U.S. patent application number 15/420663 was filed with the patent office on 2017-08-17 for ankle foot orthosis.
The applicant listed for this patent is BONUTTI RESEARCH, INC.. Invention is credited to Glen A. Phillips.
Application Number | 20170231795 15/420663 |
Document ID | / |
Family ID | 46637433 |
Filed Date | 2017-08-17 |
United States Patent
Application |
20170231795 |
Kind Code |
A1 |
Phillips; Glen A. |
August 17, 2017 |
ANKLE FOOT ORTHOSIS
Abstract
An ankle foot orthosis includes a leg member, a foot member, and
a drive member. The drive assembly includes a link member which may
be hingedly secured to the foot member at a hinge location adjacent
to the posterior end of the foot member. The drive assembly may be
operable to selectively impart pivotal movement between the foot
member and the link member about a first pivot axis, and pivotal
movement between the foot member and the leg member about a second
pivot axis at the hinge location. The leg member and the foot
member strut may be selectively movable in a medial-lateral
direction relative to a base of the foot member and the drive
assembly. The inferior-superior location of the second pivot axis
may be selectively adjustable for substantially aligning the second
pivot axis with an axis of rotation of an ankle joint of the
wearer.
Inventors: |
Phillips; Glen A.;
(Effingham, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BONUTTI RESEARCH, INC. |
Effingham |
IL |
US |
|
|
Family ID: |
46637433 |
Appl. No.: |
15/420663 |
Filed: |
January 31, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15149875 |
May 9, 2016 |
9572704 |
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15420663 |
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14643775 |
Mar 10, 2015 |
9345608 |
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15149875 |
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13872467 |
Apr 29, 2013 |
8998834 |
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14643775 |
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13026895 |
Feb 14, 2011 |
8444583 |
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13872467 |
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Current U.S.
Class: |
602/23 |
Current CPC
Class: |
A61F 5/0127 20130101;
A61F 5/0102 20130101; A61F 2005/0139 20130101; A61F 2005/0158
20130101 |
International
Class: |
A61F 5/01 20060101
A61F005/01 |
Claims
1. An orthosis for increasing range of motion of a joint, the
orthosis comprising: a first body securement portion configured to
secure to a first body portion on a first side of the joint; a
second body securement portion configured to secure to a second
body portion on a second side of the joint; a drive assembly
operatively connected to the first and second body securement
portions, wherein the drive assembly is configured to drive
movement of the first and second body securement portions relative
to one another; and an L-shaped bracket operatively connecting the
first body securement portion to the drive assembly, wherein the
L-shaped bracket is selectively movable relative to the drive
assembly to adjust a position of the first body portion relative to
the drive assembly.
2. The orthosis set forth in claim 1, wherein the first body
securement portion comprises a cuff.
3. The orthosis set forth in claim 2, wherein the cuff includes a
pad and a strap configured to secure the first body portion in the
cuff.
4. The orthosis set forth in claim 3, wherein the cuff is a leg
cuff.
5. The orthosis set forth in claim 1, wherein the L-shaped bracket
includes a first arm and a second arm extending generally
perpendicularly outward from the first arm, wherein the first arm
is operatively connected to the first body securement portion and
the second arm is operatively connected to the drive assembly.
6. The orthosis set forth in claim 5, wherein the second arm
extends perpendicularly from the second arm in a first direction,
wherein the L-shaped bracket is selectively movable relative to the
drive assembly in the first direction.
7. The orthosis set forth in claim 6, further comprising a locking
device configured to selectively lock the L-shaped bracket in a
selected position relative to the drive assembly, and unlock the
L-shaped bracket to allow movement of the L-shaped bracket relative
to the drive assembly.
8. The orthosis set forth in claim 7, wherein the locking device
comprises a screw.
9. The orthosis set forth in claim 1, further comprising a second
L-shaped bracket operatively connecting the second body securement
portion to the drive assembly.
10. The orthosis set forth in claim 1, wherein the L-shaped bracket
is selectively movable relative to the second body securement
portion.
11. The orthosis set forth in claim 1, wherein the first and second
body securement portions are operatively coupled to one another at
a hinge connection.
12. The orthosis set forth in claim 1, further comprising a locking
device configured to selectively lock the L-shaped bracket in a
selected position relative to the drive assembly, and unlock the
L-shaped bracket to allow movement of the L-shaped bracket relative
to the drive assembly.
