U.S. patent application number 13/631424 was filed with the patent office on 2013-08-01 for adjustable dorsal night splint.
This patent application is currently assigned to DJO, LLC. The applicant listed for this patent is DJO, LLC. Invention is credited to Carl Hoffmeier, Tracy Ng.
Application Number | 20130197413 13/631424 |
Document ID | / |
Family ID | 44658868 |
Filed Date | 2013-08-01 |
United States Patent
Application |
20130197413 |
Kind Code |
A1 |
Hoffmeier; Carl ; et
al. |
August 1, 2013 |
ADJUSTABLE DORSAL NIGHT SPLINT
Abstract
A dorsal night splint has dynamic adjustable features that allow
the patient to adjust the splint while in use to control the
stretching of the plantar fascia and Achilles. A semi-rigid
flexible frame is included along with a tightening strap that is
anchored to the frame and by which the patient can tension the
strap and adjust the structure of the frame to fit the patient's
desired therapeutic or prophylactic needs.
Inventors: |
Hoffmeier; Carl; (Solana
Beach, CA) ; Ng; Tracy; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DJO, LLC; |
Vista |
CA |
US |
|
|
Assignee: |
DJO, LLC
Vista
CA
|
Family ID: |
44658868 |
Appl. No.: |
13/631424 |
Filed: |
September 28, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12879818 |
Sep 10, 2010 |
8409123 |
|
|
13631424 |
|
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Current U.S.
Class: |
602/28 |
Current CPC
Class: |
A61F 5/0585 20130101;
A61F 5/30 20130101; A61F 5/0113 20130101; A61H 1/0266 20130101;
A61F 5/58 20130101 |
Class at
Publication: |
602/28 |
International
Class: |
A61H 1/02 20060101
A61H001/02 |
Claims
1-24. (canceled)
25. A splint for stretching a wearer's plantar fascia, comprising:
a frame having: a first portion that extends along a wearer's lower
leg; a second portion that extends along a wearer's foot; and a
bend portion that spans between the first and second portions; and
a tightening strap that extends between the first and second
portions, wherein adjustment of the tightening strap stretches the
wearer's plantar fascia.
26. The splint of claim 25, wherein: the first portion extends away
from the bend portion to a first end; the second portion extends
away from the bend portion to a second end; and adjustment of the
tightening strap changes a distance between the first and second
ends.
27. The splint of claim 26, wherein adjustment of the tightening
strap flexes or relaxes the bend portion.
28. The splint of claim 27, wherein the tightening strap has a
first strap end that anchors to one of the first and second
portions and a second strap end that is pulled by the user to
tighten the splint.
29. The splint of claim 28, further comprising a receptacle
positioned on one of the first and second portions of the frame,
wherein the strap loops through the receptacle.
30. The splint of claim 29, wherein: the receptacle is positioned
on the second portion of the frame; and the tightening strap
comprises: a first section that extends from the first portion of
the frame; a second section that loops through receptacle; and a
third section that extends toward the first portion of the frame
and secures to the first section.
31. The splint of claim 30, wherein the first section of the
tightening strap is riveted to the first portion of the frame.
32. The splint of claim 25, further comprising a pull tab at a
distal end of the tightening strap.
33. The splint of claim 32, wherein the pull tab is secured to the
tightening strap to maintain stretching of the wearer's plantar
fascia.
34. The splint of claim 33, further comprising a hook and loop
mechanism that secures the pull tab to the tightening strap.
35. The splint of claim 33, wherein the pull tab is secured to the
tightening strap at a point that is midway between the first and
second portions of the frame.
36. The splint of claim 25, further comprising a forefoot support
pad attached to the second portion of the frame.
37. The splint of claim 36, wherein the forefoot support pad is
releasably attached to the second portion of the frame by a hook
and loop mechanism.
38. The splint of claim 36, wherein the forefoot support pad
includes a distal lift area that fits under the user's toes and a
proximal support area that fits behind the ball of the user's foot,
wherein the distal lift area is thicker than the proximal support
area.
