| |
| United States Patent
|
6,155,997 |
| Castro |
December 5, 2000 |
Custom ankle brace system
Abstract
A custom ankle brace which is made to compensate for debilitating
conditions of an individual patient's ankle area. The brace is
custom made by creating a negative cast of the patient's
foot/ankle/lower-leg; and then prescribed markings are included on
the negative cast by the castmaker to indicate the desired geometry
of support. The markings are transferable to a positive cast to
inform the bracemaker. The custom brace has inner and outer material
layers with a stiffening element within, all fitted to the shape of
a built-up positive cast, the stiffening element having a unitary
horizontal partial sole portion and vertical back-and-sides-of-leg
portion. The stiffening element, made from a thin polymeric sheet,
is vacuum and heat fitted to the built-up positive cast.
| Inventors: |
Castro; Ernesto G.
(Mesa, AZ) |
| Appl. No.:
|
08/991,744 |
| Filed: |
December 16, 1997 |
| Current U.S.
Class: |
602/27 ;
602/6 |
| Current
International Class: |
A61F
5/01 (20060101); A61F 013/00 () |
| Field of
Search: |
602/6-8,23,27-29
264/222,223 |
References Cited
[Referenced By]
U.S. Patent
Documents
Primary Examiner: Yu; Mickey
Assistant Examiner: Pothier; Denise
Attorney, Agent or Firm:
Stoneman; Martin L.
Claims
What is claimed is:
1. An ankle brace system comprising an ankle brace, for providing
orthotic assistance to an ankle area of a patient wherein the ankle
area includes at least one abnormal protrusion enhancing disability
for normal walking, said ankle brace comprising:
a. multiple adhesively-connected material layers forming overall a
toeless boot and shaped to provide support for the abnormal
protrusion by matching the contours of the abnormal protrusion; and
b. at least one said material layer comprising a stiffener element
comprising:
i. a partial sole and arch portion lying essentially in a horizontal
plane, said partial sole and arch portion being structured and
arranged to fully conform to and cover the contours of the patient's
sole and arch substantially between the patient's heel and the ball
of the patient's foot; and
ii. an essentially vertical sides-and-back-of-leg portion fixed at
about a right angle from said plane of said partial sole and arch
portion;
iii. wherein said stiffener element is structured and arranged to
fully conform to and cover the contours of the abnormal protrusions
on the ankle area;
c. said ankle brace being constructed and arranged to be used with a
separate essentially normal shoe;
d. wherein said ankle brace further comprises closure elements for
tightening and closing said ankle brace on the patient;
e. wherein said multiple material layers are structured and arranged
to provide substantially full circumferential support about the
ankle area when said closure elements are tightened, and;
f. wherein at least one of said material layers comprises leather.
2. An ankle brace system according to claim 1 wherein at least one
of said material layers comprises a foam cushioning material.
3. An ankle brace system according to claim 2 wherein said foam
cushioning material comprises about a 1/8-inch thick, single
density, medical grade polyurethane foam.
4. An ankle brace system according to claim 1 wherein said stiffener
element comprises a polymeric material shapable when heated.
5. An ankle brace system according to claim 4 wherein said polymeric
material comprises about a 2-millimeter-thick orthopedic grade
polymer blend.
6. An ankle brace system according to claim 1 wherein the innermost
layer of said multiple adhesively-connected material layers
comprises a leather material.
7. An ankle brace system according to claim 6 wherein said innermost
layer comprises 21/2 ounce orthopedic tanned leather material.
8. An ankle brace system according to claim 1 wherein the outermost
layer of said multiple adhesively-connected material layers
comprises a leather.
9. An ankle brace system according to claim 8 wherein said outermost
layer comprises a 21/2 ounce chromium tanned cowhide leather.
10. An ankle brace system according to claim 1 wherein said
stiffener element does not have a heel portion.
11. An ankle brace system according to claim 1 wherein:
a. at least one of said material layers comprises a foam cushioning
material, said foam cushioning material comprising about a 1/8-inch
thick, single density, medical grade polyurethane foam;
b. said stiffener element comprises a polymeric material shapable
when heated, said polymeric material comprising about a
2-millimeter-thick orthopedic grade polymer blend;
c. the innermost layer of said multiple adhesively-connected
material layers comprises a leather material, said innermost layer
comprising a 21/2 ounce orthopedic tanned leather material;
d. the outermost layer of said multiple adhesively-connected
material layers comprises a leather material, said leather material
comprising a 21/2 ounce chromium tanned cowhide leather;
e. said ankle brace further comprises closure elements for
tightening and closing said ankle brace on said patient; and
f. said stiffener element does not have a heel portion.
12. An ankle brace system comprising an ankle brace, for providing
orthotic assistance to an ankle area of a patient wherein the ankle
area includes at least one abnormal protrusion enhancing disability
for normal walking, said ankle brace comprising:
a. multiple adhesively-connected material layers forming overall a
toeless boot and shaped to provide support for the abnormal
protrusion by matching the contours of the abnormal protrusion; and
b. at least one said material layer comprising a stiffener element
comprising:
i. a partial sole portion lying essentially in a horizontal plane,
said partial sole portion being structured and arranged to fully
conform to and cover the contours of the patient's sole
substantially between the patient's heel and the ball of the
patient's foot; and
ii. an essentially vertical sides-and-back-of-leg portion fixed at
about a right angle from said plane of said partial sole portion;
iii. wherein said stiffener element is structured and arranged to
fully conform to and cover the contours of the abnormal protrusions
on the ankle area;
c. said ankle brace being constructed and arranged to be used with a
separate essentially normal shoe;
d. wherein said ankle brace further comprises closure elements for
tightening and closing said ankle brace on the patient;
e. wherein said multiple material layers are structured and arranged
to provide substantially full circumferential support about the
ankle area when said closure elements are tightened, and;
f. wherein at least one of said material layers comprises leather.
