Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-04-05
2001-09-18
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S023000, C602S026000
Reexamination Certificate
active
06290664
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an improved, off-the-shelf orthopedic device for the stabilization and control of a human knee joint of the left and or the right leg and having an extended coverage but reduced area and lighter weight structure and which can be custom formed in various zones by the user or technician to closely fit to the upper and lower portions of the leg of a wearer to optimize comfort, utilization time and protection.
BACKGROUND OF THE INVENTION
The prior art describes many orthopedic devices which attempt to support and stabilize the human knee over a wide range of angular, lateral and rotational displacement of the human leg. In some cases, the device is used by athletes to protect the knee joint. In other instances, an orthopaedic injury or deformity requires a restriction in the flexion and extension or lateral movement of the articulating knee joint to assure that the user will not cause further injury by either extending or flexing beyond a certain angular limit.
Since the leg has significant tissue about the femur, the leg brace has to have significant force coverage, at a greater distance therefor above and below the knee in order to properly stabilize the knee joint. Area coverage relatively closer to the knee joint will otherwise experience a more severe bending moment of the brace against the leg which damages the tissues of the leg. This is known as insufficient leverage. To increase leverage, brace manufacturers have lengthened the cuffs. As length increases, so to does the possibility of a mismatch, or gap, between the brace and the leg's surface. These gaps are typically filled by adding padding or by heating and re-shaping the frame of the brace.
Another problem with braces are custom formability. A custom brace can be made along with the use of a mold or other physical measurement from the user. This process can be tedious and very costly if it requires participation of technicians, in addition to the user. A precise fit was only achieved by making the brace by hand on a model of the patient's leg, or by reheating a re-shapable plastic shell or by adding more and more padding materials to fill voids in the brace shape to compensate for the mismatch between the brace support and the leg. Heating a brace to re-form it requires an additional step in the fitting process. Where a patient's or user's leg musculature changes from increased or decreased athletic activity or weight gain or loss, the brace must be brought in for the technician to re-heat and re-fit. This time consuming process requires additional expertise and equipment to perform correctly and efficiently.
The addition of padding to try to achieve a custom fit from an off-the-shelf brace was even more of a disaster since more padding needs to be utilized. Padding creates a further deviation from a good fit. The padding can be compressed during utilization of the brace, and the compression “loosens” the effective fit of the brace. Even more importantly, the padding does not help maintain the most minimal profile possible and there will always be unnecessary bulk in the padded areas.
In some cases, a close covering fit based upon a mold can be as confining as conventional cuff or an extended solid support. Where solid coverage is used, especially with a reinforcement to make them lighter weight, they are not shapable. Also, custom braces are not user adjustable, in addition to being overly expensive to make.
Conventional braces are not customizable beyond a tightening or loosening of the straps holding them in place, and the adding or taking away of padding, or the application of heat to soften the frame for adjustment. This is unfortunate, since the topology of the leg, knee and calf offers ample opportunity for some customizable fit to take advantage of the user's shape and contour.
Even where the confinement problem is not present, a custom formed brace can't easily or instantly be adjusted instantly for changes in the size of the leg, such as occurs during an injury and long periods of inactivity, or such as might occur as the leg muscles are bulked up with increased athletic activity or injury, or when leg muscles reduce in size due to atrophy, or from normal human weight gain or loss.
Another problem with conventional braces is the bulky fittings which may be present to enable engagement of the straps. D ring strap fittings usually depend from fittings which are attached to the cuff through rivets or other fastening structures. Whenever the cuff structures have such extraneous additional structure for fitting the straps, user discomfort is increased from added bulk, and a low profile is impossible to achieve. Such discomfort is answered with more and thicker padding, which further reduces fit and performance.
Another problem with braces used during athletic activity is the tendency of the brace to ride down on the leg when the athlete runs. When this problem is approached by tightening the straps, discomfort and restriction of circulation occurs. Even partial downward shifting of the brace interferes with the proper operation of the brace.
Another problem with conventional braces is the lack of even compression of the soft tissues of the leg against the internal structure of the bones whose position and movement are to be controlled. As force is applied to a conventional brace, uneven support of the leg is the result. This is particularly the case with a conventional brace which uses full circumference straps since such straps follow the contour of the leg and only contain therefor the volume of the leg at the point at which the strap is located. This does not necessarily maintain original shape as a load is applied. This distortion of the shape can allow the bones to misalign sufficiently to damage the ligaments about the knee. For some designs, a misalignment problem can be worsened by the improper addition of pads to create an appearance and feel of an accurate fit in an unloaded state, but which may compress and allow misalignment and damage under load if the overall design of the conventional brace does not allow for it.
What is therefore needed is a light weight brace, having an extended length moment or leverage engagement with the leg, but without providing more skin coverage than necessary, allows for exchange of air or “breathing” to take place within the brace, and importantly enables customization adjustments to be easily performed. The customization adjustments should both take advantage of the topography of the user's leg, as well as to enable adjustment as the size of the leg changes, either because of increase or decrease in the size of the leg.
SUMMARY OF THE INVENTION
The brace of the present invention can be custom formed by the user or technician to closely fit to the upper and lower portions of the leg of a wearer to optimize factors including comfort, utilization time and protection and promote healing. These factors are individually and collectively optimized by a more perfect fit between the structural brace and the surface of the leg.
The inventive knee brace has a number of adjustable “contour zones” to quickly permit adjustment of the brace over the widely varying ranges in shape of the human leg, and without heat. This new design allows a quick optimal fit and maintains a very low profile.
The design allows the brace the maximum leverage and control by a more exacting fit close to the knee joint, as well as at the uppermost and lowermost edges of the brace. The inventive brace has “contour zones” directly above the knee and below the knee in the form of adjustment members which wrap the leg inwardly from the sidebars of the upper support to a point almost to the center line of the leg and are bendable toward or away from the surface of the leg, the bending to achieve a shape which will withstand normal use. Since the contour zone adjustment members on the upper part of the brace are somewhat elongated shape, the ability to control not only the degree of bending toward and away from the leg, b
Brown Michael A.
Harrington Curtis L.
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