39. The splint of claim 38, wherein the forefoot support pad
includes a trough spaced between the distal lift area and the
proximal support area for receiving the ball of the user's
foot.
40. The splint of claim 25, wherein each of the first portion,
second portion, and bend portion of the frame are made of a
semi-rigid material that bends upon application of a force by the
tightening strap and sturdy enough to resist the force in a
controlled manner.
41. A method of applying a splint to stretch a wearer's plantar
fascia, comprising: securing a first portion of the splint to the
wearer's lower leg with a first attaching strap; securing a second
portion of the splint to the wearer's lower leg with a second
attaching strap; and adjusting a tightening strap, wherein
adjustment of the tightening strap flexes a bend portion of the
splint that spans between the first and second portions and
stretches the wearer's plantar fascia.
42. The method of claim 41, wherein adjusting the tightening strap
comprises pulling a distal end of the tightening strap and securing
the distal end to the tightening strap.
43. The method of claim 42, wherein the distal end is secured to
the tightening strap by engaging a hook and loop mechanism.
44. The method of claim 42, wherein pulling the distal end
comprises pulling the distal end towards the first portion of the
splint.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. patent
application Ser. No. 12/879,818, filed Sep. 10, 2010, which is
hereby incorporated by reference herein in its entirety.
BACKGROUND
[0002] Plantar fasciitis is a painful condition that arises when
the plantar fascia under a patient's arch become strained or
over-stretched. The condition can be particularly painful after
extended rest periods during which the fascia stiffen and tighten.
When the patient stands after that rest period, the stiffened
fascia are pressed by the force of the patient's weight, causing
further pain.
[0003] Various devices have been used to treat this condition,
typically employing a stiff frontal frame that fits against the
front of the patient's leg and extends in an L-shape along the
patient's forefoot, being held to the patient by straps that wrap
around the patient's leg and foot. An example is the dorsal night
splint disclosed in U.S. Pat. No. 5,776,090 to Bergman. The Bergman
splint includes a frame held to the anterior side of a patient's
lower leg by straps. The frame has stiffening ribs that permit it
to hold its shape and is bent, prior to the patient putting it on,
so the frame's forefoot and foreleg portions are held at a pre-set
angle.
[0004] A variation in the Bergman splint is disclosed in U.S.
Patent Application Publication No. 2008/0208094 of Gaylord. The
Gaylord splint has an adjustable stabilizing frame that is also
pre-bent to a predetermined angle, and a soft sheet of fabric with
tensioning arms that wrap around the perimeter of the leg and frame
to anchor the frame to the lower leg. Another example is the
Exoform.RTM. Dorsal Night Splint sold by Ossur. That splint
includes a soft attachment system and a metal plate within a
plastic housing. The splint is bent by the patient into a pre-set
L-shaped form, prior to application, with the splint retaining this
pre-set angle during use. Another variation is disclosed in U.S.
Pat. No. 7,682,325 to Chan, which includes a plate that has an
accordion-like middle section and is bent into a pre-defined
shape.
[0005] The frames used in the foregoing products and other similar
technologies are cumbersome and are adjustable by the patent only
before the frames are applied to the leg. If the splint does not
fit properly, it must be removed before it can be adjusted, which
takes more time and can lead to reduced patient compliance.
[0006] Some technologies have attempted to provide more
adjustability to the device. One example is disclosed in U.S.
Patent Application Publication No. 2009/0264803 of Darby et al.,
which includes a flexible frame with a toe strap used to elevate
the patient's toes to relieve pain in the plantar fascia. That
structure provides no ability for the patient to adjust the frame
while positioned on the foot, and thus may not provide for a
sufficiently deep stretch of the plantar fascia.
[0007] An improved system is needed to address these and other
deficiencies, to achieve better fitting splints that can improve
patient therapy and produce greater patient compliance.
SUMMARY
[0008] Disclosed herein is a contoured, padded splint to be applied
to the foot and lower leg of a patient for treatment of plantar
fasciitis and Achilles tendinitis. The splint is formed as a brace
that is dynamic and adjustable by the patient, after being placed
on the patient, allowing the patient to achieve tailored flexion
and optimal comfort for addressing these conditions. Patients can
sleep at night and start their day with fascia that have been
stretched and prepared for walking.
