U.S. patent application number 09/813867 was filed with the patent office on 2001-09-06 for custom fitted orthotic device.
This patent application is currently assigned to Bio Cybernetics International. Invention is credited to Heinz, Thomas J., Park, Dae Shik.
Application Number | 20010020144 09/813867 |
Document ID | / |
Family ID | 22219184 |
Filed Date | 2001-09-06 |
United States Patent
Application |
20010020144 |
Kind Code |
A1 |
Heinz, Thomas J. ; et
al. |
September 6, 2001 |
Custom fitted orthotic device
Abstract
An orthotic device is provided, including an orthosis body
adapted to be wrapped around the torso of a wearer of the device,
the orthosis body having at least two segments in juxtaposed
relationship. Means are provided at free end portions of the at
least two segments to releasably secure the free end portions to
one another. At least two cables are provided, each cable
operatively connected to the at least two segments. At least two
sets of pulleys are mounted on the at least two segments with each
cable operatively connected to the at least two segments running
through a pulley on each of the at least two segments in
alteration, shortening of each cable pulling the at least two
segments together and tightening the orthotic device with the aid
of a mechanical advantage dependent upon the number of pulleys
mounted on each of the at least two segments.
Inventors: |
Heinz, Thomas J.;
(Flintridge, CA) ; Park, Dae Shik; (Fullerton,
CA) |
Correspondence
Address: |
ARENT FOX KINTNER PLOTKIN & KAHN, PLLC
1050 CONNECTICUT AVENUE, N.W., SUITE 600
WASHINGTON
DC
20036-5339
US
|
Assignee: |
Bio Cybernetics
International
|
Family ID: |
22219184 |
Appl. No.: |
09/813867 |
Filed: |
March 22, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09813867 |
Mar 22, 2001 |
|
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|
09334649 |
Jun 17, 1999 |
|
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6213968 |
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60089707 |
Jun 18, 1998 |
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Current U.S.
Class: |
602/19 |
Current CPC
Class: |
A61F 5/028 20130101 |
Class at
Publication: |
602/19 |
International
Class: |
A61F 005/00 |
Claims
1. An orthotic device comprising: an orthosis body adapted to be
wrapped around the torso of a wearer of the device, the orthosis
body having at least two segments in juxtaposed relationship; means
provided at free end portions of said at least two segments to
releasably secure said free end portions to one another; at least
two cables, each cable operatively connected to said at least two
segments; at least two sets of pulleys mounted on said at least two
segments with each cable operatively connected to said at least two
segments running through a pulley on each of said at least two
segments in alteration, shortening of each cable pulling said at
least two segments together and tightening the orthotic device with
the aid of a mechanical advantage dependent upon the number of
pulleys mounted on each of said at least two segments.
2. An orthotic device according to claim 1, wherein said at least
two segments comprise two segments, said at least two sets of
pulleys comprise two sets of pulleys and said at least two cables
comprising two cables.
3. An orthotic device according to claim 2, wherein said two sets
of pulleys are disposed vertically with respect to each other at
juxtaposed edges of said two segments.
4. An orthotic device according to claim 2, wherein each cable is
operatively associated with a separate set of pulleys.
5. An orthotic device according to claim 4, wherein each set of
pulleys with an associated cable provides a mechanical advantage of
about 4:1 to about 30:1.
6. An orthotic device according to claim 1, wherein each set of
pulleys comprise two banks of pulleys and each bank of pulleys of a
set of pulleys is mounted on a juxtaposed edge of an adjacent
segment.
7. An orthotic device according to claim 1, wherein each of said at
least two cables is an endless cable.
8. An orthotic device according to claim 1, wherein each of said at
least two cables comprise cables having two free ends secured to a
handle element.
9. An orthotic device according to claim 6, wherein each bank of
pulleys includes a plate on which pulleys are mounted, said plate
being detachably mounted on a segment of said at least two
segments.
10. An orthotic device according to claim 1, wherein said
detachable securing means comprise portions of hook-and-loop
fastener material disposed on overlapping portions of said free end
portions of said at least two segments.
11. An orthotic device according to claim 1, wherein at least a
portion of each of said at least two segments is formed from a
rigid material.
12. An orthotic device according to claim 1, wherein said at least
two segments comprise at least three segments, said at least two
sets of pulleys comprise two sets of pulleys and said at least two
cables comprise two cables.
13. An orthotic device according to claim 12, wherein said at least
three segments comprise at least one central segment having first
and second opposed lateral edges, at least one first lateral
segment disposed at said first opposed lateral edge of said at
least one central segment and at least one second lateral segment
disposed at said second opposed lateral edge.
14. An orthotic device according to claim 13, wherein said two sets
of pulleys are disposed horizontally with respect to each other and
includes a first set of pulleys mounted on said at least one
central segment and said at least one First lateral segment, and a
second set of pulleys is mounted on said at least one central
segment and said at least one second lateral segment.
15. An orthotic device according to claim 12, wherein each cable is
operatively associated with a separate set of pulleys.
16. An orthotic device according to claim 15, wherein each set of
pulleys-with an associated cable provides a mechanical advantage of
about 4:1 to about 30:1.
17. An orthotic device according to claim 8, wherein each handle
element has mounted thereon a portion of a hook-and-loop material
complementary to a portion of a hook-and-loop material disposed on
an outer surface of said at least two segments.
18. An orthotic device according to claim 17, wherein said handle
element is formed from a flexible material.
19. An orthotic device according to claim 1, wherein lordotic pads
are mounted at inner surfaces of the orthosis body, symmetrically
and at substantially the center of the orthosis body.
20. An orthotic device according to claim 1, wherein each set of
pulleys comprise two banks of pulleys, each bank of pulleys
including at least one pulley having a spool diameter different in
size than remaining pulleys in the set.
21. An orthotic device according to claim 13, wherein each free
edge of said at least one first lateral segment and said at least
one second lateral segment has a grasping element attached
thereto.
