U.S. patent application number 17/078261 was filed with the patent office on 2021-02-11 for forefoot orthotic device.
This patent application is currently assigned to FOREFOOT DEFENDER, LLC. The applicant listed for this patent is Jason R. Hanft. Invention is credited to Jason R. Hanft.
Application Number | 20210038420 17/078261 |
Document ID | / |
Family ID | 1000005168791 |
Filed Date | 2021-02-11 |
United States Patent
Application |
20210038420 |
Kind Code |
A1 |
Hanft; Jason R. |
February 11, 2021 |
FOREFOOT ORTHOTIC DEVICE
Abstract
A forefoot orthotic device has multiple regions configured so
that impact, propulsive or standing forces experienced by the
forefoot of the user are accelerated, decelerated, shifted,
transferred, or lessened, so as to promote pain reduction or
otherwise address or treat conditions of the forefoot. In one
implementation, the device includes expanded areas adapted to
underlie the first and fifth metatarsal heads and cushion or
offload forces therefrom. In still other variations, the device
includes a plateau and regions adjacent the plateau and sloping
downwardly therefrom, so that the time during which painful regions
of the forefoot experience force, such as during gait or standing,
is lessened in favor of transferring such forces to adjacent
regions which potentially are less in need of treatment or
protection from such forces.
Inventors: |
Hanft; Jason R.; (South
Miami, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hanft; Jason R. |
South Miami |
FL |
US |
|
|
Assignee: |
FOREFOOT DEFENDER, LLC
South Miami
FL
|
Family ID: |
1000005168791 |
Appl. No.: |
17/078261 |
Filed: |
October 23, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15406168 |
Jan 13, 2017 |
|
|
|
17078261 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/0111 20130101;
A43B 17/006 20130101; A43B 7/141 20130101; A43B 17/02 20130101;
A43B 7/1445 20130101; A43B 7/149 20130101; A61F 13/045 20130101;
A43B 7/144 20130101; A61F 5/14 20130101 |
International
Class: |
A61F 5/14 20060101
A61F005/14; A43B 7/14 20060101 A43B007/14; A43B 17/02 20060101
A43B017/02; A43B 17/00 20060101 A43B017/00; A61F 5/01 20060101
A61F005/01; A61F 13/04 20060101 A61F013/04 |
Claims
1. A forefoot orthotic device for use in connection with a user's
foot, the user's foot characterized by a forefoot and metatarsal
heads one through five, the device comprising: an element sized and
shaped to underlie the forefoot, the element having opposite upper
and lower surfaces, opposite proximal and distal ends, opposite
lateral and medial sides, and resiliently compressible material
extending between the opposite surfaces, the opposite ends and the
opposite sides; wherein the element has a central longitudinal
axis, the lower surface of the element having at least three points
defining a lower plane of reference for the element when the device
is in use; wherein the lateral and medial sides have respective
lateral and medial side edges, the lateral and medial side edges
located further from the central longitudinal axis at the distal
end than at the proximal end; two, expanded areas located at the
lateral and medial sides, respectively, on the distal end of the
element; wherein the expanded areas are laterally spaced from each
other by a predetermined amount and face upwardly to underlie the
first and the fifth metatarsal heads of the user's foot when
received on the device, the predetermined amount corresponding to a
distance between the first and fifth metatarsal heads of the user's
foot selected as a function of an intended size of the user's foot,
the intended size ranging from child size 1 to adult male size 16
and corresponding to between about 2.5 inches and 3.5 inches;
wherein the upper surface extends upwardly and inwardly from the
opposite ends and the opposite sides to define corresponding,
opposite proximal and distal areas, and opposite lateral and medial
areas, the proximal, distal, medial, and lateral areas having
respective central portions defining a plateau raised relative to
the lower plane of reference; and wherein the resiliently
compressible material of the element is configured so that the
lateral and medial areas are more rigid than portions of the
proximal area adjacent the medial and lateral areas to delay
arrival of impact force on regions of the forefoot overlying the
medial and lateral areas relative to regions of the forefoot
overlying the adjacent portions of the proximal area during an
impact phase of a gait of the user.
2. The device of claim 1, wherein the lateral and medial areas
extend transversely in an arch from the lateral and medial side
edges, the arch having a radius of curvature ranging from 80 mm to
110 mm.
3. The device of claim 2, wherein the arch comprises a top, and
wherein the top of the arch is located in the plateau.
4. The device of claim 1, wherein the resiliently compressible
material under the medial and lateral areas is thicker than the
resiliently compressible material under the adjacent portions of
the proximal area.
5. The device of claim 4, wherein the thicker resiliently
compressible material of the medial and lateral areas terminates in
an upper edge relatively higher than the adjacent portions of the
proximal area to define an uphill region on the upper surface of
the element.