13. The orthosis set forth in claim 12, wherein the L-shaped
bracket is selectively movable relative to the second body
securement portion.
14. The orthosis set forth in claim 1, wherein the drive assembly
comprises a worm and a worm gear engaging the worm.
15. The orthosis set forth in claim 14, wherein the drive assembly
comprises an input shaft having a first longitudinal end connected
to the worm, and a knob connected to a second longitudinal end of
the input shaft.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 14/643,775, filed Mar. 10, 2015, which is
continuation application of U.S. patent application Ser. No.
13/872,467, filed Apr. 29, 2013, issued as U.S. Pat. No. 8,998,834
on Apr. 7, 2015, which is a continuation application of U.S. patent
application Ser. No. 13/026,895, filed Feb. 14, 2011, issued as
U.S. Pat. No. 8,444,583 on May 21, 2013. The contents of the
above-identified applications are herein incorporated by reference
in their entirety.
BACKGROUND
[0002] The field of the invention relates generally to an ankle
foot orthosis.
[0003] In a joint, the range of motion depends upon the anatomy of
that joint and on the particular genetics of each individual.
Typically, joints move in two directions, flexion and extension.
Flexion is to bend the joint and extension is to straighten the
joint. However, in the orthopedic convention some joints only flex.
For example, the ankle has dorsiflexion and plantarflexion.
[0004] When a joint is injured either by trauma or by surgery, scar
tissue can form, often resulting in flexion or extension
contractures. Such conditions can limit the range of motion of the
joint, limiting flexion (in the case of an extension contracture)
or extension (in the case of a flexion contracture) of the injured
joint. It is often possible to treat this condition by use of a
range-of-motion (ROM) orthosis.
[0005] ROM orthoses are devices commonly used during physical
rehabilitative therapy to increase the range-of-motion over which
the patient can flex or extend the joint. Commercially available
ROM orthoses are typically attached on opposite members of the
joint and apply a torque to rotate the joint in opposition to the
contraction. The force is gradually increased to increase the
working range or angle of joint motion.
SUMMARY OF THE DISCLOSURE
[0006] In one aspect, an ankle foot orthosis generally comprises a
leg member, a foot member, and a drive member. The leg member is
configured to be releasably fastened to a leg of the wearer. The
foot member is configured to be releasably fastened to a foot of a
wearer, and the foot member has anterior and posterior ends. The
drive assembly includes a link member hingedly secured to the foot
member at a hinge location adjacent to the posterior end of the
foot member. The drive assembly is operable to selectively impart
pivotal movement between the foot member and the link member about
a first pivot axis, and pivotal movement between the foot member
and the leg member about a second pivot axis at the hinge
location.
[0007] In another aspect, a method of treating an ankle joint using
an ankle foot orthosis generally comprises fastening a foot member
of the ankle foot orthosis to a foot of a wearer, and fastening a
leg member of the ankle foot orthosis to a leg of the wearer. A
drive assembly of the ankle foot orthosis is configured to impart
pivotal movement between a link member of the drive assembly and
the foot member about a first pivot axis located adjacent to a
posterior end of the foot member, and to impart pivotal movement
between the foot member and the leg member about a second pivot
axis, to thereby impart one of dorsiflexion and plantarflexion of
the ankle joint about a rotational axis.
[0008] In yet another aspect, an ankle foot orthosis generally
comprises a leg member, a foot member, and a drive assembly. The
leg member is configured to be releasably fastened to a leg of a
wearer. The foot member is configured to be releasably fastened to
a foot of the wearer. The foot member is hingedly connected to the
leg member for pivotal movement between the foot member and the leg
member about a pivot axis. The drive assembly is operable to
selectively impart pivotal movement between the foot member and the
leg member about the pivot axis. The inferior-superior location of
the pivot axis is selectively adjustable for substantially aligning
the pivot axis with an axis of rotation of an ankle joint of the
wearer.
[0009] In another aspect, an ankle foot orthosis generally
comprises a leg member, a foot member, and a drive assembly. The
leg member is configured to be releasably fastened to a leg of a
wearer. The foot member is configured to be releasably fastened to
a foot of the wearer. The foot member includes a base and a foot
member strut extending superiorly from the base. The foot member
strut is hingedly connected to the leg member for pivotal movement
between the foot member and the leg member about a pivot axis. The
drive assembly is operable to selectively impart pivotal movement
between the foot member and the leg member about the pivot axis.