22. A thoracic lumbar sacral orthosis comprising: a rigid front
piece; a sternal notch piece, movably and adjustably secured to
said rigid front piece; a rigid rear piece, removably and
adjustably secured to said rigid front piece; and a body brace
comprising: a brace body adapted to be wrapped around the torso of
a patient, said front piece and said rear piece, said brace body
comprising at least two brace body segments; means provided at free
end portions of said at least two brace body segments for
detachably securing the two free end portions together around the
patient's torso; at least one cable operatively connected to said
at least two brace body segments; and at least one set of pulleys
mounted on each of said at least two brace segments with the cable
running through a pulley on each segment in alteration, shortening
of the cable pulling the at least two brace body segments together
and tightening the body brace with the aid of a mechanical
advantage dependent upon the number of pulleys mounted on each of
said at least two brace body segments.
23. A thoracic lumbar sacral orthosis according to claim 22,
wherein said body brace is removably and adjustably secured to said
front piece and said rear piece.
24. A thoracic lumbar sacral orthosis according to claim 23,
wherein outer surfaces of said front piece and said rear piece
include portions of hook-and-loop material complementary to
portions of hook-and-loop material on at least a portion of an
inner surface of said brace body.
25. A thoracic lumbar sacral orthosis according to claim 22,
wherein said at least two brace body segments comprise at least
three segments, said at least two sets of pulleys comprise two sets
of pulleys and said at least one cable comprises two cables.
26. A thoracic lumbar sacral orthosis according to claim 25,
wherein said at least three segments comprises at least one central
segment having first and second opposed lateral edges, at least one
first lateral segment disposed at said first opposed lateral edge
of said at least one central segment and at least one second
lateral segment disposed at said second opposed lateral edge.
27. A thoracic lumbar sacral orthosis according to claim 26,
wherein said two sets of pulleys are disposed horizontally with
respect to each other and includes a first set of pulleys mounted
on said at least one central segment and said at least one first
lateral segment, and a second set of pulleys is mounted on said at
least one central segment and said at least one second lateral
segment.
28. A thoracic lumbar sacral orthosis according to claim 25,
wherein each cable is operatively associated with a separate set of
pulleys.
29. A thoracic lumbar sacral orthosis according to claim 28,
wherein each set of pulleys with an associated cable provides a
mechanical advantage of about 4:1 to about 30:1.
30. A thoracic lumbar sacral orthosis according to claim 25,
wherein each of said at least two cables comprise cables having two
free ends secured to a handle element.
31. A thoracic lumbar sacral orthosis according to claim 30,
wherein each handle element has mounted thereto a portion of a
hook-and-loop material complementary to a portion of a
hook-and-loop material disposed on a surface of said at least two
segments.
32. A thoracic lumbar sacral orthosis according to claim 31,
wherein said handle element is formed from a flexible material.
33. A thoracic lumbar sacral orthosis according to claim 26,
wherein each free edge of said at least one first opposed lateral
segment and said at least one second opposed lateral segment has a
grasping element attached thereto.
34. A thoracic lumbar sacral orthosis according to claim 22,
wherein said at least two brace body segments comprise two
segments, said at least one set of pulleys comprise two sets of
pulleys and said at least one cable comprises two cables.
35. A thoracic lumbar sacral orthosis according to claim 22,
wherein said sternal notch piece includes an adjustment piece and
said front piece includes an adjustment piece receiving portion
provided with an adjustable member for engaging said adjustment
piece.
Description
TECHNICAL FIELD
[0001] The invention relates to body braces and other orthotic
devices used in the treatment of spinal disorders and/or used
subsequent to surgery where flexing of the torso is to be
minimized. More particularly, the invention relates to back brace
apparatus and orthotic devices for partial or substantial
immobilization of portions of the torso, the devices having
multiple modes of adjustment facilitating both rapid donning and
doffing and individualized adjustment to fit the user of the
device.
BACKGROUND ART
[0002] A common method of alleviating pain in people suffering from
back injuries and promoting healing in post-operative back surgery
patients is to stabilize the spine by means of an orthosis, such as
a brace. Such braces include a multitude of materials and designs
which can be snugly fitted around the patient's trunk. The back
portion of such orthosis may also be provided with pockets into
which are inserted lordotic pads for treating spinal lordosis.
[0003] Such braces are effective in achieving spinal stability if
worn properly and consistently; however, most patients have
difficulty in manually adjusting the brace to fit tightly enough to
provide adequate support. This is especially true in the case of
post-operative patients who are generally in pain and frequently
lack sufficient strength to make the necessary adjustments. This is
also true when the devices cover a large portion of the torso or
when materials used in the construction of the orthoses are rigid.
For many patients suffering spinal ailments, these braces are also
difficult to don, appropriately position and fasten and
subsequently remove. This is also particularly true when the
devices are large or cumbersome or when they are constructed from
rigid materials. In addition, because of the structures of many of
these devices and/or the choice of materials used in their
construction, the orthoses are quite uncomfortable, in many
instances inducing extensive perspiring and/or chafing. Without
being consistently worn and properly adjusted, such patient
non-compliance obviously reduces the effectiveness of the
brace.
[0004] Another frequently encountered problem with these types of
braces is their inability to conform to the torso as the patient
moves from a standing to a sitting position or vice versa. Thus,
although such a device may have been properly adjusted initially,
the patient is required to make any necessary adjustments manually
to vary the tension, depending on whether the patient is standing
or sitting. Similar situations and corresponding adjustments may be
required as, or shortly after, a meal is consumed or digested. In
addition, it is often difficult to adjust the brace to have exactly
the same amount of tension that a patient previously found
acceptable or even to set a particular tension for a particular
patient.
[0005] Advances have been made in recent years to provide orthotic
devices which can be more easily adjusted to the individual patient
and readjusted when their physical position changes. Thus, in U.S.
Pat. No. Re 35,940 an electromechanical back brace apparatus is
described which is provided with an electromechanical mechanism for
tightening the brace around the trunk of the patient to a desired
tension. A cable and pulley arrangement is tightened by a small
motor to provide the desired tension in the brace. A microprocessor
is also provided to control the motor to obtain desired repeatable
tension settings. While such a device facilitates rapid and
repeatable adjustment of such a brace, the inclusion of an
electromechanical mechanism and a microprocessor increases the cost
of such a device to a patient or to their medical insurance
program. In addition, there is the need to periodically replace
batteries to power the electrically operated components.