[0009] The splint generally includes a semi-rigid flexible frame
configured to be applied along the ventral (or anterior) side of
the foot and lower leg, and a tightening strap configured to allow
the patient to tighten the splint to stretch the plantar
fascia.
[0010] In certain implementations, the splint includes a semi-rigid
flexible frame with a top side and an under side, the frame forming
a proximal surface that extends vertically along a user's shin and
upper ankle, and a distal surface that extends along the top of the
user's foot. The proximal surface has a first receptacle,
positioned centrally along the face, for engaging a tightening
strap, and the distal surface has a second receptacle for also
engaging a tightening strap.
[0011] The tightening strap is an inelastic adjustable strap that
engages the first and second receptacles and is configured to be
tightened by hand after the splint is placed on the patient's lower
leg. The tightening strap can be formed in a pulley system, with an
extending end. The patient tightens the strap by pulling on the
extending end and, as the extended end is pulled, the proximal
surface and distal surface are pulled toward each other, thereby
stretching the user's plantar fascia under the arch and heel. The
proximal and distal surfaces of the frame are then anchored in a
fixed position relative to each other by securing the tightening
strap.
[0012] A soft housing is also included to fit under the user's foot
and attach the frame to the user's lower leg. In certain
embodiments, the soft housing is made of laminate, Neoprene or
other fabric.
[0013] In certain implementations, the splint includes a forefoot
support pad positioned between the user's toes and the soft
housing. The forefoot support pad is configured to fit comfortably
to the patient's toes and the ball of the foot. In certain
examples, the forefoot support pad includes a distal lift area that
fits under the toes, a proximal support area that fits behind the
ball of the patient's foot, and a trough between the support areas
which holds the ball of the patient's foot.
[0014] In certain examples, an adjustable toe strap is included to
attach to the soft housing and extend around the distal end of the
patient's toes and connect with the distal surface of the frame. In
certain examples, the toe strap is configured with an attachment
mechanism, such as a D-ring, that allows it to inter-fit with the
attachment strap and be secured to the frame by operation and
tightening of the attachment strap. In certain examples, a liner or
support pad is also used to fit between the frame and the patient's
leg, thereby providing comfort and enhanced wearability. In certain
implementations, the support pad is made of open cell foam to
provide air circulation and moisture wicking.
[0015] The frame of the splint may be configured with receptacles,
including slots, and hinge mechanisms that receive tightening
straps and serve as anchoring points for securing the splint to the
patient. In certain examples, the frame includes one or more hinged
flaps that extend along lateral and medial edges of the frame, and
each flap has a through-hole or slot that receives tightening
straps to help adjust and fit the splint to the patient. The frame
may also include tapered or cut-out sections that allow the frame
to contour to particular anatomical locations on the patient, such
as the ankle region.
[0016] Various alternative embodiments and sub-features are also
disclosed herein with respect to the splint, as will become
apparent in the following description.
BRIEF DESCRIPTION OF THE FIGURES
[0017] Exemplary implementations of the dorsal night splint are
described and shown below in the following figures, where like
numerals represent like structures in repeating figures.
[0018] FIG. 1 depicts an exemplary embodiment of a dorsal night
splint, applied to a patient's lower leg.
[0019] FIGS. 2A and 2B show top and under side views, respectively,
of the frame used in an exemplary dorsal night splint according to
the disclosure herein.
[0020] FIGS. 3A and 3B show underside views of the frame of FIGS.
2A and 2B, with an attachment mechanism.
[0021] FIGS. 4A and 4B show additional implementations and
embodiments of the frame and strapping systems of FIG. 1.
[0022] FIG. 5 shows an implementation of a dorsal night splint
having a soft housing and brace componentry in an unattached
configuration.
[0023] FIG. 6 depicts the dorsal night splint of FIG. 5 in an
attached configuration.
[0024] FIG. 7 depicts a support pad being used in a dorsal night
splint.