The leg member and the foot member strut are selectively movable in
a medial-lateral direction relative to the base of the foot member
and the drive assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective of one embodiment of an ankle foot
orthosis;
[0011] FIG. 2 is a left elevational view of the ankle foot orthosis
fastened to a foot (in phantom), with straps being removed
therefrom for illustrative purposes;
[0012] FIG. 3 is a right elevational view of the ankle foot
orthosis, with straps being removed therefrom for illustrative
purposes;
[0013] FIG. 4 is an exploded view of the ankle foot orthosis, a
foot member, a leg member and a drive assembly being exploded from
one another;
[0014] FIG. 5 is an enlarged, exploded view of the leg member of
the ankle foot orthosis;
[0015] FIG. 6 is an enlarged, exploded view of the foot member of
the ankle foot orthosis; and
[0016] FIG. 7 is an enlarged, exploded view of the drive assembly
of the ankle foot orthosis.
DETAILED DESCRIPTION OF THE DRAWINGS
[0017] Referring now to the drawings, and in particular to FIGS.
1-3, an ankle foot orthosis for use in treating an ankle joint
(i.e., a talocrural joint) of a wearer is generally indicated at
10. The illustrated ankle foot orthosis 10 includes a foot member,
generally indicated at 12, which is releasably fastenable to a foot
F of a wearer, a leg member, generally indicated at 14, which is
releasably fastenable to a leg of a wearer, and a drive assembly,
generally indicated at 16, for facilitating relative angular
movement between the foot member and the leg member. As used in the
following description, terms (e.g., inferior, superior, medial,
lateral, anterior, and posterior, among others) relating to the
locations, positions, and/or directions of components, structures,
surfaces, and/or axes, among others, of the ankle foot orthosis 10
are human anatomical terms describing relative locations,
positions, and/or directions when the ankle foot orthosis 10 is
secured to the wearer.
[0018] As explained in more detail below, operation of the drive
assembly 16 provides passive range-of-motion (ROM) treatment or
exercise of the ankle joint of the wearer. In particular, the
illustrated ankle foot orthosis 10 facilitates dorsiflexion and
plantarflexion of the ankle joint and selective positioning of the
ankle in dorsiflexion and plantarflexion. Dorsiflexion is movement
of the dorsum (superior surface) of the foot F toward the leg about
the ankle joint, thereby decreasing the angle between the dorsum of
the foot F and the leg. Plantarflexion is movement of the dorsum of
the foot F away from the leg, thereby increasing the angle between
the dorsum of the foot F and the leg. As used herein, the ankle
joint is in a neutral position when the angle between the plantar
aspect of the foot F (lying generally within an anterior-posterior
plane) and a longitudinal axis of the leg (lying generally within
an inferior-superior plane) is about 90 degrees. The ankle joint is
in a dorsiflexion position when the angle between the plantar
aspect of the foot F and the longitudinal axis of the leg is less
than about 90 degrees. The ankle joint is in a plantarflexion
position when the angle between the plantar aspect of the foot F
and the longitudinal axis of the leg is greater than about 90
degrees. The respective degrees of dorsiflexion and plantarflexion
of the ankle joint are relative to the neutral position of the
ankle joint. As seen in FIG. 2, the illustrated ankle foot orthosis
10 is shown fastened to a right lower limb of the wearer for
treating a right ankle joint of the wearer, however, it is
understood that the illustrated ankle foot orthosis may be fastened
to a left lower limb of the wearer for treating a left ankle of the
wearer.
[0019] Referring to FIGS. 1-4 and 6, the foot member 12 includes a
heel securement assembly 18, and a forefoot securement assembly 20,
both of which are connected to a generally rigid base 22. Together,
the heel securement assembly 18 and the forefoot securement
assembly 20 constitute a foot securement assembly. Although in the
illustrated embodiment the heel and forefoot assemblies 18, 20,
respectively, are formed as separate components, the two assemblies
may be formed as a one-piece unit within the scope of the present
disclosure. The foot member 12 has a longitudinal axis LA.sub.1
(FIG. 3) extending in an anterior-posterior direction. The heel
securement assembly 18 is disposed generally adjacent to a
posterior end of the base 22, and the forefoot securement assembly
20 is disposed generally adjacent to an anterior end of the base.
