Wrist-band for the prevention and the treatment of the...

Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace

Reexamination Certificate

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C128S878000, C128S879000

Reexamination Certificate

active

06383157

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to orthopedic remedies. More particularly, the present invention relates to wrist bands as used for the prevention and treatment of carpal tunnel syndrome.
2. Description of Related Art
Problems of the wrist are currently well known that have symptoms due to factors such as it cervical arthrosis or to insufficient circulation. These problems are often submitted to specialized treatment at a late stage or are treated in an improper manner.
To better illustrate the problems associated with the wrist, the movements of the human wrist are described herein. The carpiradialis and carpimedian articulation movements are used to cause the positioning of the hand in relation to the forearm. These movements can be characterized as bending movements, extension movements, radial and cubital inclination movements, and circling and rotation movements. In order to accomplish the bending movement, the palmar face of the hand bends according to the front surface of the forearm. For an extension movement, the dorsal face of the hand bends according to a rear surface of the forearm. The cubital inclination movement or adduction movement is accomplished by bending the hand toward the cubital side of the forearm. The radial inclination movement or abduction movement is carried out by bending the hand toward the radial side. The sequence and combination of the above-described movements causes the circling motion. In contrast, the rotation of the hand is obtained by the movement of the hand about its own axis.
All of these movements are accomplished through the carpiradialis and carpimedian articulations and through the flexor and extensor muscles of the forearm and of the hand. These are innervated by the median nerve which crosses the carpal canal constituted by the rigid osseous sulcus of the carpal bones on which the traverse ligament is stretched.
The neuropathy to which the present invention is addressed arises from the unbalanced relationship between the cavity constituting the carpal canal and its sheath and the respective nerve, as well as from endogenous and exogenous factors which may cause such a degenerative process. The exogenous factors can include inflammatory processes, such as rheumatoid arthritis, fractures of the wrist and of the osseous corn, acromegaly (abnormal swelling of the bones), pregnancy etc.
From the repeated observations of patients affected by such pathology, it has been noted that a very frequent etiology is due to a particular exogenous factor. This exogenous factor is the frequent constrained position of the extension and bending of the wrist which can injure the median nerve caused by the increase of the pressure occuring in the carpal canal. Consequences of this pathology are irritative disorders, diffuse pain, paresthesia (tingling), as well as a further loss of the contractile strength of some of the muscles. This can lead to the atrophy of the muscles themselves. The most usual treatment for this pathology is of a conservative nature in which anti-inflammatory medications are used along the nerve. This treatment causes inconveniences and can even cause damage to the nerve. Often, the advantage obtained by such treatment processes is only temporary.
A first alternative to such anti-inflammatory medications is the use of wrist splints. These wrist splints utilize metal splints having a padding. These splints prevent hyperextensive movements and bending so as to relieve the suffering of the nerve. However, it is necessary to arrange the wrist-splint “ad hoc and in situ” by a technician. The use of such a splint can limit the activity of the wrists related to the daily and working activities of the patient. It also may be the impossible to remove by the patient.
On the same principle as that of the splints, other orthopedic remedies are proposed which basically utilize armbands worn by the patient with the purpose of limiting the sliding of the nerve along the carpal canal as much as possible. These remedies do not allow for the normal use of the hand. Their correct positioning is not always simple. Often, these remedies are not born by the patients for suitable periods of time necessary for the treatment of the carpal tunnel syndrome.
It is important to note that such remedies are sometimes used in an improper manner for carpal tunnel syndrome. It is fundamental that it is necessary to limit the bending/extension of the wrist without blocking completely the movements of the wrist because the blocking of the wrist movement causes injury to the nerve. This is proven by the fact that carpal tunnel syndrome often arises after a wrist is fractured and plastered in place.
The present invention inventors were the inventors for Italian Patent Application Ser. No. FI/95/A/257 of Dec. 21, 1995 (otherwise identified as International Application No. PCT/IT96/00262 of Dec. 20, 1996). This patent application described a removable wrist band adjuvant for the treatment of carpal tunnel syndrome. This wrist band consisted of an armband for containing or preventing the bending movements, extension movements, radial and cubital inclination movements and movements of rotation of the carpiradialis and carpiulnaris articulations of the wrist. This device allowed for the opposing of the thumb and the normal use of the hand. This armband, padded and countershaped according to the wrist and partially to the hand, is basically constituted by a shell having a rigid, but padded frame having two sides. The smaller of the sides is turned toward the forearm and the larger of the sides is turned toward the digits of the hand. This device presented an inconvenience in that, once the patient has worn the wrist-band, it did not remain in the desired position for therapeutic purposes, but would slide along the forearm. Additionally, this device offers a non-perfect containment of the wrist relative to the bending movements of the wrist.
It is an object of the present invention to prevent carpal tunnel syndrome without using pharmacological medications and by using a device which can be positioned directly by the patient without the help of a technician.
It is another object of the present invention to provide a wrist band for use by the patient which is compatible with the daily activities of the patient and which can be easily positioned and removed by the patient.
It is another object of the present invention to provide a wrist band which does not prevent the patient from carrying out his normal working activities and which does not block completely the hand causing the suffering of the median nerve.
It is another object of the present invention to provide a wrist band device which is easy and inexpensive to manufacture without using specialized workers and which is reproducible on an industrial scale without the use of sophisticated technologies and equipments.
It is a further object of the present invention to provide a wrist band device that can be manufactured in desired quantities.
BRIEF SUMMARY OF THE INVENTION
These objects of the present invention are achieved by a wrist band of the present invention for the prevention and the treatment of carpal tunnel syndrome. The wrist band is constituted by a soft and flexible multi-layer band suitable for being placed on a portion between the hand and the forearm corresponding to the carpiradialis articulation of the user. The band has five adjacent portions of which terminal first portion is coincident with the volar face of the wrist and has three rounded sides of which one is a terminal side and the other two extend therefrom. The other two sides are a superior side and an inferior side which are connected through respective surfaces to a second portion adjacent to the first terminal portion. The second portion is approximately coincident with the dorsal face of the wrist and includes two opposite sides. These two opposite sides includes a superior rounded side which is connected through a groove to the adjacent first portion and an inferior rectilinear side whic

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