U.S. patent application number 15/916212 was filed with the patent office on 2018-12-13 for welded back brace.
The applicant listed for this patent is Ortho Systems d/b/a Ovation Medical, Ortho Systems d/b/a Ovation Medical. Invention is credited to Edwin ERWIN, Tracy E. GRIM, Kenji WATABE.
Application Number | 20180353315 15/916212 |
Document ID | / |
Family ID | 64562421 |
Filed Date | 2018-12-13 |
United States Patent
Application |
20180353315 |
Kind Code |
A1 |
GRIM; Tracy E. ; et
al. |
December 13, 2018 |
WELDED BACK BRACE
Abstract
A welded orthopedic back brace is disclosed. In an embodiment,
at least one belt member is coupled to a spinal support element.
The materials of the belt member are thermally fused to form a
unitary segment. In another embodiment, an anterior portion of a
posterior pad of the spinal support element includes thermally
fused materials to provide a user with an added degree of
comfort.
Inventors: |
GRIM; Tracy E.; (Thousand
Oaks, CA) ; WATABE; Kenji; (Ventura, CA) ;
ERWIN; Edwin; (Studio City, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ortho Systems d/b/a Ovation Medical |
Agoura Hills |
CA |
US |
|
|
Family ID: |
64562421 |
Appl. No.: |
15/916212 |
Filed: |
March 8, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15616860 |
Jun 7, 2017 |
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15916212 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/028 20130101 |
International
Class: |
A61F 5/02 20060101
A61F005/02 |
Claims
1-30. (canceled)
31. An orthopedic back brace, comprising: a spinal support element;
and a waist belt for positioning the spinal support element, the
waist belt comprising a layer of a thermoplastic polyurethane
having a first elasticity and a pre-welded thickness, and a second
material having a second elasticity and a pre-welded thickness, the
thermoplastic polyurethane and second layer thermally fused such
that a thickness of the thermally fused layers is less that a sum
of the pre-welded thicknesses.
32. The orthopedic back brace of claim 31, further comprising a
hybrid layer formed in the fusion process between the thermoplastic
polyurethane and the second material, the hybrid layer having
characteristics of both the thermoplastic polyurethane and the
second material.
33. The orthopedic back brace of claim 32, wherein voids in the
thermoplastic polyurethane are used to create directional control
of an elasticity of the belt.
34. The orthopedic back brace of claim 31, further comprising an
adhesive layer applied between the thermoplastic polyurethane and
the second material prior to the thermal fusion thereof.
35. The orthopedic back brace of claim 31, wherein the second
material is a spacer mesh material.
36. The orthopedic back brace of claim 31, further comprising a
thermally fused belt connection member.
37. The orthopedic back brace of claim 31, wherein the belt is
contoured in a direction normal to the plane of the belt during the
thermal fusion process.
38. An orthopedic back brace, comprising: a spinal support element;
and a waist belt for positioning the spinal support element, the
waist belt comprising a layer of a thermoplastic polyurethane
having a first elasticity and a pre-welded thickness, and a second
material having a second elasticity and a pre-welded thickness, the
thermoplastic polyurethane and second layer thermally fused to form
a hybrid layer between the thermoplastic polyurethane and the
second material, the hybrid layer having characteristics of both
the thermoplastic polyurethane and the second material.
39. The orthopedic back brace of claim 38, wherein voids in the
thermoplastic polyurethane are used to create directional control
of an elasticity of the belt.
40. The orthopedic back brace of claim 38, further comprising an
adhesive layer applied between the thermoplastic polyurethane and
the second material prior to the thermal fusion thereof.
41. The orthopedic back brace of claim 38, wherein the second
material is a spacer mesh material.
42. The orthopedic back brace of claim 38, further comprising a
thermally fused belt connection member.
43. The orthopedic back brace of claim 38, wherein the belt is
contoured in a direction normal to the plane of the belt during the
thermal fusion process.
44. The orthopedic back brace of claim 38, wherein the
thermoplastic polyurethane is has a smaller surface area than the
second material such that the thermoplastic polyurethane and the
second material are both visible after the thermal fusion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of, and claims priority
to, U.S. Non-Provisional patent application Ser. No. 15/616,860,
filed Jun. 7, 2017, entitled "WELDED BACK BRACE," now pending,
which is incorporated herein by reference in its entirety.
BACKGROUND
Field
[0002] The present disclosure relate generally to anatomical
supports, and more particularly, to a compact orthopedic back brace
having materials welded using thermal fusion.
Background
[0003] A number of orthopedic back braces are commercially
available for individuals suffering from various categories of back
pain. Such back braces are configured to serve a number of purposes
depending on the application to the individual. Generally,
orthopedic back braces can assist in providing proper alignment of
the spine. Incorrect spinal alignment can cause chronic pain,
weakness and other progressive conditions. Orthopedic back braces
typically include a posterior spinal element for placement against
a user's back, and a belt assembly having one or more belt straps
for securing the posterior spinal element to the user's back. The
belt assembly may assist in enabling the posterior spinal element
to press against the relevant area of the user's spine to thereby
straighten the spine and relieve discomfort.
[0004] Conventional back braces have deficiencies. For example,
many or most such orthopedic back braces typically have elements
that are sewn together or otherwise held together using stitches or
similar means. Such elements include, among others, the belt
straps, which often have several layers that are stitched together
at one or more borders in order to provide a specific amount of
rigidity and elasticity to enable the belt to perform its functions
properly. The spinal element typically also involves a collection
of materials stitched or sewn together.
[0005] Because of the stitching, the internal layers of the belt
(or spinal element) typically are independent of, and can often
move relative to, one another. As a result, the separating belt
elements can make the belt assembly more voluminous than necessary
and undesirable for a wearer. For example, the independently acting
layers of the belt member can spread in some areas and bunch up in
other areas due to shear forces. The result is a generally unwieldy
and bulky fit. Moreover, because each such layer can effective act
independently as described above, the desired properties of the
belt (e.g., rigidity, stiffness, elasticity) for achieving a given
orthopedic or medical objective often cannot be well
controlled.
[0006] Another problem with such conventional back braces is that
the physical properties and characteristics of the belt typically
lack spatial continuity. That is, because layers of different
materials often simply overlap without otherwise being connected
except at predefined seams, the properties of the materials (such
as the rigidity, flexibility, etc.) can change rapidly at seam
borders. More specifically, in areas on the belt adjacent sewn
borders, such belts typically have abrupt discontinuities in its
various properties because different materials (or identical
materials with different thicknesses) are directly sewn together at
the predefined borders. Thus, the belt may provide a region of one
or more generally elastic materials that are connected, at a sewn
border, to a rigid, inelastic material. The user can usually feel
these abrupt discontinuities and the attendant discomfort that can
result, particularly when the belt is worn for a long time.
[0007] Other conventional solutions for the belt assembly have
included combining a plurality of layers using lamination or an
adhesive, such as spray glue. However, such lamination techniques
typically involve only a partial application of adhesive over some
predefined patterned area of spots or other shapes on selected
portions of the belt layers, with the remaining areas of the belt
layers not bonded with adjacent layers and therefore free to move
relative to these adjacent layers. As a result, the layers remain
substantially independent and subject to manipulation by shear
forces. Further, the physical properties of the laminated belt
cannot be modified over different areas of the belt. Additionally,
because the layers are not integrated together and are free to
move, they add unnecessary volume and bulk to the belt assembly.
Glued belt assemblies are also typically not water resistant due to
the partial water solubility of the adhesive. Thus such belt
assemblies often also employ stitching techniques to attempt
maintain their integrity upon failure of the lamination. The added
stitching requirement makes the assembly process time-consuming and
may result in one or more of the further disadvantages described
above.
[0008] These and other shortcomings are addressed in the present
disclosure.
SUMMARY
[0009] In an aspect of the disclosure, an orthopedic back brace
includes a spinal support element and at least one belt member
coupled to the spinal support element for securing the spinal
support element to a user, wherein the at least one belt member
comprises a plurality of materials thermally fused together to form
a unitary segment.
[0010] In another aspect of the disclosure, an orthopedic back
brace includes a spinal support element including an anterior
portion of a posterior pad configured for placement against a
spinal area of a user, and at least one belt member, coupled to the
spinal support element, for extending around a user's torso to
assist in securing the spinal support element in place, wherein the
at least one belt member comprises a plurality of thermally fused
materials configured to form a unitary segment.
[0011] In another aspect of the disclosure, an orthopedic back
brace includes a spinal support element, and two belt members
coupled to the spinal support element and configured to secure the
spinal support element onto a user, wherein at least portions of
the two belt members include materials thermally fused together to
integrate the materials into a single segment.