[0006] In some situations larger orthotic devices are necessary
either because the portion of the torso being supported constitutes
a large volume or because the user of the device is large. In such
situations, a single means for tensioning the device over a large
area proves somewhat ineffective since the dimensions of the
portion of the torso being supported or in which there is contact
with the device vary significantly. That is, a single means of
adjustment may not provide the necessary conformity to the physical
profile of the patient or may provide too little tension or support
to achieve the orthotic objectives with respect to a specific
portion of the torso while imparting excessive tension or pressure
to other parts of the torso.
[0007] Accordingly, it is an object of the present invention to
provide orthotic devices which result in greater patient compliance
since the key to successful orthotic treatment is patient
compliance. The attributes of an effective orthotic device which
induces patient compliance includes ease of donning an doffing the
device, ease of adjusting the device, comfort to the wearer of the
device, and effective heat dissipation. More specifically, it is a
primary object of this invention to provide orthoses which may be
tightened around the torso of a patient to provide the necessary
support with the minimal physical effort required on the part of
the patient.
[0008] It is another object of the invention to provide orthoses
which are easily donned and doffed. It is a further object of the
present invention to include individual controls for adjustment and
custom fitting of different parts of the orthotic device. It is an
additional object to provide substantially the same pressure to all
portions of the torso supported by the orthosis.
[0009] It is another object of the present invention to provide
multiple modes of adjustment to achieve individualized adjustment
of various portions of orthosis. It is still another object of the
present invention to provide multiple and independent means of
adjustment of various portions of an orthotic device. It is yet
another object of the present invention to provide a rigid back
brace apparatus having a significant mechanical advantage that may
be individually adjusted to a desired tension and conformity to an
individual patient's dimensions.
[0010] It is yet another object of the present invention to provide
a thoracic lumbar sacral orthosis (TLSO) which is provided with
multiple means of adjustment for individually fitting to a
patient.
[0011] It is another object of the invention to provide an orthotic
device which is capable of being rapidly adjusted and, where
appropriate, readjusted to an appropriate tension. It is another
object of the present invention to provide an orthotic device to be
easily disassembled to clean component parts of the device. It is
also an object of the invention to provide orthoses which are
comfortable and which readily dissipate body heat.
DISCLOSURE OF INVENTION
[0012] The present invention is directed to braces and orthotic
devices which result in significantly increased patient compliance.
This is attributable to orthoses that are both easily donned and
doffed as well as being easily and rapidly adjustable to
accommodate changes in the position of a wearer of the device. The
orthotic devices of the invention include multiple modes of
adjustment which are independently adjustable to accommodate and
conform to varying physical profiles of a user of the device as
well as to accommodate a change in the position of the torso about
which the devices are secured. The devices of the invention provide
greater patient comfort and adjustability and result, therefore, in
greater patient compliance. Preferably, component parts of the
devices may be easily dissembled and assembled for cleaning.
[0013] The orthotic devices of the present invention, include an
orthosis or brace body adapted to be wrapped around the torso or
trunk of a user, the brace body including at least two segments.
Fasteners are provided at the distal or outer ends of the segments
of the brace body to detachably secure the ends around a user's
torso. At least two cables are operatively connected to the at
least two segments. The orthotic devices include at least two
independent sets of pulleys, each set mounted on adjacent sides of
opposing segments with each cable running through a pulley on each
adjacent segment in series and in alteration, shortening of each
cable pulling the adjacent segments together and tightening the
brace apparatus with the aid of mechanical advantage dependent upon
the number of pulleys mounted in each set of pulleys on each brace
segment.
[0014] In one embodiment of the invention, the brace body includes
at least two segments and employs at least two independent sets of
pulleys arranged vertically with one set disposed above the
other(s). In another embodiment of the invention, at least two sets
of pulleys are arranged horizontally with one set disposed in
opposition to the other(s). In each of these embodiments, several
separate and independent means of adjustment are provided,
preferably including separate adjusters for each pulley set.
[0015] In the latter embodiment of the invention, the brace body
includes at least three brace body segments and at least two
independent pulley sets with at least one set of pulleys securing a
centrally disposed brace body segment to a first lateral segment at
one side of the central brace segment and at least one other set of
pulleys joining the centrally disposed brace segment to a second
lateral brace segment disposed at an opposing side of the central
brace segment.
[0016] To facilitate disassembly and cleaning of the devices of the
invention, many of the component parts are preferably constructed
to be easily detached and separated from other component parts.
This includes each pulley set and its connecting cable. Thus, in a
preferred embodiment, each set of pulleys comprises two modular
banks of pulleys which are detachably secured to adjacent brace
segments. A cable is provided to connect pulleys in the opposing
banks of pulleys in a set in series and in alteration. The ends of
each cable preferably may be joined to form an endless cable or are
attached to a handle which also achieves the effect of an endless
cable. Preferably, the handle may be removed from the body of the
device when the modular banks of a pulley set are removed.
[0017] Although useful for custom fitting the orthotic device to
the physical profile of an individual wearing the device, in most
situations, the individualized control of adjustment and fitting of
orthotic devices according to the invention is also quite effective
when the device is intended to cover a large portion of the torso
of the wearer or the wearer is tall. Thus, it has been found that
attempting to provide both the necessary support with the
appropriate tension as well as providing sufficient comfort to the
wearer of a brace or other orthotic device frequently falls short
when a single means of control is provided to adjust the tension of
the device to suitably support and comfortably fit the affected
portion of the torso, particularly when the extent of support
extends over a large region of the torso in the longitudinal
direction of the body of the user wearing the device or when the
orthosis is constructed of rigid materials. Providing a plurality
of separate adjustment devices, as in the invention, preferably at
least two separate means of adjustment, allows for individualized
fitting for appropriate support and comfort over the surface area
covered by the device.
[0018] To improve appropriate support when used as a back brace,
such as in a body jacket, an embodiment of the present invention
includes a modular lordotic pad system. The system includes one or
more flexible and compressible pads having a size and contour
appropriate to the dimensions of the wearer of the device,
preferably located in the portion of the brace corresponding to the
lumbar region of the back.
