U.S. patent application number 10/044789 was filed with the patent office on 2002-06-20 for joint brace for medial/lateral loading.
Invention is credited to Danssaert, John L. JR., Gildersleeve, Richard E., Tillinghast, Theodore V., Verespej, James M..
Application Number | 20020077574 10/044789 |
Document ID | / |
Family ID | 22153900 |
Filed Date | 2002-06-20 |
United States Patent
Application |
20020077574 |
Kind Code |
A1 |
Gildersleeve, Richard E. ;
et al. |
June 20, 2002 |
Joint brace for medial/lateral loading
Abstract
Braces for loading and/or unloading knees, elbows and other
joints. Such braces feature a stiffener which may be substantially
permanently configured in shape to cooperate with the brace in
applying tension to locations on the limb proximal and distal to
the joint being loaded and/or unloaded, which counteract forces
applied by the stiffener to the joint. A bending tool which may be
accompanied by use of a goniometer may be employed for proper
configuration of the stiffener using the wearer's limb geometry as
a reference. Such braces are particularly effective for treating
conditions such as compartmental osteoarthritis.
Inventors: |
Gildersleeve, Richard E.;
(Escondido, CA) ; Tillinghast, Theodore V.;
(Cardiff, CA) ; Danssaert, John L. JR.; (Solana
Beach, CA) ; Verespej, James M.; (Vista, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
620 NEWPORT CENTER DRIVE
SIXTEENTH FLOOR
NEWPORT BEACH
CA
92660
US
|
Family ID: |
22153900 |
Appl. No.: |
10/044789 |
Filed: |
January 8, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10044789 |
Jan 8, 2002 |
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09825787 |
Apr 4, 2001 |
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09825787 |
Apr 4, 2001 |
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09589894 |
Jun 7, 2000 |
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09589894 |
Jun 7, 2000 |
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09079956 |
May 15, 1998 |
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Current U.S.
Class: |
602/16 ;
602/26 |
Current CPC
Class: |
B41M 5/035 20130101;
A61F 5/0125 20130101; A61F 5/0123 20130101; A61F 5/012
20130101 |
Class at
Publication: |
602/16 ;
602/26 |
International
Class: |
A61F 005/00 |
Claims
What is claimed is:
1. A method for loading a joint of a limb, the method comprising
the steps of: a. providing a joint brace, comprising: (1) a sleeve
adapted to circumscribe a proximal part of the limb, a distal part
of the limb, and portions of the joint connection the proximal and
distal parts of the limb; (2) an adjustable stiffener removably
attached to one side of the brace, the stiffener comprising: i. a
proximal portion; ii. a distal portion; iii. a connector allowing
the proximal portion and distal portions to rotate relative to each
other when the brace is installed on the wearer; iv. the proximal
and distal portions made of material which may be substantially
permanently deformed in order to configure the stiffener to a shape
adapted to allow the brace to load the joint as desired, but of
sufficient stiffness to avoid substantial permanent deformation
when the brace is loading the joint; (3) a proximal tensioning
structure adapted to apply tension to at least part of the proximal
part of the limb and at least part of the proximal portion of the
stiffener; and (4) a distal tensioning structure adapted to apply
tension to at least part of the distal part of the limb and at
least part of the distal portion of the stiffener, (5) the proximal
tensioning structure, the distal tensioning structure and the
stiffener adapted to cooperate to apply loading on the joint. b.
providing a device for configuring the joint brace, the device
comprising: (1) a body relative to which part of the stiffener may
be placed, the body including a fulcrum about which a portion of
the stiffener may be bent; and (2) a goniometer attached to the
body in the vicinity of the fulcrum for measuring the angle at
which parts of the stiffener are bent relative to each other; c.
placing the stiffener relative to the body in a manner that allows
the stiffener to be controllably bent; d. bending the stiffener to
a desired configuration using the goniometer to bend the stiffener
for proper loading of the joint; e. attaching the stiffener to the
brace; f. placing the brace on the limb of a wearer; and g.
ensuring the tensioning structures and the stiffener cause the
brace to load the joint in a predetermined manner.