6. A forefoot orthotic device for use in connection with a user's
foot, the user's foot characterized by a forefoot and metatarsal
heads one through five, the device comprising: an element sized and
shaped to underlie the forefoot, the element having opposite upper
and lower surfaces, opposite proximal and distal ends, opposite
lateral and medial sides, and resiliently compressible material
extending between the opposite surfaces, the opposite ends and the
opposite sides; wherein the element has a central longitudinal
axis, the lower surface of the element having at least three points
defining a lower plane of reference for the element when the device
is in use; wherein the lateral and medial sides have respective
lateral and medial side edges, the lateral and medial side edges
located further from the central longitudinal axis at the distal
end than at the proximal end; wherein the expanded areas are
laterally spaced from each other by a predetermined amount and face
upwardly to underlie the first and the fifth metatarsal heads of
the user's foot when received on the device, the predetermined
amount corresponding to a distance between the first and fifth
metatarsal heads of the user's foot selected as a function of an
intended size of the user's foot, the intended size ranging from
child size 1 to adult male size 16 and corresponding to between
about 2.5 inches and 3.5 inches; wherein the upper surface extends
upwardly and inwardly from the opposite ends and the opposite sides
to define corresponding, opposite proximal and distal areas, and
opposite lateral and medial areas, the proximal, distal, medial,
and lateral areas having respective central portions defining a
plateau raised relative to the lower plane of reference; and
wherein the resiliently compressible material of the element is
configured so that the medial and lateral areas are more rigid than
portions of the distal area adjacent the medial and lateral areas
to offload weight while the user is standing or impact forces
during a toe-off phase of the user's gait from regions of the
forefoot proximal of the distal area toward regions of the forefoot
overlying the distal area.
7. The device of claim 1, wherein the lower surface has a
circumference and extends inwardly and upwardly therefrom relative
to the lower plane of reference to define a concavity, and wherein
the resiliently compressible material is configured so that weight
associated with the user deflects the concavity toward the lower
plane of reference.
8. The device of claim 7, wherein the resiliently compressible
material is configured to have a thickness ranging between 4 mm and
6 mm, a durometer, according to a 00 scale, ranging from 20 to 80,
and wherein the concavity is defined to have a radius ranging from
16 mm to 22 mm and a maximum depth ranging from 4 mm to 6 mm,
whereby the concavity returns from a deflected position during
impact phase of the gait cycle to an un-deflected position after
toe-off phase of a gait cycle of the user.
9. The device of claim 1, wherein the device includes an insole
sized and shaped to underlie the foot of the user from the heel of
the user, the insole extending from the heel distally by an amount
ranging from 20 cm to 31.8 cm sufficient to underlie at least the
metatarsal heads of the user's foot, and wherein the element is
secured to the insole in a location to underlie the metatarsal
heads of the user when the device is in use.
10. The device of claim 9, wherein the element is integrated with
the insole.
11. The device of claim 10 in which the user's foot includes a
heel, a mid-foot, and an associated sagittal arch, wherein the
insole includes a first portion underlying the heel and having a
first predetermined durometer and a second portion underlying the
sagittal arch of the mid-foot and having a second predetermined
durometer, and wherein the second predetermined durometer is
greater than the first predetermined durometer by amounts ranging
between 10 and 20.
12. The device of claim 1, wherein the device includes a sleeve
sized and shaped to be worn about the forefoot of the user, wherein
the element is secured to the sleeve in a location to underlie the
forefoot of the user when the device is in use.
13. The device of claim 1, wherein the device includes footwear
selected from the group consisting of a shoe, boot, brace and cast,
the footwear having a sole positioned under the user's foot when
received in the device, and wherein the element is disposed on the
sole and positioned thereon to have the upper surface of the
element underlying the forefoot of the user when the foot is placed
in the device.
14. The device of claim 13, wherein the footwear portions include
an insole disposed above the sole, and wherein the element is
secured to or integrated with the insole.
15. A forefoot orthotic device for use in connection with a user's
foot, the user's foot characterized by a forefoot and metatarsal
heads one through five, the device comprising: an element sized and
shaped to underlie the forefoot, the element having opposite upper
and lower surfaces, opposite proximal and distal ends, opposite
lateral and medial sides, and resiliently compressible material
extending between the opposite surfaces, the opposite ends and the
opposite sides; wherein the element has a central longitudinal
axis, the lower surface of the element having at least three points
defining a lower plane of reference for the element when the device
is in use; wherein the lateral and medial sides have respective
lateral and medial side edges, the lateral and medial side edges
located further from the central longitudinal axis at the distal
end than at the proximal end; two, expanded areas located at the
lateral and medial sides, respectively, on the distal end of the
element; wherein the expanded areas are laterally spaced from each
other by a predetermined amount and face upwardly to underlie the
first and the fifth metatarsal heads of the user's foot when
received on the device, the predetermined amount corresponding to a
distance between the first and fifth metatarsal heads of the user's
foot selected as a function of an intended size of the user's foot,
the intended size ranging from child size 1 to adult male size 16
and corresponding to between about 2.5 inches and 3.5 inches;
wherein the upper surface extends upwardly and inwardly from the
opposite ends and the opposite sides to define corresponding,
opposite proximal and distal areas, and opposite lateral and medial
areas, the proximal, distal, medial, and lateral areas having
respective central portions defining a plateau raised relative to
the lower plane of reference. wherein the lower surface has a
circumference and extends inwardly and upwardly therefrom relative
to the lower plane of reference to define a concavity, and wherein
the resiliently compressible material and the concavity are
dimensioned to deflect the concavity toward the lower plane of
reference prior to a toe-off phase while in use during a gait cycle
of the user and to return the concavity from the deflected position
to an un-deflected position after the toe-off phase of the gait
cycle of the user.
16. The device of claim 15, wherein the resiliently compressible
material is configured to have a thickness ranging between 4 mm and
6 mm, a durometer, according to a 00 scale, ranging from 20 to 80,
and wherein the concavity is defined to have a radius ranging from
16 mm to 22 mm and a maximum depth ranging from 4 mm to 6 mm.