BRIEF DESCRIPTION OF DRAWINGS
[0019] Other objects, features and advantages will become evident
in light of the following detailed description, considered in
conjunction with the referenced drawings of preferred embodiments
according to the present invention. It should be understood that
these drawings are exemplary only and should not be construed as
limiting the invention in any way.
[0020] FIG. 1 shows a plan view of an outer side of a first
embodiment of an orthotic device according to the present
invention;
[0021] FIG. 2 illustrates a plan view of an inner side of the
embodiment shown in FIG. 1;
[0022] FIG. 3 illustrates an enlarged portion of the embodiment of
the present invention illustrated in FIG. 1 with a bank of a set of
the modular pulley system removed from its corresponding segment of
the orthotic device of the present invention so as to reveal the
underside of the bank;
[0023] FIG. 4 shows a bank of a modular pulley set employed in a
present invention with its cover removed;
[0024] FIG. 5 shows an inner portion of an orthosis according to
the invention containing lordotic pads;
[0025] FIG. 6 shows a first embodiment of the invention as it is
worn by a patient;
[0026] FIG. 7 shows a plan view of the outer side of a second
embodiment of an orthotic device according to the present
invention;
[0027] FIG. 8 illustrates an inner side of a rear component piece
which forms part of a thoracic lumbar sacral orthosis (TLSO) used
in conjunction with an embodiment of the present invention such as
that illustrated in FIG. 7;
[0028] FIG. 9 is an outer side of the rear component piece of the
TLSO shown in FIG. 8;
[0029] FIG. 10 shows the outer or front side of a front component
piece of a TLSO and a sternal notch piece received by the front
piece according to the present invention;
[0030] FIG. 11 illustrates an inner side of a front component piece
illustrated in FIG. 10;
[0031] FIG. 12 shows a front view of the orthotic device of FIGS.
8, 9, 10 and 11 as it is worn by a patient; and
[0032] FIG. 13 shows a side view of the orthotic device of FIGS. 8,
9, 10, 11 and 12 as it is worn by a patient.
MODES FOR CARRYING OUT THE INVENTION
[0033] FIGS. 1-6 show a first embodiment of the present invention.
FIG. 1 illustrates the outer side of a body jacket type of back
brace 10 in an extended position. The brace 10 includes a brace
body 12 made of a material suitable to achieve the type of support
sought in treating the condition of the patient wearing the
orthotic device. Accordingly, in some situations a softer, more
pliant material is preferred where the device is intended to
conform substantially to the body of the wearer and provide support
but where rigid support is not necessary. In other situations,
where flexion is to be avoided, either a more rigid material is
selected for all or a portion of the body of the orthosis (such as
in body jackets) or the orthotic device is used in conjunction with
other component parts made from a more rigid material (such as in
thoracic lumbar sacral orthoses). Suitable materials include
canvass, nylon, polyethylene, nylon mesh or other similar
materials. Where a more rigid orthotic device is sought, rigid
polyethylene may be used alone and various combinations of
materials may be employed to obtain properties of rigidity and
breathability.
[0034] It may be noted that the term "rigid", as used herein to
describe materials from which the orthoses of the invention are
constructed, does not mean totally inflexible or unyielding, since
many of materials employed can be bent when a sufficient force is
applied to a surface of the material. These materials typically
resume their original configurations when the deforming force is
removed, however. As used in describing the materials from which
the invention is constructed, rigidity refers to a resistance to
deformation exhibited when in use, orthoses constructed of such
materials are not bent or deformed when someone wearing the device
bends in a fore or aft direction or in a lateral direction using a
force to move in such direction which is considered not to be
excessive for that person.
[0035] In a preferred embodiment of the brace body 12 illustrated
in FIGS. 1, 2 and 6, two brace body segments, 12a and 12b, are
shown, each including part of the individual adjuster or tightening
means of the orthotic device. On opposite overlapping sides of
opposite distal or free ends 14a and 14b of each brace body segment
are provided complementary fastener or fastening means for securing
the two free ends 14a and 14b together after the brace is wrapped
around the patient's torso. Although, buttons and button holes,
snap fasteners or other similar fasteners commonly used in garments
may be employed to secure the free ends of the brace body 12
together, much preferred are complementary sections of
hook-and-loop fastener fabric mounted on opposite overlapping sides
of opposite body brace segments 12a and 12b at at least the free
ends thereof. In a preferred embodiment illustrated in FIGS. 1 and
2, complementary portions of hook-and-loop fabric are represented
by numeral 16b and 16c. In addition to such material being capable
of withstanding a large amount of shear stress so that the brace 10
may be kept under tension, the portions of the brace body 12
secured to one another may be easily peeled away when the apparatus
is to be taken off. Furthermore, such material allows the free ends
14a and 14b to be removably attached to one another in a variety of
positions and with the possibility of incremental adjustment,
attributes not typically found in fastening systems frequently
encountered in garments. In addition to providing such
complementary portions of hook-and-loop material at the free ends
14a and 14b of the brace body segments 12a and 12b, respectively,
horizontal strips 16a of hook-and-loop are arranged on the exterior
surface of each brace body segment to allow for removably securing
handles attached to the ends of the cable 28 used in the individual
tension adjusters.
[0036] The preferred tension adjusters used to custom fit the
orthotic devices of the present invention to the profile of the
individual wearer of these orthotic devices are shown in preferred
embodiments illustrated in FIG. 14. Thus, the preferred means of
individual adjustment and custom fitting of the orthotic devices of
the invention include at least two independent pulley sets 20. Each
set of pulleys includes a pair of opposing banks of pulleys (an
upper set including banks 22a and 22b and a lower set including
banks 24a and 24b). Each bank includes a plurality of individual
pulleys 26 (illustrated in FIG. 4) and a cable 28 is looped
serially and in alteration around the pulleys 26 and is fixed at
each end of the cable to a controlling device such as a handle,
designated as 30 (for the upper set of pulleys that includes pulley
banks 22a and 22b) and 32 (for the lower set of pulleys that
includes pulley banks 24a and 24b), so as, in effect to form an
endless cable. Although a cable which is anchored at one end, wound
around each of the pulleys in a series could be used to achieve a
suitable mechanical advantage and adjustment to accomplish the same
degree of adjustment of the endless cable of a preferred embodiment
of the invention, the cable would need to be pulled to twice the
length. This is not ergonomically desirable, nor even feasible, for
the great majority of patients.