13. An ankle brace system comprising an ankle brace, for providing
orthotic assistance to an ankle area of a patient wherein the ankle
area includes at least one abnormal protrusion enhancing disability
for normal walking, said ankle brace comprising:
a. multiple adhesively-connected material layers forming overall a
toeless boot and shaped to provide support for the abnormal
protrusion by matching the contours of the abnormal protrusion; and
b. at least one said material layer comprising a stiffener element
comprising:
i. a partial sole and arch portion lying essentially in a horizontal
plane, said partial sole and arch portion being structured and
arranged to fully conform to and cover the contours of the patient's
sole and arch substantially between the patient's heel and the ball
of the patient's foot; and
ii. an essentially vertical sides-and-back-of-leg portion fixed at
about a right angle from said plane of said partial sole and arch
portion;
iii. wherein said stiffener element is structured and arranged to
fully conform to and cover the contours of the abnormal protrusions
on the ankle area;
c. said ankle brace being constructed and arranged to be used with a
separate essentially normal shoe;
d. wherein said ankle brace further comprises closure elements for
tightening and closing said ankle brace on the patient;
e. wherein said multiple material layers are structured and arranged
to provide substantially full circumferential support about the
ankle area when said closure elements are tightened.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to providing a custom ankle brace system.
More particularly, this invention concerns such a system for being
of help to patients whose ankle conditions are of certain types and
no longer permit them to walk properly without some sort of custom
orthotic.
2. Description of the Prior Art
Typically, individuals suffer from certain conditions of the feet
which either greatly limit unaided mobility or require the use of
aids such as walkers or canes in order for the individual to be
mobile. Conditions which may cause this debilitating condition
include tibialis tendinitis or rupture, degenerate joint disease,
talocalcaneal varus or valgus, severe pronation, and/or trauma to
ankle, subtalar, or midtarsal. To treat these conditions necessarily
requires a stabilizing-type apparatus in order to stabilize the
ankle area, talocalcaneal, midtarsal, and subtalar joints so that
medial and lateral stability of the foot is achieved with the result
that the patient enjoys the benefits of greater mobility.
To compensate for the above stated conditions, a person so afflicted
must either compensate for it by purchasing a shoe or shoes that can
be many sizes larger than they would normally require, resulting in
an awkward appearance and an uncomfortable fit. Furthermore, if the
individual has an ailment that affects only one foot, he or she must
purchase multiple pairs of shoes in order to get a matching set. One
set must be purchased in order to get a shoe that fits the
unaffected foot, and the larger matching set to get a shoe that fits
the afflicted foot, resulting in a pair of shoes costing at least
double what would ordinarily be paid. Alternately, the afflicted
individual may try to correct the condition by the use of mechanical
devices such as braces which attempt to stabilize the foot so that
the heel is more aligned with the bones in the lower leg. Generally,
the braces used for these types of ailments are large, thick, and
cumbersome, which make them inconvenient to use, awkward in
appearance and awkward in fit, and often resulting in sores. Thus
there exists a need in treating the above mentioned conditions of
the feet for a therapeutic foot brace that overcomes such
disadvantages.
OBJECTS OF THE INVENTION
A primary object of the present invention is to fulfill the
above-mentioned needs by the provision of a custom ankle brace
system overcoming the above-stated problems. A further primary
object of the present invention is to provide such an ankle brace
system which is efficient and permits the patient to wear
essentially normal shoes. In addition, it is a primary object of
this invention to provide such a custom ankle brace system in
connection with, and making use of, a novel custom ankle brace.
Other objects of this invention will become apparent with reference
to the following invention descriptions.
SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, this
invention provides an ankle brace system, for orthotic assistance to
an ankle of a patient and adapted to be worn inside a shoe,
comprising the steps of: placing a thin flexible stocking-like
covering over such ankle of such patient; making markings on such
covering on its outside surface to indicate the specific geometry of
orthotic support necessary for such ankle, such markings being done
in such manner as to be information-transferable to a negative cast
overlaying such covering; with the patient's sole placed in about a
horizontal plane and lower leg placed vertically, making a negative
cast overlaying such covering; removing such negative cast from such
ankle of such patient; such markings being selected from a standard
identified group knowable to both the castmaker and the bracemaker,
and done in such manner as to include marking information at least
relating to a preferred geometry of positive cast build-up for use
in making an ankle brace for such patient; and removing such
covering from inside such negative cast, whereby such markings
remain on an inside surface of such negative cast.
Moreover, this invention provides such an ankle brace system further
comprising the steps of: making a positive cast from such negative
cast in such manner that such markings are information-transferable
to an outside surface of such positive cast; whereby such markings
remain on such outside surface of such positive cast; and using such
marking information, modifying such positive cast in such manner as
to make such positive cast build-up for use in making such ankle
brace for such patient. It also provides such an ankle brace system
wherein such step of modifying such positive cast comprises the
steps of: setting nails in such positive cast, the location and
geometry of such nails being structured and arranged so that
nailheads of such nails conform to such positive cast build-up;
applying additional positive cast material to make such positive
cast build-up; and smoothening such positive cast build-up.