17. The device of claim 15, wherein the resiliently compressible
material of the element is configured so that the lateral and
medial areas are more rigid than portions of the proximal area
adjacent the medial and lateral areas, whereby, during an impact
phase while in use, deceleration of regions of the foot overlying
the medial and lateral areas is greater than deceleration of
regions of the foot overlying the adjacent portions of the proximal
area, wherein the resiliently compressible material of the element
is configured so that the medial and lateral areas are more rigid
than portions of the distal area adjacent the medial and lateral
areas, whereby, during a toe-off phase while in use, acceleration
of forefoot portions overlying the distal area is greater than
acceleration of forefoot portions overlying the medial and lateral
areas.
18. The device of claim 17, wherein the resiliently compressible
material under the medial and lateral areas is thicker than the
resiliently compressible material under the adjacent portions of
the proximal area.
19. The device of claim 18, wherein the thicker resiliently
compressible material of the medial and lateral areas terminates in
an upper edge relatively higher than the adjacent portions of the
proximal area to define an uphill region on the upper surface of
the element.
20. The device of claim 15, wherein the device includes footwear
selected from the group consisting of a shoe, boot, brace and cast,
the footwear having a sole positioned under the user's foot when
received in the device, and wherein the element is disposed on the
sole and positioned thereon to have the upper surface of the
element underlying the forefoot of the user when the foot is placed
in the device.
Description
FIELD
[0001] This disclosure relates to orthotic devices and, more
particularly, to a forefoot orthotic device for use in connection
with a user's foot.
BACKGROUND
[0002] Orthotic devices are useful for treating disorders,
injuries, diseases or other harmful or painful foot conditions.
Orthotic devices include metatarsal pads, often made of foam, and
which cushion the metatarsal region of a user's foot which may
overlie such pad, such as when such pad is inserted within
footwear.
[0003] Orthotic devices for the forefoot of the current art suffer
from various drawbacks and disadvantages.
[0004] Accordingly, there is a need for an improved forefoot
orthotic device to address foot conditions of a user, including
injuries, disorders, diseases and their associated trauma, pain, or
other discomforts.
SUMMARY
[0005] In one possible implementation, a forefoot orthotic device
for use in connection with the user's foot includes a resiliently
compressible element sized and shaped to underlie the forefoot. The
element is sized and shaped so that there are two, expanded areas
of resiliently compressible material located toward the distal end
of the element at respective lateral and medial sides. The expanded
areas are transversely spaced from each other by a predetermined
amount corresponding to the distance between the first and fifth
metatarsal heads of the user's foot.
[0006] In further implementations, the forefoot orthotic device has
an upper surface which extends upwardly and inwardly from the
circumferential edge of the forefoot orthotic device, the surface
having an upper portion defining a plateau raised relative to a
lower plane of reference associated with the forefoot orthotic
device.
[0007] In other variations of the disclosure, the resiliently
compressible element includes lateral and medial areas which extend
upwardly in a transverse direction so as to form an arch. The arch
is located to underlie the metatarsal arch of the user's foot.
[0008] In still further versions of forefoot orthotic devices
disclosed herein, the upper surface of the orthotic device has
medial and lateral areas which are more rigid than portions of a
proximal area adjacent to such medial and lateral areas. In this
way, during use, deceleration of foot portions overlying the medial
and lateral areas is greater than deceleration of foot portions
overlying the adjacent portions of the proximal area, with the
effect that force experienced in the metatarsal area is reduced or
slowed in comparison to force experienced proximally thereto.
[0009] In still other variations, the medial and lateral areas of
the upper surface are more rigid than portions of a distal area
adjacent to such medial and lateral areas. As such, acceleration of
forefoot portions overlying the distal area is greater than
acceleration of forefoot portions overlying the medial and lateral
areas.
[0010] In still further variations, devices according to the
present disclosure may have a concavity formed in the lower surface
of the resiliently compressible element, and the resiliently
compressible material in such configuration is chosen so that
weight or force associated with the user deflects the concavity
toward a lower plane of reference during the gait cycle of such
user, or in response to standing under load associated with the
user's weight.
[0011] The forefoot orthotic device of the present disclosure
includes features which take into account biomechanics of the user,
both at various phases of the user's stance or gait, including the
impact, swing, and propulsive phases of the user's gait, as well as
points intermediate to such phases. The device is useful to address
abnormalities or unique characteristics of a person's gait from
whatever cause, whether from foot conditions or musculoskeletal
factors.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The disclosure herein will be more readily understood with
reference to the drawings, in which:
[0013] FIG. 1 is an isometric view showing a forefoot orthotic
device according to the present disclosure;
[0014] FIG. 2 is a rear-elevational view of the orthotic device of
FIG. 1;
[0015] FIG. 3 is a top-plan view of the orthotic device of FIGS.
1-2;
[0016] FIG. 4 is a front view of the orthotic device of FIGS.
1-3;
[0017] FIG. 5 is a side-elevational view of the orthotic device of
FIGS. 1-4;
[0018] FIG. 6 is a bottom-plan view of the orthotic device of FIGS.
1-5;
[0019] FIG. 7 is an exploded, isometric view of another
implementation according to the present disclosure, in the form of
an insole;
[0020] FIG. 8 is a top-plan view of the implementation of FIG.
