Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
1999-01-05
2001-05-08
Yu, Mickey (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S023000
Reexamination Certificate
active
06228044
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of foot treatment and more particularly to the field of treating ulcers on the plantar surface of the foot. The present invention also relates to the field of leg braces. Unlike other devices for treating plantar ulcers, the brace of the present invention is reuseable, adjustable to a variety of leg sizes, easily applied and capable, through the use of a novel system of bladders and other design features, of effectively off-weighting the plantar surface and reducing shearing forces thereto, thereby allowing the ulcers to heal.
BACKGROUND
The development of effective means for treating foot sores or ulcerations, especially diabetic foot ulcerations, presents a significant medical challenge. Diabetic foot ulcers result in more than 55,000 lower extremity amputations per year (nearly half of all amputations performed in the United States) and account for more hospitalizations than any other single complication of diabetes. Of the 14 million diagnosed diabetics, 15 percent, or 2.1 million, suffer from foot ulcerations. In fact, foot ulcers are the leading cause of hospitalization of patients with diabetes and account for 10 percent of the costs related to diabetic care.
The burdens of such complications can also have a devastating effect on patients and their families. Patients' quality of life can rapidly decline leaving them unable to work, and dependent on family members to spend their time and resources caring for the patient. Disabilities due to diabetes result in more than $5.6 billion per year in lost wages and earnings.
The problem is compounded by the fact that many diabetics suffer from peripheral neuropathy and thus cannot feel pain. Since pain is often a primary incentive for patient compliance, neuropathy patients frequently do not comply with voluntary off-weighting techniques, resulting in further deterioration of the wound and possibly leading to infection. It is, therefore, crucial that the off-weighting treatment device does not set patients up for failure by allowing them to walk on the wound, thus preventing healing.
The typical cycle for this medical complication is chronic foot ulceration, infection, hospitalization, amputation and rehabilitation. This costly cascade of events need not take place since two-thirds of diabetic amputees do have an adequate blood supply to heal ulcerations. The key factor for effective treatment then is to remove the patient's weight from the ulcerated site to give the ulcers an opportunity to heal.
Currently, there are several options for off-weighting diabetic foot ulcers to enable them to heal. These options have varying degrees of success depending upon the degree of patient compliance, wound location, and grade of wound. The following is a brief description of the most frequently used therapies for treating diabetic foot ulcers and their advantages and disadvantages.
Prescribing the use of crutches and/or wheelchair use is perhaps one of the simpler treatment methods. However, these options have produced poor clinical results due to lack of patient compliance. Patients with peripheral neuropathy in particular are not motivated to use these devices.
A variety of specially designed sandals and modified shoes have been tried. One sandal, referred to as the temporary healing sandal, provides a cut-out region in the sole to alleviate pressure to the ulcerated site. The problem with this type of sandal is that since the human foot is not flat, when pressure is removed from the area of the ulcer site, there is increased pressure to other metatarsal heads which creates the potential for transfer lesions. A second sandal, the custom sandal, is made from an impression of the patient's foot. Like the temporary sandal, an area in the sole aligned with the location of the ulcers is cut out to relieve pressure at the ulcerated site. Because the patient's weight is more evenly distributed as compared to the temporary healing sandal, the likelihood of transfer lesions being formed is reduced. However, this type of sandal provides no relief from shearing forces.
Several devices generically referred to as “walkers” have been designed which are similar to the sandals just described. The DH Walker, for example, is similar in design to the temporary healing sandal. It includes a flat surface upon which the foot rests, but the surface includes plugs which can be removed to accommodate the area of the wound. Not surprisingly given the similarity in design, the DH Walker suffers from the same problem as the temporary sandal in that weight is transferred to adjacent metatarsal heads and the potential for the formation of transfer lesions is great. The sandal also fails to alleviate shearing forces. Another walker called the Cam Walker is essentially equivalent to a DH walker, except that it does not have removable plugs within the device. Consequently, the Cam Walker does not effectively off-weight the wound.
A variety of modified shoes have been tried. Ipos shoes are half shoes that are cut off at the middle of the foot, leaving the forefoot overhanging the cut-off area. Studies have shown that this shoe can be effective, provided the patient is diligent in wearing it. Compliance during the evening, however, is often a problem. Moreover, the Ipos shoe is only applicable to forefoot ulcers and has a high potential for generating transfer lesions.
A different approach involves placing felt directly on the foot and then covering the felt with foam which includes a cut-out region to correspond to the location of the wound. This approach has been shown to be efficacious. However, the method can also cause damage to the skin during the removal process, since the plantar skin can be easily torn.
The Charcot Restraint Orthotic Walker (C.R.O.W.) is a cast manufactured of polypropylene which is effective in the treatment of plantar ulcerations, but only so long as the leg remains the size it was when first casted. Cost is another problem; the average casting cost is $1,200 per cast. In general, C.R.O.W.s have shown limited utility since changes in the patients' leg reduce the effectiveness at which the foot is off-weighted over time.
All of these methods have proven successful provided they are used on the right patient at the right time, and that patient compliance is not an issue. However, the primary current ambulatory method that ensures off-weighting of the wound is the Total Contact Cast (TCC). The TCC is a cast that is formed using a complicated procedure involving wrapping the patient's leg in plaster wrap and fiberglass. Although the TCC has the disadvantage of being difficult to apply, it has been shown to be effective in healing up to 90 percent of cases.
Total contact casts relieve the forces that prevent healing by: 1) shortening stride length, 2) decreasing walking velocity (which diminishes vertical forces), 3) eliminating motion at the ankle joint (sagittal plane), 4) eliminating the propulsive phase of gait, 5) redirecting body weight from the foot to the lower leg, and 6) eliminating shearing forces. One study concluded that the effectiveness of the TCC is a consequence of its ability to decrease plantar pressures to nearly imperceptible levels (as low as 0.34 N/cm
2
) and to essentially eliminate motion in the cast, thus substantially curtailing shearing forces (Todd, W. F., et al. Wound/Ostomy Management, 41: 48-49, 1995).
Yet, despite its efficacy when used properly, numerous difficulties have resulted in significantly lower TCC usage than might be expected. First, application of the total contact cast is a complex, 15-step process requiring a high degree of skill and approximately one hour of time to complete. Improper application can also have significant negative consequences. For example, casts applied over an active infection raise the potential for loss of the infected leg, improper application of the cast can create new ulcerations, and the failure to remove wrinkles in the stocking inside the cast may irritate the patient's skin.
Burek Paul P.
Jensen Jeffrey L.
Gibson Dunn & Crutcher, LLP
Pothier Denise
Rose Biomedical Research
Yu Mickey
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