Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2000-01-18
2001-07-17
Brown, Michael A. (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S005000
Reexamination Certificate
active
06261252
ABSTRACT:
TECHNICAL FIELD AND BACKGROUND OF THE INVENTION
This invention relates to a custom-moldable universal thumb spica splint. The disclosure of this application includes a package in which a splint is contained for ease of sale, distribution and use. The splint according to the invention can be packaged and dispensed in single, moisture-proof packages or in any other suitable manner.
A thumb spica splint is indicated for immobilization of the proximal area of the thumb during healing of injury to the scaphoid bone of the hand. The spica splint immobilizes the proximal area of the thumb while permitting some movement of the distal end portion. The thumb is immobilized by holding it in alignment with the hand and wrist. Thumb spica splints are known, for example, U.S. Pat. No. 4,382,439; as well as safety gloves with a dorsal thumb spica brace, for example, U.S. Pat. No. 4,524,464.
Prior art splints often include a soft component to place near the skin and a hard, shell-like outer cover. The soft component is intended not only to provide a cushion, but also to accommodate itself to the varying configurations of differing sized and shaped hands.
Other splints are glove-like in design and are provided with bendable plastic or metal stays which are bent to position the hand and wrist in the desired position.
Some other prior art splints are constructed of or include thermosetting materials, which are heated and then formed to the hand and wrist while heated. These products require a source of heat, and are susceptible to either over-or-underheating. In addition, body heat itself can soften or at least increase the flexibility of the splint, thereby decreasing the effectiveness of the protection offered by the splint.
The present invention permits quick and easy application of a protective thumb spica splint to the hand in such a way as to achieve a true custom fit from a single design. The splint according to one embodiment is universal in the sense that it can be used on either the left or right hand.
The moisture curable resin system used results in a very rigid splint which holds the shape into which it is molded. No heat is required, and a source of water is the only additional material necessary to harden the splint. Atmospheric moisture alone will cure the splint into its hardened position in a relatively short period of time, but the resin in or on the splint will typically be activated by dipping in water. The splint is inexpensive, easy to fabricate, easy to fit and comfortable to wear. Since only one splint necessary, hospitals, clinics and other emergency care facilities can easily and inexpensively maintain a full inventory of splints without complications arising from the need to constantly monitor an inventory of different sizes and shapes.
SUMMARY OF THE INVENTION
Therefore, it is an object of the invention to provide a thumb spica splint which is a universal size and shape for either the left or right hand.
It is another object of the invention to provide a thumb spica splint which is easy to apply to the wrist, hand and thumb.
It is an object of the invention to provide a thumb spica splint which can be easily placed on and removed from the hand and wrist by the patient when necessary or desirable.
It is another object of the invention to provide a thumb spica splint which hardens in the presence of moisture to form a very rigid but very lightweight protective splint.
It is another object of the invention to provide a thumb spica splint which is stored in a moisture-proof pouch until ready for application to the body part to be protected.
These and other objects of the present invention are achieved in the preferred embodiments disclosed below by providing a thumb spica splint forbeing custom-fitted to the thumb portion of the hand for immobilizing the thumb while permitting continued unrestricted use of the other fingers of the hand, and comprising an elongate, flexible inner cushion layer, an initially flexible intermediate layer overlying the inner cushion layer, the intermediate layer comprised of a fabric impregnated or coated with a moisture-curable resin which hardens upon curing to form a rigid structure of the fabric which retains a shape into which it is molded during curing, thereby also holding the flexible inner cushion layer in a conforming shape around the thumb. A flexible protective outer layer overlies the intermediate layer and is attached to the inner cushion layer for enclosing the intermediate layer and forming the inner layer, intermediate layer and outer layer into a single, integrated splint structure. The integrated splint structure is shaped to extend along and conform to the medial aspect of the lower arm and thumb to the distal joint thereof. Thumb strap means comprising an elongate thumb strap are fixedly attached by one end thereof to the splint structure adjacent the thumb for extending around the thumb and releasably attaching to a thumb strap attachment means fixedly attached to the splint structure for holding the splint structure in a supporting position around the thumb. Arm strap means comprising an elongate arm strap are fixedly attached by one end thereof to the splint structure adjacent the arm for extending around the arm and releasably attach to an arm strap attachment means fixedly attached to the splint structure for holding the splint structure in a supporting position around the arm.
According to one preferred embodiment of the invention, the fabric comprises a plurality of overlaid thicknesses of fiberglass.
According to another preferred embodiment of the invention, the plurality of thicknesses of fiberglass comprises at least five thicknesses and no more than seven thicknesses.
According to yet another preferred embodiment of the invention, the thumb attachment strap and the thumb strap attachment means comprise one or the other of male and female touch fastener elements.
According to yet another preferred embodiment ofthe invention, the arm attachment strap and the arm strap attachment means comprise one or the other of male and female touch fastener elements.
According to yet another preferred embodiment of the invention, an arm attachment strap is fixedly attached to the splint structure at an angle whereby the strap extends spirally around the arm, and the arm strap attachment means is attached to the splint structure in a longitudinally-offset position to receive and releasably mate with the spirally-extended attachment strap.
According to yet another preferred embodiment of the invention, the cushion layer comprises EVA closed cell foam.
According to yet another preferred embodiment of the invention, the splint includes a notch formed in the splint and positioned to reside over the thumbnail for permitting greater flexibility ofthe splint when being formed around the circumference ofthe thumb and for permitting observation of the degree of capillary refill when determining whether the splint has been applied with the proper degree of tightness.
According to yet another preferred embodiment of the invention, the invention includes a moisture-proofpouch in which the splint is contained in a flexible condition in moisture-free conditions until being opened immediately prior to application to the arm and thumb.
According to yet another preferred embodiment of the invention, the outer moisture-proofprotective pouch is formed of a laminated structure having at least one layer of plastic film and at least one layer of aluminum foil bonded to the plastic film.
According to yet another preferred embodiment ofthe invention, a thumb spica splint is provided for being custom-fitted to the thumb portion of the hand for immobilizing the thumb while permitting continued unrestricted use of the other fingers of the hand, and comprises an elongate, flexible inner cushion layer, an initially flexible intermediate layer overlying the inner cushion layer, the intermediate layer comprised of a fabric impregnated with a moisture-curable resin which hardens upon curing to form a rigid structure of the fabric which retains a shape into
Adams, Schwartz & Evans P.A.
Brown Michael A.
Hamilton Lalita M.
Smith & Nephew Inc.
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