7;
[0021] FIG. 9 is a side-sectional view of the implementation of
FIGS. 7-8;
[0022] FIGS. 10 and 11 are bottom plan and isometric views,
respectively, of another implementation according to the present
disclosure in the form of a sleeve or sock;
[0023] FIG. 12 is an isometric view of footwear according to the
present disclosure;
[0024] FIGS. 13 A&B and 14 A&B are orthotic scans showing
pressure or force on the forefoot without and with an orthotic
device according to the present disclosure.
DETAILED DESCRIPTION
[0025] Referring to the drawings, FIGS. 1-6 show a forefoot
orthotic device 21, configured in this implementation to be an
insert for use in footwear in connection with a user's foot.
Orthotic device 21 comprises an element 23 formed of resiliently
compressible material. Element 23 of the forefoot orthotic device
21 is shaped to have opposite proximal and distal ends 25, 27,
opposite lateral and medial sides 29, 31, and opposite upper and
lower surfaces 33, 35. The resiliently compressible material in
this implementation extends between the opposite surfaces 33, 35,
the opposite ends 25, 27, and the opposite sides 29, 31.
[0026] As further detailed in this disclosure, forefoot orthotic
device 21 is constructed, shaped, sized or otherwise configured to
address injury, disorder, pain, or other conditions of the
forefoot, whether the user is standing or moving through the gait
cycle. The features of device 21 reduce, alter, shift or offload
force and pressures experienced by the forefoot at different times
by the user while standing or during the gait cycle, so as to
reduce forces otherwise experienced by anatomical features of the
forefoot which cause pain or inhibit healing or other treatment of
associated foot disorders.
[0027] To that end, element 23 is sized and shaped to underlie the
forefoot of a user, with proximal end 25 positioned at the near or
proximal end of the user's forefoot and distal end 27 positioned
forward of proximal end 25, toward the forward or distal end of the
user's forefoot.
[0028] Lateral and medial sides 29, 31 have respective side edges
37, 39. Side edges 29, 31 are located further from a central
longitudinal axis A at distal end 27 than at proximal end 25. As
such, element 23 has defined therein two, expanded areas 41 located
at respective lateral and medial sides 29, 31, but expanded areas
41 are positioned toward distal end 27 of element 23, rather than
at proximal end 25 thereof. In this way, expanded areas 41 are able
to be positioned relative to the user's foot so as to underlie the
first and fifth metatarsal heads of the user's foot. It will be
appreciated by those skilled in the art that the lateral spacing of
expanded areas 41 may range by certain predetermined amounts to
correspond to the range of sizes of a potential user's foot,
whether from child size 1 to adult male size 16. In this
implementation, it has been found that predetermined spacing of
expanded areas 41 may range between 2.5 inches to 3.5 inches, by
predetermined amounts to correspond to corresponding foot sizes of
the intended user.
[0029] Expanded areas 41 rapidly transition the first through fifth
metatarsal head areas through the toe off phase of gait where there
is high pressure and high forces on metatarsal heads into the
propulsion and swing phase of the gait where there are lower
pressures with minimal forces on the metatarsals.
[0030] Upper surface 33 includes certain features to reduce, alter,
transfer, offload or otherwise relieve force experienced by the
user's forefoot during standing (stance) or at various points
during the user's gait cycle. For example, in this implementation,
upper surface 33 extends upwardly and inwardly from opposite ends
25, 27 and opposite sides 29, 31, and thereby defines on upper
surface 33 corresponding, opposite proximal and distal areas 43, 45
and opposite lateral and medial areas 47, 49. Areas 43, 45, 47, 49
have central portions 51 located inwardly from the edges of element
23 and, by virtue of the upward slope of upper surface 33, the
central portions 51 together define a plateau 53 which is raised
relative to a lower plane of reference B defined with reference to
lower surface 35 of element 23. In other words, in this
implementation, there are four areas 41, 43, 45, 47 which generally
slope upwardly from the circumferential edge of element 23, the
areas terminating in central portions which together define the
plateau 53 at a raised elevation relative to the areas 43, 45, 47
and 49.
[0031] In one suitable implementation, lateral and medial areas 47,
49 extend transversely from respective edges 37, 39 in an arch or
arc to form a transverse arch 58 having a radius of curvature
selected to provide support to the metatarsal arch of the user's
foot. Arch 58 may have a radius of curvature of 80 mm to 110 mm for
a size "large" orthotic for adult male sizes 8.5 to 15, and
otherwise ranging -25% to +50% from that range for other
implementations. In such implementation, the highest point of arch
58 is 8.2 mm relative to ground plane B, and may range -25% to +50%
therefrom for other sizes or implementations. In other
implementations, the top of arch 58 is located in plateau 53, and
plateau 53 has a height ranging from 5 mm to 13 mm relative to
ground plane B.
[0032] Lateral and medial areas 47, 49 may be formed of resiliently
compressible material to make areas 47, 49 firmer, more rigid, or
otherwise less compressible than adjacent portions of proximal area
43. This physical characteristic may be achieved in a number of
ways. For example, lateral and medial areas 47, 49 may have a
higher durometer, may be formed of compressible material having
different compressibility characteristics, or may employ different
thicknesses or amounts of such compressible material, so that
medial and lateral areas 47, 49 are more rigid than adjacent
portions of proximal area 43. Since lateral and medial areas 47, 49
are located closer to the user's metatarsal heads than proximal
area 43, having lateral and medial areas more rigid than adjacent
portions of proximal area 43, may have the effect that, during use,
portions of the user's foot overlying lateral and medial areas 47,
49 are decelerated more than foot portions overlying the adjacent
portions of proximal area 43. This may delay arrival of or lessen
the force experienced by the metatarsal region of the forefoot
overlying areas 47, 49 during the impact phase of the gait cycle.