[0012] In another aspect of the disclosure, an orthopedic back
brace includes a spinal support element comprising an anterior
portion of a posterior pad configured for placement against a
spinal area of a user, and at least one belt member coupled to the
spinal support element and configured to secure the spinal support
element onto a user, wherein the anterior portion comprises a
plurality of materials thermally fused together to form a unitary
segment.
[0013] In another aspect of the disclosure, the orthopedic back
brace as described above includes a posterior portion of the
posterior pad, wherein the posterior portion includes at least two
materials thermally fused together.
[0014] It is understood that other aspects will become readily
apparent to those skilled in the art from the following detailed
description, wherein it is shown and described only exemplary
configurations of a flexible support by way of illustration. As
will be realized, the present disclosure includes other and
different aspects of a flexible support and its several details are
capable of modification in various other respects, all without
departing from the spirit and scope of the present disclosure.
Accordingly, the drawings and the detailed description are to be
regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Various aspects of the present invention are illustrated by
way of example, and not by way of limitation, in the accompanying
drawings, wherein:
[0016] FIG. 1 is a front posterior view illustrating an example of
an orthopedic back brace according to the present disclosure.
[0017] FIG. 2 is a front anterior view illustrating an example of
an orthopedic back brace of the present disclosure.
[0018] FIG. 3 shows a front posterior view of the orthopedic back
brace of FIG. 1 with the posterior cover, posterior frame and
posterior cover material removed.
[0019] FIG. 4 shows a close-up front view of the pulley system.
[0020] FIG. 5 shows an anterior view of the orthopedic back brace
with the posterior pad removed.
[0021] FIG. 6 shows a perspective posterior view of the orthopedic
back brace according to the present disclosure.
[0022] FIG. 7 shows a perspective staggered view of exemplary
elements of a spinal support element and their relative order and
orientations.
[0023] FIG. 8 shows an anterior view of the posterior pad of spinal
support element of the orthopedic back brace of the present
disclosure.
[0024] FIG. 9A shows a posterior perspective view of the orthopedic
back brace having a belt member with an arrow indicating that the
belt member is to be engaged with a D-ring.
[0025] FIG. 9B shows a posterior perspective view of the same
orthopedic back brace as FIG. 9A in an alternate orientation.
[0026] FIG. 9C shows an anterior perspective view of the same
orthopedic back brace as FIG. 9A-B in another alternate
orientation.
[0027] FIG. 10 shows a posterior perspective view of the back brace
in the process of being threaded through the D-ring and being
affixed via a hook and loop connection to an anterior portion of
the belt.
[0028] FIG. 11 shows a posterior perspective view of a foam pad
used in the spinal support element in some embodiments.
[0029] FIG. 12 shows a posterior front view of the posterior frame
having a structure configured to minimize patient discomfort in
accordance with an aspect of the disclosure.
[0030] FIG. 13 shows an anterior perspective view of the posterior
frame having the structure configured to minimize patient
discomfort.
[0031] FIG. 14A discloses a front posterior view of the belt member
of the orthopedic back brace.
[0032] FIG. 14B discloses a front anterior view of the belt member
of the orthopedic back brace
[0033] FIG. 15 shows a staggered perspective view of a belt member
having its components disassembled into their constituent
parts.
[0034] FIG. 16A is a front posterior view of a belt member.
[0035] FIG. 16B shows a cross-sectional view of the belt member of
FIG. 16A along plane A-A.
[0036] FIG. 16C shows a cross-sectional view of the belt member of
FIG. 16A along plane B-B.
[0037] FIG. 16D shows a perspective view of the belt member of FIG.
16A.
[0038] FIG. 17A shows an inverted side view of the belt member of
FIG. 16A.
[0039] FIG. 17B shows a side view of the belt member of FIG.
16A.
[0040] FIG. 18A shows a vertical side view of the belt end segment
of the belt member of FIG.
[0041] 16A.
[0042] FIG. 18B shows a vertical side view of the belt member of
FIG. 16A as viewed from a proximal end section of the belt to the
distal belt an segment.
[0043] FIG. 19A shows a perspective view of a belt assembly
disposed between two tooling molds for use in thermally fusing the
belt assembly.
[0044] FIG. 19B shows an inverted perspective view of the belt
assembly and tooling molds of FIG. 19A
DETAILED DESCRIPTION
[0045] Various aspects of an orthopedic back brace will now be
presented. However, as those skilled in the art will readily
appreciate, these aspects may be extended to other anatomical
supports without departing from the spirit and scope of the present
disclosure. The detailed description set forth below in connection
with the appended drawings is intended to provide a description of
various exemplary embodiments of techniques for an orthopedic back
brace and is not intended to represent the only embodiments in
which the invention may be practiced. The term "exemplary" used
throughout this disclosure means "serving as an example, instance,
or illustration," and should not necessarily be construed as
preferred or advantageous over other embodiments presented in this
disclosure. The detailed description includes specific details for
the purpose of providing a thorough and complete disclosure that
fully conveys the scope of the invention to those skilled in the
art. However, the invention may be practiced without these specific
details. In some instances, well-known structures and components
may be shown in block diagram form, or omitted entirely, in order
to avoid obscuring the various concepts presented throughout this
disclosure. The various aspects of the present disclosure
illustrated in the drawings may not be drawn to scale. Rather, the
dimensions of the various features may be expanded or reduced for
clarity. In addition, some of the drawings may be simplified for
clarity. Thus, the drawings may not depict all of the components of
a given apparatus or method.
[0046] In accordance with various aspects of the present
disclosure, a welded orthopedic back brace is provided. In one
aspect, the back brace includes one or more belt members having
materials thermally fused together to integrate the materials to
form the one or more belt members. The use of thermal fusion to
create the belt members provides for a number of advantages over
conventional techniques. As an example, the welded nature of the
belt members integrates the belt materials together in a manner
such that the corresponding belt member form a single, unitary
segment. This is in contrast to conventional techniques, most of
which use sewing or stitching of a number of essentially
independent layers to form the belt members.
[0047] In these conventional techniques, as discussed briefly
above, often two or more materials are placed on or adjacent each
other and are sewn longitudinally along the belt borders or in
other locations on the belt member. As a result of this
configuration, conventional belt members tend to cause a user
unnecessary discomfort, particularly when worn for long periods of
time. This is in part because the materials are only attached
together at specific stitching points and as such, the materials
tend to separate in areas away from those specific stitching
points. To this end, the various materials of the belt tend to act
individually and/or independently of each other, as described
above. That is, when the back brace is donned by a user and the
belt is fit snugly around the user's waist, the materials often
bunch up in undesirable areas and otherwise move in unpredictable
ways.
[0048] Among other problems, these phenomena generally cause
discomfort to the user by adding various pressure points where the
material is thickest or in areas where the material has congregated
when the belt is worn. The discomfort can be exacerbated in belts
that are stitched at or near sensitive parts of a user's anatomy.
For example, the stitched borders may in some cases exert
substantially more pressure on a user's waist than in areas where
less or no stitching is present. In apparent recognition of these
deficiencies, practitioners have made various efforts to address
them by adding additional layers or thickness to the belt in an
effort to reduce discomfort.
[0049] However, the addition of extra layers as an attempted
solution tends to ultimately make the stitched belt members
unnecessarily voluminous. Each layer of material that constitutes a
portion of the belt member is generally an individual piece of
material and as such, contributes to the overall volume of the
belt. The volume of the belt is something which can exacerbate
problems with users who are self-conscious about wearing such
devices in public. In many cases, the volume of these conventional
belts is so large that it is not practicable for a user to wear
attire over the belt. Rather, the belt must be worn externally,
which can contribute to the negative perceptions sometimes
associated by users with such orthopedic devices.
[0050] Still other conventional solutions involve the use of a
laminate or adhesive such as spray glue over partial regions of the
belt layers which, as described above, tends to add unnecessary
cumulative volume to the belt and renders it difficult if not
impossible to control critical properties of the belt across
specific areas. Further, as indicated above, laminated belt
assemblies include substantially independent belt layers that
remain subject to shear forces and glue failures. These
conventional solutions also tend to produce abrupt discontinuities
in areas where the layers change (e.g., where a layer is removed or
thinned), more often than not resulting in noticeable user
discomfort.
[0051] In addition, the belt members serve very important functions
in the overall device--for example, to enable a secure but
comfortable fit of the posterior in order to straighten the spinal
column. To accomplish this function, the materials selected for use
in the belt members and their characteristics (thickness,
elasticity, solidity, rigidity, firmness, volume, etc.) generally
must be carefully selected in order to achieve a specific set of
results for the belt, depending on the user or the application. For
example, the belt members generally need to use materials that
include properties like elasticity, rigidity, stiffness, etc., in
order to both be efficacious and to provide comfort to the user. In
conventional back braces, this process is often accomplished by
selecting materials having entirely different properties and by
stitching the disparate materials together. As a result, there
often exists a significant gradient in areas of the belt member
where the materials, and hence the belt properties, change, which
in turn is an effect felt by the user. For instance, many
conventional back braces stitch an elastic material to a rigid
material. The sharp difference in elasticity on one portion of the
belt (and consequently on one portion of the user's body) and
rigidity on another immediately adjacent portion of the belt can be
fairly conspicuously felt by a user, and is an added discomfort.
