U.S. patent application number 11/038678 was filed with the patent office on 2006-04-13 for foot orthosis support device method and apparatus.
Invention is credited to Donald R. Buethorn.
Application Number | 20060076706 11/038678 |
Document ID | / |
Family ID | 40674302 |
Filed Date | 2006-04-13 |
United States Patent
Application |
20060076706 |
Kind Code |
A1 |
Buethorn; Donald R. |
April 13, 2006 |
Foot orthosis support device method and apparatus
Abstract
A flexible support device adapted to provide overall structural
biomechanics support and contouring of a lower limb of a patient by
a practitioner where the flexible support device having various
indentations to provide proper fitting of a bold for production of
an orthosis device in one form.
Inventors: |
Buethorn; Donald R.;
(Ferndale, WA) |
Correspondence
Address: |
DAVIS WRIGHT TREMAINE, LLP
2600 CENTURY SQUARE
1501 FOURTH AVENUE
SEATTLE
WA
98101-1688
US
|
Family ID: |
40674302 |
Appl. No.: |
11/038678 |
Filed: |
January 18, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60628807 |
Nov 17, 2004 |
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60552491 |
Mar 12, 2004 |
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60537040 |
Jan 16, 2004 |
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Current U.S.
Class: |
264/223 |
Current CPC
Class: |
B29L 2031/7532 20130101;
A43B 7/28 20130101; B29C 33/3857 20130101 |
Class at
Publication: |
264/223 |
International
Class: |
B29C 33/40 20060101
B29C033/40 |
Claims
1. A method of forming a lower limb orthosis to the lower limb
region of the patient, the lower limb region having a foot region
and an ankle region, the method comprising the steps of: a.
positioning a stockinette over the patient's foot and ankle region,
b. selecting a flexible support device from a plurality of flexible
support devices, the flexible support device having a heel cup
region and a central chamber region, c. positioning the central
cavity region of the flexible support device around the patient's
foot, d. applying a plurality of molding strips around the foot and
ankle region of the patient's foot and the flexible support device,
e. allowing the molding strips to form a mold having lower and
upper regions, f. removal of the mold by incising the mold between
the lower and upper regions, g. removing the flexible support
device from the mold, h. sending the mold to a manufacturing
facility for use in the production of a lower limb orthosis device
for the patient.
2. The method as recited in claim 1 whereas when positioning the
flexible support device, the distal regions, including the
metatarsal heads, do not cross the total sulcus having a distal
methead proximal toe rise area.
3. The method as recited in claim 1 whereas portions of the
flexible support device can be heated and formed to different
contours to accommodate the patient's foot.
4. The method as recited in claim 1 whereas the flexible support
device has a forward vertical region that defines a gap region
between the toes of the patient and the forward vertical
region.
5. The method as recited in the claim 4 whereby the gap region is
greater than one quarter of an inch.
6. The method as recited in claim 1 whereby a second stockinette is
positioned over the flexible support device prior to application of
the molding strips.
7. The method as recited in claim 6 whereby the second stockinette
is adapted to provide additional spacing between and inner surface
of the mold and the outer surface of the patient's foot.
8. The method as recited in claim 6 whereby a cutting strip is
positioned beneath the second stockinette to assist in cutting and
removal of the mold.
9. The method as recited in claim 8 whereby a non-flesh cutting
element is used to remove the mold.
10. The method as recited in claim 8 whereby the cutting strip is
attached to the first stockinette prior to application of the
second stockinette.
11. The method as recited in claim 1 whereas the flexible support
device is heated in a localized region and reformed in a manner
determined by the practitioner to accommodate protrusions or
indentations of the patient's lower limb.
12. The method as recited in claim 1 whereas the flexible support
device is incised about a substantially longitudinal direction, and
the lateral width is adjusted to provide accommodation for various
potential shapes of the foot of the patient.
13. The method as recited in claim 1 whereby the flexible support
device is retrieved from the plurality of flexible support devices
that are in a storage location, whereby the flexible support
devices are arranged in a stacked position, whereby an outer
surface of an immediately smaller flexible support device is
engaged in a chamber region of the immediately larger flexible
support device so that the plurality of flexible support devices
are arranged in a stacked manner.
14. The method as recited in claim 13 whereby the plurality of
flexible support devices in a stored position provide a gauging
system for the practitioner to properly select and reselect
individual flexible support devices for fitting the patient.
15. The method as recited in claim 1 whereby the flexible support
device provides sufficient rigidity to allow a distribution of
pressure upon adjacent regions of the foot and lower ankle region
that the practitioner is not in direct contact with to have the
mold formfitting to the contours of the patient's foot and
maintaining the correct overall biomechanical alignment.
16. The method as recited in claim 15 where a heal cup of the
flexible support device provides an initial foundational support
when molding the patient.
17. The method as recited in claim 15 where the practitioner checks
the distal regions to ensure that the metatarsal heads are not
crossing the total sulcus.
18. The method as recited in claim 1 where a two-five sub-region of
the flexible support device slopes downwardly in a longitudinally
forward direction toward the distal area and downwardly to the
laterally outward region and aids in aligning the foot by providing
propreaceptive input for the patient to bring about awareness to
the patient during the casting process.
