Method of making a composite material orthotic insert for...

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Reexamination Certificate

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C264S223000, C264S258000, C264S294000, C264SDIG003, C264SDIG005, C156S221000, C156S245000

Reexamination Certificate

active

06485661

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to orthotic inserts for use in conjunction with various types of footwear. More particularly, the present invention relates to an orthotic insert constructed of layers of fiberglass and graphite fiber materials, with the graphite layers being configured to provide enhanced control over the motions of the foot, and the device further being particularly configured to provide a long service life without cracking.
2. Background
a. Orthotic Devices
Orthotic inserts are used in conjunction with various types of footwear to enhance the functions of a person's foot. An orthotic insert can be either soft or hard: a hard insert is a substantially rigid member, desirably having a relatively thin vertical thickness dimension and extending from the calcaneal area of the foot (the heel portion) to at least the metatarsal head area of the foot (i.e., the “ball” of the foot). In general, the purpose of the rigid orthotic (sometimes called a “functional orthotic”) is to first position, and then control the movements of, the midtarsal and subtalar joints during the gait cycle which the body goes through in walking and running, and possibly other weight bearing activities.
b. The Gait Cycle
Before proceeding with a discussion of prior orthotic devices and the problems which have been encountered with the same, the “gait cycle” will be discussed here so as to provide an improved understanding of the function of the present invention. The discussion will include the following: (i) the main components of the human leg and foot, and how these function relative to one another; (ii) the gait cycle which a person goes through in a normal walking motion; and (iii) the intended function of a rigid orthotic in optimizing the coordinated operation of the person's foot and leg throughout the gait cycle.
(i) The Main Components of the Human Leg and Foot and How These Function Relative to One Another
FIGS. 1-3
show a typical human foot
10
and (in
FIGS. 2-3
) the lower part
12
of the leg
14
. The two lower bones of the leg are the tibia
16
and the fibula
18
. Below the tibia and fibula, there is the talus
20
(i.e. the “ankle bone”). Positioned below and rearwardly of the talus
20
is the calcaneus
22
(i.e. the “heel bone”). Positioned moderately below and forward of the talus
20
is the navicular
24
and forward of the calcaneus is the cuboid
26
. Extending forwardly from the navicular are the three cuneform bones
28
. Extending forwardly from the cuneform bones and the cuboid are the five metatarsals
30
. Forwardly of the metatarsals are the phalanges
32
which make up the five toes
34
.
The movement of the talus
20
relative to the tibia
16
and fibula
18
is such that it enables the entire foot to be articulated upwardly and downwardly (in the motion of raising or lowering the forward part of the foot). However, the talus is connected to the tibia and fibula in such a way that when the entire leg is rotated about its vertical axis (i.e. the axis extending the length of the leg), the talus
20
rotates together with the leg
14
.
With regard to the relationship of the talus to the calcaneus, these two move relative to one another about what is called the “subtalar joint” indicated at
36
. The subtalar joint can be described generally as a hinge joint about which the talus and calcaneus articulate relative to one another. On average, the hinge axis extends upwardly and forwardly at a slant angle of about 42° from the horizontal, and also slants forwardly and inwardly at about 16° from a straightforward direction. There is also a midtarsal joint
38
, and this will be discussed later.
To explain further the hinge motion of the subtalar joint, reference is now made to
FIGS. 4
a
and
4
b
. The talus can be considered as a vertical board
40
, and the calcaneus as a horizontally extending board
42
, these being hinge connected to one another along a diagonal hinge line
44
, with this hinge line corresponding to the subtalar joint
36
. It can be seen with reference to
FIG. 4
a
that as the talus is rotated inwardly about its vertical axis (i.e. the front part of the leg is rotated toward the center of the person's body), there is a corresponding rotation of the calcaneus (i.e. the horizontal board
42
) about a horizontal axis. It can be seen in
FIG. 4
b
that an opposite (i.e. outward) rotation of the talus (i.e. the vertical board
40
) causes a corresponding rotation of the calcaneus (i.e. the horizontal board
42
) in the opposite direction to that shown in
FIG. 4
a.
With regard to the midtarsal joint
38
, this is in reality composed of two separate joints, the talo-navicular and the calcaneal-cuboid. It is a complex joint, and no attempt will be made to illustrate or recreate its motion accurately. Instead, a somewhat simplified explanation will be presented as it relates to the present invention.
The main concern relative to the midtarsal joint is not the precise relative motion of the parts of the foot which make up this joint, but rather the locking and unlocking of the joint which occurs when there is an outward motion of the leg and talus and an opposite inward motion, respectively. When the leg is rotated inwardly, the midtarsal joint
38
is in its unlocked position so that the portion of the foot
10
forwardly of the joint (i.e. the midfoot
45
) is flexible, this being the “pronated” position of the foot. On the other hand, when the leg and talus are rotated outwardly, the foot is said to be “supinated” and the midtarsal joint is in its locked position and the midfoot is essentially a part of a rigid lever. In actuality, the midfoot never becomes completely rigid, so that even in the totally supinated position, there is some degree of flexibility in the midfoot.
This function of the midtarsal joint will now be explained relative to
FIGS. 5
a
and
5
b
. It can be seen that
FIGS. 5
a-b
are generally the same as
FIGS. 4
a-b
, except that a forward board member
46
is shown to represent the midfoot
45
, this member
46
having a downward taper in a forward direction, and also a lower horizontal plate portion
48
. This plate portion
48
is intended to represent that the plantar surface (i.e. the lower support surface) of the midfoot
45
engages the underlying support surface in a manner so as to remain generally horizontal to the support surface.
It can be seen that when the two board members
40
and
42
are in the pronated position of
FIG. 5
a
, the midtarsal joint represented at
50
in
FIGS. 5
a-b
is in a first position which will be presumed to be in unlocked position. In the unlocked position of
FIG. 5
a
, the member
46
is not rigid with the horizontal member
42
, and the forward member
46
can flex upwardly relative to the horizontal member
42
. (This is the pronated position of the foot
10
.) However, in the position of
FIG. 5
b
, the board members
46
and
42
will be presumed to be locked to one another so that the members
42
and
46
form a unitary lever. For ease of illustration, no attempt has been made to illustrate physically the unlocking relationship of
FIG. 5
a
and the locking relationship of
FIG. 5
b
. Rather, the illustrations of
FIGS. 5
a-b
are to show the relative movements and positions of these components, and the locking and unlocking mechanism is presumed to exist.
(ii) The Gait Cycle Which the Person Goes Through in a Normal Walking Motion
Reference is first made to
FIGS. 6
a
and
6
b
. As illustrated in the graph of
FIG. 6
a
, during the normal walking motion, the hip (i.e. the pelvis) moves on a transverse plane, and this movement in the gait cycle is illustrated in
FIG. 6
b
. Also, the femur (i.e. the leg bone between the knee joint and the hip) and the tibia rotate about an axis parallel to the length of the person's leg. It is this rotation of the leg about its vertical axis which is intrinsically related to the pronating and supinating of the foot during the gait cycle, and this will be exp

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