U.S. patent application number 11/147196 was filed with the patent office on 2005-10-13 for low cost orthosis for toe injuries.
Invention is credited to Rolnick, Michael A., Van Wyk, Robert A., Warden, Matthew Perry.
Application Number | 20050223597 11/147196 |
Document ID | / |
Family ID | 46304693 |
Filed Date | 2005-10-13 |
United States Patent
Application |
20050223597 |
Kind Code |
A1 |
Rolnick, Michael A. ; et
al. |
October 13, 2005 |
Low cost orthosis for toe injuries
Abstract
A low-cost orthosis for the treatment of toe injuries is
disclosed. The orthosis is a bilateral, monolithic structure molded
from polymeric foam material and having an upper portion adapted to
surround the heel, dorsal portions, and toes of a foot, and a lower
portion forming an outsole. The outsole has a wedge-shaped,
proximal portion which elevates the forefoot, the proximal portion
terminating in a cylindrical radius positioned beneath the ball of
a user's foot. The distal portion of the outsole is recessed so
that during use the orthosis can pivot on the fulcrum formed by the
previously described radius, as would occur during ambulation,
without the distal end of the orthosis contacting the floor. An
insole, formed by the upper surfaces of the outsole of the orthosis
is generally planar with a distally positioned recess in the area
of a user's toes. The orthosis disclosed mimics true physiology so
as to allow a heel strike, pivoting on the ball of the foot, and
launching from the ball of the foot while preventing weight-bearing
flexion and extension of the toes and protecting the toes from
further injury.
Inventors: |
Rolnick, Michael A.;
(Ellicott City, MD) ; Warden, Matthew Perry;
(Boston, MA) ; Van Wyk, Robert A.; (Largo,
FL) |
Correspondence
Address: |
SMITH PATENT CONSULTING CONSULTING, LLC
P.O. BOX 2726
ALEXANDRIA
VA
22301
US
|
Family ID: |
46304693 |
Appl. No.: |
11/147196 |
Filed: |
June 8, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11147196 |
Jun 8, 2005 |
|
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|
10442195 |
May 20, 2003 |
|
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60382240 |
May 23, 2002 |
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Current U.S.
Class: |
36/25R ;
602/28 |
Current CPC
Class: |
A61F 5/0195
20130101 |
Class at
Publication: |
036/025.00R ;
602/028 |
International
Class: |
A43B 013/00 |
Claims
What is claimed is:
1-31. (canceled)
32. An orthosis for the treatment of toe injuries comprising: a
lower portion comprising (a) an outsole and (b) an insole, wherein
said insole is formed by the upper surfaces of said outsole,
further wherein: said insole comprises (i) a relatively planar
proximal portion that extends from the proximal end of the orthosis
and terminates just distal of the ball of a user's foot, and (ii) a
relatively planar distal portion connected to said proximal portion
by a downwardly sloping beveled surface so as to form a recess that
prevents a user's toes from contacting the insole; and an upper
portion comprising (a) a curved vertically projecting rearward
portion which conforms closely to the heel of a foot; and (b) two
pliable, longitudinal, laterally opposed side portions, each of
which curves to wrap around the dorsum of a foot.
33. The orthosis of claim 32, wherein said upper portion further
comprises comprising a forward portion attached to the distal end
of said insole and comprising a relatively vertical lateral wall
positioned at the end of the orthosis to protect the toes from
injury during ambulation.
34. The orthosis of claim 33, wherein said lateral wall is attached
to the distal portion of said insole and perpendicularly disposed
thereto.
35. The orthosis of claim 32, wherein said orthosis is bilaterally
symmetrical.
36. The orthosis of claim 32, wherein said orthosis comprises a
monolithic structure.
37. The orthosis of claim 36, wherein said monolithic structure is
molded from a polymeric foam material.
38. The orthosis of claim 37, wherein said polymeric foam material
is selected from the group consisting of closed cell polyethylene
foam and closed cell polypropylene foam.
39. The orthosis of claim 32, further comprising a securing
mechanism to draw said longitudinal walls about the dorsum of the
user's foot.
40. The orthosis of claim 40, wherein said securing mechanism
comprises coordinating hook and loop straps.