19. The method as recited in claim 1 where following application of
the molding strips, the practitioner will exert a force on the
distal region of the foot where this force is distributed
longitudinally rearwardly to the heel region because of the
flexibly controlled deformation of the flexible support device.
20. The method as recited in claim 1 where the flexible support
device has sidewalls with the medial lateral wrap region that
provides increased support for positioning the foot into a desired
alignment as the strips harden.
Description
RELATED APPLICATIONS
[0001] This application claims priority benefit of U.S. Ser. No.
60/628,807, filed Nov. 15, 2004; U.S. Ser. No. 60/552,491, filed
Mar. 12, 2004; and U.S. Ser. No. 60/537,040, filed Jan. 16,
2004.
BACKGROUND OF THE INVENTION
[0002] Orthotics and lower limb orthosis devices, in one form, are
made for patients by practitioners for a custom fit to accommodate
a patients lower limb support needs. It has been found, in the
practice of forming foot orthotics or orthoses, that the logistics
of transporting product from the factory to the practitioner is
time-consuming, as the practitioner must first send a mold back to
the manufacturing facility. Further, there is an issue of
maintaining product at the practitioner's location whereby
constantly sending molds to the manufacturer can deplete the
practitioner's supply of stock mold materials. Therefore, in one
form it is desirable to have an embodiment where a semi-rigid
device used to make a negative mold of a patient's foot used for is
not sent back to the orthosis manufacturer, but rather, can be
stored at the practitioner's location for reuse. Further, storage
space is generally not pletiful at a practitioner's business
location, and maintaining inventory of foot molding products can be
very challenging. In one form, the embodiments below disclose a
convenient method of storing and stacking the flexible members.
[0003] The description relates to a flexible support device that is
adapted to be used in assisting in the molding casting process. In
general, a negative shape of the patient's foot is casted for
purposes of creating a dynamic angle foot orthosis. It should be
noted that the foot cast is for the lower leg including the ankle
portion, as well as the lower foot region of a patient, essentially
the biomechanical structures below the knee of a patient.
[0004] Another area of the disclosure relates to pediatric
orthotics utilizing a flexible support device. In areas where
custom orthotics are not appropriate for various budgetary reasons,
a mild support system is advantageous for various young people with
foot misalignments. Therefore, pre-made orthotics have provided a
service where foot support is appropriate.
[0005] During pronation of a foot there are three significant
segments of the foot that must be controlled. The heel area during
pronation tends to shift into eversion. Eversion is an anatomical
condition where the heel, with respect to the ankle, is
repositioned and rotates about a longitudinal axis laterally
outwardly. The longitudinal arch must maintain a proper
biomechanical position and alignment. During pronation the arch
moves medially and distally to a flat position, more so in the
medial direction. Finally, the forefoot will shift laterally
outwardly to abduction. Therefore, all three of these occurences
happen in conjunction and the heel and the arch in the forefoot
will shift commensurate with the misalignment of each general foot
region.
[0006] It should be noted that during collapse of the mid foot
longitudinal arch, the skin surface of the heel will remain
substantially intact with the weight-bearing surface, but the upper
portion of the heel will move laterally inwardly, otating about a
substantially longitudinally extending axis.
[0007] Therefore, an effective orthotic or orthosis device must
address all three of these simultaneously while providing for
movement and general athletic motions of the patient. The device
should address these misalignment issues and be comfortable and
wearable by the patient.
[0008] A further embodiment of the invention is to have an
off-the-shelf non-customized device for the patient as well.
Further, because patients that are young are growing and outsize
these devices in a relatively short amount of time, there is an
economic incentive to make a less expensive device which will have
a limited lifetime irrespective of the use and wear of the
device.
[0009] Deep foot orthotics are problematic in that they have not
often been comfortable to patients. Therefore, the challenge has
been to provide a comfortable off-the-shelf foot orthotic that
provides support and adapts to various patients' feet without
specific molding.
