U.S. patent application number 15/294110 was filed with the patent office on 2017-04-20 for customizable knee brace intended for patients with osteoarthritis.
The applicant listed for this patent is DJO, LLC. Invention is credited to Richard GILDERSLEEVE, Nicholas GOMEZ, Ian KOVACEVICH.
Application Number | 20170105865 15/294110 |
Document ID | / |
Family ID | 58517980 |
Filed Date | 2017-04-20 |
United States Patent
Application |
20170105865 |
Kind Code |
A1 |
GILDERSLEEVE; Richard ; et
al. |
April 20, 2017 |
CUSTOMIZABLE KNEE BRACE INTENDED FOR PATIENTS WITH
OSTEOARTHRITIS
Abstract
A customizable knee brace for use in the treatment of
osteoarthritis is provided. The customizable knee brace includes a
lateral upright. The lateral upright includes at least a first
semi-rigid support, a second semi-rigid support, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support. The customizable knee brace further includes a
thigh cuff constructed of formable material and coupled to the
first semi-rigid support. The customizable knee brace further
includes a shin cuff constructed of formable material and coupled
to the second semi-rigid support. The customizable knee brace
further includes an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace. The customizable
knee brace further includes at least one tensioning element
configured to adjust a tension of the elastomeric web
framework.
Inventors: |
GILDERSLEEVE; Richard;
(Carlsbad, CA) ; KOVACEVICH; Ian; (Vista, CA)
; GOMEZ; Nicholas; (Vista, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DJO, LLC |
Vista |
CA |
US |
|
|
Family ID: |
58517980 |
Appl. No.: |
15/294110 |
Filed: |
October 14, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62241989 |
Oct 15, 2015 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2005/0139 20130101;
A61F 2005/0172 20130101; A61F 2005/0179 20130101; A61F 2005/0134
20130101; A61F 5/0125 20130101; A61F 2005/0174 20130101; A61F
5/0123 20130101 |
International
Class: |
A61F 5/01 20060101
A61F005/01 |
Claims
1. A customizable knee brace for use in the treatment of
osteoarthritis, comprising: a lateral upright comprising at least:
a first semi-rigid support, a second semi-rigid support, and a
hinge physically coupling the first semi-rigid support and the
second semi-rigid support; a thigh cuff constructed of formable
material and coupled to the first semi-rigid support; a shin cuff
constructed of formable material and coupled to the second
semi-rigid support; an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace; and at least one
tensioning element configured to adjust a tension of the
elastomeric web framework.
2. The brace of claim 1, further comprising at least one removable
condyle pad coupled to the hinge and configured to provide a
spacing between the hinge and the knee of the patient.
3. The brace of claim 1, further comprising at least one strap
configured to wrap around at least a posterior portion of the knee
of the patient thereby securing the brace to the patient.
4. The brace of claim 1, further comprising a formable pad
configured to provide cushioning to the thigh or shin of the
patient.
5. The brace of claim 1, wherein the at least one tensioning
element comprises a lace coupled to the elastomeric web framework
and at least one reel element configured to adjust a tension in the
lace, thereby adjusting the tension in the elastomeric web
framework.
6. The brace of claim 1, wherein the at least one tensioning
element is configured to increase an amount of vertical tension of
the elastomeric web framework while simultaneously increasing an
offloading of a portion of a load on a desired compartment of the
knee.
7. The brace of claim 1, wherein the at least one tensioning
element is selected from the group consisting of a reel-and-lace
tensioning element, a lever-based tensioning element, a screw-based
tensioning element, a lace-and-cleat tensioning element, buckles, a
rigid post-and-strap tensioning element comprising holes, a
hook-and-loop tensioning element, and a notched band-and-pawl
tensioning element.
8. The brace of claim 1, wherein the thigh cuff is formable and
configured to conform to a thigh of the patient.
9. The brace of claim 1, wherein the shin cuff is formable and
configured to conform to a shin of the patient.
10. The brace of claim 1, wherein at least one of the first
semi-rigid support and the second semi-rigid support are configured
to be adjusted, based on anatomical needs of the patient, so as to
redistribute a portion of a load from a medial compartment of the
knee of the patient, thereby reducing knee pain.
11. The brace of claim 1, wherein the elastomeric web framework
comprises silicone.
12. The brace of claim 1, wherein, when under tension, the
elastomeric web framework is configured to both customize a fit of
the brace around the knee of the patient and redistribute at least
a portion of a load from a medial compartment of the knee of the
patient.
13. The brace of claim 1, wherein the elastomeric web framework
comprises a plurality of interconnected elastomeric segments that
define at least one alignment opening configured to receive a
patellar portion of the knee of the patient.
14. The brace of claim 1, wherein the thigh cuff and the calf cuff
are heat-formable in a temperature range at least partially
overlapping 160-180 degrees Fahrenheit.
15. A customizable knee brace for use in the treatment of
osteoarthritis, comprising: a lateral upright comprising at least:
a first semi-rigid support, a second semi-rigid support, and a
hinge physically coupling the first semi-rigid support and the
second semi-rigid support; an elastomeric web framework coupled to
the lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace; and at least one
tensioning element configured to adjust a tension of the
elastomeric web framework.
16. The brace of claim 15, further comprising: a thigh cuff
constructed of formable material and coupled to the first
semi-rigid support; and a shin cuff constructed of formable
material and coupled to the second semi-rigid support.
17. A customizable knee brace for use in the treatment of
osteoarthritis, comprising: a lateral upright comprising at least:
a first semi-rigid support, a second semi-rigid support, and a
hinge physically coupling the first semi-rigid support and the
second semi-rigid support; a thigh cuff constructed of formable
material and coupled to the first semi-rigid support; a shin cuff
constructed of formable material and coupled to the second
semi-rigid support; and an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace.
18. The brace of claim 17, further comprising at least one
tensioning element configured to adjust a tension of the
elastomeric web framework, the at least one tensioning element
selected from the group consisting of a reel-and-lace tensioning
element, a lever-based tensioning element, a screw-based tensioning
element, a lace-and-cleat tensioning element, buckles, a rigid
post-and-strap tensioning element comprising holes, a hook-and-loop
tensioning element, and a notched band-and-pawl tensioning
element.
19. A method for treating osteoarthritis utilizing a customizable
knee brace, the method comprising: forming a thigh cuff of the
customizable knee brace to conform to a thigh of a patient; forming
a shin cuff of the customizable knee brace to conform to a shin of
the patient, wherein the customizable knee brace further comprises
a lateral upright comprising at least: a first semi-rigid support
configured to be coupled to the thigh cuff, a second semi-rigid
support configured to be coupled to the shin cuff, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support; securing an area of a knee of a patient
utilizing an elastomeric web framework coupled to the lateral
upright; and adjusting a tension of the elastomeric web framework
utilizing at least one tensioning element.