Furthermore, this invention provides such an ankle brace system
further comprising the steps of: using such positive cast, making a
support brace pattern having a single vertical seam on the heel
side; making material layers to fit such support brace pattern, and
making a stiffener element for use within such material layers in
making such ankle brace for such patient; wherein such stiffener
element is conformable to such positive cast when heated and
comprises a partial sole portion and a leg back portion fixed at
about a right angle from such partial sole portion. It further
provides such an ankle brace system wherein making of such stiffener
element comprises the steps of: providing, in a form large enough to
enshroud such positive cast, a sheet of polymeric material shapable
by vacuum forming when heated; heating such sheet until readily
shapable; fully enshrouding such positive cast with such sheet by an
air-tight envelopment but for an opening connected to a vacuum
source; through such opening, using such vacuum source, creating a
negative air pressure within such sheet sufficient to cause such
sheet to conform to the shape of such positive cast; maintaining
such negative air pressure until such sheet cools sufficiently to
stiffen to such shape of such positive cast, thereby providing a
shaped element; removing such shaped element from such positive
cast; and trimming such shaped element in such manner as to provide
such stiffener element.
Additionally, this invention provides such an ankle brace system
wherein such making of such stiffener element further comprises the
steps of: providing, in a form sufficient to provide extra
stiffening to a side of such ankle of such patient opposed to the
arch side, a support segment of such polymeric material; heating
such support segment until readily shapable; and, between such step
of fully enshrouding and such step of creating a negative air
pressure, placing such heated support segment into appropriate
position on such sheet in such manner as to contact bond to such
sheet. And it also provides such an ankle brace system further
comprising the step of, using such pattern, making a resilient
element for use within such material layers in making such ankle
brace for such patient. It further provides such an ankle brace
system further comprising the step of, upon such positive cast,
assembling some such material layers (after sewing of such single
vertical seam) and such stiffener element, thereby providing a
partially-made such ankle brace. And it provides such an ankle brace
system further comprising the step of providing an arch support in
such stiffener element if and as indicated by such marking
information.
Even additionally, this invention provides an ankle brace system
further comprising the steps of: trimming such partially-made ankle
brace according to such marking information for such patient; and
applying a such material layer for use as an outer material layer of
such ankle brace; and, further, comprising the steps of removing
such partially-made ankle brace from such positive cast, and
performing final trimming, stitching, and installing of brace
closure elements.
Yet further, in accordance with a preferred embodiment thereof, this
invention provides an ankle brace system comprising an ankle brace,
for providing orthotic assistance to an ankle area of a patient
wherein such ankle area includes at least one abnormal protrusion
enhancing disability for normal walking, such ankle brace
comprising: multiple adhesively-connected material layers forming
overall a toeless boot and shaped to provide room for and support
for the abnormal protrusion; and at least one such material layer
comprising a stiffener element comprising a partial sole portion
lying essentially in a horizontal plane, and an essentially vertical
sides-and-back-of-leg portion fixed at about a right angle from such
plane of such partial sole portion; such ankle brace being
constructed and arranged to be worn by the patient with an
essentially normal shoe. And it provides such an ankle brace system
wherein at least one of such material layers comprises a foam
cushioning material; and, further, wherein such foam cushioning
material comprises about a 1/8-inch thick, single density, medical
grade polyurethane foam. It also provides such an ankle brace system
wherein such stiffener element comprises a polymeric material
shapable when heated; and, further, wherein such polymeric material
comprises about a 2-millimeter-thick orthopedic grade polymer blend
which is auto-adhesive when appropriately heated. And it provides
such an ankle brace system wherein the innermost layer of such
multiple adhesively-connected material layers comprises a leather
material; and, further, wherein such innermost layer comprises 21/2
ounce orthopedic tanned leather material. It further provides such
an ankle brace system wherein the outermost layer of such multiple
adhesively-connected material layers comprises a leather; and,
further, wherein such outermost layer comprises a 21/2 ounce
chromium tanned cowhide leather. And it provides such an ankle brace
system wherein such ankle brace further comprises closure elements
for tightening and closing such ankle brace on such patient; and,
further, wherein such stiffener element does not have a heel
portion.
Yet moreover, in accordance with a preferred embodiment thereof,
this invention provides an ankle brace system for making, using a
positive cast of the foot and lower leg of a patient, an ankle
brace, for providing orthotic assistance to an ankle area of a
patient, wherein such ankle area includes at least one abnormal
protrusion enhancing disability for normal walking, and adapted to
be worn inside a shoe, comprising the steps of: making a build-up of
such positive cast in the area of such protrusion, sufficient to
provide for patient comfort without loss of support; using such
positive cast, making a support brace pattern having a single
vertical seam on the heel side; making material layers to fit such
support brace pattern; and making a stiffener element for use within
such material layers in making such ankle brace for such patient;
wherein such stiffener element is conformable to such positive cast
when heated and comprises a partial sole portion and a leg back
portion fixed at about a right angle from such partial sole portion.
It also provides such an ankle brace system wherein making of such
stiffener element comprises the steps of: providing, in a form large
enough to enshroud such positive cast, a sheet of polymeric material
shapable by vacuum forming when heated; heating such sheet until
readily shapable; placing a talcum-powdered nylon material
completely over such positive cast in such manner as to prevent such
sheet from sticking to such positive cast; fully enshrouding such
positive cast with such sheet by an air-tight envelopment but for an
opening connected to a vacuum source; through such opening, using
such vacuum source, creating a negative air pressure within such
sheet sufficient to cause such sheet to conform to the shape of such
positive cast; maintaining such negative air pressure until such
sheet cools sufficiently to stiffen to such shape of such positive
cast, thereby providing a shaped element; removing such shaped
element from such positive cast; and trimming such shaped element in
such manner as to provide such stiffener element.