[0010] Pre-made inserts have been problematic because of the
instability associated with them.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is an upper front orthogonal view of a flexible
support device;
[0012] FIG. 2 is an isometric view of a flexible support device
showing the various regions of the device;
[0013] FIG. 3 shows an assortment of sizes of flexible support
devices;
[0014] FIG. 4 shows an assortment of sizes of flexible support
devices stacked in a convenient volumetrically efficient
fashion;
[0015] FIG. 4 shows sizing of a flexible support device with
respect to a patient's foot;
[0016] FIG. 5 shows a second sock stockinette positioned over the
flexible support device and generally around the foot of the
patient;
[0017] FIG. 6 shows positioning of a member that aids in the
prevention of injury when removing a cast;
[0018] FIG. 7 shows flexible strips in a flexible state wrapped
around the foot of the patient;
[0019] FIG. 8 shows the practitioner positioning the ankle region
of the patient for proper alignment;
[0020] FIG. 9 shows a method of removing the cast from the leg of
the patient;
[0021] FIG. 10 shows removal of the flexible support device from
the cast;
[0022] FIG. 11 shows a method of altering the flexible support
device to accommodate a patient with a narrow foot;
[0023] FIG. 12 shows a method of overlapping the flexible support
device to accommodate a narrower foot of a patient;
[0024] FIG. 13 shows a method of repositioning the flexible support
device by applying heat to a localized area;
[0025] FIG. 14 shows alteration of the flexible support device to
accommodate a particular patient;
[0026] FIG. 15 is an orthogonal view of a rigid shell device:
[0027] FIG. 16 schematically shows another device adapted to
measure the lower limb portion of a patient;
[0028] FIG. 17 shows a casting device operating in conjunction with
an insert adapted to cooperatively function in a manner to get a
proper measurement of the foot of a patient;
[0029] FIG. 18 shows another modular arrangement of devices adapted
to properly measure the lower limb of a patient for purposes of
creating an orthotic or orthosis;
[0030] FIG. 19 shows an exploded view of an orthotic support device
having a soft inner shell and a harder exterior shell;
[0031] FIG. 20 shows an isometric view of an orthotic support with
a soft inner shell having edge portions protruding beyond the edge
portions of the outer shell;
[0032] FIG. 21 shoes a bottom view of an orthotic support
device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0033] In general, the specification below will first describe one
form of casting a lower limb orthotic/orthosis device whereby a
flexible support device is employed. Thereafter, with reference to
FIGS. 15-18, a second embodiment is shown whereby the second
embodiment can be used in various forms to provide the practitioner
numerous options for producing an orthotic/orthosis device. In
general, the shell as shown in FIG. 15 can be used as a casting
device, or alternatively as a measuring device to measure the
general contours of a patient's foot where only the measurements
need to be sent to a manufacturing facility for production of an
orthosis (or simply used to provide a specific size and shape of
orthosis premade). Further, the embodiments as shown in FIGS. 15-18
can be used in a modular-type arrangement were modular components
are arranged to provide a wide variety and proper fit to the
patient. Finally, the embodiments as shown in FIGS. 19-21 show a
system where a rigid shell is employed with an interior soft shell,
where in this version, the rigid shell is essentially the end
product that provides support for the patient and the interior soft
shell can absorb localized protrusions and indentations for a more
comfortable fit for the patient.
[0034] As shown in FIG. 1 the flexible support member 20 is shown.
As shown in this figure, an axis system is defined where the arrow
indicated at 22 indicates a longitudinal axis. Likewise, the
orthogonal arrow 24 indicates a lateral axis. Finally, the arrow
that is orthogonal to the two mentioned arrows is indicating a
vertical axis 26.
[0035] As further shown in FIG. 1, the flexible foot support has a
medial region generally indicated at 28 and a lateral region
generally indicated at 30. Further, the longitudinally forward
region is generally referenced as a distal region 32 and the
opposed longitudinal region is commonly referred to as a proximal
region 34. In addition to the aforementioned regions, a plantar
region indicated at 36 defines the general upper surface that comes
in contact with the lower portion of a patient's foot. The medial
lateral wrap region generally indicated at 38 is a substantially
vertical region that is adapted to encompass the calcaneus (a
portion of the heel bone), the medial arch which is sometimes
referred to as the longitudinal arch, and the navicular. Further,
the medial lateral wrap region is adapted to cover the first
metatarsal head and the fifth metatarsal head, the base of the
fifth metatarsal head and the peroneal arch.
[0036] As shown in FIG. 2, the plantar region 36 is approximately
defined as the central region within the encompassed section 40.
The hatched region around the upper perimeter is substantially
defined as the medial lateral wrap region as described above. The
plantar region 30 is defined to have various regions as shown in
FIG. 2. Beginning in the longitudinally rearward section, the heel
depression indicated at 42 is defined as a region adapted to be
depressed to a patient's heel during a molding process. The heel
depression region 42 provides a foundation for the medial lateral
wrap region 38 as described further below and this region of the
material is adapted to work in conjunction with this longitudinally
rearward portion to correct various skeletal biomechanical
misalignments such as pronation, supination, and varus-valgus. The
peroneal arch is a region 44 where the surface raises somewhat
vertically. The peroneal arch is distal to the heel depression to
help control the heel (calcaneus position), and is right behind the
base of the fifth metatarsal. This region helps support the arches
of the foot and overall foot alignment. It should be noted that the
peroneal arch region 44 is a vertical indentation which is
represented in the outer surface of the flexible support devices
20. This can be advantageous for providing feedback to a
practitioner when casting to denote a certain position. Further,
the region 44 is a potential reference point to aid instruction
when instructing a practitioner to properly exercise a molding
process and aligning the bone structure of a patient described
further herein below.
[0037] Also shown in FIG. 2, the medial arch region 46 is defined
generally as a raised region in the central portion of the plantar
region 30. As with the peroneal arch 44, the medial arch has a
raised region which a practitioner can use to grab when conducting
and creating a mold upon a patient as described further herein
below. The flexible support member 20 by default has a raised
medial arch region. It should be noted that the member is flexible
and described further herein below. The medial arch is useful in
aligning the avicular navicular and assisting in properly aligning
the foot to a solid functional biomechanical neutral position as
opposed to a pronated foot or supinated foot. The metatarsal arch
indicated at 48 is a raised region adapted to support the
metatarsals, particularly the central metatarsals 2, 3 and 4.