Yet another problem with this approach is that, more often than
not, it is difficult to obtain a predictable set of combined
properties across specific regions of the belt materials that would
render the belt assembly an optimal solution for a specific
orthopedic application.
[0052] In contrast to these techniques, with respect to certain
embodiments to be discussed below, at least a portion of the belt
materials are welded together. That is, rather than exclusively
using stitching or another method, at least a portion of the belt
materials are thermally fused to essentially form a single, unitary
segment. Because the belt materials are thermally fused instead of
sewn, the belt members have a naturally low profile with a compact
volume that tends to be much smaller than existing solutions. As
described below with reference to FIG. 15, thermal fusion produces
an overall compression of the constituent materials. Further, using
the thermal fusion process as described herein, it is generally
easier for a developer to accurately design and achieve predictable
and continuous properties over specific areas or regions of the
belt. This is in part due to the fact that the belt behaves as a
unitary segment rather than as a collection of individual materials
with substantially different properties and different degrees of
directional freedom. As described in greater detail below, welding
the materials causes the materials to become permanently affixed
together across all welded regions, in contrast to the conventional
approaches that rely purely on stitching or lamination.
[0053] Additionally, the back brace according to the present
disclosure tends to avoid sharp gradients in property transitions
of materials. This benefit is due to the ability of thermal welding
to integrate the fused materials together. For example, when a
segment of a generally rigid material is thermally fused with a
segment of generally elastic material, the area corresponding to
the thermal fusion typically has properties that include the
properties of both of the fused materials--namely, some amount of
elasticity and some amount of rigidity. This gradual transition of
material properties, rather than sharp gradients produced by
conventional means, generally results in a much more comfortable
user experience. This, combined with more compact and lower profile
belt members, results in a back brace that is far more likely to be
worn by a user as recommended by a medical professional.
[0054] FIG. 1 is a front posterior view illustrating an example of
an orthopedic back brace 100 according to the present disclosure.
FIG. 1, more specifically, shows an outer view of the back brace
100, i.e., away from a user's waist. The back brace 100 in this
embodiment shows belt members 102 and 104 respectively coupled to a
spinal support element 114 via D-rings 126a and 126b. Although for
purposes of this embodiment two belt members are utilized, a single
belt maybe be equally suitable. Further, while the D-rings coupling
the belt members are discussed in greater detail below, it should
be understood that the belt members may generally be coupled to the
spinal support element 114 in any suitable way. In some embodiments
in which a single belt member is utilized, the belt member may be
movably or non-movably coupled to the spinal support element 114
via a slit or other connection mechanism.
[0055] Spinal support element 114 generally includes a posterior
cover 117, posterior cover window 122 and posterior cover material
120. In one exemplary embodiment, the outer part of posterior cover
117 is composed of thermoplastic polyurethane (TPU) and the
posterior cover material 120 is a mesh material. In another
exemplary embodiment, the cover material 120 is substantially
transparent and has breathable properties for enabling airflow into
spinal support element 114. Each of belt members 102 and 104
include respective belt end segments 106 and 108. In one
embodiment, belt end segments 106 and 108 are composed of unbroken
loop material (UBL). In another embodiment, only belt end segment
106 is composed of UBL and is used to engage with an opposing
segment on an anterior side of the belt, as shown with reference to
FIG. 2. In other embodiments, belt end segments 106 and 108 are
composed of another suitable material. In still other embodiments,
belt end segments 106 and 108 may have different shapes, or simply
end on one or both sides in a rectangular shape corresponding to
the remainder of the belt shape of the belt members 102 and 104.
Belt end segments 106 and 108 constitute squares, rectangles,
ellipses, or any other shape.
[0056] Belt members 102 and 104 also include an exterior layer 119a
on one side (belt member 102), and 119b on the other side (belt
member 104). In an exemplary embodiment, exterior layers 119a-b are
composed of TPU. Further, in this embodiment, exterior layers
119a-b include a series of angled oblong capsule-like shapes that
run longitudinally along belt members 102 and 104. It should be
noted that different structures composed of the same material may
have different thicknesses and other properties and may be composed
of other or different elements or combinations thereof.
[0057] Belt member 102 further includes winged members 116a on belt
member 102 and 116b on belt member 104. In an exemplary embodiment,
winged members 116a-b are also composed of UBL. Belt members 102
and 104 may also include regions 110 and 112 of material that
extend longitudinally thereacross. In an exemplary embodiment,
regions 110 and 112 are composed of UBL. In this embodiment, UBL is
provided to enable hook material disposed on pull rings 122a and
122b to attach to regions 110 and 112, respectively, so that they
can be secured and easily located as necessary by a user. However,
in other embodiments regions 110 and 112 may be composed of hook
material or another suitable material. It will be appreciated that
these details of the belt members 110 and 112 are for purposes of
illustration and that many different types, shapes and
configurations of materials may be contemplated.
[0058] Affixed to belt members 102 and 104 can further be seen pull
rings 122a and 122b. The pull rings are used to provide tension to
a pulley assembly (obscured from view) via pulley ropes 124a and
124b. In other embodiments, only a single pull ring may be more
suitable. As described further below, the pull rings 122a-b enable
a user to make micro-adjustments to the fit of the back brace.
[0059] FIG. 2 is a front anterior view illustrating an example of
the orthopedic back brace shown in FIG. 1. FIG. 2 includes an
anterior view of spinal support element 114. In this embodiment,
spinal support element 114 includes a posterior pad 202 configured
to comfortably rest flush against a designated spinal region of a
user. Thus, from the figure, an anterior portion 214 of the
posterior pad 202 is visible. While the embodiment shown in FIG. 2
includes a spinal support element 114 having a posterior pad 202 as
one component of the spinal support element 114, it will be
appreciated that spinal support element 114 need not be so limited
and may be configured in a number of ways depending on the user's
needs.
[0060] Posterior pad 202 further includes pad spacer section 204
and pad mesh element 207. In one exemplary embodiment, pad spacer
section 204 constitutes a single pad of 3-D spacer mesh material
overlaid by the pad mesh element 207. While any number of materials
can be suitably used, 3-D spacer mesh material is known for its
comfort, cushioning, strength, breathability design efficiency, and
versatility. Posterior pad 202 is further composed of mesh section
207. In an exemplary embodiment, mesh material is used in section
207 to ensure comfort and breathability. These considerations are
especially significant given that in this embodiment, section 207
may rest substantially flush against the spinal area of a user. The
user, in turn, may be experiencing pain, or may have recently had
spinal surgery in this region. The use of mesh in section 207, and
3-D spacer in section 204, assists in providing more comfort to the
user than existing solutions. In other embodiments, the entire
anterior portion 214 of posterior pad 202 may be made of a single
material, such as mesh. In one aspect of the disclosure, the mesh
section 207 and the respective pad spacer elements 204 may be
coupled together at segments 216 via a thermal fusion process as
described further below with reference to FIG. 8.
[0061] Referring still to FIG. 2, the anterior portion of belt
members 102, 104 are shown and include belt end segments 206 and
208, which correspond respectively to belt end segments 106 and 108
of FIG. 1. In one embodiment, the material of the anterior portion
221 of belt members 104 and 102 and belt end segments 206 and 208
may be composed of a 3-D spacer mesh material for providing a user
with comfort, durability and cushioning. Additionally, associated
with belt end segment 208 is a connection portion 210. In one
embodiment, connection portion 210 on belt member 104 may be
composed of hook material. Connection portion 210 thereby enables
the user to securely affix the belt around the user's waist or
torso by securely engaging the hook material of the connection
portion 210 with the UBL material on the opposing belt member 102
other side of the belt, i.e., in sections 106 and 110 (see FIG. 1).
It is noted again that while specific configurations of hook and
UBL material are recited, these details are presented for purposes
for illustration and are not intended to limit the scope of the
invention. In other embodiments, for example, another equally
suitable connection means may be employed in lieu of hook and loop
material.
[0062] Each of belt members 102 and 104 in FIG. 2 further include
winged members 220a on belt member 102 and 220b on belt member 104.
In an embodiment, the winged members 220a-b are composed of
UBL.