20. The method of claim 19, wherein the at least one tensioning
element comprises at least one reel element and a lace that
physically couples the elastomeric web framework to the lateral
upright and wherein adjusting the tension of the elastomeric web
framework comprises adjusting the at least one reel element to
adjust a tension in the lace.
21. The method of claim 19, wherein the at least one tensioning
element is selected from the group consisting of a reel-and-lace
tensioning element, a lever-based tensioning element, a screw-based
tensioning element, a lace-and-cleat tensioning element, buckles, a
rigid post-and-strap tensioning element comprising holes, a
hook-and-loop tensioning element, and a notched band-and-pawl
tensioning element.
22. The method of claim 19, further comprising bending at least one
of the first semi-rigid support and the second semi-rigid support
to a desired angle based at least in part on an alignment of the
knee so as to redistribute a portion of a load from a medial
compartment of the knee of the patient.
23. The method of claim 19, wherein adjusting the tension of the
elastomeric web framework redistributes at least a portion of a
load from a medial compartment of the knee of the patient.
24. The method of claim 19, wherein adjusting the tension of the
elastomeric web framework comprises increasing an amount of
vertical tension of the elastomeric web framework while
simultaneously increasing an offloading of a portion of a load on a
desired compartment of the knee.
25. The method of claim 19, further comprising disposing at least
one removable condyle pad between the hinge and the knee of the
patient, thereby providing a desired spacing between the hinge and
the knee of the patient.
26. The method of claim 19, further comprising wrapping at least
one strap, coupled to the lateral upright, around at least a
posterior portion of the knee of the patient thereby securing the
brace to the patient.
27. The method of claim 19, further comprising disposing a formable
pad at the thigh or shin of the patient.
28. A kit for providing a customizable knee brace for use in the
treatment of osteoarthritis, the kit comprising: the customizable
knee brace, comprising: a lateral upright comprising at least: a
first semi-rigid support, a second semi-rigid support, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support; a thigh cuff constructed of formable material
and coupled to the first semi-rigid support; a shin cuff
constructed of formable material and coupled to the second
semi-rigid support; an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace; and at least one
tensioning element configured to adjust a tension of the
elastomeric web framework; the kit further comprising a plurality
of heating pads configurable to heat the thigh cuff and the shin
cuff for forming to the patient's thigh and shin, respectively.
29. The kit of claim 28, further comprising packaging configured to
reduce or substantially eliminate alteration of a shape of any
portion of the customizable knee brace during transit within the
kit.
30. The kit of claim 28, further comprising a plurality of
removable condyle pads having various thicknesses, the removable
condyle pads configured to provide desired spacings, associated
with the various thicknesses, between the hinge and the knee of the
patient when the customizable knee brace is worn by the
patient.
31. The kit of claim 28, further comprising at least one strap
coupled to the lateral upright and configured to wrap around at
least a posterior portion of the knee of the patient thereby
securing the brace to the patient.
32. The kit of claim 28, further comprising a formable pad
configured to provide cushioning to the thigh or shin of the
patient.
33. The kit of claim 28, wherein the at least one tensioning
element comprises a lace coupled to the elastomeric web framework
and at least one reel element configured to adjust a tension in the
lace, thereby adjusting the tension of the elastomeric web
framework.
34. The kit of claim 28, wherein the at least one tensioning
element is configured to increase an amount of vertical tension of
the elastomeric web framework while simultaneously increasing an
offloading of a portion of a load on a desired compartment of the
knee.
35. The kit of claim 28, wherein the at least one tensioning
element is selected from the group consisting of a reel-and-lace
tensioning element, a lever-based tensioning element, a screw-based
tensioning element, a lace-and-cleat tensioning element, buckles, a
rigid post-and-strap tensioning element comprising holes, a
hook-and-loop tensioning element, and a notched band-and-pawl
tensioning element.
36. The kit of claim 28, wherein the thigh cuff is heat-formable
and configured to conform to a thigh of the patient.
37. The kit of claim 28, wherein the shin cuff is heat-formable and
configured to conform to a shin of the patient.
38. The kit of claim 28, wherein at least one of the first
semi-rigid support and the second semi-rigid support are configured
to be adjusted, based on anatomical needs of the patient, so as to
redistribute a portion of a load from a medial compartment of the
knee of the patient.
39. The kit of claim 28, wherein the elastomeric web framework
comprises silicone.
40. The kit of claim 28, wherein, when under tension, the
elastomeric web framework is configured to both customize a fit of
the brace around the knee of the patient and redistribute at least
a portion of a load from a medial compartment of the knee of the
patient.
41. The kit of claim 28, wherein the elastomeric web framework
comprises a plurality of interconnected elastomeric segments that
define at least one alignment opening configured to receive a
patellar portion of the knee of the patient.
42. The kit of claim 28, wherein the thigh cuff and the shin cuff
are heat-formable in a temperature range at least partially
overlapping 160-180 degrees Fahrenheit.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 62/241,989, filed Oct. 15, 2015, and incorporates
the same by reference in its entirely herein.
BACKGROUND
[0002] Field of the Disclosure
[0003] Disclosed herein is a customizable knee brace intended for
patients with osteoarthritis. Methods of treating a patient having
osteoarthritis are likewise provided.
[0004] Description of the Related Technology
[0005] Osteoarthritis (OA), commonly known as wear-and-tear
arthritis, is a condition in which the natural cushioning between
joints wears away. Osteoarthritis is one of the most frequent
causes of physical disability among adults, with over 20 million
people in the United States having the disease. By 2030, it is
estimated that 20% of all Americans, approximately 70 million
people, will be at risk for osteoarthritis. A degenerative joint
disease, osteoarthritis causes chronic pain in the affected joint
when the joint is statically or dynamically loaded.
[0006] Primary osteoarthritis often affects weight bearing joints,
such as the knee. Repetitive use of a joint, such as the knee, over
time can irritate and inflame the cartilage, causing joint pain and
swelling. Eventually, cartilage begins to degenerate and as
cartilage is diminished, the bones of the knee joints rub more
closely against one another with less of the shock-absorbing
benefits of cartilage. The rubbing can result in pain, swelling,
stiffness, decreased mobility as well as the possibility of bone
spur formation. The most common cause of osteoarthritis of the knee
is age. However, several factors increase the risk of developing
significant arthritis including age, weight, repetitive stress
injuries, and certain athletic endeavors such as soccer, tennis, or
long-distance running.
[0007] In an affected knee, osteoarthritis pain is often caused by
an unbalanced loading on the medial or lateral compartment of the
joint. Such unbalanced loading can generate increased pressure and
reduce the clearance space between the condyles of the femur and
tibial plateau. Increased pressure between the femoral and tibial
surfaces in an affected compartment of the knee joint can lead to
cartilage degeneration. As the cartilage degenerates, the
osteoarthritis sufferer experiences increased pain in the knee.