[0038] Further shown in FIG. 2 is the metatarsal depression
generally indicated at 50. This region is defined as a region that
supports and aligns the metatarsal heads.
[0039] The most forward distal region indicated at 52 is the toe
rise region. This region is divided into a drop first toe region
subregion 54 and a two-five region 56. The drop toe region 54 is
positioned slightly vertically lower with respect to the two-five
subregion 56. From the sulcus, the two-five subregion 56 slopes
downwardly in the longitudinally forward direction toward the
distal area and downwardly to the laterally outward region
indicated by arrow 58. This region helps align the foot and allows
propreaceptive input for the client so that the foot may be aligned
properly. Specifically, the surface allows the client to become
aware of his feet and his foot placement. Therefore the raised
region brings this awareness to the client during the casting
process, allowing for a better mold.
[0040] There will now be discussion of the molding process, during
which a practitioner will take a mold of the lower foot region of a
patient. As shown in FIG. 3, the first step in the molding process
is to choose the proper size of a flexible support device. FIG. 3
shows an assortment of sizes of flexible support devices to
accommodate a wide variety of patients. As shown in this figure,
the variety of flexible support devices 20 are adapted to be
stacked as shown. In other words, the cavity region of a larger
flexible support device will support the next smaller size. In a
storage location, the flexible support devices are arranged in a
stacked position whereby an outer surface of an immediately smaller
flexible support device is engaged in a chamber region of the
immediately larger flexible support device so the plurality of
flexible support devices are arranged in a stacked manner. This
allows for storage of quite a few flexible support devices in a
practitioner's office. Further, this stacking method facilitates in
sizing up the proper flexible support member 20 so the practitioner
can easily identify which size would be appropriate. For example,
if the practitioner chooses one of the central sizes and it is does
not properly fit the patient, the practitioner can gauge the
difference of size required and skip a set number of increments
smaller or larger to gauge the approximate appropriate size for the
particular patient.
[0041] Thereafter (or prior to sizing), a stockinette is placed on
the patient's foot as shown in FIG. 4. A stockinette is defined
broadly as a flexible cover to provide some protection and at least
partial separation between respective inner and outer portions of
the stockinette. In one form the stockinette is made from a
fabric-like material, similar to an expandable sock. The foot is
then placed into a properly sized flexible support device 20. The
various plantar services described above with reference to FIG. 2
must be aligned with the corresponding anatomy of the patient's
foot. In particular, the heel region of the patient should be
pressed firmly against the substantially vertical surface of the
proximal location of the medial lateral wrap. Referring back to
FIG. 2, the proximal location of the medial lateral wrap generally
indicated at 39 is referred to as the heel cup. One advantageous
aspect of the heel cup 39 is that it provides an initial
foundational support when molding. When not providing a vertical
support region in the heel cup the prior art support members will
move with respect to the foot to improper locations. This leads to
improper casting and an eventual poor support device. Therefore,
having the heel cup region 39 aids in preventing an improper
casting.
[0042] Now referring to FIG. 5, it can be seen that the heel region
70 of the patient is pressed firmly against the heel cup region 39
of the flexible support devices 20. After the heel is properly
aligned in the rearward, proximal location of the flexible support
device 20, the practitioner must check the distal regions to ensure
that the metatarsal heads are not crossing the total sulcus.
Referring back to FIG. 2, the total sulcus indicated at 45 is the
distal methead proximal toe rise area indicated at the laterally
extending line designated by 45. Although other portions of the
anatomy could be aligned to the flexible support device, this
region is accessible to view by the practitioner and generally, the
intermediate plantar surface regions will be properly positioned
corresponding to the anatomy of the patient. Referring back to FIG.
4, it is advantageous to have the overall length of the flexible
support device slightly longer than the toes 72 of the patient. In
other words, this region is not critical for a proper mold and
therefore the extra space indicated at 73 between the toes 72 and
the forward vertical region 33 will not generally be a problem in
molding. In one form, the gap region between the forward surface of
the patient's toes 72 and the forward vertical region 33 is
approximately a quarter of an inch or greater.
[0043] FIG. 5 further shows the application of a second stockinette
74. In one application, a second stockinette is applied over the
flexible support device 20 and the initial layer of stockinette.
The second layer of stockinette is advantageous for removal of the
layer of the cast that is to be applied which is described below.
Further, it has a second advantage of aiding the removal of the
flexible support device 20 after the mold has at least partially
cured and taken a substantially rigid form (also described further
below). Further, the second stockinette 74 increases the net volume
of the positive mold which represents the foot and ankle region,
the first and second stockinettes and the flexible support device
20.