[0063] FIG. 3 shows a front posterior view of the orthopedic back
brace of FIG. 1 with the posterior cover 117, posterior cover
window 122 and posterior cover material 120 removed. As is more
readily apparent from this view, belt members 102 and 104 are
coupled to spinal support element 114 via a pulley system 302 and
D-rings 126a and 126b. More specifically, in this exemplary
embodiment, belt member 102 is threaded through D-ring 126a and is
coupled to an anterior side of the belt member 102 via a hook and
loop connection. Thus, for example, an anterior side of the belt
member 102 may contain areas of hook material closer to the inner
anterior edge (not shown) of belt member 102 that mate with the UBL
material on winged members 220a (see FIG. 2). Similarly, in this
embodiment, belt member 104 is threaded through D-ring 126b and is
coupled to an anterior side of the belt member 104 via a hook and
loop connection. For example, an anterior side of the belt member
104 may also contain areas of hook material closer to the inner
anterior edge of belt member 104 that mate with the UBL material on
winged members 220b. These embodiments are described further with
respect to FIGS. 9A-C, below.
[0064] Thus, more simply, belt members 102 and 104 in this
embodiment are securably coupled to spinal support element 114 via
their fold-over hook and loop connection on the anterior side of
the belt members 102 and 104. It will be appreciated that other
embodiments may be equally suitable for coupling the belt members
to the spinal support element. For example, the belt members 102
and 104 may in alternative embodiments be permanently affixed to
spinal support element 114, via D-rings 126a and 126b or otherwise.
In other embodiments, the belt members 102 and 104 may be threaded
through D-rings 126a-b such that the belt mates via a hook and loop
connection on the posterior side rather than the anterior side, as
shown. Numerous other arrangements may be equally suitable
depending on the application and objectives.
[0065] FIG. 3 further shows that D-rings 126a-b are coupled to
spinal support element 114 via a pulley system 302 (FIG. 4). Also
shown in FIG. 3 as part of spinal support element 114 is posterior
frame 304. In one embodiment, posterior frame 304 comprises a
plastic pad designed and shaped to fit the contour of the spinal
region of a user of a particular size. Posterior frame 304 may
include a specific amount of rigidity so as to adequately influence
a position, and/or maintain a proper alignment, of the spinal
column of a user. Posterior frame 304 includes a plurality of
capsule-shaped orifices 306 and 308 disposed across back pad 304
and configured to provide breathability. The use of orifices 306
and 308 may also influence the flexibility of posterior frame 304.
In general, posterior frame 304 is composed of a material having a
thickness and geometrical shape that is suitable for providing the
requisite spinal support given the medical or orthopedic
application.
[0066] In some embodiments, posterior frame 304 may include, or be
coupled to, one or more additional pads positioned between
posterior frame 304 on one hand, and posterior pad 202 (FIG. 2) on
the other hand, for further support and to provide additional
levels of cushioning and breathability. For example, posterior
frame 304 may overlay another foam back pad and/or back wing
section which is then covered by posterior pad 202 (FIG. 2). In one
embodiment, to provide a layer of extra comfort with breathability,
a foam pad with orifices (FIG. 11) is inserted between the
posterior frame 304 and posterior pad 202. The details and
configuration of the back panels may, in short, vary in accordance
with the embodiment and application.
[0067] FIG. 4 shows a close-up front view of the pulley system 302
in accordance with the present disclosure. In one embodiment, the
D-rings 126a and 126b of pulley system 302 are respectively coupled
to posterior frame 304 via any suitable connection means, such as a
direct plastic connection or a slidable connection using plastic
protrusions slidably engaged with slits in posterior frame 304,
etc. As discussed above, once a user has donned the back brace and
engaged the belt member at the front of the user's body, the user
can provide micro-adjustments to the fit of the back brace by
pulling on pull rings 122a and 122b, which in turn provides tension
to pulley ropes 124a and 124b. Pulley rope 124a is threaded through
guide 412 and winds around various sections of pulley posts 404
before termination at the anchor 408. Similarly, pulley rope 124b
is threaded through guide 410 and winds around various sections of
pulley posts 402 before being terminated at anchor 406. Using the
pulley system as is conventionally known, the tension on the pulley
ropes 124a-b causes the D-rings to exert lateral forces on spinal
support element 114 (or components thereof) such that the spinal
support element can be more securely tightened across the user's
spinal region. The D-rings 126a-b may be (slidably coupled) to
posterior frame 304 for engaging the back pad 304 in response to
tension from pulley ropes 124a-b, as discussed further below.
[0068] In alternative arrangements, a single pulley rope may be
used to provide the force to tighten the back brace. In still other
configurations, a pulley system is not employed, and the belt
members are coupled directly to spinal support element 114 and
adjustment is performed by the user providing tension directly to
the belt member(s).
[0069] FIG. 5 shows an anterior view of the orthopedic back brace
500 with the posterior pad 202 (FIG. 2) removed. An anterior side
of posterior frame 304 (FIG. 3) is shown. Posterior frame 304
includes orifices 306 and 308 for breathability and for
accommodating various design considerations as known in the art.
Posterior frame 304 may be secured to other components of spinal
support element 114 via attachment openings 310 or other suitable
methods. Horizontally disposed orifices 312 are, in an embodiment,
used to enable a connection to D-rings 126a-b (FIG. 4). More
specifically, the underside of D-rings 126a-b (relative to a viewer
of the posterior side of the back brace (FIG. 1)) may include
plastic extrusions that protrude through orifices 312 and are
secured on the opposite side of the orifices by flaps or other
elements. This configuration enables D-rings 126a-b to be slidably
coupled to posterior frame 304 and to engage and tighten the
posterior frame 304 when tension on the pulley strings 124a-b is
provided. Orifices 312, in some embodiments, may provide further
positive design characteristics, may be used with connectors,
and/or may beneficially affect the bendability of the spinal
support element 114. As indicated above, in other embodiments
spinal support element 114 may include additional layers or
components made of plastic, foam or other material disposed between
posterior frame 304 and posterior pad 202. For example, a 3-D
spacer mesh wing pad and/or another foam pad (FIG. 11) may be used
to add additional breathable comfort to accommodate various design
considerations.
[0070] FIG. 6 shows a perspective posterior view of the orthopedic
back brace 600 according to the present disclosure. Portions of
back brace 600 have been disassembled for clarity. Belt members 102
and 104 are coupled respectively to spinal support element 114 via
D-rings 126a-b and pulley system 302 (FIG. 3). Also shown is
exterior layer 119a-b disposed longitudinally across the respective
belt members 102 and 104. Further shown is posterior cover 117,
posterior cover window 122, and posterior cover material 120. In an
embodiment, posterior cover 117, posterior frame and posterior
cover material 120 are welded together via a thermal fusion process
as described herein.
[0071] FIG. 7 shows a perspective staggered view of exemplary
elements of a spinal support element 114 and their relative order
and orientations according to an exemplary embodiment. Thus, FIG. 7
illustrates how the various components may be stacked together to
form spinal support element 114. These details are illustrative in
nature and a large number of different embodiments using more or
substantially less layers of elements or materials may be equally
suitable in other embodiments.
[0072] Towards the left side of FIG. 7, the components comprising
the posterior portion of spinal support element 114 are shown
(i.e., that portion opposite the user's back). Similarly, towards
the right side of FIG. 7, the components comprising the anterior
portion of spinal support element 114 are shown. That is to say,
certain components are configured to be flush against a user's back
as set forth in greater detail below.
[0073] Starting from the left, posterior cover window 122 may be
affixed to posterior cover 117. In turn, posterior cover 117 may be
affixed to posterior cover material 120. In various embodiments,
two or more of posterior cover window 122, posterior cover 117 and
posterior cover material 120 are thermally fused together to form a
more compact and integrated posterior cover of spinal support
element 114, which eliminates the need for stitching. In other
embodiments, stitching or adhesives may be use to combine these
materials. In still other embodiments, the entire network of
materials or some portion thereof may be welded together to form a
unitary sleeve or cover.
[0074] Posterior cover material 120 is thereupon shown adjacent
posterior frame 304 (FIG. 3). It should be noted that the pulley
assembly 302 and associated D-rings 126a-b are not shown here for
ease of clarity. However, as discussed above, D-rings are generally
coupled to a surface of posterior frame 304. Referring still to
FIG. 7, posterior frame 304 is affixed flush against foam pad 702.
In an embodiment, foam pad 702 is an open cell foam or styrene foam
material used to provide cushioning and breathability for the user.
Foam pad 702, in turn, is secured to pad spacer section 204, which
is affixed to pad mesh element 207. Pad spacer section 204 and pad
mesh element 207 form an anterior portion of posterior pad 202 of
spinal support element 114, which anterior portion rests flush
against a user's back.