In other words, the spacial and angular relationship between
proximal area 43 and lateral and medial areas 47, 49 of increased
rigidity, slows the speed at which the metatarsal region of the
user's forefoot distal to proximal area 43 receives force from the
impact phase of the user's gait. Additionally, the presence of
increased resiliency or rigidity in lateral and medial areas 47, 49
slows the rate at which the forefoot is fully loaded during
standing or stance phase of the gait. In one suitable
implementation, lateral and medial areas 47, 49 have a thickness
ranging from 2 mm to 20 mm whereas, distal and proximal areas 43,
45 adjacent thereto have thicknesses averaging 1 mm to 10 mm.
[0033] The slope and shape of lateral and medial areas 47, 49
direct force experienced by overlying forefoot portions laterally
or medially, respectively. Additionally, areas 47, 49 accelerate
transition from foot strike to propulsion for overlying forefoot
portions during the gait cycle.
[0034] The greater rigidity, resilience, or stiffness of lateral
and medial areas 47, 49 may be achieved by having resiliently
compressible material of greater thickness at areas 47, 49 than in
proximal area 43. Alternately or additionally, element 23 of
orthotic device 21 may comprise resiliently compressible material
having different physical or chemical characteristics at different
regions of element 23, such that the compression load deflection
value, rigidity, resilience or compressibility of the resiliently
compressible material in lateral and medial areas 47, 49 is
different from the characteristics of the resiliently compressible
material in proximal area 43. Such differences can be tuned or
selected so that, again, lateral and medial areas 47, 49 decelerate
overlying foot portions more readily than foot portions overlying
proximal area 43, again with the result of slowing down the arrival
of impact force on the metatarsal area forward of proximal area 43
and allowing such forces to dwell in proximal area 43 for a greater
period of time during the gait cycle, especially the impact phase
thereof.
[0035] In another variation, distal area 45 may be shaped,
configured or otherwise adapted to be less rigid, deflect more
readily and/or have a compression load deflection value less than
plateau 53 or lateral and medial areas 47, 49. In this way, under
comparable load during use, acceleration of forefoot portions
overlying distal area 45 is greater than acceleration of forefoot
portions overlying lateral and medial areas 47, 49. As such, during
stance or gait, weight or impact forces experienced in the
metatarsal portions of the forefoot proximal or interior to distal
area 45 are offloaded or directed toward distal area 45 so that
sensitive or pain-prone regions of the forefoot overlying plateau
53 or lateral and medial areas 47, 49 are minimized, in favor of
offloading toward less painful, stronger or otherwise more
desirable regions toward the front of the user's forefoot or foot
overlying distal area 45.
[0036] Distal area 45 may be shaped to slope toward the distal edge
and toward lateral and medial edges to direct forces forward, as
well as medially and laterally away from the midline of the
foot.
[0037] Lateral and medial areas 47, 49 terminate in respective
upper edges 54 which are located relatively higher than adjacent
portions of proximal area 43 to define an uphill region 55, and
likewise lateral and medial areas 47, 49 have distal edges 56
adjacent distal portion 45 located relatively higher than distal
area 45 and thereby defining a downhill region 57 in distal area
45. As such, during the gait cycle, such as during impact phase,
deceleration of foot portions overlying uphill region 55 is less
than deceleration of foot portions overlying lateral and medial
areas 47, 49, plateau 53, and arch 58 to delay impact force on
metatarsal regions forward or distal to proximal area 43. At other
points of the gait cycle, such as the end of the impact phase or in
the beginning of the propulsive phase, downhill region 57
accelerates forefoot portions overlying distal area 45 more than
forefoot portions overlying arch 58, medial areas 47, 49 or plateau
53, to encourage offloading or force transfer from anterior or
proximal portions of the metatarsals or forefoot forward, such as
toward upper metatarsal regions of the foot forward of the
metatarsal heads. Force transfer or offload as described above
likewise occurs when the user is standing or otherwise at stance
phase.
[0038] In still other implementations of device 21, lower surface
35 has an outer circumference 59 and extends inwardly and upwardly
therefrom relative to lower plane of reference B to form a
concavity 61 between lower surface 35 and plane of reference B. The
durometer, compression load deflection value, or other
characteristics of the resiliently compressible material above
concavity 61 may be selected so that force or weight associated
with the user, whether standing or during the gait cycle, deflects
or collapses concavity 61 toward lower plane of reference B,
thereby reducing impact forces otherwise experienced by the
forefoot such as on the metatarsal heads.
[0039] The characteristics of the resiliently compressible material
defining concavity 61 may, likewise, be selected so that concavity
61 not only collapses toward lower plane of reference B, but may be
selected so that the collapse occurs at points during the gait
cycle when the foot portions overlying concavity 61 are impacting
concavity 61, and the resiliency of concavity 61 is sufficient so
that concavity 61 springs back when the force or weight exerted on
concavity 61 by overlying portions of the foot are reduced.
Otherwise stated, when foot portions overlying concavity 61 are
impacting the ground or otherwise exerting sufficient force,
concavity 61 will deflect and collapse toward lower plane of
reference B, and when the impact phase of the gait cycle has
completed and the user is in the toe-off or later phases of the
gait cycle, concavity 61 will, at least partially return to its
original shape in response to reduced force or weight being exerted
by the overlying foot portion.