Even additionally, this invention provides such an ankle brace
system wherein such making of such stiffener element further
comprises the steps of: providing, in a form sufficient to provide
extra stiffening to a side of such ankle of such patient opposed to
the arch side, a support segment of such polymeric material; heating
such support segment until readily shapable; and, between such step
of fully enshrouding and such step of creating a negative air
pressure, placing such heated support segment into appropriate
position on such sheet in such manner as to contact bond to such
sheet. It also provides such an ankle brace system further
comprising the step of: upon such positive cast, assembling some
such material layers (after sewing of such single vertical seam) and
such stiffener element, thereby providing a partially-made such
ankle brace. And it provides such an ankle brace system wherein such
stiffener element is conformed in shape to such positive cast by the
application of sufficient heat and pressure to such stiffener
element, while such stiffener element is upon such positive cast, to
conform the shape of the inside of such stiffener element to the
shape of the outside of such positive cast. And it also provides
such an ankle brace system further comprising the steps of: removing
such partially-made ankle brace from such positive cast; and
performing final trimming, stitching, and installing of brace
closure elements.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front perspective view of a the foot of a patient
wearing a custom ankle brace according to the present invention and
used by the patient while wearing an essentially normal shoe.
FIG. 2 is a front perspective view of a preferred embodiment of the
custom ankle brace of this invention.
FIG. 3 is a perspective illustration of a foot of a patient, showing
a foot with a sensitive bony growth and severe pronation as an
example of a typical person who would use the custom ankle brace of
the present invention.
FIG. 4 is a similar perspective view illustrating the problems
encountered by a patient with an unsupported foot in conventional
footwear.
FIG. 5 is a side elevation view of a preferred embodiment of the
custom ankle brace of this invention.
FIG. 6 is a vertical cross-section view through the section 6--6 of
FIG. 5.
FIG. 7 is an enlarged cross-sectional view of the area pointed to by
the arrows at 7, illustrating the material layers, inner to outer,
from left to right in this figure.
FIG. 8 is an enlarged cross-sectional view, showing the material
layers, in the aspect of FIG. 5.
FIG. 9 is a side elevation view illustrating the foot and lower leg
of a patient upon whom has been placed a thin flexible stocking-like
covering.
FIG. 10A is a similar view to FIG. 9 but showing a representative
set of markings placed by the user upon the stocking-like covering
as indicia explained hereinafter.
FIG. 10B is a close-up view of one representative marking as indicia
explained hereinafter.
FIG. 10C is a close-up view of another representative marking as
indicia explained hereinafter.
FIG. 10D is a close-up view of yet another representative marking as
indicia explained hereinafter.
FIG. 10E is a close-up view of still another representative marking
as indicia explained hereinafter.
FIG. 10F is a close-up view of yet still another representative
marking as indicia explained hereinafter.
FIG. 11 is a side elevation view illustrating the beginning of the
making of a negative cast of the foot and lower leg of a patient,
showing particularly the placing of a length of surgical tubing
against the center front of the foot and leg to facilitate removal
of a plaster cast mold from the illustrated cotton stockinette, and
showing the wrapping, first, of elastic plaster bandages are wrapped
around the cotton stockinette, followed by a solid plaster bandage,
all of the quick-dry typical medical cast plaster.
FIG. 12 is a front perspective view illustrating the removing of the
plaster cast negative mold and cotton stockinette from the patient's
foot by first cutting the plaster cast along the implanted surgical
tubing, as with the illustrated rotary saw, and then cutting the
cotton stockinette, as with the illustrated scissors.
FIG. 13 is a front perspective view showing the assembly of FIG. 12
after the there illustrated cutting.
FIG. 14 is a rear perspective view showing the separating and
removing of the stockinette from the plaster cast mold, with a
cut-away view of the markings transferred to the inside of the
plaster cast negative mold from the cotton stockinette.
FIG. 15 is a partial perspective view illustrating the reassembly of
the illustrated plaster cast negative mold.
FIG. 16 is a partial perspective view illustrating the insertion
into the negative cast of a piece of steel rebar (preferably about
3/8" in diameter) into the center of the negative cast "leg" and the
pouring in of plaster cast material.
FIG. 17 is a partial perspective view illustrating the removal of
the negative plaster cast mold from the positive plaster cast mold
inside, preferably, as illustrated, with help of a rotary saw.
FIG. 18 is a side view showing that the indelible marks on the
negative cast have transferred to the outside of the positive cast,
creating a replica of the patient's foot/leg with the markings shown
for the additional support, etc.
FIG. 19 is a close-up view, partially in section, showing the
markings that have survived transfer from the stockinette to the
negative cast and now to the positive cast.
FIG. 20 is a typical horizontal cross-section view in the ankle area
of a patient, illustrating the use of small nails (as more
particularly hereinafter described) to assist in the build-up of the
positive cast at the places and in the manner indicated by the
markings, and showing a plaster build up along the markings to a
thickness indicated by the small nails installation and the sanding
of the cast/mold smooth until it is the desired shape.
FIG. 21 is a close-up view, partially in section, of the ankle area
of FIG. 19, illustrating the accomplished build-up areas in
accordance with the markings.
FIG. 22 illustrates a representative shape of a paper pattern cut
using the positive cast, cutting the pattern so that there is only a
single seam at the rear of the pattern (the rear of the ankle).
FIG. 23 is illustrative of the step of sewing the rear seams of the
ankle brace, such sewing being a well known art.
FIG. 24 illustrates the inner leather layer in a seam-sewn form.
FIG. 25 illustrates the inner layer placed upon the positive cast
for conforming to the cast.