2. The method of claim 1 in which the joint to be loaded is a knee,
the connector of the stiffener is bicentric and the body and
goniometer of the device are configured to permit controllable
bending of each portion of the stiffener, the method comprising the
additional steps of: a. bending each portion of the stiffener to
desired shape using the goniometer in order to create a stiffener
configuration that is adapted to treat compartmental osteoarthritis
of the knee; b. attaching the stiffener to the side of the brace
opposite to the side of the knee on which loading is desired to be
reduced; c. ensuring that the tensioning structures apply tension
properly to reduce the load on said side of the knee with a
predetermined force in order to treat the compartmental
osteoarthritis.
3. The method of claim 1 further comprising the step of recording
angles from the goniometer at which the stiffener is bent.
4. The method of claim 1 further comprising the step of heating the
stiffener to promote bending.
5. The method of claim 1 in which the brace further includes an
inflatable condyle interposed between the joint and the stiffener,
and further comprising the step of loading the knee by inflating
the condyle.
6. A method for loading a joint of a limb, the method comprising
the steps of: a. providing a joint brace, comprising: (1) a sleeve
adapted to circumscribe a proximal part of the limb, a distal part
of the limb, and portions of the joint connecting the proximal and
distal parts of the limb; (2) an adjustable stiffener removably
attached to one side of the brace, the stiffener comprising: i. a
proximal portion; ii. a distal portion; iii. a connector allowing
the proximal portion and distal portions to rotate relative to each
other when the brace is installed on the wearer; iv. the proximal
and distal portions made of material which may be substantially
permanently deformed in order to configure the stiffener to a shape
adapted to allow the brace to load the joint as desired, but of
sufficient stiffness to avoid substantial permanent deformation
when the brace is loading the joint; (3) the stiffener adapted to
apply force on the joint which is counteracted by forces on other
parts of the limb; b. providing a device for configuring the joint
brace, the device comprising: (1) a body relative to which part of
the stiffener may be placed, the body including a fulcrum about
which a portion of the stiffener may be bent; and (2) a goniometer
attached to the body in the vicinity of the fulcrum for measuring
the angle at which parts of the stiffener are bent relative to each
other; c. placing the stiffener relative to the body in a manner
that allows the stiffener to be controllably bent; d. bending the
stiffener to a desired configuration using the goniometer to bend
the stiffener for proper loading of the joint; e. attaching the
stiffener to the brace; f. placing the brace on the limb of a
wearer; and g. ensuring the stiffener causes the brace to load the
joint in a predetermined matter.
7. The method of claim 6 in which the joint to be loaded is a knee,
the connector of the stiffener is bicentric and the body and
goniometer of the device are configured to permit controllable
bending of each portion of the stiffener, the method comprising the
additional steps of: a. bending each portion of the stiffener to a
desired shape using the goniometer in order to create a stiffener
configuration that is adapted to treat compartmental osteoarthritis
of the knee; b. attaching the stiffener to the brace and applying
the brace to the leg; and; c. ensuring that the stiffener loads the
knee with a predetermined force in order to treat the compartmental
osteoarthritis.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional of pending U.S.
patent application Ser. No. 09/589,894, filed Jun. 7, 2000, which
is a divisional of U.S. patent application Ser. No. 09/326,384,
filed Jun. 4, 1999, now abandoned. The entire contents of these
prior applications is hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to braces for applying forces
to knees and other joints in a medial/lateral plane or as otherwise
desired. Such braces employ stiffeners which may be preferably
removed and configured to a desired shape for imparting a
predetermined force on the joint when employed in the joint
brace.
[0004] 2. Description of the Related Art
[0005] Conventional approaches to compartmental osteoarthritis and
other joint maladies have included placing a brace on the limb
surrounding the joint. Such braces aim to impart force or leverage
on the joint in order to relieve compressive forces within a
portion of the joint, or to reduce the load on that portion. For
instance, in knee compartmental osteoarthritis situations, braces
have been employed which feature rigid bars situated on the leg
opposite or adjacent to the affected compartment of the knee. The
bars include medial/lateral hinges which allow portions of the bars
to be pivoted or swiveled in the frontal (varus/valgus) plane with
respect to one another and locked into a desired configuration. The
brace so configured when installed on the knee then imparts
leverage at least partially to unload the affected compartment, and
the adjustable hinges allow the magnitude of the force to be
controlled or varied. Such adjustable hinges may employ set screws
or other adjustment structure. Often, however, the adjustment
structure requires use of a special tool and virtually always
introduces bulkiness accompanied, paradoxically, by structural
compromise and complexity.
