Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2001-12-14
2004-02-24
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S008000
Reexamination Certificate
active
06695801
ABSTRACT:
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention relates to methods and apparatus for supporting or immobilizing a body part. More specifically, the present invention relates to methods and apparatus for making and using a custom-fit, lightweight, durable orthopedic appliance (or “orthopedic splint”) for use as a splint, cast, or protective pad.
2. The Relevant Technology
Many common injuries require that a body part or surface be covered with a protective dressing in order to provide support, promote healing, prevent further injury, selectively immobilize the injury, and act as a shock-absorbent buffer around it. In many such injuries, especially where the hard, durable dressings currently known in the art are used, it is generally preferred that the dressing be kept in place once it has been applied. This may be desired in order to preserve the precise setting of a bone needed for proper healing, to prevent the patient from moving or using the injured part, to enclose and protect an open wound, or to accomplish a combination of these functions.
Durable, long-lasting dressings such as these are key to medical efficiency and treatment since they can last weeks without replacement by a doctor. This saves both the patient and the doctor significant time, expense, and discomfort. Dressings of this type are often required after accidental injuries, and may also be used after some surgical procedures.
Methods and devices for stabilizing body parts and surfaces face challenges to be successful. First, since a dressing may need to be worn for extended periods, it is preferably clean; strong; resistant to wear, degradation, and rotting, etc.; waterproof, and presentable in appearance. This helps such dressings to remain clean and sterile and to protect the underlying skin from irritation and infection.
Since many emergency situations require the immobilization of a body part or surface, dressings which are quick to apply and which are strong and supportive are preferred. Further, in such emergency or first aid situations, such dressings should be easy to apply and use, thus allowing them to be employed by untrained volunteers when no trained medical personnel are available.
Finally, in an era when people are embracing lifestyles of increased physical activity, patients demand that casts and splints leave them able to participate in as many activities as possible. As a result, lightweight, small, waterproof, and strong solutions to the casting problem are advantageous.
Many methods and devices are currently known and relied on in the art for stabilizing body parts or surfaces. Prime examples of these are casts and splints including plaster casts, casts made up of synthetic resins, and splints made of resins, plastics, or metals. Many of these materials are easily conformable to the shape and size of the body part of the patient, and are able to strongly support the needed limb.
Plaster casts were formerly the most widely used form of casting. In this casting method, strips of cloth impregnated with plaster are immersed in water and carefully wound around the affected limb in layers. This mass is then painstakingly shaped and then allowed to harden over a period which may last hours to obtain a full set of the plaster. The result is a thick, solid, and often heavy cast amply capable of supporting the injured limb.
Such plaster casts are useful in many applications, but also generally suffer from disadvantages ranging from long setting periods during which the cast is not solid, and which may thus be more easily damaged, high weight and density, impermeability to X-rays, susceptibility to damage and weakening from exposure to water, and bulkiness.
Casts made of synthetic resins have become popular in recent years due to their ability to harden in a shorter period of time (relative to plaster), their lighter weight and lower density (relative to plaster), their resistance to damage from water, their permeability to X-rays, and the ability to provide them in attractive colors. These casts are popular among wearers since they are lighter and less bulky, while still retaining the needed characteristic of strength. The drawbacks of this technology include the need for wet handling and clean up or special equipment, including in some cases, equipment for producing UV rays to harden the resins, and lesser ability to form and mold the casting material.
In addition to these techniques, there is a wide range of technologies available for removably splinting a wound. These technologies allow the patient to remove the dressing when needed and replace it on their own. Many such devices involve metal or plastic supports which are pre-formed and molded within padding or foam to brace the wound. Though useful in many applications, these devices are only very poorly adaptable to the anatomy of the user, and involve increased cost, weight, and inconvenience.
Accordingly, a need exists for a lightweight orthopedic splint appliance useful for casting and splinting wounds which is easy to use, moldable to the anatomy of the patient, quick to harden without water application or external chemicals, strong, durable, waterproof, and attractive. It would be an advancement in the art to provide a self-contained orthopedic splint that does not require the use of water, gloves, or other accessories to enable use in the field or any other circumstance. Such a device is disclosed herein.
BRIEF SUMMARY OF THE INVENTION
The apparatus of the present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available orthopedic splint and casting systems, including those referenced above.
To achieve the foregoing objects, and in accordance with the invention as embodied and broadly described herein, a form-in-place orthopedic splint system is provided. The orthopedic system includes an outer envelope having an inner face and an outer face, where the inner face has a textured surface. The outer envelope contains a liquid polyol composition which is in contact with this textured surface of the inner face. The inner envelope contains an isocyanate composition, and keeps the isocyanate segregated from the polyol in the interior of the outer envelope. This inner envelope is adapted, however, to be ruptured by a user, thus allowing the polyol and isocyanate to mix and react, causing the formation of a polyurethane foam. The inner envelope may be ruptured by many means currently known in the art including, but not limited to, pressure, tension, physical perforation, tearing, and puncturing. In many forms of the instant invention, the inner and outer envelopes may be made of a high density polyethylene or similar polymeric material. Polyethylene is notably suitable since it is an oriented plastic which may be easily torn in a predictable direction. Polyethylene is substantially water impermeable, and thus prevents water from entering the envelopes containing the reagents. The materials used in the envelopes should be substantially water impermeable to prevent the entry of water into the envelopes since water will react with isocyanate, thus fouling the reaction with the polyol composition. In some forms, the inner envelope is between about 2 and about 4 mils thick. In others, the high density polyethylene is about 2 mils thick.
In many of these embodiments of the instant invention, the outer envelope of the orthopedic splint is shaped and configured to conform to a specific body part. Specifically, the orthopedic splint may be adapted to conform to the hand, elbow, wrist, thumb, forearm, shoulder, foot, ankle, knee, leg, or other desired body parts. Those skilled in the art of constructing orthopedic splints and casts would be familiar with such known useful splint shapes, styles, and conformations.
The polyurethane foam may be adapted to have a relatively short cure time of between about 8 and 15 minutes. In some forms of the instant invention, the polyol and isocyan
Toronto Russ
Toronto Tom
Hamilton Lalita M
Lucchesi Nicholas D.
Madson & Metcalf
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