[0037] The number of pulleys provided in each bank of pulleys is
determined by such factors as the amount of space provided for
pulleys within each bank and the mechanical advantage being sought.
The size of the particular bank of pulleys is determined in part by
the size of the orthotic device and manufacturing considerations.
Larger devices allow for concomitantly larger pulley sets and their
respective banks of pulleys. The appropriate mechanical advantage
is determined with a consideration of the strength of the user or
the type of ailment necessitating the use of the orthotic device,
the rigidity of the orthosis being adjusted, the volume of the
torso covered by the device, portion thereof being adjusted.
Generally, each pulley system used in the orthoses of the invention
is constructed with an appropriate number of pulleys to provide a
minimum of effort to achieve abdominal compression but not high
enough to cause injury by over-tensioning the orthosis. Typically,
this equates to a mechanical advantage for each pulley system in
the range of about 4:1 to about 30:1. For those devices which
require less effort to tighten, such as smaller orthoses and those
formed from compliant materials such as those used only to treat
the lumbar region of a patient, a mechanical advantage of about 4:1
to about 8:1 is preferred. For orthoses which are larger or are
constructed at least in part from rigid material, such as body
jackets, a mechanical advantage of about 6:1 to about 18:1 is
preferred. In orthotic devices which are very large or are
substantially rigid because of the rigid nature of the materials
from which they are constructed or the number of rigid component
parts, such as thoracic lumbar sacral orthoses, a mechanical
advantage of about 12:1 to about 30:1 is preferred.
[0038] As illustrated in FIGS. 1, 3 and 6, the ends of each cable
28 are preferably attached to a controlling or handle device for
each set of pulleys. The device may include an easily graspable
member, such as a cloth tab, loop, ring or bail. In the preferred
embodiments illustrated in FIGS. 1, 3 and 6, a bail shaped member
34, formed from metal or preferably plastic, either rigid or
flexible, is secured or formed as part of a tab member 36.
Preferably, the handle also includes a means of detachably securing
the handle 30 or 32 to a body brace segment after adjustment has
been made or the device has been removed from the wearer. Such
means of securing could include a series of clasps or a buckle and
strap arrangement. However, most preferred is a hook-and-loop
arrangement. In such a system, a piece of hook-and-loop fabric 38
is affixed to the underside of a portion of the handle such as
member 36. After adjustment has been made and the appropriate
tension has been established in the cable 28, the handle may be
releasably secured to a brace body segment 12a or 12b by placing
the hook-and-loop fabric portion 38 attached to the handle member
36 in contact with a portion of the complementary hook-and-loop
material 16a on the body brace segment 12a or 12b, as, illustrated
in FIG. 1. When a portion of hook-and-loop material is used as ;a
securing means on the handle it is preferred to use a thin
moderately flexible plastic, such as polyethylene, to form the
handle can be pulled to and conform to the side of the patient.
[0039] Each bank of pulleys 22a, 22b, 24 and 24b of the pulley sets
20 is secured to a portion of a body brace segment 12a and 12b
adjacent a juxtaposed body brace segment edge thereof (14c or 14d).
The proximate or juxtaposed edges 14c and 14d of the adjacent body
brace segments 12a and 12b may be joined together by a portion of
flexible pliant material which secures the juxtaposed edges 14c and
14c at opposite edges of the portion of pliant material or the
brace body 12 may be formed as a single unitary object including
brace body segments 12a, 12b and an intermediate section lying
there between. Preferably, however, brace body segments 12a and 12b
of the brace body 12 are separate, detached segments joined to one
another solely by cable 28. This allows for greater heat
dissipation by a wearer and facilitates disassembly and
cleaning.
[0040] Although the individual pulleys may be secured directly to
the material from which the brace body 12 is formed, it is much
preferred that they are secured to a plate, such as plate 40
illustrated in FIGS. 3 and 4. The plate 40 may be affixed to the
material from which the body brace segments are formed by any
convenient fastening means, such as rivets, staples, etc. However,
it is preferred that each bank of pulleys is formed as a modular
unit attached to the other bank of pulleys in the pulley set on the
opposing juxtaposed edge (14c or 14d) of the opposing brace body
segment by means of one of the cables 28. As a modular unit, the
plate 40 is detachably secured to a brace body segment 12a or 12b
by any convenient detachable fastening means, such as complementary
tabs and slots, hook-and-loop fabric, etc. Preferably, however,
mushroom shaped rivets or pins 42 having an exposed flanged portion
are placed near the edge portions 14c and 14d of each brace body
segment. Plates 40 of each pulley bank 22a, 22b, 24a, and 24b, are
provided with commensurately shaped and spaced key hole-shaped
slots 44 which detachably engage mushroom-shaped pins 42. The
dimensions of the narrow portions of each of the key hole-shaped
slots 44 are such that the plates 40 of each of the modular banks
of pulleys may be detachably mounted or dismounted on the pins 42
by applying a suitable amount of hand pressure. To provide
additional reinforcement, the pins may be affixed to a separate
flap 46 secured to the main brace body segment 12a or 12b.
Preferably flap 46 is made from a material having high tensile
strength which resists tearing and the pins 42 being pulled from
the flap. Preferably, the flap 46 has a rigidity equal to or
greater than the main portion of the body brace segments 12a and
12b.
[0041] Although each of the pulleys in a bank may be of the same
size and spaced from the next adjacent pulley, a greater force is
achieved. Accordingly, in situations where the nature of the
anatomy varies in the area over which the pulley set extends, an
embodiment such as that illustrated in FIG. 4 may be preferred.
Thus, pulleys with larger diameter spools and/or larger
center-to-center distances between spools may be placed at one end
of the pulley bank and the band may be oriented such that the
portion of the bank in which smaller pulley spools are located
and/or where the center-to-center distance between spools is
smaller is proximate to or superposed on the region of the anatomy
where the greatest resistance to compression exists.