[0025] FIGS. 8A and 8B depict examples of the support pad of FIG. 7
in a dorsal night splint.
DETAILED DESCRIPTION
[0026] Disclosed herein is a contoured, padded splint to be applied
to the lower leg of a patient for treatment of plantar fasciitis
and Achilles tendinitis. The splint is dynamic and adjustable by
the patient, allowing the patient to achieve tailored flexion and
optimal comfort for addressing these conditions. Wearing the splint
allows patients to sleep comfortably at night and start their day
on a better foot.
[0027] The splint includes a semi-rigid flexible frame configured
to fit along the ventral (anterior) side of the foot and lower leg,
and an inelastic tightening strap configured to allow the patient
to tighten the splint and stretch the plantar fascia.
[0028] An exemplary embodiment of the splint is shown in FIG. 1 as
the splint 100. The splint 100 has a flexible, semi-rigid frame 102
that is applied to a user's lower leg by a flexible soft housing
114 that wraps around the dorsal (posterior) side of the foot and
anchors the frame 102 to the leg. As shown, the frame 102 fits over
a support pad 140 that cushions the frame 102 against the leg. The
pad fits between the patient and the frame 102 and cushions the
patient's leg with respect to the frame 102. In certain
implementations, the support pad 140 is made of a layer of
open-cell foam affixed to a closed-cell foam liner, the closed cell
foam liner having hook-and-loop material that attaches to
complementary hook-and-loop material on the under side of the frame
102. The open cell foam of the pad 140 provides for air circulation
to cool the patient and moderate moisture within the brace, thus
improving its usability for nighttime wear. A flexible strap 120 is
also included, extending from the distal surface 106, in front of
the patient's foot, over the distal tip of the pad 140 and
connecting to the splint on the bottom side of the soft housing
114.
[0029] The frame 102 includes a proximal surface 104 that fits
along the user's lower leg, a distal surface 106 that fits along
the user's foot, and a bend 105 that spans between the proximal and
distal surfaces. A tightening strap 108 with pull tab 109 extends
between the proximal surface 104 and the distal surface 106 of the
frame 102, allowing the patient to adjust and tighten the splint by
hand while it is applied to the patient's leg, as explained more
fully below. The frame 102 is constructed of a semi-rigid but
flexible material, which can bend upon the application of a force
applied by a tensioning strap but is also sturdy enough to resist
that force in a controlled manner, unlike a cloth or sock which
would simply fold or stretch when the force is applied. In certain
implementations, the frame is made of flexible polypropylene by
injection molding, but lightweight aluminum or other semi-rigid
materials could also be used.
[0030] FIGS. 2A and 2B illustrate the frame 102 and its cross strap
108 in further detail. As shown in FIGS. 2A and 2B, the frame 102
has a plurality of hinged flaps 121 and 125 and slots 116 and 118
positioned along respective edges of the frame. In certain
embodiments, the hinged flaps and slots are co-molded with the
frame and integral to the polypropylene material of the frame. As
shown, the flap 121 is connected to the edge 131 of the frame by a
thin piece of plastic 123, which because of its thin cross section
can bend as a hinge point. Similarly, the flap 125 is connected to
the edge 135 of the frame by a thin plastic hinge section 127. The
edge 135 forms a cut-out or narrowing section of the frame,
providing the carve-out section 133 of bend area 105 that tapers in
toward the center of the frame, for a more particular and
comfortable fit around the user's ankle. The slot 113 is formed
along the edge of the distal surface of the frame by a raised ridge
175 that extends above the distal surface of the frame. Similar
structures are also included on the opposite side of the splint. As
explained below, the hinged flaps and slots receive straps from the
soft housing 114 to help secure the frame 102 to the leg.
