Surgery: splint – brace – or bandage – Bandage structure – Support covering
Reexamination Certificate
2000-04-06
2002-06-04
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
Support covering
C602S060000, C602S061000, C002S016000, C128S881000
Reexamination Certificate
active
06398749
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to elbow supports and a method for fabricating the same. The purpose of the support addresses a condition known as Epicondylitis, a very common and painful injury. It comprises an inflammation of the tendons which connect the extensor and flexor muscles to the epicondyle bones of the elbow.
BACKGROUND OF THE INVENTION
Epicondylitis is an inflammation or slight tearing of tendons or muscles around the elbow joint. This can occur at the medial epicondyle, the lateral epicondyle or both. The extensor muscle group is on the lateral side (outside) of the forearm and helps turn the wrist palm up. The flexor muscle group is on the medial side (inside) of the forearm and helps turn the wrist palmdown. Tendons attach the extensor/flexor muscles to the epicondyles of the elbow. The epicondyles are the two bony knobs on either side (lateral/medial) of the elbow.
To address the epicondylitis condition, various support devices have been provided to direct lateral and medial compression and focus tendon compression. The lateral/medial compression helps the tendons and muscles remain parallel to reduce stress, pain, inflammation, and to allow healing to begin. These side by side compressions help hold the muscles and tendons in-place so that they are less bowed, stretched or unstretched. Pain from epicondylitis is greatly reduced by providing focus compression directly at the pain source, the tendons of the extensor or flexor muscles. Focused compression is achieved by the use of a separate pad in the elbow support. The pad is placed where the focus compression is needed. Products on the market have pads made of various materials such as air pillows, gel pads, and soft polyurethane foam pads.
One illustration of the prior art is found in the applicant's own product known as the Epi-Sport, manufactured and marketed by FLA Orthopedics, Inc. subsidiary Clinitex Medical Corp. The Epi-Sport product utilizes a curvilinear body or clasp of synthetic material to encircle more than 180 degrees of the forearm closely adjacent to the elbow. Optionally, one end portion is wider than the other end portion, with the two end portions and the intervening medial portion defining a clasp having a C shaped cross-section. The clasp relies on its shape to apply pressure on the tendons of the forearm. An elongated compression strap is secured to the outside of the medial portion of the C shaped body on the outside, and extends in both directions. One end of the strap terminates in a buckle, and the other terminates in a reversely foldable member. The reversely foldable member carries a releasable securable material on one surface. The back or outside of the medial portion of the strap also carries a section of a releasable securable member. When the strap is pulled snug, it can easily be secured in-place with one hand by mating the two releasable securable members.
SUMMARY OF THE INVENTION
The present invention is directed to improved elbow supports which are generally similar to the described prior art supports. More particularly, the invention is directed to a unique method for fabricating such devices. The elbow support comprises a curvate clasp having a generally C shaped cross section, with the clasp encircling the forearm of the wearer in excess of 180 but less than 360 degrees. In one preferred embodiment the clasp carries an inner compression pad at each of its ends. These oppositely disposed pads are designed to focus compression to hold the muscles and tendons in place. The clasp is itself encircled by an attached strap, which may be tightened to secure the desired amount of compression from the pads.
In fabricating the elbow support, the material for forming the clasp is first prepared by forming a laminated composite material. The laminated composite material preferably comprises a flat sheet of a compressible heat formable closed cell foam, which is sandwiched between surface sheets of fabric. The fabrics are adhesively or otherwise attached to the sheet foam. The foam may be formed of any of a number of suitable synthetic materials, such as polypropylene, urethane, polyurethane, olefin, polyolefin, and similar materials. One example of such a material is a polyolefin film marketed under the trademark Volara.
The inner liner, or fabric covering the inner surface of the foam sheet, is preferably of a soft material. The inner fabric ideally is capable of moving moisture, but this is not essential. One example of a satisfactory inner fabric is a material sold under the trademark Orthowick, which wicks moisture. On the other hand, polypropylenes, polyesters, cottons, acrylics, cellulose acetates, spandex, and other such fabrics are also suitable. The fabric covering the outer surface of the support clasp is chosen for its durability and appearance. This outer fabric may be formed of a nylon mesh, or similar primarily knitted type long wearing material. Neither the inner nor the outer fabric material is critical, and numerous similar fabrics may be used.
The composite fabric-foam-fabric laminate is next die cut or otherwise cut to the desired clasp body shape to create an uncompressed clasp body blank. The edges of this laminated clasp blank may then be sewn to provide a neat and attractive binding. The strap also may optionally be attached at this time, such as by sewing or other suitable means such as adhesive.
The thus assembled clasp body blank is then subjected to selective compression and forming into the desired C shaped form. The compression is selectively applied, so as provide in the C shaped clasp a sufficiently high density to furnish the desired rigidity. At the same time the compression step also provides one or more substantially uncompressed integral pressure pads. The clasp body is generally of a substantially uniform density over the major portion of its body, with the exception of the pressure pads. The pressure pads have a lesser density than the remainder of the compressed body, and may not have been subjected to significant compression. In any event, they form integral, generally bulbous protrusions from the inner end surfaces of the clasp body. These protrusions are disposed in a manner to provide compression against the tendons in the forearm at the desired point or points. The pressure pads may be pre-lined with fabric through the use of the preformed laminated closed cell foam material. On the other hand cut outs may be formed for the pressure pads, so that they are unlined.
The clasp is compressed and formed into its C shaped configuration under heat and pressure. It is in the nature of the closed cell foam of which the clasp is formed that it will retain its formed shape and density after the heat and pressure are removed.
Accordingly, it is a principal object of the present invention to provide an improved elbow support having integral compression pads fabricated pursuant to an efficient and economical new method.
It is another object of the invention to provide a new, effective and economical method for fabricating improved elbow supports having integral pressure pads which are accurately disposed using minimal method steps.
It is another object of the invention to provide a method for fabricating a wrist support by procuring for the clasp body a composite sheet material comprising a synthetic resin foam sandwiched between fabric liners, cutting the sheet to define a clasp body blank, selectively compressing the composite sheet material forming the blank to form at least one substantially uncompressed compression pad of foam, attaching a strap to the clasp body, and forming the clasp body into a curvate shape.
It is another object of the invention to provide an elbow support comprising a generally C-shaped clasp body having at least one foam compression pad extending into the interior of the body for adjustable compression into the forearm of a wearer, an elongated compression strap attached to an outer surface of the clasp body and extending therearound, the strap having a buckle at one end and a releasable securable
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