Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-10-02
2003-02-11
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S020000, C602S021000
Reexamination Certificate
active
06517501
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a wrist support useful in combating the effects known as Carpal Tunnel Syndrome, and the method of making the same.
BACKGROUND OF THE INVENTION
Carpal tunnel syndrome is a well known, commonly occurring hand condition, sometimes referred to as median compression neuropathy within the carpal canal. The most common symptoms of this condition include intermittent pain and numbness of the hand. Such pain or numbness results from compression of the median nerve which extends from the wrist centrally into the palm of the hand between the palm heel and the ball of the thumb. In carpal tunnel syndrome, a dense fibrous tissue called the transverse carpal ligament forms over the median nerve and compresses it, producing the symptoms of pain and numbness.
Treatment of carpal tunnel syndrome varies according to the severity of the condition. Severe conditions usually require hand surgery to sever the transverse carpal ligament. For less severe cases, the use of a splint which immobilizes the wrist is sometimes effective, often in combination with an anti-inflammatory medication. Such treatments are generally expensive, painful, and may reduce the patient's ability to use the affected hand.
Carpal tunnel syndrome is a particular problem for workers in industries which require repeated manual operations with a held implement or tool. In many such industries it is a leading cause of workmen's compensation claims.
Many different devices have been proposed for treating or preventing carpal tunnel syndrome. For example, protective gloves have been proposed as one means of preventing carpal tunnel syndrome due to wrist flexing. Berger U.S. Pat. No. 4,531,241 issued Jul. 30, 1985, describes a glove having a pad which covers the palm, wrist and a portion of the forearm. The glove restricts free action of the wrist. Fabry et al., U.S. Pat. No. 4,850,341 issued Jul. 25, 1989, describes a glove with a tapered pad designed for use by meat cutters or others using an implement with an action similar to using a knife. While this glove is useful for some applications, its pad configuration is not convenient for other types of actions in which the palm bends, particularly across the central fold of the hand. Fabry U.S. Pat. No. 5,214,799 issued Jun. 1, 1993, describes a glove for preventing carpal tunnel syndrome which has palm-covering padding to protect the wearer's hand. The padding is made of a resilient flexible material such as foam rubber intended to provide protection from vibrations and shocks. The padding has a fold line extending diagonally across the palm to facilitate gripping the handle of an implement. All of these glove type braces and supports have the effect of unduly restricting the motion of the wearer's hand.
Modern day keyboarding is a commonplace and widespread activity which is associated with Carpal Tunnel Syndrome, which is also referred to as Repetitive Motion Trauma. In response to this problem keyboard wrist rests and wrist supports have become ubiquitous. Keyboard wrist rests are manufactured in various widths for use with calculators, computer keyboards, typewriters and the like. These keyboard wrist rests are intended to keep the hands and wrists at a 15 degree angle, which is referred to as the neutral position.
Another type of wrist supports which are used may be classified as sewn orthopedic wrist supports or braces. These devices more or less encase the wrist and at least a portion of the hand. They are manufactured in various colors and provide three levels of support, light, medium and heavy. Those which are intended to provide light or medium support include elastic or neoprene material with a thumb-hole. The material wraps around the hand and wrist and is fastened with a hook and loop closure. Products for providing heavy support more closely resemble a brace, using plastic or metal strips called “stays” as the means to obtain the rigidity necessary to stabilize and position the hand and wrist joint. It is uncomfortable to wear most such devices for keyboarding.
Still other devices which have been proposed for treating carpal tunnel syndrome include pull on supports or braces, plastic or metal splints secured by straps, bracelet like appliances, laced immobilizing braces, and wrist braces.
Peters U.S. Pat. No. 5,160,314 issued Nov. 3, 1992, describes a unitary body support adapted to be pulled onto and positioned about the hand and wrist area and adapted to anatomically conform to the wrist and basal hand of the wearer. The brace comprises a sleeve constructed of a resilient elasticized fabric including an outer layer having a brush ed looped texture. The sleeve is provided with a thumb opening and means for receiving a removable palmar stabilizing stay. The sleeve includes an integral compression strap which is sufficiently long to extend around the wrist at least once, and which is provided at its free end with hook attachment means for releasable engagement with the outer fabric loops.
Lemmen U.S. Pat. No. 5,417,645 issued May 23, 1995, describes an elongated flexible plastic or metal splint which extends from the center of the palm upwards along the wrist. It is secured in position by wrist and palmar strapping.
Eck U.S. Pat. No. 5,746,707 issued May 5, 1998 describes a wrist and two digit restraining device comprising a rigid metal or plastic splint element which receives the wrist, extends to support the heel and palm of the hand, and terminates at the base of the second, third and fourth fingers. Attachment straps are provided for the wrist support, thumb support and finger support. The device imposes a degree of restraint which would preclude keyboarding and many other activities.
Sucher U.S. Pat. No. 5,468,220 issued Nov. 21, 1995 describes a bracelet-like appliance which comprises a C-shaped member having a central portion located over the dorsal side of the wrist and two arms encircling the wrist. Each arm has a pad for engaging the palm near the attachment edges of the carpal ligament at the medial border and the lateral border of the carpal bones. The bracelet also includes a pad attached to the central portion for engaging the dorsal part of the wrist. The member is shaped to cause the pad attached to the central portion to press against the dorsal side of the wrist while the ends of each arm press in the opposite direction on the edges of the palm. The C-shaped member is a single piece of resilient, malleable material, such as aluminum, or is divided into sections interconnected by spring loaded hinges.
Harris et al. U.S. Pat. No. 5,769,804 issued Jun. 23, 1998 describes a laced wrist support comprising a preformed shell shaped to fit the patient's wrist with a thumb hole through the shell for receiving the wearer's thumb. An elastic tongue extends across the shell before being fully latched using a multi-strand lace extending over the elastic tongue. The multistrand lace is itself latched in place using a pair of self adhering hook and loop, fasteners.
Davini U.S. Pat. No. 5,385,537 issued Jan. 31, 1995 describes a wrist brace formed of semi-rigid material having a V-shaped cross section which cradles the wrist of the wearer. The semi-rigid brace is held in place by an attached flexible strap.
SUMMARY OF THE INVENTION
The invention relates to user wearable wrist supports and uses low temperature moldable, formable plastic, normally closed-cell foam, to replace the elastic material found in traditional wrist supports. This foam material is fabricated into the finished product using the improved method of the invention. The wrist support comprises a curvate clasp having a generally C shaped cross section, with the clasp encircling the wrist of the wearer. The clasp is secured by a strap, which may be formed during the wrist support fabrication.
In fabricating the wrist support, the material for forming the wrist support clasp is first prepared by forming a laminated composite material. The laminated composite material preferably comprises a flat sheet of a compres
Brown Michael A.
Dougherty & Clements LLP
FLA Orthopedics, Inc.
Thanh Quang D
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