[0008] Orthopedic knee braces are commonly applied to the leg to
treat osteoarthritis of the knee and other painful knee conditions.
Such braces typically include an upper support portion, a lower
support portion, and one or more hinge assemblies pivotally
interconnecting the upper and lower support portions. The upper
support portion is secured to the wearer's upper leg, while the
lower support portion is secured to the wearer's lower leg. The
hinge assembly is located to a side of the wearer's knee and a
condyle pad is typically located between each hinge assembly and
the adjacent side of the knee. For example, a thickness of the
adjacent condyle pad may be increased or the pad may be moved
closer to the knee. The applied force generates resultant forces in
the medial/lateral plane above and below the knee. The upper and
lower support portions of the brace, respectively, apply these
resultant forces on the side of the affected compartment. The
applied and resultant forces comprise the three-point bending load
on the leg. This load realigns the knee. By realigning the
orientation of the knee joint, the knee brace reduces the load in
the affected compartment of the knee, thereby lessening the pain
and the other negative effects of osteoarthritis.
[0009] Osteoarthritis knee braces are primarily designed to correct
the abnormal bending of the knee joint inwards or outwards (i.e.,
Varus or Valgus correction, respectively) and prevent the
"bone-on-bone" contact of the femur and tibia bones in the medial
and/or lateral compartment of the knee joint as the patient bares
weight during ambulation. This action of lifting the femur, pulling
down the tibia or keeping the femur and tibia bones from coming in
contact during the straightening of the knee during heel strike of
the foot is often called "unloading" of the knee joint. By
unloading the knee joint, the constant irritation of the
degenerated cartilage in the effected compartment of the knee
(medial or lateral) can lead to a reduction in pain and a further
reduction in injury to the knee joint.
[0010] Osteoarthritis knee braces also provide improved alignment
of the upper and lower aspects of the knee joint by preventing the
bending inwards or outwards of the knee joint during gait. U.S.
Pat. No. 3,581,741 to Rosman, discloses a knee brace comprising an
upper rigid body portion and a lower rigid body portion pivotably
coupled together on the lateral side in a manner so that they may
pivot relative to each other about an axis generally perpendicular
to the zone of overlap and may slide relative to each other in all
radial directions generally parallel to the zone of overlap. A
majority of knee orthotics available to treat osteoarthritis of the
knee utilize a single upright attached to an upper thigh cuff and
lower shin cuff. The upright is located on the side of the
collapsed compartment of the knee (i.e., medial side for medial
compartment osteoarthritis or lateral side for lateral compartment
osteoarthritis). The attached cuffs "unload" the biomechanical
force from the affected compartment of the knee by increasing the
joint space on the affected side as the knee goes from flexion to
extension.
[0011] Some osteoarthritis knee braces use an angled strap that
extends from the upper part of the brace, from the single upright,
across the opposite side of the knee joint to the lower part of the
brace to improve the alignment of the knee during ambulation and
more evenly balance the forces on the knee during gait kinetics.
The strap provides a three point leverage system that attempts to
pull the knee joint into proper alignment during gait. A
combination of the single sided upright with cuff attachments and
the valgus-producing strap have shown to provide improved
performance in severe osteoarthritis. However, it is difficult to
set the desired degrees of flexion and extension in such devices
and therefore these devices are known to fall short of providing a
close-to-complete alleviation of the pain and discomfort from
osteoarthritis and a return to normal walking gait, let alone
providing any corrective and therapeutic force system to
rehabilitate the effected knee joint and surrounding muscles.
Further, patient discomfort and brace slippage is a real and common
problem with these prior art braces.
[0012] Some knee braces utilize a single upright support attached
to an upper thigh cuff and lower shin cuff. The upright support is
located opposite or adjacent to the side of the collapsed
compartment of the knee. The attached cuffs "unload" the
biomechanical force on the affected compartment of the knee by
increasing the joint space on the affected side as the knee goes
from flexion to extension. Other known brace designs employ a
double upright strut, which immobilizes the knee by unloading the
degenerative knee compartment. In some such braces, non-slippage
and comfort pads are employed along inner lateral surfaces of the
upright struts.
[0013] Patients who suffer joint pain may also benefit from the use
of compression sleeves or wrap-arounds. Available compression
sleeves use a flexible, elastic fabric, such as neoprene, designed
to be pulled over or wrapped around the joint. Compression sleeves
can improve joint stability and also provide some insulation or
heat to the joint. In some instances, a compression sleeve may
include one or more rods which may provide support to the
joint.
[0014] There remains a need for improved osteoarthritis braces to
serve the needs of the growing population of osteoarthritis
sufferers. Moreover, there exists a need for a customizable
osteoarthritis brace.
SUMMARY
[0015] A customizable knee brace for use in the treatment of
osteoarthritis is provided. The customizable knee brace includes a
lateral upright. The lateral upright includes at least a first
semi-rigid support, a second semi-rigid support, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support. The customizable knee brace further includes a
thigh cuff constructed of formable material and coupled to the
first semi-rigid support. The customizable knee brace further
includes a shin cuff constructed of formable material and coupled
to the second semi-rigid support. The customizable knee brace
further includes an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace. The customizable
knee brace further includes at least one tensioning element
configured to adjust a tension of the elastomeric web
framework.
[0016] Another customizable knee brace for use in the treatment of
osteoarthritis is provided. The customizable knee brace includes a
lateral upright. The lateral upright includes at least a first
semi-rigid support, a second semi-rigid support, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support. The customizable knee brace further includes an
elastomeric web framework coupled to the lateral upright and
configured to secure an area of a knee of a patient when wearing
the customizable knee brace. The customizable knee brace further
includes at least one tensioning element configured to adjust a
tension of the elastomeric web framework.
[0017] Another customizable knee brace for use in the treatment of
osteoarthritis is provided. The customizable knee brace includes a
lateral upright. The lateral upright includes at least a first
semi-rigid support, a second semi-rigid support, and a hinge
physically coupling the first semi-rigid support and the second
semi-rigid support. The customizable knee brace further includes a
thigh cuff constructed of formable material and coupled to the
first semi-rigid support. The customizable knee brace further
includes a shin cuff constructed of formable material and coupled
to the second semi-rigid support. The customizable knee brace
further includes an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace.
[0018] A method for treating osteoarthritis utilizing a
customizable knee brace is provided. The method includes forming a
thigh cuff of the customizable knee brace to a thigh of a patient.
The method includes forming a shin cuff of the customizable knee
brace to a shin of the patient. The customizable knee brace further
comprises a lateral upright comprising at least a first semi-rigid
support configured to be coupled to the thigh cuff, a second
semi-rigid support configured to be coupled to the shin cuff, and a
hinge physically coupling the first semi-rigid support and the
second semi-rigid support. The method further includes securing an
area of a knee of a patient utilizing an elastomeric web framework
coupled to the lateral upright. The method includes adjusting a
tension of the elastomeric web framework utilizing at least one
tensioning element.