[0031] The frame also has receptacles 110 and 112, located
centrally across the top side of the frame, for engaging the
tightening strap 108. The tightening strap 108 is made of nylon or
other inelastic material and is folded into a plurality of sections
that loop through the receptacles and fold back upon each other,
forming a pulley and anchoring system. As shown in FIG. 1, the
strap 108 extends directly between the proximal surface 104 and the
distal surface 106, bypassing the bend 105, which creates a large
space 153 between the strap 108 and the bend 105 along the upper
surface 102a of the frame. The spacing and anchoring, and the
inelasticity of the strap, allow the patient to secure and tighten
the frame by hand while wearing it, thereby adjusting the tension
on the plantar fascia and Achilles.
[0032] More particularly, as shown in FIGS. 3A-3B and 4A-4B, the
strap 108 has a top section 108a, a bottom section 108b, a distal
end section 108c, a proximal end section 108d and a section 108e.
The receptacle 112 includes three slots 112a, 112b, and 112c, and
the receptacle 110 includes slots 110a and 110b. The proximal end
section 108d of the strap 108 is riveted to the under side 102b of
the distal surface 106 of the frame 102, creating an anchor point
at the rivet 114, and the strap 108 extends through slot 112a at
the bottom section 108b. The bottom section 108b extends above the
exterior of the frame 102 toward the proximal surface of the frame
102, spaced above the top side 102a (and the bend 105), and
protrudes into the slot 110b, forming a fold that loops underneath
the proximal surface 104 and then back through the slot 110a. The
top portion 108a of the strap extends back across the exterior face
of the frame, toward the distal surface of the frame, and into the
slot 112b. After passing through slot 112b, the section 108e of the
strap 108 forms another fold that passes under the under side 102b
of the distal portion of the frame 102 and extends through the slot
112c. After passing through the slot 112c, the strap section 108c
extends out the front of the brace where it is received by the
patient for tightening. As shown, the pull tab 109 is positioned on
one side (or may surround) the distal tip of the strap section
108c.
[0033] To tighten the brace, the patient pulls the tab 109 toward
him or herself, which pulls the section 108c and in turn pulls the
section 108a and then the section 108b. Because of the anchoring of
the section 108d against the rivet 114, pulling the strap tightens
and lifts the distal surface 106 toward the proximal surface 104,
as illustrated by the directional arrow 151 of FIG. 1, thereby
lifting the patient's forefoot toward the shin to stretch the
fascia tissue on the underside of the foot. The distal surface is
drawn toward the proximal surface until the two surfaces reach a
desired relative position, whereupon the patent attaches the pull
tab 109 to the remainder of the strap 108 (e.g., by Velcro or other
hook-and-loop attachment) to anchor the strap and the two surfaces
in that position. As shown, the tab 109 is secured to the surface
108a of the strap at a position located between the receptacles 110
and 112 (e.g., a mid-way point), which centers the force applied by
the distal and proximal surfaces of the frame between the two
receptacles. The two surfaces are thereby anchored in the relative
position, having a fixed angle between them which angle can be
adjusted by the user while wearing the splint. The tensioning strap
108 thus allows the patient to easily adjust the structure of the
frame itself to a desired position and tension while in use. The
user can thereby select and apply a constant stretching force to
the plantar fascia.
[0034] Also shown in FIGS. 3A and 3B, on the underside 102b of the
frame 102, sections 150, 152, 154, 156, and 158 contain Velcro or
other hook-and-loop attachment mechanisms and are included to
connect the support pad 140 (which has complementary hook-and-loop
materials on its surface) to the frame 102.
[0035] FIG. 4A further illustrates the forefoot strap 120. The
strap 120 further lifts and supports the plantar fascia and the
Achilles tendon. The strap 120 is configured with a D-ring 122 on
an end thereof. The D-ring receives the distal section 108c of the
strap 108. Thus, when the strap 108 is tightened by pulling the tab
109, the D-ring 122 is pulled tight against the splint by the strap
108, thereby anchoring the strap 120 to the strap 108. The distal
end 160 of the strap 120 is anchored by Velcro or another
attachment mechanism to the bottom side of the soft housing 114.
When so anchored, the strap 120 extends from the bottom of the
housing 114 across the front of the support pad 140, arcing over
the patient's toes and anchoring to the top side of the soft
housing 114.