41. The orthosis of claim 32, wherein said outsole comprises: (i) a
proximal portion, extending from the proximal end of the orthosis
and terminating in an upwardly sloping curved surface disposed
under the ball of a user's foot, that increases in thickness
distally so as to cause the insole to be inclined, and (ii) a
distal portion, connected to said proximal portion by said curved
surface, that is elevated above said proximal portion such that
when said orthosis is pivoted on said curved surface during
ambulation, the distal end of said outsole does not contact the
floor
42. The orthosis of claim 41, wherein the proximal portion of said
outsole is wedge-shaped.
43. The orthosis of claim 41, wherein the curved surface of the
proximal portion of said outsole has a radius of at least 0.25
inches
44. The orthosis of claim 41, wherein the distal portion of said
outsole slopes upwardly distally.
45. The orthosis of claim 32, wherein the angle of inclination of
said insole is between five and sixteen degrees.
46. An orthosis for the treatment of toe injuries comprising: a
lower portion comprising (a) an outsole and (b) an insole, wherein
said insole is formed by the upper surfaces of said outsole,
further wherein: said outsole comprises: (i) a proximal portion,
extending from the proximal end of the orthosis and terminating in
an upwardly sloping curved surface disposed under the ball of a
user's foot, that increases in thickness distally so as to cause
the insole to be inclined, and (ii) a distal portion, connected to
said proximal portion by said curved surface, that is elevated
above said proximal portion such that when said orthosis is pivoted
on said curved surface during ambulation, the distal end of said
outsole does not contact the floor, and said insole comprises (i) a
relatively planar proximal portion that extends from the proximal
end of the orthosis and terminates just distal of the ball of a
user's foot, and (ii) a relatively planar distal portion connected
to said proximal portion by a downwardly sloping beveled surface so
as to form a recess that prevents a user's toes from contacting the
insole; and an upper portion comprising (a) a curved vertically
projecting rearward portion which conforms closely to the heel of a
foot; and (b) two pliable, longitudinal, laterally opposed side
portions, each of which curves to wrap around the dorsum of a
foot.
47. The orthosis of claim 46, wherein said upper portion further
comprises comprising a forward portion attached to the distal end
of said insole and comprising a relatively vertical lateral wall
positioned at the end of the orthosis to protect the toes from
injury during ambulation.
48. The orthosis of claim 47, wherein said lateral wall is attached
to the distal portion of said insole and perpendicularly disposed
thereto.
49. The orthosis of claim 46, wherein said orthosis is bilaterally
symmetrical.
50. The orthosis of claim 46, wherein said orthosis comprises a
monolithic structure.
51. The orthosis of claim 50, wherein said monolithic structure is
molded from a polymeric foam material.
52. The orthosis of claim 51, wherein said polymeric foam material
is selected from the group consisting of a closed cell polyethylene
foam and a closed cell polypropylene foam.
53. The orthosis of claim 46, further comprising a securing
mechanism to draw said longitudinal walls about the dorsum of the
user's foot.
54. The orthosis of claim 53, wherein said securing mechanism
comprises coordinating hook and loop straps.
55. The orthosis of claim 46, wherein the proximal portion of said
outsole is wedge-shaped.
56. The orthosis of claim 46, wherein the curved surface of the
proximal portion of said outsole has a radius of at least 0.25
inches
57. The orthosis of claim 46, wherein the distal portion of said
outsole slopes upwardly distally.
58. The orthosis of claim 46, wherein the angle of inclination of
said insole is between five and sixteen degrees.
Description
[0001] This application claims the benefit of provisional
application 60/382,240 filed May 23, 2002.
BACKGROUND OF THE INVENTION
[0002] This invention relates to the treatment of injuries to the
foot, and more particularly, to a low cost orthosis for treating
patients with toe injuries.
[0003] Toe injuries are extremely common, both sprains and
fractures. Treatment generally consists of reducing any fracture
and splinting the toe by taping it to an adjacent uninjured toe
with gauze between the toes. The patient is given additional
padding and tape so that he can revise the splinting which will be
required for about one week. Additional treatment includes rest,
ice, elevation and anti-inflammatory medication. Comfort may be
provided by use of a cane, crutches, or other method which
minimizes weight-bearing flexion and extension of the toes. Wearing
shoes generally causes increased pain due to confinement and
rubbing of the toe by the shoe. Some patients find that wearing a
soft slipper or a sneaker with the toe section cut off gives
comfort. Symptoms generally improve within one week.