[0019] A kit for providing a customizable knee brace for use in the
treatment of osteoarthritis is provided. The kit includes the
customizable knee brace, which includes a lateral upright including
a first semi-rigid support, a second semi-rigid support, and a
hinge physically coupling the first semi-rigid support and the
second semi-rigid support. The customizable knee brace further
includes a thigh cuff constructed of formable material and coupled
to the first semi-rigid support. The customizable knee brace
further includes a shin cuff constructed of formable material and
coupled to the second semi-rigid support. The customizable knee
brace further includes an elastomeric web framework coupled to the
lateral upright and configured to secure an area of a knee of a
patient when wearing the customizable knee brace. The customizable
knee brace further includes at least one tensioning element
configured to adjust a tension of the elastomeric web framework.
The kit may further include a plurality of heating pads
configurable to heat the thigh cuff and the shin cuff for forming
to the patient's thigh and shin, respectively.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 illustrates a perspective view of a customizable knee
brace for use in the treatment of osteoarthritis, in accordance
with some embodiments.
[0021] FIG. 2 illustrates a plan view of an embodiment of an upper
portion of the customizable knee brace of FIG. 1, utilizing a
reel-and-lace tensioning element, in accordance with some
embodiments.
[0022] FIG. 3 illustrates a plan view of another embodiment of an
upper portion of the customizable knee brace of FIG. 1, utilizing a
reel-and-lace tensioning element, in accordance with some
embodiments.
[0023] FIG. 4 illustrates a perspective, magnified view of the
lateral upright of customizable knee brace of FIG. 1, in accordance
with some embodiments.
[0024] FIG. 5 illustrates an exploded perspective view of the
lateral upright of FIGS. 1 and 4, in accordance with some
embodiments.
[0025] FIG. 6 illustrates an exploded perspective view of the
removable condyle pads for coupling to the lateral upright of FIGS.
1, 4 and 5, in accordance with some embodiments.
[0026] FIG. 7 illustrates a perspective view of the medial element
of the customizable knee brace of FIG. 1, in accordance with some
embodiments.
[0027] FIG. 8 illustrates a kit for reducing or substantially
eliminating deformation of elements of the customizable knee brace
of FIG. 1 during physical transportation and/or storage, in
accordance with some embodiments.
[0028] FIG. 9 illustrates a flowchart for a method of treatment of
osteoarthritis utilizing a customizable knee brace as described in
any of the preceding FIGs., in accordance with some
embodiments.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS
[0029] As an initial matter, a skilled artisan will appreciate that
the embodiments disclosed herein have broad application and
utility. Several embodiments may be discussed for illustrative
purposes in providing a full and enabling disclosure. Moreover,
many adaptations, variations, modifications, and equivalent
arrangements will be implicitly disclosed by the embodiments
described herein and fall within the scope of this description.
[0030] Several embodiments of a customizable knee brace intended
for patients with abnormal knee function who suffer from
osteoarthritis (OA). As will be described in greater detail below
and as illustrated in the FIGs., some embodiments of this
customizable knee brace comprise a lateral upright, a thigh cuff
and a shin cuff, each constructed of formable material, and an
anterior elastomeric web framework configured to wrap around and
conform to the patient's knee joint. The embodiments described
herein benefit from, in part, the surprising development of a fully
customizable, easy to wear, and light weight solution for patients
suffering from OA.
[0031] Such customizable knee braces offer significant benefits
over current braces. For example, customizable knee braces as
described herein are a fully customizable, easy to wear, and
lightweight solution for patients suffering from OA. More
specifically, clinicians and patients may customize the fit of the
customizable knee braces to redistribute a portion of a load from
an affected compartment of the knee of the patient (e.g., medial
compartment, lateral compartment, patellofemoral compartment, or
any combination thereof), thereby reducing knee pain. Assisting in
proper fit and effective redistribution of the load on the knee,
the thigh cuff and the shin cuff are both heat formable at a
relatively low heat, as will be described in greater detail in
connection with at least FIGS. 1 and 9 below. A strapping system is
further provided, which may be initially sized and also capable of
being further trimmed as required, based at least in part on the
anatomy, needs and condition of the particular patient.
[0032] Embodiments described herein provide pain relief for OA
utilizing frontal-plane three-point leverage offloading with
extension assist afforded by the anterior elastomeric web
framework. Such three-point leverage offloading is accomplished in
a plurality of manners. For example, portions of the lateral
upright may be configured to be adjusted (e.g., bent or formed to
an ideal or desired offloading angle with respect to the femur,
tibia, knee joint, or outside surface of the upper and/or lower
leg), based on anatomical needs of the patient, so as to
effectively redistribute a portion of a load from an affected
compartment of the knee of the patient, thereby reducing knee pain.
Moreover, as will be described in more detail in connection with
the following FIGs., a hinge of the lateral upright may be adjusted
to increase or decrease offloading. In addition, at least one
tensioning element may be configured to adjust a tension of the
elastomeric web framework to increase or decrease offload from an
affected compartment of the patient's knee joint while
simultaneously providing varying degrees of extension assist to the
knee joint and adjustment of the fit of the customizable knee
brace.
[0033] Although the present embodiments are particularly
well-suited for use in treating osteoarthritis of the knee, such
customizable braces may also be utilized and/or modified for use in
treating other joints including, for example, ankle, elbow, neck,
back, and/or wrist.
[0034] FIG. 1 illustrates a perspective view of a customizable knee
brace 100 for use in the treatment of osteoarthritis, in accordance
with some embodiments. Customizable knee brace 100 is illustrated
in FIG. 1 before fitting to a patient's knee, in a substantially
flat orientation. Customizable knee brace 100 comprises a lateral
upright 110, which comprises a first semi-rigid support 102, a
second semi-rigid support 104, and a hinge 106 physically coupling
first semi-rigid support 102 and second semi-rigid support 104. In
some embodiments, hinge 106 may be a unicentric joint (e.g., having
a single axis of rotation or freedom of movement). In some other
embodiments, hinge 106 may be a polycentric joint (e.g., having a
plurality of axes of rotation or freedom of movement). In some
embodiments, at least one of first semi-rigid support 102 and
second semi-rigid support 104 are configured to be adjusted, based
on anatomical needs of the patient, so as to redistribute a portion
of a load from an affected compartment of the knee of the patient,
thereby reducing knee pain. For example, a treating clinician or
the patient may bend or form one or both of first semi-rigid
support 102 and second semi-rigid support 104 such that it forms an
ideal or desired offloading angle with respect to the femur, tibia,
knee joint, or external surface of the upper and/or lower leg of
the patient when the customizable knee brace 100 is properly worn.