SUMMARY OF THE INVENTION
[0006] The present invention provides braces for loading and
unloading joints which alleviate the need for medial/lateral
structure configuration adjustment devices such as hinges. Braces
according to the present invention include a stiffener. The
stiffener is preferably removably attached to the brace so that it
can be adjusted in configuration while apart from the brace. The
configuration of the stiffener may be permanently or substantially
permanently adjusted or deformed by bending. In one version of the
invention, the bending may occur in a bending tool which may
include a goniometer for measuring the degree of deformation of,
and the consequent loading to be applied by, the stiffener.
[0007] The stiffener so placed in the bending tool and bent to a
desired configuration is deformed in a manner that is permanent or
at least substantially permanent in the range of temperatures and
forces encountered by the average brace wearer. The stiffener so
configured is attached to or inserted in the brace, which may be
formed of elastic, non-elastic or partially elastic material. The
brace when installed properly on a limb loads or unloads portions
of the joint with a predetermined force, a proxy for whose
magnitude may, but need not be, determined by measuring a patient's
limb alignment with a goniometer and configuring the stiffener with
a bias relative to the patient's limb alignment. The amount of bias
then corresponds to the magnitude of that force.
[0008] The stiffeners may be formed of metal, in which case bending
for permanent or substantially permanent deformation may occur at
room temperature. Stiffeners may also be formed of desired plastics
or composite materials in which case bending for permanent or
substantially permanent deformation can occur while heated; when
the stiffener returns from its temperature excursion to the normal
range of temperatures encountered by brace wearers, the deformation
imparted by the bending is permanent and/or semi-permanent. That
is, application of loads to the stiffener while the brace is in use
does not cause the shape of the stiffener to "creep" or relax back
to its previous, preconfiguration shape, or to suffer substantial
plastic deformation. The stiffener instead "springs back" to its
deformed configuration when the loads are removed.
[0009] It is accordingly an object of the present invention to
provide knee braces for medial/lateral loading and unloading of
body joints which employ stiffeners whose configuration may be
readily adjusted to control the degree of loading and/or unloading,
but which are inexpensive and efficient to manufacture.
[0010] It is an additional object of the present invention to
provide braces for loading and unloading body joints whose
stiffeners may be configured in shape without the need for special
hinges or configuration structure such as set screws.
[0011] It is an additional object of the present invention to
provide braces for loading and unloading body joints which include
stiffeners whose configuration may be adjusted to a desired shape
using a measuring device which may be adjusted to conform to the
geometry of the leg and then used to configure the stiffener to
apply proper loading.
[0012] It is an additional object of the present invention to
provide braces for loading and unloading body joints whose
stiffeners may be configured in shape using a bending tool and
accompanying goniometer to control conformance to limb geometry,
and/or, if desired, the magnitude, recordability and repeatability
of the configuration change and consequent loading/unloading on the
body joint.
[0013] It is an additional object of the present invention to
provide braces for loading and unloading body joints whose
stiffeners may be manually configured simply by being bent to a
desired and predetermined shape to control and impart loading
and/or unloading to the body joint, but which do not relax back to
their non-configured shape as a result of such loading and/or
unloading.
[0014] It is an additional object of the present invention to
provide braces for loading and unloading body joints and which may
be easily and quickly adjusted by a clinician in a manner that
requires only a single visit by the patient.
[0015] Other objects, features and advantages of the present
invention will become apparent with respect to the remainder of
this document.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a front elevational view of a brace according to a
first embodiment of the present invention.
[0017] FIG. 1A is a front elevational view of a brace according to
a second embodiment of the present invention.
[0018] FIG. 1B is a schematic front elevational view of a brace
according to a third embodiment of the present invention.