[0044] As shown in FIG. 6, a cutting strip 76 that is shown beneath
the second stockinette 74 is "wormed in" down a portion of the
patient's leg and foot region. In one form, this is located in the
forward central region to facilitate a buffer region when removing
the mold. This cutting strip is applied underneath one of the two
stockinettes. In another form the cutting strip is applied in the
outer surface of the stockinette 76. Appling the cutting strip 76
is an optional process for aiding in the removal of the mold if a
non-flesh-cutting element is used to remove the mold. It in another
version, the cutting strip is taped or otherwise attached to the
inner stockinette.
[0045] As shown in FIG. 7, pliable molding strips 95 are wrapped
around the second stockinette 76 (see FIG. 6) in one form the
molding strips are fiberglass, but any substance that is initially
pliable and can harden to a mold after a few minutes would suffice.
The preset state of the fiberglass rolling is generally a condition
where the fiberglass tape is wet and wrapped around the entire
ankle foot region with the stockinette applied thereon as shown in
FIG. 6. The molding strips 95 are defined broadly to cover all
materials that have the ability to be applied in a very flexible
form fitting manner and harden to at least a semi-rigid state to
preserve a negative mold of the outer surface of the inner
structure members (e.g. the contour of the lower limb and the
flexible support device). When the molding strips are all applied
to the foot region they collectively form a wrap 97 as shown in
FIG. 7.
[0046] Before the wrap 97 hardens, the practitioner engages in an
alignment and feature definition process. This process essentially
positions the foot into a proper neutral biomechanical position to
form a proper mold. As described above, the features of the
flexible support device 20, given its flexibility, allow the
practitioner to have a greater amount of control over the
manipulation of the position of the various features of the foot
and lower limb regions of the patient. In other words, without some
flexibility of the flexible support device 20, the anatomical
features of the foot would not be manipulated. However, the
flexible support device is sufficiently rigid to allow a
distribution of pressure upon adjacent regions of the foot and
lower ankle region that the practitioner is not in direct contact
with. The goal is to have the mold formfitting to the contours of
the patient's foot and maintaining the correct overall
biomechanical alignment.
[0047] The aforementioned arch regions as shown in FIG. 2 assist in
aligning the arches to form a proper mold. As shown in FIG. 7, the
hindfoot is stabilized with the hand indicated at 90. The thumb is
on the navicular bone of the patient and supply a vertical force
indicated by arrow 92 helps to define a longitudinal arch. The
fingers span the instep region 94 and the forward tip portions of
the practitioner's fingers grasp the calcaneus region and in some
cases help remove the pronation of the patient. If the patient does
not have a pronation problem, the left-hand 90 will support the
ankle region so it is properly neutrally aligned. The palm of the
hand 90 is on the medial side of the foot and the fingers extend
around the back of the heel.
[0048] The practitioner's other hand 96 of the practitioner brings
the forefoot to the neutral position. A neutral position must be
executed about a longitudinal axis so the portion of the foot is
properly positioned. Further, the medial and lateral alignment must
be properly aligned as well. It is important to keep the heel
vertical, therefore there may be some sacrifice in keeping the
forefoot horizontal in order to properly align the heel region of
the patient's foot. The heel alignment is the base, and given the
individual's range of motion, the best biomechanical alignment is
obtained. The flexible support device provides a more gradual
transition from the forefoot to the rear foot because the rigidity
and flexibility of the flexible support device 20 will allow any
manipulation to extend longitudinally rearwardly and supply a force
along the surface of the foot. In other words, even though the
practitioner will exert a force on the distal region of the foot,
this force is distributed longitudinally rearwardly to the heel
region because of the flexibly controlled deformation of the
flexible support device. Without the flexible support device 20,
any manipulation by the practitioner's fingers will create a
localized depression upon the wrap 97. However, with the flexible
support device contained thereunder, any manipulation is not
directly applied but it is more uniformly distributed around the
adjacent regions were pressure is applied. Given that the flexible
support device already has a preset form of key features and
depressions as described in FIG. 2, these features are better
maintained. The flexible support device provides a more natural
transition of manipulation from the rearward portion of the foot to
the forward portion of the foot.
[0049] As shown in FIG. 8, the process of the alignment and feature
definition process is substantially complete and the wrap 97 is
beginning to cure to some degree and taking a solidified form. At
this point the practitioner has the ability to manipulate localized
regions for a better detailed fit. As shown in FIG. 8, the
practitioner is contouring the heel to a proper alignment. Of
course the practitioner may choose to contour other regions to take
a proper neutral biomechanical set form. It should be noted that
when pressure is applied the medial lateral wrap portion 38 as
shown in FIG. 2, the precured wrap 97 disperses pressure and aids
in not allowing "flesh displacement". In other words, particularly
in younger patients with more "fleshy" feet that contain greater
fat deposits, the medial lateral wrap 38 region allows a more
proper distribution of pressure when the wet flexible wrap 97 is
applied therearound. The flexible support device 20 having a
central chamber region aids in positioning the patient's foot from
the beginning of the molding procedure. In other words, instead of
having a substantially planar device without sidewalls, the medial
lateral wrap region aids in initially positioning the foot so the
margin of error is reduced for the alignment of the various arch
and depression regions 42-50 discussed in FIG. 2 and the
corresponding anatomical portions of the foot. The patient's foot
is channeled into this chamber region and there are less
manipulation and alignment issues for the practitioner to be
concerned with when performing the mold.