Accordingly, in some embodiments, first semi-rigid support 102 and
second semi-rigid support 104 may be constructed of a material such
as heat-formable plastic, metal, or any other suitably rigid
material, currently know or unknown, that is sufficiently rigid to
provide the required support to and force against the knee joint
and that, in some embodiments, may also be adjusted or bent to a
desired angle either through use of an adjusting machine or
manually, by hand, and in some embodiments, once sufficiently
heated.
[0035] For treatment of medial compartment OA, lateral upright 110
may be disposed along the lateral side of the patient's affected
leg such that hinge 106 substantially aligns with the lateral side
of the knee joint and the axis along which the knee bends, first
semi-rigid support 102 is disposed along the lateral, lower portion
of the patients upper leg (e.g., the thigh), and second semi-rigid
support 104 is disposed along the lateral, upper portion of the
patients lower leg (e.g., the shin and/or calf). Accordingly, when
worn, the lateral upright 110 (e.g., first semi-rigid support 102,
hinge 106, and/or second semi-rigid support 104) may exert a force
from the lateral side toward the medial side of the knee joint
(i.e., a Varus adjustment), thereby increasing the separation
between the femur and tibia in the medial compartment of the knee
and, accordingly, providing a redistribution of a portion of the
load away from the medial compartment of the knee. In at least this
manner, knee pain may be reduced for the patient suffering from
medial OA.
[0036] For treatment of lateral compartment OA, lateral upright 110
may be disposed along the medial side of the patient's affected leg
such that hinge 106 substantially aligns with the medial side of
the knee joint and the axis along which the knee bends, first
semi-rigid support 102 is disposed along the medial, lower portion
of the patients upper leg (e.g., the thigh), and second semi-rigid
support 104 is disposed along the medial, upper portion of the
patients lower leg (e.g., the shin and/or calf). Accordingly, when
worn, the lateral upright 110 (e.g., first semi-rigid support 102,
hinge 106, and/or second semi-rigid support 104) may exert a force
from the medial side toward the lateral side of the knee joint
(i.e., a Valgus adjustment), thereby increasing the separation
between the femur and tibia in the lateral compartment of the knee
and, accordingly, providing a redistribution of a portion of the
load away from the lateral compartment of the knee. In at least
this manner, knee pain may be reduced for the patient suffering
from lateral OA.
[0037] In some embodiments, customizable knee brace 100 may further
comprise at least one removable condyle pad 108a, 108b, 108c
coupled to hinge 106, between hinge 106 and the knee of the
patient, thereby providing a desired spacing between hinge 106 and
the knee of the patient. In some embodiments, removable condyle
pad(s) 108a, 108b, 108c may be secured to hinge 106 via Velcro, a
removable or permanent adhesive, one or more mounting brackets,
screws, clips or any other suitable method of coupling. Moreover, a
single removable condyle pads 108a, 108b, 108c may be utilized at a
time, or multiple removable condyle pads 108a, 108b, 108c may be
stacked to provide a desired spacing between hinge 106 and the
patient's knee. By coupling one or more of a plurality of removable
condyle pads 108a, 108b, 108c to hinge 106, each having a different
thickness, the alignment of the knee may be further adjusted, in
some instances, with a finer granularity and greater range of
thicknesses than would otherwise be possible.
[0038] Customizable knee brace 100 may further comprise a thigh
cuff 112 coupled to first semi-rigid support 102. In some
embodiments, thigh cuff 112 may be constructed of heat-formable
material allowing it to be adjusted, bent and/or shaped to conform
to at least the anterior portion of the patient's thigh by applying
modest heat (e.g., in a temperature range at least partially
overlapping 160-180 degrees Fahrenheit) and, thereby, improve the
fit to the patient. In some embodiments, this heat-formable
material may be substantially rigid at temperatures it would be
expected to endure while being worn by the patient (e.g.,
temperature ranges below 120 degrees Fahrenheit). In some other
embodiments, thigh cuff 112 may comprise a formable metal. In this
way, thigh cuff 112 may be thermoformable, adjustable, and/or
reformable such that a clinician and/or the patient may mold the
brace directly to the patient for an improved fit, comfort, and
joint stabilization in a desired orientation. Thigh cuff 112 may
have the additional benefit of providing some measure of local
tissue compression as well as promoting desired patellar and/or
general knee joint alignment, either of which may provide reduced
inflammation and/or pain in the knee joint. In addition, in some
embodiments, thigh cuff 112 may also be light weight, easy to
clean, and/or waterproof.
[0039] Customizable knee brace 100 may further comprise a shin cuff
114 coupled to second semi-rigid support 104. In some embodiments,
shin cuff 114 is constructed of heat-formable material allowing it
to be adjusted, bent and/or shaped to conform to at least the
anterior portion of the patient's thigh by applying modest heat
(e.g., in a temperature range at least partially overlapping
160-180 degrees Fahrenheit) and, thereby, improve the fit to the
patient. In some embodiments, this heat-formable material may be
substantially rigid at temperatures it would be expected to endure
while being worn by the patient (e.g., temperature ranges below 120
degrees Fahrenheit). In some other embodiments, shin cuff 114 may
comprise a formable metal. In this way, shin cuff 114 may be
thermoformable, adjustable, and/or reformable such that a clinician
and/or the patient may mold the brace directly to the patient for
an improved fit, comfort, and joint stabilization in a desired
orientation. Shin cuff 114 may have the additional benefit of
providing some measure of local tissue compression as well as
promoting desired patellar and/or general knee joint alignment,
either of which may provide reduced inflammation and/or pain in the
knee joint. In addition, in some embodiments, shin cuff 114 may
also be light weight, easy to clean, and/or waterproof.
[0040] Customizable knee brace 100 may further comprise a medial
element 120, which comprises a first support 122, a second support
124, and a hinge 126 physically coupling first support 122 and
second support 124. In some embodiments, first support 122 may be
coupled to thigh cuff 112 and second support 124 may be coupled to
shin cuff 114. In this way, medial element 120 may provide support
for both the brace and the patient's knee on the side of the knee
opposite lateral upright 110. In some embodiments, first support
122 and second support 124 may be constructed of a material such as
plastic, metal or any other suitable material, currently known or
unknown, that may provide suitable strength to adequately support
the patient's knee as well as customizable knee brace 100
itself.
[0041] For treatment of medial compartment OA, medial element 120
may be disposed along the medial side of the patient's affected leg
such that hinge 126 substantially aligns with the medial side of
the knee joint and the axis along which the knee bends, first
support 122 is disposed along the medial, lower portion of the
patients upper leg (e.g., the thigh), and second support 124 is
disposed along the medial, upper portion of the patients lower leg
(e.g., the shin and/or calf).
[0042] For treatment of lateral compartment OA, medial element 120
may be disposed along the lateral side of the patient's affected
leg such that hinge 126 substantially aligns with the lateral side
of the knee joint and the axis along which the knee bends, first
support 122 is disposed along the lateral, lower portion of the
patients upper leg (e.g., the thigh), and second support 124 is
disposed along the lateral, upper portion of the patients lower leg
(e.g., the shin and/or calf).
