Method an apparatus for treatment of compressive syndrome...

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

Reexamination Certificate

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C128S878000, C128S879000, C002S020000

Reexamination Certificate

active

06315748

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is broadly concerned with improved method and apparatus for the treatment of compressive syndrome physical disorders characterized by a region of localized, undue compression of body tissue, for example, carpal tunnel syndrome. More particularly, the invention is concerned with such methods and devices wherein use is made of a central tensioning segment formed of resilient, stretchable material (e.g., synthetic elastomer or latex rubber) together with a plurality of adhesive attachment straps of limited stretchability secured to the tensioning segment for securement of the device on a person's body. The tensioning segment exerts a continuous yielding or tensile force through the straps, serving to at least partially reduce the troublesome tissue compression.
2. Description of the Prior Art
Carpal tunnel syndrome and related conditions result from repeated trauma to the tendons and soft tissue structures forming a part of the wrist. Excessive pressure on the carpal tunnel contents, including the flexor tendons, nerves and bursa, results in abnormal function, weakness, inflammation, pain, numbness and ultimately in nerve tissue injury.
The flexor retinaculum is a thick, relatively unyielding ligamentous band that crosses the groove on the palmer surface of the carpal bones. It is composed of the palmer (volar) carpal ligament and transverse (anterior annular) carpal ligament. The palmer carpal ligament is attached medially and laterally to the styloid processes of the radius and ulna. The transverse carpal ligament is attached medially to the pisiform bone and the hamulus of the hamate, and laterally to the tuberosity of the scaphoid and palmer surface of the ridge of the greater multangular (trapezium). The fibers of these ligaments merge at the distal end of palmer and proximal end of the transverse ligament. Together with the carpal bones and articulations, they form a tunnel through which pass the deep flexor tendons and median nerve.
The median nerve passes through the carpal tunnel adjacent the flexor retinaculum and between it and the flexor tendons and their bursa. The carpal tunnel is barely adequate to accommodate these structures and it is generally felt that any narrowing of the diameter of the tunnel or decrease in the diameter to contents ratio, causes injury to the median nerve by repeatedly pressing it against the relatively unyieldable retinaculum. Repetitive and/or constant forceful movement, in particular extension movements of the hand, are thought to repeatedly traumatize the median nerve in this manner, as does the repetitive and/or constant force contracture of the thenar muscles.
Current medical treatment of carpal tunnel syndrome consists of rest, restriction from traumatizing activities, limiting movement with restrictive splints, anti-inflammatory medication and cortisone injections. In advanced cases surgery is used to transect and spread the transverse carpal ligament to allow more room for the contents of the carpal tunnel, i.e., an increase in the diameter to contents ratio. Some form of wrist support or splint is normally used in the early stages of treatment. They are used in an attempt to delay progression of the condition or as an adjunct to some other treatment in an effort to lessen the pain and aid in the return to normal function. Subsequent to surgery, wrist splints are frequently used to support the wrist and aid in recovery. Thus it is important that a presurgical device be provided which corrects the condition or prevents further development and/or progression of the condition.
Given the widespread incidence of carpal tunnel syndrome and similar disorders, many attempts have been made to provide orthopedic supports or braces for the wrists which will alleviate the symptoms and/or provide a means of eliminating the problem in its entirety. For example, U.S. Pat. No. 5,921,949 describes a corrective support designed specifically for the treatment of a tunnel syndrome. However, none of these past efforts have resulted in a truly effective device or treatment for the syndrome. Therefore, the traditional treatments described previously remain the methods of choice in most cases.
In addition to carpal tunnel syndrome, a number of other compressive syndrome conditions have been identified. These include radial tunnel syndrome (sometimes referred to as “tennis elbow”). In this condition, the supinator muscle, while turning the wrist in the clockwise direction compresses the radial nerve. The radial nerve feeds the muscles of the back of the forearm. It is most commonly seen with twisting activities of the arm. Pain if first noticed at the lateral side of the elbow, about two inches toward the wrist from the elbow. Rest is currently the best treatment to allow swelling to go down. DeQuervain's Tenosynovitis is a problem of the abductor pollicis longus and extensor policis longus tendons which irritate the bursa coating, called tenosynovius becoming tenosynovitis when inflammation occurs. Irritation continues forming scar tissues. The present treatment protocol attempts to reduce the swelling in the area by reducing the usage.
Frozen shoulder is a joint dysfunction and is often caused by adherence of the anterinferior aspect of the joint capsule to the humeral head. This condition often occurs after injury, being a scar formation type dysfunction. Piriformis Syndrome is a condition where the sciatic nerve is compressed between the piriformis muscle and the gemellus muscle.
Guyons' Canal syndrome is a common nerve compression affecting the ulnar nerve and possibly the ulnar artery as it passes through a tunnel in the wrists on the lateral portion. The problem is similar to carpal tunnel syndrome, but involves a completely different nerve. Sometimes both conditions can be causing problems in the same hand.
Thoracic Kyphosis is the loss of movement in the upper back area, described as a derangement syndrome and is caused by adaptive shortening, as a result from poor postural habits over a sustained period. Derangement syndrome is believed to be caused by a disturbance of some structure with the joint causing mechanical deformation of pain sensitive structures.
Trigger points are muscle conditions where an involved area is relatively spasm, building up lactic acid in the muscle, with resultant pain.
After surgery, scar tissue can ball up and contract, in unnatural orientations. This can cause severe pain to a patient.
While all of these types of compressive syndrome conditions have been recognized for many years, there has been no readily available, non-surgical treatment available to alleviate the symptoms thereof.
SUMMARY OF THE INVENTION
The present invention overcomes the problems outlined above and provides an improved device for the treatment of compressive syndrome disorders such as carpal tunnel syndrome, but also including radial tunnel syndrome, DeQuervain's Tenosynovitis, frozen shoulder, Piriformis Syndrome, Guyon's Canal Syndrome, thoracic kyphosis, and scar tissue conditions. Broadly speaking, the devices of the invention include a tensioning segment formed of elastic, stretchable material adapted for placement on a persons body proximal to the region of localized tissue compression, together with a plurality of elongated, adhesives straps secured at respective locations to the tensioning segment; the straps have less stretchability (and are preferably essentially non-stretchable) than the tensioning segment and are configured for securing the tensioning segment in place on a person's body. When applied, the tensioning segment of the device exerts yielding or tensile forces through the straps serving to at least partially reduce tissue compression.
In the case of a carpal tunnel syndrome treatment device, the tensioning segment is adapted to overlie the back of a person's hand, and has three individuals straps secured thereto. Two of the attachment straps are oriented to extend end opposite directions from the tensioning segme

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