[0040] The particular sizes, shapes and physical characteristics of
element 23 and its various components and areas may be varied to
accomplish the force or weight transference described herein, the
related acceleration or deceleration of overlying portions of the
foot relative to each other, and to promote protection, healing or
treatment of forefoot conditions of the user. In one suitable
implementation, using the 00 durometer scale of ASTM Standard 2240,
incorporated herein by reference, the resiliently compressible
material of element 23 has values ranging from 20 to 80. Concavity
61 may be substantially dome shaped, having an average radius
ranging from 12 mm to 25 mm. Concavity 61 may have a maximum depth
ranging from 1 mm to 7 mm, with the point or area of maximum depth
located below plateau 53. Plateau 53 may have a maximum height
ranging from 5 mm to 13 mm. In one implementation, resiliently
compressible material defining concavity 61 has a thickness of 4
mm, concavity 61 has a radius of 16-22 mm, and a maximum depth of 4
to 6 mm, with the resiliently compressible material having a
durometer ranging from 40 to 50. Such configuration has been found
suitable to cause concavity 61 to deflect or collapse during the
impact phase of a user within the weight range of an average adult,
and will, likewise, spring back during the toe-off or later phases
of said user.
[0041] The thickness of resiliently compressible material between
upper surface 33 and lower surface 35 may range from 4 mm to 12 mm.
In certain implementations, thickness of resiliently compressible
material between concavity 61 and plateau 53 may range between 4 mm
and 6 mm. The foregoing thickness may be reduced toward the outer
circumferential edges of element 23, especially the outer edges of
proximal and distal ends 25, 27, to avoid overlying foot portions
"feeling" discontinuities between element 23 and adjacent areas of
the shoe, brace, boot, cast or insole.
[0042] In certain implementations, such as those illustrated, upper
surface 33 of element 23 may be conceptually divided into the four
areas discussed above, namely areas 43, 45, 47 and 49, as well as
an additional plateau 53 defined at the inner portions of such
areas. Plateau 53 may be considered a fifth area. In one variation,
at least one of the areas, such as proximal area 43, extends
upwardly from its proximal end 25 toward distal end 27 with an
average angle of 9.2.degree., in one preferred implementation, but
may also range from 8.degree. to 10.degree. in other
implementations, and terminating in a first, U-shaped boundary 63.
The U-shaped boundary 63 extends transversely from the lateral to
the medial sides and has a corresponding first apex 65 located at a
height of 8.2 mm in one implementation, or may also range from 5 mm
to 12 mm relative to lower plane of reference B. The exact
selection of height may vary -25% to +50% to correspond to a
respective foot size of the user, such as sizes ranging from child
size 1 to adult male size 16.
[0043] Lateral and medial sides 29, 31 and corresponding lateral
and medial areas 47, 49 may be shaped and configured such that each
of areas 47, 49 have a curvilinear, triangular shape with a base 67
located at the respective lateral or medial side 29, 31 and such
triangular shape having tapering, curvilinear edges extending
inwardly to second and third apices 69, 71. In the illustrated
embodiment, first, second and third apices correspond to upper
edges rather than single points, and define edges of plateau region
53, and second and third apices have a height ranging from 5 mm to
12 mm relative to lower plane B. The term apex or apices, as used
herein, thus encompasses both high points as well as high
edges.
[0044] Furthermore, distal area 45 may extend upwardly from the
distal end toward plateau 53 with an average angle of 17.8.degree.
in one preferred implementation, or ranging from 15.degree. to
20.degree., in other preferred implementations, terminating in a
second, U-shaped boundary 73. The second, U-shaped boundary has a
corresponding fourth apex which may either be a point or, as
illustrated, an upper edge located at a height selected as 8.2 mm,
or to range from 5 mm to 12 mm relative to lower plane B in other
preferred implementations. The apex of distal area 45 may define a
forward boundary of plateau 53.
[0045] As shown in FIGS. 1 and 3, expanded areas 41 include sloped
portions 42 of lateral and medial areas 47, 49 and distal area 45,
as well as portions of U-shaped boundary 73 and its associated
bevel 75. In one implementation, U-shaped boundary 73 comprises the
apex of sloped portions 42. Given that areas 41 are located to
proximate to the likely position of metatarsal heads one and five
of a user's foot when element 23 is in use, sloped portions 42 of
expanded areas 41 act to transfer impact or propulsive forces
otherwise experienced by metatarsal heads 1 and 5 medially in the
case of metatarsal head 1 and laterally in the case of metatarsal
head 5, thereby reducing forces likely to be experienced by
metatarsal heads one and five. Sloped portions 42 may have multiple
radii of curvature corresponding to the shapes of areas 45, 47, 49
and bevel 75. In one implementation, in expanded areas 41, areas
47, 49 have radii of curvature ranging from 90 mm to 100 mm. When
features are described in terms of a radius of curvature, the
center of curvature is located below upper surface 33, unless
apparent otherwise by reference to the drawings or otherwise
specified.
[0046] First and second U-shaped boundaries 63, 73 include bevels
75 characterized by having greater slope than respective adjacent
portions of upper surface 33. Bevels 75 follow the contours of
first and second boundaries 63, 73 in this variation, and have
heights which decrease from the lateral, medial edge 37, 39 toward
plateau 53, eventually becoming zero at plateau 53, so that bevels
75 terminate at plateau 53 and first and second boundaries 63, 73
are coplanar with plateau 53 at such upper termination point of
bevels 75. Bevels 75 have radii of curvature (with center point of
curvature located above upper surface 33) ranging from 2 mm to 5
mm.