[0004] The treatment for toes following surgical correction of
mallet toe, hammer toe, or claw toe, or following the removal of
hard or soft corns also requires that weight-bearing flexion and
extension of the affected toe be prevented and that the toe be
protected from further injury due to contact with fixed objects.
The treatment of inflammations and infections of the toes is
similar. Patient comfort is enhanced by preventing weight-bearing
movement of the toes and preventing their contact with other
objects.
[0005] Common to all treatments is that movement of the injured toe
be prevented. This severely limits patient mobility since walking
involves a heel strike, pivoting on the ball of the foot, and
launching, with the ball of the foot and the toes supporting the
patient's weight during the launch. Weight-bearing flexion and
extension of the toes occurs with each step. Use of crutches can
limit this flexion and extension, however, patient mobility is
limited and no protection is given to the injured toe to prevent
additional injury due to accidental contact with fixed objects.
Wearing a soft slipper or a sneaker with the toe section cut off,
while providing some patient comfort, will often not totally
eliminate weight-bearing flexion and extension of the toes and will
expose the injured toes to additional injury since the toes are
unprotected.
[0006] Orthoses exist for the treatment of other injuries to the
forefoot. Typical of these is the Orthowedge Healing Shoe (Markell
Shoe Company, Yonkers, N.Y.) which, according to their literature,
"elevates and unweights the forefoot after surgery or injury". The
outsole of the shoe is much thicker than that of a standard shoe so
as to form a platform, and is angled somewhat so that the forefoot
is elevated above the heel area. The weight-bearing portion of the
outsole extends from the heel of the shoe a distance which places
its distal end under the distal half of the arch. The outsole then
tapers abruptly to a reduced thickness which extends distally a
distance which places the distal end of the outsole slightly beyond
the distal end of the wearer's toes. The toe region of the shoe is
open so as to minimize contact with the injured region of the foot.
The upper portion of the shoe is made from soft, compliant
materials and has a dorsal split along its top surface. This allows
the foot to be inserted into the shoe with a motion that is
substantially orthogonal to the sole of the shoe thereby preventing
inadvertent contact between the injured forefoot and the shoe. This
is in contrast to a standard shoe which requires insertion of the
forefoot with a motion substantially parallel to the insole of the
shoe. The Markell shoe elevates the forefoot so as to prevent the
distal end of the orthosis from contacting the floor during
walking. Pivoting and launch occur from the distal end of the
weight-bearing portion of the outsole, which is beneath the
metatarsal arch of the user's foot. This unnatural pivot and
launch, and the thickness of the platform in the heel area make
walking ungainly. The unnatural pivoting effect is amplified by the
distal limit of the weight-bearing region which is a defined edge
rather than a radius. Because the insole is essentially a flat
surface, during pivot and launch some weight-bearing flexion of the
toes still occurs. Additionally, an orthosis of this type is of
rather complex construction, containing a variety of materials and
designed to have a life significantly longer than that generally
required for treating a toe injury.
[0007] No effective orthosis is available for the treatment of
injuries, infections, or inflammation of the toes.
[0008] It is accordingly an object of this invention to provide an
orthosis for treatment of toe injuries.
[0009] It is also an object of this invention to provide an
orthosis for toe injuries which mimics true physiology during
walking so as to minimize its effect on the patient's gait.
[0010] It is also an object of this invention to provide an
orthosis for toe injuries which allows a launch from the ball of
the foot without load-bearing flexion or extension of the toes.
[0011] It is also an object of this invention to provide an
orthosis for toe injuries which protects the toes from further
injury.
[0012] It is also an object of this invention to provide an
orthosis for toe injuries which is lightweight and effective.
[0013] It is further an object of this invention to provide an
orthosis for toe injuries which is of simple construction.
[0014] It is finally an object of this invention to provide an
orthosis for treatment of toe injuries which is low cost.
[0015] It is further an object of this invention to provide an
orthosis for toe injuries which can be used on either the left or
the right foot.
