Patent Application
20090192428
The present invention relates to a soft wrap for treating plantar fasciitis.
Human injuries resulting from accidents and occupational and recreational physical activities are frequent. Such injuries and consequent pain frequently result from overloading, repetitive strain and other causes resulting in injuries to muscles, tendons, ligaments and other body tissue. Such injuries result not only in pain but also in the need to limit or eliminate physical activity involving the injured area, with resulting loss of time, diminished work, and diminished recreational activities.
Plantar fasciitis is one of the most common causes of heel pain. This condition occurs in a wide variety of individuals. Commonly, age at onset is in the mid-40's, but plantar fasciitis can develop at any age, particularly in young athletes who put extreme exertion on their feet such as basketball and volleyball players. Many studies have shown a female-male predominance of 3:1. Many patients with plantar fasciitis also have moderate pronation; about 15% have high-arched, ridge foot; and the remainder have an anatomically normal or non-affected foot. Some 45% of the patients who undergo radiography for suspected plantar fasciitis are found to have a subcalcaneal or “bone” spur.
Evidence of the need for effective therapy is apparent when it is considered that over 95% of all heel pain is diagnosed as plantar fasciitis. Plantar fasciitis is best described as an inflammation of the ligament that runs from the heel to the ball of the foot, which helps support the arch. Patients with plantar fasciitis will experience pain, upon standing, on the bottom or inside of their heel. Typically, the pain is worse in the morning when getting out of bed and after resting when the person stands up, putting stretching pressure on the tendons.
Typically the primary anatomic cause of plantar fasciitis is some degree of microtrauma and tearing at the site of the Plantar Fascia insertion. These abnormalities, which may also be present at the origin of the Plantar Fascia, result from repetitive trauma and collagen degeneration and angiofibroblastic hyperplasia. Upon physical examination the range of motion of the affected ankle is less than that of the contralateral ankle. By pressing the thumb against the middle of the affected heel, the physician can delineate the area of the Plantar Fascial pain. Pressure similarly applied underneath the calcaneus reveals the area of subcalcaneal pain. The correlation between plantar fasciitis and subcalcaneal spurs is not significant, therefore radiographic findings are not specific. Conservative treatment, including night splints, results in relief of plantar fasciitis in 85% of patients. In 15% of patients in whom this approach fails, surgery is indicated.
One medical method known in the art in reducing Plantar Fascial pain is to stretch the Plantar Fascia for a period of time. By keeping the Plantar Fascia on stretch, it is believed that an ultimate reduction of the internal tension of the Plantar Fascia can be achieved. Through this treatment, it is believed that the pain associated with this medical condition can be reduced, and possibly eliminated.
A typical treatment program would have the patient wear the splint while sleeping, and remove the splint immediately upon awakening in the morning. The patient will continue wearing the night splint for a 3-month period. After that time the patient will be weaned off of the splint in 2-week increments, using the device every other night, then every third night, then every fourth night, and from then on as needed.
A number of plantar fasciitis night splints are known in the art. One successful unit is commonly assigned U.S. Pat. No. 6,267,742. There are many others that have been patented. However, none have the suspension architecture or offer the comfort, ease of use, compactability, or degrees of rotation and angulation of U.S. Pat. No. 6,267,742.
By way of illustration of the splint state of the art, U.S. Pat. No. 4,649,939, issued to R. Curtis on Mar. 17, 1987 utilized over a shoe. U.S. Pat. No. 5,038,762, issued to H. Hess, et. al., on Aug. 13, 1991, teaches of a U-Shaped yoke which can be wrapped about the heel and ankle. U.S. Pat. No. 5,090,404, issued to C. Kallassy on Feb. 25, 1992, teach of another way to place a strap about the heel and foot. U.S. Pat. No. 5,257,969 issued to C. Mance on Nov. 2, 1993 teaches of a foot support which consists of a toe pouch and straps the wrap about the ankle. U.S. Pat. No. 5,425,701 issued to C. Oster et al. on Jun. 20, 1995, teaches of a boot with upright struts which attach to a foot pad designable for each patient's foot shape. U.S. Pat. No. 5,472,411 issued to H. Montag, et. al., on Dec. 5, 1995 teaches of a U-shaped flexible joint collar which wraps about the foot, heel and ankle.
