Orthopaedic brace having one-piece cuff

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

Reexamination Certificate

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Details

C602S023000, C602S026000

Reexamination Certificate

active

06331169

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to orthopaedic braces and, more particularly, to an orthopaedic brace having a cuff formed as a single piece from bendable sheet material.
When a joint has been weakened by injury or other infirmity, orthopaedic braces often are used to stabilize and protect the joint during the rehabilitation process. A typical brace comprises a number of rigid structural components dynamically linked together by hinges, such that the axes of the hinges align with the joint being stabilized. The rigid structural components are secured to the body of the wearer above and below the joint by flexible straps to support and protect the joint when the wearer is active.
By way of example, when the knee is injured, a knee brace can be used to stabilize the knee joint which connects the upper leg (i.e., the femur) and the lower leg (i.e., the tibia). Typical knee braces comprise an upper leg cuff that generally conforms to the shape of the upper leg above the knee joint and a lower leg cuff which generally conforms to the shape of the lower leg below the knee joint. The upper and lower leg cuffs are dynamically connected to each other by hinges in alignment with the knee joint.
The upper and lower leg cuffs of the knee brace usually are of a three-piece construction, comprising a center band which conforms to the leg of the wearer, and two elongated bars connected to the ends of the center band. The bars extend away from the center band in a common direction toward the knee joint, there they terminate in a toothed configuration forming a part of the hinge. The cuffs generally are constructed from metal which preferably is coated with a rubber-like covering. The rubber-like covering is designed to protect the wearer and others from exposed metal parts on the brace which could cause injury, for example, during an athletic event.
Problems have existed in the past regarding orthopaedic braces, such as knee braces having a three-piece construction of the type described above. For example, the ends of the bars are usually joined to the ends of the center band by rivets inserted through aligned holes in the overlapping portions of the center band and bars. Since the bars and center band are each coated with a rubber-like material prior to assembly in overlapping relation by the rivets, the rubber-like coating adds to the overall thickness of the cuff in the area where the center band is riveted to the bars. Because the connection between the bars and center band is not a metal-to-metal connection, the cuff is susceptible to being weakened, and sometimes loosened, in the area of the riveted connection.
Another drawback of the three-piece orthopaedic brace is attributable to the labor costs that are associated with the multiple manufacturing steps that must be taken to assemble each cuff. First, the center band and bars must be fabricated and thereafter separately coated with the rubber-like covering. After the rubber-like covering has been applied, the ends of the bars are connected to the center band by the rivets, followed by bending of the center band to conform to the leg of the wearer. All of these separate fabrication and assembly steps add to the overall cost of the brace.
Further, the construction of orthopaedic braces having cuffs of this type are not conducive to a lightweight brace. It also is difficult to produce an orthopaedic brace having a streamlined appearance, due to the rivets and bulk produced from the overlapping components.
Accordingly, there has existed a definite need for an orthopaedic brace cuff which eliminates the use of rivets, which is more streamlined in appearance, which can be constructed using a reduced amount of labor without sacrificing structural integrity, and which is as lightweight as possible. The present invention satisfies these and other needs, and provides further related advantages.
SUMMARY OF THE INVENTION
The present invention is embodied in an orthopaedic brace for use in stabilizing a joint that, for example, has been weakened by injury or other infirmity. The brace comprises a cuff formed of a single piece that is shaped to conform to the body part of a wearer. A molded one-piece covering is applied to selected portions of the cuff so that no metal parts are exposed. This one-piece construction provides an orthopaedic brace cuff that is streamlined in appearance, relatively inexpensive to manufacture, light in weight, yet provides an extremely strong brace.
More particularly, the cuff of the orthopaedic brace comprises a general U-shaped frame formed as a single piece from bendable sheet material. With reference to an embodiment of the invention in which the brace comprises a knee brace, for example, the frame has a center segment which is bent in an arcuate manner to conform to the leg of the wearer, and two extensions projecting from the ends of the center segment. These extensions project from the center segment in a common direction toward the knee joint where they terminate in a toothed configuration to form part of a hinge. The knee brace preferably comprises an upper leg cuff and a lower leg cuff joined to each other by hinges on opposite lateral sides of the knee joint.
In one aspect of the invention, the center segment of the cuff has a reduced stiffness as compared to the stiffness of the extensions. This allows the center segment to more easily bend during the manufacturing process and conform to a particular shape. However, the stiffness in the extensions is not reduced, thereby providing the necessary structural strength in this area of the brace. In one embodiment, the reduced stiffness of the center segment is provided by forming the center segment from a material having a reduced thickness as compared to the thickness of the extensions. Preferred materials for forming the cuff include metal, such as aluminum, or a composite material.
In another aspect of the invention, a series of apertures are provided in the center segment. These apertures are designed to render the center segment lighter and more readily bendable during the fabrication process.
In still another aspect of the invention, all or selected portions of the cuff are coated with a molded one-piece covering that closely and securely engages opposite surfaces of the cuff. In the preferred embodiment, the covering comprises a thermoplastic material, such as Krayton or other suitable rubber-like materials. If desired, the covering can be applied to the center segment so as to define a recess for receiving a pad or cushion designed to contact the wearer's leg. The portion of the covering defining the perimeter of the cuff around the recess may further define a raised lip. This raised lip assists in aligning the pad to the center segment.
The cuff preferably is fabricated from sheet material, for example, an elongated flat sheet of metal, such as aluminum, or a composite material. The sheet has a longitudinal portion along one edge having a thickness that is reduced as compared to the thickness of the remainder of the sheet. Using stamping techniques, a plurality of the U-shaped frames forming the cuff can be stamped from the sheet. Each frame that is stamped, therefore, will comprise a single-piece construction, having the center segment and two extensions projecting from the ends of the center segment in a common direction, as described above. However, the center segment of the frame is formed by the portion of the sheet that is of reduced thickness, and the extensions are formed from the remainder of the sheet which is thicker. This advantageously yields a frame that is more easily bendable at the center segment during the fabrication process, yet provides a high degree of structural strength in the extensions.
The sheet material may be fabricated by an extrusion process which forms the longitudinal portion of the sheet with the reduced thickness. Alternatively, the sheet may be machined along the longitudinal portion to reduce its thickness.
After the frame has been produced by the stamping process described above, the f

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