[0075] Generally, one or more of the structures of FIG. 7 may be
included in the spinal support element 114. The elements may be
affixed or attached to one another in a variety of ways. In some
exemplary embodiments, one or more of the elements of FIG. 7 are
placed flush against each other with no direct connection. In other
embodiments, one or more of the elements of FIG. 7 are affixed
together at or near respective border areas of the elements, or
other areas. The manner of connection may vary widely and may
involve one more of adhesives, thermal fusion as herein described,
clamping mechanisms, or other hardware elements used for connection
means.
[0076] In an exemplary embodiment, posterior cover window 122 is
composed of substantially transparent breathable mesh material that
enables a viewer to observe the interior of the spinal support
element 114. Posterior cover material 120 may also be substantially
transparent such that a viewer can observe portions of the pulley
system 302 and the posterior frame 304 via posterior cover window
122, as is most evident with reference to FIG. 1. This window and
the transparent mesh material provides additional relief to the
user because each layer of the structure of FIG. 7 provides
breathability. The resulting spinal support element 114
consequently enables air to flow from an area external to posterior
cover window 122 via the various structures to the user's affected
area, which may reduce itching and irritation and risk of skin
infection, and which may promote healing. This is in contrast to
conventional back braces in which the affected area may be
substantially limited or altogether obscured from external exposure
of air.
[0077] FIG. 8 shows an anterior view of the posterior pad 202 of
spinal support element 114 of the orthopedic back brace. In this
embodiment, spinal support element 114 includes a posterior pad 202
composed of pad spacer section 204 and pad mesh element 207. In one
configuration, the materials are welded together using thermal
fusion. For example, pad mesh element 207 is thermally fused along
regions 802a and 802b to pad spacer section 204. Pad spacer section
204 may, in turn, be welded to other materials included in spinal
support element 114 to create a thin, low profile support. For
example, pad spacer section 204 may be thermally fused to foam pad
702 (FIGS. 7 and 11) and/or to posterior cover 117 on the other
side of the spinal support element 114. In this latter embodiment,
pad spacer section 204 may constitute a sleeve that is thermally
welded at the borders of the spinal support element 114 to the
posterior cover 117 on the posterior side of the spinal support
element 114. Thus, in this embodiment, the materials on the
anterior and posterior sides of spinal support element 114 may be
at least partially welded together such that spinal support element
114 is a substantially integrated and unitary component.
[0078] Referring back to FIG. 8, two strips of material 802a and
802b are used both to define the borders between pad spacer section
204 and pad mesh element 207 and to facilitate the thermal fusion
process by acting as an intermediate or filler material, as
discussed further below. In an exemplary embodiment, the strips of
material 802a-b are composed of UBL, although various other
materials may be equally suitable.
[0079] The use of welded materials on the anterior portion of
posterior pad 202 of spinal support element 114 provides numerous
advantages. For example, pad spacer section 204 may be welded to
the pad mesh element 207 using another material, such as a thin
strip of UBL tape disposed along segments 802a-b, to facilitate a
weld having a smooth and comfortable transition. This feature is in
contrast to conventional techniques which use stitching on the
posterior pad. The use of stitching causes small but noticeable
"bumps" or rigid protrusions in the material along the borders of
the stitched materials. Since the anterior portion of the posterior
pad 202 is flush against a user's spine, the rigid protrusions
resulting from stitching are usually noticeable and potentially
uncomfortable for a user, especially after long periods of use. The
welding, as discussed above, enables a smooth transition between
pad mesh element 207 on one hand, and 3-D spacer elements 204 on
the other hand, such that any rigid protrusion otherwise formed
through a stitching process is eliminated.
[0080] More fundamentally, the welded nature of the materials helps
provides a low profile, lightweight spinal support element. Welding
the materials provides a manufacturer with the ability to use
different materials together even if the materials have otherwise
disparate properties. This is in contrast to conventional back
braces, which typically are more limited in their use of materials.
Manufacturers of these conventional braces generally must use
thicker materials to avoid stretching problems, which only
increases the bulk of the back brace. In the back braced described
herein, by contrast, comfortable segments of various types of
materials such as different mesh materials may be seamlessly bound
together. The use of such porous materials provides further
breathability and comfort to the user.
[0081] Still referring to FIG. 8, the welding of pad mesh element
to 207 and pad spacer section 204 is such that foam pad 702 is
partially visible via the window composed of pad mesh element 207
and pad spacer section 204. The capsule shaped orifices contained
in the foam pad 702 may be visible, or partially visible, through
the pad spacer section 204 and pad mesh element 207. Generally, the
configuration of spinal support element 114 and its constituent
components may vary in a number of ways depending on the
application and objectives for the back brace and remain within the
spirit and scope of the present disclosure.
[0082] Referring to FIG. 9A, an exemplary embodiment is shown for
macro-fitting the belt around the waist of the user by using the
end sections 902 and 904 of the belt members 102 and 104 proximate
to the spinal support element 114. FIG. 9A shows a posterior
perspective view of the orthopedic back brace having belt member
104 with an arrow indicating that belt member 104 is to be engaged
with D-ring 126b. Thus, as part of a first step if the belt is not
already assembled, a user or other professional can engage the belt
members 102 and 104 with respective D-rings 126a-b.
[0083] FIG. 9B shows a posterior perspective view of the same
orthopedic back brace as FIG. 9A in an alternate orientation.
[0084] FIG. 9C shows an anterior perspective view of the same
orthopedic back brace as FIG. 9A-B. The anterior portion of belt
member 104 includes winged members 220b, which may be composed of a
hook and loop material such as UBL. Further shown on belt member
104 are square-shaped regions 906a and 906b positioned near the end
904 of the belt member 104. In an embodiment, in a case where the
winged members constitute UBL material, the corresponding squared
sections 906a-b are composed of hook material and are ultimately
used to engage with the winged members 220b to secure the belt at
the correct macro-fit. FIG. 9C further shows belt member 102
already threaded through D-ring 126b and securably fastened via a
hook and loop connection using similar hook squares on belt 102 to
engage with the UBL winged members 220a.
[0085] FIG. 10 shows a posterior perspective view of the back brace
in the process of being threaded through the D-ring 126b and being
affixed via a hook and loop connection to an anterior portion of
the belt (at winged members 220b (FIG. 9C)). It can be seen more
clearly in FIG. 10 that in the embodiments of FIGS. 9A-C and 10,
the belt end is threaded through D-ring 126b such that belt end 904
will be affixed to an anterior or inner portion of belt member 104.
However, in alternate configurations, the belt members may fold
through the D-rings 126a-b or other slit components in the opposite
direction such that belt ends 902 and 904 and their respective hook
sections 906a-b engage a posterior or outer side of the belt (such
as engaging with UBL on winged members 116b in FIG. 1), instead of
the belt members 102 and 104 being folded inward as in the
embodiment shown. In alternative embodiments, the location and
shape of the various hook and loop elements may vary. In still
other embodiments, the one or more belt members may be permanently
affixed to the spinal support element 114, via other components or
directly.
[0086] FIG. 11 shows a posterior perspective view of foam pad 702
used in the spinal support element 114 in some embodiments. As
described above, foam pad 702 may be made of a suitable material
such as open cell foam or styrene foam for providing cushioning
support to a user. Foam pad further provides breathable orifices
805 to further facilitate the flow of air in and out of the spinal
support element structure 114 for patient comfort. In an
embodiment, the orifices are die cut.
[0087] FIG. 12 shows a posterior front view of posterior frame 304
having a structure configured to minimize patient discomfort in
accordance with an aspect of the disclosure. As discussed in
connection with previous embodiments, posterior frame 304 may be a
generally semi-rigid structure used to provide the necessary
support to the spinal column when the back brace is worn by a user.
As noted previously, posterior frame 304 includes various capsule
shaped orifices 306 for breathability and in some embodiments, for
effecting the bendability or other design considerations relevant
to the posterior frame 304 for maximum effectiveness. Further shown
are orifices 312 to enable the posterior frame 304 to slidably
connect to the D-rings 126a-b in accordance with an exemplary
embodiment.
[0088] Oftentimes, the user of the back brace has just gone through
surgery or otherwise has bruising, pain or other trauma to the
affected area of the spine over which the orthopedic back brace is
configured to operate. In conventional back braces, the rigid or
semi-rigid portion of a spinal pad can serve to significantly
exacerbate the pain of the user. This is particularly true where
the user has surgical wounds or other trauma in the affected area.
In these cases, conventional back braces, due to the rigidity in
the area of the plastic spinal pad, tends to provide a significant
amount of force and pressure to the affected area, tending to cause
a user afflicted with such trauma considerable pain. As a result,
the user is less motivated to wear the back brace.