Another type of orthotic device is a soft wrap for support. U.S. Pat. No. 5,620,413, issued to D. Olson on Jul. 14, 1995 teaches of an ankle brace and wrap comprised of a support sleeve to fit over the foot. U.S. Design Pat. No. Des. 388,174 issued to W. Stano on Dec. 23, 1997 teaches of an ankle brace which wraps about the lower leg, ankle, and foot. U.S. Pat. No. 5,645,525, issued to R. Krivosha on Jul. 8, 1997 teaches of a heel stabilizing device which fits over the foot and heel. While these devices teach a flexible means of foot support, they do not teach a soft wrap means to keep the foot on stretch which would properly facilitate the treatment indicated for a diagnosis of plantar fasciitis, and at the same time allow pressure adjustment of the soft wrap on the ankle and foot.
Olson U.S. Pat. No. 5,620,413 does teach a soft wrap with straps, but it is an ankle compression wrap, not allowing any pressure adjustment on the ankle or foot. And it is designed for Achilles tendon treatment, not plantar faciitis. Another commercially successful soft wrap is Thermoskin® Plantors FXT, which uses a sock with a strap from the toe to ankle front to keep the plantar fascia on stretch. This can and does cause toe pain.
There is therefore a continuing need to develop units which provide doctors with choices to allow balancing of cost, convenience, and adjustments to allow maximum flexibility to fit individual patient needs.
In summary, while soft wrap night splints have been used in the past for plantar fasciitis, all that are used are deficient in either comfort, suspension architecture, adjustability, or ease of patient use.
Accordingly a primary objection of the present invention is to provide a soft wrap for treating plantar fasciitis that allows independent compression adjustment on the ankle, and the middle of the foot, while simultaneously allowing full flexible tension adjustment to stretch the plantar fascia.
It is a further objective of the invention to provide a soft wrap meeting the above objective wherein the wrap can be made from a single piece of wrap material.
Yet a further objective of the present invention to provide a wrap of a material which has a covering cloth to allow hook and pile fasteners for straps and therefore is complete adjustability without having mechanical strap fasteners.
Yet a further objective of the invention is to provide all of the above features in a soft wrap that does not use any rigid shell, making it less expensive to manufacture and fully flexible and adjustable.
The method and manner of accomplishing these and other objectives is described below.
An adjustable soft wrap for treating plantar fasciitis is provided. A soft wrap is cut from material in such a manner to allow independent compression adjustment on the ankle and the middle of the foot while simultaneously having straps to allow tension adjustment of the stretch tension on the planter fascia.
The foot wrap 10 is made of a soft, durable natural fiber or foamed polymeric material designed to encompass a portion of the foot, the ankle and lower leg. Preferably, the wrap is made so that the anterior of the portion which covers the leg and the top of the portion which covers the foot can be opened, adjusted and then closed and secured. Preferably, these means of securing the wrap include covering cloth useable with hook and pile fasteners sold under the trademark “Velcro”.
The use of the exterior covering cloth that is useable with hook and pile fastener means that the tension straps (explained below) do not need to have any adjustable mechanical hardware to be fully adjustable. This will maximize patient comfort.
As used herein the term thistle cloth refers to a foam/fabric laminate with a hook compatible fabric that serves as the outer covering.
As shown in
The operation of the unit works as follows. Looking at
Tension strap ends 22 and 24 of strap 23 are wrapped and crossed as shown in
It can therefore be seen that complete and independent adjustability are provided for the wrap around the ankle and the wrap around the front of the foot offering 100% compression adjustment. Similarly tension strap ends 22 and 24 can be completely adjusted to provide whatever tension one desires on the plantar fascia, and this is done without having any mechanical contrivances attached to the straps. As a result for this maximized and adjustability is also maximized. This adjustability and maximized comfort has never been achieved in a soft wrap plantar fascia orthotic before.
It can therefore be seen that the invention accomplishes at least all of its stated objectives.