FIG. 26 illustrates the resilient foam layer after placement upon
and being adhesively connected to the inner layer, all performed
upon the positive cast.
FIG. 27 illustrates a cross-sectional view through the area x of
FIG. 26, showing the beveling and feathering of the ends of the
inner layer and the foam layer.
FIG. 28 illustrates the polymer stiffening element placed upon the
assembled inner and foam layers and conforming to shape of the
positive mold (as, for example, by heating), and adhesively
connected to the foam layer.
FIG. 29 illustrates the trimming of the polymer stiffening element,
including, as illustrated, the usual cutting away of the heel
portion of the stiffening element.
FIG. 30 illustrates the leather outer layer placed upon the layers
below (including the stiffening element) and adhesively connected to
them.
FIG. 31 illustrates the ankle brace removed from the positive cast
and undergoing final stitching including having a tongue and eyelets
(or other closures) completed (and ready for final fitting to the
patient).
FIG. 32 illustrates the removal of the pieces comprising the
stiffening element from a sheet of stiffening element material.
FIG. 33 illustrates the heating step in which the pieces comprising
the stiffening element are heated in an oven.
FIG. 34 illustrates the positive cast with a nylon material placed
thereon.
FIG. 35 illustrates the vacuum fitting means to be used in vacuum
fitting the stiffening element to the positive cast.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT AND THE BEST MODE OF
PRACTICE
FIG. 1 illustrates the custom ankle brace 104 of this invention
according to a preferred embodiment thereof. Shown is a shoe 102
worn over the custom ankle brace 104, both holding the patient's
foot 100. Typically, the custom ankle brace 104 allows for the
patient to wear a shoe size 1/2 size larger than normal. This is a
marked improvement for patients with the type of ailments that the
present invention was designed for and it's intended use. Each
custom ankle brace 104 is custom manufactured to the specific needs
and physical properties of the individual patient's foot 100. FIG. 2
illustrates just the custom ankle brace 104. FIG. 3 represents one
possible combination of foot ailments suggesting the use of the
custom ankle brace 104. In FIG. 3, a patient's foot 100 is shown
with severe pronation and a sensitive bony prominences 101 that
would make it difficult for the patient to wear a shoe 102, as
illustrated in FIG. 4, and difficult to walk without the use of a
brace. Often these patients have had one or more surgeries and may
have sensitive scarred areas as well. Generally, the braces used for
these types of ailments are large, thick and cumbersome. The patient
must purchase a shoe 102 or shoes that are one or many shoe sizes
larger than they would normally require. Prior to the initial custom
ankle brace 104 manufacturing process, an examination of the
patient's foot 100 is performed by a person skilled in the art of
said foot ailments and brace-making. A determination of the areas of
support that are needed by the patient is made.
FIG. 5 through FIG. 8 more fully illustrate the configuration of
custom ankle brace 104 and the layering configuration that is
utilized in its construction. Specifically shown in FIG. 5 is the
custom ankle brace 104, in elevation, having an outer covering 166
substantially covering a predetermined length of the patients calf,
the patient's heel, and a substantial portion of the patient's sole.
Also shown in dotted lines in FIG. 5 is a stiffener element 160,
hidden from view in this figure, which in the preferred embodiment
is a 2 millimeter thick UCOpoly orthopedic polymer blend. It is used
to provide substantially rigid support for the patient's foot 100,
and to maintain the patient's sole in a relatively horizontal plane
when the lower leg is vertical, thus assisting walking as normally
as possible. The various layers comprising the boot 104 are
specially made so as to fully conform to the contours of each
patients foot, as is more clearly shown in FIG. 6, with said process
of making each layer being more fully hereinafter explained. As
shown in FIG. 7, with respect to those portions of the boot 104
comprising the stiffener element 160, the boot 104 consists of four
individual layers: the leather lining 152, the foam or resilient
layer 158, the stiffener element 160, and the outer leather covering
166. The relative location of each of the above layers with respect
to the finished boot is more clearly shown in the elevation view of
the boot 104 illustrated in FIG. 8. This construction as shown in
the figures embodies in this invention multiple adhesively-connected
material layers forming overall a toeless boot and shaped to provide
room for and support for the abnormal protrusion; and at least one
such material layer comprising a stiffener element comprising a
partial sole and arch portion lying essentially in a horizontal
plane, and an essentially vertical sides-and-back-of-leg portion
fixed at about a right angle from such plane of such partial sole
and arch portion, such ankle brace being constructed and arranged to
be worn by the patient with an essentially normal shoe.
The first step in the custom ankle brace 104 manufacturing process
is to make a negative mold plaster casting or negative cast 116
(shown in FIGS. 12-15) of the patient's foot 100. As shown in FIG.
9, a cotton stockinette 108 is placed upon the patient's foot 100,
embodying in this invention the step of placing a thin flexible
stocking-like covering over such ankle of such patient. FIG. 10A
shows the next step in the custom ankle brace 104 manufacturing
process which involves marking the cotton stockinette 108 on the
previously determined "problem" areas of the foot 100 with markings
103 that will later, e.g., require positive cast build-up for
required shaping for reinforcement and/or additional padding, with
an indelible type black marker. It is possible several other types
or colors of markers might be usable without detracting from the
present invention. As will be described in greater detail below, the
marks on the cotton stockinette 108 will transfer to the negative
cast 116 and then positive cast 130 (see FIG. 18) and eventually
will be used by the custom ankle brace 104 manufacturer to build-up
the custom ankle brace 104 positive cast 130. This marking step
embodies herein the step of making markings on such covering on its
outside surface to indicate the specific geometry of orthotic
support necessary for such ankle, such markings being done in such
manner as to be information-transferable to a negative cast
overlaying such covering.