In the illustrated embodiment, the heel securement assembly 18
includes a heel cup 24, which at least partially receives and
supports the heel of the wearer, and a strap 26 (FIGS. 1 and 6)
secured to the heel cup. In the illustrated embodiment, the heel
cup 24 is fixedly secured to the base 22, although the heel cup may
be selectively movable (i.e., selectively slidable) on the base to
adjust the position of the heel cup on the base. In the illustrated
embodiment, the heel cup 24 has a generally low profile and is
sized and shaped such that a posterior portion of the heel cup 24
does not contact the wearer's Achilles tendon. The heel cup 24 may
include a pad 27 or may otherwise be provided with cushioning
material for comfort.
[0020] Referring to FIGS. 1 and 6, the strap 26 of the heel
securement assembly 18 is extendable over the foot F of the wearer,
generally adjacent to the wearer's ankle, when the wearer's heel is
received in the heel cup 24 to releasably fasten the cup to the
wearer's heel. As seen best in FIG. 6, the illustrated strap 26 is
of a two-piece construction including a first strap component 26a
that loops through a D-ring 28 of a second strap component 26b. The
first strap component 26a includes fastening components, such as
hook and loop components, so that the strap 26 is adjustable and
may be tightened over the wearer's foot F. A pad or other
cushioning component may be provided on the strap 26 to provide
comfort. The heel securement assembly 18 may have other
configurations, and other ways of releasably fastening the foot
member 12 to the heel of the wearer are within the scope of the
present disclosure.
[0021] Referring to FIGS. 1-4 and 6, the forefoot securement
assembly 20 includes a forefoot plate 32 for supporting the
forefoot of the wearer, and a strap 34 (FIGS. 1 and 6) secured to
the forefoot plate. The forefoot plate 32 includes a pad 35, which
has a generally planar support surface on which the forefoot of the
wearer rests. The illustrated pad 35 provides cushioning and
comfort to the person, although the forefoot plate 32 may not
include a cushioning pad. In the illustrated embodiment, the
forefoot plate 32 is selectively movable on the base 22 in an
anterior-posterior direction to accommodate feet having different
lengths. As seen best in FIGS. 2, 3 and 6, the forefoot plate 32 is
secured to a carriage 36. The carriage 36 includes pins 37 that
slidably retain the carriage on a flange or rail 38 of the base 22.
A locking device (e.g., a thumb screw 39 in the illustrated
embodiment) facilitates selective locking of the carriage 36, and
thus the forefoot plate 32, in a selected anterior-posterior
position on the base 22. Other ways of making the forefoot
securement assembly 20 selectively movable do not depart from the
scope of the present disclosure. Moreover, the forefoot securement
assembly 20 may not be selectively movable without departing from
the scope of the present disclosure.
[0022] The illustrated strap 34 of the forefoot securement assembly
20 is looped through a D-ring 40 attached to the forefoot plate 32.
The strap 34 includes a releasable fastening component, such as
hook and look components, to adjustably tighten the strap and
releasably fasten the forefoot of the wearer to the plate 32. The
forefoot securement assembly 20 may have other configurations, and
other ways of releasably fastening the forefoot of the wearer to
the foot member 12 are within the scope of the present
disclosure.
[0023] Referring particularly to FIG. 6, the base 22 of the foot
member 12 may be formed from a rigid plastic material or from
another suitable material. In one embodiment, the base 22 is
constructed to support weight of a wearer's lower limb when the
wearer is seated and the base is contacting a floor or other foot
support surface, as this is the preferred position of the wearer
when treating the ankle joint using the ankle foot orthosis 10. It
is understood, however, that the wearer may be in a lying position
or another position while the ankle foot orthosis 10 applies
treatment. An outsole member 41 is secured to a bottom (i.e.,
inferior surface) of the base 18. The outsole member 20 is made of
a suitable material, such as non-skid polyethylene or other
suitable material, to inhibit the foot member 12 from sliding on
the floor or other foot support surface.
[0024] In the illustrated embodiment, the bottom surface of the
base 22 has posterior and anterior portions, 42, 44, respective.
The posterior portion 42 extends from adjacent the posterior end of
the base 22 to a location intermediate the posterior and anterior
ends of the base. The posterior portion 42 is generally planar and
is intended to contact and rest on a planar floor or other support
surface. In the illustrated embodiment, the posterior portion 42
lies in a plane that is angularly offset from (i.e., non-parallel
to) the plane defined by the support surface of the forefoot
securement assembly 20 (e.g., the superior surface of the pad 35).