[0089] Accordingly, in one aspect of the disclosure, a set of
strategically-positioned perforations in posterior frame 304 enable
a breathable and movable "doorway" to partially open and provide
relief to the user by avoiding excess or undue pressure on the
injured area. As seen in FIG. 12, posterior frame 304 includes a
generally central region positioned between line segment 1208 which
is the area that is typically directly against the injured area. In
FIG. 12, perforations 1202a and 1202b in the plastic material are
provided and are connected together by another
orthogonally-disposed perforation 1204. Additional perforations
1206a and 1206b run transversely through perforation 1204, and
perforations 1206c and 1206d run orthogonally to perforation 1202b,
such that a network of perforations is defined. This network
ultimately defines a pair of flaps 1220a and 1220b. When the
orthopedic back brace as described herein is donned by a user, the
network of perforations, and particularly perforations 1202a-b and
1204, enables the flaps 1220a-b to partially open to thereby
relieve pressure due to spinal processes (e.g., natural spinal
movements) on the affected area of the user's spine. In this way,
the orthopedic back brace of the present disclosure provides the
necessary amount of compression and adjustment to the spinal region
without causing further trauma or unnecessary pressure on the
affected area of the user.
[0090] In the embodiment shown, perforations 1206a-d have been
strategically placed to further allow a user to connect the
posterior frame 304 of spinal support element to a single or double
loop on a user's pant to prevent unwanted sliding or movement of
the orthopedic back brace when the user sits or performs other
movements. Additionally, perforations 1206c-d and a portion of
perforation 1202b may produce another flap orthogonal to flaps
1220a-b, which flap may be used to clip onto an edge of a user's
pant in lieu of using a belt loop connection.
[0091] In addition, in some embodiments, perforations 1206a-d, or
positional variations of such perforations, may be configured to
provide additional degrees of freedom or orientations such that the
flap sections 1220a and 1220b (and segments within the flap
sections 1220a and 1220b) can move in slightly different
orientations to further relieve undue compression in an injured
spinal area while maintaining an effective overall compression to
straighten the spine.
[0092] In short, flaps 1220a-b can be made to provide comfort and
support and pressure relief in the most delicate area of the user's
spine, and this support can be provided, in one embodiment, by
enabling the network of perforations to allow the segments and
flaps 1220a-b to partially open. Advantageously, such flaps also
provide a mild pressure gradient rather than a sharp change in
compression as in conventional approaches. In particular,
conventional attempts to address this problem include the use of
small "windows" or holes in the frame of a back brace. Unlike the
flexible flap structure as described in the present disclosure,
these conventional window mechanisms tend to compress against the
user's back and cause the user to experience "window edema" in
which substantial pain and swelling within the confines of the
window area may occur. Also, these conventional windows
intrinsically include sharp demarcation lines defined by the window
perimeter, which lines can result in abrupt and painful pressure
differences on the affected area.
[0093] The above-described flap solution, by contrast, provides
gradient support and relief, and substantially eliminates the
deficiencies caused by sharp edges per conventional solutions. The
gradient support as described above also reduces pressure on the
affected area significantly, including when the user is sitting,
while concurrently maintaining the structure of the posterior frame
304.
[0094] It will be appreciated that, while a specific network of
perforations is described herein to effect the desired objectives,
the principles of the present invention can be practiced using
different configurations, and different networks or types of
perforations. That is, the segments 1220a and 1220b and the
associated network of perforations is illustrative in nature, and
any number and shape of perforations, flaps, etc., can be further
designed to accommodate the sensitive areas of the patient's spinal
region without departing from the spirit and scope of the teachings
herein.
[0095] FIG. 13 shows an anterior perspective view of the posterior
frame having the structure configured to minimize patient
discomfort. The anterior side 1210 of posterior frame 304 is
slightly angled outwardly about an axis defined by line 1208. Thus,
when the posterior frame 304 is compressed against a user's spine
as the user dons and properly fits the back brace, the overall
structure of posterior frame 304 provides the compression and
spinal support needed for the user while the network of
perforations located in an affected area of the user can extend
outwardly to relieve pain and uncomfortable pressure on the user's
spine, including on a recent surgical scar or an injury.
[0096] In another aspect of the disclosure, a compact and
low-profile orthopedic back brace is disclosed which uses thermal
fusion to integrate together the materials in the belt member. As
noted above, conventional back braces use stitching as a primary
means of assembling the belt members. As a result, conventional
back braces are unduly large and bulky. As for the stitched belt
members of the present art, the various layers are bulky and are
generally independent of one another. Because they are independent,
they tend to separate in some areas and congregate or "bunch up" in
other areas. It is the experience of the inventors that users
generally prefer smaller and more compact orthopedic devices,
given, among other problems. the potential for particularly
self-conscious people to avoid wearing the devices altogether.
[0097] In addition to their bulkiness and layer independence of the
belt members, conventional back braces have other deficiencies.
Oftentimes it is desirable to use materials in the belt member(s)
having different properties or characteristics in order to achieve
a particular objective. Such particular objectives may include, by
way of example, a specific amount of rigidity in various areas of
the belt member and a specific amount of elasticity in other areas
of the belt member. Sometimes it is desirable to combine these
characteristics and obtain specific degrees of rigidity, stiffness,
elasticity, or specific gradients of such characteristics across
the area of the belt members. Conventional back braces endeavor to
obtain these objectives by stitching disparate materials
together.
[0098] For example, such conventional back braces may have belt
members with regions in which two versions of a given material--one
thick and the other thinner--are stitched together. Additionally,
such conventional back braces may have belt members with different
types of materials stitched together to achieve the aforementioned
objectives. A significant disadvantage to this process is that
where materials having different characteristics are stitched
together at some border region along a surface of the belt member,
that border region will generally be characterized by a sharp and
abrupt discontinuity in the physical characteristics and properties
of the belt member along that border region. For example, a
conventional back brace may use a belt member having a thick,
relatively inelastic material that in turn is sewn to a relatively
elastic material. The properties at the stitched region change
dramatically from inelastic to elastic--a change that may result in
uncomfortable pressure points or other anomalies, and one is more
often than not noticeable to the user of such conventional back
braces.
[0099] In contrast to conventional back braces, a more compact and
lower-profile orthopedic back brace includes materials welded
together, at least in part, by thermal fusion. Generally, welding
is a process where two or more pieces of materials such as
thermoplastics, foam, mesh, etc., are fused together by use of
heat, pressure and the passage of time. The process of applying
heat softens the material and enables it to affix or fuse to
another material when an adequate amount of pressure is applied. A
filler material may be used in some thermal fusion processes, such
as the use of an adhesive to join two materials that have
properties that are not necessarily amenable to the welding process
without the filler material.
[0100] Different types of welding are available and any suitable
welding technique may be contemplated herein. Additionally,
different types of weldable materials are available, each with
different melting temperatures or bonding properties. These and
other variables dictate various factors like whether two different
materials can be thermally fused together directly, or whether an
additional filler material is desirable.
[0101] Some examples of welding methods include heat press, RF
welding, sonic welding, and a number of forms of high frequency
welding. Depending on materials and bonding methods, different
bonding and melting temperatures of the materials are involved in
the typical welding process. In general, the temperature range is
90 C-250 C, but this range may not be applicable to all such
processes, and some temperatures may be higher or lower than the
aforesaid range. Radio frequency (RF), sonic and most forms of high
frequency welding create heat by vibrating materials against each
other. This phenomenon enables the materials to create their own
heat energy, which in turn fuses the materials. Other methods of
thermal fusion may include use of a heat press, whereby application
of high temperature to the layers thermally fuses them. In one
embodiment, high frequency welding is used to create the orthopedic
back brace described in the present disclosure.
[0102] In contrast to the conventional back braces described above,
the thermal fusion process heats the materials and with added
pressure, causes the materials to fuse as a substantially
integrated unit around the fusion areas. Thus, at the region of
thermal fusion, the resulting integrated material typically
possesses collective characteristics or properties of each of the
constituent original materials. As a result, at regions where the
materials are fused together, a gradual gradient or change in
material characteristics (e.g., rigidity, elasticity, stiffness,
etc.) can be designed and implemented in the belt member. As a
result, when a user wears the orthopedic back brace as described
wherein, the user is much less likely to notice abrupt
discontinuities resulting from these phenomena. This effect is due
in part to the fact that the thermal fusion process integrates the
materials together to form a unitary segment rather than a set of
independent layers of materials as seen in conventional techniques.
Where welding is used on the fabrics and materials, the gradients
in properties can be designed to be very gradual.