[0019] FIG. 2 is a rear view of the brace of FIG. 1.
[0020] FIG. 3 is a left side elevational view of a second
embodiment of a brace according to a third embodiment of the
present invention, showing a stiffener in outline.
[0021] FIG. 4 is a perspective view of a bending tool according to
the present invention for controllable configuration of the
stiffeners of the braces of FIGS. 1-3.
[0022] FIG. 5 is a rear perspective view of the bending tool of
FIG. 4 in combination with a goniometer according to a preferred
embodiment of the present invention.
[0023] FIG. 6 is a perspective view of a brace stiffener according
to a preferred embodiment of the present invention inserted into a
bending tool with accompanying goniometer for controllable
configuration and consequent body joint loading and unloading when
the stiffener is installed in the brace and the brace properly
applied; here, the stiffener is configured neutrally before being
configured to load the knee as desired when installed in the brace
of FIG. 1.
[0024] FIG. 7 is a top plan view of a brace stiffener according to
a preferred embodiment of the present invention inserted into a
bending tool with accompanying goniometer for controllable
configuration and consequent body joint loading and unloading when
the stiffener is installed in the brace and the brace properly
applied; here, the stiffener is configured to apply relatively
large force to the knee when installed in the brace of FIG. 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0025] FIGS. 1 and 2 show a first embodiment of a brace 10
according to the present invention. Brace 10 is shown applied on
the left leg of a wearer. FIG. 1 is a front-on view of the left leg
of the wearer, while FIG. 2 is a rear view of the left leg of the
wearer with the brace 10 applied.
[0026] Brace 10 shown in FIGS. 1 and 2 is formed of a sleeve 12 in
combination with a number of other components. Sleeve 12 may be
formed of any desirable fabric such as fully-, non-, or
partially-stretchable fabric which may or may not be breathable.
Sleeve 12 may be fabricated using conventional stitching to conform
to knees, elbows or other body joints as desired. Sleeve 12 in the
embodiment shown in FIGS. 1 and 2 features a knee cap opening 14 in
order to alleviate pressure directly on the patella and, if
desired, for stabilization of the patella relative to other parts
of the knee. In the embodiment shown in FIGS. 1 and 2, opening 14
initiates a discontinuity in sleeve 12 which allows adjustment
dimensionally about the thigh. The discontinuity shown in FIGS. 1
and 2 is a flap 16. Flap 16 cooperates with a corresponding section
18 of sleeve 12 to allow flap 16 to be fastened removably to
section 18 so that the upper or proximal portion 20 of sleeve 12
may be dimensioned to the body part (here, thigh) for a
comfortable, secure fit. (Distal portion 21 of sleeve 12 could also
contain a discontinuity if desired.) Flap 16 may be removably
attached to section 18 using hook and loop fastener or any other
desired fastening structure. Sleeve 12 need not contain any
discontinuity such as flap 16/section 18, or knee cap opening 14.
Flap 16 may be oriented at any angle or direction as desired; its
leading edge may be inclined, as shown in FIG. 1, for example, or
the opposite direction.
[0027] Sleeve 12 contains on one side (which may correspond to the
lateral or medial side of the leg or other limb when the brace is
worn) a stiffener 22 which may be removably enclosed in a stiffener
sheath 24. Sheath 24 may be a fabric section sewn to sleeve 12, a
pocket, or any other structure which attaches stiffener 22 to
sleeve 12, whether removably or in a manner which fixes the
position of stiffener 22 relative to sleeve 12. In the preferred
embodiment, sheath 24 is a pocket structure formed by stitching
material to sleeve 12; the pocket is generally configured in shape
to conform to the shape of the stiffener 22. A slit 23 at one end
of the sheath 24 allows the stiffener 22 to be inserted and
removed. Stiffener 22 and portions of the sheath 24 may feature
hook and loop patches in order to reduce the possibility that
stiffener 22 would rotate relative to sheath 24 and sleeve 12.