For example, the posterior portion 42 may lie in a plane that is
angularly offset between about 10.degree. and about 30.degree.. In
this way, when the foot F of the wearer is fastened to the ankle
foot orthosis 10 and the contact portion 42 of the bottom surface
of the base 22 is resting on a planar support surface, the foot F
extends upward at an angle relative to the planar support surface
that is substantially equal to the angular offset between the
posterior portion 42 and the plane defined by the support surface
of the forefoot securement assembly 20. The anterior portion 44 of
the bottom surface of the base 22 extends from adjacent the
posterior portion 42 to adjacent the anterior end of the base. The
anterior portion 44 is generally convex or arcuate to enhance
strength of the base 22. It is understood that the bottom surface
of the base 22, and the base in general, may be of other
configurations without departing from the scope of the present
disclosure.
[0025] Referring to FIGS. 1-5, the leg member 14 includes a leg
cuff 48 adapted to receive and partially encircle a circumference
of a leg of the wearer, and a pair of straps 50 (FIG. 1) secured to
the leg cuff for releasably fastening the leg cuff to the leg. The
leg cuff 48 has a longitudinal axis LA.sub.2 (FIG. 3) extending in
an inferior-superior direction and extends along the length of the
wearer's leg when the cuff is fastened to the leg. The leg cuff 48
may be formed from plastic or other material and include a pad 52,
or other cushioning material, to provide comfort to the person.
Each strap 50 is looped through a D-ring 54 secured to the leg cuff
48, and each strap includes releasable fastening components, such
as hook and loop components, so that the straps are adjustable to
tighten the straps over the wearer's leg. The leg member 14 may be
of other configurations, and other ways of releasably fastening the
leg member 14 to the leg of the wearer are within the scope of the
present disclosure.
[0026] Referring still to FIGS. 1-5, the leg member 14 includes a
strut 62 attached to a side of the leg cuff 48, and a bracket 64
connecting the leg member strut to the drive assembly 16. The leg
member strut 62 is generally rigid and elongate, and may be made
from metal or other material. The leg member strut 62 is fixedly
secured to, such as by fasteners (e.g., screws), the side of the
leg cuff 48, and is fixedly secured to the bracket 64, such as by
screws 65 (FIG. 5) or other fasteners or in other ways. Although
the leg member strut 62 is substantially rigid, the strut has a
bendable portion 66 adjacent to the bracket 64. The bendable
portion 66 is pre-bent and bendable in a generally medial-lateral
direction to accommodate wearers having different degrees of
varus/valgus of the knee. Although the illustrated ankle foot
orthosis 10 includes a single leg member strut 62, in another
embodiment the ankle foot orthosis may include one or more
additional leg member struts secured to the other side of the leg
member 14 or at other locations on the leg member without departing
from the scope of the present disclosure.
[0027] As seen best in FIGS. 1 and 5, the illustrated bracket 64 is
generally L-shaped having a lateral portion (broadly, a first
portion) extending posteriorly from the leg member strut 62, and a
posterior portion (broadly, a second portion) extending medially
from a posterior end of the lateral portion. As seen best in FIGS.
1-3, the leg member strut 62 is fixedly attached to the lateral
portion of the bracket 64, and the posterior portion of the bracket
is slidably attached to a bracket securement component 70 of the
drive assembly 16. More specifically, the posterior portion of the
bracket 64 is slidably received in a slot-shaped opening 71 (FIG.