[0042] By forming the pulley sets 20 as modular units which may be
detachably secured to the brace body segments 12a and 12b or flaps
46, allows facile removal of the component parts of the orthotic
device for cleaning. In addition, in the arrangement of the
orthosis shown in FIG. 1, the pulley sets are so arranged that
pulley bank 22b is arranged above pulley bank 24b with handles 30
and 32 arranged to extend to the same side of the orthosis and the
same brace body segment 12b. This is a typical arrangement for most
wearers of body braces (as shown in FIG. 6) since most individuals
exhibit greater strength in their dominant arm. However, based on
individual preference or where comparable strength exists in each
arm, some users may prefer an arrangement in which each arm
controls one of the cables attached to one of the handles 30 or 32,
to allow individual adjustment of each pulley set 20. This may be
easily accomplished with a preferred embodiment of the invention in
which modular pulley sets are employed since the individual pulley
banks may be detached from their corresponding pins and the pulley
set rotated 180.degree. in the plane of the extended orthosis to
allow reattachment of the pulley set 20 such that the handle 30 or
32 of the pulley set being repositioned is arranged to extend over
the opposite brace body segment.
[0043] Each pulley bank 22a, 22b, 24a and 24b includes a cover 48
removably attached to the base plate 40 by any convenient fastener
means, such as screws, bolts, recesses and engaging tabs, etc.
[0044] To apply appropriate support and pressure to portions of the
spine, as required by the patient's condition, a preferred
embodiment of the invention includes appropriately configured
lordotic pads 52, provided to adjust for lordosis, for the lower
curve of the back. These pads are positioned on the interior of the
orthotic device 10 adjacent the abutting edges 14c and 14d.
Although such pads may be permanently retained in the device by
sewing in place and/or by covering with a suitable material, it is
preferred that they be removably retained in the brace by
transverse elastic straps 50 disposed at positions on brace
segments 12a and 12b which allow the straps to transversely contact
and hold each pad at approximately the ends and mid points of each
orthotic pad. Preferably, each pad is formed from a high density
compressible, elastic foam material.
[0045] Although in many applications it may be unnecessary to
provide a lining on the interior surface of the brace body 12, to
achieve additional comfort, a liner is preferred, and most
preferred is one made of compressed foam. Preferably the liner is
easily cleaned and most preferably is removable for cleaning. A
particularly preferred liner is designated by numeral 54 and is a
perforated foam containing a "waffle" pattern in which the pattern
is defined by interconnecting channels or troughs that intersect at
the apertures to provide air circulation next to the body. A nylon
mesh may be used over the foam liner 54 to provide increased
rigidity as well as breathability.
[0046] In using this embodiment of the invention, the wearer merely
places the device 10 around the waist with the portion of the body
brace 10 having the pulley sets 20 arranged on the exterior surface
and to the rear of the user. The free ends 14a and 14b are arranged
one over the other in appropriate engagement. In the preferred
embodiment, this involves engaging the appropriate hook-and-loop
portions in facing relationship. Once the orthotic device is
secured around the torso, the wearer may then separately pull each
of the handles 30 and 32 to adjust the tension of the device to
provide the degree of comfort and conformity of the brace provided
by the separate adjustments of the pulley system. After adjustment,
the wearer merely presses the side of the handle with the
hook-and-loop material thereon against the complementary
hook-and-loop strip 16a on the brace body 12. When the user changes
body positions, tension of the individual pulley systems and of the
overall brace may be subsequently readjusted.
[0047] Although the orthotic devices of the present invention
permit custom fitting and adjusting over a wide range of
dimensional variables, it is preferred to provide the present
invention in a range of sizes to permit an orthotist to tailor
individualized fitting of the devices to a wide range of
individuals within different size and profile ranges. In a
preferred embodiment of the invention, an edge or bias binding 54
is provided to prevent the materials from which the brace body 12
is formed from fraying or, where several layers, such as a nylon
mesh and/or rigid outer layer and/or a foam cushioning liner are
provided, from separating of the adhered or laminated layers. In
another preferred embodiment of the invention, the orthoses do not
include a bias binding, thereby permitting the orthotist to cut the
brace body in order to custom fit the device to the user.
[0048] Another embodiment of the invention is shown in FIG. 7.
Although similar to the first embodiment in a number of respects,
including the provision of a plurality of adjustment means,
particularly preferred being a plurality of pulley sets, the
arrangement of the pulley sets and the number of segments of the
brace body differ from the first embodiment. In this embodiment,
the same reference numerals are used to represent the same or
similar elements as represented in the embodiments illustrated in
FIGS. 1-6. FIG. 7 shows a plan view of the exterior or outer side
of a second embodiment of the back brace apparatus in an extended
position. The brace 110 includes a brace body 112 made of the same
or similar materials discussed above with respect to the first
embodiment of the invention illustrated in FIGS. 1-6. In the
embodiment of the invention illustrated in FIG. 7, although two
pulley sets 120L and 120R are employed, rather than being arranged
vertically, one above the other, as in the embodiment illustrated
in FIGS. 1-3, this embodiment includes an arrangement where the
pulley sets are disposed horizontally and laterally. In contrast to
the first embodiment in which the pulley sets 20 are arranged
vertically and tension originates at the rear portion of the brace
by individually tightening the posteriorly arranged pulley sets,
the second embodiment of the invention includes pulley sets 120L
and 120R which are arranged laterally and which are disposed at the
sides of the device when the orthotic device 110 is placed on the
torso of the user. In addition, in contrast to the minimum of two
brace body segments 12a and 12b of the brace body 12 illustrated in
FIGS. 1 to 3, the brace body 112 of the second embodiment,
illustrated in FIG. 7, includes a minimum of 3 brace body segments:
a central brace body segment 112c, intended to be placed
surrounding the rear and the sides of the wearer and two distal or
free end brace body segments 112a and 112b, arranged in symmetrical
and juxtaposed relationship to central brace body segment 112c and
intended to be placed surrounding the sides and anterior portion of
the torso. Each of the brace body segments 112a, 112b and 112c may
be joined by flexible, pliant material, formed as a unitary
structure from the same piece of material or may be formed as
separate component parts, such as the options existing for the
first embodiment of the invention. Preferably, brace body segments
112a, 112b and 112c are formed as separate segments for reasons
similar to those mentioned above for the first segment. The
posterior segment 112c may be formed as a single unit or, as
illustrated in FIG. 7, preferably as two units joined at opposing
edges 114f and 114g. This reduces weight and permits better heat
dissipation.