[0028] The side of sleeve 12 opposite the side featuring the
stiffener sheath 24 may include an anchor 26 such as a tube or
additional thickness of material sewn or otherwise attached to the
sleeve 12. Anchor 26 may help reduce or limit migration and
bunching of sleeve 12. Such lines of stitching 28 and additional
material are not required, but they may be employed as desired for
additional stabilization, cushioning, fit and feel. Stiffener
sheath 24 and anchor 26 may also serve as an anchor for
distribution of forces from lines of stitching 28 or other portions
of sleeve 12 or brace 10.
[0029] Brace 10 shown in FIG. 1 also includes at least two
tensioning structures 30 for applying tension to portions of
stiffener 22 relative to the body part distally and proximally of
the joint circumscribed by the brace 10. In the embodiment shown in
FIGS. 1, 2 and 3, tensioning structures 30 may be straps 32 which
may be, but need not be, fastened to sleeve 12 and which may be
tightened and fastened to themselves or portions of brace 10 in
order to tension stiffener 22 portions relative to the limb being
treated. In the embodiments shown in FIGS. 1, 2 and 3, tensioning
structures 30 (straps 32) are attached to the sleeve 12 by
stitching at loops 34, which may be plastic D rings or other
devices. Loops 34 obviously need not be included. Straps 32
preferably circumscribe the leg of the wearer; one end with
hook/loop fastener material extends through a loop 34 and fastens
back onto itself for a 200.degree./a mechanical advantage using
hook/loop material on another portion of the strap 32. Tensioning
structures 30 may be any structure, whether or not attached to
sleeve 12 or constituting portions of the sleeve 12, which tension
portions of stiffener 22 against the body part to which the brace
10 is applied. Tensioning structures 30 may, for instance, as shown
in FIG. 1A, be portions of sleeve 12 or structures within sleeve
12. Elastic or nonelastic members, members integral to or that are
simply a part of sleeves 12 and any other structure appropriate to
tension stiffener 22 portions against the leg or body part both
distally and proximately of the joint can serve the function of
tensioning structures 30 according to present invention, regardless
of what particular structural niceties may be involved or which
particular way they may apply such tension. The effect or result is
to cause stiffener 22 to pull both distal and proximal portions of
the limb toward stiffener 22 while pushing the joint circumscribed
by the brace away from stiffener 22 thereby to impart relative
force or leverage to the joint and thus reduce the load on the side
of the joint opposite to the side in which stiffener 22 is located.
(Such reduction in the loading on portions of a joint, whether
partially or completely may sometimes be referred to as
"unloading." Simultaneously with such unloading, complementary
loading of other portions of the joint occurs. Accordingly, the
application of force on part of or all of the joint by stiffener or
brace or portions of them may be referred to as "unloading,"
"loading," "reducing the load" on the joint or portions of it.)
[0030] In the embodiment shown in FIG. 1, the stiffener 22 on the
lateral side of the left knee reduces the load on the medial
compartment of the knee for treatment of medial side compartmental
osteoarthritis of the knee. Brace 10 may be manufactured for the
left and right legs, respectively, and further manufactured for
unloading of lateral or medial sides of the joint for each of those
legs. Thus, for instance, two versions of left leg braces may be
manufactured, one accommodating a stiffener 22 on its lateral side
for treatment of the medial side of the knee, and one for
accommodating a stiffener 22 on its medial side for unloading of
the lateral side of the knee. Brace 10 may also be manufactured to
feature a stiffener sheath 24 on each of its sides for treatment
for medial or lateral side of the joint, and/or for left or right
limb, in order to minimize inventory and manufacturing diversity
requirements.
[0031] FIGS. 1 and 1A also show (in relief) an inflatable cushion
or condyle 64 interposed between the stiffener 22 and the joint
being treated. The condyle 64, which may be a conventional
inflatable condyle, may be inflated using a conventional inflation
device 68 such as shown in FIG. 1A, through slot 66 in sleeve 22.
Inflation/deflation modes of hand pump device 68 may be mediated
through valve control and valve 70. Other sorts of condyles,
including non inflatable ones, and other sorts of inflation devices
may also be used.