[0103] Moreover, because the thermal fusion process typically
involves applying significant pressure to the material, the
materials involved in the process are generally compactified. That
is, they are made smaller by virtue of being integrated together at
the fusion regions. As a result, the orthopedic back brace as
disclosed herein can advantageously be made significantly smaller
and more compact than conventional devices. Because the back brace
as disclosed herein is less bulky and unwieldy, it is more
comfortable to wear than conventional devices. Moreover, the
thermal fusion process need not be applied at a defined border
region, unlike in stitching processes. Rather, the thermal fusion
process may be applied across a substantial region of the overall
materials. As a result, the resulting unitary segment may
substantially less voluminous and may be seamlessly fused together
with properties having values spread gradually across the segment.
In short, unlike conventional techniques that use stitched belts
with independently acting layers, the belt members of the back
brace disclosed herein may in some embodiments form a unitary
segment that can essentially act as a single integrated
material.
[0104] FIG. 14A discloses a front posterior view of the belt member
104. As described above, belt member 104 includes winged member
116b which in one embodiment includes UBL material. Further
included are exterior layers 119b, belt end segments 108, and UBL
region 112. FIG. 14B discloses a front anterior view of the belt
member 104. The anterior portion includes winged members 220b, hook
sections 906a (used in one embodiment for securing the belt member
104 to D-ring 126b via a hook and loop connection with winged
members 220b), belt end segment 208 and connection portion 210. In
an embodiment, each of these materials of belt member 104 are
welded together using thermal fusion to form a unitary segment
acting as a single structure and having continuous properties as
described above.
[0105] FIG. 15 shows a perspective view of belt member 104 having
its components disassembled into their constituent parts. These
include winged members 116b, exterior layer 119b, anterior portion
221, winged members 220b, connection portion 210, glue portion 223,
and hook regions 906a-b. In the embodiment shown, winged members
116b and 220b are composed of UBL and are made to be substantially
rigid to enable a better fit against the waist and front torso of
the user. This rigidity can, in one example, be gradually provided
to winged members 116b and 220b by thermally fusing winged members
116b to exterior layer 119b and by thermally fusing winged members
220b to anterior portion 210. In an exemplary embodiment, exterior
layer 119b is composed of TPU. TPU has several advantages when used
in a thermal fusion process. For one, TPU can fuse with other
materials, such as hook and loop materials, directly without the
use of a filler material. During the thermal fusion of UBL winged
members 116b to exterior TPU layer 119b, the TPU can act as an
adhesive and can melt to integrate with the UBL in winged member
116b. In addition to its ability to act as an adhesive, TPU is a
versatile material that can be made to be elastic or inelastic
depending on its thickness. Consequently, where more stretch is
desired on a belt member, TPU can be limited or it can be made
thinner. In addition, thermal fusion in general, and particularly
thermal fusion of TPU with UBL, causes compression of the
integrated materials. This compression is highly advantageous as it
enables the belt to be made smaller, as previously described.
[0106] Referring still to FIG. 15, exterior layer 119b may be
thermally fused to anterior portion 221. In an embodiment, anterior
portion 221 is composed of 3-D spacer mesh. Here again, the TPU of
exterior layer 119b seamlessly fuses with the 3-D spacer mesh of
anterior portion 221, compressing the materials further. While in
some embodiments the exterior layer 119b is directly fused to
anterior portion 221, in other embodiments a thin adhesive film may
be placed between exterior layer 119b and anterior portion 221 to
enable greater control over the bonding process for more consistent
bonding.
[0107] In a further exemplary embodiment, a hot melt glue board or
polycarbonate section 223 is applied between exterior layer 119b
and anterior portion 221 at an end section 225 of the anterior
portion 221 and exterior layer 119b. Because the glue board is
rigid at room temperature and hardens further during the thermal
fusion process, further rigidity to the end section 225 of anterior
portion 221 can be provided for a more controlled and comfortable
fit. It should be noted that end section 225 may generally
correspond to the area of one of belt end segments 106 and 108
(FIG. 1). This area corresponds to a front stomach area of the
user, wherein some stiffness is beneficial for comfort and for
ensuring a secure fit, thereby enabling the back brace to properly
function. In an exemplary embodiment, the section 223 is only
applied at one of belt segments 106 or 108. Other configurations
may not utilize section 223.
[0108] In addition, connection portion 210 may be thermally fused
to an anterior side of anterior portion 221. Winged members 220b
may be welded to the anterior side of anterior portion 221 in like
manner. In turn, square hook sections 906a and 906b may be welded
over the winged member 220b. In an embodiment, winged member 220b
is composed of UBL.
[0109] FIG. 15 further shows UBL segment 1502 and belt end segments
1504a-b, also composed of UBL in the present embodiment. UBL
segment 1502 and belt end segments 1504a-b are thermally fused to
exterior layer 119b.
[0110] The amount of materials used, such as the thickness of the
TPU and 3-D spacer mesh, can be controlled to achieve certain
target properties within the belt. The use of an adhesive during
thermal fusion can be beneficial in some situations. For example,
the adhesive has a low melting point such that during welding, the
adhesive may melt first and fuse to two other materials that
otherwise have higher melting points.
[0111] Referring back to FIG. 1, in some embodiments a binding or
piping process may be applied along the tangent edge 151 of belt
members 102 and 104 to secure the edges of the belt members 102 and
104.
[0112] The use of welding as described herein has several
additional advantages. Because most or all of the materials of the
belt assembly are fused together, the welded belt assembly may be
made waterproof. Further, the welded belt assembly may be
contoured. While conventional stitching and lamination techniques
typically result in flat belt assemblies characterized by
essentially two-dimensional features not naturally aligned with the
dimensions of the user's anatomy, thermal fusion can be used in
accordance with an embodiment to contour the belt to an effectively
three-dimensional shape. More specifically, in this embodiment,
thermal fusion can be used to shape the belt to conform to the
anatomy of a user. This capability may provide a significant
additional benefit of comfort to a user. Moreover, such welding
processes can be employed to provide a variety of different shapes
and customized contours that are configured to fit securely and
comfortably given a particular user's size and anatomy.
[0113] FIG. 16A is a front posterior view of belt member 102,
including exterior layers 119a, belt end segment 106 and region
110. FIG. 16A further defines cross sections A-A and B-B of belt
102. FIG. 16B shows a cross-sectional view of belt member 102 along
plane A-A. The view along plane A-A coincides in this embodiment
with belt end segment 106 and region 110. Because the belt layers
are welded together, the belt member 102 can be gradually contoured
(1604). While the magnitude of the contour may be exaggerated for
illustration purposes in FIG. 16B, this contour can be specifically
designed to accommodate the anatomy of a user or class of users and
can be customized to meet the needs of users with different body
shapes. FIG. 16C shows a cross-sectional view of belt member 102
along plane B-B. Plane B-B corresponds to a central area of belt
member 102 and, as in the previous illustration, this region can be
similarly contoured in an appropriate manner to conform to a user's
anatomy for a secure and comfortable fit. Conventional back braces
lack this feature. In conventional braces, the otherwise flat belt
must be secured to the curved shape of a user's anatomy by
tightening the belt sufficiently to enable the back brace to
properly function. This tightening may result in additional
pressure points and discomfort, particularly after the conventional
brace is worn for long periods of time. FIG. 16D shows a
perspective view of the belt member of FIG. 16A. FIG. 17A shows an
inverted side view of the belt member 102, including belt end
segment 106, region 110, exterior layer 119a, and winged section
116a. FIG. 17B shows a side view of the belt member 102. FIG. 18A
shows a vertical side view as seen toward the belt end segment 106.
FIG. 18B shows a vertical side view of the belt member of FIG. 16A
as viewed from a proximal end section of the belt to the distal
belt an segment. In each of these views, the contour may not be
drawn to scale and/or may be enhanced for clarity.
[0114] FIG. 19A shows a perspective view of a belt assembly
disposed between two tooling molds for use in thermally fusing the
belt assembly. This figure illustrates a technique for thermally
fusing the belt assembly. Belt member 102 is shaped in this example
using tooling core mold 1902, which may form a positive side of a
mold, and complementary tooling cavity mold 1904, which may form a
negative side of the mold. The tooling molds 1902 and 1904 may be
machined or otherwise constructed to include the desired
three-dimensional contour as described above, if a contour is
desired. In one embodiment, the tooling molds 1902 and 1904 are
composed of a metal alloy, such as an aluminum alloy, or another
material conducive to transporting heat for use in the fusion
process. The various belt layers (see, e.g., FIG. 15) may initially
be assembled on top of one another on tooling mold 1902. In an
exemplary embodiment, a plurality of pins (not shown) may extend
around a perimeter of tooling mold 1902 and may be used to
temporarily secure the yet unbonded belt materials prior to
welding. In other embodiments, other temporary fastening mechanisms
may be used. (In the illustration, belt assembly is seen after
welding as a pre-molded belt member 102 having a contour for
clarity). Thereupon, the tooling mold 1904, designed with a contour
that complements that of tooling shell 1902 fits over tooling mold
1904 and heat and pressure are applied over time to thereby fuse
the materials together and create an integrated structure which may
be contoured.