SUMMARY OF THE INVENTION
[0016] These and other objects are accomplished by the invention
herein disclosed consisting of a generally shoe shaped orthosis
molded as a monolithic structure from a semi-rigid polymeric foam
material such as closed cell polypropylene foam. The insole of the
orthosis has a planar, proximal, weight-bearing portion extending
from the heel to the distal end of the metatarsals of a user's
foot, and a planar, distal portion, generally parallel to the
aforementioned proximal portion but recessed a distance below this
proximal portion. The proximal portion increases in width distally
from the heel to the distal limit of the portion so as to generally
conform to the shape of a user's foot. The distal portion is of a
constant width equal to the width of the distal end of the proximal
portion of the insole.
[0017] The outsole of the orthosis has a proximal, weight-bearing
region and a distal region. The proximal end of the proximal region
has a thickness approximating that of the heel of a standard shoe.
The proximal region increases in thickness along its distal length,
the region ending slightly distal to the distal end of the
metatarsals of a user's foot. The distal end of the weight-bearing
region forms a lateral axially, cylindrical radius extending the
width of the outsole. The non-weight-bearing, distal portion of the
outsole is of reduced thickness, is displaced vertically above the
distal end of the weight-bearing region and is angled upward so
that the orthosis can pivot on the previously described cylindrical
radius at the distal end of the proximal portion, through an angle
as would occur during walking, without the distal end of the
outsole contacting the floor.
[0018] The previously described insole is inclined upward by the
increasing thickness of the weight-bearing portion of the outsole.
The proximal, heel portion of the insole is surrounded by a more or
less vertical wall extending to a height slightly below a user's
ankle, the wall being of sufficient thickness, rigidity and height
to prevent the heel from lifting from the interior weight-bearing
surface when the orthosis is pivoted on the fulcrum formed by the
cylindrical radius at the distal end of the proximal portion of the
outsole. Two pliable, longitudinal, laterally opposed walls
surround the approximately distal half of the proximal portion of
the insole and the recessed distal portion of the insole. These
longitudinal walls have a height such that, when wrapped partially
over both sides of the dorsum of a user's foot, a small gap remains
between the ends of these walls atop the dorsum of the foot. The
far distal portions of the longitudinal walls wrap over a more or
less vertical, lateral wall at the distal end of the distal region
of the insole so as to form a toe box of sufficient height and
width to protect the toes of a user's foot. The distal end, lateral
wall is of sufficient thickness to protect a user's toes from
injury due to contact between the orthosis and a fixed object
during ambulation. A securing means such as hook and loop straps
secures the longitudinal walls about the foot.
[0019] During use, a user's toes are surrounded by a toe box formed
on the bottom by the recessed distal region of the insole, with
lateral sides and top formed by the distal portion of the wrapped
longitudinal walls and on its distal end by the wall at the distal
end of the recessed distal region. This toe box is of sufficient
size to preclude contact between the injured toe with its
associated dressing and the interior of the orthosis. During
ambulation, the orthosis pivots on the fulcrum formed by the distal
radius of the weight-bearing portion of the outsole so as to give
maximum launch. However, the distal, non-weight bearing portion of
the outsole does not contact the floor. Since the heel of the
orthosis is comparable in height to that of a standard shoe,
walking with a somewhat normal gait is possible if a shoe having a
comparable heel thickness is worn on the uninjured foot. The device
is designed in such a manner that it can be molded complete in a
monolithic manner to its final shape in a single operation thereby
allowing it to be produced at low cost. Because the orthosis is
molded from polypropylene or similar foam, it has sufficient use
life to treat most toe injuries and is lightweight. The bilateral
symmetry of the device allows it to be used on either the left or
right foot. The orthosis is molded in a range of incremental sizes.
A cloth liner conforming generally to the interior shape of the
orthosis, and having a dorsal split may be added to improve user
comfort.
[0020] The more important features of the invention have been
outlined rather broadly in order that the detailed description
thereof that follows may be better understood, and in order that
the present contribution to the art may be better appreciated.
There are, of course, additional features of the invention that
will be descried hereinafter and which will form the subject matter
of the claims appended hereto.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a perspective view of an orthosis formed in
accordance with the principles of this invention.