[0043] Customizable knee brace 100 may further comprise an
elastomeric web framework 130 coupled to at least one of lateral
upright 110, thigh cuff 112, shin cuff 114 and medial element 120.
Elastomeric web framework 130 may comprise a plurality of
interconnected elastomeric segments 132 that define a plurality of
permanent openings, at least one of which includes an alignment
opening 134 configured to receive a patellar portion of the knee of
the patient when customizable knee brace 100 is properly worn. In
some embodiments, at least segments of the plurality of
interconnected elastomeric segments 132 that define alignment
opening 134 may have a substantially similar thickness and
cross-section to one another and, preferably, have a non-planar
cross section (e.g., the cross-sections of those segments comprise
at least one edge that is not prescribed by a straight line).
Elastomeric web framework 130 is elastically stretchable and
provides a light-weight, comfortable, secure fitting that supports
correct knee alignment utilizing three points of leverage during
gait. In some embodiments, elastomeric web framework 130 may
comprise silicone, however, the present application is not so
limited, and elastomeric web framework 130 may comprise any
suitably stretchable and flexible material. Moreover, the web-like
framework provides a breathable, stable, yet flexible brace that
may not otherwise be possible even utilizing similar materials but
not the web-like structure. In some embodiments, at least portions
of a surface of elastomeric framework 130 may comprise texturing
elements to promote increased gripping and reduced slippage when
customizable knee brace 100 is worn.
[0044] When properly worn, elastomeric web framework 130 may be
tensioned utilizing at least one tensioning element 140, as will be
described in more detail below, and extends in both a first, axial
direction 136 and a second, circumferential direction 138 such that
it abuts at least the lower thigh, knee, and upper shin as is
disclosed in U.S. Patent Pub. No. U.S. 2006/0030804, the contents
of which are incorporated by reference in their entirety. Such
tensioning allows customizable knee brace 100 as a whole, and
elastomeric web framework 130 in particular, to conform to the
patient's knee, thereby absorbing physical shock and returning
kinetic energy while ambulating in addition to providing increased
stability and integrity of customizable knee brace 100 by virtue of
the connection with at least one of lateral upright 110, thigh cuff
112, shin cuff 114, and medial element 120. Moreover, elastomeric
web framework 130 is configured to disperse energy across the knee
and can additionally address patellofemoral pain associated with OA
at least by securing and tracking an area of a knee of a patient
(e.g., the patella), while both customizing a fit of the brace
around the knee of the patient and redistributing at least a
portion of a load from a desired compartment of the knee of the
patient (e.g., one or more of the medial, lateral, and
patellofemoral compartments) when wearing the customizable knee
brace. In some embodiments, tensioning elastomeric web framework
130 may increase offloading of a portion of a load on a desired
compartment of the knee (e.g., the medial or lateral compartment)
while also increasing an amount of vertical tension in elastomeric
web framework 130.
[0045] At least one tensioning element 140 is configured to adjust
a tension of elastomeric web framework 130. In some
implementations, tensioning element(s) 140 may be disposed on
lateral upright 110 (e.g., on one or both of first semi-rigid
support 102 and second semi-rigid support 104). However, the
present application is not so limited and tensioning element(s) 140
may be disposed at any suitable location on customizable knee brace
100. FIG. 1 illustrates a reel-and-lace tensioning element, which
comprises a lace 142 coupled to elastomeric web framework 130 and
at least one reel element 144 configure to adjust a tension in lace
142, thereby adjusting the tension in elastomeric web framework
130. Tensioning element(s) 140 are described in more detail in
connection with at least FIGS. 2 and 3. Tensioning element(s) 140
are configured to provide for micro-adjustment of the tension
applied to elastomeric web framework 130, which not only allows
adjustment of the offloading of a portion of a load from a desired
compartment of the knee of the patient, but also simultaneously
improves the fit of elastomeric web framework 130 against the
surface of the patient's knee and preventing gapping and reducing
pooching of the web. In this way, tensioning element(s) 140
maintains desired tension across substantially the entirety of
elastomeric web framework 130, from thigh cuff 112 to shin cuff 114
and from lateral upright 110 to medial element 120.
[0046] Although FIG. 1 illustrates a reel-and-lace tensioning
element, the present application is not so limited, and tensioning
element(s) 140 may also, or alternatively, comprise any of a
lever-based tensioning element, a screw-based tensioning element, a
lace-and-cleat tensioning element, similar to those utilized on
sail boats, buckles, a rigid post-and-strap tensioning element with
belt-type holes, a hook-and-loop (e.g., Velcro.RTM.) tensioning
element, a notched band-and-pawl tensioning element, similar to
those utilized on ski boots, or any other apparatus configured to
adjust a tension in another element.
[0047] Customizable knee brace 100 may additionally comprise at
least one strap 150 configured to wrap around at least a posterior
portion of the patient's knee thereby securing the brace to the
patient. In some embodiments, strap(s) 150 may be physically
coupled to medial element 120 and may be configured to couple to
respective fastening element(s) 152, which are configured to
receive strap(s) 150 and are coupled to lateral upright 110 (as
shown in FIG. 1). In some other embodiments, strap(s) 150 may be
physically coupled to lateral upright 110 and may be configured to
couple to respective fastening element(s) 152 coupled to medial
element 120 (opposite of that shown in FIG. 1). Strap(s) 150 may be
sized appropriately for the requirements of the patient and of the
customizable knee brace 100. In some embodiments, strap(s) 150 may
be further trimmed by a clinician and/or the patient in accordance
with the requirements of the patient and of the customizable knee
brace 100. Further, in some embodiments, strap(s) 150 may be
removable for hygienic cleansing or for any other desired
purpose.
[0048] Customizable knee brace 100 may additionally comprise a
thigh pad 154 configured to provide cushioning to the patient's
thigh. In some embodiments, thigh pad 154 may be formable,
preferably heat-formable, may comprise foam, fabric, rubber, or any
other cushioning material, and may promote improved comfort and fit
of customizable knee brace 100. In some embodiments, thigh pad 154
may be physically coupled to and removable from at least thigh cuff
112 and, in some embodiments, may also be coupled to and removable
from either or both of lateral upright 110 and medial element
120.
[0049] Customizable knee brace 100 may additionally comprise a calf
pad 158 configured to provide cushioning to the patient's calf. In
some embodiments, calf pad 158 may be formable, preferably
heat-formable, may comprise foam, fabric, rubber, or any other
cushioning material, and may promote improved comfort and fit of
customizable knee brace 100. In some embodiments, calf pad 158 may
be physically coupled to and removable from at least shin cuff 114
and, in some embodiments, may also be coupled to and removable from
either or both of lateral upright 110 and medial element 120.
