Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-11-14
2003-06-03
Pothier, Denise M. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S028000, C005S650000, C128S882000
Reexamination Certificate
active
06572573
ABSTRACT:
TECHNICAL FIELD AND BACKGROUND OF THE INVENTION
This invention relates to a heel elevating device. The invention elevates the foot of a patient who is in a reclined position, and who is beginning to experience skin breakdown or has developed a pressure sore or pressure ulcer, venous ulcer, or diabetic ulcer on a portion of the foot, especially the heel. By elevating the foot and preventing it from contacting the bed sheets or other surface, further incidence of skin damage is reduced. Skin tissue which is already damaged heals faster because it does not come into contact with any type of hard surface, and air is allowed to circulate around it. Air circulation is essential to healing pressure sores, pressure ulcers, venous ulcers, or diabetic ulcers.
In addition, the invention is applicable for hospital, rehabilitation center, nursing home and home care patients who are bedridden or spend a considerable amount of time in bed. These patients are highly susceptible to developing pressure sores and pressure ulcers on a portion of the foot, especially the heel. It is also applicable for persons with diabetes who are very susceptible to diabetic foot ulcers caused by poor circulation, and non-diabetic persons with poor circulation who are susceptible to venous ulcers.
The present invention is further applicable in passive stretch therapy for persons having recently undergone knee surgery, or having suffered some type of knee injury. “Passive stretch” is a procedure for regaining total extension of the knee. The procedure involves placing a weighted bag on the knee of a patient in a reclined or sitting position on a bed or therapy table. The weight causes the knee to extend. Treatments last approximately 15 to 20 minutes each, and are repeated over several days or weeks until the patient has attained total extension of the knee.
The invention is placed under the patient's ankle and maintains the foot, ankle, knee and leg in a generally fixed position, preventing the weight placed on the knee from shifting during treatment. The U-shaped design of the invention, and inner liner, adjustable top strap, and adjustable foot-drop strap secure the foot and ankle in an upright position, while maintaining a high level of comfort for the patient. In addition, the invention raises the ankle and foot which in turn aids in the knee extension process. Patients who cannot be placed in a knee brace because they are tissue compromised (at high risk of developing pressure sores and/or ulcers caused by skin contact with the knee brace) can also be helped by using this invention during passive stretch for knee extension therapy.
The invention is especially applicable for use by the following types of persons:
(a). Hospitalized patients who have come out of surgery with heel shear (heel has rubbed on the operating room table during the surgical procedure).
(b). Hospital, hospice, rehabilitation center, nursing home, and home care patients who are bedridden or spend a considerable amount of time in bed. These patients are highly susceptible to developing skin shear, pressure sores and pressure ulcers on any portion of the foot, especially the heel.
(c). Persons with diabetes who have diabetic foot ulcers caused by this disease.
(d). Persons with poor circulation who develop venous ulcers as a result of circulatory impairment.
(e). Hospital and independent rehabilitation center in-patients and out-patients who are undergoing passive stretch for knee extension therapy as a result of orthopedic knee surgery or a knee injury.
There are a number of heel protectors and heel elevators in the prior art, but none of which adequately satisfy the needs of patients and care-givers as compared to the present invention. These products are divided into the following general categories based on estimated cost of the product:
Relatively Low Price Heel Protectors ($6 to $12 range)
These type products generally cover the bottom and sides of the foot and attach across the top of the foot with VELCRO™ hook and loop straps. They are usually made of open-cell foam or a cotton pad sewn into a nylon cover, and is designed to cushion the foot from contact with bed sheets or any hard surface. These products do not work satisfactorily for patients who already have skin shear, chaffing, pressure sores, pressure ulcers, venous ulcers or diabetic ulcers.
Some primary disadvantages are that these products apply pressure to the affected area or areas on the heel and/or foot causing pain and further skin damage. Even though these products are made of a very soft material, constant contact of this material with irritated or compromised skin tissue can create new sores or ulcers. Moreover, skin tissue can be torn or damaged when the device is removed because the material of this device may stick to the skin or wound. These products block air circulation necessary for healing and for patient comfort, and do nothing to help prevent “foot-drop”, a condition that often results from trauma or paralysis of the muscles which flex the foot. This condition results from failure to maintain the foot in a normal 90° fixed position, and can cause dragging of the foot.
Relatively Low Price Heel Elevators ($12 to $25 range)
These type products generally include open-cell foam circles or blocks with a cut-out hole for the ankle. Some have a permanently attached or removable adjustable foot-drop strap and an adjustable top strap, but no cushion liner. The type of open-cell foam used in these products often collapses, forming a rigid surface area which in turn can cause skin irritation, skin shear, chaffing, pressure sores or pressure ulcers. When the product collapses under the weight of the patient's calf, ankle and foot, the heel and foot end up resting on the bed sheets or other relatively hard surface areas. Since the hole for the ankle is pre-cut and cannot be adjusted, it can be too tight for some patients and too loose for others.
In addition, most of these type products do not have a foot-drop strap, and none of them can be machine washed for re-use. The foam base without a padded liner provides an extremely hard and abrasive surface for the ankle which can cause ankle pressure sores or pressure ulcers. Furthermore, these products generally do not remain in the proper position when the patient flexes his/her knee or turns from side to side.
Mid-Price Heel Elevators ($25 to $40 range)
Two commercially-available, inflatable products in this category include THE HEELER™ and WAFFLE BOOT™. THE HEELER™ has a thin removable shearling liner, and the WAFFLE BOOT™ has a thin synthetic cloth type liner. Both liners must be removed for laundering because the vinyl inflatable bases cannot withstand machine washing and drying. Liners are often misplaced or lost and replacements must be purchased. The vinyl base of both products can be over inflated creating excessive pressure at the point of contact with the ankle and Achilles tendon which can result in skin breakdown in these areas. The base can also be under inflated causing the heel and Achilles tendon area to come into contact with bed sheets or other relatively hard surface areas. The base can also be easily punctured making the product no longer usable.
The WAFFLE BOOT™ has a built-in foot-drop strap which helps to prevent foot-drop, and keep the product in the proper position when the patient moves or turns from side to side. The HEELER™ does not have a foot-drop strap, and frequently will not remain in the proper position if the patient flexes his/her knee or turns from side to side. The product of the present invention falls in this category.
Relatively High Price Heel Elevators ($175-$200 range)
One commercially-available product in this category is sold under the trademark MULTIPODUS BOOT™. This product is a half-boot design that is open on the top half and extends from the top of the calf to the bottom of the ankle. The product is formed of a hard plastic outer shell with a thin shearling liner, and a series of VELCRO™ straps that secure the product to the calf and ankle. A metal bracket ext
Adams, Schwartz & Evans P.A.
Pothier Denise M.
Tharos LLC
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