FIGS. 10B, 10C, 10D, 10E, and 10F show possible combinations of
these marks as described herein as the best mode of practice. Use of
other styles of markings is possible, but it is important that the
markings be standard and identified enough so that the castmaker who
makes the marks reads them the same way as the bracemaker. FIG. 10B
shows a mark used to indicate a bony prominence which will result in
a 5 mm (millimeter) build-up on the positive cast 130. This mark, as
shown in FIG. 10B, is a solid circle 138 around an X 126; the X 126
marking the apex of the bony prominence. The diameter of the solid
circle 138 is determined by the experience and skill of the
brace-maker and indicates the area of plaster build up desired on
the positive cast 130. FIG. 10C shows a mark used to indicate an
extreme bony prominence, which will result in a 10 mm (1 centimeter)
plaster build-up on the positive cast 130. This mark, as shown in
FIG. 10C, is a solid circle 138 around multiple crossing "X" 126
marks on the extreme bony prominence apex. The diameter of the solid
circle 138 is determined by the experience and skill of the
brace-maker and indicates the area of plaster build-up desired on
the positive cast 130. FIG. 10D shows a mark used to indicate bone
that is not prominent but will need a small plaster build-up for
additional support, typically 1.5 mm-3 mm on the positive cast 130.
This mark is a solid circle 138 around the bone with two parallel
lines 132 along the bone. FIG. 10E shows a mark used to indicate
painful or sensitive tissue, including scar tissue. An oblong circle
144 is drawn around the sensitive or painful tissue which will
result in a 5 mm-10 mm plaster build-up on the positive cast 130.
The plaster build-up will allow room for the use of added padding
174, e.g., as shown in FIG. 31, in the painful areas. FIG. 10E also
shows scar tissue as marked with a longer straight line and several
small shorter lines crossing perpendicular to the longer straight
line 134. FIG. 10F shows a mark used to indicate where extra support
is needed or wanted as determined by the experience and skill of the
brace-maker and indicates the area of plaster build-up that will be
added to the positive cast 130. Shown here as an example is the mark
used to indicate a flat arch with a needed extra support that will
require cutting out of the positive cast 130 in the medial arch and
anterior sastitacacum area of the foot. This mark is indicated by
several lines 136 parallel to each other along the area of support,
the amount to be cut out being directly correlated with the
closeness of the markings. The thickness of the plaster built-up on
the positive cast 130 is determined by the experience and skill of
the brace-maker. This step embodies in this invention the step of
such markings being selected from a standard identified group
knowable to both the castmaker and the bracemaker, and done in such
manner as to include marking information at least relating to a
preferred geometry of positive cast build-up for use in making an
ankle brace for such patient.
FIG. 11 shows the next step in the custom ankle brace 104
manufacturing process which is a continuation of forming the
negative cast 116. With the castmaker making sure that the patient's
sole is steady in a horizontal plane and that the patient's lower
leg is placed vertically, elastic plaster bandages 112 are wrapped
around the cotton stockinette 108 in a manner consistent with the
experience and skill of the brace-maker, followed by a more solid
plaster bandage 114. The solid plaster bandage 114 is wrapped around
the elastic plaster bandage 112 wrap and both wraps cover a small
diameter surgical tubing 110 which is preferably used and placed as
shown in FIG. 11 along the centerline of the top of the foot 100.
This surgical tubing 110 will be used to facilitate removal of the
negative cast 116 as shown in FIG. 12. The wet plaster 122 used for
this process is standard in the medical industry and known as quick
dry medical cast plaster. This step embodies herein the step of,
with the patient's sole placed in about a horizontal plane and lower
leg placed vertically, making a negative cast overlaying such
covering.
In FIG. 12, the next step in the custom ankle brace 104
manufacturing process is shown, which is a continuation of forming
the negative cast 116. The negative cast 116 is removed from the
patients foot 100. The negative cast 116 is cut off with a plaster
cast cutting tool 118, usually a rotary saw of a type well-known by
a person skilled in the art. As shown, the cut is made along the
surgical tubing 110 previously implanted during the elastic plaster
bandage 112 wrap sequence. Before the cut is made, to assist in
realigning of the cut line of the negative cast 116 before it used
to make a positive cast, alignment marks 146 across the cut line are
made.
The next step in the manufacturing of custom ankle brace 104 is a
continuation of forming the negative cast 116. And, as shown in FIG.
13, the negative cast 116 is separated; and then, as shown in FIG.
14, the cotton stockinette 108 is removed from the negative cast
116. The cotton stockinette 108 is carefully removed and peeled away
from the negative cast 116. When done correctly, the previous
markings 103, described above and preferably of the types shown in
FIG. 10B through FIG. 10F, will have transferred to the inside of
the negative cast 116 as shown in FIG. 14. This step embodies herein
the step of removing such covering from inside such negative cast,
whereby such markings remain on an inside surface of such negative
cast.
FIG. 15 illustrates the next step in the custom ankle brace 104
manufacturing process and final step in the forming of the negative
cast 116, the reassembly of the negative cast 116 performed in the
usual and well-known manner. The two sides, partially separated
during removal from the patient's foot 100, are reassembled by
gently urging the cut ends together, making sure the previously
marked alignment marks 146 are in alignment.
