Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2002-10-15
2004-03-30
Lucchesi, Nicholas D. (Department: 3624)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C005S006000, C005S023000, C005S026100
Reexamination Certificate
active
06712780
ABSTRACT:
TECHNICAL FIELD AND BACKGROUND OF THE INVENTION
This invention relates to a custom-formable knee immobilizer product, knee immobilizer and method.
The invention has particular application in the orthopedic medical field, where injured or diseased knees are often supported and immobilized with a splint or brace so that the patient can continue to walk, albeit with a stiff leg, while the injury heals. Typical injuries which can sometimes require immobilization may include, but are not limited to, pulled or torn quadriceps muscles and tendons and/or the patellar tendon, chondromalacia patellae, pulled or torn medial or lateral collateral ligaments, and posterior or anterior cruciate ligaments. Certain related degenerative conditions, as well post-operative recovery and therapy following a wide range of orthopedic surgical procedures, may also require immobilization of the knee.
In such cases, it is essential to immobilize the knee in such a way as to prevent articulation, which can strain healing muscles, tendons, ligaments and bone surfaces. In addition, the knee must be stabilized to prevent eversion and inversion.
The invention of the present application takes advantage of polymer chemistry to permit quick and easy molding of an immobilizer to the knee and adjacent thigh and calf portions of the leg. The close, custom fit achieved is in distinct contrast to so-called “one size fits all” braces or splints wherein bendable plastic rods or stays provide support, and are held in place by a heavy fabric tube.
The particular embodiment of the immobilizer disclosed in this application will accommodate a wide range of sizes and can be fitted to either the right or left knee. Thus, a much reduced inventory is required. This feature also substantially reduces design and manufacturing costs, and promotes use through ease of fitting. The custom-fit of the immobilizer not only permits easy removal for bathing, dressing or adjustment, but also easy and mistake-proof replacement even by children.
Prior art immobilizers include numerous types of splints and braces which typically include a soft component to place near the skin and a semi-rigid metal or plastic stays which are bent into a shape conforming to the aspect of the knee against which the stay resides. The soft component, for example, fiber padding, foam or an air bladder, is intended not only to provide a cushion, but also to accommodate itself to the varying configurations of differing sized and shaped body parts. For this reason, the cushioned part is substantially greater in thickness than required merely to provide the protection from injury or irritation caused by direct contact with the stays.
Some prior art knee braces include stays which are constructed of thermosetting materials which are heated and then formed to the body 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 increase the flexibility of the stays, thereby decreasing the effectiveness of the protection offered.
The present invention permits quick and easy application of a immobilizer to a knee in such a way as to achieve a true custom fit. The moisture curable resin system used results in a very rigid splint which holds the shape of the molded splint to a very high degree. No heat is required, and a source of water is the only additional material necessary to achieve a cure. Atmospheric moisture alone will cure the splint into its hardened position in a relatively short period of time, but in practice the resin in or on the splint will typically be activated by dipping the splint in water and then removing the excess water by rolling the splint in a towel immediately before the splint is applied to the knee.
SUMMARY OF THE INVENTION
Therefore, it is an object of the invention to provide a custom-formable knee immobilizer.
It is another object of the invention to provide a knee immobilizer which can be molded to a knee to stabilize the knee against articulation, eversion and inversion.
It is another object of the invention to provide a knee immobilizer which can be custom-formed to a particular patient.
It is another object of the invention to provide knee immobilizer having a shape which permits it to be used on either the left or the right knee.
It is another object of the invention to provide knee immobilizer which hardens in the presence of moisture to form a very rigid but very lightweight splint portion.
It is another object of the invention to provide a knee immobilizer which is stored in a moisture-proof pouch until ready for being custom-fitted to the knee.
It is another object of the invention to provide a knee immobilizer which is custom-molded to a patient's knee in such a way that it can be initially held in place with an elongate elastic strip to reduce edema, and thereafter held in place with a strap or straps during later stages of healing.
These and other objects of the present invention are achieved in the preferred embodiments disclosed below by providing a knee immobilizer for being custom-formed to the shape of a knee while flexible and upon hardening providing a rigid, knee-supporting custom fit. The knee immobilizer includes an elongate splint with a substrate impregnated or coated with a reactive system. The system hardens upon exposure to moisture to form a rigid, self-supporting structure. A flexible outer cover overlies the substrate for forming an integrated splint structure for being molded while flexible to an aspect of the knee. The immobilizer also includes a bandage for extending around the knee and holding the splint in a supporting position on the knee. A splint support cooperates with the splint and the bandage for maintaining the splint on the bandage in a conforming shape against the knee and substantially immobilizing the knee in a predetermined position.
According to one preferred embodiment of the invention, the splint support includes first and second complementary hook-and-loop elements on respective matable surfaces of the bandage and the splint.
According to another preferred embodiment of the invention, the splint support includes a vertically-extending pocket formed in the bandage for positioning and supporting the splint in a vertically-extending position against the knee.
According to yet another preferred embodiment of the invention, the substrate includes a plurality of knitted or woven fabric layers.
According to yet another preferred embodiment of the invention, the bandage includes a foam sheet material.
According to yet another preferred embodiment of the invention, the foam sheet material is selected from the group consisting of open or closed cell EVA or polyurethane.
According to yet another preferred embodiment of the invention, the bandage includes a fabric material covering at least one side of the foam sheet material.
According to yet another preferred embodiment of the invention, the flexible outer cover is formed of a material selected from the group consisting of woven, knitted or non-woven fabric.
According to yet another preferred embodiment of the invention, the reactive system includes a blended polyisocyanate, polyol, catalyst and stabilizer.
According to yet another preferred embodiment of the invention, the bandage is a tube for being pulled onto the leg over the foot.
According to yet another preferred embodiment of the invention, the bandage includes a flat sheet having cooperating mechanical fasteners for releasably holding the sheet around the knee.
According to yet another preferred embodiment of the invention, the mechanical fasteners include first and second complementary hook-and-loop elements on matable surfaces of said flat sheet.
According to yet another preferred embodiment of the invention, the knee immobilizer includes an elongate elastic strip for being wrapped around the knee over the bandage and splint during curing of the reactive system, thereby holding the bandage and splint in a closely conforming position on the knee.
According to yet another preferred embodiment of
Adams Evans P.A.
BSN Medical Inc.
Hamilton Lalita M.
Lucchesi Nicholas D.
LandOfFree
Custom-formable knee immobilizer product, knee immobilizer... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Custom-formable knee immobilizer product, knee immobilizer..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Custom-formable knee immobilizer product, knee immobilizer... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3260117