Orthopedic cast and method of making the same

Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace

Reexamination Certificate

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Details

C602S008000, C602S020000, C602S023000

Reexamination Certificate

active

06613006

ABSTRACT:

FIELD OF THE INVENTION
The present invention generally relates to casts for immobilizing a human extremity and a method of making the same.
BACKGROUND OF THE INVENTION
Traditional casting applications for fractures include plaster-of-paris casts and casts formed from glass fiber materials. Plaster-of-paris casts may be constructed by wrapping a fractured extremity and its surrounding area (the “affected body part” or “affected extremity”) with wetted plaster-of-paris covered cloth strips to immobilize the body part upon the hardening of the plaster-of-paris. Casts formed from glass fiber materials may be wrapping an affected body part with a warm, flexible glass fiber fabric to immobilize the body part upon the cooling and stiffening of the glass fiber cast. Although these types of traditional casting applications are quite popular, each casting system has many associated drawbacks, including treatment-related problems and materials-related problems.
The treatment-related problems associated with traditional casting applications result from traditional casts prohibiting the affected body part covered by the cast from being adequately viewed and accessed the treatment of various maladies. For instance, edema, or the collection of fluid in bodily tissue, may occur in the soft tissue surrounding a fracture. With traditional casting applications, edema may go unnoticed until it causes circulatory impairment and/or excruciating pain, requiring cast removal and reapplication, or, in extreme circumstances, the loss of the extremity. Additionally, although current treatment protocol for edema calls for rest, immobilization, cold treatment, and elevation of the fractured limb, cold therapy cannot be applied directly to a casted extremity because the cast covers the affected body part.
Similarly, traditional casting applications also preclude the ability to visualize and topically treat any cutaneous wounds that may have been sustained before or in conjunction with the trauma that causes the fracture. Traditional casts also prevent the monitoring of the healing progress of these wounds, preventing health care providers from observing the wounds for signs of secondary infections. Secondary infections may be devastating in conjunction with fractures, requiring extensive antibiotic therapy, cast removal for observation and treatment, surgical debridement, and, in extreme cases, surgical amputations.
The probability for these types of complications is much greater in pediatric, geriatric, circulatory impaired and immune deficient patients. For example, pediatric patients may be unable to convey that their symptoms from complications are other than those common to fractures, resulting in delayed and prolonged treatment. In geriatric patients, decreased neurological function may result in symptoms going unnoticed by the patient until infection is beyond medicinal treatment, requiring cast removal, surgical intervention, and cast reapplication. For circulatory impaired and immune deficient patients, the decreased circulatory function or immune deficiency may result in prolonged healing periods and a reduction in the ability of the body to resist and fight infection, ultimately yielding the same results.
One materials-related problems associated with traditional casting applications is that traditional casts typically require cotton padding between the tissue of the affected body part and the cast. This padding inherently absorbs moisture, sweat, and water that may have been inadvertently introduced to the cast. Because of the lack of ventilation, the padding may retain this moisture for the duration of the casted period. The moisture and lack of ventilation provide an ideal environment for pathogenic microorganisms.
Also, both plaster and glass fiber casts are heavy and opaque, providing no ventilation to covered tissues. Severe itching may cause the patient to introduce a foreign object to scratch the itch, often resulting in abrasions to the covered tissue. Further, traditional plaster-of-paris casts degrade considerably when exposed to water.
Finally, of less significance to the healing process, but of considerable concern to patients, is the problems that the bulk of traditional casts pose on wardrobes. Most wardrobes will not accommodate the bulk and inflexibility of a cast on a limb, requiring either the purchase of new clothing to fit over the cast, or the splitting of the seams of current clothing to fit over the cast, thereby requiring the purchase of new clothing once the cast is removed.
BRIEF SUMMARY OF THE INVENTION
Thus, there is a need to provide a cast that is waterproof, ventilated, and capable of providing access to the affected area for observation and treatment. The present invention is a mesh cast comprising composite material and multiple apertures. It is desired to have mesh design having at least 40% apertures volume. The mesh cast is constructed of a composite waterproof material that is pre-impregnated with resin material, and is approximately 70% lighter and less bulky than current traditional casts. The mesh design allows for ventilation of cutaneous tissues by permitting air to flow freely over a fractured extremity and its immediately area (the “affected extremity”). The mesh design further allows one to view the cutaneous tissues to permit monitoring of the cutaneous tissue for signs of medical complications associated with fractures, including edema and secondary infection. The mesh cast further allows one to practice personal hygiene measures, such as bathing, directly through the cast. When applied to an affected extremity, the mesh cast secures the affected extremity to allow for healing of the fracture of the affected extremity such that the affected extremity is substantially immobilized.
The composite mesh cast allows the health care provider and the patient to immediately recognize and address edema, permitting early and rapid management. Additionally, cold therapy may be applied to the affected extremity without removal of the composite mesh cast. Similarly, the health care provider may perform a sensory nervous evaluation without removal of the composite mesh cast. Likewise, a Transcutaneous Electrical Nerve Stimulator (“TENS”) unit may be used to relieve pain without removal of the composite mesh cast.
Because the patient may practice personal hygiene without removal of the composite mesh cast, and because of the increased ventilation associated with the composite mesh, severe itching is virtually eliminated. In the event that cutaneous wounds are sustained before or in conjunction with the trauma that caused the fracture, the mesh design allows for visualization and observation of wound healing and signs of secondary infections. Secondary infections may also be observed at the initial stages, and treated proactively with topical medications and oral antibiotics, eliminating the need for extensive antibiotic therapy, cast removal for observation and treatment, and surgical intervention. In the event that a primary infection is present prior to casting, wounds may be medicinally treated and their progress observed. Because it is unnecessary to use an absorbent such as cotton, with the composite mesh cast, the tissues are not in constant contact with moisture, and thus the ideal environment for pathogenic microorganisms is eliminated.
For high-risk patients such as pediatric, geriatric, circulatory impaired and immune deficient, these benefits associated with the composite mesh cast greatly reduce secondary complications which may have devastating impacts on these patients. For those patients with decreased neurological function (e.g., paraplegia, quadriplegia, etc.) signs of secondary infections may be noticed before the patient notices symptoms. For patients with decreased circulatory function or immune deficiency, complications may be observed and treated early, reducing or eliminating surgical intervention and prolonged healing regimens. Finally, because of the reduction in bulk of the composite mesh cast as compared to traditional plaster or fiberg

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