[0050] As shown in FIG. 9, the cast is removed by incising the
front portion with any conventional type of tool. Any particular
chosen method of cutting the cast after it has cured can be
employed. It should be noted that the flexible support device 20
aids in the removal of the cured cast from the patient's foot
because it allows for a distribution of pressure around the lateral
regions of the foot during removal. The flexible support device 20
further minimizes distortion during cast removal when the forward
central region of the cast must be expanded and pried laterally
outwardly to allow the foot and ankle to be interposed and removed
therein between the cut portion. Minimizing the deformation of the
cast is useful when the cast is not fully cured, which can be a
problem when colder water is used when beginning the curing process
of the cast, or other reasons that may lead to a slow curing
process.
[0051] FIG. 10 illustrates one particular use of the flexible
support device 20. As shown in this figure, the flexible support
device 20 is removed from the cast 80. This allows for reuse of the
flexible support device. This removal can be executed by the
practitioner and the practitioner can thereafter properly store the
flexible support device in the manner as shown in FIG. 4. This is
particularly advantageous because in one form of prior art
practice, the entire cast is sent to a third-party company which
makes the final orthosis support device. This allows the
practitioner to refrain from sending support devices adapted to be
positioned on the lower portion of the patient's foot to be mailed
along with the cast to a third party fabricator. This depletes the
supply of support devices for the practitioner, who makes the cast
at a location which is generally not the location where the final
orthosis support device is created. Therefore with the present
invention, the practitioner maintains his supply of the flexible
support devices as shown in FIG. 4.
[0052] There will now be a discussion of various adjustments that
can be made during the molding process with initial reference to
FIG. 11. As shown in this figure, the flexible support device 20 is
incised in a substantial longitudinal direction. Now referring to
FIG. 12, the flexible support device can be overlapped at the
region indicated at 90 to provide for a patient's foot that may be
narrower in the lateral direction. This provides flexibility for
various shapes feet of patients. It should be noted that when a
shorter and wider foot is required to be molded, the medial lateral
wrap region's have a certain amount of flexibility to allow this
wider foot to be contained in the chamber region of the flexible
support device 20. The support infrastructure of the various
interior surfaces described on FIG. 2 is maintained even when a
wider foot is entered in the chamber region of the flexible support
device 20.
[0053] In the situation where there are bony prominences or extreme
shapes of a patient's foot which require special accommodation,
reference is made to FIGS. 13 to 16. As shown in FIG. 13, a heating
element 100 supplies heat to a specific location of the flexible
support device 20. It should be noted that any area of the flexible
support device can be heated and manipulated to accommodate any
specific situation with a patient. It is often at the discretion of
the practitioner to accommodate various extreme anatomical features
of the patient, or any disfigurements. Therefore, by way of
example, a formation process is shown in FIGS. 13-16. FIG. 13 shows
the heating of the medial region where the first prominent method
would be slightly extruded on the patient. As shown in FIG. 14, the
region 102 is biased laterally outwardly to accommodate this
feature of the patient. Of course various methods of alteration are
available, such as an alteration to the flexible support member 20,
where the base of the fifth metatarsal bone region 106 is heated so
the material becomes plastic and formable where the practitioner
can manipulate the region 106 outwardly to accommodate an outward
extension of the patient's foot in this region.
[0054] It should be noted that the flexible support device 20 is
particular adapted for external posting. During this process,
shim-like devices are positioned either externally of the wrap or
in some cases wrapped internally thereunder. The shim-like devices
provide a consistent support surface for maintaining the foot
position in a certain natural alignment positioned for molding. As
described above, the application of pressure of the shim allows for
a more consistent natural transition of forefoot to rear foot,
given the rigidity of the flexible support device and the
flexibility of the device as well. It should further be noted that
the various features as shown in FIGS. 1 and 2 provide assurance
that the internal arches of the patient's foot are maintained in
the manipulation of the patient's foot during the molding
process.
[0055] The embodiments as shown in FIG. 15 relate to a rigid shell
device (control module) that can be used for casting or only as a
measuring device for determining proper orthoses for the lower leg.
In general, the full lower shells comprise a support module shown
in FIG. 15 having an approximate section that extends up above the
ankle. This is made of a flexible material such as plastic in a
similar manner as the flexible support device 20 described above
and has a central slit region that allows for it to be adjustable.
The key features are molded into this module, such as an arch or
other anatomical regions as described in shown in FIGS. 1 and 2.
Further, prominent features of the foot are compensated for as
well.
[0056] In one form, the control module 120, which is one form of a
flexible support device, can be used to assist in casting whereby
modules are placed around the patient's foot and squeeze tight for
proper fitting. Thereafter, the practitioner, using standard mold
casting techniques that are described above, is able to create a
correct negative cast of the patient's foot. Thereafter, this cast
is sent to a facility (or executed on site) whereby the control
module is a known fixture of a cast and making an improper positive
model of the patient's foot can be avoided. Thereafter, there is a
positive model (mold) that is used to create an orthosis support
device.