[0032] FIG. 2 shows a rear view of the brace shown in FIG. 1, and
FIG. 3 shows a side view of a brace whose straps 32 are attached on
the side of the brace 10 on which stiffener 22 and stiffener sheath
24 are located.
[0033] FIG. 1B shows in a schematic manner another embodiment of a
brace 10 according to the present invention where the stiffener 22
is to be located on the same side of the knee as the compartment to
be unloaded. Here, proximal portion 36 and distal portion 38 of the
stiffener 22 are curved inward toward the limb, rather than outward
from the limb as in FIG. 1. The effect or result is to cause
stiffener 22 to pull the joint circumscribed by the tensioning
structure 80 towards the stiffener 22 while pushing both distal and
proximal portions of the limb away from the stiffener.
[0034] FIG. 3 shows a stiffener 22 in relief enclosed in a
stiffener sheath 24. Stiffener 22 may include a proximal portion
36, a distal portion 38 and a connector 40 which structurally
connects proximal portion 36 and distal portion 38 but allows them
to rotate or otherwise move relative to each other to accommodate
movement of the body joint circumscribed by brace 10. In the
embodiment shown in FIG. 3, connector 40 is a bicentric hinge of
the sort disclosed in U.S. Pat. No. 4,697,583 to Mason, et. al.,
which is incorporated herein by this reference. Gears in such hinge
permit only controlled rotation of proximal portion 36 relative to
the distal portion 38, so that horizontal axis 42 of connector 40
bisects the angle formed by proximal portion 36 and distal portion
38. Connector 40 may be a monocentric hinge, a non geared bicentric
hinge, or any other linkage or structure which may be desired to
accommodate movement of the body joint; it may, in cases where no
movement is desired such as where the stiffener 22 acts as a
splint, simply be part of the structure of the stiffener 22. Many
such structures are conventional; for example, connector 40 may be
formed of portions of proximal portion 36 and distal portion 38,
such as versions in which a combination of slots in such members
cooperate with pins to allow movement of the portions relative to
each other.
[0035] FIGS. 4-6 show a bending tool 44 for configuring stiffener
22 to apply proper loading and unloading to a joint circumscribed
by brace 10. Device 44, whatever form it may take, seeks the result
of allowing substantially permanent deformation of portions of
stiffener 22 into a configuration which, when the stiffener 22 is
used in combination with the structures on brace 10, allows the
joint circumscribed by brace 10 to receive loading and/or unloading
forces of a magnitude and in a direction as desired for effective
treatment or therapy. The term "substantially permanent
deformation" means that when the stiffener 22 as properly
configured is used in combination with brace 10 to load and/or
unload the joint, the bending of the stiffener 22 in its spring
like fashion to load and/or unload the joint will not cause the
configuration of the stiffener 22 (at normal temperatures
encountered by the wearer) to creep or relax substantially to
another shape such as, for instance, the shape it had before being
deformed in device 44.
[0036] Stiffener 22 may be formed, for instance, of metal, or it
may be formed of plastics or composite material. Metal stiffeners
preferably feature a structure and modulus of elasticity which
allow manual substantially permanent deformation. Manual bending is
an acceptable form of substantially permanent deformation in such
cases. For instance, and in general, causing proximal and distal
portions 36 and 38 respectively to be oriented more outwardly from
the limb can be expected to cause stiffener 22 to impart greater
unloading to the medial compartment of the knee shown in FIG. 1. By
contrast, causing such portions to be oriented more inwardly toward
the limb can be expected to cause stiffener 22 to impart greater
unloading to the medial compartment of the knee shown in FIG.
1B.
[0037] Stiffener 22 formed of plastics or composite may be of a
sort which can be heated prior to or during the bending operation,
as by use of a hair dryer, hot liquid or other suitable application
of heat. After configuration and deformation, upon return of
temperature to that normally encountered by the wearer of braces
such as these, the modulus of elasticity of such stiffener 22
increases to a point where the stiffener 22 becomes spring-like
rather than pliable or malleable so that stiffener 22 is thus able
to impart loading and/or unloading to the joint circumscribed by
brace 10.