[0047] Plateau 53 in the illustrated implementation is at the
convergence of areas 43, 45, 47, and 49 of device 21. Its geometric
shape and materials properties allow for support in the metatarsal
arch area, thereby providing additional offloading of the
metatarsal heads and forefoot.
[0048] Plateau 53 may be particularly effective during the time in
which the heel is off the ground and the foot is transitioning
between forefoot strike and propulsion. Plateau 53 provides upward
pressure into the metatarsal arch, thereby increasing the reduction
of ground forces and perceived pressure on the bottom of the
foot.
[0049] Though the illustrated implementations of forefoot orthotic
device 21 are suitable as inserts into footwear, the
implementations of this disclosure include a forefoot orthotic
device which comprises an insole 121, shown in FIGS. 7-9. Insole
121 is sized and shaped to underlie the foot of the user from the
heel of the user and extending from the heel distally by an amount
sufficient to underlie at least the metatarsal heads of the user's
foot, such amount dictated by predetermined sizes of the user's
foot ranging from child size 5 to adult male size 15, generally
from 8'' (20.3 cm) to 121/2'' (31.8 cm). In this implementation,
insole 121 includes element 123 with upper surface 133 having
expanded areas 141, a proximal area 243, a distal area 145, lateral
and medial areas 47, 49 and a plateau 153, the foregoing areas
having the features, shapes and configurations similar to those
discussed with reference to element 23 in FIGS. 1-6. Element 123 is
secured to insole 121 at a location adapted to underlie the
forefoot of the user when insole 121 is in use. Element 123 may be
integrated with the insole, either on the surface thereof, or
within the insole as illustrated in FIG. 9. Insole 121 may be
configured to allow removal of element 123 therefrom. In one
implementation, insole for a size "large" as defined previously has
a total length from heel to toe of 30 to 31 cm.
[0050] Optionally, insole 121 may be shaped to relieve pressure,
provide support to, or otherwise treat areas of the foot other than
the forefoot. For example, insole 121 may include a first portion
127 located on the "footprint" of the insole to underlie the user's
heel and a second portion 131 distal to the first portion 127 and
having an upper supporting surface 158 located to underlie the
user's sagittal arch or mid-foot, distal to the calcaneal cuboid
joint. Durometers (scale 00, ASTM 2240) for first portion 127 may
be selected to range between 30 and 60, and second portion 131 to
range between 45 and 70, with a relative difference preferably of
between 10 and 20. Related teachings and disclosures of co-pending
U.S. patent application Ser. No. 13/965,672, published as US
2015/0047221, entitled "Orthotic Insert Device," by the same
inventor, are hereby incorporated by reference into this
application.
[0051] The advantageous features of element 23, 123 may be adapted
for use in any number of footwear environments, including shoes
(including sneakers), boots, braces and casts, whether for
protection, relief, treatment, or prophylactic use, and whether for
temporary or continuous everyday use. Such footwear may incorporate
element 23, 123 to treat forefoot conditions while the footwear is
being worn. One implementation of the foregoing is shown in FIG.
10, wherein a brace 221 includes an insole having forefoot element
223 integrated therein.
[0052] Referring now to FIGS. 10 and 11, another implementation of
this disclosure involves combining forefoot element 323 with a
suitable sock or sleeve 321, which sleeve 321 is shown
appropriately worn about the forefoot of a user in FIG. 10, so that
expanded areas 341 are adjacent to or underlie metatarsal heads one
and five, thereby obtaining the various functional advantages
described with reference to the expanded areas of previous
embodiments. Element 323 is substantially similar to elements 23,
123, 223 described previously and the combination of element 323
with a sock or sleeve 321 as shown permits the various treatment,
pain relieving, and other therapeutic benefits described. In the
implementation shown in FIGS. 10 and 11, bevels 375 are generally
wider than corresponding bevels 75, have larger radii of curvature,
ranging from 5 mm to 15 mm, and have widths ranging from 6 mm to 50
mm for proximal ones of bevels 375 and from 2 mm to 15 mm for the
distal ones of bevels 375.
[0053] Having described the structures and features of forefoot
orthotic devices 21, 121 and 221, their uses and advantages are
apparent. The forefoot orthotic devices are inserted or fitted to
one or both feet of a user to treat ailments, pain, disorders,
amputations, or any number of other foot conditions affecting the
forefoot and which may benefit from transfer or movement of forces
arising during movement or weight at stance, from the regions of
forefoot insult to adjacent regions where less pain may be
experienced. Dimensions may be varied within a range corresponding
to the respective foot size of the anticipated user.
[0054] Expanded areas 41, 141 are located to offload weight or
force experienced by metatarsal heads one and five away from their
normal point of contact with the ground, either by urging force
forward of boundary 73 or laterally in the case of metatarsal head
five, or medially in the case of metatarsal head one.