[0036] As noted above, the frame 102 is secured to the patient's
leg by the flexible housing 114. The flexible housing 114 is
preferably made of laminate material including 0.050'' thick
open-cell foam sandwiched between two layers of UBL (unbroken loop,
a material that mates with hook material, e.g., from Velcro), the
combination of which forms a soft, comfortable, breathable wrap
that is easily attachable and detachable by the user. Other soft
materials, such as Neoprene, may also be used. In use, the flexible
housing 114 fits around the dorsal side of the patient's foot and
lower leg. In the illustrated implementations, the housing 114 has
attachment straps and hook-and-loop attachment surfaces for
securing it to the frame 102. As shown more particularly in FIG. 5,
the housing 114 includes the straps 115, 117, and 119, each strap
having an analogous strap on the opposite side of the housing 114.
As shown, the strap 115 has an end 115a and an end 115b. The end
115a fits within the slot 116a of the hinged flap 121. The strap
end 115b fits within the corresponding slot 116b on the opposite
side of the frame. Similarly, the strap 117a fits within the slot
118a of the hinged flap 125a, and the strap 117b fits within the
slot 118b of the hinged flap 125b. The strap 119 fits within the
slot 113, which has a raised ridge 170a that rises above the distal
surface of the frame. The raised ridge 170a forms a tunnel through
which the strap extension 119a can pass. A similar structure is
used on the opposite side of the splint 100 for the receipt and
tightening of the strap 119b. In use, the straps are inserted
within their respective slots, from the under side 102b of the
brace, and pulled up through the slots and folded and secured back
upon themselves with the hook-and-loop connection. When fully
assembled, the straps are fitted with respect to the frame as shown
in FIG. 6.
[0037] As shown in FIGS. 7 and 8A-8B, a forefoot pad 130 may also
be used with the splint to help provide support for the patient's
toes and the ball of the foot, further enhancing support for the
plantar fascia. The foot pad 130 is placed underneath the foot and
within the inner surface of the housing 114 and is releasably
connected to the housing 114 by hook-and-loop material or another
releasable attachment mechanism. As shown, the forefoot pad 130
includes an upper section 132, a lower section 134, and a trough
136. The upper section 132 is positioned to fit underneath the
patient's toes, the lower section 134 is positioned to fit behind
the ball of the patient's foot and support the upper arch, and the
trough 136 is positioned to receive the ball of the foot. As shown
in FIG. 8B, the upper section 132 has a thickness 135 that is
greater than the thickness 133 of the lower section 134. The upper
section 132 thus provides a distal lifting area, and is configured
to lift the patient's toes higher than the upper arch would be
lifted by the lower section 134. This distal lifting area works in
concert with the toe strap 120, as well as the cross strap 108, to
support the plantar fascia. The lower section 134 provides a
proximal support area for the region of the patient's foot
immediately behind the ball.
[0038] FIG. 7 shows the assembled and attached splint structure of
FIG. 6 having the strap 119 released and opened, and showing the
insertion of the forefoot pad 130. As shown and described above,
the forefoot pad 130 fits underneath the patient's foot, and
supports the toes and ball of the foot as described above. After
insertion of the pad, the strap 119 is then connected to the frame
as described above to secure the frame (and the forefoot pad 130)
to the patient.
[0039] It is to be understood that the forgoing description is
merely illustrative. While several embodiments have been provided
in the present disclosure, it should be understood that the
disclosed systems, components, and methods may be embodied in many
other specific forms, variations and modifications without
departing from the scope of the present disclosure.
[0040] The disclosed features may be implemented in
sub-combinations with one or more other features described herein,
and the various features described or illustrated above may be
combined or integrated in other systems or certain features may be
omitted, or not implemented. A variety of orthopedic bracing
products may be implemented based on the disclosure and still fall
within the scope.
[0041] Examples of changes, substitutions, and alterations could be
made by one of skill in the art without departing from the scope of
the information disclosed herein. Certain particular aspects,
advantages, and modifications are within the scope of the following
claims. All references cited herein are incorporated by reference
in their entirety and made part of this application.
* * * * *