[0038] Device 44 shown in FIG. 4 is one form of a device for
substantially permanent deformation of the sort of stiffener 22
shown in FIG. 3 which features a bicentric hinge. Device 44, which
may be formed of metal, plastic or any other desired material,
features a body 46 with a cavity 48 adapted to receive the
connector 40 and portions of proximal portion 36 and distal portion
38 of stiffener 22. Cavity 48 walls define two fulcra 50, 50A
against and about which proximal portion 36 and distal portion 38
of stiffener 22 may be controllably bent or deformed. FIG. 6 shows
a stiffener 22 in combination with device 44 for such substantially
permanent deformation.
[0039] FIGS. 5 and 6 show use of a goniometer for measuring the
degree of bending or deformation of each of proximal portion 36 and
distal portion 38 of stiffener 22. Pins 52 on device body 46
receive grommets into the goniometer 56. Goniometer 56 may be
permanently or removably attached to body 46 using hook/loop
fastener 58 on goniometer 56 and device 44. Any other desired
fastener may be used, or no fastener at all.
[0040] Device 44 may assume any shape or configuration expedient
for the result of controllably substantially permanently deforming
portions of stiffener. Alternatively, device 44 need not be used at
all if not desired. A wearer or medical professional may simply
bend or deform the stiffener 22 at any point along its length using
whatever implements are deemed appropriate in order to create a
shape and configuration that is substantially permanent and that
properly loads and/or unloads the joint circumscribed by brace
10.
[0041] According to the embodiments shown in the Figures, the
stiffener 22 may be configured by substantially permanently
deforming it in device 44 or as otherwise desired in order to apply
proper loading/unloading to the joint being treated. Indicia 60 and
61 on the goniometer 56 may be employed for this purpose. Indicia
60 may, but need not, appear on the central portion of the
goniometer 56. Indicia 61 appear on arms 62. In practice, the
clinician or qualified other person aligns arms 62 of goniometer 56
with the calf and thigh of the wearer's leg to be treated with
brace 10 shown in FIG. 1; the position of the arms 62 may be noted
using indicia 60. While the arms 62 of goniometer 56 are maintained
in this position on the goniometer 56, the goniometer 56 may then
be placed on device 44 for configuration of stiffener 22. As shown
in FIG. 6, the proximal portion 36 and distal portion 38 of
stiffener 22 may be manually bent in device 44 to align with a
center index 61 on each arm 62; the stiffener has thus been
configured to correspond in shape to the geometry of the limb of
the wearer to be treated.
[0042] Stiffener 22 may then be configured, or configured
continuously as part of the process stated in the previous
sentence, in device 44 to orient proximal portion 36 and distal
portion 38 as appropriate in order to load the joint properly. As
shown in FIG. 7, indicia 61 on arms 62 of goniometer 56 may be used
for this purpose. Orientation of portions 36 and 38 parallel to the
zero degree indicia 61 results in neutral loading, since the
stiffener is simply configured to the shape of the limb as
reflected by the arms 62 being set relative to indicia 60 during
the limb measuring steps mentioned above. Orientation of portions
36 and 38 substantially parallel to the six degree loading indicia
61 results in relatively large forces applied to the knee, while
orientation substantially parallel to the three degree loading
indicia results in relatively lighter forces applied to the
knee.
[0043] After configuration, the stiffener is attached to the brace
10. Tensioning structures 30 are properly tensioned and fastened to
apply tension to proximal portion 20 and distal portion 21 of the
limb while the central portions of the stiffener 22 apply
compressive forces to the joint in order to unload the side of
joint opposite the stiffener 22. In a brace with no straps, flap 16
may be adjusted as desired to assist in this purpose. If the
stiffener 22 is permanently attached to brace 10, it is configured
by remaining within brace 10. Patient comfort and clinician
empirical inspection may be employed, among other techniques, which
may or may not involve conventional measurement apparatus, to
ensure that tensioning structures 30 and stiffener 22 properly
apply forces to load and/or unload the joint.
[0044] The foregoing is provided for purposes of explanation and
disclosure of preferred embodiments of the present invention.
Modifications, additions and/or deletions may be made to the
structures where their components shown and described in this
document without departing from the scope or spirit of the
invention.
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