[0055] Testing has confirmed the various functions and advantageous
features described herein in relation to the current art. As
previously explained, the features described herein have been shown
to decelerate the speed at which certain regions of the forefoot
hit the ground in comparison to other forefoot regions at certain
times of the gait cycle, and accelerate such speed at other times
of the gait cycle. Pressure is decreased under the first through
fifth metatarsals, especially by virtue of expanded areas 41 and
arch 58 and underlying the metatarsal region. Standing or at
stance, weight otherwise experienced in the metatarsal region is
transferred from such region to adjacent regions which may be prone
to less pain, or such transference may encourage healing of
conditions by reducing weight-bearing activities. The combination
of features described above decreases impact force in the forefoot
region generally, decreases total time on portions of the forefoot,
especially the metatarsal heads, and/or acts to decrease load on
the forefoot relative to other portions of the foot.
[0056] Testing of certain implementations has shown that the
features described herein decrease the area of the forefoot
contacting the ground or shoe sole in favor of areas outside the
forefoot experiencing such contact, and, thereby, force or pressure
on the metatarsal heads is correspondingly reduced. These results
are applicable whether at stance or during gait. During gait cycle,
not only does the device decrease the pressure under all five
metatarsal heads, according to tests results, but the length of
time potentially sensitive areas of the forefoot are in contact
with the ground is shortened as well, especially under the first
and fifth metatarsal heads. Testing has shown a 25-80% reduction in
pressure or force on metatarsal heads and the forefoot region in
general, and a 30-90% decrease in time that the metatarsal heads
are experiencing forces otherwise associated with the gait cycle,
such reductions being compared to the user's gait without the
device described herein.
[0057] FIGS. 13A, 13B, and 14A and 14B, are scans showing pressure
or force on the forefoot without and with an orthotic device
according to the present disclosure. FIGS. 13A, 13B show the
forefoot of a left foot when standing, that is, statically, 13A
corresponding to the forefoot without a device according to the
present disclosure, and FIG. 13B showing pressure or force on the
forefoot when a forefoot orthotic device according to the present
disclosure is worn inside a shoe or other footwear. Referring to
FIG. 13A, the scan of this test shows regions 422 corresponding to
the great toe, and having green and yellow force bands which
correspond to greater force or pressure on that region than on
region 422 of FIG. 13B (ranging from blue to black) corresponding
to the great toe overlying an orthotic device according to the
present disclosure. Similarly, another region of greater pressure
424 shown in green in FIG. 13A corresponds to the first metatarsal
head, and can be contrasted with a corresponding region of lower,
pressure or force 424' (shown in blue) of FIG. 13B. Further, there
is a substantial absence of pressure or force along portions of the
first metatarsal shown at 425' (FIG. 13B) by a white region, in
contrast to a blue region of greater force (426) shown in FIG. 13A.
Still further, referring to FIG. 13A, force or pressure on
metatarsal heads 2-5 is shown by color topography regions 428,
including green, yellow and brown regions in FIG. 13A without an
orthotic device, as opposed to the lesser forces or pressures on
metatarsal heads 2-5 shown by the blue areas 428' in FIG. 13B.
[0058] FIGS. 14A and 14B show dynamic test results of the forces or
pressures on the forefoot without and with an orthotic device
according to the present invention shown in terms of force or
pressure experienced by the forefoot proximate to the moment of
toe-off during the gait cycle. FIG. 14A is a left foot of a user
without the device disclosed herein, and FIG. 14B is the right foot
of the same user with an orthotic device as disclosed herein. Force
or pressure in the regions of metatarsal heads one through five are
shown with increased force or pressure without an orthotic device
in region 522' of FIG. 14A with corresponding orange coloration,
whereas metatarsal heads one through five have decreased force and
pressure exerted thereon when overlying the disclosed orthotic
device, as shown in FIG. 14B, at regions 522'. Furthermore, the
first metatarsal, that is, the "great toe," experiences greater
force shown as orange at region 524, without the orthotic device of
the present disclosure, as opposed to the lower forces or pressure
shown as blue or black in regions 522' in FIG. 14B corresponding to
the great toe. As in the static test, the first metatarsal has an
area of substantially reduced force or pressure (shown as white
526') in contrast to higher pressure in region 526 of the first
metatarsal, shown by reference 526 in FIG. 14A. In general terms,
the test results indicated in FIGS. 13A, 13B, and 14A, 14B,
demonstrate how orthotic devices 21, 121, 221, 321, decrease
contact area, that is, the area experiencing force, in the
forefoot, and decrease pressure (that is, force) on metatarsal
heads 1-5, including substantial decreases in reference to
metatarsal one itself.
[0059] While one or more particular implementations have been set
out in this disclosure, it will be appreciated that various
alternatives to the disclosed structures are likewise contemplated
and within the scope of this disclosure. For example, although
element 23 has been illustrated as substantially comprising
resiliently compressible material, other materials may be employed,
such as non-compressible, flexible material, or non-resilient
material. Suitable materials include foam, polymeric, metallic,
thermoset or other suitable materials such as foam, plastic, metal,
wood, cellulose or other non-foam or non-plastic materials, alone
or in combination. Forefoot orthotic devices herein may employ
cloth, antimicrobial, or other materials to enhance ease-of-use,
longevity, or versatility. Element 23, 123, 223 may comprise a
single molded piece, may consist of multiple substrates, or may be
formed of multiple components fused together at opposing edges.
[0060] While the illustrated devices are substantially symmetric
along longitudinal axis A (FIG. 1), other implementations may be
asymmetric, may include only one of the expanded areas 41, or may
be altered symmetrically or asymmetrically to account for left and
right feet, or to account for other foot conditions.
[0061] Still further variations are contemplated by the disclosure
herein, which should be understood to extend to the boundaries of
the appended claims and equivalents thereto.
* * * * *