Bellacure’s nonsurgical, drug-free OA treatment device is worn around the knee to provide pain relief to those suffering from osteoarthritis. The general principle of pain relief is based on the clinically proven applied valgus moment, or applied force, which relieves pressure from the arthritic compartment of the knee. Bellacure, however, has evolved this principle by developing an biomechanical dosing system that allows repeatable application of pain-relieving forces at an intensity level unmatched in orthopedics.
The TD Skin is the interface between the patient’s body and the OA treatment device. It is made up of a carefully designed, layered construction using high-stretch, lightweight and breathable fabrics. The inner layer resting against the skin is a unique blend of nylon and elastic fibers that provides excellent stretch memory for a secure and repeatable fit. The smooth inside surface is ideal for a soft, comfortable feel. A hypoallergenic, silicone-coated elastic band on the top inside edge keeps the device in place. The outer layer is primarily comprised of a nylon and spandex blend for high stretch, abrasion resistance and breathability. The smooth outer surface allows clothing to be easily pulled over.
The dosing mechanism is the means by which the patient dials in the prescribed dosage of pain relief. It is a tensioning mechanism wherein four independent micro-cables, which automatically adjust themselves to the patient’s leg diameter, are tightened in order to apply the forces of the clinically proven “valgus moment.” After the device is pulled into place, the patient engages the dosing cap by pressing in toward the leg until the dial snaps into place, and then simply rotates the cap to apply the dose. The dosing mechanism presses against an air bladder to distribute pressure comfortably around the knee.
The micro-cables originating at the dosing mechanism cross around the leg in four directions and connect to the internal support shells. The cable guides, pockets that encapsulate the micro-cables, incorporate dense nylon-elastic webbing in order to distribute cable pressure (generated when the dosing mechanism is tightened) comfortably across the leg.
Hidden inside the zipper enclosure are support shells that allow the forces generated by the dosing mechanism to be comfortably distributed around the thigh and calf. The shells are made of fiber-reinforced, high-impact nylon and are designed to fit most leg shapes. They provide rigidity along the midline of the leg where necessary to ensure proper placement of pain-relieving forces. Yet they are also flexible in specific areas to facilitate proper alignment and a comfortable fit.
There is just one strap on the OA treatment device. The alignment strap needs adjustment only during the initial fitting and once set correctly provides stable alignment of the support shells with respect to the patient’s leg.
*please note: the hinge goes on the affected side
PDAC approved billing code is L1843.