FIG. 16 shows the next step in the custom ankle brace 104
manufacturing process and the first step in creating a positive cast
130. The inside of the negative cast 116 is coated with a releasing
agent, typically a soap solution of a kind well known to those in
the art. A 3/8" steel rebar rod 120 is placed in the center of the
negative cast 116 as medical quick dry wet plaster 122 casting
material is poured into the negative cast 116. This 3/8 steel rebar
rod 120 is used to hold the positive cast 130 during various phases
in the custom ankle brace 104 manufacturing process. After the wet
plaster 122 has set, the negative cast 116 is removed as shown in
FIG. 17. The negative cast 116 is cut off with a plaster cutting
tool 118. The cut is made along the surgical tubing 110 previously
implanted during the elastic plaster bandage 112 wrap sequence and
still attached to the negative cast 116. The indelible markings 103
will have transferred to the exterior of the positive cast 130,
creating a replica of the patient's foot 100 with the brace-maker's
markings 103 as shown in FIG. 18. This step embodies herein the step
of making a positive cast from such negative cast in such manner
that such markings are information-transferable to an outside
surface of such positive cast, whereby such markings remain on such
outside surface of such positive cast.
FIGS. 19-21 illustrate the next steps in the custom ankle brace 104
manufacturing process and the final step in creating a positive cast
130. Specifically illustrated in FIG. 19 is the working of the
positive cast 130 by adding small nails 140 where plaster build-up
is indicated by the markings 103. These small nails 140 are inserted
into the positive cast 130 until the spacing between the top of the
small nail 140 head and the positive cast 130 is equal to the amount
of plaster build-up (5 millimeter, 10 millimeter, etc.) that will be
needed as indicated by the indelible markings 103 previously
applied. As shown in FIGS. 20 and 21, additional wet plaster 122 is
then applied until it is even with the small nail 140 heads and in
conjunction with the areas that will need extra support as
determined by the skill of the brace-maker. After the added wet
plaster 122 has set the brace-maker will begin the process of
sanding the positive cast 130 smooth until it is the correct shape
as determined by the experience and skill of the brace-maker. These
steps embody herein the steps of using such marking information,
modifying such positive cast in such manner as to make such positive
cast build-up for use in making such ankle brace for such patient;
more particularly wherein such step of modifying such positive cast
comprises the steps of setting nails in such positive cast, the
location and geometry of such nails being structured and arranged so
that nailheads of such nails conform to such positive cast build-up,
applying additional positive cast material to make such positive
cast build-up, and smoothening such positive cast build-up.
The next step in making the custom ankle brace 104, is cutting a
paper pattern 150, shown in FIG. 22, using the positive cast 130.
The paper pattern 150 is cut by a person so skilled in the art such
that the only seam is at rear of the custom ankle brace 104, as
shown by the illustrated example pattern 150. This step embodies
herein the step of, using such positive cast, making a support brace
pattern having a single vertical seam on the heel side. After the
paper pattern 150 is complete, it is used to cut out the custom
ankle brace 104 leather lining or inner layer 152, which in the
preferred embodiment consists of a soft leather material, preferably
a 21/2 ounce orthopedic tanned leather material. The inner layer 152
is stitched, as in the example shown in FIG. 23, so that the inner
layer 152 contains only one seam 154 located approximately in the
posterior of the brace 104 and extending from the patient's heel
upward to the top of the custom ankle brace 104 as shown in FIG. 24.
The cut inner layer 152 is then formed and molded on the positive
cast 130 for proper fit as shown in FIG. 25. [The 3/8 steel rebar
rod 120 protruding from the positive cast 130 may be placed in a
holding "tube" or vice on the workbench of the brace-maker to
facilitate the application of the inner layer 152, and any
additional layers, as well as other work done on the custom ankle
brace 104, as required.] The next step is to cut a 1/8 inch single
density medical grade polyurethane foam layer or resilient layer 158
to match the previously cut inner layer 152 using the paper pattern
150. FIG. 26 illustrates the process of forming and gluing the
resilient layer 158 to the inner layer 152 and forming it around the
positive cast 130. The brace-maker uses a selected contact bond glue
to bond the separate layers together. After the glue has set, the
resilient layer 158 is beveled at the ends with a buffing wheel to
smoothly transition into the inner layer 152 at the perimeter ends
as illustrated in FIG. 27. This embodies herein the step of making
material layers to fit such support brace pattern.
The next step in the construction of the custom ankle brace 104
involves the formation of the stiffener element 160 for use within
such material layers in making such ankle brace for such patient,
stiffener element 160 being the main element that is used to provide
medial and lateral stability of the foot. It is important that the
stiffener element be conformable to such positive cast when heated
and that it comprise a partial sole portion and a leg back portion
fixed at about a right angle from such partial sole portion (as
desired for walking and as illustrated in the figures). As
illustrated in FIGS. 32-35, the formation of the stiffener element
comprises the steps of cutting a first stiffener piece 176 with
dimensions of approximately 16" by 24" from a sheet 177 of heat
formable polymer material. In the preferred embodiment, a
UCOpoly.RTM. orthopedic polymer blend with a thickness of 2
millimeters is used. Next, a second stiffener piece 178 is cut from
the same kind of sheet of heat formable polymer material. Such
second stiffener piece 178 is be used to provide extra support where
needed and has dimensions consistent with providing the needed extra
support as determined by the brace maker. Next, the first stiffener
piece 176 and the second stiffener piece 178 are heated in an oven
179 to a temperature of approximately 400 degrees Fahrenheit for
approximately 3 minutes as illustrated in FIG. 33. Illustrated in
FIG. 35 is the vacuum fitting process specifically showing a vacuum
fitting means embodied by a vacuum pump and motor 180, a valve 182,
and a suction inlet pipe 184. In applicant's preferred embodiment, a
1/4 horsepower motor is used to run the vacuum pump. Prior to
attachment of the positive cast 130 to the vacuum fitting means, the
positive cast 130 is fitted with a talcum-powdered nylon material or
stocking 185 (shown applied in FIG. 34) which is used to prevent the
heated first stiffener piece 176 from adhering to the resilient
layer 158. The attachment of the positive cast 130 to the vacuum
fitting means is accomplished by sliding the 3/8" steel rebar rod
120, extending from the upper end of the positive cast 130, into the
end opening of the suction inlet pipe 184. The heated first
stiffener piece 176 is then removed from the oven while wearing
appropriate gloves and placed fully around the positive cast 130.