Although shown as separate, in some embodiments, thigh pad 154 and
calf pad 158 may comprise a unitary member configured to provide
cushioning to both the patient's posterior thigh and calf.
[0050] In some embodiments, customizable knee brace 100 may further
comprise a removable wearable sleeve (not shown in FIG. 1)
configured to be worn over the knee joint and under the remainder
of customizable knee brace 100. In some embodiments, the wearable
sleeve may comprise a lightweight, stretchy and breathable material
that provides some degree of compression to the patient's knee
joint.
[0051] Through the combined operation of any combination of lateral
upright 110, medial element 120, thigh cuff 112, shin cuff 114,
elastomeric web framework 130, tensioning element(s) 140, strap(s)
150, thigh pad 154, and/or shin pad 158, medial-lateral and
rotation control, with or without Varus/Valgus adjustment, may be
customized to fit a specific patient.
[0052] FIG. 2 illustrates a plan view of an embodiment of an upper
portion of customizable knee brace 100 of FIG. 1, utilizing a
reel-and-lace tensioning element, in accordance with some
embodiments. FIG. 2 illustrates lateral upright 110, comprising
first semi-rigid support 102, second semi-rigid support 104 and
hinge 106, thigh cuff 112, shin cuff 114, medial element 120,
comprising first support 122, second support 124 and hinge 126,
elastomeric web framework 130, comprising the plurality of
interconnected elastomeric segments 132 defining alignment opening
134, and tensioning element 140, comprising lace 142 (not shown in
FIG. 2) and reel element 144, as previously described in connection
with FIG. 1. FIG. 2 illustrates an embodiment where elastomeric web
framework 130 at least partially overlaps thigh cuff 112. In
addition, FIG. 2 illustrates tensioning element 140 as a
reel-and-lace tensioning element, comprising lace 142 coupled to
elastomeric web framework 130 and reel element 144 configured to
adjust a tension in lace 142, thereby adjusting the tension in
elastomeric web framework 130. As shown in FIG. 2, lace 142 may be
anchored at one or both ends to elastomeric web framework 130.
However, lace 142 may also be anchored at one or both ends to
lateral upright 110, for example, to first semi-rigid upright 102.
Lace 142 may be threaded between elastomeric web framework 130 and
lateral upright 110 one or more times, passing through guides 206
coupled to one or both of elastomeric web framework 130 and lateral
upright 110, which allow lace 142 to slide freely along guides 206
as lace 142 is tensioned. In operation, rotating reel element 144
causes lace 142 to move such that elastomeric web framework 130
moves toward or away from lateral upright 110, and adjusting the
tension in elastomeric web framework 130. In some embodiments,
reel-and-lace tensioning element 140 may comprise an integrated
dial or reel system such as the Boa closure systems developed by
Boa Technologies, Inc.
[0053] Although FIG. 2 illustrates lace 142 anchored at one or both
ends to elastomeric web framework 130, the present application is
not so limited and lace 142 may be anchored at one or both ends of
one or more of lateral upright 110, thigh cuff 112, shin cuff 114
(not shown in FIG. 2), medial element 120 and elastomeric web
framework 130. In such embodiments, lace 142 may be threaded
between elastomeric web framework 130 and at least one of lateral
upright 110, thigh cuff 112, shin cuff 114 (not shown in FIG. 2)
and/or medial element 120 one or more times, passing through guides
206 coupled to one or more of elastomeric web framework 130,
lateral upright 110, thigh cuff 112, shin cuff 114, and/or medial
element 120 (not shown in FIG. 2), which allow lace 142 to slide
freely along guides 206 as lace 142 is tensioned.
[0054] FIG. 3 illustrates a plan view of another embodiment of an
upper portion of customizable knee brace 100 of FIG. 1, utilizing a
reel-and-lace tensioning element, in accordance with some
embodiments. FIG. 3 illustrates each aspect previously described in
connection with FIG. 2, however, illustrating elastomeric web
framework 130 as being disposed adjacent to, but not overlapping,
thigh cuff 112.
[0055] FIG. 4 illustrates a perspective, magnified view of lateral
upright 110 of customizable knee brace 100 of FIG. 1, in accordance
with some embodiments. FIG. 4 illustrates first semi-rigid support
102, second semi-rigid support 104, hinge 106, tensioning elements
140 and fastening elements 152, as previously described in
connection with FIG. 1. Compared to FIG. 1, FIG. 4 shows a larger
view with more detail for each of these elements.
[0056] FIG. 5 illustrates an exploded perspective view of lateral
upright 110 of FIGS. 1 and 4, in accordance with some embodiments.
Although several additional elements of lateral upright 110 are
described in connection with FIG. 5, all, a subset of all, or none,
of these additional elements may be required for proper operation
depending on the specific embodiment.
[0057] FIG. 5 illustrates a logo plate 502, a hinge bezel 504, an
unthreaded hinge plate 506, and a first low friction washer 508
disposed on an outside (e.g., lateral side) of first semi-rigid
support 102 and second semi-rigid support 104 of lateral upright
110. FIG. 5 further illustrates a second low friction washer 510, a
threaded hinge plate 512, plastic threaded hinge plate 514, and a
condyle plate 516 on an inside (e.g., medial side) of first
semi-rigid support 102 and second semi-rigid support 104 of lateral
upright 110. Each of hinge bezel 504, unthreaded hinge plate 506,
first low friction washer 508, first semi-rigid support 102, second
semi-rigid support 104, second low friction washer 510, threaded
hinge plate 512, plastic threaded hinge plate 514, and condyle
plate 516 may comprise holes to receive screws 518, which are
configured to secure the elements of lateral upright 110 together
into a functional, integrated unit. FIG. 5 further illustrates
removable condyle pads 108a, 108b, 108c, as previously described in
connection with FIG. 1.
[0058] FIG. 6 illustrates an exploded perspective view of removable
condyle pads 108a, 108b, 108c for coupling to lateral upright 100
of FIGS. 1, 4 and 5, in accordance with some embodiments. FIG. 6
illustrates first semi-rigid support 102, second semi-rigid support
104, hinge 106, and removable condyle pads 108a, 108b, 108c, as
previously described in connection with FIG. 1. In some
embodiments, each of removable condyle pads 108a, 108b, 108c may
have a different thickness. Accordingly, a clinician and/or patient
may select one of removable condyle pads 108a, 108b, 108c for
coupling to hinge 106 in order to provide a desired spacing between
hinge 106 and the knee of the patient. In some other embodiments, a
combination of removable condyle pads 108a, 108b, 108c may be
utilized simultaneously in order to provide a greater selection and
greater range of spacings between hinge 106 and the knee of the
patient as compared to selecting only one of removable condyle pads
108a, 108b, 108c.