[0057] It should be noted that it is advantageous to have the
lateral lower portion extend over the foot as well as have the
proximal section extend up the lower calf of the patient to control
foot position during the casting.
[0058] A second application is to use the control module as a
sizing shell, whereby no casting is conducting by the practitioner,
but the particular size of the control module is relayed back to
the manufacturer of the final braces to eliminate casting and the
physical mailing of the cast which is expensive and causes a time
delay.
[0059] To facilitate the communication of the proper sizing of the
foot without taking a cast, marking indications, such as shown in
FIG. 15, can be employed whereby the ridge 130 will engage certain
coinciding locations with certain markings 132 which would be
indicated by certain measurements. As shown in FIG. 16, this could
be accomplished with a strap like system having a base support 140
having a plurality of flexible measuring devices 142.
[0060] Another element of the apparatus is to have modular
components as shown in FIG. 17. As shown in this figure, there is a
rigid foot structure component 150 having a central lower cavity
region 152 that is adapted to receive an orthotic-like insert 154.
The theory is that the practitioner can fit the shell to the
patient and further have the flexibility of fitting one of the
stock orthotic molds to the patient as well. The shell can have
various lines 156 or other adjustment features to quantify the
position and orientation of the orthotic-like insert 154.
[0061] As shown in FIG. 18, the modularity can further extend to
having a lower semi-rigid fitting module 160 and then an upper
semi-rigid module module 162. These modules can work in combination
and be taken from a plurality of modules that could be stacked in a
manner similar to FIG. 3 to properly fit the patient.
[0062] This concept can be taken further to having an off-the-shelf
type orthotic with mix-and-match components to properly fit the
patient.
[0063] Now referring to the embodiment shown in FIGS. 19-21, the
apparatus 220 comprises an outer support shell 222 and an inner
liner 224. In general, this embodiment employs a rigid shell to
provide a proper orthosis devise for the patient and further uses
an inner soft shell liner to accommodate various bio-structural
variations between patient to patient. In general, this embodiment
does not employ casting, but rather the plastic shell itself is
provided as the end product for the user to wear for lower limb
support.
[0064] The outer shell has an interior chamber region and the inner
liner has an exterior surface that is adapted to engage the inner
surface of the outer shell 222. The outer support shell 222
comprises a perimeter support region 226 having medial and lateral
sections 228 and 230. The outer support shell 222 further has a
heel cup 232 in the rearward portion of the device 220. The
perimeter support region 226 is positioned in a location that is an
approximate support location for the patient. In other words, the
outer shell provides a rigid support to control the biomechanical
positioning and alignment of the patient.
[0065] The outer support shell is made of a rigid material such as
plastic, but does provided a certain amount of flexibility or
comfort to account for various foot positions which the patient may
be in without allowing the foot to completely collapse.
[0066] The embodiment shown in FIGS. 19 and 21 is adapted to be an
off-the-shelf type orthotic utilizing proprioceptive feedback
(sensory feedback); this is important in providing the patient with
a heightened sense of foot position to aid in proper alignment of
his or her feet.
[0067] The perimeter region 226 provides a certain amount of
flexibility; when it is depressed by hand with a modest grip, the
size will deflect inward or outwardly a few millimeters. It is
mportant to note that this flexibility provides functionality for
accommodating a wide range of patients' feet. Further, the
flexibility allows for a footwear device such as a shoe or a boot
to press upon the outer surface of the outer support shell to
provide a better and more accommodating fit. The outer support
shell 222 has an overall thickness between 0.5 and 3 millimeters in
the broader range. A more preferable range is between 1/16 of an
inch to 90 thousandths of an inch. In one form, a polyethylene base
plastic is used to mold the outer support shell 222. Of course
other materials providing flexibility and strength can be
employed.
[0068] As shown in FIG. 21 the under portion of the outer support
shell 222 comprises a variety of support sub region surfaces. It
should be noted that this underside of the surface correlates to a
raised region on the chamber region of the outer support shell 222.
As shown in this figure, the peroneal surface 244 is located on the
laterally outward region; the metatarsal raised region is located
in the forward medial region and adapted to engage the metatarsals
of the patient. The medial longitudinal arch indicated at 248 is
adapted to provide the common support in the laterally inward
medial region of the patient. These arches are accentuated to some
degree to give proprioceptive feedback to the patient so he or she
will be induced to mentally align his or her foot to enhance his or
her development of voluntary control of foot alignment.
[0069] As shown in FIG. 20, the outer support shell 222 has a
rearward upper perimeter ridge region 250. This region is
positioned vertically below the perimeter ridge 266 of the inner
support liner to provide a blending of pressures from the perimeter
region 250. In other words, by positioning the perimeter ridge 66
above the lower rigid ridge 250, less direct edge pressure is
applied to the foot region of the patient. The inner liner 224
provides the smooth transition to prevent that focused edge
pressure that would otherwise be present and create discomfort with
the patient. The upper portion of the inner liner allows for an
automatic adjustment of the pressure, so the upper perimeter ridge
region 250 need not be custom to the patient; rather, the apparatus
220 is self-adjusting to each patient.