4) of the bracket securement component 70, whereby the bracket 64
is capable of selectively sliding laterally relative to the drive
assembly 16. A locking device, which is in the form of a set screw
72 in the illustrated embodiment, facilitates selective locking and
unlocking of the bracket 64 in a selected medial-lateral position
relative to the drive assembly 16. Through this configuration and
for purposes explained in more detail below, the leg member 14 is
capable of moving in a medial-lateral direction relative to the
foot member 12 and the drive assembly 16. Other ways of allowing
the leg member 14 to be selectively moved in the medial-lateral
direction relative to the foot member 12 and the drive assembly 16
do not depart from the scope of the present disclosure. Moreover,
it is understood that the leg member 14 may not be selectively
movable in the medial-lateral direction relative to the foot member
12 and the drive assembly 16 without departing from the scope of
the present disclosure
[0028] Referring now to FIGS. 1-4 and 6, the illustrated foot
member 12 includes a strut, generally indicated at 74, that is
hingedly secured to the bracket 64, more specifically the lateral
portion of the bracket, to allow for pivotal movement between the
leg member 14 and the foot member 12 about a pivot axis PA.sub.1
(FIGS. 3 and 4). As explained in more detail below, the pivot axis
PA.sub.1 lies in a generally medial-lateral plane and is preferably
substantially coaxial with the rotational axis of the ankle joint
during use. The foot member strut 74 is generally L-shaped and
extends from the bracket 64 to the base 22 of the foot member 12,
below (inferior to) the heel cup 24. The foot member strut 74 is
constructed as a two-piece assembly, including a superior component
76 (broadly, a first component) and an inferior component 78
(broadly, a second component). The superior component 76 is
hingedly secured, such as by a shoulder screw 80 or a pin, to the
lateral portion of the bracket 64. It is understood that the foot
member strut 74 may be hingedly secured to the leg member strut 62
in an embodiment which does not include the bracket 64. It is
understood that the ankle foot orthosis 10 may not include the foot
member strut and/or the leg member strut 62 without departing from
the scope of the present disclosure. In such an example, the leg
member 14 and the foot member 12 would still be pivotable, relative
to one another, about the pivot axis PA.sub.1, but the leg member
and the foot member would not be hingedly connected to one another
at the pivot axis.
[0029] In the illustrated embodiment, the superior component 76 is
selectively slidable relative to the inferior component 78 in a
generally inferior-superior direction to facilitate selective
alignment of the pivot axis PA.sub.1 with the rotational axis of
the ankle joint. Aligning the pivot axis PA.sub.1 with the
rotational axis of the ankle joint reduces ankle compression and
minimizes the occurrence of the heel lifting off the heel cup 24
during operation of the drive assembly 16. The superior component
76 is lockable in a selected inferior-superior position using a
locking device 81, which in the illustrated embodiment is in the
form of a screw received in a slot-shaped opening 82 of the
superior component. A malleolus pad 83 is attached to the inner
side of the superior component at the pivotal axis to provide
comfort and prevent chaffing of skin at the ankle. In the
illustrated embodiment, the malleolus pad 83 is positioned adjacent
the lateral malleolus LM, although it is understood that in other
embodiments the malleolus pad may be adjacent the medial malleolus.
It is understood that the foot member strut 74 may be a one-piece
component and/or non-adjustable in length in the inferior-superior
direction without departing from the scope of the present
disclosure.
[0030] The inferior component 78 is generally L-shaped and is
slidably connected to the base 22 of the foot member 12. The
inferior component 78 is received in a track 84 defined by the base
and is freely slidable relative to the foot member 12 such that
medial-lateral movement of the bracket 64 imparts sliding
medial-lateral movement of the foot member strut 74 relative to the
foot member. Thus, the leg cuff 48, the leg member strut 66, the
bracket 64, and the foot member strut 74 are movable together in a
medial-lateral direction. In this way, the ankle foot orthosis 10
can be adjusted based on the thickness (i.e., a medial-lateral
dimension) of the lateral portion of the wearer's lower leg and
ankle to facilitate proper positioning of the wearer's heel and
forefoot on the foot member 12. For example, the wearer may have
swelling (i.e., edema) of the ankle and/or an ankle wrap or bandage
around his/her ankle. In such a situation, the bracket 64 may be
slid relative to the bracket securement component 70 to allow the
wearer to properly position his/her heel and forefoot on the foot
member 12.
[0031] In the illustrated embodiment, the base 22 has two tracks 84
on opposite sides of the base, although only one of the tracks is
used, depending on whether the orthosis is configured for the right
ankle or the left ankle. In this way, the base is modular, wherein
only one type of base needs to be manufactured for both a right
ankle foot orthosis and a left ankle foot orthosis. In a left ankle
foot orthosis, the foot member strut 74 is received in the other
track. The inferior component 78 may be made from plastic or other
material. In another embodiment, a locking device (not shown) may
be associated with the inferior component 78 to prevent unintended
sliding of the inferior component relative to the foot member
12.
[0032] Referring to FIGS. 1-4 and 7, the drive assembly 16 is
generally in the form of a rack and pinion drive assembly.
