface area for adhesion of the overmolded material to the
supports 76, 72.
[0081] Further variations of hinge assemblies are shown in FIGS.
8-10. Flexion-extension hinge 90 includes proximal and distal hinge
supports 92, 94. Proximal and distal free hinges 96, 98 are
connected to the proximal and distal hinge supports 92, 94.
[0082] As shown in FIG. 8, the proximal and distal hinge supports
92, 94 have a substantially planar configuration.
[0083] In a variation, as seen in FIG. 9, the proximal and distal
hinge supports 92, 94 have a bent configuration. In this manner,
the hinge assembly may better conform to the geometry of the knee
joint and leg.
[0084] The components of the hinge assembly of FIG. 8 are shown in
an exploded view in FIG. 10. The proximal and distal free hinges 96
and 98 are composed of a number of elements. First connection
members 100 connect to the proximal and distal hinge supports 92,
94 via connectors 112, which may be rivets, screws, welds, snap
connections, or any other suitable connectors.
[0085] A clearance hole 104 is defined horizontally through a first
end and a first side of the first connection member 100. Second
connection members 102 are correspondingly shaped to engage the
first end and first side of the first connection members 100. The
second connection members include a threaded hole 106 defined in a
first end and a first side thereof, such that a pivot pin 108
passes through the clearance hole 104 and is threaded into the
threaded hole 106. In order to provide relative free rotation of
the first and second connection members 100, 102, a biasing member
110, such as a spring, is provided between the threaded hole 106
and the clearance hole 104 to bias the contacting surfaces of the
threaded and clearance holes 106, 104 away from each other.
[0086] The second connection members 102 are connected to proximal
and distal shell supports utilizing any suitable connection
mechanism, similar to connector 112.
[0087] The components of the hinge assembly of FIGS. 8-10 may be
formed from any suitable material, such as metals or plastics. For
example, all of the components may be injection molded plastics
which may be snap fit together to form the hinge assembly.
[0088] For example, in the variation of a hinge assembly as shown
in FIGS. 11 and 12, components may be snap fit together. The
flexion-extension hinge 120 includes proximal and distal hinge
supports 122, 124. Proximal and distal free hinges 126, 128 are
connected to the proximal and distal hinge supports 122, 124.
[0089] The components of the hinge assembly of FIG. 11 are shown in
an exploded view in FIG. 12. The proximal and distal free hinges
126 and 128 are composed of a number of elements. First connection
members 130 connect to the proximal and distal hinge supports 122,
124 via connectors 144, which may be any suitable connectors, as
discussed above.
[0090] A clearance hole 136 is defined horizontally through a first
end and a first side of the first connection member 130. Second
connection members 132 are correspondingly shaped to engage the
first end and first side of the first connection members 130. The
second connection members include a threaded hole 138 defined in a
first end and a first side thereof, such that a pivot pin 140
passes through the clearance hole 136 and is threaded into the
threaded hole 138. As discussed above a biasing member 142, such as
a spring, is provided between the threaded hole 138 and the
clearance hole 136 to bias the contacting surfaces of the threaded
and clearance holes 138, 136 away from each other.
[0091] As an added variation, one or both of the proximal and
distal free hinges 126 and 128 may be locked against free rotation
in order to provide medial-lateral stability when necessary. Such
locking can occur by any known mechanism, including, but not
limited to, the mechanisms disclosed in U.S. Pat. No.
5,302,169.
[0092] In such circumstances, the brace using the hinge assembly of
FIGS. 11 and 12 can be positioned on the leg with the free hinges
126, 128 unlocked. The stability straps can then be tightened to
obtain the desired amount of varus/valgus rotation. One or both of
the free hinges 126, 128 can then be locked to provide added
medial-lateral stability.
[0093] Returning to the hinge components, the second connection
members 122 include a cap member 134 that snap fits onto the second
connection member. Both the cap member 134 and the second
connection members 122 are connected to proximal and distal shell
supports utilizing any suitable connection mechanism, similar to
connector 144.
[0094] It will be recognized that any of the described variations,
or equivalent, free hinge configurations may be utilized in an
orthopedic brace according to this disclosure.
[0095] D. Detailed Description of a Variation of a Knee Brace
[0096] A variation of the knee brace of FIG. 1 is shown in FIG. 13.
The knee brace 210 of FIG. 13 has the same essential configuration
as the knee brace 10 of FIG. 1, and the same reference numerals
describe similar or the same components.
[0097] The knee brace 210 of FIG. 13 utilizes a single proximal
articulating free hinge 40. The free hinge can be constructed in
any manner described herein. In contrast to the knee brace 10, the
knee brace 210 utilizes either a distal upright with no distal free
hinge, or a distal hinge that is oriented with the desired
varus/valgus angle and locked as described above. Such a lockable
hinge can provide additional medial-lateral stability, while the
proximal free hinge 40 provides adaptability to the knee brace 210,
in a manner previously described.
[0098] Thus, the knee brace 210 provides the added benefits of
utilizing a free hinge to promote adjustability and adaptability,
while retaining the benefits of additional rigidity by utilizing a
standard strut support or a lockable hinge.
[0099] While the free hinge 40 is shown in the proximal position in
the knee brace 210, it will be understood that the orientations of
the free hinge and the strut or lockable hinge may be alternated,
such that a distal free hinge is provided and a proximal strut with
no proximal free hinge, or a proximal hinge that is oriented with
the desired varus/valgus angle and locked as described above.
[0100] E. Conclusion
[0101] While a particular embodiment of an orthopedic device is
discussed above utilizing injection molded parts, the components of
the knee brace described herein may be formed in any suitable
manner recognized by a skilled artisan, such as casting, machining,
stereolithography, or any other suitable process.
[0102] The disclosed embodiment of an orthopedic device provides an
improved knee brace that has a lower profile than a typical brace,
and further allows for a great variation in varus/valgus rotation
of the knee joint by utilizing free hinges.
[0103] It is understood that the size of the brace and the
components thereof can be adjusted so that a large number of
different users having different sized joints and body parts may
benefit from the present design.
[0104] It is also understood that the locations of the various
connection points can be alternated from those shown, such that the
connection points may be altered from the positions as illustrated
herein.
[0105] Of course, it is to be understood that not necessarily all
objects or advantages may be achieved in accordance with any
particular embodiment of the invention. Thus, for example, those
skilled in the art will recognize that the invention may be
embodied or carried out in a manner that achieves or optimizes one
advantage or group of advantages as taught herein without
necessarily achieving other objects or advantages as may be taught
or suggested herein.
[0106] The skilled artisan will recognize the interchangeability of
various disclosed features. In addition to the variations described
herein, other known equivalents for each feature can be mixed and
matched by one of ordinary skill in this art to construct a knee
brace in accordance with principles of the present invention.
[0107] Although this invention has been disclosed in the context of
certain exemplary embodiments and examples, it therefore will be
understood by those skilled in the art that the present invention
extends beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the invention and obvious
modifications and equivalents thereof. Thus, it is intended that
the scope of the present invention herein disclosed should not be
limited by the particular disclosed embodiments described
above.
* * * * *