[0022] FIG. 2 is a perspective view of an orthosis formed in
accordance with the principles of this invention as it appears
prior to use.
[0023] FIG. 3 is a plan view of the object of FIG. 2.
[0024] FIG. 4 is a side elevational view of the object of FIG.
2.
[0025] FIG. 5 is a side sectional view of an orthosis constructed
in accordance with the principles of this invention with a
superimposed foot profile as during use.
[0026] FIG. 6 is a side sectional view of an orthosis constructed
in accordance with the principles of this invention with a
superimposed foot profile as during use with the orthosis rotated
as would occur during use for walking.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0027] Referring to FIG. 1, orthosis 1 having a proximal end 2 and
a distal end 4 has an outsole 6 having a proximal weight-bearing
portion 8 with a proximal end 9 and a cylindrical radius 10 at its
distal end 12, and a distal portion 14. At proximal end 2 of
orthosis 1, more or less vertical wall 16 of height 18 and
thickness 19 surrounds the proximal radius 20 so as to form a
pocket which conforms closely to the heel of a user's foot. Pliant
longitudinal walls 22 and 24 wrap partially over the dorsum of a
user's foot and are secured with hook and loop straps 26 and 27.
Distal regions 28 and 30 of longitudinal walls 22 and 24 overlap
lateral distal end wall 32.
[0028] As best seen in FIGS. 2 through 5, insole 40 of orthosis 1
has a planar, proximal, weight-bearing portion 42 of length 43
extending from the heel to the distal end of the metatarsals of a
user's foot, and a planar, distal portion 44 of length 46 and width
48 which is generally parallel to proximal portion 42 but recessed
distance 50 below proximal portion 42. The proximal portion 42 of
radius 52 at its proximal end increases to width 48 at its distal
end 54 so as to generally conform to the shape of a user's foot.
Regions 42 and 44 are joined by beveled surface 56.
[0029] Weight-bearing, proximal region 8 of outsole 6 of height 60
at proximal end 9 increases in thickness to height 62 at distal end
12 so as to incline insole 40 at angle 64, height 60 approximating
the heel height of a sneaker or dress shoe. Distal portion 14 of
outsole 6 is displaced vertically distance 66 above the distal end
12 of the proximal portion 8 and is angled upward at angle 68 so
that orthosis 1 can pivot on radius 10 through an angle 70 as would
occur during walking, without distal end 72 of outsole 6 contacting
the floor.
[0030] Referring to FIG. 5, during use a user's toes 80 are
surrounded by a toe box 82 formed on the bottom by the recessed
distal portion 44 of insole 40, with lateral sides and top formed
by the distal portions of the wrapped longitudinal walls 22 and 24
(not shown) and on its distal end by wall 32. Toe box 82 is of
sufficient size to preclude contact between toes 80 with associated
dressings and the interior of orthosis 1.
[0031] Referring to FIG. 6, during ambulation, orthosis 1 pivots
through angle 90 on the fulcrum formed by radius 10 of proximal
portion 8 of outsole 6 so as to give maximum launch. However,
distal end 72 of distal portion 14 of outsole 6 does not contact
floor 92. Since heel thickness 60 of orthosis 1 is comparable in
height to that of a standard shoe, walking with a somewhat normal
gait is possible if a shoe having a comparable heel thickness is
worn on the uninjured foot.
[0032] Referring again to FIGS. 3 and 4, an inner volume 100 is
defined by the inner surfaces of lateral walls 22 and 24, of
proximal wall 16 and of lateral distal wall 32 of orthosis 1.
Orthosis 1 can be molded in a mold of simple construction since the
surfaces defining volume 100 allow the mold half which produces the
volume to be withdrawn in a simple linear motion. Similarly,
orthosis 1 can be withdrawn from the mating mold half with a simple
linear motion. A slight draft angle can be imparted to vertical
surfaces to aid in the molding process.
[0033] Although the invention has been taught with specific
reference to the preferred embodiment, someone skilled in the art
will recognize that changes can be made in form and detail without
departing from the spirit and scope of the invention. The described
embodiments are to be considered only as illustrative and not
restrictive. The scope of the invention is, therefore, indicated by
the appended claims rather than by the foregoing description.
* * * * *