The free ends of the first stiffener piece 176 are touched together
and touched to the suction inlet pipe 184 (near its end opening)
thereby forming an air-tight shroud (see FIG. 35) around the
positive cast 130. Next, the heated second stiffener piece 178 is
placed in the desired position on the first stiffener piece 176,
thereby auto-sealing the first stiffener piece 176 and the second
stiffener piece 178 together since they are both still hot.
Applicant has found that by creating negative pressure within the
sealed first stiffener piece 176, a custom fit stiffener element 160
which more fully matches the contours of the individual patient's
feet may be obtained. FIG. 35 illustrates that the negative pressure
is obtained by opening valve 182 thereby allowing the vacuum 180 to
vacate the air trapped within the shroud of the sealed first
stiffener piece 176 so that the first stiffener piece 176 becomes
vacuum fitted to the positive cast 130. The negative pressure is
maintained until the stiffener element 160 cools to a temperature
which will allow physical handling of the stiffener element without
altering its physical shape, usually about one minute. These
described steps (here and just below) embody in this invention the
steps of: providing, in a form large enough to enshroud such
positive cast, a sheet of polymeric material shapable by vacuum
forming when heated; heating such sheet until readily shapable;
fully enshrouding such positive cast with such sheet by an air-tight
envelopment but for an opening connected to a vacuum source; through
such opening, using such vacuum source, creating a negative air
pressure within such sheet sufficient to cause such sheet to conform
to the shape of such positive cast; maintaining such negative air
pressure until such sheet cools sufficiently to stiffen to such
shape of such positive cast, thereby providing a shaped element;
removing such shaped element from such positive cast; and trimming
such shaped element in such manner as to provide such stiffener
element. Further embodied herein by such steps are the steps of
providing, in a form sufficient to provide extra stiffening to a
side of such ankle of such patient opposed to the arch side, a
support segment of such polymeric material; heating such support
segment until readily shapable; and, between such step of fully
enshrouding and such step of creating a negative air pressure,
placing such heated support segment into appropriate position on
such sheet in such manner as to contact bond to such sheet.
Next, the positive cast 130 encased in the stiffener element 160 is
removed from the vacuum fitting means and the stiffener element 160
is marked along a trim line wherein such trim line is located by the
brace maker according to the amount and type of support required by
the individual patient (as previously indicated by the markings 103
on the positive cast 130). The stiffener element 160 is then removed
from the positive cast 130, trimmed along the trim lines which
usually preferably includes removal of the heel portion as shown in
FIG. 29 for better fit within a normal shoe. Then the trimmed
stiffener element 160 is re-attached to the positive cast 130 by
contact-bond gluing (preferably an appropriate rubber cement) the
stiffener element 160 over the 1/8-inch single density medical grade
polyurethane foam (the resilient layer 158) and inner layer 152 as
illustrated in FIG. 28.
As stated and as shown on FIG. 29, the next step in the custom ankle
brace 104 manufacturing process involves the trimming of the custom
ankle brace 104 and specifically the 2 millimeter thick UCOpoly.RTM.
orthopedic polymer blend comprising the stiffener element 160 to
accommodate the specific reinforcements and support required and as
indicated by the markings 103 on the positive cast 130 and as
discussed herein. In the example shown in FIG. 29, the heel portion
164 is removed to better fit within a normal shoe. Next, all the
perimeter edges are beveled and shaped to form a smooth transition
to the other layers as determined by the skill and experience of the
brace-maker. Additional padding 174 (shown by the hidden lines in
FIG. 31) that may be required by the castmaker is also added during
this phase of the manufacturing process.
FIG. 30 illustrates the application of the final outer leather
covering 166 of the custom ankle brace 104. The paper pattern 150 is
used to cut the final outer leather covering 166. The final outer
leather covering 166 is cut and sewn with a single seam at the rear
154 (as shown in FIG. 24), and contact bond glued to the lower
layers, preferably with a rubber cement. The final outer leather
covering 166 is then stitched and sewn to the lower inner layer 152
layer. Leather covering 166 is preferably a 21/2 ounce chromium
tanned cowhide leather.
FIG. 31 illustrates the last step in the manufacture of the custom
ankle brace 104, the attachment of the leather "tongue" 170 piece
and the lacing/eyelet grommets 172. Other methods of closure of the
custom ankle brace 104 are available, including the use of "Velcro"
straps. FIG. 31 shows the lacing/eyelet grommets 172 along the
centerline of the foot; however, the placement may be altered to
provide a more comfortable fit to the patient when required without
detracting from the present invention. The final fitting and
adjustments, if needed, will be as determined by the skill and
experience of the brace-maker or fitter.
Although applicant has described applicant's preferred embodiments
of this invention, it will be understood that the broadest scope of
this invention includes such modifications as diverse shapes and
sizes and materials. Such scope is limited only by the below claims
as read in connection with the above specification.
Further, many other advantages of applicant's invention will be
apparent to those skilled in the art from the above descriptions and
the below claims.
* * * * *
|
|