[0070] The inner liner 224 protects the side of the foot as it
shifts positions from the proximal edge of the support shell. In
other words, the patient is less likely to engage the perimeter
rigid region 250 and have their flesh have a localized pressure
developing an irritation.
[0071] There will now be a description of the inner liner 224 with
initial reference to FIG. 19. As shown in this figure, the inner
liner 224 comprises a base region 260 and a forward region 262. The
inner liner 224 further has an upper region 264 that comprises a
perimeter ridge 266. The construction of this inner liner 224 is
generally made from foam. In one form, the inner liner 224 is made
from closed-cell 5-pound density foam from ethylene vinyl
acetate.
[0072] The forward region of the outer support shell 222 has a
lateral region 270. As shown in FIG. 20, the inner liner 224 has an
extension region 272 that extends longitudinally forward from the
region 270. The inner liner 324 is adapted to extend out and cover
the base and the metatarsal head. The support shell is adapted to
be terminated just prior to the fifth metatarsal head on the
lateral side. It should be noted in FIG. 20 that the medial side is
adapted to be cut back before the first metatarsal head.
[0073] By having the outer support shell 222 provide the rigid
structure so the extension 272 is positioned at substantially right
angles from the lateral region to the plantar region, the inner
shell provides some rigidity to prevent abduction of the foot when
the foot pronates. This is a condition when the medial longitudinal
arch of the patient collapses.
[0074] Now referring to FIG. 18, the general area indicated at 80
is defined as a pivot region where the metatarsal heads
approximately end and, in an operating environment, the patient
will pivot when walking or running. It should be noted that the
region 270 terminates prior to this pivot region 280 to not
interfere with the pivoting action. However, the region 272 of the
inner shell 224 being more flexible and made from foam-like
material will accommodate the pivoting action during walking or
running (or other bipedal motion).
[0075] Therefore, it can be appreciated that the apparatus 220 is
well suited to prevent pronation of a patient's foot which is a
common joint misalignments biomechanical issue in many young
patients. The medial section 226 of the perimeter support region
will have a tendency to apply a pressure on the medial region to
prevent the eversion described above. Further, with the cup region
orientated where the rearward surface extends in a plane that is
substantially orthoganal to the longitudinal axis and the medial
region in a plane orthogonal to the lateral axis, additional
support is provided and added rigidity is a benefit to prevent this
rotation of the heel described above.
[0076] The depth allows the flexible support shell to function
properly because having the vertical region indicated at 227 in
FIG. 19 allows for a greater moment of inertia when a moment is
applied about a lateral axis such as a pressure from the patients
foot in the lateral arch region. This is particularly advantageous
because less material and structure is required to provide that
rigidity, creating a lighter more compact orthotic.
[0077] The final component of providing a proper biomechanical
alignment for the patient is preventing the forefoot from abducting
laterally outwardly with respect to the heel region of the patient.
As described above in greater detail the extension region 270
provides a base region for supporting the portion of the inner
liner region 272 to aid in supporting in controlling the abduction.
As described above, the flexible foam insert provides flexibility
during running where it will actually collapse to a certain degree
to provide the range of motion for the patient.
[0078] The apparatus 220 is particularly useful in an environment
of footwear such as a shoe where the upper perimeter region 266 of
the insert is adapted to position laterally outwardly with respect
to the center chamber region of the shoe. In other words, the
region 272 is easily repositioned and grasped laterally outwardly
by the patient and the perimeter region of the patient's foot will
easily glide past the outer support shell 222 and be positioned in
proper foot position in the shoe. It should further be noted that
given the overall length of the apparatus, it will fit properly in
a shoe and not be positioned vertically forward with respect to the
shoe to prevent movement of the soft liner inner liner 224.
[0079] In one form, a layer on the upper surface of the inner liner
224 can be applied to aid in breathability of the apparatus 220.
Further, the coefficient of friction between the foot and foot and
stocking of the patient can be adjusted to prevent discomfort such
as excessive footwear which may cause blisters or the like.
[0080] A further modification can be employed where the lower
surface of the outer support shell can be filled with some form of
material to provide extra support and rigidity. In one form, the
aforementioned arch regions can be enhanced and amplified to
facilitate the proprioceptive feedback to the patient.
[0081] One form of manufacturing and making the outer support shell
is employing common thermal sheet forming techniques such as
draping. However, many forms of manufacture can be employed such as
injection molding, milling etc.
[0082] While the present invention is illustrated by description of
several embodiments and while the illustrative embodiments are
described in detail, it is not the intention of the applicants to
restrict or in any way limit the scope of the appended claims to
such detail. Additional advantages and modifications within the
scope of the appended claims will readily appear to those sufficed
in the art. The invention in its broader aspects is therefore not
limited to the specific details, representative apparatus and
methods, and illustrative examples shown and described.
Accordingly, departures may be made from such details without
departing from the spirit or scope of applicants' general
concept.
* * * * *