Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-06-07
2001-05-29
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S005000, C602S016000
Reexamination Certificate
active
06238360
ABSTRACT:
The present invention relates to braces for applying forces to knees and other joints in a medial/lateral plane or as otherwise desired. Such braces employ stiffeners which may be preferably removed and configured to a desired shape for imparting a predetermined force on the joint when employed in the joint brace.
BACKGROUND OF THE INVENTION
Conventional approaches to compartmental osteoarthritis and other joint maladies have included placing a brace on the limb surrounding the joint. Such braces aim to impart force or leverage on the joint in order to relieve compressive forces within a portion of the joint, or to reduce the load on that portion. For instance, in knee compartmental osteoarthritis situations, braces have been employed which feature rigid bars situated on the leg opposite or adjacent to the affected compartment of the knee. The bars include medial/lateral hinges which allow portions of the bars to be pivoted or swiveled in the frontal (varus/valgus) plane with respect to one another and locked into a desired configuration. The brace so configured when installed on the knee then imparts leverage at least partially to unload the affected compartment, and the adjustable hinges allow the magnitude of the force to be controlled or varied. Such adjustable hinges may employ set screws or other adjustment structure. Often, however, the adjustment structure requires use of a special tool and virtually always introduces bulkiness accompanied, paradoxically, by structural compromise and complexity.
SUMMARY OF THE INVENTION
The present invention provides braces for loading and unloading joints which alleviate the need for medial/lateral structure configuration adjustment devices such as hinges. Braces according to the present invention include a stiffener. The stiffener is preferably removably attached to the brace so that it can be adjusted in configuration while apart from the brace. The configuration of the stiffener may be permanently or substantially permanently adjusted or deformed by bending. In one version of the invention, the bending may occur in a bending tool which may include a goniometer for measuring the degree of deformation of, and the consequent loading to be applied by, the stiffener.
The stiffener so placed in the bending tool and bent to a desired configuration is deformed in a manner that is permanent or at least substantially permanent in the range of temperatures and forces encountered by the average brace wearer. The stiffener so configured is attached to or inserted in the brace, which may be formed of elastic, non-elastic or partially elastic material. The brace when installed properly on a limb loads or unloads portions of the joint with a predetermined force, a proxy for whose magnitude may, but need not be, determined by measuring a patient's limb alignment with a goniometer and configuring the stiffener with a bias relative to the patient's limb alignment. The amount of bias then corresponds to the magnitude of that force.
The stiffeners may be formed of metal, in which case bending for permanent or substantially permanent deformation may occur at room temperature. Stiffeners may also be formed of desired plastics or composite materials in which case bending for permanent or substantially permanent deformation can occur while heated; when the stiffener returns from its temperature excursion to the normal range of temperatures encountered by brace wearers, the deformation imparted by the bending is permanent and/or semi-permanent. That is, application of loads to the stiffener while the brace is in use does not cause the shape of the stiffener to “creep” or relax back to its previous, preconfiguration shape, or to suffer substantial plastic deformation. The stiffener instead “springs back” to its deformed configuration when the loads are removed.
It is accordingly an object of the present invention to provide knee braces for medial/lateral loading and unloading of body joints which employ stiffeners whose configuration may be readily adjusted to control the degree of loading and/or unloading, but which are inexpensive and efficient to manufacture.
It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be configured in shape without the need for special hinges or configuration structure such as set screws.
It is an additional object of the present invention to provide braces for loading and unloading body joints which include stiffeners whose configuration may be adjusted to a desired shape using a measuring device which may be adjusted to conform to the geometry of the leg and then used to configure the stiffener to apply proper loading.
It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be configured in shape using a bending tool and accompanying goniometer to control conformance to limb geometry, and/or, if desired, the magnitude, recordability and repeatability of the configuration change and consequent loading/unloading on the body joint.
It is an additional object of the present invention to provide braces for loading and unloading body joints whose stiffeners may be manually configured simply by being bent to a desired and predetermined shape to control and impart loading and/or unloading to the body joint, but which do not relax back to their non-configured shape as a result of such loading and/or unloading.
It is an additional object of the present invention to provide braces for loading and unloading body joints and which may be easily and quickly adjusted by a clinician in a manner that requires only a single visit by the patient.
Other objects, features and advantages of the present invention will become apparent with respect to the remainder of this document.
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Danssaert, Jr. John L.
Gildersleeve Richard E.
Tillinghast Theodore V.
Verespei James M.
DJ Orthopedics, LLC
Knobbe Martens Olson & Bear LLP
Lewis Kim M.
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