Surgery: splint – brace – or bandage – Bandage structure – Support covering
Reexamination Certificate
1999-02-24
2003-02-18
Pothier, Denise M. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
Support covering
C602S075000
Reexamination Certificate
active
06520926
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to an improved compression support sleeve constructed to stay comfortably in place during strenuous activity without the need for stays or straps and without causing irritation of the underlying skin. More particularly, it is concerned with a sleeve of laminate multilayer construction having a skin-contacting surface substantially coated with a thin layer of discontinuous silicone microdots. Advantageously, the resulting sleeve construction is freely stretchable to conform to the muscles and joints of a user, while providing slip-resistant support and augmented compression without impairing breathability of the device.
The upright posture of the human body renders it particularly susceptible to strains, sprains and other injuries which are generally manifested by swelling, inflammation and discomfort. When severe, an injury may result in impaired mobility and necessitate restriction of movement and activity. The body is also subject to formation of fibrin clots which may obstruct vessels in the peripheral circulation when the body is in the prone position for prolonged periods. In addition to localized morbidity, such clots may also break free and travel to the heart or lungs causing more serious damage.
Orthopedic injuries have economic as well as physical repercussions for professional athletes engaged in competitive sports. Sidelined athletes lose not only the opportunity to perform, but experience a reduction in their overall level of fitness during periods of restricted activity, necessitating a period of retraining prior to resumption of competition. Of course, most individuals are not professional athletes and they engage in less strenuous activities such as jogging, calisthenics, walking and occasional competitive sports.
However, non professional athletes also experience discomfort when injured and their level of physical fitness is also impaired by injury-enforced inactivity. Moreover, amateur athletes may be more likely to be susceptible to injury, since they generally lack the advice of professional trainers as well as the fitness and judgment developed by professional athletes. Those who engage in infrequent bouts of strenuous exercise without training are most at risk of injury. However, even the well-trained amateur athlete is subject to occasional strains and sprains. Some individuals are particularly at risk of injury because of previous traumatic injury which has left continuing weakness in a joint or limb. Other individuals are at greater risk because of their advanced age or general state of health and fitness.
The importance of providing compression support to limbs and joints which have been injured or weakened or which are subject to stress, such as may be caused by strenuous exercise, is well recognized. So-called R.I.C.E. therapy (rest, ice, compression, elevation) is commonly recommended for implementation following minor athletic injuries. Such therapy is known to be particularly effective when cold and compression are applied immediately following an injury and the compression is continued for a period of about 24 to 48 hours. The need to provide compression to facilitate venous return in bed bound patients in order to prevent formation of blood clots is similarly well recognized.
Orthopedic compression bandages, braces and sleeves have long been employed to provide support for athletic and medical purposes. They are commonly worn over the wrists, elbows, knees and ankles. They are also frequently employed on the lower legs and forearms, and, less frequently, on the upper legs and arms, shoulders and chest. They provide support during normal movement, which support may be especially required by persons recovering from previous injuries or by persons who are frail or elderly. Such compression devices also provide support for ligaments, tendons, muscles and joints against the stresses of over extension which may occur during exercise. In this manner, they help to prevent orthopedic and muscular injury or reinjury. Elastomeric sleeves have also been employed, commonly in the form of stockings, to provide compression in order to facilitate peripheral venous return from the legs of bed bound patients, thereby helping to prevent embolism.
Such compression support devices are often of elastomeric construction, either in the form of sleeves, dressings or strips which may be slipped over or wound around the affected area and fastened by means of hook and loop fasteners or specialized clips or pins.
A number of materials have been employed in the construction of such support devices. Dressing, strip and sleeve-type supports are generally constructed of knitted or woven elastic webbing consisting of elastic or cotton-wound elastic threads or of stretchable synthetic resin compositions such as neoprene. Laminate multilayer composite materials have recently become available which are thinner than previously used woven elastics and especially neoprene. Such multilayer materials may be fabricated into sleeve or bandage-type supports. They are often five layers thick, with a synthetic resinous film layer sandwiched between two adhesive layers, each of which is covered by an outer layer of a stretchable synthetic fabric such as nylon. However, the skin-contacting layer is quite slick, and the support tends to migrate along the skin unless it is sized and custom fitted to the limb of a wearer. This is especially true of supports placed about the knee as such supports slip or migrate along the leg.
Known knitted, woven and laminate materials tend to experience slippage along the limb and to wrinkle or bunch up, causing compression of the limb to be uneven. Such shifting and uneven displacement of the material against the skin causes dermal irritation and discomfort to the wearer. Slippage of laminate supports can be limited, but not eliminated by custom fitting. However, such fitting requires personal consultation with a professional fitter. Thus, it is expensive and consequently unavailable to most users. Moreover, changes in body weight, weight distribution or development of musculature because of growth, exercise or aging may necessitate periodic refitting of the brace to maintain proper support.
Because of these problems, some braces have been constructed of rubber-like polymeric materials such as neoprene, which tends to stay in place because of its high coefficient of friction against the skin. Neoprene supports are generally thicker and bulkier than braces constructed of other materials, and such materials have not proven to be satisfactory for frequent or sustained use because of their lack of permeability to air and water. Supports constructed of neoprene do not permit the underlying skin of the wearer to breathe. Because such impermeable supports lack ventilation to carry away body heat and moisture, extended or frequent wear may be uncomfortable as well as irritating to the skin. If such irritation is prolonged, it can result in morbidity such as dermatitis and sloughing of the skin. Such impermeable materials are especially unsuitable for compression bandages to be worn by amputees or individuals with impaired circulation, who may develop necroses. In addition, since impermeable supports provide no outlet for perspiration excreted by the wearer, a salt residue is deposited on the inner surface of the support which eventually serves to impair elasticity and shorten its effective life span.
Since braces constructed entirely of impermeable, slip-resistant materials have not proven to be satisfactory, attempts have been made to construct braces from a combination of elastomeric and slip-resistant materials. One current technique is to apply a continuous bead or band of a slip-resistant material such as silicone around the upper inner surface of the support. Certain applications, such as ankle braces, may require bands at both the upper and lower inner surfaces in order to control slippage. However, the slip-resistant material is impermeable, lacks ventilation, and is consequently uncomfortable agai
Lohmann Rauscher, Inc.
McMahon John C.
Pothier Denise M.
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