Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-05-31
2004-07-27
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S023000, C128S882000
Reexamination Certificate
active
06767332
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an ankle support to either reduce the tendency for ankle injury or to reduce further injury to an injured ankle during physical activity in which the ankle maybe subjected to potentially injurious loads and displacements. The ankle support is designed to be form fitting to the portion of the leg above the ankle to reduce or eliminate loading to the foot. The ankle support includes a platform (heel stirrup) to align the foot and is adapted to be inserted into a shoe. Adjustable straps or other suitable attachment assemblies are used to secure the support device to the user.
BACKGROUND OF THE INVENTION
Today, an increasing number of individuals are engaging in more active life styles. Such an increase is leading to a proliferation of active involvement in sporting activities, such as basketball, football, baseball, tennis, soccer, skiing, jogging, and the like. Participating in both recreational and professional sports and other healthier activities, including “weekend athletes”, may aggravate an existing ankle injury, or may injure a previously healthy ankle. There is therefore a substantial need for an active ankle support to reduce and minimize the potential for initial or further ankle injury. Additionally, it is useful to have such a device adapted to be fitted by the user, and which can fit within the shoe for active wear.
A common injury to the ankle is ligament damage. This injury is quite painful and may require months to heal. The increased incidence of such injuries, and the desire of the injured individual to continue with a healthy, active level of sports and exercise, requires an ankle support which can reduce or eliminate loading on the foot, and thus the injured ligaments. To be used during active participation in physical activity, however, it must be able to be worn with the type of shoe required for that particular activity. Individuals as well can use the same support to reduce the likelihood of incurring an ankle injury.
In the past, athletes often relied on taping or wrapping an ankle to provide support. Such support, however, creates a limited amount of mobility, and may even hinder the effectiveness of a particular activity. It also requires special training and know how to properly wrap the ankle to reduce injury. As such, the “weekend athlete” is often unable to properly apply taping, wrapping, or other support device on his or her own.
There are numerous varieties of ankle braces available covering a wide spectrum of stabilization and design characteristics. Some are custom fit, some allow unrestricted or excessively restricted motion, some require excessive strapping, and even others require specific control of the talus and other anklebones. None of the current devices, however, allows for a combination of the following: a) a restrictive support formed from flexible polymer support material operable to engage and allow an additional amount of flexion, rotation, or extension during more severe loading events; b) a support capable of reducing or eliminating load to the foot; c) conformable and easy to use polymer supports and flexible straps for firmly securing the support to the ankle and lower leg of the user; and, d) ability to place a shoe over the support so as to allow continued participation in a sporting activity. These features along with padding or cushioning are the basis of the ankle support of the present invention. The need for an ankle support with these functional characteristics, as well as one which is easy to use, inexpensive, off-the-shelf and actively functional, is readily apparent.
Though numerous ankle supports have been previously described, none describe the use of a conformal, reshapeable, controlled range of motion (ROM) ankle support which reduces loading on a foot and can be worn in a shoe. For example, U.S. Pat. No. 5,676,642 by R. Peters describes an active ankle device that is modular, has uncontrolled ROM, and does not reduce loading to the foot. Further, it is not designed to be worn within a shoe. U.S. Pat No. 5,368,551 by R. Zuckerman, U.S. Pat. No. 5,250,021 by S. Chang, U.S. Pat. No. 5,078,128 by T. Grim and T. Kasper, U.S. Pat. No. 4,414,965 by D. Mancdin and R. Jones, U.S. Pat. No. 5,031,607 by R. Peters, and U.S. Pat. No. 4,974,583 by M. Freitas each describe ankle support devices. These supports, however, are modular, complicated, cumbersome, and do not specify specific ROM. Furthermore, they cannot fit within a shoe, and do not reduce load to the foot.
U.S. Pat No. 5,242,379 by Harris et al. describes an ankle brace having a floating pivot hinge. The ankle support of the present invention does not in corporate such a hinge. Further, the present invention reduces load to the foot and can fit within a shoe, unlike the '379 Patent. In U.S. Pat No. 5,797,865 by R. Finley, a light-weight plastic ankle restraint is described to limit movement of an injured ankle. However, it does not reduce load to the foot and is not capable of being inserted into a shoe during active wear as is the present invention. U.S. Pat. No. 5,496,263 by N. Fuller et al. describes an ankle brace having at least one single taloric control device. Importantly, the '263 Patent does not restrict loading to the foot and is not designed to be inserted into a shoe.
U.S. Pat. No. 4,977,891 by T. Grim describes an ankle support with inflatable bladders attached to rigid side supports. It does not allow for reduced loading to the foot nor can it be inserted into a shoe as with the present invention. U.S. Pat. No. 5,951,504 by J. Iglesias et al. describes an ankle brace having an adjustable heel strap together with rigid side supports, and made of a flexible resilient material. Although the present invention takes advantage of flexible, resilient materials, the '504 Patent does not reduce loading to the foot and is not designed to be worn within a shoe. Furthermore, the allowable ROM is not defined as for the present invention.
U.S. Pat. No. 5,944,078 by C. Hubbard describes a support which allows loading on the foot and full ROM of the ankle in contrast to the present invention. U.S. Pat. No. 5,908,398 by Harris restricts ankle motion, but again, does not restrict loading on the foot nor allows for a shoe to be worn over the device. U.S. Pat. No. 5,368,551 by R. Zuckerman describes another leg and foot support device with lateral support struts, adapted to snap into the footplate. The footplate is curved to allow a rolling motion against the foot, but does not restrict load to the foot as in the present invention. The '551 Patent further states that current ankle support designs are weak and can break at the junction between the struts and foot boot, and that cracking in this region may exacerbate ankle injury. The present invention is specially designed to be disposable so as to avoid or reduce this additional aspect of ankle support design and performance.
U.S. Pat. No. 5,620,411 by G. Schumann describes an ankle brace that allows the inherent elastic properties of the device material to provide an unspecified amount of ROM. However, there is no description of restricting load to the foot or allowance for the device to be inserted into a shoe. U.S. Pat. No. 5,501,659 by J. Morris and J. Stetman describes a brace to inhibit inversion and aversion of the ankle while also accommodating plantar and dorsal flexion. The present invention restricts the latter flexion motion and also reduces load transferred to the foot, unlike the '639 Patent. U.S. Pat. No. 5,899,872 by R. Gilmour describes a foot and ankle support having a boot element and shaped components for the lower leg. The Gilmour support may also include a complete shell. Unlike the present invention, ROM restrictions are not defined, nor does the '872 ankle support restrict loading to the foot.
There are also several Patents from between 1974 and 1983 that describe ankle supports having non-specified restrictions ROM, foot and lower-leg attachment straps to secure the support in place, and the use of elastic m
Davidson James A.
Pardue Chris C.
Fulbright & Jaworski L.L.P.
Lucchesi Nicholas D.
Mathew Fenn C
Pardue Chris C.
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