[0049] The pulley sets 120L and 120R each consist of two pulley
banks which provide a means of adjusting the tension and distance
between the posterior brace body segment 112c and in each set one
of the two free end segments 112a and 112b. Thus, pulley 120L
includes pulley bank 122a, attached to brace body segment 112a
adjacent edge 114c and pulley bank 122b, attached to proximate,
juxtaposed brace body segment 112c adjacent edge 114e. A cable 28
runs serially and in alteration through the pulleys of each of the
pulley banks 122a and 122b, thereby operatively connecting each of
the banks in the pulley set 120L. The ends of the cable are
attached to a handle, such as handle 130 which is provided with
features similar to handle 30 of the first embodiment. Likewise,
pulley set 120R includes pulley banks 122c and 122d, affixed to
proximate, juxtaposed facing portions of brace body segments 112c
and 112b, respectively, at juxtaposed edges 114f and 114d,
respectively. A cable 28, operatively connects the cable banks of
122c and 122d of pulley set 120R serially and in alteration, the
ends of cable 28 being attached to a handle 132 similar to or the
same as handles 30 and 32 of the first embodiment or 130 of this
embodiment. Since the pulley sets in this embodiment are arranged
horizontally and laterally rather than vertically, one above the
other, as in the first embodiment, it is preferred that the pulley
sets 120L and 120R, and their concomitant handles 130 and 132, be
so arranged that they are pulled from opposite sides of the body
rather than the same side of body. However, where the condition of
the user so requires, and where the preferred embodiment of the
device includes modular pulley sets, preferred as in the first
embodiment, one of the pulley sets may be detachably removed from
its respective brace body and rotated 180.degree. in the plane of a
brace body segment so that both handles may be pulled from the same
side of the body.
[0050] Orthotic device 110 may be provided with similar fastening
or closure means as used in the orthosis 10. Preferably, the means
for both closure and fastening around the torso of the individual,
as well as gross adjustment of the device, and preferably for
securing of the individual handles 130 and 132 is provided by
hook-and-loop fabric portions. As in the first embodiment, the
hook-and-loop portions used for fastening and gross adjustment of
the device may be provided at the free or distal ends of the brace
body segments such that they are in superposed relationship when
the free ends overlap. In the embodiment shown in FIG. 7, the
portions of hook-and-loop material are provided near the free edges
114a and 114b at appropriate positions and on the interior and
exterior surfaces of the device and also appropriately positioned
to detachably secure handles 130 and 132. In addition, edges 114a
and 114b of brace body segments 112a and 112b, respectively may be
configured more closely to the shape of edges 14a and 14b of the
first embodiment illustrated in FIGS. 1 and 2, particularly when
orthosis 110 is used as a stand alone device. That is, edges 114a
and 114b may be shaped in the form of projecting tabs which allow
brace body segments 112a and 112b to more fully overlap one another
and more easily engage a fastening and closure means provided at
the free ends of these segments. The configuration of the free end
brace body segments 112a and 112b shown in FIG. 7 are quite
compatible, however, with another embodiment of the invention
discussed below.
[0051] As indicated above, depending upon the particular ailment or
medical condition of the patient, the orthoses of the present
invention my be formed from either flexible materials or rigid
materials. In both of the previously discussed embodiments of the
invention, when a rigid body jacket is desirable, either portions
of, or the entire device, may be formed of a rigid plastic
material, in which the rigidity of the plastic is selected based
upon the amount of patient body flexure which can be tolerated for
the ailment or prescribed treatment procedure of the user of the
device. In many instances, all or a portion of the orthosis,
particularly the rear portion of the device, is formed from a rigid
plastic material. This is true for rigid body jackets. In many
instances, as a result of surgery, forward flexure of the patient
is to be minimized or substantially eliminated. In such instances,
a physician may prescribe a thoracic lumbar sacral orthosis (TLSO),
which is intended to prevent forward flexure of the upper portion
of the torso. The body braces of the present invention may be used
with additional component parts to form TLSOs which are both easily
donned and doffed and include multiple means of adjustment which
allow the devices to be individually and separately adjusted to
provide extensive posterior and anterior adjustment options, as
well as assuring that certain portions of the body brace conform to
the profile and body dimensions of the wearer. Although the
preferred TLSO orthosis of the invention is discussed herein in
terms of a combination with the body brace device 110, shown in
FIG. 7, it should be understood that similarly constructed and
arranged devices, discussed below, may also be used in conjunction
with all of the body braces discussed herein, such as body brace
10.
[0052] The three component parts used in addition to and in
conjunction with the previously described body brace type of
orthotic devices of the invention to form the TLSO devices of the
invention include the component parts illustrated in FIGS. 8 to 11.
These components include sternal notch piece 260, shown in FIGS.
10, 12 and 13. The sternal notch piece 260 includes a rigid
adjustment piece 262 formed form a metal such as steel or a rigid
high tensile strength plastic. The adjustment piece 262, formed as
a post, is provided with adjustment apertures 264 to allow
positioning of the sternal notch piece. Attached to the upper
portion of the adjustment piece 262 of the sternal notch piece is a
body connecting piece, 266, formed as one or two segments intended
to contact the sternum region of a patient when the TLSO is worn.
On the inner surface of the body contacting piece 266 is affixed
compressible elastic foam pads (not shown). The body contacting
piece 266 is pivotally secured to the post 262 by means of a
hinge-like arrangement including a rod or a spindle 268 disposed
transverse the body contacting piece 266 and formed as part of or
secured at the rear thereof at both ends of the rod 268, the rod
being in turn secured to the adjustable post 262 by means of a
sleeve and/or clamp 269 attached to the adjustment piece 262 and
which encircles the rod 268 at approximately its midpoint.
