Surgery: splint – brace – or bandage – Bandage structure – Support covering
Reexamination Certificate
2000-06-23
2003-09-02
Pothier, Denise M. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
Support covering
C602S062000
Reexamination Certificate
active
06613007
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to elastic garments or wraps that exert a compressive force when worn. An aspect of the invention is a compression stocking useful in the prevention and/or treatment of medical conditions of the lower extremities and vascular system in the lower extremities.
BACKGROUND OF THE INVENTION
Therapeutic garments and elastic bandages that exert a compressive force are often utilized in the prevention and therapy of lower extremity vascular system disorders, such as edema, emboli, and thrombophlebitis. For example, compressive stockings are utilized to improve vascular circulation and to reduce edema and the possibility of emboli in the legs. Compression therapy is often utilized for the prevention and treatment of conditions caused by chronic venous insufficiency, including stasis ulceration in the leg. Elastic bandages, for example, have traditionally been used for compressive therapy of vascular disorders, including ulcers, of the lower extremities.
Therapeutic or compressive stockings are constructed to apply compressive pressure to a wearer's legs. Compressive pressure may be greatest at the foot and gradually decrease from the foot towards the upper, or proximal, part of the leg. Alternatively, compressive pressure may be greatest at the ankle and gradually decrease towards the upper part of the leg. The amount of compressive pressure applied depends on the particular use and needs of the wearer. In order to achieve the intended preventative and/or therapeutic effect and to avoid complications of compressive pressure intervention, compressive pressure must be applied accurately. For example, should a greater amount of compressive pressure be applied higher on the leg than lower on the leg, blood flow may be impaired with a possible tourniquet effect occurring.
Further details on therapeutic compressive stockings, their use and construction, may be found in U.S. Pat. Nos. 4,015,448, issued Apr. 5, 1977; U.S. Pat. No. 4,172,456, issued Oct. 30, 1979; U.S. Pat. No. 4,513,740, issued Apr. 30, 1985; U.S. Pat. No. 4,745,917, issued May 24, 1988; and U.S. Pat. No. 5,005,567, issued Apr. 9, 1991. The disclosure of each of these patents is hereby incorporated herein by reference.
When elastic bandages are used, the bandages are wrapped onto the leg with the greatest pressure at the foot or ankle, and compressive pressures are manually reduced as the bandages are wrapped up the leg. Applying correct pressures at particular locations, and properly graduating pressures, so as to avoid creating a tourniquet effect when wrapping elastic bandages is difficult. Elastic bandages also come in a variety of styles, with stretch characteristics varying widely from product to product, making proper application of correct compression difficult.
The compressive pressure applied by stockings at a particular anatomical location may be determined and measured by various techniques. As will be recognized in the art, there is no standardized system for testing and measuring compressive pressures. A commonly used system for measuring compressive pressures is a British system, which may be used with pressure testing equipment made by Instron and by Hatra. (See, British Standard Specification for Graduated Compression Hosiery, BS 6612: 1985.) The British system divides compressive pressures into three levels, each level being referred to as a class. In Class I, 14 to 19 mm Hg (millimeters of mercury) of compressive pressure is provided. In Class II, 18 to 25 mm Hg of compressive pressure is provided. In Class III, 24 to 35 mm Hg of compressive pressure is provided. A Class I stocking would therefore provide 14 to 19 mm Hg of compressive pressure at the point of greatest compressive pressure. A Class II stocking would provide 18 to 25 mm Hg of compressive pressure at the point of greatest compressive pressure, and a Class III stocking would provide 24 to 35 mm Hg compressive pressure at the point of greatest compressive pressure. Suggested preventative and therapeutic uses for each class of pressure are also defined by the British system. Another system for measuring compressive pressures is a German system, which may be used with testing equipment made by Holenstein. The German system categorizes compressive pressures between 20 and 30 mm Hg as Class I, between 30 and 40 mm Hg as Class II, and between 40 and 50 mm Hg as Class III. (See also, European Committee for Standardization, CEN-TC 205WG2 Medical Compression Hosiery.)
There are no recognized standards for testing elastic bandages to accurately determine compressive pressures. Pressures applied by elastic bandages have been described by the amount of stretch of the elastic material, such as 50%, 100%, and 200%. Controlling the amount of compressive pressure a bandage will exert when applied requires extensive technical knowledge of bandage stretch characteristics, as well as experience. Some elastic bandages have incorporated methods to assist a care-giver in proper application. For example, visual indicators may be used to signify the degree of stretch, and thus compressive force, provided by an elastic bandage. A continuous pattern of geometric shapes may be formed on an elastic bandage by using indicator yams or with print. Either the shape of the geometric design or the spacing between shapes in a pattern may change when tension is applied to the bandage, indicating a change in compressive force. Such designs in elastic bandages have been used to indicate compressive pressures as high as 40 to 50 mm Hg.
Compressive stockings, due to the compressive pressures they apply, are generally more difficult to place on the leg than conventional dress hosiery. To be most effective, the area or areas of the stockings having the highest compressive pressure, and thus the most difficult to apply, should be located at the feet or more distal portions of the leg, such as the ankle. Consequently, compressive stockings are often especially difficult for the elderly or persons with compromised mobility to apply to their legs. In addition, higher compressive pressures are indicated for the prevention and treatment of leg ulcerations. As a result, compressive stockings that use higher compressive pressures, such as for leg ulcerations, may be even more difficult to apply.
It has been generally found that most persons can place, or apply, Class I stockings with minimal or no assistance. However, many patients are unable to apply or remove stockings with Class II or Class III pressures without assistance by a care-giver or medical personnel. Such stockings may also be difficult for the care-giver to apply. As discussed above, compression therapy is often utilized for the prevention and treatment of ulcers, for which Class II or Class III compressive pressures may be beneficial. Often, patients suffering from leg ulcers have difficulty applying stockings with Class II or Class III compressive pressures due to age or disability, such as compromised mobility. Such patients may also have difficulty removing such stockings, particularly if they are applied by a care-giver. It may also be difficult for a care-giver to remove such stockings due to the compressive pressures involved.
For compressive therapy to be most effective, higher pressures may be required. The very high pressures that may be required for both prevention and therapy may preclude use of a stocking, as construction of a stocking having such higher compressive force may cause the stocking to be too tight to apply over the heel of a person's foot. As an alternative, high pressure elastic bandages which can be applied directly to a leg, without placement over the foot as with compressive stockings, may be used. Pressures higher than those supplied by a stocking can be applied by an elastic bandage. Using a high pressure elastic bandage, a leg is generally wrapped by a care-giver, rather than by a patient, as applying desired pressures with proper pressure graduation up the leg requires training and experience. Because of the difficulty of properly app
Carolon Company
Kilpatrick & Stockton LLP
Pothier Denise M.
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