Accordingly, the drive assembly 16 includes a rack 85, and a pinion
86 operably coupled to the rack. The ankle foot orthosis 10 may
include other types of drive assemblies besides the illustrated
rack and pinion drive assembly 16. The rack 85, which broadly
constitutes a link member, is hingedly secured to the foot member
12 at a securement location generally adjacent to the posterior end
of the base 22. The rack 85 is hingedly connected to the foot
member 12 by a pin 88 so that the rack is pivotable about a pivot
axis PA.sub.2 (FIGS. 1 and 3). The rack 85 may be hingedly secured
to the foot member 12 in other ways. The rack 85 is generally
elongate, having a longitudinal axis LA.sub.3 (FIG. 3) extending
slightly posteriorly from adjacent the posterior end of the base 22
of the foot member 12 and superiorly toward the leg cuff 48. The
longitudinal axis LA.sub.3 of the rack 85 is disposed posterior to
the heel cup 24 and the leg member 14, and is generally coplanar
with the longitudinal axis LA.sub.1 of the foot member 12, such
that when the wearer's heel is fastened to the heel cup 24, the
Achilles tendon of the wearer is also generally coplanar with the
longitudinal axis LA.sub.3 of the rack 85.
[0033] The rack 85 includes a plurality of teeth 90 extending
substantially linearly along the length of the rack. The pinion 86
operably engages the teeth 90 of the rack 85, whereby rotation of
the pinion imparts relative movement between the pinion and the
rack, which, in turn, imparts pivotal movement between the rack and
the foot member 12 about the pivot axis PA.sub.2 and imparts
pivotal movement between the foot member and the leg member 14
about the pivot axis PA.sub.1, as explained in more detail below.
In the illustrated embodiment, the teeth 90 define a linear
longitudinal axis that is generally coplanar with the longitudinal
axis LA.sub.1 of the foot member 12, and when the wearer's heel is
fastened to the heel cup 24, the teeth are generally coplanar with
the Achilles tendon of the wearer. Through the configuration and
position of the drive assembly 16, the drive assembly provides a
force directly to the foot member 12 to create a moment about the
pivot axis PA.sub.1 and the rotational axis of the ankle joint.
[0034] As seen best in FIG. 7, rotation of the pinion 86 is driven
by a manually rotatable input shaft 94 secured to a gear box 95
that is slidably secured to the rack 85 and moves with the rack. In
the illustrated embodiment, the bracket securement component 70 is
attached to the gear box 95 and moves with the gear box. The gear
box 95 and the rack 85 are pivotable relative to one another about
a pivot axis PA.sub.3. As such, rotation of the pinion 86 also
imparts relative pivotal movement between the gear box 95 (and the
securement component 70) and the rack 85. The input shaft 94 has a
knob 96 secured at a superior longitudinal end and a worm 98
secured at an inferior longitudinal end, which is received in the
gear box 95. The input shaft 94 extends superiorly from the gear
box 95 at a lateral angle relative to the longitudinal axis
LA.sub.3 of the rack 85. Through this configuration, the knob 96 is
adjacent the lateral side of the leg cuff 48, as positioned on the
right lower limb in the illustrated embodiment, so that the knob 96
is accessible to the wearer using his/her right hand, in the
illustrated embodiment, when the wearer is seated. It is understood
that the knob 96 may be adjacent the medial side of the leg cuff
48, as positioned on a right lower limb or a left lower limb,
without departing from the scope of the present invention. Within
the gear box 95, the worm 98 operably engages a worm gear 100,
which is coaxially secured to the pinion 86 via a drive shaft 102
(e.g., a hexagonal shaft). The worm gear 100 has a diameter larger
than the diameter of the pinion 86 to provide a mechanical
advantage. A bushing 104 for the drive shaft 102 is disposed
between the worm gear 100 and the pinion 86. The drive shaft 102
passes through the bushing 104 and a spacer 106 that spaces the
bushing apart from the worm gear 100. The bushing engages the inner
surface of the gear box 95 to inhibit canting or slanting of the
drive shaft, thereby retaining the worm gear 100 and the pinion 86
in operative engagement with the worm 98 and the rack 85,
respectively. The drive assembly 16 may have other configurations
without departing from the scope of the present disclosure.
[0035] In one exemplary method of using the ankle foot orthosis 10,
the wearer's foot F and leg are placed in the orthosis. The
wearer's foot F is placed in the orthosis 10 by placing the heel in
the heel cup 24 and placing the forefoot on the forefoot plate 32.