[0053] A substantially rigid breast plate or front piece 270 (shown
in FIGS. 10 and 11) is used to movably secure the sternal notch
piece 260 to the TLSO. Front piece 270, formed from a rigid plastic
material, such as polyethylene, includes an adjustment piece
receiving portion 272 arranged vertically in the front piece. The
adjustment piece receiving portion 272 includes a channel formed
therein (not shown) commensurate in shape and length to slidably
receive adjustment post 262 of the sternal notch piece 260. Placed
intermediate the channel entranceway of the adjustment piece
receiving portion 272, and the bottom of the adjustment piece
receiving portion 272 is provided an aperture engaging device 274
intended to engage adjustment apertures 264 of the adjustment post
262. Preferably, the aperture engaging device 274 is a
mushroom-shaped spring loaded pin, the free end or tip of which may
be retracted partially from the post receiving portion channel
against the tension of the spring by pulling outwardly on the
exposed head of the pin to disengage the tip of the pin from
apertures 264. Release of the pin to a biased position permits
engagement of the tip of the pin 274 with a specific aperture 264.
By pulling outwardly on the pin 274, the pin is released from an
aperture and the adjustment post 262 may be slidably repositioned
and the pin therefore released in order to bias against the
adjustment post. If the pin does not immediately engage an aperture
264 in the post 262, the post may be raised or lowered to the
nearest suitable position.
[0054] At the lateral upper portions of the body contacting piece
266 are located strap engaging members 269, formed preferably as
slotted tabs which are pivotally secured to the body contacting pad
266 such that they rotate substantially in the plane of the pads.
The strap engaging members 269 are intended to engage or retain
straps 282 (shown in FIGS. 8, 9, 12 and 13), which are secured to a
back piece 280 by strap retainers 284, which may be the same or
similar to strap engaging members 269, thereby removably securing
the front piece 270 to the back piece 280. The straps or belts 282
include buckles or other adjustment means (not shown) which allow
for gross adjustment to fit the wearer of the orthotic device. The
distal or free ends 286 of the straps 282 pass through the slots of
the strap retainers 269 of the body contact pieces 266. The straps
282 and/or the free ends 286 of the straps include fastening means
(not shown) to secure the straps 282 which have passed-through the
strap retainers 269. Suitable fasteners including buckles, snaps
or, preferably, complementary hook-and-loop fabric fasteners,
secured at appropriate positions to the straps, such that when the
free ends of the straps have passed through the slots of the strap
engaging members 269 and folded back on themselves, they are
removably secured thereto.
[0055] The back piece 280 may be formed from materials similar to
those from which the front piece is formed. Each of the front and
back pieces is preferably formed from a rigid plastic material that
yields to bending under sufficient pressure but which has a memory
and springs back to its original shape when pressure is released.
The rigidity of the front piece 270 and back piece 280 must be
sufficiently high that when the TLSO is properly placed on the
patient in combination with a body brace of the invention, and the
sternal notch piece 260 is appropriately adjusted, forward movement
of the torso, particularly the upper part of the torso, is
minimized or prevented. Plastic materials such as nylon and
polyethylene are preferred. Portions of the front piece 270 or back
piece 280 may also include a mesh material, such as nylon mesh to
provide breathability. Both the front piece and the back piece may
include a cushioning liner at the surface of the component pieces
intended to be placed in contact with the wearer. Preferably the
cushioning liners are formed from a dense, substantially
non-compressive type of foam and preferably have a foraminous
waffle structure, preferably of the type discussed above. Such
liners may be formed or laminated to the inner surfaces of the
front piece 270 or back piece 280 or may be formed as separate
removable liners which are detachably secured to the interior
surfaces of the front piece 270 and the back piece 280 by suitable
fasteners such as snaps or complementary portions of hook-and-loop
material. It is preferred that the removable feature be
incorporated into the device to permit ease of cleaning.
[0056] As illustrated in FIGS. 7 and 8, the back piece 280 is
provided with two lateral wing portions 288 having a
cross-sectional configuration that is generally curved to broadly
conform to the size of a human torso. Each of the lateral wing
portions 288 is formed from a moderately rigid plastic material,
such as nylon mesh to increase breathability, and which has a
configurational memory, in that it may be temporarily bent or
flexed to a substantial degree but it reverts its original
configuration when forces causing such temporary deformations are
removed.
[0057] The inner surface of the back piece (as shown in FIG. 8)
includes elastic retention straps 250 sewn at appropriate locations
to allow for the retention and removal of lordotic pads of the type
discussed above in connection with the first embodiment of the
invention. Front piece 270 and back piece 280 may be provided with
detachable retaining means and/or fasteners proximate to the
lateral edges thereof such that the body brace 110 (or 10) is
retained in the appropriate position when the TLSO is assembled.
Preferred are strips of hook-and-loop material 271 and 281 placed
on the exterior surfaces proximate to the lateral edges of the
front and back pieces 270 and 280, respectively. These strips of
hook-and-loop material engage complementary portions of
hook-and-loop material adhered at appropriate corresponding
locations on the interior surface of the body brace 10 or 110.
[0058] When preferred embodiments of the invention are employed,
the adjustment piece 262 of the sternal notch piece 260 is placed
in the channel of the front piece 270. The straps 282 of the rear
piece 280 are threaded through the slots of the strap retention
pieces 269 and secured, thereby joining the front piece 270 to the
rear piece 280.
[0059] In using the TLSO devices of the present invention, the TLSO
component parts e.g., the front piece 270, sternal notch piece 260
(FIG. 10) and back piece 280 (FIGS. 8 and 9), are joined and
thereafter the assembled components are placed on the wearer. The
components are adjusted to the wearer, as indicated above, and a
body brace, preferably body brace 110, is fitted around the torso
of the wearer and secured in place with the fastening means
provided. When an embodiment of the invention that includes a
hook-and-loop fastening system is employed, the body brace 110 is
merely pressed in place to secure the orthosis. To doff the device,
of a body brace end segment, lateral edge such as 114a or 114b, is
pulled away from the front piece 270 and the donning process is
reversed. To assist in the removal process, a preferred embodiment
provides a grasping member such as D-shaped ring 118 held in place
with a strip of cloth sewn in place at lateral edges of each body
brace end segment (e.g., 114a and 114b). The D-shaped rings 118
allow the wearer to firmly grasp and pull the edges more
positively.
* * * * *