Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-03-14
2003-04-01
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S008000
Reexamination Certificate
active
06540706
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable.
CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable.
BACKGROUND OF THE INVENTION
The present invention relates to an orthopedic splint product. More particularly, the splint product of the present invention includes a moisture-impervious layer that functions as both packaging for the splint product and as a moisture/vapor barrier once the splint product is on the patient.
Casts and splints have traditionally been made by coating or impregnating a substrate, usually fabric, such as gauze, mesh or fiberglass, with a dry casting material such as plaster of Paris. The coated substrate is then dipped in water or some other liquid-activating substance to initiate the setting of the casting material. Following this, the coated substrate is squeezed to remove excess water, placed on the appropriate part of the patient, wrapped with an elastic bandage, and allowed to cure.
One disadvantage with these traditional casts and splints is that initiating setting is often messy and time consuming. Still further, the activating process requires multiple supplies and considerable skill. Usually the person applying a traditional cast or splint wears gloves and protective clothing, and often a protective layer of material is placed on the patient to protect the skin (see, for example, U.S. Pat. No. 4,193,395, which refers to covering the body part receiving the splint with a stockinette). The traditional casts and splints can be even messier if colored resins and/or substrates are used.
Other casting materials have been proposed that enclose the casting material in sleeves or coverings so that direct contact with the casting material is not necessary. Examples of such casting devices are described in U.S. Pat. Nos. 4,235,228, 4,442,833, 4,454,874, 4,628,917, 4,770,299, 4,869,046 and 4,899,738. However, these devices still have the disadvantage of requiring the device to be submerged in water and then wrung out before being applied to the appropriate body part of the patient. This method of application results in a wet layer of material being put in direct contact with a patient's skin. This may be uncomfortable and irritating and can, in time, cause maceration and sloughing of the skin. Another disadvantage with these casting materials is that, like traditional casts, they require submergence in a bucket of water or running water to initiate setting, and this limits their portability.
Other devices have been proposed that include a totally moisture impermeable layer for placement next to the skin, as discussed in U.S. Pat. No. 4,454,874. While this type of splint or cast may prevent moisture from the casting material from contacting the skin, the disadvantage with such a device is that moisture that is normally released from the skin becomes trapped. This moisture builds up under the impermeable layer and may cause tissue damage and/or odor.
It has further been suggested to apply a separate dry pad to a patient or adhere this dry pad to a casting device after it is wetted such as, for example, as described in U.S. Pat. Nos. 4,193,395 and 4,628,917. One disadvantage with such devices is that they are not unitary. If an adhesive is used to hold the components together, it usually does not hold well in a moisture environment. Still further, the separate dry pad may restrict the respiration of vapor.
Devices have also been proposed that use hydrophobic material on the patient contact side, as discussed in U.S. Pat. Nos. 4,770,299, 4,869,046 and 4,899,738. However, these devices still require immersing the device in water for activation of the resin. The immersion and squeezing of the device results in water being trapped or retained in the spaces of the hydrophobic material causing a wet surface to be presented to a patient. Still further, such devices may trap moisture next to the patient's skin.
Still other devices are described in U.S. Pat. Nos. 5,171,208 and 5,318,504. These devices provide a layer of water-impermeable, water vapor-permeable film on the side of the device in contact with the patient's skin. The film is placed next to the patient's skin to release trapped moisture while the cast or splint is in place on the patient. Still further, the film prevents water or other liquid from penetrating through the device to contact the patient's skin while the device is curing or if the device is exposed to liquid. These devices can be made without the need to be fully immersed in liquid when made with a preformed liquid-containing pouch formed of water-permeable, spun-bonded polypropylene. One disadvantage with these devices is that water cannot be removed from these devices once they are activated. Excess water remaining in the product could cause mold to grow. Still further, another disadvantage with these devices is that padding is exposed to moisture in these devices. Furthermore, these devices are stored in metallic packaging, which is separate from the product.
Another disadvantage with casting or splint products that are currently available is that those that use a low viscosity resin, when formulated to give a proper set time, typically result in unacceptably high temperature exothermic reactions, which can result in burning the patient. High viscosity resins, on the other hand, typically require complicated techniques for application, such as solvent coating the resin onto the fabric or substrate. Further, the fabrics or scrim materials used in such splints have typically been relatively inextensible in order to provide sufficient strength for the resulting splint. This results in a splinting material that has poor extensibility and that does not conform well to the body part to which it is applied.
As mentioned previously, a common disadvantage with a number of the splinting materials in the prior art is that they do not exhibit sufficient water vapor permeability, and skin maceration therefore can result from their use. Also, many of the splinting products currently available must be removed before a patient is x-rayed. Still further, many of the splinting products currently available are comprised of fiberglass, and health risks have been associated with the use of fiberglass. Even further, many of the splinting products currently available are disposed in landfills once they are removed.
To overcome the deficiencies found with conventional splinting and casting products, a splinting device that provides initial stiffness for quick immobilization while allowing time for molding the splinting material to the body is needed. Still further, this device should minimize the effects of exothermic reactions during its set-time and should discourage conditions that cause skin maceration while the splint is in place. A splint product of the present invention should also avoid the use of fiberglass to prevent health risks and should be made of environmentally friendly components.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a splint product that incorporates faster setting and slower setting substrate layers to provide fast green strength in the outer layers and conformability and a lower exotherm near a patient's skin.
It is a further object of this invention to provide a splint product having a moisture barrier layer near the skin and a padding layer against the skin designed to wick moisture away from the skin so as to provide greater patient comfort.
Another object of the present invention is to provide a splint product that can be activated using a variety of wetting techniques so as to increase the utility of the device.
Another object of the present invention is to provide a splint product that is radiolucent so that it does not have to be removed to monitor a patient's recovery.
A further object of the present invention is to provide a splint product that can be disposed of by burning it so that it is considered environmentally friendly.
According to the present invention, the foregoing and other objects are achieved by a splint product
DeCamp Larry R.
Goulette Monroe Patricia A.
Kilburn Randall S.
Martin James C.
Brown Michael A.
M-Pact Worldwide L.L.C.
Stinson Morrison & Hecker LLP
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