The forefoot plate 32 may be slidably adjusted, such as by
loosening the set screw 36 and sliding the forefoot plate on the
base 22, so that the strap 34 extends over the toes and the toes do
not extend past the anterior edge of the plate. The wearer's leg is
inserted into the leg cuff 48, such as by spreading apart the
lateral and medial sides to allow the leg to enter the cuff. The
medial-lateral position of the leg cuff 48, the bracket 64, and the
foot member strut 74 relative to the wearer's foot F (and the foot
member 12 and the drive assembly 16) may be adjusted to accommodate
the thickness of the inferior portion of the wearer's leg and
ankle. The set screw 72 is loosened to allow the bracket 64 to
slide freely relative to the bracket securement component 70. When
the leg cuff 48, the bracket 64, and the foot member strut 74 are
in the selected medial-lateral position, the set screw 72 is
tightened.
[0036] The inferior-superior position of the pivot axis PA.sub.1
can be adjusted if the pivot axis is not substantially coaxial with
the rotational axis of the ankle joint. The inferior-superior
position of the pivot axis PA.sub.1 is adjusted by loosening the
screw 81 connecting the superior component 76 to the inferior
component 78 of the foot strut 66, and then sliding the superior
component either superiorly or inferiorly relative to the inferior
component. The screw 81 is tightened when the pivot axis PA.sub.1
is coaxial with the rotational axis of the ankle joint. Alignment
of the pivot axis PA.sub.1 with the rotational axis of the ankle
joint may be accomplished by substantially aligning the pin 80, and
the malleolus pad 83 with the lateral malleolus LM, in the
illustrated embodiment, or the medial malleolus in another
embodiment.
[0037] After the confirming that the wearer's leg and foot F are
properly positioned in the ankle foot orthosis 10, the straps 26,
34 of the foot member 12 and the straps 50 of the leg member 48 are
tightened to fasten the ankle foot orthosis to the foot F and leg
of the wearer. With the ankle foot orthosis 10 fastened to the
wearer's leg and foot F and the wearer preferably seated, the knob
96 is rotated, either by the wearer or another person, to provide
passive range-of-motion (ROM) exercise of the ankle joint. In
particular, rotation of the knob 96 in a selected direction
decreases the spacing between the pinion 86 and the pivot axis
PA.sub.2, causing respective pivoting movement between the rack 85
and the foot member 12 about the pivot axis PA.sub.2, and between
the bracket 64 (and the leg cuff 48) and the foot member 12 about
pivot axis PA.sub.1, to thereby impart plantarflexion of the ankle
joint. Rotation of the knob 96 in a selected, opposite direction
increases the spacing between the pinion 86 and the pivot axis
PA.sub.2, causing respective pivoting movement between the rack 85
and the foot member 12 about the pivot axis PA.sub.2, and between
the bracket 64 (and the leg cuff 48) and the foot member 12 about
the pivot axis PA.sub.1, to thereby impart dorsiflexion of the
ankle joint. In one embodiment, the drive assembly 16 of the ankle
foot orthosis 10 is configured to facilitate movement and
positioning of the ankle joint from about 0 degrees to about 40
degrees of dorsiflexion and from about 0 degrees to about 52
degrees of plantarflexion.
[0038] In one treatment protocol, the ankle joint may be moved to a
first position in one of dorsiflexion and plantarflexion for a
predetermined amount of time (e.g., about 5 minutes), and then the
drive assembly 16 is operated to move the ankle joint to a second
position in said one of dorsiflexion and plantarflexion of another
predetermined amount of time (e.g., another 5 minutes). The drive
assembly 16 may also be operated to move the ankle joint any number
of subsequent positions. Maintaining the ankle joint in the first
and second positions and any other subsequent positions for the
predetermined amount of time allows connective tissue of the ankle
joint to be stretched. In particular, this type of treatment
utilizes the principles of stress relaxation to stretch the
connective tissue of the joint. In another embodiment, the ankle
foot orthosis 10 may also be configured to provide a dynamic
stretch to the ankle joint.
[0039] This written description uses examples to disclose the
invention, including the best mode, and also to enable any person
skilled in the art to practice the invention, including making and
using any devices or systems and performing any incorporated
methods. The patentable scope of the invention is defined by the
claims, and may include other examples that occur to those skilled
in the art. Such other examples are intended to be within the scope
of the claims if they have structural elements that do not differ
from the literal language of the claims, or if they include
equivalent structural elements with insubstantial differences from
the literal languages of the claims.
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