[0115] FIG. 19B shows an inverted perspective view of the belt
assembly and tooling molds of FIG. 19A. As shown in the
illustration, tooling mold 1904 in this example in inwardly
contoured in a desired shape to accommodate the belt assembly and
tooling mold 1902.
[0116] Advantageously, whereas conventional techniques often
require multiple stitching and/or gluing steps to form the
resulting belt assembly and spinal support element, the welding
process as described with respect to FIGS. 19A-B, above, can often
be performed in a single step. For example, the material can be
fused and contoured concurrently by using the above-described
tooling molds.
[0117] It will be appreciated that alternatively or additionally,
portions of the spinal support element 114 may also be contoured to
form a three-dimensional shape. For example, posterior pad 202
(FIG. 2) may be thermally fused and contoured, whether by itself or
along with other portions of spinal support element 114.
[0118] As described above, one benefit of the welding techniques is
that properties of the belt member 102 itself, and specific regions
of the belt, can be more carefully and strategically controlled
than with conventional techniques. As an illustration, belt member
102 may include an exterior layer 119a composed of TPU (FIG. 1)
fused with an anterior portion 221 composed of 3-D spacer mesh. The
fusing of the TPU with the spacer mesh can substantially increase
the strength of the fused TPU and spacer mesh as compared with the
spacer mesh alone. In addition, the thermal fusion process is
flexible. For example, hot melt glue (such as portion 223 in FIG.
15) can be inserted in the belt assembly being fabricated fused at
an end segment 206 or 208 one of belt members 102 or 104 (or both)
to increase the rigidity of the front section of the belt as worn
by a user. This process can be contemporaneous with the belt
assembly, as described above.
[0119] To demonstrate and verify the effectiveness of the thermal
process versus conventional techniques, the inventors compiled test
data regarding the relative stretching of various materials. The
test data can be summarized as follows:
TABLE-US-00001 TABLE 1 Stretch Test Stretch Stretch Test Percent
Test (mm)- Change (mm)- Distance from Initial with 10 Initial
Distance pound load to Final Material without after 2 Distance
Description Process Load minutes (%) Spacer Only -- 205 245 19.51
TPU Only -- 203 225 10.84 Spacer and Longitudinal 200 222 11.00 TPU
Stitch Spacer and Vertical Stitch 200 223 11.5 TPU Spacer and
Welded 200 204 2.00 TPU
[0120] Summarizing the data in the above table, the inventors
provided the listed materials and subjected them to a stretch test.
The stretch test measured an initial distance of the material(s)
without the presence of a stretching load, and a final distance of
the material(s) upon application of a 10 pound stretching force.
When 3-D spacer mesh was used alone as a benchmark, it was noted
that the spacer buckled and necked substantially and elongated
19.51% as a result of the stretch. The TPU stretch test yielded an
elongation of 10.84%. a little greater than 1/2 that of the spacer
material. The stretch of the TPU also showed signs of bucking and
necking of the material.
[0121] Next, segments of spacer mesh and TPU material were combined
using vertical stitching. That is when viewing the material as a
rectangle having a height substantially less than its base, the
stitching was disposed vertically across adjacent left and right
edges of the rectangle. The combined material was then stretched in
the longitudinal direction (along the long axis of the rectangular
material), resulting in an 11.5% elongation. It was apparent to the
inventors that, even though the spacer mesh and TPU materials were
stitched together, the TPU was sustaining the majority of the
tension to hold the materials. It was concluded that the stitching
of these materials does not create a generally stronger combination
of the two materials.
[0122] Thereupon, the same spacer mesh and TPU material was used
except that stitching was also applied longitudinally on each side
of the combined segment. Thus, stitching traversed the perimeter of
the material. The combined material was then stretched in the
longitudinal direction, resulting in an 11.0% elongation,
substantially similar to the case with only the vertical stitching.
The same conclusions were reached as with respect to the vertical
stitching case, and it was further concluded that the addition of
longitudinal stitching does not create a generally stronger
combination of the two materials.
[0123] Finally, the spacer mesh and TPU material were thermally
fused pursuant to the principles described in the present
disclosure. Subject to the stretch test, the combined materials
elongated a mere 2%--more than five times less than either of the
stitched cases. The welded combination is consequently
substantially stronger than the combinations that rely only on
stitching. The inventors further observed that the fused materials
exhibited minimum buckling and necking. Thus, based on the observed
data, the inventors have concluded that the thermally fused nature
of the belt assembly as well as, in some embodiments, portions of
the spinal support element, yield a stronger, more durable, longer
lasting orthopedic back brace as compared to conventional
structures.
[0124] Table 2 shows a compilation of data taken for various
material combinations based on the application of the thermal
fusion process. Specifically, Table 2 describes the average
vertical pull of various material samples.
TABLE-US-00002 TABLE 2 Pull Test Pull test Data Percent
(Kilogram-Force Change (kgf)) from Material Name (Vertical Average)
Spacer Spacer 34.57 NA Spacer + TPU 78.7 127.65 Spacer + Hot Melt
67.04 93.93 Spacer + Hot Melt + 76.43 121.09 TPU Spacer + Hot Melt
+ 82.82 139.57 TPU + UBL
[0125] The data in Table 2 indicates, for example, that various
characteristics (including strength) of the belt assembly may be
achieved using different material combinations. In other
embodiments, different welding parameters (e.g., temperature,
pressure time of exposure) may be used to achieve different
characteristics. In Table 2, the different material combinations
may be used in different regions across the belt assembly to create
gradual property gradients in the belt assembly. Further, the data
reveals that the strength of the welded combination of spacer mesh
and TPU material is more than twice that of spacer alone. Hot melt
may be used for stiffness and rigidity in select portions of the
belt assembly, but the data reveals that the strength is less than
the spacer mesh/TPU weld. However, it is noteworthy from the data
that adding hot melt to the spacer mesh/TPU combination assists in
regaining that strength. The data also reveals that the welded
combination of spacer, hot melt, TPU and UBL creates the strongest
integrated material.
[0126] In short, using the principles described herein, the belt
segment can be thermally fused to form a single integrated segment
having well-controlled properties. The light weight, low volume
nature of the resulting back brace will consequently be attractive
to current users of large and bulky orthopedic devices, and new
users of such devices.
[0127] While the belt segments of the orthopedic back brace have
been described above as created substantially entirely using
thermal fusion, it should be understood that this description is
intended to be illustrative in nature and that stitching on the
belt may also be used. For example, the use of sewing in one more
parts of the belt members may be beneficial or cost effective in
some instances such that some embodiments contemplate a belt that
is partially integrated using thermal fusion and partially formed
using conventional means such as stitching. These embodiments,
which take advantage of the thermal fusion process to achieve all
the benefits hereinbefore described, are within the scope of the
present disclosure. It will also be appreciated that the materials
described above are exemplary in nature, and new or different
materials may be used or welded to form the belt assembly and/or
the spinal support element. In addition, in some embodiments,
portions or regions of the belt assembly and/or spinal support
element may be composed of a single material. In still other
embodiments, stitching and/or lamination may be used in combination
with welding techniques, such as in other portions of the belt
assembly or spinal support element, without departing from the
spirit and scope of the present disclosure.
[0128] It is to be understood that the specific order or hierarchy
of steps in the methods disclosed is an illustration of exemplary
processes. Based upon design preferences, it is understood that the
specific order or hierarchy of steps in the methods may be
rearranged. The accompanying method claims present elements of the
various steps in a sample order, and are not meant to be limited to
the specific order or hierarchy presented unless specifically
recited therein.
[0129] The various aspects of a flexible support presented
throughout this disclosure are provided to enable one of ordinary
skill in the art to practice the present invention. Various
modifications to aspects presented throughout this disclosure will
be readily apparent to those skilled in the art, and the concepts
disclosed herein may be extended to other flexible supports. Thus,
the claims are not intended to be limited to the various aspects of
this disclosure, but are to be accorded the full scope consistent
with the language of the claims. All structural and functional
equivalents to the elements of the various aspects described
throughout this disclosure that are known or later come to be known
to those of ordinary skill in the art are expressly incorporated
herein by reference and are intended to be encompassed by the
claims. Moreover, nothing disclosed herein is intended to be
dedicated to the public regardless of whether such disclosure is
explicitly recited in the claims. No claim element is to be
construed under the provisions of 35 U.S.C. .sctn. 112, sixth
paragraph, unless the element is expressly recited using the phrase
"means for" or, in the case of a method claim, the element is
recited using the phrase "step for."
* * * * *