[0059] FIG. 7 illustrates a perspective view of medial element 120
of customizable knee brace 100 of FIG. 1, in accordance with some
embodiments. FIG. 7 illustrates first support 122, second support
124, and hinge 126, as previously described in connection with FIG.
1. Compared to FIG. 1, FIG. 7 merely shows a larger view with more
detail for each of these elements.
[0060] FIG. 8 illustrates a kit 800 for reducing or substantially
eliminating deformation of elements of the customizable knee brace
of FIG. 1 during physical transportation and/or storage, in
accordance with some embodiments. In some embodiments, kit 800 may
comprise each element or a subset of the elements of customizable
knee brace 100, as previously described in connection with FIG. 1.
In some embodiments, customizable knee brace 100 may be assembled
in kit 800. In some other embodiments, customizable knee brace 100
may be unassembled as its constituent elements in kit 800. In some
embodiments, kit 800 may further comprise a plurality of heating
pads 802 configured to be applied directly to thigh cuff 112 and/or
shin cuff 114 to heat them into a temperature range within which
they become formable, as previously described, such that a
clinician and/or the patient may conform thigh cuff 112 and shin
cuff 114 to the patient's thigh and calf for a customized fit. In
some embodiments, heating pads 802 may further comprise a surface
having an adhesive thereon such that heating pads 802 may be
adhered for heating the respective element of customizable knee
brace 100. In some embodiments, kit 800 may further comprise
packaging 804 configured to reduce or substantially eliminate
alteration of a shape of any portion of customizable knee brace 100
during transit or storage within kit 800. In some embodiments,
packaging 804 may comprise a plurality of foam inserts defining
spaces within which at least respective portions of customizable
knee brace 100 (e.g., thigh cuff 112 and shin cuff 114) may be
inserted such that the general shape of customizable knee brace 100
is maintained during transport and/or storage.
[0061] FIG. 9 illustrates a flowchart 900 for a method of treatment
of osteoarthritis utilizing a customizable knee brace as described
in any of the preceding FIGs., in accordance with some embodiments.
Although particular steps are described herein, the present
application is not so limited and alternative methods of treatment
of OA utilizing a customizable knee brace may include a subset of
these steps, in the same or different order, and may additionally
include one or more addition steps not described herein.
[0062] Flowchart 900 may include step 902, which includes forming a
thigh cuff of the customizable knee brace to conform to a thigh of
a patient. For example, as previously described in connection with
at least FIG. 1, thigh cuff 112 may be heat-formed to conform to
the patient's thigh in a temperature range that at least partially
overlaps 160-180 degrees Fahrenheit, or comprise a formable
metal.
[0063] Flowchart 900 may include step 904, which includes forming a
shin cuff of the customizable knee brace to conform to a shin of
the patient. For example, as previously described in connection
with at least FIG. 1, shin cuff 114 may be heat-formed to conform
to the patient's shin in a temperature range that at least
partially overlaps 160-180 degrees Fahrenheit, or comprise a
formable metal. In some embodiments, as previously described in
connection with at least FIG. 1, customizable knee brace 100 may
further comprise lateral upright 110, which comprises at least
first semi-rigid support 102 configured to be coupled to thigh cuff
112, second semi-rigid support 104 configured to be coupled to shin
cuff 114, and hinge 106 physically coupling first semi-rigid
support 102 and second semi-rigid support 104.
[0064] Flowchart 900 may include step 906, which includes securing
an area of a knee of a patient utilizing an elastomeric web
framework coupled to the lateral upright. For example, as
previously described in connection with at least FIG. 1, the
patella of the patient may be secured utilizing alignment opening
134 of elastomeric web framework 130, which may be coupled to
lateral upright 110.
[0065] Flowchart 900 may include step 908, which includes adjusting
a tension of the elastomeric web framework utilizing at least one
tensioning element. For example, as previously described in
connection with at least FIGS. 1-3, tension in elastomeric web
framework 130 may be adjusted utilizing tensioning element(s) 140.
Adjusting the tension of elastomeric web framework 130
redistributes at least a portion of a load from a medial
compartment (or from a lateral compartment) of the patient's knee.
In some embodiments, adjusting the tension of elastomeric web
framework 130 comprises increasing an amount of vertical tension of
elastomeric web framework 130 while simultaneously increasing an
offloading of a portion of a load on a desired compartment of the
knee (e.g., the medial or lateral compartments).
[0066] As previously described in connection with at least FIGS. 1
and 2, tensioning element(s) may comprise at least one reel element
144 and lace 142 that physically couples elastomeric web framework
130 to lateral upright 110. In such embodiments, adjusting the
tension of elastomeric web framework 130 may comprise adjusting the
at least one reel element 144 to adjust a tension in lace 142.
[0067] In some embodiments, flowchart 900 may further include
bending at least one of the first semi-rigid support and the second
semi-rigid support to a desired angle based at least in part on an
alignment of the knee so as to redistribute a portion of a load
from a medial compartment of the knee of the patient. For example,
as previously described in connection with at least FIG. 1, one or
both of first semi-rigid support 102 and second semi-rigid support
104 may be adjusted or bent to a desired angle based at least in
part on an alignment of the patient's knee so as to redistribute a
portion of a load from a medial compartment (or from a lateral
compartment) of the patient's knee.
[0068] In some embodiments, flowchart 900 may further include
disposing at least one removable condyle pad between the hinge and
the knee of the patient, thereby providing a desired spacing
between the hinge and the knee of the patient. For example, as
previously described in connection with at least FIGS. 1 and 4-6,
removable condyle pads 108a, 108b, 108c may each have different
thicknesses and may be coupled between hinge 106 and the patient's
knee, thereby providing a desired spacing between hinge 106 and the
patient's knee.
[0069] In some embodiments, flowchart 900 may further include
wrapping at least one strap, coupled to the lateral upright, around
at least a posterior portion of the knee of the patient thereby
securing the brace to the patient. For example, as previously
described in connection with at least FIG. 1, strap(s) 150, which
may be coupled to lateral upright 110 and/or medial element 120,
may be wrapped around at least a posterior portion of the patient's
knee, thereby securing customizable knee brace 100 to the
patient.
[0070] In some embodiments, flowchart 900 may further include
disposing a formable pad at the knee of the patient. For example,
as previously described in connection with at least FIG. 1, one or
both of thigh pad 154 and shin pad 158 may be disposed at, over, or
on the patient's thigh and/or shin.
[0071] While certain embodiments are described herein in detail, it
is to be understood that this disclosure is illustrative and
exemplary, and is made merely for the purposes of providing a full
and enabling disclosure. The detailed disclosure herein of one or
more embodiments is not intended, nor is to be construed, to limit
the scope of patent protection, for which scope is to be defined by
the claims and the equivalents thereof. It is not intended that the
scope of patent protection be defined by reading into any claim a
limitation found herein that does not explicitly appear in the
claim itself.
* * * * *