Known orthopedic devices are used for providing stability, protection, support, rehabilitation and/or unloading a portion of the human anatomy. These devices, however, are often considered as being physically bulky, heavy, and costly requiring numerous manufacturing processes to be produced.
An example of an orthopedic device is a knee brace. As is well understood, knee braces are widely used to treat a variety of knee infirmities. Such braces may be configured to impart forces or leverage on the limbs surrounding the knee joint to relieve compressive forces within a portion of the knee joint, or to reduce the load on that portion of the knee. If knee ligaments are weak and infirm, a knee brace may stabilize, protect, support, unload, and/or rehabilitate the knee.
The knee is acknowledged as one of the weakest joints in the body and serves as the articulating joint between the thigh and calf muscle groups. The knee is held together primarily by small but powerful ligaments. Knee instability arising out of cartilage damage, ligament strain, and other causes is relatively commonplace since the knee joint is subjected to significant loads during the course of almost any physical activity requiring legs.
A healthy knee has an even distribution of pressure in both its medial and lateral compartments. It is normal for a person with a healthy knee to place a varus moment on the knee when standing so pressure between the medial and lateral compartments is uneven but still natural.
Compartmental osteoarthritis is a problematic knee infirmity, and may arise when there is a persistent uneven distribution of pressure in one of the medial and lateral compartments of the knee. Compartmental osteoarthritis can be caused by injury, obesity, misalignment of the knee, or due to aging of the knee. A major problem resulting from osteoarthritis is that smooth cartilage lining the inside of the knee wears away. This leads to a narrowing of the joint space due to the development of cysts and erosions in the bone ends. Because of the narrowing of the joint, bone comes directly in contact with bone, and an uneven distribution of pressure develops across the knee, which may cause the formation of bone spurs around the joint. All of these changes ultimately lead to increasing pain and stiffness of the joint.
While there are no cures to osteoarthritis, there are many treatments. Individuals who have a diagnosis of isolated lateral or medial compartmental osteoarthritis of the knee are confronted with a variety of treatment options such as medications, surgery, and nonsurgical interventions. Nonsurgical interventions include using canes, lateral shoe wedges, and knee braces.
Knee bracing is useful in providing compartment pain relief by reducing the load on the compartment through applying an opposing external valgus or varus moment about the knee joint. Unloading knee braces have been shown to significantly reduce osteoarthritis knee pain while improving knee function. U.S. Pat. No. 5,277,698, granted Jan. 11, 1994, describes a brace having rigid upper and lower cuffs connected to one another by a hinge assembly, and a diagonal or helical dynamic force strap arranged to generate a three-point leverage system that unloads a compartment of the knee. Alternatively, U.S. Pat. No. 7,198,610, granted Apr. 3, 2007, describes a variation of the three-point leverage system in U.S. Pat. No. 5,277,698, including flexible uprights connected by a hinge assembly, and dual dynamic force straps used to disperse counterforces across two points of contact on a leg to unload a compartment of the knee. U.S. Pat. Nos. 5,277,698 and 7,198,610 are incorporated herein by reference in their entirety.
Individuals suffering from osteoarthritis of the knee have varying degrees of discomfort and undergo stages of worsening osteoarthritis. Many of the known unloading braces may be too aggressive, unnecessary for individuals with minor osteoarthritis, moderate or mild knee ligament instabilities, and may require cost-effective solutions. Rather than significant forces urged on the knee by a dynamic unloading strap, the individuals require a combination of support on the knee with some unloading capabilities. Such individuals may require a streamlined brace that is durable while having minimal impact on activities and clothing selections. h is yet further desirable that the knee brace has lightweight shells and the brace can be moderately adjusted for differences in patient anatomy and accommodate a wide range of varus/valgus alignments enabling on-the-fly adjustability for unloading force and compressive forces on the leg and knee.
Various soft-good or sleeve braces exist to assist persons with damaged muscle tissue, cartilage and ligaments in the knee area, but few treat osteoarthritis of the knee, particularly with a dynamic force strap. The sleeve braces often rely on elasticity of the sleeve to snugly hold the knee by enclosing the knee in either a tubular configuration or a wrap-type brace that is openable and wraps about the knee to form a tubular configuration.
An advantage of the soft braces is that the tubular configuration may apply radial compression to the knee, and straps may increase the radial compression on the knee. Disadvantages occur in that the stretchability of the soft braces may be too tight, and either is too restrictive or insufficiently restrictive to movement. Various strapping arrangements have been proposed that attempt to cure the deficiencies but many lack flexibility in strapping along various portions of the leg and insufficiently accommodate a wearer's leg anatomy.
Few knee braces have been able to harmonize effective unloading of the knee in combination with a sleeve-type brace without the necessity of a substantial frame system. In the instance of a dynamic force strap, it has been difficult to present a solution that mitigates rotation and migration of the sleeve from unloading of the knee by a dynamic force strap, while providing therapeutic compression and augmenting the dynamic force strap.