Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2001-02-23
2002-03-26
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S027000, C128S882000
Reexamination Certificate
active
06361514
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to orthopaedic appliances, and more specifically it relates to a universal walking splint used to substantially immobilize the ankle joint and/or lower leg.
BACKGROUND OF THE INVENTION
One of the most common orthopaedic injuries is the ankle sprain. The treatment objective is usually to relieve the pain and to immobilize the joint and the ligaments to promote healing of the torn fibers.
Immobilization is accomplished by a variety of methods. One method is to wrap an elastic bandage around the foot and ankle, occasionally incorporating U-shaped felt pads that are placed so that the soft tissue surrounding the malleolus is compressed to minimize swelling. Crutches are used for partial weight bearing for several days or weeks. The elastic bandage does not afford the complete immobilization needed for solid healing of severely torn ligaments and its use is associated with a higher incidence of reinjury. Daily activities are limited by the associated use of crutches.
A second method of immobilization is the application of a plaster cast with the addition of a walking heel or boot. Plaster casts permit firm immobilization, but require a two- or three-day period of walking with crutches, using extreme care not to bear weight on the cast because to do so may cause it to soften, rendering it useless. Since these casts usually stay on for at least two weeks before they are removed and/or replaced, they cause itching and sometimes dermatitis secondary to perspiration and bacterial overgrowth. As tissue swelling about the ankle decreases and muscle atrophy occurs in the calf, the cast becomes loose and uncomfortable. Thus, the extremity may need to be recasted, entailing more physician time and expense and another period of crutch usage.
Such products are also useful for non-displaced fractures, stress fractures, calcaneal fractures, internally fixed fractures, post-surgical immobilization, and chronic plantar fasciitis. In all these instances, immobilization of the lower leg and ankle joint is essential.
Another more recent method of treatment involves the application to the ankle of various preformed apparatus, such as braces and nonplaster casts. While these advantages have resulted in widespread acceptance, none of the appliances except Davies account for the bilaterality of the extremities, that is left and right side. It is suspected that one reason for the lack of acceptance is the failure of the appliance to account for the bilaterality of the extremities, i.e., left and right sides. When one observes the foot and ankle, it is apparent that there are marked differences between the medial and lateral aspects. First of all, the medial side is larger. Secondly, the first metatarsophalangeal joint is located anteriorly to the fifth metatarsophalangeal joint and is more prominent. Thirdly, there is an arch located on the medial aspect of the foot, but none on the lateral aspect. Fourthly, the medial malleolus is located anteriorly and superiorly to the lateral malleolus. The foregoing anatomical facts would seem to preclude a comfortable fit by any snug fitting cast or apparatus that encases the foot and ankle, but does not incorporate at least some features of bilaterality into its design.
An improvement over these conventional prior art ankle splints is the splint currently manufactured by Brown Medical, Inc. and licensed under U.S. Pat. No. 4,505,269, dated Mar. 19, 1985. In this patent, the walking splint has a discreet, posterior member, a discreet anterior member, a discreet lateral member, and a discreet medial member, all bound by wrapping straps extending across the lower leg and around the foot. While this product is satisfactory, it lacked left-right flexibility. Put another way, with the product described in U.S. Pat. No. 4,505,269, a clinic needed to have left and right units. This, of course, increases expense and the size of inventory needed.
In order to overcome need for substantial inventory to allow immediate fitting of right or left feet, many in the field of orthopaedic appliances have gone to universal right/left splints. One problem with this, however, is that for the unit to be universal, it cannot have an arch support, since the arch supports are in different locations for the right and left foot. To illustrate, one can think of walking in shoes without arch supports. Eventually your feet tire, potentially leading to a host of orthopaedic problems in your feet, knees, hips and back. Thus, the device, which itself began its life as an orthopaedic aid, in fact may often cause orthopaedic problems!
It is, therefore, an object of the present invention to provide a splint for immobilizing the ankle joint and capable of being worn comfortably, which is universal, i.e., can be used with either a right or left foot, but at the same time still have an arch support properly located for either a right or left foot.
It is a further object of this invention to provide such a splint as indicated above with an arch support which is adjustable to allow customizing a universal splint for either the right or left foot.
A further object of this invention is to provide such a splint which is lower in cost to produce, since it uses a universal shell, and therefore requires only a single universal injection mold for manufacture.
SUMMARY OF THE INVENTION
A universal walking splint removably attachable to the lower leg and foot to substantially immobilize the ankle joint, with the universal splint having a universal sole insert pad positioned inside of the splint's posterior shell, and an arch support that is both adjustable and attachable to the sole insert pad to provide a selective arch support when properly located under either the right foot arch or the left foot arch. The arch support pad is a compressible foam material, preferably with an adhesive layer which can be exposed by peeling off a protective cover, allowing the adhesive layer of the arch pad to adhere to the sole insert for proper conformity to the wearer's arch.
REFERENCES:
patent: 3955565 (1976-05-01), Johnson
patent: 4184273 (1980-01-01), Boyer
patent: 4217893 (1980-08-01), Payton
patent: 4505269 (1985-03-01), Davies
patent: 5833639 (1998-11-01), Nunes
Brown Ivan E.
Kounkel Teryle L.
Mills Rebecca A.
Petrosenko Robert D.
Brown Michael A.
Brown Medical Industries
Zarley McKee Thomte, Voorhees & Sease PLC
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